Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Diltiazem
laboratory: Sanofi-Aventis France
Sustained release coated tablet
Box of 50
Preventive treatment of angina pectoris attacks, especially in exercise angina, spontaneous angina including Prinzmetal angina.
Dosage BI-TILDIEM LP 120 mg Tablet coated with sustained release Box of 50
In exercise angina: treatment will be initiated with 1 tablet at 90 mg morning and evening. If appropriate the dosage may be increased to 1 tablet at 120 mg in the morning and evening.
In exceptional cases, the dosage may be increased to 2 90 mg tablets morning and evening.
In elderly patients, a fortiori having bradycardia and / or polypharmacy, in patients with renal insufficiency and hepatic insufficiency, the daily dose will not exceed 1 tablet 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 angina: the treatment is 1 tablet at 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 tablet should be swallowed with a little water, without being crunched.
Given the prolonged release process, it is usual to find the tablet membrane in the stool, the active ingredient having been previously released.
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,
BI-Tildiem LP side effects
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.
· 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.
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).
· 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 Steven-Johnson syndrome and toxic epidermal necrosis), exfoliative dermatitis, generalized acute exanthematous pustulosis, photosensitivity reactions (including lichenoid keratosis in sun-exposed skin areas), sweating, erythema possibly being febrile and / or desquamative.
· 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.
· 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