Yellow pill with heart shape on it

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Cardicor 1. Qualitative and quantitative composition Cardicor 1. Pharmaceutical form Film-coated tablet. Clinical particulars 4. Patients should be stable without acute failure when bisoprolol treatment is initiated. It is recommended that the treating physician should be experienced in the management of chronic heart failure.

Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter. The maximum recommended dose is 10 mg once daily. Close monitoring of vital s heart rate, blood pressure and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating the therapy.

Treatment modification. If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered. In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage of the concomitant medication is recommended. It may also be necessary to temporarily lower the dose of bisoprolol or to consider discontinuation. If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patients condition. Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.

Patients with hepatic or renal impairment. There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.

Older people. There is no paediatric experience with bisoprolol, therefore its use cannot be recommended in paediatric patients.

Method of administration. Bisoprolol tablets should be taken in the morning and can be taken with food. They should be swallowed with liquid and should not be chewed. Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition. The initiation and cessation of treatment with bisoprolol necessitates regular monitoring.

As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions.

Epinephrine treatment does not always yield the expected therapeutic effect. Despite its high beta1-selectivity, angina attacks cannot be completely excluded when bisoprolol is administered to patients with Prinzmetal's angina. Aggravation of symptoms may occur especially when starting therapy. It is currently recommended that maintenance beta-blockade be continued peri-operatively.

The anaesthetist must be aware of beta-blockade because of the potential for interactions with other drugs, resulting in bradyarrhythmias, attenuation of the reflex tachycardia and the decreased reflex ability to compensate for blood loss. If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia. Combination of bisoprolol with calcium antagonists of the verapamil or diltiazem type, with Class I antiarrhythmic drugs and with centrally acting antihypertensive drugs is generally not recommended, for details please refer to section 4.

Although cardioselective beta1 beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with obstructive airways diseases, unless there are compelling clinical reasons for their use. Where such reasons exist, Cardicor may be used with caution. In patients with obstructive airways diseases, the treatment with bisoprolol should be started at the lowest possible dose and patients should be carefully monitored for new symptoms e.

In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilating therapy should be given concomitantly. Occasionally an increase of the airway resistance may occur in patients with asthma, therefore the dose of beta 2 -stimulants may have to be increased. Patients with psoriasis or with a history of psoriasis should only be given beta-blockers e.

In patients with phaeochromocytoma bisoprolol must not be administered until after alpha-receptor blockade. Under treatment with bisoprolol the symptoms of a thyreotoxicosis may be masked. Calcium antagonists of the verapamil type and to a lesser extent of the diltiazem type: Negative influence on contractility and atrio-ventricular conduction. Class I antiarrhythmic drugs e. Centrally acting antihypertensive drugs such as clonidine and others e. Combinations to be used with caution.

Calcium antagonists of the dihydropyridine type such as felodipine and amlodipine: Concomitant use may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded. Class-III antiarrhythmic drugs e.

Topical beta-blockers e. Parasympathomimetic drugs: Concomitant use may increase atrio-ventricular conduction time and the risk of bradycardia. Insulin and oral antidiabetic drugs: Increase of blood sugar lowering effect. Blockade of beta-adrenoreceptors may mask symptoms of hypoglycaemia. Anaesthetic agents: Attenuation of the reflex tachycardia and increase of the risk of hypotension for further information on general anaesthesia see also section 4. Digitalis glycosides: Reduction of heart rate, increase of atrio-ventricular conduction time.

Concomitant use with antihypertensive agents as well as with other drugs with blood pressure lowering potential e. Combinations to be considered. Mefloquine: increased risk of bradycardia Monoamine oxidase inhibitors except MAO-B inhibitors : Enhanced hypotensive effect of the beta-blockers but also risk for hypertensive crisis.

In general, beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Adverse effects e. If treatment with beta-adrenoceptor blockers is necessary, beta 1 -selective adrenoceptor blockers are preferable. Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, the uteroplacental blood flow and the fetal growth should be monitored. In case of harmful effects on pregnancy or the fetus alternative treatment should be considered.

The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days. It is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended during administration of bisoprolol. However, due to individual variations in reactions to the drug, the ability to drive a vehicle or to operate machinery may be impaired. This should be considered particularly at start of treatment and upon change of medication as well as in conjunction with alcohol. Common: worsening of heart failure.

Uncommon: AV-conduction disturbances. Nervous system disorders: Common: dizziness, headache. Rare: syncope Eye disorders: Rare: reduced tear flow to be considered if the patient uses lenses. Very rare: conjunctivitis.

Ear and labyrinth disorders: Rare: hearing disorders. Respiratory, thoracic and mediastinal disorders: Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease. Rare: allergic rhinitis.

Gastrointestinal disorders: Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation. Skin and subcutaneous tissue disorders: Rare: hypersensitivity reactions pruritus, flush, rash and angioedema. Very rare: alopecia.

Beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash Musculoskeletal and connective tissue disorders: Uncommon: muscular weakness and cramps. Vascular disorders: Common: feeling of coldness or numbness in the extremities, hypotension. Uncommon: orthostatic hypotension. General disorders: Common: asthenia, fatigue. Hepatobiliary disorders: Rare: hepatitis. Reproductive system and breast disorders: Rare: erectile dysfunction. Psychiatric disorders: Uncommon: sleep disorder, depression. Rare: nightmare, hallucination. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Healthcare professionals are asked to report any suspected adverse reactions via: Yellow Card Scheme Website: www. With overdose e. In general the most common s expected with overdosage of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. There is a wide interindividual variation in sensitivity to one single high dose of bisoprolol and patients with heart failure are probably very sensitive.

Therefore it is mandatory to initiate the treatment of these patients with a gradual uptitration according to the scheme given in section 4. If overdose occurs, bisoprolol treatment should be stopped and supportive and symptomatic treatment should be provided.

Limited data suggest that bisoprolol is hardly dialysable. Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures should be considered when clinically warranted. Bradycardia: Administer intravenous atropine. If the response is inadequate, isoprenaline or another agent with positive chronotropic properties may be given cautiously.

Under some circumstances, transvenous pacemaker insertion may be necessary. Hypotension: Intravenous fluids and vasopressors should be administered. Intravenous glucagon may be useful. AV block second or third degree : Patients should be carefully monitored and treated with isoprenaline infusion or transvenous cardiac pacemaker insertion.

Yellow pill with heart shape on it

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