Adalat 10mg Soft Capsules
Adalat ® 10mg Soft Capsules
(nifedipine)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important infromation for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only.
* Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Adalat 10mg Soft Capsules but will be referred to as Adalat capsules throughout the rest of this leaflet.
What is in this leaflet
^ What Adalat capsules are and what they are used for ^ What you need to know before you take Adalat capsules ^ How to take Adalat capsules ^ Possible side effects ^ How to store Adalat capsules
Contents of the pack and other information
Ref: 1515/180116/1/F
[1) What Adalat capsules are and what they are used for
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.
[2) What you need to know 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 nifedipine, any other similar medicines (known as dihydropyridines) or any of the other ingredients of this medicine (listed in section 6).
* 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.
Warnings and precautions
Talk to your doctor before taking Adalat capsules
* 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 pregnant.
* If you are breast-feeding.
* 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 if you are taking, have recently taken or might take any other medicines.
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).
Adalat capsules with food and drink
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 breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
You may be able to use Adalat capsules but only after special consideration and agreement by your doctor.
Do not take Adalat capsules if you are breast-feeding. If you need to take Adalat capsules while breast-feeding, tell your doctor before taking this medicine.
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.
Adalat capsules contains Yellow orange S (E110)
May cause allergic reactions.
How to take Adalat capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
* To start with, you may be given a lower strength (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 older 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.
Do not take them with grapefruit juice.
You can take Adalat capsules either with or without food.
Use in children and adolescents: 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.
|
Adalat ® 10mg soft capsules |
Ref: 1515/180116/1/B |
|
(nifedipine) | |
|
Patient Information Leaflet (continued) | |
|
If you take more Adalat capsules than you should |
Rare side effects |
|
(These may affect up to 1 in 1,000 people) | |
|
^ Get medical help immediately. If possible, take your capsules or the box |
* pins and needles |
|
with you to show the doctor. |
* inflammation of the gums, tender or swollen gums, bleeding gums |
|
Taking too many capsules may cause your blood pressure to become too |
Other side effects |
|
low and your heartbeats to speed up or slow down. It may also lead to an |
(Frequency not known: frequency cannot be estimated from the available |
|
increase in your blood sugar level or an increase in the acidity of your blood, |
data) |
|
swelling in the lungs, low blood oxygen levels and disturbances in |
* vomiting. |
|
consciousness, possibly leading to unconsciousness. |
* a reduction in the number of white blood cells (leucopenia) |
|
* a more severe decrease in a specific class of white blood cell | |
|
If you forget to take Adalat capsules |
(agranulocytosis) |
|
Take your normal dose immediately and continue taking your capsules as |
* increased blood sugar (hyperglycaemia) |
|
prescribed, waiting 8 hours before taking your next dose. |
* decreased skin sensitivity (hypoaesthesia) |
|
Do not take a double dose to make up for a forgotten dose. |
* drowsiness (somnolence) |
|
If you have any further questions on the use of this medicine, ask your |
* eye pain |
|
doctor. |
* 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) | |
|
■ 4 Possible side effects |
* small, raised areas of bleeding in the skin (palpable purpura) |
|
* joint pain | |
|
* muscle pain | |
|
Like all medicines, this medicine can cause side effects, although not | |
|
everybody gets them. |
All of these symptoms usually go away when treatment with Adalat capsules |
|
is stopped. | |
|
Serious side effects: | |
|
If you notice: |
Reporting of side effects |
|
* severe, sudden generalised allergic reaction including very rarely |
If you get any side effects, talk to your doctor or pharmacist. This includes |
|
life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, |
any possible side effects not listed in this leaflet. You can also report side |
|
fast pulse) or swelling (including potentially life-threatening swelling of the |
effects directly (see details below). By reporting side effects you can help |
|
airway) |
provide more information on the safety of this medicine. |
|
* other allergic reactions causing swelling under the skin (possibly severe |
United Kingdom |
|
and including swelling of the larynx that may result in a life-threatening |
Yellow Card Scheme |
|
outcome) |
We bsite: www. mhra.gov.u k/yellowcard |
|
* fast heart beat (tachycardia) | |
|
* shortness of breath or difficulty breathing | |
|
* mild to moderate allergic reactions |
M5> How to store Adalat capsules |
|
* itching (possibly severe), a rash or hives | |
|
* Keep out of the sight and reach of children. | |
|
Contact your doctor immediately and do not take the next dose as |
* Do not store above 30°C. |
|
these may be the first signs of allergic reaction which may become |
* Store your medicine in the original package. |
|
severe. |
* Protect from light. |
|
* Do not take Adalat capsules after the expiry date stated on blister label or | |
|
If you develop: |
carton. The expiry date refers to the last day of that month. |
|
* a skin reaction or blistering / peeling of the skin and/or mucosal reactions |
* If your medicine becomes discoloured or show any other signs of |
|
(in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis) |
deterioration, ask your pharmacist who will advise you what to do. |
|
* Medicines should not be disposed of via wastewater or household waste. | |
|
^ Contact your doctor immediately before you continue treatment as |
Ask your pharmacist how to dispose of medicines no longer required. |
|
these may be signs of a severe reaction. |
These measures will help to protect the environment. |
|
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: |
V6) Contents of the pack and other information |
|
Common side effects |
What Adalat capsules contain |
|
(These may affect up to 1 in 10 people) |
The active ingredient Nifedipine |
|
* headache |
Each capsule contains 10mg nifedipine. |
|
* flushing |
Also contains glycerol, purified water, saccharin sodium, |
|
* general feeling of being unwell |
peppermint oil and macrogol 400. |
|
* constipation |
The capsule shell contains gelatine, glycerol 85%, titanium dioxide (E171) |
|
* swelling, particularly of the ankles and legs |
and yellow orange S (E110). |
|
Uncommon side effects |
What Adalat capsules looks like and contents of the pack |
|
(These may affect up to 1 in 100 people) |
Orange, oblong soft gel capsule containing a yellow viscous fluid. |
|
* stomach pain (abdominal pain) |
Each pack contains 90 soft capsules. |
|
* unspecific pain | |
|
* chills |
Manufacturer and Licence Holder |
|
* low blood pressure when standing up (symptoms include fainting, |
Manufactured by Bayer Pharma AG, D-51368 Leverkusen Germany and is |
|
dizziness, light headedness, occasional palpitations, blurred vision and |
procured from within the EU and repackaged by the Product Licence Holder: |
|
sometimes confusion) |
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, |
|
* fainting |
Worcestershire, B98 0RE. |
|
* irregular heartbeat (palpitations) | |
|
* dry mouth |
POM PL 15184/1515 Adalat 10mg soft capsules |
|
* indigestion or upset stomach | |
|
* wind (flatulence) |
Adalat is a registered trademark of Bayer Aktiengesellschaft. |
|
* feeling sick (nausea) | |
|
* muscle cramps |
Revision date: 18/01/16 |
|
* joint swelling | |
|
* sleep disorders * anxiety or nervousness |
Blind or partially sighted? |
|
* reddening of the skin |
Is this leaflet hard to see or read? |
|
* nose bleeds * nasal congestion |
Phone Lexon UK Ltd, Tel: 01527 505414 |
|
* sensation of spinning or whirling motion (vertigo) |
for help. |
|
* 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 |
Ref: 1515/180116/2/F
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important infromation for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only.
* Do not pass it on to others. It may harm them, even if their sigs of illness are the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Nifedipine 10mg Soft Capsules but will be referred to as Nifedipine capsules throughout the rest of this leaflet.
What is in this leaflet
^ What Nifedipine capsules are and what they are used for ^ What you need to know before you take Nifedipine capsules ^ How to take Nifedipine capsules ^ Possible side effects ^ How to store Nifedipine capsules
Contents of the pack and other information
What Nifedipine capsules are and what they are used for
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.
What you need to know 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 nifedipine, any other similar medicines (known as dihydropyridines) or any of the other ingredients of this medicine (listed in section 6).
* 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.
Warnings and precautions
Talk to your doctor before taking Nifedipine capsules
* 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 pregnant.
* If you are breast-feeding.
* 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.
* 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 if you are taking, have recently taken or might take any other medicines.
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).
Nifedipine capsules with food and drink
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 breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
You may be able to use Nifedipine capsules but only after special consideration and agreement by your doctor.
Do not take Nifedipine capsules if you are breast-feeding. If you need to take Nifedipine capsules while breast-feeding, tell your doctor before taking this medicine.
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.
Nifedipine capsules contains Yellow orange S (E110)
May cause allergic reactions.
[3) How to take Nifedipine capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
* To start with, you may be given a lower strength (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 older 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.
Do not take them with grapefruit juice.
You can take Nifedipine capsules either with or without food.
Use in children and adolescents: 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.
|
Nifedipine 10mg soft capsules |
Ref: 1515/180116/2/B |
|
Patient Information Leaflet (continued) | |
|
If you take more Nifedipine capsules than you should |
Rare side effects |
|
(These may affect up to 1 in 1,000 people) | |
|
^ Get medical help immediately. If possible, take your capsules or the box |
* pins and needles |
|
with you to show the doctor. |
* inflammation of the gums, tender or swollen gums, bleeding gums |
|
Taking too many capsules may cause your blood pressure to become too |
Other side effects |
|
low and your heartbeats to speed up or slow down. It may also lead to an |
(Frequency not known: frequency cannot be estimated from the available |
|
increase in your blood sugar level or an increase in the acidity of your blood, |
data) |
|
swelling in the lungs, low blood oxygen levels and disturbances in |
* vomiting. |
|
consciousness, possibly leading to unconsciousness. |
* a reduction in the number of white blood cells (leucopenia) |
|
* a more severe decrease in a specific class of white blood cell | |
|
If you forget to take Nifedipine capsules |
(agranulocytosis) |
|
Take your normal dose immediately and continue taking your capsules as |
* increased blood sugar (hyperglycaemia) |
|
prescribed, waiting 8 hours before taking your next dose. |
* decreased skin sensitivity (hypoaesthesia) |
|
Do not take a double dose to make up for a forgotten dose. |
* drowsiness (somnolence) |
|
If you have any further questions on the use of this medicine, ask your |
* eye pain |
|
doctor. |
* chest pain (angina pectoris) |
|
* heartburn or indigestion (gastroesophageal sphincter insufficiency) | |
|
* yellowing of the whites of the eyes or skin (jaundice) | |
|
■ 4 Possible side effects |
* sensitivity to light (photosensitivity allergic reaction) |
|
* small, raised areas of bleeding in the skin (palpable purpura) | |
|
* joint pain | |
|
* muscle pain | |
|
Like all medicines, this medicine can cause side effects, although not | |
|
everybody gets them. |
All of these symptoms usually go away when treatment with Nifedipine |
|
capsules is stopped. | |
|
Serious side effects: | |
|
If you notice: |
Reporting of side effects |
|
* severe, sudden generalised allergic reaction including very rarely |
If you get any side effects, talk to your doctor or pharmacist. This includes |
|
life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, |
any possible side effects not listed in this leaflet. You can also report side |
|
fast pulse) or swelling (including potentially life-threatening swelling of the |
effects directly (see details below). By reporting side effects you can help |
|
airway) |
provide more information on the safety of this medicine. |
|
* other allergic reactions causing swelling under the skin (possibly severe |
United Kingdom |
|
and including swelling of the larynx that may result in a life-threatening |
Yellow Card Scheme |
|
outcome) |
We bsite: www. mhra.gov.u k/yellowcard |
|
* fast heart beat (tachycardia) * shortness of breath or difficulty breathing | |
|
* mild to moderate allergic reactions |
M5> How to store Nifedipine capsules |
|
* itching (possibly severe), a rash or hives | |
|
* Keep out of the sight and reach of children. | |
|
Contact your doctor immediately and do not take the next dose as |
* Do not store above 30°C. |
|
these may be the first signs of allergic reaction which may become |
* Store your medicine in the original package. |
|
severe. |
* Protect from light. |
|
If you develop: |
* Do not take Nifedipine capsules after the expiry date stated on blister label |
|
or carton. The expiry date refers to the last day of that month. | |
|
* a skin reaction or blistering / peeling of the skin and/or mucosal reactions |
* If your medicine becomes discoloured or show any other signs of |
|
(in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis) |
deterioration, ask your pharmacist who will advise you what to do. |
|
* Medicines should not be disposed of via wastewater or household waste. | |
|
^ Contact your doctor immediately before you continue treatment as |
Ask your pharmacist how to dispose of medicines no longer required. |
|
these may be signs of a severe reaction. |
These measures will help to protect the environment. |
|
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: |
V6) Contents of the pack and other information |
|
Common side effects |
What Nifedipine capsules contain |
|
(These may affect up to 1 in 10 people) |
The active ingredient Nifedipine |
|
* headache |
Each capsule contains 10mg nifedipine. |
|
* flushing |
Also contains glycerol, purified water, saccharin sodium, |
|
* general feeling of being unwell |
peppermint oil and macrogol 400. |
|
* constipation |
The capsule shell contains gelatine, glycerol 85%, titanium dioxide (E171) |
|
* swelling, particularly of the ankles and legs |
and yellow orange S (E110). |
|
Uncommon side effects |
What Nifedipine capsules looks like and contents of the pack |
|
(These may affect up to 1 in 100 people) |
Orange, oblong soft gel capsule containing a yellow viscous fluid. |
|
* stomach pain (abdominal pain) |
Each pack contains 90 soft capsules. |
|
* unspecific pain | |
|
* chills |
Manufacturer and Licence Holder |
|
* low blood pressure when standing up (symptoms include fainting, |
Manufactured by Bayer Pharma AG, D-51368 Leverkusen Germany and is |
|
dizziness, light headedness, occasional palpitations, blurred vision and |
procured from within the EU and repackaged by the Product Licence Holder: |
|
sometimes confusion) |
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, |
|
* fainting |
Worcestershire, B98 0RE. |
|
* irregular heartbeat (palpitations) | |
|
* dry mouth |
POM PL 15184/1515 Nifedipine 10mg soft capsules |
|
* indigestion or upset stomach * wind (flatulence) | |
|
Nifedipine is a registered trademark of Bayer Aktiengesellschaft. | |
|
* feeling sick (nausea) | |
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* muscle cramps |
Revision date: 18/01/16 |
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* joint swelling | |
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* sleep disorders * anxiety or nervousness |
Blind or partially sighted? |
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* reddening of the skin |
Is this leaflet hard to see or read? |
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* nose bleeds * nasal congestion |
Phone Lexon UK Ltd, Tel: 01527 505414 |
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* sensation of spinning or whirling motion (vertigo) |
for help. |
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* migraine | |
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* dizziness | |
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* trembling | |
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* increase in the need to pass water (urinate) | |
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* painful or difficult urination | |
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* inability to achieve or maintain an erection (impotence) | |
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* blurred vision | |
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* temporary increase in certain liver enzymes |