DIFRAREL 100 mg Cpr enr Plq/6x10 (60)

Film-coated tablet.
Box of 20 or of 60, in thermoformed blister packs.

For one coated tablet :

Vaccinium myrtillus anthocyanosides extract: 100,000 mg
Beta-carotene: 5,000 mg

Excipient with known effect: each tablet contains 160,000 mg of sucrose.

In adults:

• Adjunctive treatment of functional manifestations of venolymphatic insufficiency (heavy legs, pain, restless legs on lying down).
• Adjunctive symptomatic treatment of functional disorders of capillary fragility.
• Adjunctive treatment of decreased visual acuity and visual field disorders presumed to be of vascular origin.

Medical advice is necessary for the treatment of functional disorders of capillary fragility and of decreased visual acuity and visual field disorders presumed to be of vascular origin.

MEDICINE RESERVED FOR ADULTS.

Dosage

3 to 6 tablets per day.

Treatment must be given as a course of 20 days per month, then renewed if necessary.

Method of administration

Oral use

The tablets are to be swallowed, not chewed, with a glass of water.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

Given the potential increased risk of lung cancer associated with taking beta-carotene in smokers, the use of DIFRAREL 100 mg, coated tablet is not recommended in patients who smoke or former smokers.

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

The data available to date do not suggest the existence of clinically significant interactions.

Pregnancy:

There is no reliable data on teratogenicity in animals.

In clinical practice, no malformative or foetotoxic effect has appeared to date. However, follow-up of pregnancies exposed to this medicine is insufficient to exclude any risk.

Consequently, as a precautionary measure, it is preferable not to use this medicine during pregnancy.

Breastfeeding:

Due to the lack of data on the passage of this medicine into breast milk, its use should be avoided during breastfeeding.

Rarely: digestive disorders.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to 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 Centres - Website: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported. However, excessive use may lead to an exacerbation of undesirable effects.

Pharmacotherapeutic class: VASCULOPROTECTIVE, ATC code: C05CX

(C: cardiovascular system)

(S: sensory organs)

3 years

Store at a temperature not exceeding 25 °C.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.