Ginkor Fort 120gel

Dosage

- Venous-lymphatic insufficiency: 2 capsules per day, one in the morning and one in the evening for one to two months, depending on the intensity of the symptoms.

If symptoms persist beyond 1 month of use, a doctor or qualified healthcare professional should be consulted.

- Hemorrhoidal crisis: 3 to 4 capsules per day for 7 days, as an initial treatment, divided among meals.

Pediatric population

Efficacy and safety in children and adolescents have not been established. No data are available.

Method of administration

Oral route

capsule: Ginkgo biloba extract (1) 14 mg, Troxerutin 300 mg, Heptaminol hydrochloride 300 mg.

Excipients: Magnesium stearate, anhydrous colloidal silica, yellow iron oxide (E 172), indigotine, titanium dioxide (E 171), gelatin, q.s. 1 capsule. (1) Standardized extract titrated to 24% ginkgo glycosides and 6% ginkgolides bilobalide.

Contraindications:

· Hypersensitivity to the active substance(s) or to any of the excipients listed in the section List of excipients.

· Related to heptaminol: hyperthyroidism, association with MAOIs due to the risk of hypertensive crisis (see section Interactions with other medicinal products and other forms of interaction).

Blood pressure will be closely monitored at the start of treatment in subjects with severe hypertension, due to the presence of heptaminol.

In patients with a predisposition to bleeding (hemorrhagic condition) and who are receiving concomitant anticoagulant and antiplatelet therapy, a doctor should be consulted before taking this medication.

Preparations containing ginkgo may increase the predisposition to bleeding. As a precaution, this medication should be discontinued 3 to 4 days before any surgical procedure.

In epileptic patients, the occurrence of additional seizures triggered by the ingestion of preparations containing ginkgo cannot be ruled out.

The concomitant use of ginkgo-containing preparations with efavirenz is not recommended (see section Drug Interactions).

- Hemorrhoidal crisis: administration of this product does not replace specific treatment for other anal diseases. Treatment should be short-term. If symptoms do not improve rapidly, a proctological examination should be performed and the treatment reviewed.

- Venous and lymphatic insufficiency: this medication is most effective when combined with a healthy lifestyle:

o Avoid exposure to the sun, heat, prolonged standing, excess weight.

o Prolonged walking and wearing appropriate compression stockings promote venous circulation.

Pregnancy and breastfeeding (see section Fertility, pregnancy and breastfeeding).

Athletes should be aware that this product contains an active ingredient (heptaminol) which may cause a positive result in doping tests.

Pregnancy and Breastfeeding:
Pregnancy

Animal studies are insufficient to draw conclusions regarding reproductive toxicity (see section Preclinical safety data).

There is insufficient data on the use of GINKOR FORT in pregnant women.

Given the vasoactive properties of heptaminol and the anti-aggregatory properties of ginkgo biloba, GINKOR FORT should not be used during pregnancy.

Breastfeeding

In the absence of data on passage into breast milk, use is not recommended during breastfeeding.

Fertility

Effects on female fertility have been observed in mice with ginkgo biloba (see section Preclinical safety data).