
Company: Takeda UK Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Candesartan cilexetil 2mg, 4mg, 8mg, 16mg, 32mg.
Description: 2mg: Round white tablets. 4mg: Round white tablets with a single score line on both sides. 8mg: Round pale pink tablets with a single score line on both sides. 16mg: Round light pink tablets with one convex side and one scored flat side, embossed 16 on convex side. 32mg: Round light pink tablets with convex sides, debossed 32 on one side and scored on the other.
Presentation: 2mg-7, €1.81; 2mg-28, €7.26; 4mg-7, €3.30. 4mg-28, €13.20; 8mg-28, 15.81; 16mg-28, €19.22; 32mg-28, €24.63.
Indications: Essential Hypertension. Treatment of patients with heart failure and left ventricle systolic dysfunction (LVEF ≤40%) as add-on therapy to ACE-inhibitors or when ACE-inhibitors are not tolerated.
Pharmacology: Candesartan cilexetil is a prodrug suitable for oral use. It is rapidly converted to the active substance, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract. Candesartan is an angiotensin II receptor antagonist, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor. It has no agonist activity.
Dosage: Adult: Hypertension: Initially 8mg once daily. Usual maintenance dose: 8mg, may be increased to 16mg. If blood pressure not sufficiently controlled after 4 weeks, may be increased to 32mg. Renal impairment (incl. haemodialysis) and those at risk of hypotension due to intravascular volume depletion: 4mg initially. Moderate hepatic impairment: 2mg initially. Heart failure: Initially 4mg once daily. Titrate up to 32mg once daily by doubling the dose at intervals of at least 2 weeks. Children: Safety and efficacy not established.
Contraindications: Hypersensitivity to candesartan cilexetil or to any of the excipients. Pregnancy and lactation. Severe hepatic impairment and/or cholestasis.
Special precautions: Not recommended: Primary hyperaldosteronism. Caution: Haemodynamically relevant aortic mitral valve stenosis, obstructive hypertrophic cardiomyopathy, severe congestive heart failure, underlying renal disease (incl. renal artery stenosis), haemodialysis (carefully titrate with thorough monitoring of blood pressure), anaesthesia and surgery. Monitor renal function, serum potassium and creatinine levels (heart failure, elderly, renal impairment, concomitant ACE inhibitor). Hypotension may occur. Contains lactose.
Drug interactions: Possible interaction with NSAIDs. Antihypertensive effect may be enhanced by other antihypertensives. K+ -sparing diuretics, K+ supplements, salt substitutes containing K+, or other medicinal products that may increase K+ levels, lithium.
Adverse drug reactions: Hypertension: Respiratory infection, dizziness/vertigo, headache. Heart failure: Hyperkalaemia, hypotension, renal impairment.
Full prescribing information and references available from Takeda UK Ltd. Telephone: +44 (1628) 537900. Fax: +44 (1628) 526615.