Medicinal Products

DILTIAZEM LP BIOGARAN 120 mg

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Diltiazem
laboratory: Biogaran

Sustained-Release Capsule
Box of 28
All forms

Indication

Preventive treatment of angina pectoris attacks, especially in exercise angina, spontaneous angina including Prinzmetal angina.

Dosage DILTIAZEM LP BIOGARAN 120 mg Prolonged-release capsule Box of 28

In exercise angina: treatment will be initiated with 1 capsule at 90 mg morning and evening. If appropriate the dosage may be increased to 1 capsule at 120 mg in the morning and evening.

In exceptional cases, the dosage may be increased to 2 capsules at 90 mg in the morning and evening.

In elderly patients, a fortiori with bradycardia and / or polypharmacy, in patients with renal insufficiency and hepatic insufficiency, the daily dosage will not exceed 1 capsule at 90 mg in the morning and evening (see Warnings and precautions for use section). ) except in very special cases where it may be increased.

In spontaneous angina including Prinzmetal's angina: the treatment is from 1 capsule to 120 mg morning and evening. The catch should be spaced 12 hours apart.

Children: since tolerance and efficacy have not been established, the use of diltiazem is not recommended in children.

Diltiazem should be used with caution in patients with renal or hepatic impairment (see Warnings and Precautions ).

The capsule should be swallowed with a little water, without being crunched.

Against indications

This medicine MUST NEVER BE USED in case of:

Hypersensitivity to diltiazem or any of the excipients,

· Sinus dysfunction,

· Non-paired second and third degree atrioventricular blocks,

· Left ventricular failure with pulmonary stasis,

· Severe bradycardia (less than or equal to 40 beats per min),

· Association with:

o dantrolene as an infusion,

o the pimozide,

o Cisapride,

o Dihydroergotamine,

o ergotamine,

o Nifedipine,

o sertindole.

Adverse effects Diltiazem LP Biogaran

Classification of adverse reactions according to expected frequencies: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000); indeterminate frequency (can not be estimated based on available data).

Within each group frequency, adverse effects are presented in descending order of severity.

Heart conditions

· Frequent: atrioventricular blocks (may be 1st, 2nd or 3rd degree, possible branch blocks), palpitations.

· Uncommon: bradycardia.

· Not known: Sino-atrial blocks and congestive heart failure.

Vascular disorders

The manifestations corresponding to vasodilation (headache, flushing, and in particular edema of the lower limbs) are dose-dependent, related to the pharmacological activity of the active ingredient. They occur more readily in the elderly.

· Frequent: flushing.

· Uncommon: orthostatic hypotension.

· Not known: vasculitis (including leukocytoclastic vasculitis).

Gastrointestinal disorders

· Common: constipation, dyspepsia, epigastralgia, nausea.

· Uncommon: vomiting, diarrhea

· Rare: dry mouth.

· Not known: gingival hyperplasia.

Skin and subcutaneous tissue disorders

· Common: erythema

· Rare: hives.

· Not known: Quincke's edema, rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrosis), exfoliative dermatitis, generalized acute exanthematous pustulosis, photosensitivity reactions (including lichenoid keratosis in skin areas exposed to the sun), sweating, erythema possibly being febrile and / or desquamative.

Hepatobiliary disorders

· Uncommon: Isolated, moderate and usually transient increases in liver enzymes (ASAT, ALT, LDH, alkaline phosphatase) have been observed during the initial period of treatment.

· Not known: clinical hepatitis reversible upon discontinuation of treatment.

Nervous system disorders

· Common: headache, dizziness

· Not known: extrapyramidal symptoms usually reversible upon discontinuation of treatment.

Psychiatric disorders

· Uncommon: nervousness, insomnia.

· Not known: changes in mood (especially depression).

Reproductive system disorders

· Not known: Gynecomastia usually reversible upon discontinuation of treatment.

General disorders and administration site conditions

· Very common: oedemas of the lower limbs.

· Common: malaise, asthenia.

Blood and lymphatic system disorders

· Not known: thrombocytopenia

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