CO-TENIDONE

When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. 5mg chlortalidone. For patients who do not respond to this dose, the dosage can be increased to the 100mg atenolol and 50mg chlortalidone dose Co-tenidone.

Where necessary, another antihypertensive drug, such as a vasodilator, can be added.

Special Populations:

Elderly: Dosage requirements are often lower in this age group. Use in children and adolescents (< 18 years) There is no experience of using Co-tenidone in children and adolescents. Therefore Co-tenidone should not be administered to children and adolescents.

Use in patients with renal impairment Due to the properties of the chlortalidone component, Co-tenidone has reduced efficacy in the presence of renal insufficiency. 3). Use in patients with hepatic impairment Dose adjustments are not required in patients with hepatic impairment.

In clinical studies, the possible adverse reactions are usually attributable to the pharmacological actions of its components. 01%), not known (cannot be estimated from available data): Blood and lymphatic system disorders: Rare: Purpura, thrombocytopenia, leucopenia (related to chlortalidone).

Psychiatric disorders:

Uncommon: Sleep disturbances of the type noted with other beta-blockers.

Rare:

Mood changes, nightmares, confusion, psychoses and hallucinations.

Nervous system disorders:

Rare: Dizziness, headache, paraesthesia.

Eye disorders:

Rare: Dry eyes, visual disturbances.

Frequency not known: choroidal effusion Cardiac disorders:

Common: Bradycardia Rare: Heart failure deterioration, precipitation of heart block.

Vascular disorders:

Common: Cold extremities.

Rare:

Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud’s phenomenon.

Respiratory, thoracic and mediastinal disorders:

Rare: Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints.

Gastrointestinal disorders:

Common: Gastrointestinal disturbances (including nausea related to chlortalidone).

Rare:

Dry mouth.

Not known:

Constipation Hepatobiliary disorders: Rare: Hepatic toxicity including intrahepatic cholestasis, pancreatitis (related to chlortalidone).

Skin and subcutaneous tissue disorders:

Rare: Alopecia, psoriasiform skin reaction, exacerbation of psoriasis, skin rashes.

Reproductive system and breast disorders:

Rare: Impotence.

General disorders and administration site conditions:

Common: Fatigue.

Investigations:

Common (related to chlortalidone): Hyperuricaemia, hyponatraemia, hypokalaemia, impaired glucose tolerance.

Uncommon:

Elevations of transaminase levels.

Very rare:

An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear.

Musculoskeletal and connective tissue disorders:

Not known: Lupus-like syndrome Discontinuation of Co-tenidone should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

3) may be used in patients whose signs of heart failure have been controlled. Caution must be exercised in patients whose cardiac reserve is poor. • may increase the number and duration of angina attacks in patients with Prinzmetal's angina due to unopposed alpha receptor mediated coronary artery vasoconstriction.

Atenolol is a beta-1 selective beta-blocker; consequently the use of Co-tenidone may be considered although utmost caution must be exercised. 3) Co-tenidone may also aggravate less severe peripheral arterial circulatory disturbances.

• due to its negative effect on conduction time, caution must be exercised if it is given to patients with first degree heart block. • may mask the symptoms of hypoglycaemia, in particular, tachycardia. Beta- blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas.

Diabetic patients should be advised to carefully monitor blood glucose levels. 5). • may mask the cardiovascular signs of thyrotoxicosis. • will reduce heart rate, as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms which may be attributable to a slow heart rate, the dose may be reduced.

• should not be discontinued abruptly in patients suffering from ischaemic heart disease. • may cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction to such allergens.

Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. • patients with bronchospastic disease should, in general, not receive beta blockers due to increasing in airways resistance. Atenolol is a beta1-selective beta-blocker; however this selectivity is not absolute.

Therefore the lowest possible dose of Co-tenidone should be used and utmost caution must be exercised. If increased airways resistance does occur, Co-tenidone should be discontinued and bronchodilator therapy (eg salbutamol) administered if necessary.

• systemic effects of oral beta-blockers may be potentiated when used concomitantly with ophthalmic beta-blockers. • in patients with phaeochromocytoma Co-tenidone must be administered only after alfa-receptor blockade. Blood pressure should be monitored closely.

• Caution must be exercised when using anaesthetic agents with Co-tenidone. The anesthetist should be informed and the choice of anaesthetic should be an agent with as little negative inotropic activity as possible. Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia ( slower heart rate) and increase the risk of hypotension.

Anaesthetic agents causing myocardial depression are best avoided. Due to its chlortalidone component: • plasma electrolyte should be periodically determined in appropriate intervals to detect possible electrolyte imbalance especially hypokalaemia and hyponatraemia • hypokalaemia and hyponatraemia may occur.

Measurement of electrolytes is recommended, especially in the older patient, those receiving digitalis preparations for cardiac failure, those taking an abnormal (low in potassium) diet or those suffering from gastrointestinal complaints.

Hypokalaemia may predispose to arrhythmias in patients receiving digitalis. • because chlortalidone may impair glucose tolerance diabetic patients should be aware of the potential for increased glucose levels. Close monitoring of glycaemia is recommended in the initial phase of therapy and in prolonged therapy test for glucosuria should be carried out at regular intervals.

• in patients with impaired hepatic function or progressive liver disease, minor alterations in fluid and electrolyte balance may precipitate hepatic coma. • hyperuricaemia may occur. Only a minor increase in serum uric acid usually occurs but in cases of prolonged elevation, the concurrent use of a uricosuric agent will reverse the hyperuricaemia.

Choroidal effusion, acute myopia and secondary angle-closure glaucoma:

Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.

Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.

Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy The product label will state 'Do not take this medicine if you have a history of wheezing or asthma'. Patients with anamnestically known psoriasis should take atenolol only after careful consideration.

Co-tenidone should not be used in patients with any of the following: • known hypersensitivity to atenolol and chlortalidone (or to sulphonamide derived medicinal products) or any other component of the product • second or third degree heart block • sick-sinus syndrome • bradycardia • uncontrolled heart failure • cardiogenic shock • hypotension • severe peripheral arterial circulatory disturbances • severe renal failure • metabolic acidosis • untreated phaeochromocytoma • pregnancy and lactation