Leaflet: information for the user

Tebofortán® 120 mg

Film-coated tablets

Extract ofGinkgo bilobaEGb761®

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
This medicine can be obtained without a prescription, for the treatment of minor ailments without the intervention of a doctor. Nevertheless, you must useTebofortánwith care to obtain the best results
Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. See section 4.
• You must consult a doctor if you worsen or do not improve after 3 months of treatment.

1. What isTebofortánand for what it is used

2. What you need to know before starting to takeTebofortán

3. How to takeTebofortán

4. Possible side effects

5. Storage ofTebofortán

6. Contents of the package and additional information

Coated tablets containing 120 mg of Ginkgo biloba extractEGb 761®. This plant-based medication is indicated for the improvement of age-related cognitive decline.

Do not take Tebofortan:

- 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 Tebofortan 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 Tebofortan.

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 takenTebofortanso that they can decide how to proceed.

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

You should consult your doctor if you worsen or do not improve.

Children and adolescents:

It should not be administered to children under 18 years of age.

Tebofortan 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 have to take any other medication.

Tebofortan with food and drinks::

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,believe you may be pregnant or intend to become pregnant, or are in a breastfeeding period, 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 the same.

Driving and operating machines:

No effects on driving and operating machines have been described.

Tebofortan contains lactose:

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Tebofortan contains cornstarch.

This medication is taken orally.

Follow exactly the administration instructions of the medication 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 2 times a day, morning and night (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 treatment period of 3 months, consult your doctor about the convenience of continuing.

If you take more Tebofortán than you should:

No cases of overdose are known. If you have taken a large amount of Tebofortán tablets, you may see increased adverse reactions indicated in section 4.

Possible side effects.

Inform your doctor in this case. 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 the treatment with Tebofortán:

If you have any other doubt 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. According to 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 also headaches, dizziness, and vertigo or exacerbation of existing vertigo.

There are isolated reports indicating bleeding of individual organs.

If any of the previously mentioned adverse effects 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 about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about 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: 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 packaging and unused medicines at your local SIGRE collection point. Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

No special storage conditions are required.

Composition of Tebofortán per tablet:

The active ingredient is 120.0 mg of dried Ginkgo biloba leaf extract EGb 761^® (plant dry matter/extract ratio: 35-67:1), obtained with 60% m/m acetone, quantified at 26.4 – 32.4 mg of calculated flavonoids as flavonoid glycosides and at 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 micrograms are ginkgolic acids.

The other components are sodium croscarmellose, colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol 1500, magnesium stearate, cornstarch, microcrystalline cellulose, dimethicone, alpha-octadecyl omega-hydroxypoly(oxyethylene) 5, sorbic acid (E-200), talc, and iron oxide red (E-172) colorant.

Appearance of the product and content of the packaging:

Red-coated, round, film-coated tablets. Tebofortán 120 mg is presented in cardboard boxes containing 15, 30, 45, or 60 tablets in blisters.

Holder of the marketing authorization and responsible for manufacturing:

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:

Local representative:

SCHWABE FARMA IBÉRICA, S.A.U.

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

Date of the last review of this leaflet: September 2024

The 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/.