Adalat 5mg Soft Capsules
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have more questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you.
* Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Adalat 5mg soft capsules and will be referred to as Adalat capsules throughout the leaflet.
In this leaflet:
G What Adalat capsules are Q Before you take Adalat capsules G How to take Adalat capsules G Possible side effects G How to store Adalat capsules G Further information
O What Adalat capsules are
Adalat capsules contain nifedipine, which belongs to a group of medicines called calcium antagonists.
Adalat capsules are used to treat high blood pressure, angina (chest pain) or a condition called Raynaud’s phenomenon which causes discolouration (often whitening) of the fingers and toes.
For high blood pressure: Adalat capsules work by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.
For angina: Adalat capsules work by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart.
Adalat capsules can increase the risk of serious heart problems in patients with high blood pressure or angina. Because of this, Adalat capsules are only used in these patients if no other treatments are appropriate.
For Raynaud's phenomenon: Adalat capsules work by relaxing and expanding the blood vessels in the fingers and toes. This helps ensure a good blood supply.
G Before you take Adalat capsules
Do not take Adalat capsules:
* If you have had a heart attack within the last month.
* If you get a sudden angina attack. Adalat capsules will not help relieve symptoms of angina quickly.
* If you have unstable angina.
* If you are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Adalat capsules are listed in section 6.
* If you are pregnant.
* If you are breastfeeding. If you need to take Adalat capsules, you should stop breastfeeding before you start to take this medicine.
* If you are taking rifampicin, an antibiotic.
* If you have been told that you have a narrowing of the aortic heart valve (stenosis).
* If you have ever had a collapse caused by a heart problem
(cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.
* If your blood pressure continues to rise despite treatment (malignant hypertension).
Tell your doctor and do not take Adalat capsules if any of these apply
to you.
Your doctor will take special care:
* If you have low blood pressure. Your blood pressure may be decreased further by this treatment.
* If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).
* If you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor.
* If you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Adalat capsules.
* If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of Adalat capsules.
Talk to your doctor before you take Adalat capsules if any of these apply to you.
Tell your doctor:
* If your chest pain (angina) gets worse (comes on more often or
more severely) over a matter of hours or days. You may be advised not to take Adalat capsules.
* If you have chest pains after taking your first dose of Adalat capsules. Your doctor may wish to change your treatment.
* If you notice increased breathlessness.
* If you notice swelling of the ankles.
Tell your doctor before you take the next dose if any of these apply to you.
Also tell your doctor:
* If you are giving a urine sample. Adalat capsules may interfere with the results of certain urine tests.
* If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Adalat capsules have been shown to impair sperm function.
Other medicines and Adalat capsules
Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.
Some medicines may affect the way Adalat capsules work. Tell your doctor if you are taking:
* Other medicines to treat high blood pressure.
* Rifampicin (an antibiotic).
* Cimetidine (to treat stomach ulcers).
* Digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions).
* Quinupristin/dalfopristin (a combination antibiotic).
* Phenytoin, carbamazepine or valproic acid (to treat epilepsy).
* Cisapride (to treat reduced movements of the gullet and stomach).
* Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).
* Erythromycin (an antibiotic).
* Ketoconazole, itraconazole or fluconazole (anti-fungal medicines).
* Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV).
* Fluoxetine or nefazodone (to treat depression).
* Tacrolimus (to prevent the rejection of transplanted organs).
* Phenobarbital (usually used to treat insomnia or anxiety).
Food and drink with Adalat capsules
You can take Adalat capsules either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat capsules.
Do not start taking Adalat capsules within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Adalat capsules. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.
Pregnancy and breastfeeding
Do not take Adalat capsules if you are pregnant. If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Adalat capsules.
You may be able to use Adalat capsules after week 20 of your pregnancy, but only after special consideration and agreement by your doctor.
Do not take Adalat capsules if you are breastfeeding. If you need to take Adalat capsules, you should stop breastfeeding before you start taking the tablets.
Driving and using machines
Adalat capsules may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way.
This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.
G How to take Adalat capsules
Take the capsules as prescribed by your doctor.
* The recommended starting dose is one 5 mg capsule every 8 hours. This allows your doctor to monitor how you are responding so that the best long-term dose can be identified.
* The dose can be increased to a maximum of 20 mg every 8 hours.
* Lower doses may be prescribed for elderly patients or for patients who have liver problems.
* Swallow the capsules whole with a little water.
* Continue to take the capsules for as long as your doctor has told you to.
Patient Information Leaflet (continued)
Do not take them with grapefruit juice.
You can take Adalat capsules either with or without food.
Use in children: Adalat capsules are not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population.
If you take too many capsules
Get medical help immediately. If possible, take your capsules or the box with you to show the doctor.
Taking too many capsules may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.
If you forget to take the capsules
Take your normal dose immediately and continue taking your capsules as prescribed, waiting 8 hours before taking your next dose.
Do not take a double dose to make up for the missed dose.
O Possible side effects
Like all medicines, Adalat capsules can have side effects, although not everybody gets them.
Serious side effects If you notice:
* severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) or swelling (including potentially lifethreatening swelling of the airway)
* other allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life threatening outcome)
* fast heart beat (tachycardia)
* shortness of breath or difficulty breathing
* mild to moderate allergic reactions
* itching (possibly severe), a rash or hives
Contact your doctor immediately and do not take the next dose as
these may be the first signs of allergic reaction which may become severe.
If you develop:
* a skin reaction or blistering/peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis)
Contact your doctor immediately before you continue treatment as
these may be signs of a severe reaction.
Less serious side effects
Apart from the side effects listed above, these are the other side effects of Adalat capsules, starting with the more common ones:
Common side effects
(These may affect up to 1 in 10 people)
* headache
* flushing
* general feeling of being unwell
* constipation
* swelling, particularly of the ankles and legs
Uncommon side effects
(These may affect up to 1 in 100 people)
* stomach pain (abdominal pain)
* unspecific pain
* chills
* low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)
* fainting
* irregular heartbeat (palpitations)
* dry mouth
* indigestion or upset stomach
* wind (flatulence)
* feeling sick (nausea)
* muscle cramps
* joint swelling
* sleep disorders
* anxiety or nervousness
* reddening of the skin
* nose bleeds
* nasal congestion
* sensation of spinning or whirling motion (vertigo)
* migraine
* dizziness
* trembling
* increase in the need to pass water (urinate)
* painful or difficult urination
* inability to achieve or maintain an erection (impotence)
* blurred vision
* temporary increase in certain liver enzymes Rare side effects
(These may affect up to 1 in 1,000 people)
* pins and needles
* inflammation of the gums, tender or swollen gums, bleeding gums
Other side effects
(Frequency unknown)
* vomiting
* a reduction in the number of white blood cells (leucopenia)
* a more severe decrease in a specific class of white blood cell (agranulocytosis)
* increased blood sugar (hyperglycaemia)
* decreased skin sensitivity (hypoaesthesia)
* drowsiness (somnolence)
* eye pain
* chest pain (angina pectoris)
* heartburn or indigestion (gastroesophageal sphincter insufficiency)
* yellowing of the whites of the eyes or skin (jaundice)
* sensitivity to light (photosensitivity allergic reaction)
* small, raised areas of bleeding in the skin (palpable purpura)
* joint pain
* muscle pain
All of these symptoms usually go away when treatment with Adalat capsules is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
G How to store Adalat capsules
Keep out of the sight and reach of children.
Store your medicine in its original container.
Protect from strong light and only remove the capsule from the blister strip when you are about to take it.
Do not store above 30°C.
Do not use after the expiry date which is marked on both the outer carton and on each blister strip of capsules.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do. Medicines should not be disposed of via waterwaste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
G Further information
What Adalat capsules contain
Adalat capsules contain the active ingredient, nifedipine.
Adalat capsules also contain glycerol, purified water, saccharin sodium, peppermint oil and macrogol 400.
The capsule shell contains gelatine, glycerol, titanium dioxide (E171) and Sunset yellow (E110).
Sunset yellow (E110) may cause allergic reactions.
What Adalat capsules looks like and contents of the pack
Orange, softgel capsule (3 minims oval) containing a yellow viscous fluid. Each pack contains 90 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Healthcare Manufacturing S.r.l., Via Delle Groane, 126 20024 Garbagnate Milanese, Italy and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0rE.
[POMl PL 33723/0198 Adalat 5mg soft capsules
Adalat is a registered trademark of Bayer Aktiengesellschaft.
Revision date: 08/04/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have more questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you.
* Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Nifedipine 5mg soft capsules and will be referred to as Nifedipine capsules throughout the leaflet.
In this leaflet:
G What Nifedipine capsules are G Before you take Nifedipine capsules G How to take Nifedipine capsules G Possible side effects G How to store Nifedipine capsules G Further information
O What Nifedipine capsules are
Nifedipine capsules contain nifedipine, which belongs to a group of medicines called calcium antagonists.
Nifedipine capsules are used to treat high blood pressure, angina (chest pain) or a condition called Raynaud’s phenomenon which causes discolouration (often whitening) of the fingers and toes.
For high blood pressure: Nifedipine capsules work by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.
For angina: Nifedipine capsules work by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart.
Nifedipine capsules can increase the risk of serious heart problems in patients with high blood pressure or angina. Because of this, Nifedipine capsules are only used in these patients if no other treatments are appropriate.
For Raynaud's phenomenon: Nifedipine capsules work by relaxing and expanding the blood vessels in the fingers and toes. This helps ensure a good blood supply.
G Before you take Nifedipine capsules
Do not take Nifedipine capsules:
* If you have had a heart attack within the last month.
* If you get a sudden angina attack. Nifedipine capsules will not help relieve symptoms of angina quickly.
* If you have unstable angina.
* If you are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Nifedipine capsules are listed in section 6.
* If you are pregnant.
* If you are breastfeeding. If you need to take Nifedipine capsules, you should stop breastfeeding before you start to take this medicine.
* If you are taking rifampicin, an antibiotic.
* If you have been told that you have a narrowing of the aortic heart valve (stenosis).
* If you have ever had a collapse caused by a heart problem
(cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.
* If your blood pressure continues to rise despite treatment (malignant hypertension).
Tell your doctor and do not take Nifedipine capsules if any of these
apply to you.
Your doctor will take special care:
* If you have low blood pressure. Your blood pressure may be decreased further by this treatment.
* If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).
* If you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor.
* If you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Nifedipine capsules.
* If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of Nifedipine capsules.
Talk to your doctor before you take Nifedipine capsules if any of these apply to you.
Tell your doctor:
* If your chest pain (angina) gets worse (comes on more often or
more severely) over a matter of hours or days. You may be advised not to take Nifedipine capsules.
* If you have chest pains after taking your first dose of Nifedipine capsules. Your doctor may wish to change your treatment.
* If you notice increased breathlessness.
* If you notice swelling of the ankles.
Tell your doctor before you take the next dose if any of these apply to you.
Also tell your doctor:
* If you are giving a urine sample. Nifedipine capsules may interfere with the results of certain urine tests.
* If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Nifedipine capsules have been shown to impair sperm function.
Other medicines and Nifedipine capsules
Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.
Some medicines may affect the way Nifedipine capsules work. Tell your doctor if you are taking:
* Other medicines to treat high blood pressure.
* Rifampicin (an antibiotic).
* Cimetidine (to treat stomach ulcers).
* Digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions).
* Quinupristin/dalfopristin (a combination antibiotic).
* Phenytoin, carbamazepine or valproic acid (to treat epilepsy).
* Cisapride (to treat reduced movements of the gullet and stomach).
* Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).
* Erythromycin (an antibiotic).
* Ketoconazole, itraconazole or fluconazole (anti-fungal medicines).
* Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV).
* Fluoxetine or nefazodone (to treat depression).
* Tacrolimus (to prevent the rejection of transplanted organs).
* Phenobarbital (usually used to treat insomnia or anxiety).
Food and drink with Nifedipine capsules
You can take Nifedipine capsules either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Nifedipine capsules.
Do not start taking Nifedipine capsules within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Nifedipine capsules. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.
Pregnancy and breastfeeding
Do not take Nifedipine capsules if you are pregnant. If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Nifedipine capsules.
You may be able to use Nifedipine capsules after week 20 of your pregnancy, but only after special consideration and agreement by your doctor.
Do not take Nifedipine capsules if you are breastfeeding. If you need to take Nifedipine capsules, you should stop breastfeeding before you start taking the tablets.
Driving and using machines
Nifedipine capsules may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way.
This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.
G How to take Nifedipine capsules
Take the capsules as prescribed by your doctor.
* The recommended starting dose is one 5 mg capsule every 8 hours. This allows your doctor to monitor how you are responding so that the best long-term dose can be identified.
* The dose can be increased to a maximum of 20 mg every 8 hours.
* Lower doses may be prescribed for elderly patients or for patients who have liver problems.
* Swallow the capsules whole with a little water.
* Continue to take the capsules for as long as your doctor has told you to.
Patient Information Leaflet (continued)
Do not take them with grapefruit juice.
You can take Nifedipine capsules either with or without food.
Use in children: Nifedipine capsules are not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population.
If you take too many capsules
Get medical help immediately. If possible, take your capsules or the box with you to show the doctor.
Taking too many capsules may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.
If you forget to take the capsules
Take your normal dose immediately and continue taking your capsules as prescribed, waiting 8 hours before taking your next dose.
Do not take a double dose to make up for the missed dose.
O Possible side effects
Like all medicines, Nifedipine capsules can have side effects, although not everybody gets them.
Serious side effects If you notice:
* severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) or swelling (including potentially lifethreatening swelling of the airway)
* other allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life threatening outcome)
* fast heart beat (tachycardia)
* shortness of breath or difficulty breathing
* mild to moderate allergic reactions
* itching (possibly severe), a rash or hives
Contact your doctor immediately and do not take the next dose as
these may be the first signs of allergic reaction which may become severe.
If you develop:
* a skin reaction or blistering/peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis)
Contact your doctor immediately before you continue treatment as
these may be signs of a severe reaction.
Less serious side effects
Apart from the side effects listed above, these are the other side effects of Nifedipine capsules, starting with the more common ones:
Common side effects
(These may affect up to 1 in 10 people)
* headache
* flushing
* general feeling of being unwell
* constipation
* swelling, particularly of the ankles and legs
Uncommon side effects
(These may affect up to 1 in 100 people)
* stomach pain (abdominal pain)
* unspecific pain
* chills
* low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)
* fainting
* irregular heartbeat (palpitations)
* dry mouth
* indigestion or upset stomach
* wind (flatulence)
* feeling sick (nausea)
* muscle cramps
* joint swelling
* sleep disorders
* anxiety or nervousness
* reddening of the skin
* nose bleeds
* nasal congestion
* sensation of spinning or whirling motion (vertigo)
* migraine
* dizziness
* trembling
* increase in the need to pass water (urinate)
* painful or difficult urination
* inability to achieve or maintain an erection (impotence)
* blurred vision
* temporary increase in certain liver enzymes Rare side effects
(These may affect up to 1 in 1,000 people)
* pins and needles
* inflammation of the gums, tender or swollen gums, bleeding gums
Other side effects
(Frequency unknown)
* vomiting
* a reduction in the number of white blood cells (leucopenia)
* a more severe decrease in a specific class of white blood cell (agranulocytosis)
* increased blood sugar (hyperglycaemia)
* decreased skin sensitivity (hypoaesthesia)
* drowsiness (somnolence)
* eye pain
* chest pain (angina pectoris)
* heartburn or indigestion (gastroesophageal sphincter insufficiency)
* yellowing of the whites of the eyes or skin (jaundice)
* sensitivity to light (photosensitivity allergic reaction)
* small, raised areas of bleeding in the skin (palpable purpura)
* joint pain
* muscle pain
All of these symptoms usually go away when treatment with Nifedipine capsules is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
G How to store Nifedipine capsules
Keep out of the sight and reach of children.
Store your medicine in its original container.
Protect from strong light and only remove the capsule from the blister strip when you are about to take it.
Do not store above 30°C.
Do not use after the expiry date which is marked on both the outer carton and on each blister strip of capsules.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do. Medicines should not be disposed of via waterwaste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
G Further information
What Nifedipine capsules contain
Nifedipine capsules contain the active ingredient, nifedipine.
Nifedipine capsules also contain glycerol, purified water, saccharin sodium, peppermint oil and macrogol 400.
The capsule shell contains gelatine, glycerol, titanium dioxide (E171) and Sunset yellow (E110).
Sunset yellow (E110) may cause allergic reactions.
What Nifedipine capsules looks like and contents of the pack
Orange, softgel capsule (3 minims oval) containing a yellow viscous fluid. Each pack contains 84 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Healthcare Manufacturing S.r.l., Via Delle Groane, 126 20024 Garbagnate Milanese, Italy and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.
IPOMI PL 33723/0198 Nifedipine 5mg soft capsules
Revision date: 08/04/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have more questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you.
* Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Adalat 5mg soft capsules and will be referred to as Adalat capsules throughout the leaflet.
In this leaflet:
G What Adalat capsules are Q Before you take Adalat capsules G How to take Adalat capsules G Possible side effects G How to store Adalat capsules G Further information
O What Adalat capsules are
Adalat capsules contain nifedipine, which belongs to a group of medicines called calcium antagonists.
Adalat capsules are used to treat high blood pressure, angina (chest pain) or a condition called Raynaud’s phenomenon which causes discolouration (often whitening) of the fingers and toes.
For high blood pressure: Adalat capsules work by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.
For angina: Adalat capsules work by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart.
Adalat capsules can increase the risk of serious heart problems in patients with high blood pressure or angina. Because of this, Adalat capsules are only used in these patients if no other treatments are appropriate.
For Raynaud's phenomenon: Adalat capsules work by relaxing and expanding the blood vessels in the fingers and toes. This helps ensure a good blood supply.
G Before you take Adalat capsules
Do not take Adalat capsules:
* If you have had a heart attack within the last month.
* If you get a sudden angina attack. Adalat capsules will not help relieve symptoms of angina quickly.
* If you have unstable angina.
* If you are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Adalat capsules are listed in section 6.
* If you are pregnant.
* If you are breastfeeding. If you need to take Adalat capsules, you should stop breastfeeding before you start to take this medicine.
* If you are taking rifampicin, an antibiotic.
* If you have been told that you have a narrowing of the aortic heart valve (stenosis).
* If you have ever had a collapse caused by a heart problem
(cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.
* If your blood pressure continues to rise despite treatment (malignant hypertension).
Tell your doctor and do not take Adalat capsules if any of these apply
to you.
Your doctor will take special care:
* If you have low blood pressure. Your blood pressure may be decreased further by this treatment.
* If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).
* If you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor.
* If you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Adalat capsules.
* If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of Adalat capsules.
Talk to your doctor before you take Adalat capsules if any of these apply to you.
Tell your doctor:
* If your chest pain (angina) gets worse (comes on more often or
more severely) over a matter of hours or days. You may be advised not to take Adalat capsules.
* If you have chest pains after taking your first dose of Adalat capsules. Your doctor may wish to change your treatment.
* If you notice increased breathlessness.
* If you notice swelling of the ankles.
Tell your doctor before you take the next dose if any of these apply to you.
Also tell your doctor:
* If you are giving a urine sample. Adalat capsules may interfere with the results of certain urine tests.
* If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Adalat capsules have been shown to impair sperm function.
Other medicines and Adalat capsules
Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.
Some medicines may affect the way Adalat capsules work. Tell your doctor if you are taking:
* Other medicines to treat high blood pressure.
* Rifampicin (an antibiotic).
* Cimetidine (to treat stomach ulcers).
* Digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions).
* Quinupristin/dalfopristin (a combination antibiotic).
* Phenytoin, carbamazepine or valproic acid (to treat epilepsy).
* Cisapride (to treat reduced movements of the gullet and stomach).
* Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).
* Erythromycin (an antibiotic).
* Ketoconazole, itraconazole or fluconazole (anti-fungal medicines).
* Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV).
* Fluoxetine or nefazodone (to treat depression).
* Tacrolimus (to prevent the rejection of transplanted organs).
* Phenobarbital (usually used to treat insomnia or anxiety).
Food and drink with Adalat capsules
You can take Adalat capsules either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat capsules.
Do not start taking Adalat capsules within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Adalat capsules. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.
Pregnancy and breastfeeding
Do not take Adalat capsules if you are pregnant. If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Adalat capsules.
You may be able to use Adalat capsules after week 20 of your pregnancy, but only after special consideration and agreement by your doctor.
Do not take Adalat capsules if you are breastfeeding. If you need to take Adalat capsules, you should stop breastfeeding before you start taking the tablets.
Driving and using machines
Adalat capsules may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way.
This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.
G How to take Adalat capsules
Take the capsules as prescribed by your doctor.
* The recommended starting dose is one 5 mg capsule every 8 hours. This allows your doctor to monitor how you are responding so that the best long-term dose can be identified.
* The dose can be increased to a maximum of 20 mg every 8 hours.
* Lower doses may be prescribed for elderly patients or for patients who have liver problems.
* Swallow the capsules whole with a little water.
* Continue to take the capsules for as long as your doctor has told you to.
Patient Information Leaflet (continued)
Do not take them with grapefruit juice.
You can take Adalat capsules either with or without food.
Use in children: Adalat capsules are not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population.
If you take too many capsules
Get medical help immediately. If possible, take your capsules or the box with you to show the doctor.
Taking too many capsules may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.
If you forget to take the capsules
Take your normal dose immediately and continue taking your capsules as prescribed, waiting 8 hours before taking your next dose.
Do not take a double dose to make up for the missed dose.
O Possible side effects
Like all medicines, Adalat capsules can have side effects, although not everybody gets them.
Serious side effects If you notice:
* severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) or swelling (including potentially lifethreatening swelling of the airway)
* other allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life threatening outcome)
* fast heart beat (tachycardia)
* shortness of breath or difficulty breathing
* mild to moderate allergic reactions
* itching (possibly severe), a rash or hives
Contact your doctor immediately and do not take the next dose as
these may be the first signs of allergic reaction which may become severe.
If you develop:
* a skin reaction or blistering/peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis)
Contact your doctor immediately before you continue treatment as
these may be signs of a severe reaction.
Less serious side effects
Apart from the side effects listed above, these are the other side effects of Adalat capsules, starting with the more common ones:
Common side effects
(These may affect up to 1 in 10 people)
* headache
* flushing
* general feeling of being unwell
* constipation
* swelling, particularly of the ankles and legs
Uncommon side effects
(These may affect up to 1 in 100 people)
* stomach pain (abdominal pain)
* unspecific pain
* chills
* low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)
* fainting
* irregular heartbeat (palpitations)
* dry mouth
* indigestion or upset stomach
* wind (flatulence)
* feeling sick (nausea)
* muscle cramps
* joint swelling
* sleep disorders
* anxiety or nervousness
* reddening of the skin
* nose bleeds
* nasal congestion
* sensation of spinning or whirling motion (vertigo)
* migraine
* dizziness
* trembling
* increase in the need to pass water (urinate)
* painful or difficult urination
* inability to achieve or maintain an erection (impotence)
* blurred vision
* temporary increase in certain liver enzymes Rare side effects
(These may affect up to 1 in 1,000 people)
* pins and needles
* inflammation of the gums, tender or swollen gums, bleeding gums
Other side effects
(Frequency unknown)
* vomiting
* a reduction in the number of white blood cells (leucopenia)
* a more severe decrease in a specific class of white blood cell (agranulocytosis)
* increased blood sugar (hyperglycaemia)
* decreased skin sensitivity (hypoaesthesia)
* drowsiness (somnolence)
* eye pain
* chest pain (angina pectoris)
* heartburn or indigestion (gastroesophageal sphincter insufficiency)
* yellowing of the whites of the eyes or skin (jaundice)
* sensitivity to light (photosensitivity allergic reaction)
* small, raised areas of bleeding in the skin (palpable purpura)
* joint pain
* muscle pain
All of these symptoms usually go away when treatment with Adalat capsules is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
G How to store Adalat capsules
Keep out of the sight and reach of children.
Store your medicine in its original container.
Protect from strong light and only remove the capsule from the blister strip when you are about to take it.
Do not store above 30°C.
Do not use after the expiry date which is marked on both the outer carton and on each blister strip of capsules.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do. Medicines should not be disposed of via waterwaste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
G Further information
What Adalat capsules contain
Adalat capsules contain the active ingredient, nifedipine.
Adalat capsules also contain glycerol, purified water, saccharin sodium, peppermint oil and macrogol 400.
The capsule shell contains gelatine, glycerol, titanium dioxide (E171) and Sunset yellow (E110).
Sunset yellow (E110) may cause allergic reactions.
What Adalat capsules looks like and contents of the pack
Orange, softgel capsule (3 minims oval) containing a yellow viscous fluid. Each pack contains 90 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Pharma AG, D-51368 Leverkusen, Germany and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.
[POMl PL 33723/0198 Adalat 5mg soft capsules
Adalat is a registered trademark of Bayer Aktiengesellschaft.
Revision date: 08/04/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have more questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you.
* Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Nifedipine 5mg soft capsules and will be referred to as Nifedipine capsules throughout the leaflet.
In this leaflet:
G What Nifedipine capsules are G Before you take Nifedipine capsules G How to take Nifedipine capsules G Possible side effects G How to store Nifedipine capsules G Further information
O What Nifedipine capsules are
Nifedipine capsules contain nifedipine, which belongs to a group of medicines called calcium antagonists.
Nifedipine capsules are used to treat high blood pressure, angina (chest pain) or a condition called Raynaud’s phenomenon which causes discolouration (often whitening) of the fingers and toes.
For high blood pressure: Nifedipine capsules work by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.
For angina: Nifedipine capsules work by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart.
Nifedipine capsules can increase the risk of serious heart problems in patients with high blood pressure or angina. Because of this, Nifedipine capsules are only used in these patients if no other treatments are appropriate.
For Raynaud's phenomenon: Nifedipine capsules work by relaxing and expanding the blood vessels in the fingers and toes. This helps ensure a good blood supply.
G Before you take Nifedipine capsules
Do not take Nifedipine capsules:
* If you have had a heart attack within the last month.
* If you get a sudden angina attack. Nifedipine capsules will not help relieve symptoms of angina quickly.
* If you have unstable angina.
* If you are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Nifedipine capsules are listed in section 6.
* If you are pregnant.
* If you are breastfeeding. If you need to take Nifedipine capsules, you should stop breastfeeding before you start to take this medicine.
* If you are taking rifampicin, an antibiotic.
* If you have been told that you have a narrowing of the aortic heart valve (stenosis).
* If you have ever had a collapse caused by a heart problem
(cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.
* If your blood pressure continues to rise despite treatment (malignant hypertension).
Tell your doctor and do not take Nifedipine capsules if any of these
apply to you.
Your doctor will take special care:
* If you have low blood pressure. Your blood pressure may be decreased further by this treatment.
* If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).
* If you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor.
* If you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Nifedipine capsules.
* If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of Nifedipine capsules.
Talk to your doctor before you take Nifedipine capsules if any of these apply to you.
Tell your doctor:
* If your chest pain (angina) gets worse (comes on more often or
more severely) over a matter of hours or days. You may be advised not to take Nifedipine capsules.
* If you have chest pains after taking your first dose of Nifedipine capsules. Your doctor may wish to change your treatment.
* If you notice increased breathlessness.
* If you notice swelling of the ankles.
Tell your doctor before you take the next dose if any of these apply to you.
Also tell your doctor:
* If you are giving a urine sample. Nifedipine capsules may interfere with the results of certain urine tests.
* If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Nifedipine capsules have been shown to impair sperm function.
Other medicines and Nifedipine capsules
Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.
Some medicines may affect the way Nifedipine capsules work. Tell your doctor if you are taking:
* Other medicines to treat high blood pressure.
* Rifampicin (an antibiotic).
* Cimetidine (to treat stomach ulcers).
* Digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions).
* Quinupristin/dalfopristin (a combination antibiotic).
* Phenytoin, carbamazepine or valproic acid (to treat epilepsy).
* Cisapride (to treat reduced movements of the gullet and stomach).
* Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).
* Erythromycin (an antibiotic).
* Ketoconazole, itraconazole or fluconazole (anti-fungal medicines).
* Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV).
* Fluoxetine or nefazodone (to treat depression).
* Tacrolimus (to prevent the rejection of transplanted organs).
* Phenobarbital (usually used to treat insomnia or anxiety).
Food and drink with Nifedipine capsules
You can take Nifedipine capsules either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Nifedipine capsules.
Do not start taking Nifedipine capsules within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Nifedipine capsules. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.
Pregnancy and breastfeeding
Do not take Nifedipine capsules if you are pregnant. If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Nifedipine capsules.
You may be able to use Nifedipine capsules after week 20 of your pregnancy, but only after special consideration and agreement by your doctor.
Do not take Nifedipine capsules if you are breastfeeding. If you need to take Nifedipine capsules, you should stop breastfeeding before you start taking the tablets.
Driving and using machines
Nifedipine capsules may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way.
This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.
G How to take Nifedipine capsules
Take the capsules as prescribed by your doctor.
* The recommended starting dose is one 5 mg capsule every 8 hours. This allows your doctor to monitor how you are responding so that the best long-term dose can be identified.
* The dose can be increased to a maximum of 20 mg every 8 hours.
* Lower doses may be prescribed for elderly patients or for patients who have liver problems.
* Swallow the capsules whole with a little water.
* Continue to take the capsules for as long as your doctor has told you to.
Patient Information Leaflet (continued)
Do not take them with grapefruit juice.
You can take Nifedipine capsules either with or without food.
Use in children: Nifedipine capsules are not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population.
If you take too many capsules
Get medical help immediately. If possible, take your capsules or the box with you to show the doctor.
Taking too many capsules may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.
If you forget to take the capsules
Take your normal dose immediately and continue taking your capsules as prescribed, waiting 8 hours before taking your next dose.
Do not take a double dose to make up for the missed dose.
O Possible side effects
Like all medicines, Nifedipine capsules can have side effects, although not everybody gets them.
Serious side effects If you notice:
* severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) or swelling (including potentially lifethreatening swelling of the airway)
* other allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life threatening outcome)
* fast heart beat (tachycardia)
* shortness of breath or difficulty breathing
* mild to moderate allergic reactions
* itching (possibly severe), a rash or hives
Contact your doctor immediately and do not take the next dose as
these may be the first signs of allergic reaction which may become severe.
If you develop:
* a skin reaction or blistering/peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis)
Contact your doctor immediately before you continue treatment as
these may be signs of a severe reaction.
Less serious side effects
Apart from the side effects listed above, these are the other side effects of Nifedipine capsules, starting with the more common ones:
Common side effects
(These may affect up to 1 in 10 people)
* headache
* flushing
* general feeling of being unwell
* constipation
* swelling, particularly of the ankles and legs
Uncommon side effects
(These may affect up to 1 in 100 people)
* stomach pain (abdominal pain)
* unspecific pain
* chills
* low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)
* fainting
* irregular heartbeat (palpitations)
* dry mouth
* indigestion or upset stomach
* wind (flatulence)
* feeling sick (nausea)
* muscle cramps
* joint swelling
* sleep disorders
* anxiety or nervousness
* reddening of the skin
* nose bleeds
* nasal congestion
* sensation of spinning or whirling motion (vertigo)
* migraine
* dizziness
* trembling
* increase in the need to pass water (urinate)
* painful or difficult urination
* inability to achieve or maintain an erection (impotence)
* blurred vision
* temporary increase in certain liver enzymes Rare side effects
(These may affect up to 1 in 1,000 people)
* pins and needles
* inflammation of the gums, tender or swollen gums, bleeding gums
Other side effects
(Frequency unknown)
* vomiting
* a reduction in the number of white blood cells (leucopenia)
* a more severe decrease in a specific class of white blood cell (agranulocytosis)
* increased blood sugar (hyperglycaemia)
* decreased skin sensitivity (hypoaesthesia)
* drowsiness (somnolence)
* eye pain
* chest pain (angina pectoris)
* heartburn or indigestion (gastroesophageal sphincter insufficiency)
* yellowing of the whites of the eyes or skin (jaundice)
* sensitivity to light (photosensitivity allergic reaction)
* small, raised areas of bleeding in the skin (palpable purpura)
* joint pain
* muscle pain
All of these symptoms usually go away when treatment with Nifedipine capsules is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
G How to store Nifedipine capsules
Keep out of the sight and reach of children.
Store your medicine in its original container.
Protect from strong light and only remove the capsule from the blister strip when you are about to take it.
Do not store above 30°C.
Do not use after the expiry date which is marked on both the outer carton and on each blister strip of capsules.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do. Medicines should not be disposed of via waterwaste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
G Further information
What Nifedipine capsules contain
Nifedipine capsules contain the active ingredient, nifedipine.
Nifedipine capsules also contain glycerol, purified water, saccharin sodium, peppermint oil and macrogol 400.
The capsule shell contains gelatine, glycerol, titanium dioxide (E171) and Sunset yellow (E110).
Sunset yellow (E110) may cause allergic reactions.
What Nifedipine capsules looks like and contents of the pack
Orange, softgel capsule (3 minims oval) containing a yellow viscous fluid. Each pack contains 84 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Pharma AG, D-51368 Leverkusen, Germany and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0Re.
IPOMI PL 33723/0198 Nifedipine 5mg soft capsules
Revision date: 08/04/14