POM: Prescription only medicine
This information is intended for use by health professionals
PosologyAdultsOne tablet daily. Most patients with hypertension will give a satisfactory response to a single tablet daily of Tenoretic. There is little or no further fall in blood pressure with increased dosage and, where necessary, another antihypertensive drug, such as a vasodilator, can be added.ElderlyDosage requirements are often lower in this age group.Paediatric populationThe use of Tenoretic is not recommended in children. The safety and efficacy of Tenoretic in children has not yet been established.Renal ImpairmentDue to the properties of the chlortalidone component, Tenoretic tablets has reduced efficacy in the presence of renal insufficiency. This fixed dose combination should thus not be administrated to patients with severe renal impairment (see section 4.3).
Method of administrationTenoretic 100 mg/25 mg film-coated tablets are administered orally.
Due to its beta-blocker component Tenoretic tablets:- although contraindicated in uncontrolled heart failure (See section 4.3) 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 beta1-selective beta-blocker; consequently the use of Tenoretic tablets may be considered although utmost caution must be exercised. - although contraindicated in severe peripheral arterial circulatory disturbances (See section 4.3) 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.- 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 Tenoretic tablets should be used and utmost caution must be exercised. If increased airways resistance does occur, Tenoretic tablets should be discontinued and bronchodilator therapy (e.g. salbutamol) administered if necessary.The label and patient information leaflet for this product state the following warning: If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor.- systemic effects of oral beta-blockers may be potentiated when used concomitantly with ophthalmic beta-blockers.- in patients with phaeochromocytoma must be administered only after alfa-receptor blockade. Blood pressure should be monitored closely.- caution must be exercised when using anaesthetic agents with Tenoretic tablets. 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.
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 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.
Due to atenolol:Combined use of beta-blockers and calcium channel blockers with negative inotropic effects e.g. verapamil, diltiazem, can lead to an exaggeration of these effects particularly in patients with impaired ventricular function and/or sino-atrial or atrio-ventricular conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure. Neither the beta-blocker nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other.Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.Digitalis glycosides, in association with beta-blockers, may increase atrio-ventricular conduction time.Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are co-administered, the beta-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped.Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.Concomitant use of prostaglandin synthetase inhibiting drugs (e.g. ibuprofen, indometacin) may decrease the hypotensive effects of beta-blockersCaution must be exercised when using anaesthetic agents with Tenoretic tablets (see section 4.4).Due to Chlortalidone:The chlortalidone component may reduce the renal clearance of lithium leading to increased serum concentrations. Dose adjustments of lithium may therefore be necessary.Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering effects of these drugs.
Due to the combination product:Concomitant therapy with dihydropyridines e.g. nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.Concomitant use of baclofen may increase the antihypertensive effect making dose adjustments necessary.
Tabulated list of adverse reactionsTenoretic tablets are 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 the 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|
|Eye disorders||Rare||Dry eyes, visual disturbances|
|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)|
|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|
Reporting of suspected adverse reactionsReporting 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. Website: www.mhra.gov.uk/yellowcard
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