Medicinal Products

DIACTANE Ge 200 mg

Generic drug from Praxilene
Therapeutic class: Cardiology and angiology
Active ingredients: Naftidrofuryl
laboratory: Menarini

Coated tablet
Box of 20
All forms

Indication

Symptomatic treatment of intermittent claudication of chronic occlusive arterial diseases of the lower limbs (stage 2).

Dosage DIACTANE Ge 200 mg Film-coated tablet Box of 20

Dosage

Oral way.

· Arteriopathies of the lower limbs: 1 tablet, 3 times daily, or 600 mg of naftidrofuryl.

Treatment with naftidrofuryl has only a symptomatic effect, allowing a moderate improvement in walking distance within 6 months after initiation of treatment. It is of interest only in addition to other therapies or measures recommended in stage 2 AOMIs (management of cardiovascular risk factors, regular physical exercise, smoking cessation in particular).

The response to treatment should be re-evaluated after 6 months and its continuation reconsidered in the absence of improvement.

Administration mode

The catches will be distributed during meals.

Swallow the tablets without chewing, always with a large glass of water.

Against indications

Hypersensitivity to naftidrofuryl or any of the excipients

· Known hypoxaluria

· History of recurrent renal calcium lithiasis.

Adverse effects Diactane GE

Gastrointestinal disorders

· Digestive disorders (diarrhea, vomiting, epigastric pain).

· In some patients who took the drug without a drink at bedtime, discontinuation of the tablet resulted in local esophagitis.

· Cases of ulceration of the oral mucosa have been reported.

Hepatobiliary disorders

· Cases of severe hepatic impairment, of the acute cytolytic type, have been reported (see Warnings and Precautions ).

Renal and urinary disorders

· Renal calcium oxalic acid (see Warnings and Precautions ) section.

Skin and subcutaneous tissue disorders

· Rashes.

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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