ACTION AND MECHANISM

- Vasodilator. Ginkgo leaves appear to improve cerebral and peripheral blood flow due to possible vasodilatory and antiplatelet effects, improving the rheological properties of the blood.

The exact mechanism and the active ingredients responsible are unknown, although it is postulated that they could be flavonoids, such as quercetin, and terpenoids such as ginkgolides and bilobalides.

SPECIAL WARNINGS

- Discontinue treatment at least 2 weeks before scheduled surgery due to the risk of increased bleeding time.

SENIORS

No specific problems have been described in the elderly that would require a dosage adjustment.

COMPOSITION

Each tablet contains 240 mg of Ginkgo biloba leaf dry extract EGb761® (35-67:1; acetone 60% w/w), quantified to 52.8-64.8 mg of flavonoid glycosides and 12.96-15.84 mg of terpene lactones, of which 6.72-8.16 mg are ginkgolides A, B, and C and 6.24-7.68 mg are bilobalides and no more than 1.2 mcg are ginkgolic acids.

PATIENT ADVICE

- Tell your doctor and/or pharmacist if:

* Symptoms continue or worsen during ginkgo use.

* She is going to undergo surgery.

CONTRAINDICATIONS

- Hypersensitivity to ginkgo or any other component of the medication.

EFFECTS ON DRIVING

It does not appear to have significant effects.

PREGNANCY

Animal safety : no data available.

Safety in humans : There are no adequate and well-controlled studies in humans. Its administration is not recommended.

Effects on fertility : no specific studies have been conducted in humans.

INDICATIONS

“Tebofortan Indications”

- Improvement in age-related cognitive decline.

INTERACTIONS

- Anticoagulants. Ginkgo may increase the risk of bleeding when combined with anticoagulant or antiplatelet drugs.

LACTATION

Animal safety : no data available.

Safety in humans : It is unknown whether it is excreted in breast milk, and the potential consequences for the infant. Its administration is not recommended.

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents < 18 years, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

- Tablets: Swallow without chewing with plenty of liquid. Do not take lying down.

Administration with food : administer separately from meals.

POSOLOGY

“Tebofortan Dosage”

- Adults:

* Tebofortan 120 mg: 1 tablet twice a day, in the morning and at night.

* Tebofortan 240 mg: 1 tablet a day.

- Children and adolescents < 18 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Treatment duration : at least 8 weeks. Discontinue treatment if no improvement is observed within 3 months.

Missed dose : Take the missed dose as soon as possible, unless it is almost time for the next dose. Take the next dose at the usual time. Do not double the next dose.

DOSAGE IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made.

PRECAUTIONS

- [COAGULATION DISORDERS]. Ginkgo may increase the risk of bleeding, so caution is advised in patients with coagulation disorders or [HEMORRHAGE].

Stop treatment at least 2 weeks before surgery.

- [EPILEPSY]. It cannot be ruled out that it could increase the risk of [SEIZURES].

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains lactose. Patients with hereditary lactose or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

ADVERSE REACTIONS

Adverse reactions are usually mild and transient.

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Immune system disorders: frequency unknown [HYPERSENSITIVITY REACTIONS], with [ERYTHEMA] or [PRURITUS].

- Nervous system disorders: frequency unknown [HEADACHE], [DIZZINESS], [VERTIGO].

- Gastrointestinal disorders: frequency unknown [DIARRHEA], [ABDOMINAL PAIN], [NAUSEA].

OVERDOSE

Symptoms : no cases have been described.

Measures to be taken :

- Antidote: there is no specific antidote.

- General disposal measures: none have been described.

- Monitoring: patient's clinical status.

- Treatment: symptomatic.