Product Information for the Patient

Tebofortán® 240 mg

Film-Coated Tablets

Extract ofGinkgo bilobaEGb761®

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

This medication can be obtained without a prescription for the treatment of minor conditions without the intervention of a doctor. However, you must useTebofortánwith care to achieve the best results.
Follow exactly the administration instructions contained in this product information or those indicated by your doctor or pharmacist.

• Keep this product information, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 months of treatment.

1. What isTebofortánand what it is used for

2. What you need to know before starting to takeTebofortán

3. How to takeTebofortán

4. Possible adverse effects

5. Storage ofTebofortán

6. Contents of the pack and additional information

Coated tablets containing 240 mg of Ginkgo bilobaextract EGb 761®. This plant-based medication is indicated for the improvement of age-related cognitive decline.

Do not take Tebofortán:

- If you are allergic to Ginkgo biloba or any of the other components of this medication (listed in section 6).

- Because there is not enough clinical experience with the use of Tebofortán in children, it is not recommended for use in children and adolescents under 18 years of age.

- In case of pregnancy (see Pregnancy, breastfeeding, and fertility).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Tebofortán.

If symptoms worsen or persist during use of the medication, consult your doctor.

In case of increased bleeding tendency (diathesis hemorrhagica) and simultaneous treatment with anticoagulant medications, this medication should only be taken after consulting with your doctor. Isolated reports indicate the possibility that preparations containing Ginkgo may increase the bleeding tendency. This medication should be discontinued before a surgical procedure. Inform your doctor in due time that you have taken Tebofortán so that they can decide how to proceed.

If you suffer from epilepsy attacks, consult your doctor before starting treatment with Tebofortán.

Children and adolescents:

Should not be administered to children and adolescents under 18 years of age.

Tebofortán use with other medications:

No clinically relevant interactions are known to date.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Tebofortán use with food and beverages:

Do not take the tablets while lying down. The tablets should be swallowed without chewing with something to drink (preferably with a glass of water). The medication should be taken separately from meals.

Pregnancy, breastfeeding, and fertility:

If you are pregnant, think you may be pregnant, or intend to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medication.

As a general precaution and due to the lack of data, this medication should not be taken during pregnancy.

No clinical data are available on its use during breastfeeding, so it is not recommended to use this medication during this period.

Driving and operating machines:

No effects on driving and operating machines have been described.

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This medication is taken orally.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults over 18 years: The recommended dose is 1 tablet per day (240 mg of Ginkgo biloba extract per day).

Treatment duration:

The treatment duration should be at least 8 weeks. If symptoms worsen or do not improve after a 3-month treatment period, consult your doctor about the convenience of continuing.

If you take more Tebofortán than you should:

No cases of overdose have been reported. If you have taken a large amount of Tebofortán tablets, you may experience increased adverse reactions indicated in section 4.

Possible adverse effects.

Inform your doctor. He will decide what measures to take.

In cases of overdose or accidental ingestion, go to a medical center immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tebofortán:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tebofortán:

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Tebofortán may produce adverse effects, although not all people may experience them.

There are no verified data on the frequency of adverse effects observed during treatment with preparations containing Ginkgo biloba, as these effects are known only through individual reports from patients, doctors, or pharmacists. In accordance with these reports, the following secondary effects may occur during treatment with Tebofortán:

In people with hypersensitivity, anaphylactic shock or skin allergic reactions (redness, swelling, itching) may occur.

Adverse reactions mainly consist of gastrointestinal problems such as diarrhea, abdominal pain, and nausea, but dizziness, headaches, and vertigo have also been described.

There are isolated reports indicating bleeding of individual organs, although no causal relationship with Tebofortán has been established.

The frequency of the adverse effects described above is unknown.

If any of the secondary effects mentioned above occur, do not take more Tebofortán and consult your doctor to determine the severity and, possibly, the necessary measures to take.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after Expiration Date:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at your local SIGRE collection point. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

No special storage conditions are required.

Composition of Tebofortán per tablet:

The active ingredient is 240.0 mg of dried Ginkgo biloba leaf extract EGb 761® (plant dry matter/extract ratio: 35-67:1), obtained with 60% m/m acetone, quantified to 52.8-64.8 mg of calculated flavonoids as flavonoid glycosides and 12.96-15.84 mg of terpenic lactones, of which 6.72-8.16 mg are ginkgolides A, B, and C, and 6.24-7.68 mg are bilobalides, and not more than 1.2 micrograms are ginkgolic acids.

The other components are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, and precipitated silica.

Tablet coating: microcrystalline cellulose, 6 mPas hypromellose, 15 mPas hypromellose, red iron oxide (E 172), yellow iron oxide (E 172), stearic acid, and talc.

Appearance of the product and content of the packaging:

Oval-shaped, brown-coated tablets. Tebofortán 240 mg is presented in cardboard boxes containing 10, 15, 30, 45, or 60 tablets in blisters.

Marketing authorization holder's title and responsible manufacturer:

Dr. Willmar Schwabe GmbH & Co.KG

Willmar-Schwabe-Straße 4

76227 Karlsruhe / Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

SCHWABE FARMA IBÉRICA, S.A.U.

Avenida de la Industria, 4. Edificio 2, escalera 1, 2nd floor.
28108 Alcobendas, Madrid

Last review date of this leaflet: October 2021.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.