Medicinal Products

DILTIAZEM LP MYLAN 300 mg

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

Sustained-Release Capsule
Box of 90
All forms

Indication

Preventive treatment of stable angina attacks.

Hypertension.

Dosage DILTIAZEM LP MYLAN 300 mg Prolonged-release capsule Box of 90

Stable angor and high blood pressure.

The treatment will be initiated by a capsule of DILTIAZEM MYLAN 200 mg once a day, especially in the elderly patient, renal failure and hepatic insufficiency.

The dosage may be increased to one DILTIAZEM MYLAN 300 mg 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 ).

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 Mylan

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: urticaria.

Frequency not known: Quincke's edema, rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrolysis), exfoliative dermatitis, generalized acute exanthematous pustulosis, photosensitivity reactions (including lichenoid keratosis in sun-exposed skin areas), sweating, erythema may possibly be febrile and / or desquamative.

Hepatobiliary disorders

Uncommon: Isolated, moderate and usually transient increases in hepatic enzymes (ASAT, ALT, LDH, alkaline phosphatase) have been observed at the initial treatment period.

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: mood changes (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.

Frequent: 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 must report any suspected adverse reactions 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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