CONCOR COR 2.5 mg Merck Serono - HCP

1 CONCOR COR mg Merck Serono Composition - severe bronchial asthma or severe chronic Active substance: Bisoprolol fumarate (2:1). obstructive lung disease, One film-coated tablet contains - late stages of peripheral arterial occlusive disease Medicinally active ingredient: mg bisoprolol or vascular spasm in toes and fingers (Reynaud's fumarate (2:1). syndrome), - untreated tumours of the adrenal medulla (pheo- Other ingredients chromocytoma), Colloidal silicon dioxide, magnesium (stearate, pal- - metabolic acidosis, mitate, oleate), crospovidone, corn starch, micro- - known hypersensitivity to bisoprolol, or to any of crystalline cellulose, calcium hydrogen phosphate, the tablet constituents. dimethicone, macrogol 400, titanium dioxide (E 171), Side Effects hypromellose. Besides the desired main effects, drugs can also Substance group have undesirable effects, so-called adverse reactions, Cardioselective beta-receptor blocker.

2 Which by no means occur in every patient, however. Indications The following data are based on the therapeutic Treatment of stable chronic, moderate to severe experience obtained after approval of bisoprolol heart failure (myocardial insufficiency) with impaired for the therapy of hypertension as well as coronary systolic ventricular function (ejection fraction 35%, heart disease. determined by echocardiography) in addition to ACE Central Nervous System inhibitors and diuretics, and optionally cardiac glyco- Occasionally: Tiredness*, exhaustion*, dizziness*, sides. headache*;. Contraindications Rare: Sleep disorders, depression;. CONCOR COR must not be taken in: Very rarely: Nightmares, hallucinations - acute myocardial insufficiency (heart failure) or Eyes during a deterioration (decompensation) of the Very rarely: Reduced tear flow (to be taken into heart failure requiring intravenous therapy with consideration in patients wearing contact lenses).

3 Substances increasing the contractility of the heart, Single cases: Conjunctivitis. - shock induced by disorders of cardiac function Ears (cardiogenic shock), Very rarely: Hearing disorders - severe disturbances of atrioventricular impulse conduction (second or third degree AV block) with- Cardiovascular System out a pacemaker), Occasionally: Sensation of cold and numb extremi- - sick sinus syndrome, ties; Rarely: Slowing of heart rate (bradycardia), - disturbed conduction between sinus node and atri- disturbed atrioventricular impulse conduction (AV. um (sinoatrial block), block), deterioration of heart failure, stronger drop - markedly slowed heart rate (pulse rate less than in blood pressure (also when standing up from a 60 beats/min) before the start of treatment, supine position, orthostatic hypotension). - markedly decreased blood pressure (systolic blood Respiratory System pressure below 100 mmHg), Rarely: Bronchospasm in patients with a history of CONCOR COR mg - bronchial asthma or obstructive airways disease; - disturbed cardiac blood flow due to vasospasms of Very rarely: Allergic cold (rhinitis).

4 The coronary vessels (Prinzmetal's angina). Gastrointestinal Tract - peripheral arterial occlusive disease (intensification Occasionally: Nausea, vomiting, diarrhea, constipa- of complaints may occur especially when starting tion; Muscles and Skeleton (locomotor system): therapy). In patients with a personal or family history of pso- Rare: Muscle weakness, muscle cramps. riasis, beta-receptor blockers ( CONCOR Cor Skin mg) should only be used if the benefit-to-risk Very rarely: Hypersensitivity reactions (itching, tem- ratio has been carefully weighed. porary flush, rash); Single cases: Beta-receptor In patients with a tumour of the adrenal medulla blockers can trigger psoriasis, aggravate the condi- (pheochromocytoma) CONCOR Cor mg may only tion or lead to psoriasiform rash. Loss of hair. be administered after previous alpha-receptor block- Genitourinary Organs ade. Very rarely: Potency disorders.

5 Pregnancy and Lactation Metabolism During pregnancy CONCOR Cor mg should only be Very rarely: Increased liver enzyme values (GOT, used after the doctor has carefully weighed the ben- GPT), hepatitis, increased triglyceride values. efit to-risk ratio. In general beta-blockers reduce pla- cental blood flow and can affect the development of *These symptoms occur especially at the start of the unborn child. Placental and uterine blood flow as treatment. They are mild and usually disappear with- well as the growth of the unborn child must be moni- in 1 to 2 weeks after the start of treatment. tored and, if required, alternative therapeutic mea- If any other adverse effects not referred to in this sures considered. The newborn child must be moni- package leaflet, you should report these also to your tored closely after delivery. Symptoms of reduced doctor or pharmacist. blood glucose and slowed pulse rate generally occur Your doctor will decide about any possibly required within the first 3 days of life.

6 It is not known wheth- countermeasures. er bisoprolol passes into breast milk. Therefore, Precautions breastfeeding is not recommended during CONCOR In the following cases you may take CONCOR COR Cor mg therapy. mg only under certain conditions and with partic- CONCOR COR should not be used in children as no ular caution: Please consult your doctor about this. adequate therapeutic experience in this context is This also applies if you have been affected by any of available. the following in the past: No dose adjustment is required in elderly patients. - bronchospasm (bronchial asthma, obstructive air- No adequate therapeutic experience is available way diseases) to date with regard to heart failure patients over 80. - treatment with inhalation anesthetics years of age. - diabetes mellitus with extremely fluctuating blood Warnings glucose levels; symptoms of markedly reduced The treatments of myocardial insufficiency with blood glucose (hypoglycemia) can be masked CONCOR COR mg requires regular monitoring.

7 - strict fasting This is absolutely necessary especially at the start - ongoing desensitization therapy, of therapy. - mild disturbances of atrioventricular conduction In bronchial asthma or other chronic obstructive (first degree AV block) pulmonary diseases that may be associated with CONCOR COR mg - symptoms concomitant bronchodilator therapy is dosage please inform your doctor immediately. indicated. Depending on the extent of overdosage your doctor An increase in airways resistance may occasionally can then decide which measures to take. The most occur in asthma patients, requiring a higher 2-sym- frequent signs of CONCOR COR mg overdosage pathomimetic dose. include slowed heart beat (bradycardia), marked Like other beta-blockers, bisoprolol can increase the drop in blood pressure, bronchospasm, acute heart sensitivity to allergens and the severity of anaphy- failure as well as hypoglycaemia.

8 Lactic reactions, acute general allergic reactions. In the case of overdosage therapy with CONCOR COR. Adrenaline does not always produce the desired mg should be discontinued after consultation of therapeutic effect in these cases. the attending physician. The symptoms of thyroid hyperfunction (thyrotoxico- Do not take the double dose the next time but con- sis) can be masked by bisoprolol. tinue your regimen as prescribed either under So far no adequate therapeutic experience is avail- Dosage instructions or by your doctor. able for CONCOR COR mg in heart failure patients Please do not interrupt or stop treatment with with concomitant insulin-dependent type-I diabetes CONCOR COR mg without having consulted your mellitus, impaired kidney function (serum creatinine doctor. mg/dl), impaired liver function, restrictive car- You should not discontinue treatment with CONCOR diomyopathy, congenital heart diseases or haemo- COR mg abruptly as this may lead to temporary dynamically relevant cardiac valve diseases.

9 Deterioration of the heart failure. The dose should be No adequate therapeutic experience is available gradually reduced ( halving of the dose at week- either in patients with mild heart failure (NYHA II) as ly intervals). well as heart failure and myocardial infarction within This should be observed especially in patients with the last 3 months. Therapy with bisoprolol should disturbed coronary blood flow. not be discontinued abruptly without compelling indi- Drug Interactions cation. Simultaneous administration of the following drugs In a study on patients with coronary heart disease is not recommended: bisoprolol did not affect the driving performance of Increased lowering of blood pressure, delayed atrio- the patients. However, due to individually different ventricular impulse conduction as well as reduced reactions to the drug, the ability to drive a vehicle,contractility of the heart muscle have been observed to operate machinery, or to work without a firm hold after simultaneous use of calcium antagonists.

10 May be impaired. This is particularly the case at the Concurrent use of bisoprolol and clonidine can lead start of treatment, when the dosage is increased or to a stronger reduction of heart rate and to delayed the medication changed as well as in conjunction impulse conduction in the heart. Discontinuation with alcohol. of clonidine can also bring about an excessive Notes on Stability increase in blood pressure. The expiry date of this pack printed on the folding Simultaneous administration of monoamineoxidase box and on the brim of each blister strip. Do not use inhibitors (except MAO-B inhibitors) can affect the this pack once the expiry date has elapsed. blood pressure (lowering of blood pressure, but also Storage excessive increase in blood pressure). Do not store CONCOR COR mg above 25 C. The following drugs may only be used at the same OVERDOSAGE time under certain conditions and with particular In the case of suspected CONCOR COR mg over- caution: CONCOR COR mg - The depressant effects of CONCOR COR mg and COR mg can slightly shorten the half-life of biso- antiarrhythmics on impulse conduction and contrac- prolol.