Nifedalat Tablets

NIFEDALAT 20 SR contains the active substance nifedipine, which belongs to a group of medicines called calcium antagonists. NIFEDALAT 20 SR is used to treat mild to moderate high blood pressure (hypertension) and to prevent the condition called chronic stable angina pectoris (chest pain coming from the heart) in adults.

Do not take NIFEDALAT 20 SR:

• if you are hypersensitive (allergic) to nifedipine or any of the other ingredients of NIFEDALAT 20 SR (listed in section 6).
• if you have a liver disease that prevents your liver from working properly.
• if you have an obstruction or narrowing in your intestines, or have had this in the past.
• if you have ever had an obstruction in the gullet (the oesophagus - the tube connecting the throat to the stomach).
• if you have inflammation of the bowel or intestines.
• if you have ever had a collapse caused by a heart problem (cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.
• if you are pregnant or breastfeeding.
• if you are a child or below the age of 18 years.

Warnings and precautions

Take special care with NIFEDALAT 20 SR:

• if you have low blood pressure, or if you are already taking other medicines to treat high blood pressure, and you were prescribed NIFEDALAT 20 SR for your angina. Your blood pressure may be decreased further by this treatment.
• if you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).
• if you have been told that you have a narrowing of the aortic heart valve (stenosis).
• 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 NIFEDALAT 20 SR.
• if you have chest pains after taking your first dose of NIFEDALAT 20 SR. Your doctor may wish to change your treatment.
• if you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor.
• if you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take NIFEDALAT 20 SR.
• if you are giving a urine sample. NIFEDALAT 20 SR may interfere with the results of certain urine tests.
• if you are to have a barium contrast x-ray (barium meal). NIFEDALAT 20 SR may affect the results of the test.
• if you notice increased breathlessness.
• if you notice swelling of the ankles.

Children and adolescents

NIFEDALAT 20 SR 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.

Other medicines and NIFEDALAT 20 SR

Always tell your healthcare provider if you are taking any other medicine (This includes all complementary or traditional medicines). Some medicines may affect the way NIFEDALAT 20 SR works. Tell your doctor if you are taking:

• rifampicin (an antibiotic)
• erythromycin (macrolide antibiotics)
• indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV)
• ketoconazole, itraconazole or fluconazole (anti-fungal medicines)
• fluoxetine or nefazodone (to treat depression)
• quinupristin/ dalfopristin (a combination antibiotic)

Do not share medicines prescribed for you with any other person. Always take NIFEDALAT 20 SR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 20 mg to 40 mg twice per day. Swallow the tablets whole. Do not bite, chew or break them. Taking your tablets at the same time each day will have the best effect on your blood pressure. It will also help you remember when to take the tablets. Take the tablets with a glass of fluid. Do not take them with grapefruit juice. Your doctor will tell you how long your treatment with NIFEDALAT 20 SR will last. If you have the impression that the effect of NIFEDALAT 20 SR is too strong or too weak, tell your doctor or pharmacist.

NIFEDALAT 20 SR can have side effects. Not all side effects reported for NIFEDALAT 20 SR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NIFEDALAT 20 SR, please consult your healthcare provider for advice. If any of the following happens, stop taking NIFEDALAT 20 SR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse)
• 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)
• shortness of breath (frequency not known) or difficulty breathing

These are all very serious side effects. If you have them, you may have had a serious reaction to NIFEDALAT 20 SR You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• a skin reaction or blistering or peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headache
• swelling, particularly of the ankles and legs
• flushing
• constipation
• general feeling of being unwell.

Less frequent side effects:

• anxiety or nervousness
• sleep disorders
• sensation of spinning or whirling motion (vertigo)
• migraine
• dizziness
• trembling
• pins and needles
• blurred vision
• irregular heartbeat (palpitations)
• low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)
• nosebleed
• nasal congestion
• stomach pain (abdominal pain)
• feeling sick (nausea)
• indigestion or upset stomach
• wind (flatulence)
• dry mouth
• inflammation of the gums, tender or swollen gums, bleeding gums
• temporary increase in certain liver enzymes
• reddening of the skin
• muscle cramps
• joint swelling
• increase in the need to pass water (urinate)
• painful or difficult urination
• inability to achieve or maintain an erection (impotence)
• unspecified pain
• chills.

Frequency not known:

• a more severe decrease in a specific class of white blood cell (agranulocytosis)
• a reduction in the number of white blood cells (leucopenia)
• increased blood sugar (hyperglycaemia)
• depression
• decreased skin sensitivity (hypoaesthesia)
• drowsiness (somnolence)
• difficulty sleeping (insomnia)
• eye pain
• chest pain (angina pectoris)
• heart attack
• vomiting
• heartburn or indigestion (gastroesophageal 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
• temporary enlargement of male breast tissue
• sweating
• feeling of warmth
• tiredness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store in a dry place at or below 25 º C. Keep the blisters in the carton until required for use. Protect from light. Do not use after the expiry date stated on the label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).