Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Diltiazem
Box of 28
Preventive treatment of stable angina attacks.
Dosage DILTIAZEM LP SANDOZ 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 120 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.
Given the prolonged release process, it is usual to find the membrane of the capsule 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,
Adverse effects Diltiazem LP Sandoz
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