Fidocare XL Tablets

Fidocare XL contains nifedipine, which belongs to a group of medicines called calcium antagonists. Fidocare XL is used to treat:

• high blood pressure or
• angina (chest pain)

Do not take Fidocare XL:

• If you are hypersensitive (allergic) to nifedipine, any other similar medicines (known as dihydropyridines) or any of the other ingredients of Fidocare XL (listed in section 6).
• If you have had a heart attack within the last month.
• If you get a sudden angina attack. Fidocare XL 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 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 suffer from inflammation of the bowel or intestines, such as Crohn's disease.
• If you are pregnant or breastfeeding.
• If your blood pressure continues to rise despite treatment (malignant hypertension).

Do not take Fidocare XL if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you are given Fidocare XL.

Warnings and precautions

Take special care with Fidocare XL:

• If you have low blood pressure and you were prescribed Fidocare XL for your angina. Your blood pressure may be decreased further by this treatment.
• If you have been diagnosed with heart failure or a narrowed heart valve (aortic stenosis), take extra precautions.
• If you are taking other medicines to treat high blood pressure (e.g. beta-blockers). If you are changing from a beta-blocker to Fidocare XL, 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 Fidocare XL.
• If you are giving a urine sample. Fidocare XL may interfere with the results of certain urine tests.
• If you are to have a barium contrast x-ray (barium meal). These tablets may affect the results of the test.

Children and adolescents

Fidocare XL is not intended to be used in children and adolescents under the age of 18 years.

Other medicines and Fidocare XL

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are taking:

• other medicines to treat high blood pressure
• rifampicin (an antibiotic) (see ‘ Do not take Fidocare XL’ )
• cimetidine (to treat stomach ulcers)
• digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions)

Do not share medicines prescribed for you with any other person. Always take Fidocare XL exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you have the impression that the effect of Fidocare XL is too strong or too weak, talk to your doctor or pharmacist.

The tablets should be swallowed whole with a glass of water, either with or without food. The tablets should be taken at approximately 24-hour intervals, i.e. at the same time each day, preferably during the morning. Fidocare XL must be swallowed whole; under no circumstances should they be bitten, chewed or broken up. Do not take the tablets with grapefruit juice.

Fidocare XL 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.

Use in elderly: No dose adjustment 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: Fidocare XL 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 problems: Fidocare XL should not be administered to patients with liver problems.

If you take more Fidocare XL 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 heartbeat 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.

If you forget to take Fidocare XL: Take your normal dose immediately and continue taking your tablets at the usual time of day, waiting at least 12 hours before taking the next dose. Do not take a double dose to make up for a forgotten individual dose. If you have any further questions on the use of this medicine, ask your doctor.

Fidocare XL can have side effects. Not all side effects reported for Fidocare XL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Fidocare XL, please consult your healthcare provider for advice.

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

• allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life-threatening outcome), itching (possibly severe), a rash or hives
• fast heartbeat (tachycardia)
• shortness of breath (frequency not known) or difficulty breathing
• a skin reaction or blistering/peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (called toxic epidermal necrolysis)
• yellowing of your skin and eyes (also called jaundice).

These are all very serious side effects. If you have them, you may have had a serious reaction to Fidocare XL. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headache
• pain in eye
• swelling particularly of the ankles and legs
• flushing
• a general feeling of being unwell
• constipation.

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)
• 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
• 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)
• 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
• 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 side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of Fidocare XL.

• Store at or below 25 °C.
• Protect from light and moisture.
• Keep the blister strips in the outer carton and keep the carton closed until required for use.
• Store all medicines out of reach of children.
• Do not use the tablets after the expiry date printed on the container.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).