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PAGE 1: FRONT FACE (INSIDE OF REEL)

NIFEDIPINE 5 mg AND 10 mg CAPSULES

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 any further 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.

IN THIS LEAFLET:

1.    What Nifedipine is and what it is used for

2.    Before you take Nifedipine

3.    How to take Nifedipine

4.    Possible side effects

5.    How to store Nifedipine

6.    Further information

OWHAT NIFEDIPINE IS AND WHAT IT IS USED FOR

Nifedipine is a selective calcium channel blocker. It slows the rate at which calcium flows into cells, and thus modifies the contraction of muscles, particularly heart muscle and causes a reduction in blood pressure.

Nifedipine is used:

•    to prevent angina attacks in patients suffering from chronic stable angina

•    for the treatment of high blood pressure and to improve the circulation to the limbs e.g. in the treatment of Raynaud's phenomenon, where poor blood circulation makes toes and fingers numb and pale.

^2 BEFORE YOU TAKE NIFEDIPINE

Do NOT take Nifedipine if you:

•    are allergic (hypersensitive) to nifedipine or any of the other ingredients of this medicine or other dihydropyridines e.g. nicardipine, felodipine

•    have significant aortic stenosis (abnormal narrowing of the aortic valve in the heart)

•    have unstable angina pectoris (chest pain)

•    have had a heart attack within the last month

•    are currently having an acute angina (chest pain) attack

•    are pregnant or able/planning to become pregnant, or are breast-feeding

•    are taking rifampicin (an antibiotic used to treat tuberculosis)

•    have suffered a collapse of your blood circulation system (cardiogenic shock)

•    experience increase in the blood pressure despite treatment (malignant hypertension).

Take special care with Nifedipine

Talk to your doctor before you start to take

this medicine if you:

•    are diabetic

•    have severe high or low blood pressure

•    have poor cardiac reserve (a reduction in the ability of the heart to do work)

•    are on dialysis and have very high blood pressure and low blood volume

•    have liver problems. Your doctor may need to do some blood tests. You may also be given a lower dose of nifedipine.

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.

•    if you have chest pains after taking your first dose of nifedipine. 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 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 have been shown to impair sperm function.

Taking other medicines Do NOT take Nifedipine if you are taking rifampicin (an antibiotic used to treat tuberculosis).

Talk to your doctor if you are taking any of the following:

•    erythromycin or quinupristin and dalfopristin (antibacterial drugs)

•    ketoconazole, itraconazole or fluconazole (anti-fungal drugs)

•    fluoxetine or nefazodone (antidepressants)

•    indinavir, nelfinavir, ritonavir, amprenavir or saquinavir (drugs used to treat HIV)

•    quinupristin/ dalfopristin (antibiotics)

•    tacrolimus (used following organ transplant)

•    cisapride (to treat heartburn and inflammation of the gullet)

•    cimetidine (for stomach ulcers)

•    quinidine or digoxin (for the heart), diltiazem (a heart drug), or any other drugs to control blood pressure

•    phenytoin, carbamazepine, valproic acid or phenobarbitone (for epilepsy)

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

•    diuretics, P-blockers, ACE-inhibitors, AT-1 antagonists, other calcium antagonists, a-adrenergic blocking agents, PDE5 inhibitors, a-methyldopa (blood pressure lowering drugs).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of Nifedipine

•    Nifedipine capsules contain E110 (sunset yellow) which may cause allergic reactions.

Taking Nifedipine with food and drink Do NOT take Nifedipine capsules with grapefruit juice, because this affects the amount of nifedipine which enters the bloodstream.

Pregnancy and breast-feeding.

Do NOT take Nifedipine if you are pregnant, planning to become pregnant or are breast-feeding. Ask your doctor for advice before taking any medicine.

You may be able to use nifedipine capsules after week 20 of your pregnancy, but only after special consideration and agreement by your doctor.

Driving and using machines Nifedipine may cause effects such as visual disturbances, drowsiness and low blood pressure particularly at the start of treatment, on changing from another medication, or if taken in combination with alcohol; these effects can affect your ability to drive or operate machinery. If affected, do NOT drive or operate machinery.

^ HOW TO TAKE NIFEDIPINE

Always take Nifedipine 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 preferably with a glass of water.

The usual dose is:

•    Adults

5 mg every 8 hours. The dose may be adjusted according to response up to 20 mg every 8 hours.

•    Elderly

A lower maintenance dose of Nifedipine may be required in the elderly.

•    Children

Nifedipine is not recommended for use in children and adolescents below 18 years of

PAGE 2: REAR FACE (OUTSIDE OF REEL)

age, because there are only limited data on the safety and efficacy in this population.

If you take more Nifedipine than you should If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause severe low blood pressure and very fast heart rate or very slow heart rate. Additional signs include nausea, vomiting, drowsiness, dizziness, confusion, tiredness, flushing and unconsciousness. Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.

If you forget to take Nifedipine

If you forget to take a capsule, take one as

soon as you remember, unless it is nearly

time to take the next one. Do not take a

double dose to make up for a forgotten dose.

If you stop taking Nifedipine

Do not stop taking your medicine without

talking to your doctor first even if you feel

better.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

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

If the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or nettle rash)

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

This is a very serious but rare side effect.

You may need urgent medical attention or hospitalisation.

•    Talk to your doctor immediately if you get increasing chest pain shortly after taking Nifedipine.

The following side effects have been reported at the approximate frequencies shown: Common (affecting fewer than one person in ten but more than one person in 100)

•    headache

•    swelling of the hands and feet

•    widening of blood vessels (vasodilatation)

•    constipation

•    general feeling of being unwell. Uncommon (affecting fewer than one person in 100 but more than one person in 1000)

•    anxiety or nervousness

•    sleep disorders

•    vertigo (a feeling of dizziness or "spinning")

•    migraine

•    dizziness

•    shaking

•    agitation

•    problems with sight

•    irregular heartbeats (palpitations)

•    low blood pressure on standing (symptoms include fainting, dizziness, light headedness, occasional palpitation, blurred vision and sometimes confusion)

•    fainting (syncope)

•    nose bleeds

•    nasal congestion

•    stomach pain (abdominal pain)

•    wind

•    feeling sick (nausea)

•    dry mouth

•    indigestion or heartburn, diarrhoea or other stomach problems

•    temporary increase in certain liver enzymes

•    reddening of the skin

•    sweating

•    muscle cramps

•    joint swelling

•    increase in the need to pass water (urinate)

•    painful or difficult urination

•    inability to achieve or maintain erection (impotence)

•    unspecific pain

•    chills

•    lethargy.

Rare (affecting fewer than one person in 1000 but more than one person in 10,000)

•    itching, nettle rash

•    pins and needles

•    inflammation of the gums, tender or swollen gums, bleeding gums.

Other side effects (Frequency unknown)

•    a more severe decrease in a specific class of white blood cell (agranulocytosis)

•    a reduction in the number of white blood cells (leucopenia)

•    sensitivity to light (photosensitivity allergic reaction)

•    small, raised areas of bleeding in the skin (palpable purpura)

•    increased blood sugar (hyperglycaemia)

•    decreased skin sensitivity (hypoaesthesia)

•    drowsiness (somnolence)

•    eye pain

•    chest pain (angina pectoris)

•    shortness of breath (dyspnoea)

•    vomiting

•    heartburn or indigestion (gastroesophageal sphincter insufficiency)

•    yellowing of the whites of the eyes or skin (jaundice)

•    joint pain

•    muscle pain.

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.

^ HOW TO STORE NIFEDIPINE

Keep out of the reach and sight of children.

Store in the original package.

Do not store above 25°C. Do not use Nifedipine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.

FURTHER INFORMATION

What Nifedipine capsules contain:

•    The active ingredient is either 5 mg or

10    mg of nifedipine

•    The other ingredients are polyethylene glycol 400, glycerol (E422), peppermint

011    and sodium saccharin (E954). The capsule shell contains gelatin, glycerol (E422), and the colours titanium dioxide (E171), sunset yellow (E110) and erythrosine (E127). The white printing ink contains propylene glycol, titanium dioxide (E171), polyvinyl acetate phthalate and polyethylene glycol.

What Nifedipine capsules look like and contents of the pack:

•    Nifedipine 5 mg capsules are opaque, oval, soft gelatin capsules containing an orange liquid. Overprinted 2L3 in white.

•    Nifedipine 10 mg capsules are opaque, oblong, soft gelatin capsules containing an orange liquid. Overprinted 2L4 in white.

•    The products are available in packs of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 and 168.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and company responsible for manufacture is TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: August 2013.

PL 00289/0745-6

^ET7W71

TEVA UK LIMITED    160x323