Presese 5 mg/10 mg Tablets

PRESESE belongs to a group of medicines called beta-blockers. PRESESE is used in combination with other medicines to treat stable chronic (long-term) moderate to severe heart failure.

Do not take PRESESE:

• If you are hypersensitive (allergic) to bisoprolol, or any of the other ingredients of PRESESE (listed in section 6).
• If you are in acute heart failure or if you require injection of inotropic medicines (medicines which increase the force of contraction of the heart)
• If you have had cardiac shock (inadequate heart function)
• If you suffer from heart block and do not have a pacemaker
• If you suffer from very slow heartbeats (less than 50/minute) or sick sinus syndrome (a syndrome of slow heart beats with rapid dysrhymtics)
• If you suffer from sinoatrial block (interference of impulse to heart chamber)
• If you have very poor circulation or Raynaud’s syndrome
• If you have low blood pressure
• If you suffer from an untreated phaeochromocytoma (a tumour on the adrenal glands)
• If you suffer from severe bronchial asthma, bronchitis or have severe breathing difficulties.
• If you are pregnant or breast-feeding.
• If you suffer from an overactive thyroid gland producing an excessive amount of thyroid hormones.
• If you have metabolic acidosis (a condition that occurs when the body produces too much acid or when the kidneys are not removing enough acid from the body)
• In children.

Warnings and precautions

Special care should be taken with PRESESE:

• Before taking PRESESE, tell your doctor if you suffer from any of the following:
• asthma or any other lung disease.
• diabetes mellitus (taking PRESESE can make it harder for you to tell when you have low blood sugar)
• you are having desensitisation therapy for allergies
• heart problems or first degree heart block (a condition in which nerve signals to the heart are disturbed, possibly causing it occasionally to skip a beat, or beat irregularly).
• irregular heartbeat, sudden onset of chest pain, suffer from a mild form of angina and Prinzmetal’s angina (a form of unstable angina)
• poor circulation
• psoriasis
• kidney disease – If you have severe kidney problems, your doctor will adjust the dosage of PRESESE.
• a phaeochromocytoma (a tumour on the adrenal glands)

- Also tell your doctor if:

• you are fasting
• you are taking or receiving any other medicines such as anaesthetics, calcium antagonists, medicines used to treat heart disease and irregular heartbeat such as disopyramide and verapamil, and clonidine (medicine used to treat high blood pressure, migraine and menopausal flushing). Care is required if you are being transferred from clonidine to PRESESE. If you are taking PRESESE and clonidine together, the clonidine should not be stopped until several days after PRESESE have been withdrawn.
• you need to have any type of surgery. Tell the surgeon and anaesthetist ahead of time that you are using PRESESE.
• If you are elderly (over the age of 60 years).
• PRESESE may mask the signs of thyroid overactivity.
• Your doctor will monitor you regularly when you start taking PRESESE.
• If you have a history of severe allergic reactions that have required adrenaline, PRESESE may make your system unresponsive to the usual effective dose of adrenaline.
• Stopping treatment with PRESESE: Do not stop treatment suddenly without talking to your doctor first.

Children and adolescents

Safety and efficacy in children have not been established.

Do not share medicines prescribed for you with any other person. Always take PRESESE exactly as your doctor has instructed you. Your doctor will tell you how long your treatment with PRESESE will last. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of PRESESE is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you how many tablets to take. You should take PRESESE in the morning. PRESESE can be taken with food.

Swallow the tablet/s with some liquid and do not chew or crush them. Adults and the elderly: When you first start taking PRESESE your doctor will increase the strength of the tablets you take gradually, until you receive the dose that suits you best.

Your doctor will usually start your treatment with: PRESESE 1.25 mg, once daily.

If you take more PRESESE than you should: Overdose symptoms may include slow heart rate and severe low blood pressure. Wheezing or shortness of breath and heart failure may occur. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take PRESESE: Do not take a double dose to make up for a missed dose. Take the normal dose as soon as you remember and then carry on with the usual dose the next day.

Effects when treatment with PRESESE is stopped: Stopping treatment with PRESESE: Do not stop treatment suddenly or change the recommended dose without talking to your doctor first. If you need to stop treatment, it is usually done gradually, to avoid side effects.

PRESESE can have side effects. Tell your doctor if any of the above side-effects are severe, bothersome, do not go away or about any concerns you have while taking PRESESE. Not all side-effects reported for PRESESE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRESESE, please consult your doctor, pharmacist or other health care professional for advice.

PRESESE can have side-effects. Get emergency medical help if you have any of these signs of an allergic reaction:

• Hives/rash; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side-effects:

• Slow, fast or pounding heartbeats
• Chest pain
• Dizziness, light headedness or fainting
• Feeling short of breath, even with mild exertion
• Swelling of ankles, feet, or lower legs
• Unusual bleeding or bruising
• Hallucinations (false perceptions), loss of contact with reality
• Numbness, tingling, or cold feeling in your hands and feet.
• Too few white blood cells; lack of energy, fatigue, lethargy.
• Bronchospasm (constriction of air passages causing difficulty in breathing).
• Hepatitis (inflammation of the liver) - characterised by yellowing of your skin or the whites of your eyes).

You may notice tiredness, exhaustion, dizziness and headache, especially during the first two weeks of treatment. Other side effects include:

Frequent:

• Fatigue, unusual tiredness or weakness.
• Feeling short of breath, even with mild exertion
• Mild headache
• Sweating
• Low blood pressure
• High blood pressure
• Nausea (queasiness, feeling that one is about to vomit)
• Vomiting
• Diarrhoea (frequent or lose watery stools)
• Constipation
• Decreased sexual ability

Less frequent:

• Difficulty in sleeping
• Restlessness
• Depression
• Problems with vision
• Skin reactions (rash, itching)
• Loss of hair
• Restlessness
• Inflammation of the mouth
• Problems with hearing
• Muscle cramps
• Muscle weakness
• Weight gain
• Low blood sugar
• Increased levels of uric acid in the blood
• Increased blood levels of some fats
• Light headedness or fainting (especially when getting up from a lying down position)
• Nightmares
• Increased liver enzymes (you would notice yellowing of your skin or the whites of your eyes)
• Impotence (loss of male sexual ability)
• Runny nose
• Dry eyes, changes in vision
• Conjunctivitis.

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 or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PRESESE.

Store at or below 25 °C (room temperature). Protect from light and moisture. Do not remove the blister strip from the carton until required for use. Keep the container well closed. Store 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 or sewerage systems (e.g. toilets).