Nifedipine Capsules 5 Mg
PACKAGE LEAFLET: INFORMATION FORTHE USER
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Read all ofthis leaflet carefully before you start
taking this medicine because it contains
'important information for you
|* Keep this leaflet. You may need to read it again
• If you have further questions, ask your doctor, or pharmacist or nurse
• 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 or nurse.
^hat is in this leaflet:
1. 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
5 How to store Nifedipine Capsules
6. Contents of the pack and other information.
1. WHATNIFEDIPINECAPSULES ARE AND WHAT THEY ARE USED FOR
[Nifedipine Capsules contain nifedipine. This belongs to a group of medicines called calcium Antagonists.
Nifedipine works by relaxing and expanding blood Vessels allowing blood to flow more easily. Nifedipine is used in the treatment of high blood pressure and Raynaud's phenomenon (a condition where spasm of the blood vessels in the fingers bauses them to go white, with numbness and discomfort). It is also used for the prevention of bhronic stable angina pectoris.
iNifedipine Capsules should not be used for the treatment of acute attacks of angina.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIFEDIPINE CAPSULES
Do not take Nifedipine Capsules if:
|* you are allergic to nifedipine, any other
dihydropyridine drugs, or any of the ingredients in this medicine (listed in section 6)
• you are, or might be pregnant, or you are | breast-feeding
• you are suffering from shock induced by heart circulatory collapse
• you have aortic stenosis (narrowing of the opening of the aortic heart valve)
• you suffer with unstable angina
L you are having, or have had a heart attack in the last month
l you are taking rifampicin (see Other medicines I section).
Warnings and precautions:
Talk to your doctor, or pharmacist or nurse before taking this medicine:
Ifyou have low blood pressure. Your blood i pressure may be decreased further by this treatment
|» Ifyou have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve)
• Ifyou are a diabetic. The treatment for your diabetes may need to be adjusted. Ifyou have any questions about this, ask your doctor
|* Ifyou are on kidney dialysis. Ifyou have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Nifedipine I Capsules
• Ifyour liver is not working properly your doctor may need to do some blood tests. You may also be given a lower dose of this
I medicine
,• Ifyour chest pain (angina) gets worse I (comes on more often or more severely) over a I matter of hours or days. You may be advised ' not to take Nifedipine Capsules i* Ifyou are taking other medications (see section Taking other medicines).
a
Pregnancy:
Do not take Nifedipine Capsules ifyou are pregnant. Ifyou are pregnant, thinkyou might be pregnant or are planning a family, talk to 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.
Breast-feeding:
You should not take Nifedipine Capsules while breast-feeding.
If you are unsure you should talk to your doctor.
Driving and using machines:
Side effects such as dizziness and visual disturbances may affect your ability to drive or operate machinery. You should avoid driving or operating machinery if you suffer from any such side-effects.
Other medicines and Nifedipine Capsules:
Tell your doctor, or pharmacist or nurse 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, phenobarbital, 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).
Taking Nifedipine Capsules with food and drink:
This medicine can be taken with or without food.
Alcohol can increase the effect of Nifedipine, this may be dangerous. Ask your doctor or pharmacist for advice if you wish to drink alcohol while taking this medicine.
Do not drink grapefruitjuice 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 grapefruitjuice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Nifedipine Capsules. Grapefruitjuice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.
3. HOW TO TAKE NIFEDIPINE CAPSULES
Always take Nifedipine Capsules exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The capsules should be swallowed with water.
Adults:
The recommended starting dose is 5mg, every 8 hours. This may then be adjusted by your doctor, according to your body's response.
Your doctor may increase your dosage to 20mg, every 8 hours, if necessary.
'Patients with liver problems or those on other will be carefully monitored by their
Ipatients with kidney problems will be given the ^normal recommended dosage.
Elderly patients:
|Lowermaintenance doses of nifedipine may be required.
Children:
[Nifedipine Capsules are not recommended for use in children and adolescents below 18 years ofage, because there are only limited data on the safety and efficacy in this population.
medication
doctor.
• 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 ,
(Thesemayaffectupto 1 in 1,000 —
people)
• pins and needles
• inflammation of the gums, tender or swollen gums, bleeding gums.
If you experience any unexpected anginal pain soon after taking nifedipine, stop taking the medicine and tell your doctor immediately.
Ilfyou take more Nifedipine Capsules than you should:
Ilfyou take too many capsules you should contact your nearest hospital casualty department immediately. Take the remaining capsules and box with you. Taking too many capsules may cause ^our blood pressure to become too low and your heartbeat to speed up or slow down. It may also [lead to an increase in your blood sugar level or an increase in the acidity ofyour blood, swelling in the Jungs, low blood oxygen levels and disturbances in consciousness, possibly leading to [unconsciousness.
ilfyou forget to take Nifedipine Capsules:
Jfyou have missed a dose, take the missed dose s soon as you remember unless your next dose is ue within 2 hours. Do not take double the dose next time. If you are concerned consult your doctor.
Ilfyou stop taking Nifedipine Capsules:
Consult your doctor before you stop taking |nifedipine as your original symptoms may return if you stop taking it.
Like all medicines, Nifedipine Capsules can have pide effects, although not everybody gets them.
Other side effects
(Frequency unknown)
• vomiting
• a reduction in the number ofwhite blood cells (leucopenia)
• a more severe decrease in a specific class of white blood cell (agranulocytosis)
• increased blood sugar (byperg/ycaem/a)
• decreased skin sensitivity (bypoaesfbes/a)
• drowsiness (somno/ence)
• eye pain
• chest pain (ang/na pecfobs)
• heartburn or indigestion (gasfroesopbagea/ 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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
Serious side effects:
Ifyou notice any ofthe following, contact your doctor immediately and do not take the next dose as these may be the first signs of an allergic reaction which may become severe:
l» 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 life-threatening 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 heartbeat (tachycardia)
i» shortness of breath or difficulty breathing '• mild to moderate allergic reactions i» itching (possibly severe), a rash or hives.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the label. The expiry date refers to the last day of that month.
Store these capsules in a dry place below 25°C and protect them from light.
If you notice any defects such as split capsules, take them to your pharmacist for advice.
Other side effects which may occur: Common side effects
.(These may affect uptolinlO people)
L headache
• flushing
I* general feeling of being unwell
• constipation
|* swelling, particularly of the ankles and legs
• tiredness and lack of energy (lethargy)
|* swelling or enlargement of breasts in male (gynaecomastia).
Uncommon side effects
[(These may affect up tolinlOO people)
• stomach pain (abctom/na/ pa/p)
» unspecific pain
L chills
• low blood pressure when standing up
I (symptoms include fainting, dizziness, light , headedness, occasional palpitations, blurred vision and sometimes confusion)
• fainting
I* irregular heartbeat (palpitations)
• dry mouth
|* indigestion or upset stomach
• wind (ffafu/ence)
|* feeling sick (nausea)
• muscle cramps [• joint swelling
• sleep disorders
[• anxiety or nervousness
• reddening of the skin » nose bleeds
L nasal congestion
» sensation of spinning or whirling motion " (vertigo) m migraine L dizziness
Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Nifedipine Capsules contain:
Nifedipine Capsules 5mg contain the active ingredient nifedipine at 5mg per capsule.
Nifedipine Capsules 10mg contain the active ingredient nifedipine at 10mg per capsule.
What Nifedipine Capsules look like and contents of the pack:
Nifedipine Capsules 5mg are shiny, oval, light maroon soft gelatine capsules. Plain practically odourless.
Nifedipine Capsules 10mg are shiny, oval, dark maroon soft gelatine capsules. Plain practically odourless.
Marketing Authorisation Holder:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate, Riverside Way Dartford, DA1 5BS, United Kingdom
Manufacturer:
R P Scherer SPA
Viale Europa 3, 20075 Lodi, Milan, Italy Date of preparation: May 2013