Tebofortan 120 Mg 30 Film-coated Tablets

They are film-coated tablets with 120 mg of Ginkgo biloba EGb 761® extract. This herbal medicine is indicated for the improvement of age-related cognitive decline.

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Tebofortan (120 Mg 30 Coated Tablets)

Extract of Ginkgo biloba EGb761®

COMPOSITION

Each tablet contains 120 mg of dry extract of Ginkgo biloba leaves EGb761® (35-67: 1; acetone 60% m / m), quantified at 26.4-32.4 mg of flavonic glycosides and 6.48-7 92 mg of terpenic lactones, of which 3.36-4.08 mg are ginkgolides A, B, and C and 3.12-3.84 mg are bilobalides and no more than 0.6 mcg are ginkgolic acids.

 

ACTION AND MECHANISM

- Vasodilator. Ginkgo leaves seem to improve cerebral and peripheral blood flow due to possible vasodilator 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.

 

INDICATIONS

"Indications Tebofortan"

- Improvement of cognitive deterioration associated with age.

 

POSOLOGY

"TEBOFORTAN DOSAGE"

- Adults:

* Tebofortan 120 mg: 1 tablet 2 times a day, in the morning and in the evening.

* Tebofortan 240 mg: 1 tablet per day.

- Children and adolescents <18 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Duration of treatment : at least 8 weeks. Suspend treatment if no improvement is observed in 3 months.

Missed dose : administer the forgotten dose as soon as possible, unless there is a short time for the next one. Administer the next dose at the usual time. Do not double the next dose.

 

DOSAGE IN KIDNEY INSUFFICIENCY

No specific dosage recommendations have been made.

 

DOSAGE IN LIVER INSUFFICIENCY

No specific dosage recommendations have been made.

 

RULES FOR CORRECT ADMINISTRATION

- Tablets: swallow without chewing with a sufficient amount of liquid. Do not drink lying down.

Administration with food : administer separately from meals.

 

CONTRAINDICATIONS

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

 

PRECAUTIONS

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

Stop treatment at least 2 weeks before surgery.

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

 

PRECAUTIONS RELATING TO EXCIPIENTS

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

 

ADVICE TO THE PATIENT

- Warn your doctor and / or pharmacist if:

* Symptoms continue or worsen while using ginkgo.

* You are going to have surgery.

 

SPECIAL WARNINGS

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

 

INTERACTIONS

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

 

PREGNANCY

Animal safety : no data available.

Safety in humans : There are no adequate and well-controlled studies in humans. It is recommended to avoid its administration.

Effects on Fertility : No specific studies have been performed in humans.

 

LACTATION

Animal safety : no data available.

Safety in humans : it is not known if it is excreted with milk, and the consequences it could have for the infant. It is recommended to avoid its administration.

 

KIDS

Safety and efficacy have not been evaluated in children and adolescents <18 years of age, so it is recommended to avoid its use.

 

SENIORS

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

 

EFFECTS ON DRIVING

It does not appear to present significant effects.

 

ADVERSE REACTIONS

Adverse reactions are usually mild and transient.

Adverse reactions are described according to each frequency range, 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 [PRURITO].

- 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: have not been described.

- Monitoring: clinical status of the patient.

- Treatment: symptomatic.

Tebofortan 120 Mg 30 Coated Tablets Leaflet

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