Medicinal Products

DELTAZEN LP Ge 300 mg

Generic drug from Dilrene LP GE
Therapeutic class: Cardiology and angiology
Active ingredients: Diltiazem
laboratory: Sanofi-Aventis France

Sustained-Release Capsule
Box of 28
All forms

Indication

Hypertension.

Dosage DELTAZEN LP Gé 300 mg Prolonged-release capsule Box of 28

One capsule a day, before or during meals. The time taken during the day is indifferent, but it must remain relatively constant in the same patient. The capsule should be swallowed with a little liquid.

Diltiazem 300 mg may be prescribed:

· As monotherapy,

· Substituted for another anti-hypertensive,

· Associated with other antihypertensives besides verapamil, beta-blockers; for the latter, precautions are necessary (see section Interactions with other medicinal products and other forms of interaction ).

The capsule should be swallowed without being opened or crunched.

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 should never be used in case of:

· Hypersensitivity to diltiazem,

· Sinus dysfunction,

· Auriculo-ventricular blocks of degrees II and III not paired,

· Left ventricular failure with pulmonary stasis,

· Severe bradycardia (less than or equal to 40 beats per min),

· Combination with dantrolene as an infusion (see section Interactions with other medicinal products and other forms of interaction ).

· In case of bowel obstruction due to the presence of castor oil.

· in association with :

· Dantrolene as an infusion,

· The pimozide

· Cisapride,

· Dihydroergotamine,

· Ergotamine,

· Nifedipine,

· The sertindole.

Adverse effects Deltazen LP GE

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

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