“You can’t beat a healthy heart.”
High Blood Pressure Medication
SCHEDULING STATUS S3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
BILOCOR 5 tablets
BILOCOR 10 tablets
Please read this patient information leaflet carefully before using BILOCOR
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- BILOCOR has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
WHAT BILOCOR CONTAINS
The active substance is bisoprolol fumarate
BILOCOR 5: Each tablet contains 5 mg bisoprolol fumarate
BILOCOR 10: Each tablet contains 10 mg bisoprolol fumarate
The other ingredients are crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose. BILOCOR also contains the colourants iron oxide yellow and iron oxide red (BILOCOR 10 only).
BILOCOR contains lactose monohydrate (see BEFORE YOU TAKE BILOCOR).
WHAT BILOCOR IS USED FOR
BILOCOR is used to treat mild to moderate high blood pressure and recurring angina pectoris. Angina pectoris is a disease in which the cardiac muscles receive less oxygen than is necessary. This generally occurs during exercise and the most common symptom is chest pain.
BEFORE YOU TAKE BILOCOR
DO NOT take BILOCOR if:
- You are (allergic) to bisoprolol fumarate or any of the other ingredients of BILOCOR (see WHAT BILOCOR CONTAINS).
- You suffer from severe asthma or from other severe breathing difficulties.
- You suffer from late stage peripheral arterial occlusive disease, including severe forms of Raynaud’s syndrome (a condition where the blood supply to the tips of the fingers or toes may become restricted as to cause tissue damage).
- You have a weak, irregular or slow heartbeat.
- You suffer from acute heart failure or if you are receiving therapy for a weak heart.
- You suffer from metabolic acidosis (this sometimes occurs as an acute complication of diabetes).
- You have low blood pressure.
- You suffer from phaeochromocytoma (marked by high blood pressure, raised heart rate and headache).
- You suffer from a condition marked by excessive production of thyroid hormones.
- You are pregnant or breast-feeding (see Pregnancy and Breast-feeding).
Take special care with BILOCOR:
- If you have liver or kidney problems.
- If you suffer from an irregular heartbeat, you experience sudden onset of chest pain, or if you already suffer from a mild form of angina.
- Less severe blood circulation problems in your limbs (resulting in temporary discoloration of the skin and numbness of the fingers or toes).
- If you suffer from phaeochromocytoma (marked by high blood pressure, raised heart rate and headache); this condition should be treated first, prior to taking BILOCOR.
- If you suffer from or have suffered from psoriasis (marked by severe skin rashes).
- If you suffer from diabetes mellitus (low blood sugar levels may be masked by this medicine).
- If you suffer from asthma or from any other breathing difficulties.
- If you are fasting.
In addition, tell your doctor if:
- You are due to receive an anaesthetic (e.g. before an operation).
- You are going to have desensitization therapy (e.g. to prevent hay fever), since BILOCOR may make it more likely that you will experience an allergic reaction, or more severe reaction.
Taking BILOCOR with food and drink:
The tablets can be taken with or without food.
Pregnancy and Breast-feeding:
DO NOT use BILOCOR if you are pregnant or suspect that you are pregnant. Contact you doctor or healthcare professional immediately.
DO NOT use BILOCOR during breast-feeding.
Driving and using machinery:
BILOCOR may cause dizziness, drowsiness or muscle cramps. Please make sure you know how BILOCOR affects you before driving or using machinery.
Important information about some of the ingredients of BILOCOR:
BILOCOR contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking BILOCOR.
Taking other medicines with BILOCOR:
- If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of BILOCOR with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.
The following medicines may interact with BILOCOR:
- Medicines used to treat angina, irregular heartbeat or high blood pressure (known as calcium antagonists, such as verapamil and diltiazem).
- Medicines used to treat high blood pressure (such as clonidine, methyldopa, moxonodine and rilmenidine) may further decrease blood pressure when taken with BILOCOR.
- You may experience extremely low blood sugar levels when taking BILOCOR with oral blood sugar lowering medication or insulin.
- You may have myocardial depression (depression of the heart muscle) when taking antiarrhythmic medicines, such as amiodarone (used to treat an irregular or rapid heartbeat.
- Certain medicines used to treat mental illness e.g. phenothiazines.
- Medicines used to treat acute heart problems (e.g. isoprenaline and dobutamine) since these medicines may stop BILOCOR working correctly.
- Using the medicines reserpine or guanethidine with BILOCOR may cause life-threatening vasoconstriction (constricting of the blood vessels).
- Digoxin (used improve the strength and efficiency of the heart or control the rate and rhythm of the heart) may be used with BILOCOR. Your doctor should monitor your pulse rate and response regularly.
- Dihydropyridine-type calcium antagonists, such as nifedipine, used to treat high blood pressure or angina pectoris.
- Medicines used to treat irregular or abnormal heartbeat, such as disopyramide or quinidine.
- Medicines used to treat conditions such as Alzheimer’s disease or glaucoma (known as parasympathomimetics) such as tacrine or carbachol.
- Beta-blockers applied locally (such as timolol eye drops to treat glaucoma).
- Digitalis, used to treat heart failure.
- Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (e.g. ibuprofen or diclofenac). These medicines may reduce the effects of BILOCOR.
- Medicines which can result in the lowering of blood pressure (e.g. medicines specifically given to lower blood pressure, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), or during anaesthesia (barbiturates such as phenobartital).
- Moxisylyte which is used to treat circulatory problems like Raynaud’s syndrome.
- Halofantrine, mefloquine and quinine used for the prevention or treatment of malaria.
- The effects of BILOCOR may be increased when taken with monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
- Rifampicin, an antibiotic used to treat infections, including tuberculosis (TB).
- If you are due to have an operation, tell the anaesthetist or the medical staff you are taking BILOCOR.
HOW TO TAKE BILOCOR
Do not share medicines prescribed for you with any other person.
Always take BILOCOR exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
If you have the impression that the effect of BILOCOR is too strong or too weak, tell your doctor or pharmacist.
The usual dose is 5 mg to 10 mg once daily.
The maximum recommended dose is 20 mg per day.
The tablets should be taken in the morning, with or without food.
If you take more BILOCOR than you should:
In the event of overdosage, consult your doctor or pharmacist, if neither is available, seek help at the nearest hospital or poison control centre. Take this leaflet and the rest of the remaining tablets with you so the doctor will know what you have taken.
If you have taken too much BILOCOR you may experience the following: a slowed heart rate, severe difficulty in breathing, feeling dizzy, or trembling (due to decreased blood sugar). Heart problems, coma and convulsions have also been reported.
If you forget to take BILOCOR:
Take the missed dose of BILOCOR as soon as possible. However, if it is almost time for your next dose, continue to take the next tablet at the usual time. Do not take a double dose.
Effects when treatment with BILOCOR is stopped:
If you have to stop BILOCOR treatment early, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may become worse.
BILOCOR can have side-effects.
Not all side-effects reported for BILOCOR are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
If any of the following happen, stop taking BILOCOR and tell your doctor immediately or go to the casualty department at your nearest hospital:
- swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing.
- a rash or itching.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BILOCOR. You may need urgent medical attention. All of these side effects are very serious, but are very rare.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- Changes to heart rate which may cause dizziness and weakness.
- Worsening of heart failure which can cause a persistent chesty cough due to a build-up of fluid on the lungs.
These are all serious, but rare, side-effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Side-effects that may occur more frequently include:
- Drowsiness, unusual tiredness or weakness.
- Dizziness, headache and extreme tiredness (these are generally mild, especially at the beginning of therapy and often disappear within 1 – 2 weeks).
- Feeling of coldness or numbness in hands or feet.
- Low blood pressure (you may feel light-headed).
- Decreased sexual ability.
Less frequent side-effects that may occur include the following:
- Loss of memory, anxiety, confusion, hallucinations, depression, nervousness, nightmares and vivid dreams, trouble sleeping.
- Dizziness on standing, fainting.
- Irritation and redness of the eye (conjunctivitis), dry, sore eyes. Reduced tear flow which may lead to problems if you wear contact lenses.
- Hearing problems.
- Raynaud’s syndrome (a condition where the blood supply to the tips of the fingers or toes may become restricted as to cause tissue damage).
- Allergic runny nose, sneezing and itching, nasal congestion, breathing problems in patients with asthma, chronic lung disease or other problems of the airways.
- Nausea, vomiting, diarrhoea, constipation.
- Inflammation of the liver which can cause yellowing of the skin or the whites of the eyes.
- Hair-loss (which will grow back after treatment with BILOCOR is stopped).
- Itching of the skin, skin rash, appearance or worsening of scaly skin rash (psoriasis).
- Back pain, joint pain or chest pain, muscle cramps, muscle weakness.
- Impaired erection.
- Physical weakness or lack of energy.
Side-effects that may occur, but with unknown frequency, include the following:
- Systemic Lupus Erythematosus (also known as ‘lupus’ or ‘SLE’) a disease characterised by inflammation and damage to various body tissues.
- Restlessness, lack of energy, loss of contact with reality.
- Problems seeing.
- Temporary loss of hearing.
- Fluid retention.
- Inflammation, excessive fibrous connective tissue or fluid in the lungs leading to breathing difficulties or a sharp stabbing pain in the chest.
- Stomach cramps, dry mouth, weight gain, inflammation of the mouth or lips.
- Sweating, irritation of the skin.
Side-effects are more common in patients with kidney problems.
If you notice any side-effects not mentioned in this leaflet, please inform your doctor or pharmacist.
STORAGE AND DISPOSING OF BILOCOR
- Store at or below 25 °C.
- Protect from light.
- Keep the blisters in the carton until required for use.
- KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
- Return all unused medicine to your pharmacist.
- Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).
PRESENTATION OF BILOCOR
Opaque or clear Al/PVC/PVdC blister packs containing 30 tablets.
IDENTIFICATION OF BILOCOR
BILOCOR 5: Pale yellow, mottled round normal convex tablet embossed with BI over break-line and 5 on one side and plain on the reverse.
BILOCOR 10: Mottled beige round normal convex tablet embossed with BI over break-line and 10 on one side and plain on the reverse.
RSA S3 38/5.2/0053
NAM NS2 06/5.2/0061
BOT S2 1101939
RSA S3 38/5.2/0051
NAM NS2 06/5.2/0062
BOT S2 1101940
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Cape Town, South Africa
DATE OF PUBLICATION
23 July 2010