Generic drug from Dilrene LP GE
Therapeutic class: Cardiology and angiology
Active ingredients: Diltiazem
Box of 30
Dosage DILTIAZEM LP BIOGARAN 300 mg Prolonged-release capsule Box of 30
The treatment will be initiated by a diltiazem capsule dosed at 200 mg once a day, especially in the elderly patient, renal failure and hepatic insufficiency.
The dosage may be increased to one capsule of DILTIAZEM BIOGARAN LP 300 mg, sustained release capsule per day depending on the therapeutic response and tolerance.
In children: since tolerance and efficacy have not been established, the use of diltiazem is not recommended in children.
The time taken during the day is indifferent, but it must remain relatively constant in the same patient.
The capsule should be swallowed without being opened or crunched.
Diltiazem should be used with caution in patients with renal or hepatic impairment (see Warnings and Precautions ).
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 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.
· 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 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.
· 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