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PACKAGE LEAFLET: INFORMATION FOR THE USER

NIFEDIPINE CAPSULES 5mg and 10mg

[Nifedipine]

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, 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. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Nifedipine Capsules are and what they are used for

2.    What you need to know before you take Nifedipine Capsules

3.    How to take Nifedipine Capsules

4.    Possible side effects

5.    How to store Nifedipine Capsules

6.    Contents of the pack and other information

1.    WHAT NIFEDIPINE CAPSULES ARE AND WHAT THEY ARE USED FOR

The active ingredient, nifedipine, is one of a group of medicines called calcium antagonists. These relax and expand blood vessels.

Nifedipine Capsules are used for:

•    High blood pressure

•    To reduce the frequency of angina attacks

•    Raynaud's phenomenon, a condition in which the circulation of blood to fingers and toes is reduced.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIFEDIPINE CAPSULES

Do not take Nifedipine

•    If you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6)

•    If you have previously had an allergic reaction to the active ingredient nifedipine or to any other similar drugs (known as dihydropyridines). If you are unsure about this, ask your doctor

•    If you are taking the antibiotic, rifampicin

•    If you have been told that you have a narrowing (stenosis) of the aortic valve of the heart or have experience a collapse which was caused by a heart problem

•    For the treatment of a heart attack or within one month of a heart attack

•    To treat an angina attack

•    If your blood pressure is continuing to rise despite treatment. This is a condition known as malignant hypertension.

If the severity or frequency of your angina has rapidly worsened over a matter of hours or days, you must contact a doctor. You may be advised not to take Nifedipine Capsules.

If you are unsure whether you might have any of these conditions, please ask your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Nifedipine Capsules:

•    If you experience chest pains within 30-60 minutes of taking your FIRST dose of nifedipine, contact your doctor BEFORE YOU TAKE THE NEXT DOSE as he may change your treatment

•    If you suffer with angina you may notice an increase in the number and severity of the angina attacks at the start of treatment with nifedipine

•    If you are taking other medicines that affect the way your body metabolises nifedipine (see section: Other medicines and Nifedipine Capsules)

•    If you have impaired liver function

•    If you are pregnant

•    If you are breast-feeding

•    If you are pregnant and have to have intravenous magnesium sulphate as there may be a sudden fall in blood pressure.

Please tell your doctor if you:

•    Suffer from low blood pressure and have nifedipine prescribed for angina or Raynaud's syndrome

•    Heart condition where your heart cannot cope with increased strain (poor cardiac reserve), or your heart condition gets worse

•    Have increased breathlessness or swelling of the ankles

•    Are a diabetic as your treatment may need to be adjusted

•    Are having dialysis and have a very high blood pressure as you may experience a sudden drop in blood pressure.

Your doctor may want to monitor your blood pressure during treatment with Nifedipine Capsules.

Also tell your doctor:

•    If you are giving a urine sample as nifedipine may interfere with the results of certain urine tests

•    If you are a man who has been unable to father a child by IVF. Drugs like nifedipine have been shown to impair sperm function

Other medicines and Nifedipine Capsules:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking:

•    Other drugs to treat high blood pressure

•    Cimetidine, to treat stomach ulcers

•    The medicines digoxin, diltiazem, quinidine or beta-blockers, which are used to treat heart conditions

•    The antibiotics rifampicin and combination treatment quinupristin/dalfopristin

•    The anti-epileptic drugs phenytoin, carbamazepine or valproic acid

•    Cisapride, a drug used to treat reduced movements of the gullet and stomach.

The effect of the following drugs on nifedipine is uncertain. Therefore, as an additional precaution, please tell your doctor or pharmacist if you are taking:

•    The antibiotic erythromycin

•    The antifungals ketoconazole, itraconazole or fluconazole

•    The HIV protease inhibitors indinavir, nelfinavir, ritonavir, saquinavir or amprenavir

•    The antidepressant drugs fluoxetine and nefazodone

•    Tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs

•    The barbiturate phenobarbital, used primarily to treat insomnia and anxiety

•    Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).

Nifedipine Capsules with food and drink:

You should not start taking Nifedipine Capsules within three days of drinking grapefruit juice. If you have, speak to your doctor. In addition you should not drink grapefruit juice whilst taking Nifedipine Capsules. This is because grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least three days after the last ingestion of grapefruit juice.

Pregnancy and breast-feeding:

Do not take this medicine if you are pregnant or breastfeeding. If you are taking it and think that you may be pregnant or are planning a family, consult your doctor.

Driving and using machines:

It is possible that you may react to nifedipine. Reactions may be dizziness, lethargy and visual disturbances but can vary in intensity from individual to individual and may impair your ability to drive or operate machinery. This applies particularly at the start of treatment, on changing the medication and in combination with alcohol.

Nifedipine Capsules contain sunset yellow (E110)

May cause allergic reactions.

3. HOW TO TAKE NIFEDIPINE CAPSULES

Always take Nifedipine Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The capsules should be swallowed with a little water.

You should not take your capsule(s) with grapefruit juice.

•    The recommended dose is 5mg every 8 hours. The dose may be increased to a maximum dose of 20mg every

8 hours.

•    If you suffer from a liver disorder, your doctor may want to start your treatment on a low dose and increase it with careful monitoring of your blood pressure or angina.

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Elderly: lower doses of this medicine may be prescribed by your doctor.

It is possible that you may have to take these capsules indefinitely. You may want to discuss this with your doctor.

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.

DO NOT EXCEED THE PRESCRIBED DOSE

If you take more Nifedipine Capsules than you should:

Exceeding the correct dosage or taking an overdose may cause your blood pressure to become too low and your heart beats to become irregular. Also, it may lead to dizziness, confusion, visual disturbances, low blood oxygen levels and possibly unconsciousness.

If you take more than the prescribed dose, or in the event of an overdose, seek medical advice immediately and, if possible take your capsules or the box with you to show the doctor.

If you forget to take Nifedipine Capsules:

You should take your normal dose immediately and then continue taking your capsules as prescribed, waiting 8 hours before taking your next dose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Nifedipine Capsules:

You should take Nifedipine Capsules for as long as your doctor tells you to. It may be dangerous to stop taking Nifedipine Capsules before talking to your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions:

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing swelling of the eye lids, face or lips, rash, reddening of the skin or itching (especially affecting your whole body).

Serious side effects:

•    Liver problems including jaundice (yellowing of the skin or whites of the eyes)

•    As with similar drugs, which act on blood vessels, chest pain may occur at the start of treatment with Nifedipine Capsules. Because of the nature of coronary artery disease, heart attacks have occurred in patients treated with the active ingredient, nifedipine. It has not been shown that these heart attacks were due to treatment with nifedipine

•    A skin reaction or blistering/peeling of the skin and/or mucosal reactions (in the mouth/nose or penis/vagina) (Toxic Epidermal Necrolysis)

If you experience any of the above side effects, contact your doctor immediately.

Common: may affect up to 1 in 10 people:

Headache

Swelling of the ankles and legs Flushing Constipation Generally feeling unwell Uncommon: may affect up to 1 in 100 people:

Dizziness Feeling tired Feeling sick (nausea Rash Itching

Muscle pain and cramps Shaking

Problems with your eyesight Needing to pass water more often Joint swelling Migraine Nose bleeds Nasal congestion Sleep disturbances Low blood pressure Fainting Indigestion Dry mouth Stomach discomfort Feeling cold

Impotence Feeling anxious Vertigo

General pains

Red or purple discolouration of the skin Rare: may affect up to 1 in 1,000 people:

Gum disease

Enlargement of breast in males Mood changes Sensitivity to light Pins and needles Flaking skin Pruritus Rash Vomiting

Shortness of breath Not known: frequency cannot be estimated from the available data:

•    Low white blood cell count

•    High blood sugar

•    Loss of sensation

•    Eye pain

•    Chest pain

•    Jaundice

•    Muscle aches and pains

All of the symptoms above usually go away when treatment with nifedipine 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.

5.    HOW TO STORE NIFEDIPINE CAPSULES

Keep out of the sight and reach of children.

Store in the original container.

Do not store above 25°C.

The capsules should be protected from strong light, so only remove the capsule from the container or blister strip when you are about to take it.

Do not use Nifedipine Capsules after the expiry date which is stated on the label. The expiry refers to the last day of that month.

Do not use Nifedipine Capsules if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Nifepidine Capsules contain:

The active substance(s) is Nifedipine BP/PH.Eur.

The capsules contain either 5mg or 10mg of nifedipine.

The other ingredients are: Macrogols (Polyethylene glycol 400), Propylene glycol, Peppermint oil, Saccharin sodium. Ingredients of shell: Gelatin, Glycerol, Titanium dioxide, Sunset yellow supra (Colorant), Andrisorb 85/70.

What Nifedipine Capsules look like and contents of the pack:

Nifedipine 5mg Capsules:

Description: Orange oval, soft gelatine capsules containing a clear liquid fill material.

Nifedipine 10mg Capsules:

Description: Orange oblong, soft gelatine capsules containing a clear liquid fill material.

Contents of pack: Blister pack.

14 capsules in a blister, 6 blisters in a carton

Marketing Authorisation Holder

Co-pharma Limited Unit 4, Metro Centre, Tolpits Lane Watford, Herts, UK, WD18 9SS Tel: 01923 255580 Fax: 01923 255581

This leaflet was last revised 09/2015

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6138

180 x 300 mm

Back Side

ARTWORK DETAIL LABEL