Nebilet 5mg Tablet

Treatment of mild to moderate essential hypertension.

Adults: Take one 5 mg tablet daily, preferable at the same time of the day, with or without meals. Combination with other antihypertensive agents: An additional antihypertensive effect has been observed only when NEBILET 5 mg is combined with hydrochlorthiazide 12,5 - 25 mg. Patients with renal insufficiency: The recommended starting dose is 2,5 mg daily. The daily dose may be increased to 5 mg if needed. Patients with hepatic insufficiency: There is no data in patients with hepatic insufficiency or impaired liver function. Therefore the use of NEBILET 5 mg is contraindicated in these patients. Elderly: in patients over 65 years, the recommended starting dose is 2,5 mg daily. The dose may be increased to 5 mg daily if needed. Due to limited experience in patients above 75 years, caution must be exercised and these patients monitored closely.

Hypersensitivity to NEBILET 5 mg
Liver insufficiency or liver function impairment.
Pregnancy and lactation.
NEBILET 5 mg is contraindicated in:

• Cardiogenic shock
• Untreated phaeochromocytoma
• Uncontrolled heart failure
• Metabolic acidosis
• Sick sinus syndrome, including
• Bradycardia (heart rate < 50 bpm)
• sino-atrial block
• Bronchial asthma
• 2nd and 3rd degree heart block
• Hypotension
• History of bronchospasm and bronchial asthma
• Verapamil therapy
• Children, as safety and efficacy has not been demonstrated.

Beta-adrenergic antagonists may increase the sensitivity to allergens and the severity of anaphylactic reactions.

Cardiovascular: Beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure, unless their condition has been stabilized. One of the pharmacological actions of beta-blockers is to reduce the heart rate. Abrupt discontinuation of therapy may cause exacerbation of angina pectoris in patients suffering from ischaemic heart disease. Discontinuation of therapy should be gradual (over a period of 1-2 weeks) and patients should be advised to limit the extent of their physical activity during the period that their medicine may be discontinued. If the pulse rate drops below 50-55 bpm at rest and/or the patient experiences symptoms suggestive of bradycardia, the dosage should be reduced. Beta-adrenergic antagonists should be used with caution in:

• Peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication) as the disorders may be aggravated
• 1st degree heart block because of the negative effect of beta-blockers on conduction time
• Prinzmetal's angina due to unopposed alpha receptor mediated coronary artery vasoconstriction. Beta-blockers may increase the number and duration of anginal attacks.

Metabolic/Endocrinological: Symptoms of hypoglycaemia (tachycardia, palpitations) may be masked in diabetic patients. Tachycardic symptoms may be masked in hyperthyroidism. Abrupt withdrawal may intensify symptoms.

Respiratory: Bronchospasm may occur in patients suffering from asthma, bronchitis and other chronic pulmonary diseases.

Other: Psoriasis may be aggravated. Patients with phaeochromocytoma should not receive beta-blockers without concomitant alpha-adrenoreceptor blocking therapy. Beta-blockers may unmask myasthenia gravis. Adverse reactions are more common in patients with renal decompensation, and in patients who receive beta-blockers intravenously.

Caution should be exercised when administering beta-blockers with calcium antagonists of the verapamil or diltiazem type because of their negative effect on contractility and atrioventricular conduction. Exaggeration of these effects can occur particularly in patients with impaired ventricular function and/or SA or AV-conduction abnormalities. Neither medicine should therefore be administered intravenously within 48 hours of discontinuing the other.

Caution should be exercised when administering beta-blockers with Class I anti-arrhythmic drugs and amiodarone as their effect on atrial conduction time and their negative inotropic effect may be potentiated. Such interactions can have life threatening consequences.

Beta-blockers increase the risk of rebound hypertension after sudden withdrawal of chronic clonidine treatment.

Digitalis glycosides associated with beta-blockers may increase atrio-ventricular conduction times. Nebivolol does not influence the kinetics of digoxin and clinical trials have not shown any evidence of an interaction. Special note: Digitalisation of patients receiving long term beta-blocker therapy may be necessary if congestive cardiac failure is likely to develop. The combination can be considered despite the potentiation of the negative chronotropic effect of the two medicines. Careful control of dosages and of individual patientu2019s response (notably pulse rate) is essential in this situation.

Insulin and oral antidiabetic drugs: Glucose levels are unaffected, however symptoms of hypoglycaemia may be masked.

Concomitant use of beta-blockers and anaesthetics e.g. ether, cyclopropane and trichloroethylene may attenuate reflex tachycardia and increase the risk of hypotension.

Provided NEBILET 5 mg is taken with a meal and an antacid between meals, the two treatments can be co-prescribed. Sympathicomimetic agents may counteract the effect of beta-blockers. Concomitant administration of tricyclic antidepressants, barbiturates and phenothiazines may increase the blood pressure lowering effect. Concomitant administration of serotonin re-uptake inhibitors or other compounds predominantly metabolised by the CYP2D6 pathway may delay oxidative metabolism of beta-blockers.

NEBILET 5 mg is contraindicated in pregnancy and lactation.

Patients should be advised not to drive or operate machinery until they know how NEBILET 5 mg affects them.

The most common side effects (incidence between 1 and 10 %) are headache, dizziness, tiredness and paraesthesia. Other side effects reported in 1 % of patients are: diarrhoea, constipation, nausea, dyspnoea and oedema. Typical beta-adrenergic antagonist side effects reported in less than 1 % of patients are: bradycardia, slowed AV-conduction/AV-block, hypotension, heart failure, increase of intermittent claudication, impaired vision, impotence, depression, nightmare, dyspepsia, flatulence, vomiting, bronchospasm and rash. The following side effects have also been reported with some beta-adrenergic antagonists: hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud phenomenon, dry eyes and mucocutaneous toxicity of the practolol-type, sleep disturbances and abdominal cramping. Congestive heart failure or heart block may be precipitated in patients with underlying cardiac disorders. Pneumonitis, pleurisy, paraesthesia, peripheral neuropathy, overt psychosis, myopathies, skin rash, pruritus, and reversible alopecia have been reported. Ocular symptoms include decreased tear production, blurred vision and soreness. Haematological reactions include non-thrombocytopenic purpura, thrombocytopenia, and less frequently agranulocytosis. Transient eosinophilia can occur. Metabolic changes affect glucose control and cholesterol concentrations. Other side effects include a lupus like syndrome, male impotence, hypoglycaemia, sclerosing peritonitis and retroperitoneal fibrosis. Severe peripheral vascular disease and even peripheral gangrene may be precipitated.

Symptoms: Bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.
Treatment: Blood glucose levels should be checked and symptomatic and supportive therapy given.