ADIZEM-SR

Posology Angina Adults:

The usual initial dose is 90 mg twice daily. Dosage may be increased gradually to 120 mg twice daily or 180 mg twice daily if required. Patients’ responses may vary and dosage requirements can differ significantly between individual patients.

Elderly and patients with impaired renal or hepatic function:

In the elderly, dosage should commence at 60 mg diltiazem hydrochloride twice daily and the dose carefully titrated as required.

Hypertension Adults:

The usual dose is one Adizem-SR 120 capsule twice daily. Patients may benefit by titrating from a lower total daily dose.

Elderly and patients with impaired renal or hepatic function:

The starting dose should be 60 mg diltiazem hydrochloride twice daily, increasing to one Adizem-SR 90 mg capsule twice daily and then to one Adizem-SR 120 mg capsule twice daily if clinically indicated.

Paediatric population:

The Adizem preparations are not recommended for children. Safety and efficacy in children has not been established. Method of administration Oral. To be taken at 12 hour intervals. Dosage may be taken with or without food, and should be swallowed whole and not chewed.

In order to avoid confusion, it is suggested that patients once titrated to an effective dose using either Adizem-SR tablets or capsules should remain on this treatment and should not be changed between different presentations. 5).

The following frequencies are the basis for assessing undesirable effects:

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). Very common Common Uncommon Rare Not known Blood and lymphatic system disorders Thrombocytopenia Immune system disorders Hypersensitivity Psychiatric disorders Nervousness, insomnia Mood changes (including depression) Nervous system disorders Headache, dizziness Extrapyramidal syndrome Very common Common Uncommon Rare Not known Cardiac disorders Atrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitations Bradycardia Sinoatrial block, congestive heart failure Vascular disorders Flushing Orthostatic hypotension Vasculitis (including leukocytoclastic vasculitis), hypotension Gastrointestinal disorders Constipation, dyspepsia, gastric pain, nausea Vomiting, diarrhoea Dry mouth Gingival hyperplasia Hepatobiliary disorders Hepatic enzymes increase (AST, ALT, LDH, ALP increase) Hepatitis Skin and subcutaneous tissue disorders Erythema, pruritus Urticaria Photosensitivity (including lichenoid keratosis at sun exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrolysis), hyperhidrosis, exfoliative dermatitis, acute generalised exanthematous pustulosis, desquamative erythema with or without fever, allergic dermatitis, lupus-like syndrome Reproductive system and breast disorders Gynaecomastia General disorders and administration site conditions Peripheral oedema Malaise, fatigue 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 or search for MHRA Yellow Card in Google Play or Apple App Store.

The product should be used with caution in patients with reduced left ventricular function. Patients with bradycardia (risk of exacerbation), first degree AV block or prolonged PR interval should be observed closely. Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension.

Careful monitoring of renal function is advised. Diltiazem is considered unsafe in patients with acute porphyria. Prior to general anaesthesia, the anaesthetist must be informed of ongoing diltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers.

Increase of plasma concentrations of diltiazem may be observed in the elderly and in patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.

Calcium channel blocking agents, such as diltiazem, may be associated with mood changes, including depression. Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk of developing an intestinal obstruction.

Tablet residues from slow release formulations of the product may pass into the patient’s stools; however, this finding has no clinical relevance. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains less than 1mmol sodium (23mg) per capsule, that is to say essentially ‘sodium-free’.

Hypersensitivity to diltiazem or to any of the excipients. Pregnancy and in women of child bearing capacity. Patients with severe bradycardia (less than 40 bpm), second or third degree heart block, sick sinus syndrome, decompensated cardiac failure, patients with left ventricular failure with pulmonary congestion.

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