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Carvena

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Indications:

Adjunctive therapy for the treatment of symptomatic congestive heart failure to reduce morbidity and increase patient well-being. Treatment of hypertension. Long-term management of stable angina pectoris.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients. NYHA (New York Heart Association) Class IV decompensated heart failure requiring intravenous inotropic support, liver dysfunction. As with other beta-blocking agents: history of bronchospasm or asthma, 2nd and 3rd degree A-V heart block, (unless a permanent pacemaker is in place), severe bradycardia (< 50 bpm), cardiogenic shock, sick sinus syndrome (including sino-atrial block) and severe hypotension (systolic blood pressure < 85 mmHg). This medicinal product contains lactose therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption should not take this medicine. This medicinal product contains sucrose therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine

Adverse reactions:

Clinical Trials Adverse events are listed separately for each indication because of differences in the background diseases. IN CONGESTIVE HEART FAILURE: Haematological Rare: thrombocytopenia. Leucopenia has been reported in isolated cases. Metabolic Common: weight increase and hypercholesterolaemia. Hyperglycaemia, hypoglycaemia and worsening control of blood glucose are also common in patients with pre-existing diabetes mellitus . Central nervous system Very common: dizziness, headaches are usually mild and occur particularly at the start of treatment. Asthenia (including fatigue). Cardiovascular system Common: bradycardia, postural hypotension, hypotension, oedema (including generalised, peripheral, dependent and genital oedema, oedema of the legs, hypervolaemia and fluid overload). Uncommon: syncope (including presyncope), AV-block and cardiac failure during up-titration. Angina pectoris has been reported rarely. Gastro-intestinal system Common: nausea, diarrhoea, vomiting and abdominal pain. Others Common: vision abnormalities. Rare: acute renal failure and renal function abnormalities in patients with diffuse vascular disease and/or impaired renal function . The frequency of adverse experiences is not dose dependent, with the exception of dizziness, abnormal vision and bradycardia. IN HYPERTENSION AND ANGINA: The profile is similar to that observed in congestive heart failure although the incidence of events is generally lower in patients with hypertension or angina treated with this medicine. Blood chemistry and haematological Isolated cases of changes in serum transaminases, thrombocytopenia and leucopenia have been reported. Central nervous system Common: dizziness, headaches and fatigue, which are usually mild and occur particularly at the beginning of treatment. Uncommon: depressed mood, sleep disturbance, paraesthesia, asthenia. Cardiovascular system Common: postural hypotension, hypotension, especially at the beginning of treatment and bradycardia. Uncommon: syncope, disturbances of peripheral circulation (cold extremities, (PVD), exacerbation of intermittent claudication and Raynauds phenomenon). AV-block, angina pectoris (including chest pain), symptoms of heart failure and peripheral oedema. Respiratory system Common: asthma and dyspnoea in predisposed patients. Rare: stuffy nose, flu-like symptoms. Gastro-intestinal system Common: gastro-intestinal upset (with symptoms such as nausea, abdominal pain, diarrhoea). Uncommon: constipation and vomiting. Skin and appendages Uncommon: skin reactions (e.g. allergic exanthema, dermatitis, urticaria, pruritus and lichen planusNON-BREAKING HYPHEN (8209)like reactions). Psoriatic skin lesions may occur or existing lesions exacerbated. Others Common: pain in the extremities, reduced lacrimation and eye irritation. Uncommon: cases of sexual impotence and disturbed vision. Rare: dryness of the mouth and disturbances of micturition. Isolated cases of allergic reactions have been reported. Post-marketing experience Isolated cases of urinary incontinence in women, which resolved upon discontinuation of the medication, have been reported.

Interactions:

During general anaesthesia attention should be paid to the potential synergistic negative inotropic effects of carvedilol and anaesthetic drugs. As with other antihypertensives, there is a potential for pronounced hypotension during general anaesthesia. this medicine may potentiate the effect of other concomitantly administered drugs that are anti-hypertensive in action (e.g. alpha1-receptor antagonists) or have hypotension as part of their adverse effect profile. Patients taking both agents with beta-blocking properties and a drug that can deplete catecholamines (e.g. reserpine and monoamine oxidase inhibitors) should be observed closely for signs of hypotension and/or severe bradycardia. As with other drugs with beta-blocking activity, caution should be exercised when administering Class I antiarrhythmic drugs or calcium antagonists such as verapamil. These drugs should not be administered intravenously. Trough plasma digoxin levels may be increased by approximately 16% in hypertensive patients co-administered this medicine and digoxin. Increased monitoring of digoxin levels is recommended when initiating, adjusting or discontinuing this medicine. Modest increases in mean trough cyclosporin concentrations were observed following initiation of carvedilol treatment in 21 renal transplant patients suffering from chronic vascular rejection. In about 30% of patients, the dose of cyclosporin had to be reduced in order to maintain cyclosporin concentrations within the therapeutic range, while in the remainder, no adjustment was needed. On average, the dose of cyclosporin was reduced about 20% in these patients. Due to wide interindividual variability in the dose adjustment required, it is recommended that cyclosporin concentrations be monitored closely after initiation of carvedilol therapy and that the dose of cyclosporin be adjusted as appropriate. When treatment with this medicine and clonidine together is to be terminated, carvedilol should be withdrawn first, several days before gradually decreasing the dosage of clonidine. Care may be required in those receiving inducers of mixed function oxidases e.g. rifampicin, as serum levels of carvedilol may be reduced or inhibitors of mixed function oxidases e.g. cimetidine, as serum levels may be increased. The effects of insulin or oral hypoglycaemics may be intensified. The signs of hypoglycaemia (especially palpitation) may be masked or attenuated.

Warnings:

Carvedilol can be administered with caution to patients with obstructive respiratory disorders provided that adequate supervision is maintained. If increased airways resistance develops, consideration must be given to discontinuation of the beta-blocker, depending on the degree of airways resistance and the benefit derived from beta -blockade. Special care should be taken in patients whose cardiac reserve is poor. Heart failure should be satisfactorily controlled with appropriate therapy before carvedilol is started. In hypertensive patients who have congestive heart failure controlled with digoxin, diuretics and/or an ACE inhibitor, this medicine should be used with caution since both digoxin and this medicine may slow A-V conduction. As with other drugs with beta-blocking activity, this medicine may mask the signs of hyperthyroidism and the early signs of acute hypoglycaemia in patients with diabetes mellitus. Alternatives to beta-blocking agents are generally preferred in insulin-dependent patients. In congestive heart failure patients with diabetes, the use of this medicine may be associated with worsening control of blood glucose. Therefore, regular monitoring of blood glucose is required in diabetics when this medicine is initiated or up-titrated and hypoglycaemic therapy adjusted accordingly. Reversible deterioration of renal function has been observed with this medicine therapy in congestive heart failure patients with low blood pressure (systolic BP < 100 mmHg), ischaemic heart disease and diffuse vascular disease, and/or underlying renal insufficiency. In CHF patients with these risk factors, renal function should be monitored during up-titration of this medicine and the drug discontinued or dosage reduced if worsening of renal failure occurs. In congestive heart failure patients, worsening cardiac failure or fluid retention may occur during up-titration of this medicine. If such symptoms occur, diuretics should be increased and the this medicine dose should not be advanced until clinical stability resumes. Occasionally it may be necessary to lower the this medicine dose or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of this medicine. Wearers of contact lenses should be advised of the possibility of reduced lacrimation. Although angina has not been reported on stopping treatment, discontinuation should be gradual in patients with ischaemic heart disease, as this medicine has beta-blocking activity. If this medicine induces bradycardia, with a decrease in pulse rate to less than 55 beats per minute, the dosage of this medicine should be reduced. Care should be taken in administering this medicine to patients with a history of serious hypersensitivity reactions and in those undergoing desensitisation therapy as beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions. In patients suffering from the peripheral circulatory disorder Raynaud’s phenomenon, there may be exacerbation of symptoms. Patients with a history of psoriasis associated with beta-blocker therapy should be given this medicine only after consideration of the risk-benefit ratio. In patients with phaeochromocytoma, an alpha-blocking agent should be initiated prior to the use of any beta-blocking agent. There is no experience of the use of carvedilol in this condition. Therefore, caution should be taken in the administration of this medicine to patients suspected of having phaeochromocytoma. Agents with non-selective beta-blocking activity may provoke chest pain in patients with Prinzmetal’s variant angina. There is no clinical experience with carvedilol in these patients, although the alpha-blocking activity of this medicine may prevent such symptoms. However, caution should be taken in the administration of this medicine to patients suspected of having Prinzmetal’s variant angina. Usage of carvedilol in patients with symptomatic congestive heart failure has not been shown to reduce mortality.

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