ADIZEM XL

Route of administration Oral Posology Dosage requirements may differ between patients with angina and patients with hypertension. In addition, individual patients’ responses may vary necessitating careful titration. This range of capsule strengths facilitates titration to the optimal dose.

The capsules should be swallowed whole and not chewed.

Adults:

For patients new to diltiazem therapy the usual starting dose is one 240 mg capsule daily. d. ). ) if required.

Elderly and patients with impaired hepatic and renal function:

For patients new to diltiazem therapy, the usual starting dose is one 120 mg capsule daily. If necessary the dose may be gradually increased but careful monitoring of this group of patients is advised. Elderly patients transferring to ADIZEM-XL capsules should receive the same total daily dose of diltiazem, titrating upwards as required Children: ADIZEM-XL capsules are not recommended for children.

Safety and efficacy in children have not been established. In order to avoid confusion, it is suggested that patients once titrated to an effective dose using ADIZEM-XL capsules, should remain on this treatment and should not be changed between different presentations.

5, Interactions with other Medicinal Products and Other Forms of Interaction).

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 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 Very common Common Uncommon Rare Not known 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 Steven-Johnson's syndrome and toxic epidermal necrolysis), hyperhidrosis, exfoliative dermatitis, acute generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever, allergic dermatitis Reproductive system and breast disorders Gynecomastia 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.

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. Diltiazem is considered unsafe in patients with acute porphyria.

Prior to general anaesthesia, the anaesthesist 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 to develop 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.

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.

5). Hypersensitivity to diltiazem or to any of the excipients.