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Composition of Praxilene : Naftidrofuryl hydrogen oxalate 200mg

Excipients: Eudragit RSPO, compritol 888, lactose monohydrate, talc, magnesium stearate, eudragit NE 30 D, methocel E5, macrogol 4000 q.s for one 415 mg coated tablet.

Box of 20 coated tablets being 4 g of naftidrofuryl (INN) hydrogen oxalate.

Praxilene - Naftidrofuryl hydrogen oxalate 200mg

Pharmaceutical form Et Packing size

Film coated tablet

Box of 2 blisters x 10 tablets = 20 coated tablets

Indication

– Symptomatic treatment of intermittent claudication due to chronic occlusive arterial disease of the lower limbs (stage II).

Dosage and administration

Oral route

Arterial disease of the lower limbs: 1 tablet, 3 times a day, equivalent to 600 mg of naftidrofuryl/day.

Naftidrofuryl therapy has only a symptomatic effect, allowing a moderate improvement in walking distance in the 6 months after initiation of therapy. It should only be used as an adjunct to other treatments or measures recommended in stage 2 chronic occlusive arterial disease (such as management of cardiovascular risk factors, regular exercising, and stopping smoking).

The response to the treatment must be re-assess after 6 months and the decision to continue the treatment must be reconsidered in the absence of improvement.

Method of administration

Doses should be taken with meals.

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

Elderly

Praxilene is mainly for use in elderly people. Advanced age does not appear to influence the pharmacokinetic profile of oral naftidrofuryl. Therefore it is not necessary to adjust the dosage of naftidrofuryl in this population.

Paediatric patients

Praxilene is not indicated for use in children.

Contra-indications

Praxilene must not be used in these following cases:

*        Hypersensitivity with naftidrofuryl or other compositions of this medicine

*        Known hyperoxaluria

*        History of recurrent calcium-containing kidney stone

If there is any doubt, it is essential to consult your doctor or pharmacist.

Special warning and precautions for use

Administration of this medicinal product may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones.

The oxalate content in one 200-mg tablet is 38 mg. Therefore, a sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis. Administration of this medicinal product without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take Praxilene with a large glass of water. Cases of serious liver damage of acute cytolytic have been reported. In case of suspected liver damage, transaminase levels must be checked. Treatment should be discontinued if symptoms suggestive of liver damage occur and if there is an increase in transaminases levels, even if the increase is moderate.

Naftidrofuryl is not a treatment for hypertension.

Due to Praxilene contain lactose, it is contraindicated in case of congenital galactosemia, glucose and galactose malabsorption syndrome or in case of lactase deficiency.

Pregnancy and lactation

This medicinal product is mainly used in elderly subjects in whom there is no risk of pregnancy. In the absence of relevant clinical data, the use of naftidrofuryl is inadvisable during pregnancy and lactation.

Effects on ability to drive ana use machines

Naftidrofuryl has no influence on the ability to drive and use machines.

Interaction

In order to avoid possible interaction with other medicines, it is necessary to inform your doctor or pharmacist of any medicines you are taking in concurrent with Praxilene.

Side Effects

The following undesirable effects may occur under treatment with naftidrofuryl.

Frequencies are defined as follows: Very common > =1/10; Common > =1/100, < 1/10; Uncommon > =1/1,000, < 1/100; Rare >= 1/10.000, < 1/1,000: Very rare < 1/10,000; Not known (cannot be estimated from the available data).

Gastro-intestinal disorders

Uncommon: Diarrhoea, nausea, vomiting and epigastric pain.

Not known: In some patients who took the medicinal product without liquid before going to bed, the tablet became stuck in the throat causing local oesophagitis.

Cases of oral mucosa ulcerations have been reported.

Renal and urinary disorders

Very rare: Calcium oxalate kidney stones (see Special warning and precautions for use).

Skin and subcutaneous tissue disorders

Uncommon: Skin rash.

Hepatobiliary Disorders:

Rate: Liver damage. Cases of serious liver damage, of the acute cytolytic type, have been reported (see Special warning and precautions for use).

Inform your doctor in case of any adverse reaction related to drug use.

Pharmacodynamic Properties

Peripheral Vasolidator

ATC Code: C04AX21

(C: cardiovascular system)

Naftidrofuryl exerts two synergistic effects resulting in a broad anti-ischaemic action:

At vascular level: as a specific 5-HT2 receptor antagonist, naftidrofuryl antagonizes the vasoconstrictive and pro- aggregant actions of serotonin.

At cellular level: as an activator of ATP production, naftidrofuryl enhances the metabolism of ischaemic cells.

Clinical efficacy

In stage II peripheral arterial disease, naftidrofuryl significantly increased walking distance on a treadmill in comparison with placebo.

An improvement in the intensity and frequency of exertional pain and an improvement in daily activities were observed in a clinical study in patients with intermittent claudication.

Pharmacokinetic Properties

Absorption: Digestive absorption is rapid: peak plasma levels are reached within 2.5 hours after dosing.

Distribution: The binding rate to plasma proteins is 92%.

Naftidrofuryl crosses the blood-brain barrier and probably the placenta.

Metabolism:Naftidrofuryl is transformed, mainly by hydrolysis, into different inactive metabolites.

Elimination: 80% is excreted in the urine in the form of metabolites, mainly conjugated. The elimination half-life is approximately 3 to 4 hours.

Overdose

In case of massive ingestion, acute intoxication may be manifested as depression of cardiac conduction, confusion and convulsion.

The treatment should be gastric lavage, activated charcoal may be used if necessary, cardiovascular function should be monitored and symptomatic treatment considered. Convulsions may be managed by diazepam.

Shelf-life: 24 months from manufacturing date.

Do not use after the expiry date.

Storage: Store at the temperature below 25°C.

Keep medicines out of the reach of Children

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