ACTION AND MECHANISM

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

PATIENT ADVICE

- Tell your doctor and/or pharmacist if:

* Symptoms continue or worsen while using ginkgo.

* You are going to undergo surgery.

CONTRAINDICATIONS

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

ADVANCED AGE

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

EFFECTS ON DRIVING

It does not appear to have significant effects.

PREGNANCY

Animal safety : no data available.

Human safety : Adequate and well-controlled studies in humans are lacking. It is recommended to avoid administration.

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

INDICATIONS

“TEBOFORTAN”

- Improvement of age-related cognitive decline.

INTERACTIONS

- Antiplatelet agents. Ginkgo may increase the risk of bleeding when combined with antiplatelet agents.

LACTATION

Animal safety : no data available.

Human safety : It is unknown whether it is excreted in milk, and what consequences this could have for the infant. It is recommended to avoid administration.

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents under 18 years of age, so its use is recommended to be avoided. There is no recommendation for use in these patients.

RULES FOR CORRECT ADMINISTRATION

- Tablets: Swallow whole with plenty of liquid. Do not take while lying down.

Administration with food : administer separately from meals.

POSOLOGY

“TEBOFORTAN DOSAGE”

- Adults:

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

* Tebofortan 240 mg: 1 tablet daily.

- 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 : Administer the missed dose as soon as possible, unless it is almost time for the next dose. Administer the next dose at the regular time. Do not double the next dose.

DOSAGE IN LIVER FAILURE

No specific dosage recommendations have been made.

DOSAGE IN KIDNEY FAILURE

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 [HEMORRHAGY].

Discontinue treatment at least 2 weeks before surgery.

- [EPILEPSY]. It cannot be ruled out that the risk of [SEIZURES] may be increased.

PRECAUTIONS RELATED TO EXCIPIENTS

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

- This medicine contains fructose. Patients with [FRUCTOSE INTOLERANCE] should not take this medicine.

ADVERSE REACTIONS

Adverse reactions are usually mild and transient.

Adverse reactions are described according to each frequency interval, considering very frequent (>10%), frequent (1-10%), unfrequent (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 elimination measures: none have been described.

- Monitoring: clinical status of the patient.

- Treatment: symptomatic.