CELECTOL

Posology Adults The initial dose is 200 mg orally taken once daily with a glass of water. Celectol should preferably be taken first thing in the morning, 30 minutes before food or 2 hours after a meal. If response is inadequate, the dose may be increased to 400 mg once daily according to the therapeutic response.

In hypertensive patients additional treatment with other anti-hypertensive agents is possible, in particular with diuretics. When a combination is initiated an increased monitoring the blood pressure is recommended. Elderly Dosage as for adults.

However close monitoring of elderly patients should be exercised, as renal and hepatic functions may be decreased in this population. Paediatric population Not recommended. 4). 3). 3). Method of administration Oral administration.

Adverse drug reactions are listed below by system organ class and frequency.

Frequencies are defined as:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia (in particular, tachycardia).

5) Psychiatric disorders: Common: depression Uncommon: insomnia Not known: libido decrease, hallucination, nightmare Confusion and psychoses have also been reported.

Nervous system disorders:

Common: tremor, paraesthesia, headache, asthenia, somnolence, dizziness Eye disorders: Not known: xerophthalamias, impaired vision Cardiac disorders: Uncommon: palpitations Not known: bradycardia, syncope, cardiac failure and arrhythmias (including slowed A-V conduction and in susceptible patients there may be precipitation of existing A-V block).

4) Uncommon: hypotension, peripheral coldness Respiratory, thoracic and mediastinal disorders: Uncommon: dyspnoea Not known: bronchospasm (in patients with bronchial asthma or with a history of bronchial complaints) and interstitial pneumonitis Gastrointestinal disorders: Common: vomiting, nausea, abdominal pain, dry mouth Not known: diarrhoea Skin and subcutaneous tissue disorders: Common: hyperhidrosis, erythema, rash, pruritus Not known: dermatitis psoriasiform, aggravation of psoriasis, alopecia Musculoskeletal and connective tissue disorders: Uncommon: muscle spasms Not known: systemic lupus erythematosus, arthralgia Reproductive system and breast disorders: Common: erectile dysfunction Investigations: Common: increase in antinuclear antibodies (ANAs) Not known: hepatic transaminases increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Asthma and bronchospastic diseases Although cardio selective 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 chronic obstructive airways disease, and in patients with a history of bronchospasm or bronchial asthma, unless there are compelling clinical reasons for their use.

Where such reasons exist, celiprolol may be used but with the utmost caution under specialist supervision.

The label will carry the following warning:

Do not take this medicine if you have wheezing or asthma. Impaired renal and hepatic function Celectol may be used in patients with mild to moderate degrees of reduced renal function as celiprolol is cleared by both renal and non-renal excretory pathways.

A reduction in dosage by half may be appropriate in patients with creatinine clearances in the range of 15 – 40 ml per minute. However, careful surveillance of such patients is recommended until steady state blood levels are achieved which typically would be within one week.

Celectol is not recommended for patients with creatinine clearance less than 15 ml per minute. Patients with hepatic impairment should also be carefully monitored after commencing therapy and a reduced dosage should be considered. Withdrawal In patients with coronary insufficiency, treatment should not be discontinued abruptly.

Sudden withdrawal of beta-blockers in patients with ischaemic heart disease may result in the appearance of anginal attacks of increased frequency or severity or deterioration in cardiac state. Although no adverse effects due to abrupt cessation of Celectol have been seen in clinical trials, therapy should be gradually reduced over 1 – 2 weeks, at the same time, if necessary, initiating replacement therapy to prevent exacerbation of angina pectoris.

1. • Cardiogenic shock, uncontrolled heart failure, sick-sinus syndrome, (including sino-atrial block), second or third degree heart block or severe bradycardia (≤ 50 beats per minute). • Severe renal impairment with creatinine clearance less than 15 ml per minute.

• Acute episodes of asthma. • Untreated phaeochromocytoma. • Metabolic acidosis. • Hypotension (systolic blood pressure less than 100 mmHg). • Late stages of peripheral arterial occlusive disease and Raynaud’s syndrome. Celectol film-coated tablets should not be prescribed for patients being treated with theophylline.