Tebofortan 120 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Tebofortán® 120 mg
Film-coated tablets
Ginkgo biloba extract EGb761®
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you. This medicine is available without prescription, for the treatment of minor conditions without the intervention of a doctor. However, you should use Tebofortán carefully to achieve the best results. Always follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 months of treatment.
Leaflet Contents
- What Tebofortán is and what it is used for
- What you need to know before taking Tebofortán
- How to take Tebofortán
- Possible adverse effects
- How to store Tebofortán
- Contents of the pack and other information
1. What Tebofortán is and what it is used for
These are film-coated tablets containing 120 mg of Ginkgo biloba extract EGb 761®. This herbal medicinal product is indicated for the improvement of age-associated cognitive decline.
2. What you need to know before starting to take Tebofortan:
Do not take Tebofortan:
- If you are allergic to Ginkgo biloba or to any of the other components of this medicine (listed in section 6).
- Because there is insufficient clinical experience with the use of Tebofortan in children, its use is not recommended in children and adolescents under 18 years of age.
- During pregnancy (see Pregnancy, breastfeeding and fertility).
Warnings and precautions:
Talk to your doctor or pharmacist before starting to take Tebofortan.
If you have an increased tendency to bleeding (hemorrhagic diathesis) or are being treated simultaneously with anticoagulant medicines, this medicine should only be taken after consulting your doctor. Isolated reports suggest that preparations containing Ginkgo may increase the risk of bleeding. This medication should be discontinued before any surgical procedure. Inform your doctor promptly that you have been taking Tebofortan so that appropriate decisions can be made.
If you suffer from epileptic seizures, consult your doctor before starting treatment with Tebofortan.
You should consult your doctor if your symptoms worsen or do not improve.
Children and adolescents:
Tebofortan must not be administered to children under 18 years of age.
Taking Tebofortan with other medicines:
No clinically relevant interactions are currently known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Tebofortan with food and drink:
Do not take the tablets while lying down. The tablets must be swallowed whole with some liquid (preferably a glass of water). The medicine should be taken apart from meals.
Pregnancy, breastfeeding and fertility:
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a general precaution, and due to lack of data, this medicine should not be taken during pregnancy.
There are no clinical data on the use of this medicine during breastfeeding; therefore, its use is not recommended during this period.
Driving and using machines:
No effects on driving and using machines have been reported.
Tebofortan contains lactose:
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Tebofortan contains corn starch.
3. How to take Tebofortan
This medicine is for oral use.
Follow exactly the dosage instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults over 18 years: The recommended dose is 1 tablet twice daily, in the morning and evening (240 mg of Ginkgo biloba extract per day).
Duration of treatment:
The treatment should last at least 8 weeks. If symptoms worsen or do not improve after a 3-month treatment period, consult your doctor regarding the appropriateness of continuing the treatment.
If you take more Tebofortan than you should:
There are no known cases of overdose. If you have taken a large amount of Tebofortan tablets, the adverse reactions listed in section 4, Possible side effects, may be intensified.
In such a case, inform your doctor. He or she will decide which measures to take.
In cases of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Tebofortan:
Do not take a double dose to make up for missed doses.
If you stop taking Tebofortan:
If you have any further questions about using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Tebofortán may cause adverse effects, although not everyone will 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 from individual reports from patients, physicians, or pharmacists. According to these reports, the following side effects may occur during treatment with Tebofortán:
In individuals with hypersensitivity, allergic 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 headache, dizziness, vertigo, or worsening of pre-existing vertigo.
There have been isolated reports indicating bleeding from individual organs.
If any of the aforementioned side effects occur, stop taking Tebofortán and consult your doctor, who will assess the severity and determine any necessary measures.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tebofortán
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after Exp.: The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.
No special storage conditions are required.
6. Contents of the package and other information:
Composition of Tebofortán per tablet:
The active substance is 120.0 mg of dry extract from Ginkgo biloba leaves EGb 761® (ratio of dry plant material to extract: 35-67:1), obtained with 60% m/m acetone, quantified to contain 26.4 – 32.4 mg of flavonoids calculated as flavonoid glycosides and 6.48 – 7.92 mg of terpene 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 croscarmellose sodium, colloidal anhydrous silica, hypromellose, monohydrate lactose, macrogol 1500, magnesium stearate, maize starch, microcrystalline cellulose, dimethicone, alpha-octadecyl omega-hydroxypoly(oxethylene)5, sorbic acid (E-200), talc, and red iron oxide pigment (E-172).
Appearance of the product and contents of the pack:
Red, round, film-coated tablets. Tebofortán 120 mg is available in cardboard boxes containing 15, 30, 45, or 60 tablets in blisters.
Marketing Authorization Holder and Manufacturer:
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Straße 4
76227 Karlsruhe / Germany
Further information on this medicinal product is available upon request to 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, 2ª planta. 28108 Alcobendas, Madrid
Date of the most recent revision of this leaflet: September 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/