PRESESE Film-coated tablet Ref.[115297] Active ingredients: Bisoprolol

Posology

The treatment of stable chronic heart failure with PRESESE has to be initiated with a titration phase as given in the description below:

The treatment with PRESESE is to be started with a gradual up titration according to the following steps:

• 1.25 mg once daily for 1 week, if well tolerated increase to
• 2.5 mg once daily for a further week, if well tolerated increase to
• 3.75 mg once daily for a further week, if well tolerated increase to
• 5 mg once daily for the 4 following weeks, if well tolerated increase to
• 10 mg once daily for maintenance therapy.

After initiation of treatment with 1,25 mg, the patients should be observed over a period of approximately 4 hours (especially with regards to blood pressure, heart rate, conduction disturbances and signs of worsening of heart failure). The maximum recommended dose is 10 mg once daily.

Occurrence of adverse events may prevent all patients being treated with the maximum recommended dose. If necessary, the dose reached can also be decreased step by step. The treatment may be interrupted if necessary and reintroduced as appropriate. During the titration phase, in case of worsening of the heart failure or intolerance, it is recommended to first reduce the dose of PRESESE, or to stop immediately if necessary (in cases of severe hypotension, worsening of heart failure with acute pulmonary oedema, cardiogenic shock, symptomatic bradycardia or AV block).

Treatment of stable chronic heart failure with PRESESE is generally a long-term treatment. The treatment with PRESESE is not recommended to be stopped abruptly since this might lead to transitory worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased by dividing into halves, weekly.

There is wide interindividual variation in sensitivity to one single high dose of bisoprolol. Therefore, it is mandatory to initiate the treatment of these patients with a gradual up titration according to the scheme given.

Special populations

Elderly patients are more likely to have age-related peripheral vascular disease which may require caution.

Paediatric population

Safety and efficacy in children have not been established.

Method of administration

PRESESE should be taken in the morning and can be taken with food. They should be swallowed with liquid and should not be chewed.

Overdosage may produce bradycardia and severe hypotension. Bronchospasm and heart failure may be produced in certain individuals as well as acute cardiac insufficiency, cardiac conduction block, heart failure, cardiogenic shock and hypoglycaemia.

Coma and convulsions have also been reported, and some patients may develop severe and occasionally fatal cardiovascular depression. Cases of overdose should be observed for at least 4 hours, as apnoea and cardiovascular collapse may appear suddenly.

Treatment

Generally, in cases of overdose, the patient should stop taking PRESESE and supportive and symptomatic treatment should be provided.

Repeated activated charcoal is necessary in severe overdose

The data available suggest that bisoprolol is not dialysable to any extent.

Atropine may be administered intravenously to treat severe bradycardia. If the response is inadequate, isoprenaline or another medicine with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary Alternatively, dobutamine may be required to reverse beta-blockade. Cardiac pacing may be required for severe bradycardia.

Hypotension: Vasopressors and I.V. fluids should be administered.

Glucagon may be given intravenously, with sympathomimetics used as an alternative or given with glucagon.

AV block (second or third degree): Monitor patients closely and treat with isoprenaline infusion or insert a cardiac pacemaker.

Acute worsening of heart failure: Recommended treatment includes I.V. diuretics, inotropic medicines and vasodilating medicines.

Bronchospasm should be treated with bronchodilator therapy such as isoprenaline, β₂-sympathomimetic medicines and/or aminophylline. Beta-agonist (e.g. salbutamol) or xanthines may also be given.

Hypoglycaemia: I.V. glucose or glucagon can be administered.

24 months.

Store at or below 25°C. Protect from light and moisture.

Keep blisters in the original carton until required for use.

Keep the containers tightly closed.

PRESESE 5 mg TABLETS AND PRESESE 10 mg TABLETS

Blister pack:

Tablets are packed in printed peelable lidding silver foil (50 g/m² paper/12 micron polyster/20 micron Aluminium foil/7 g/m² HSL) and cold form film (25 micron polyamide/45 micron Aluminium foil/60 micron PVC film). One blister contains 10 tablets.

Pack size: 30's: Each carton contains 3 blisters of 10 tablets each.

HDPE Container Pack:

Tablets are packed in white opaque round 40 ml HDPE container with a white opaque ribbed stock (RS) HDPE closure, with induction sealing wad containing one silica gel sachet. Each container which is enclosed in an outer cardboard carton contains 30 tablets.

Pack size: 30's - One HDPE container contains 30 tablets.

Any unused product or waste material should be disposed of in accordance with local requirements.