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Nivaten Retard 10mg and 20mg Tablets (Nifedipine)

WHAT'S IN YOUR MEDICINE

•    Actavis supplies Nivaten Retard in two strengths.

•    Each film-coated tablet contains either 10mg or 20mg of the active ingredient Nifedipine.

•    The tablets also contain colloidal silica, lactose, magnesium stearate, maize starch, polysorbate 80, propylene glycol, E171, E172, E460, E463, E464, E553.

These tablets do not contain sodium.

•    Nivaten Retard 10mg Tablets are available in pack sizes of 56, 60, 84, 90, 112, 120, 168, 180*.

•    Nivaten Retard 20mg Tablets are available in pack sizes of 56, 60, 100, 168, 1000, 5000*.

[* only the marketed pack size will appear on the final leaflet]

•    Your tablets are made by Actavis, Barnstaple, EX32 8NS, UK, who are also the Marketing Authorisation holder.

ABOUT YOUR MEDICINE

Nifedipine is one of a group of medicines called calcium channel blockers. These medicines work by reducing the pain (angina pectoris) which occurs when the heart is starved of oxygen, by improving oxygen supply to the heart muscle. Nifedipine also relaxes the muscle lining of small blood vessels throughout the body and in this way brings high blood pressure down to normal.

Nivaten Retard Tablets may be used for:

•    The treatment of high blood pressure (hypertension).

•    Prevention of angina (chest pain).

•    The treatment of Prinzmetal’s (variant) angina (under a cardiologist’s supervision).

BEFORE TAKING YOUR MEDICINE

Do not take Nivaten Retard if you

•    have ever had an allergic reaction to Nivaten, nifedipine, any of the ingredients in the tabletor any other dihydropyridine-type calcium channel blocker e.g. nicardipine or isradipine. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

•    have had a recent heart attack. Nivaten should not be used to treat a heart attack or within one month of a heart attackhave ever collapsed due to a heart problem (cardiovascular shock) where you became breathless, pale and experienced a cold sweat and dry mouth.

•    get more severe or frequent chest pains over a matter of hours or days (unstable angina) you must contact your doctor. Nivaten is intended to reduce the frequency of angina attacks and must not be used to treat an angina attack at the time when it occurs.

•    suffer from very high blood pressure (malignant hypertension) which is often associated with kidney damage.

•    are taking an antibiotic called rifampicin.

•    have a liver disease.

•    have inflammation of the bowel or intestines.

•    have an obstruction in the gullet (the oesophagus - the tube connecting the throat to the stomach), stomach or intestines.

•    have a ‘Kock pouch’ (a surgically reconstructed intestinal reservoir with an opening through the abdominal wall).

Take special care with Nivaten Retard if you

•    have a narrowing (stenosis) of the aorta.

•    experience chest pains within four hours of taking your first dose of Nivaten, you notice increased breathlessness or swelling in the ankles (tell your doctor if any of these apply to you)

•    suffer from low blood pressure (hypotension).

•    have heart failure.or have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).

•    are receiving kidney dialysis

•    are a diabetic. Nivaten may cause temporary high blood sugar levels. Your doctor may need to alter the dosages of medicines you are taking.

•    have a narrowing of your stomach or intestines.

•    are giving a urine sample or are to have a Barium contrast x-ray (your results may be affected).

•    have liver problems (your doctor will monitor your condition and may want to reduce your dose).

Check with your doctor or pharmacist if you are taking any of the following

•    Medicines to treat high blood pressure such as methyldopa, diuretics, beta-blockers, ACE-inhibitors, Angiotensin 1 (ATI) receptor-antagonists, other calcium antagonists, adrenergic blocking agents, PDE5 inhibitors

•    Cimetidine for stomach ulcers or cisapride for overcoming slow gut movements.

•    Quinidine or digoxin for heart problems.

•    Rifampicin, erythromycin, ketoconazole or quinupristin with dalfopristin for infections.

•    Vincristine to treat leukaemia

•    Phenytoin, carbamazepine, valoproic acid or phenobarbital to treat treat epilepsy

•    Magnesiumsulphate injections during pregnancy.

•    Tacrolimus to prevent rejection of transplanted organs.

•    Ritonavir used to treat HIV.

•    Fluoxetine or nefazodone used to treat depression.

Taking Nivaten with food and drink

Do not take with grapefruit juice, as this may make Nivaten Retard work too strongly. Avoid alcohol whilst taking this medicine.

Nivaten contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

Driving and using machines

These tablets can affect your ability to drive or operate machinery, particularly at the start of treatment, on changing treatment or in combination with alcohol. Do not drive or operate machinery until you are sure you are not affected.

Pregnancy breast-feeding and fertility

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. Male fertility may be temporarily affected by Nivaten.

TAKING YOUR MEDICINE

Follow your doctor’s instructions. Check the pharmacy label to see how many tablets to take and how often to take them. If you are still unsure ask your pharmacist or doctor.

The usual dosage(s) are:

Adult	Initially 10mg every 12 hours, then according to your response. Dosage may be adjusted to 40mg every 12 hours.
Elderly	A lower maintenance dose compared to younger patients may be given.
Children	Nifedipine is 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.
Liver problems	If you have liver problems, your doctor will monitor your condition and may want to reduce your dose.

•    Swallow these tablets whole with water regardless of food at the same times each day. Do not chew the tablets.

•    Take this medicine for as long as your doctor tells you to.

If you take more Nivaten Retard than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. If a severe overdose has been taken there may be signs such as low blood pressure, a fast or slow heartbeat, changes in heart rhythm, an increase in blood sugars, metabolic acidosis (abnormal chemical levels in the blood), hypoxia (tissue oxygen defiency), cardiogenic shock (where you become breathless, pale and experience a cold sweat and dry mouth), fluid on the lung.

If you forget to take Nivaten Retard

If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

AFTER TAKING YOUR MEDICINE

Like all medicines, Nivaten can sometimes cause unwanted side effects. Most of them are due to the effect of nifedipine on widening blood vessels and usually disappear on stopping treatment.

If the following happens, stop taking Nivaten Retard and tell your doctor immediately or contact the casualty department at your nearest hospital:

•    An allergic reaction: swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

•    Fast heart beat.

•    Itching, a rash or hives, blistering/peeling of skin and areas such as the mouth, nose, penis/vagina (Toxic Epidermal Necrolysis).

Known side effects in people taking this medicine are as follows:

Common (occurs in between 1 in 10 and 1 in 100 people)

headache, swollen ankles and legs, widening of blood vessels causing flushing,

constipation, feeling unwell, tiredness

Uncommon (occurs in between 1 in 100 and 1 in 1,000 people) anxiety, sleep disorders, nervousness, vertigo, migraine, dizziness, trembling, visual disturbances, palpitations, low blood pressure, fainting, nosebleeds, nasal congestion, stomach pain, feeling sick, indigestion, wind, dry mouth, temporary increase in liver enzymes, rash, skin redness, itching, sweating, muscle cramps, joint swelling, needing to pass urine more frequently or pain when urinating, reduced sexual potency (impotence), a general unwell feeling, unspecific pain, chills. fainting or feeling faint on changing posture due to low blood pressure,diarrhoea Rare (occurs in between 1 in 1000 and 1 in 10,000 people)

‘pins and needles’ (paresthesia), itching, hives, rash, abnormal sensation when skin is touched (dysaesthesia), increased sensitivity to touch (hyperaesthesia) inflamed, bleeding, tender or swollen gums mood changespoor eyesight,bloating, changes in levels of a certain digestive enzyme called GGTP, jaundice (yellowing of the skin and whites of the eyes),purpura (seen as blood spots, bruising and discolouration of the skin).

Very rare (occurs in less than 1 in 10,000 people)

throbbing and burning pain brought on by exertion or heat, felt in the hands or feet with a reddening of the skin of those parts (erythromelalgia), inflammation and shedding of the skin (exfoliative dermatitis), enlarged breasts in older men on long term treatment,abnormal liver function test results.

Not Known (frequency cannot be determined from the data)

a large decrease in numbers of white blood cells (leukopenia) leading possibly to mouth ulcers and fever, a large decrease in the numbers of neutrophil blood cells (agranulocytosis), increase in blood sugars (hyperglycaemia), reduced sense of touch or sensation (hypoaesthesia), drowsiness, eye pain, chest pain, difficulty breathing, being sick, stomach pain or distress caused by ulcers or by a mass of foreign material found in the stomach which may require surgery for removal, difficulty swallowing, gastroesophageal sphincter insufficiency (causing symptoms such as heart burn or indigestion), disease of the liver causing yellowing of the skin or whites of the eyes (jaundice), sensitivity of the skin to light, raised blood spots, bruising or discolouration of the skin (palpable purpura), joint or muscle pain.

Worsening of existing angina is rare. Heart attack can occur, but it is difficult to tell whether this is caused by Nivaten or existing heart disease.

Tell your doctor if you notice or are worried by any of the side effects listed. Tell your doctor or pharmacist if you notice any other effects not listed.

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.

STORING YOUR MEDICINE

•    Do not use the tablets after the end of the expiry month (use by date) shown on the product packaging.

•    Keep the tablets stored in the original container.

•    Do not transfer them to another container.

•    Keep Nivaten Retard out of the reach and sight of children in a secure place.

•    Remember that this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

•    Return all unused medicines to your pharmacist for safe disposal.

If you would like a leaflet with larger text, please contact 01271 385257.

This leaflet was last revised in February 2014.