Medicinal Products

DILTIAZEM BGR LP 300 mg

Generic drug from Mono-Tildiem LP
Therapeutic class: Cardiology and angiology
Active ingredients: Diltiazem, Diltiazem
laboratory: Biogaran

Sustained-Release Capsule
box of 90
All forms

Indication

Preventive treatment of stable angina attacks.

Hypertension.

Dosage DILTIAZEM BGR LP 300 mg prolonged-release capsule box of 90

Preventive treatment of stable angina attacks.

Hypertension.

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 Bgr

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 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.

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

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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