Generic drug from Tildiem
Therapeutic class: Cardiology and angiology
Active ingredients: Diltiazem
laboratory: Teva Sante
Box of 30
Preventive treatment of angina pectoris attacks, especially in exercise angina, spontaneous angina including Prinzmetal angina.
Dosage DILTIAZEM TEVA 60 mg Tablet Box of 30
The usual dosage is 1 tablet (60 mg) three times a day at the beginning of meals.
In severe cases, the dosage may be increased to 4 (240 mg) or 6 tablets (360 mg) per day.
Since tolerance and efficacy have not been established, the use of diltiazem is not recommended in children.
Route of administration:
The tablet should be swallowed with a little liquid, without being crunched.
Diltiazem should be used with caution in patients with renal or hepatic impairment (see Warnings and Precautions ).
· Sinus dysfunction.
· Auriculo-ventricular blocks of degrees II and III not paired.
· Left ventricular insufficiency with pulmonary stasis.
· Combination with dantrolene infusion (see section Interactions with other medicinal products and other forms of interaction ).
· Diltiazem hydrochloride is generally not recommended in women who are or may be pregnant (see section Pregnancy and breast-feeding ).
· In combination with cisapride, pimozide, ergotamine and dihydroergotamine.
Adverse effects Diltiazem Teva
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