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PATIENT INFORMATION LEAFLET NIFOPRESS RETARD® TABLETS 20MG (Nifedipine)

In this leaflet:

1.    What Nifopress Retard® Tablets are and what they are used for

2.    Before you take Nifopress Retard® Tablets

3.    How to take Nifopress Retard® Tablets

4.    Possible side effects

5.    How to store Nifopress Retard® Tablets

6.    Further information

1. WHAT NIFOPRESS RETARD® TABLETS ARE AND WHAT THEY ARE USED FOR

Nifopress Retard® Tablets contain the active substance Nifedipine. This belongs to a group of medicines known as calcium antagonists. These work by opening up the blood vessels and increasing the flow of blood through them.

Nifopress Retard® Tablets are used:

•    To stop the symptoms of angina. Angina is chest pain caused by a narrowing of the arteries in the heart muscle

•    For the treatment of mild to moderate high blood pressure (hypertension).

2. BEFORE YOU TAKE NIFOPRESS RETARD® TABLETS

DO NOT take Nifopress Retard^® Tablets if:

•    If you have had a heart attack within the last month.

•    If you get a sudden angina attack. Nifopress Retard® tablets will not help to relieve the symptoms of angina quickly.

•    If you are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any other ingredients. The ingredients of Nifopress Retard® tablets are listed in section 6.

•    If you are pregnant.

•    If you are breast feeding. If you need to take Nifopress Retard® tablets, 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 valve (stenosis).

•    If you have ever had a collapse caused by a heart problem (cardiogenic shock), during which you become breathless, pale and have a cold sweat and dry mouth.

•    If your blood pressure continues to rise despite treatment (malignant hypertension).

Talk to your doctor before you take Nifopress Retard^® tablets if any of these applies to you.

Nifedipine Retard^® Tablets should not be given to children.

Take special care with Nifopress Retard^® Tablets and check with your doctor or pharmacist

before taking your medicine if:

•    You have any liver or kidney problems

•    You have heart problems which cause you to get breathless even with the slightest exercise

•    You suffer from low blood pressure causing dizziness or fainting on standing up

•    You are diabetic.

The treatment of your diabetes may need to be adjusted. If you have any questions about this ask your doctor.

•    You have had kidney dialysis. If you have very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Nifopress Retard® tablets.

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 Nifopress Retard® tablets

•    If you have chest pain after taking your first dose of Nifopress Retard® tablets. Your doctor may wish to change your treatment

•    If you notice increased difficulty in breathing

•    If you notice swelling of the ankles.

Tell your doctor before you take the next dose if this applies to you.

Also tell your doctor

•    If you have given a urine sample. Nifopress Retard® may interfere with the results of certain urine tests.

•    If you are a man who has not been able to father a child by in vitro-fertilisation. Drugs like Nifopress Retard^® have been shown to impair sperm function.

Taking other medicines

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

Some medicines may affect the way Nifopress tablets work. Tell your doctor if you are taking:

•    Other medicines used to treat high blood pressure and/or chest pain

•    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).

Taking Nifopress Retard® Tablets with food and drink

The tablets should be swallowed whole with a glass of water either during or after eating. Do not bite or chew the tablet.

Do not drink grapefruit juice or eat grapefruit while taking Nifopress tablets.

Do not start taking Nifopress tablets 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 while taking Nifopress tablets. 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

Do not take Nifopress retard^® tablets if you are pregnant. If you are pregnant, think you may be

pregnant or are planning a family, tell your doctor before taking Nifopress Retard^® Tablets. You may be able to use Nifopress Retard® after week 20 of your pregnancy, but only after special consideration and agreement by your doctor.

Do not take Nifopress Retard® tablets if you are breast-feeding. If you need to take Nifopress Retard®, you should stop breast-feeding before you start taking the tablets.

Driving and using machines

Nifopress Retard® tablets 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.

Important information about some of the ingredients of Nifopress Retard^® Tablets

This medicine contains lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. HOW TO TAKE NIFOPRESS RETARD® TABLETS

Always take Nifopress Retard® Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

•    one tablet (20mg) twice-daily. This may be adjusted up or down depending on your condition.

If you take more Nifopress Retard^® Tablets than you should

Taking too many Nifopress Retard^® tablets can cause a severe drop in blood pressure, a slow heart rate and unconsciousness. If you take more tablets then you should contact your doctor or hospital immediately. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken.

If you forget to take your Nifopress Retard^® Tablets

•    If you forget to take a tablet, take it if you remember within 12 hours of your usual time. If more than 12 hours have passed, you should not take the missed tablet but should take your next tablet at the normal time when it is due.

If you stop taking Nifopress Retard^® Tablets

Do not stop taking your tablets suddenly as your condition may get worse. Consult your doctor first.

If you have any further questions about these tablets, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nifopress Retard® Tablets can cause side effects, although not everybody gets them.

If you notice:

•    hives on the body, lips, eyes or tongue

•    fast heart beat (tachycardia)

•    itching of the skin or rash

•    shortness of breath or difficulty breathing.

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.

Apart from the side effects listed above, these are the other side effects of Nifopress Retard®, starting with the more common ones:

Common side effects

(These may affect up to 1 in 10 people)

•    headache

•    general feeling of being unwell

•    swelling, particularly of the ankles and legs.

•    flushing

•    constipation

Uncommon side effects

(These may affect up to 1 in 100 people)

•    stomach pain (abdominal pain)

•    chills

•    fainting

•    irregular heartbeat (palpitations)

•    rapid heart beats

•    dry mouth

•    indigestion or upset stomach

•    feeling sick (nausea)

•    joint swelling

•    anxiety or nervousness

•    nose bleeds

•    sensation of spinning or whirling motion (vertigo)

•    dizziness

•    increase in the need to pass water (urinate)

•    inability to achieve or maintain an erection (impotence)

•    unspecific pain

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

•    wind (flatulence)

•    muscle cramps

•    sleep disorders

•    reddening of the skin

•    nasal congestion

•    migraine

•    trembling

•    painful or difficult urination

•    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

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

•    increased blood sugar

•    decreased skin sensitivity

•    drowsiness

•    eye pain

•    chest pain

•    shortness in breath

•    heartburn or indigestion

•    yellowing of the whites of the eyes or skin

•    peeling off the top layer of skin from the lower layer of the skin

•    sensitivity to light

•    small, raised areas of bleeding in the skin

•    joint pain, muscle pain.

All of these symptoms usually go away when treatment with Nifopress Retard® is stopped.

If you get side effects

Tell your doctor or pharmacist if any side effect gets serious, or if you get any effects not listed in this leaflet.

5. HOW TO STORE NIFOPRESS RETARD® TABLETS

Keep out of the reach and sight of children.

Do not use Nifopress Retard® Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

•    Store in the original package in order to protect them from light.

•    Do not store above 25°C.

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. FURTHER INFORMATION

What Nifopress Retard® Tablets Contain

The active substance is Nifedipine.

The other ingredients are polysorbate 80, maize starch, microcrystalline cellulose, lactose, magnesium stearate, red ferric oxide E172, polyethylene glycol 4000, hydroxypropylmethyl cellulose and titanium dioxide (E171).

What Nifopress Retard^® Tablets look like and contents of the pack

Nifopress Retard® are circular biconvex coated tablets, pink-brownish in colour and embossed with “NR” on one face and “20” on the other. Nifopress Retard® Tablets 20mg come in pack sizes of 56, 100 or 112.

This leaflet was last revised in November 2014.