Tebofortan 240 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Tebofortan® 240 mg
film-coated tablets
Ginkgo biloba extract EGb761®
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
This medicine is available without a prescription, for the treatment of minor conditions without the intervention of a doctor. However, you should use Tebofortan 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 further information, consult your pharmacist.
- If you experience 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.
Contents of the leaflet
- What Tebofortan is and what it is used for
- What you need to know before taking Tebofortan
- How to take Tebofortan
- Possible side effects
- How to store Tebofortan
- Contents of the pack and other information
1. What Tebofortán is and what it is used for
These are film-coated tablets containing 240 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).
- Due to 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:
Consult your doctor or pharmacist before starting to take Tebofortan.
If symptoms worsen or persist during treatment, you should consult your doctor.
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 prior to surgical intervention. Inform your doctor in due time that you have taken Tebofortan so that they can decide on the appropriate course of action.
If you suffer from epileptic seizures, consult your doctor before starting treatment with Tebofortan.
Children and adolescents:
Tebofortan must not be administered to children and adolescents 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 should be swallowed whole with some liquid (preferably a glass of water). The medicine should be taken separately 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 available 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.
3. How to take Tebofortan
This medicine is for oral use.
Always follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults over 18 years of age: The recommended dose is 1 tablet per day (240 mg of Ginkgo biloba extract per day).
Duration of treatment:
Treatment should last at least 8 weeks. If symptoms worsen or do not improve after 3 months of treatment, consult your doctor regarding the appropriateness of continuing 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 the use of this medicine, consult 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 disturbances such as diarrhoea, abdominal pain, and nausea; headache, dizziness, and vertigo have also been reported.
There have been isolated reports indicating bleeding from individual organs, although a causal relationship with Tebofortán has not been established.
The frequency of the adverse effects described above is unknown.
If any of the aforementioned side effects occur, stop taking Tebofortán and consult your doctor so they can assess the severity and, if necessary, determine the appropriate measures.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tebofortan
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 following Exp.:. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
No special storage conditions are required.
6. Contents of the pack and other information:
Composition of Tebofortan per tablet:
The active substance is 240.0 mg of dry extract from Ginkgo biloba leaves EGb 761® (ratio of dry plant/extract: 35-67:1), obtained with 60% m/m acetone, quantified as 52.8–64.8 mg of flavonoids expressed as flavonic glycosides and 12.96–15.84 mg of terpene lactones, of which 6.72–8.16 mg are ginkgolides A, B, and C, and 6.24–7.68 mg are bilobalides, and no 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, hypromellose 6 mPas, hypromellose 15 mPas, iron oxide red (E 172), iron oxide yellow (E 172), stearic acid, and talc.
Appearance of the product and contents of the pack:
Film-coated oval brown tablets. Tebofortan 240 mg is available in cardboard boxes containing 10, 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
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 review of this leaflet: October 2021.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/