CO-TENIDONE

Posology Adults:

One tablet daily.

Elderly:

One tablet daily. The elderly with hypertension who do not respond to low dose therapy with a single agent should have a satisfactory response to a single tablet daily of co-tenidone. g. as a vasodilator, may be appropriate.

Paediatric population:

The use of co-tenidone is not recommended in children. The safety and efficacy of co-tenidone in children has not yet been established.

Renal impairment:

Due to the properties of the chlortalidone component, Co-tenidone has reduced efficacy in the presence of renal insufficiency. 3). Method of administration Oral administration.

Tabulated list of adverse reactions Co-tenidone tablets were well tolerated in clinical studies, the undesired events reported are usually attributable to the pharmacological actions of its components. The following undesired events, listed by body system, have been reported with the following frequencies: 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 available data): System Organ Class Frequency Adverse Drug Reaction 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 Not known Depression Eye disorders Rare Dry eyes, visual disturbances 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 Not known Hypersensitivity reactions, including angioedema and urticaria Musculoskeletal and connective tissue disorders Not known Lupus-like syndrome 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 Cases of choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 modify warning signs of hypoglycaemia as tachycardia, palpitation and sweating. 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. • may cause a hypersensitivity reaction including angioedema and urticaria • 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 pheochromocytoma 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 anaesthetist 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 and increase the risk of hypotension.

Anaesthetic agents causing myocardial depression are best avoided. • Co-tenidone should be used with caution in patients with a predisposition to uricaemia or gout since chlorthalidone may cause a rise in serum uric acid levels. Prolonged elevation can be corrected by the use of a uricosuric agent.

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. • impaired glucose tolerance may occur and 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 carries 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. This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

1 • bradycardia • cardiogenic shock • hypotension • metabolic acidosis • severe peripheral arterial circulatory disturbances • second- or third-degree heart block • sick sinus syndrome • untreated phaeochromocytoma • severe renal failure • uncontrolled heart failure Co-tenidone tablets must not be given during pregnancy or lactation.