Dapinelat

DAPINELAT contains a medicine called nifedipine. This belongs to a group of medicines called calcium antagonists. DAPINELAT may be used to treat the following:

• high blood pressure or angina (chest pain)

Do not take DAPINELAT:

• If you are allergic to nifedipine, any other similar medicines (known as dihydropyridines) or any of the other ingredients of this medicine (listed in section 6),
• If you have had a heart attack within the last month, if you get a sudden angina attack. Nifedipine will not help relieve symptoms of angina quickly, if you have unstable angina
• If you have ever had a collapse caused by a heart problem (cardiogenic shock)
• If you are taking rifampicin, an antibiotic
• 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, had an obstruction in the gullet (the oesophagus - the tube connecting the throat to the stomach)
• If you have a “kock pouch” (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut
• If you have inflammation of the bowel or intestines, such as crohn’s disease
• If you are pregnant or breast-feeding
• If your blood pressure continues to rise despite treatment (malignant hypertension)
• If you have very low blood pressure (severe hypotension), in cases of manifest heart failure and if you have been told that you have a narrowing of the aortic heart valve (stenosis)

Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you are given DAPINELAT.

Warnings and Precautions

Do not break, bite or chew your tablets

Tell your doctor or health care provider before taking this medicine

Take special care with DAPINELAT:

• If you have low blood pressure and you were prescribed DAPINELAT for your angina. Your blood pressure may be decreased further by this treatment
• If you are pregnant
• If you are breast - feeding. If you need to take DAPINELAT, you should stop breastfeeding before you start to take this medicine
• If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of DAPINELAT.
• If you are taking other medicines to treat high blood pressure (e.g. beta - blockers). If you are changing from a beta - blocker to nifedipine, you should gradually reduce your beta-blocker after discussion with your doctor
• If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve)
• 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 DAPINELAT.

How DAPINELAT is given

Do not share medicines prescribed for you with any other person. Always take DAPINELAT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. DAPINELAT is specially formulated so that you only have to take one dose each day.

Dose for high blood pressure: the usual dose is 1 tablet, once a day.

Dose for angina: the dose depends on your individual requirements. Your doctor will decide how much you should take. Your doctor will tell you how long your treatment with DAPINELAT will last. Do not stop treatment early because. If you have the impression that the effect of DAPINELAT is too strong or too weak, tell your doctor or pharmacist.

The tablets should be swallowed whole with a glass of water, either with or without food. Taking your tablets at the same time each day will have the best effect on your blood pressure, preferably during the morning. It will also help you remember when to take the tablets, DAPINELAT must be swallowed whole; under no circumstances should they be bitten, chewed or broken up. Do not take them with grapefruit juice.

Use in elderly

No dose adaptation in elderly people above 65 years is necessary.

Use in adults and the elderly with kidney problems

No dosage adjustment is required in patients with kidney problems.

Use in children and adolescents

DAPINELAT 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.

Use in patients with liver impairment

DAPINELAT should not be administered to patients with liver impairment.

If you missed a dose of DAPINELAT Do not take / receive a double dose to make up for forgotten individual doses. If you have any further questions on the use of this medicine, ask your doctor.

If you take more DAPINELAT than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Taking too many tablets may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.

DAPINELAT can have side effects. Not all side effects reported for DAPINELAT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• allergic reactions causing swelling under the skin including swelling of the larynx that may result in a life-threatening outcome, itching, a rash or hives,
• fast heart beat (tachycardia),
• shortness of breath (frequency not known) or difficulty breathing,
• If you develop a skin reaction or blistering / peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DAPINELAT. You may need urgent medical attention.

Tell your doctor if you notice any of the following side effects.

Frequent side effects:

• Headache
• Pain in eye
• Swelling particularly of the ankles and legs, flushing
• Constipation
• Feeling unwell

Less frequent side effects:

• Anxiety or nervousness, sleep disorders, sensation of spinning or whirling motion (vertigo), migraine, dizziness, trembling, abnormal sensation (dysesthesia), drowsiness (somnolence), visual disturbances, blurred vision, irregular heartbeat (palpitations), fast heart beat (tachycardia), chest pain (angina), fall in blood pressure, fainting (syncope), nose bleeds, 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, heartburn or indigestion (gastroesophageal sphincter insufficiency), temporary increase in certain liver enzymes, small, redness of skin, raised areas of bleeding in the skin (palpable purpura), muscle cramps, joint swelling, increase in the need to pass water, painful or difficult urination, inability to achieve or maintain an erection, unspecific pain, chills.

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), severe, sudden generalised allergic reaction including very rarely life-threatening shock, increased blood sugar (hyperglycaemia), decreased skin sensitivity (hypoaesthesia), difficulty in breathing, swelling in lungs, stomach pain or distress caused by a mass of foreign material found in the stomach which may require surgery for removal, difficulty swallowing, abdominal pain, caused by obstruction of the gut or ulcers in the gut, vomiting, yellowing of the whites of the eyes or skin (jaundice), sensitivity to light (photosensitivity allergic reaction), enlargement of a man's breasts (gynaecomastia)

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

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Keep this medicine out of the sight and reach of children. Store at or below 25 °C. Not to be removed from the outer carton until required for use.