Medicinal Products

DILTIAZEM GNR LP 300 mg

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

Sustained-Release Capsule
box of 30
All forms

Indication

Angor and mild to moderate hypertension.

Dosage DILTIAZEM GNR LP 300 mg prolonged-release capsule box of 30

Angor and mild to moderate hypertension.

Against indications

This medicine MUST NEVER BE USED in case of:

· Sinus dysfunction,

· Non-paired second and third degree atrioventricular blocks,

· Myocardial infarction with complications

o severe bradycardia (less than or equal to 40 beats per min),

o severe hypotension (systolic blood pressure less than 90 mmHg)

o left ventricular failure with pulmonary stasis,

· Combination with dantrolene infusion, nifedipine, ergot derivatives, cisapride, sertindole and pimozide,

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Adverse effects Diltiazem Lp Gnr

The following adverse reactions are listed by system organ class and frequency, based on data from clinical trials with diltiazem, using the following convention: 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.

Very common

Frequent

Rare

Rare

Not known frequency

Blood and lymphatic system disorders

thrombocytopenia

Psychiatric disorders

Nervousness, insomnia

Mood changes (including depression)

Nervous system disorders

Headache, dizziness

Extrapyramidal symptoms

Heart conditions

Auriculo-ventricular blocks (may be 1st, 2nd or 3rd degree, possible branch blocks), palpitations.

bradycardia

Sino-atrial blocks and congestive heart failure

Vascular disorders

Flushing

Orthostatic hypotension

Vasculitis (including leukocytoclastic vasculitis)

Gastrointestinal disorders

Constipation, dyspepsia, gastric pain, nausea

Vomiting, diarrhea

Oral dryness

Gingival hyperplasia

Hepatobiliary disorders

Increases in liver enzymes (ASAT, ALT, LDH, alkaline phosphatase)

hepatitis

Skin and subcutaneous tissue disorders

Erythema

Urticaria

Photosensitivity reactions (including lichenoid keratosis on skin areas exposed to the sun), angioneurotic edema, rash, erythema multiforme (including Steven-Johnson syndrome and toxic epidermal necrosis), sweating, exfoliative dermatitis, generalized acute exanthematous pustulosis, erythema possibly be feverish and / or desquamative.

Reproductive system and breast disorders

gynecomastia

General disorders and administration site conditions

Peripheral edema

Discomfort

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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