TEBOFORTAN 240 mg FILM-COATED TABLETS
Ask a doctor about a prescription for TEBOFORTAN 240 mg FILM-COATED TABLETS
How to use TEBOFORTAN 240 mg FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the Patient
Tebofortan® 240 mg
film-coated tablets
Extract ofGinkgo bilobaEGb761®
Read the entire package leaflet 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 use Tebofortancarefully to obtain the best results. Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.
- Keep this package leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 3 months of treatment.
Contents of the Package Leaflet
- What is Tebofortan and what is it used for
- What you need to know before taking Tebofortan
- How to take Tebofortan
- Possible side effects
- Storage of Tebofortan
- Package contents and additional information
1. What is Tebofortan and what is it used for
They are film-coated tablets with 240 mg of Ginkgo bilobaextract EGb 761®. This plant-based medication is indicated for the improvement of age-related cognitive decline.
2. What you need to know before taking Tebofortan:
Do not take Tebofortan:
- If you are allergic to Ginkgo bilobaor any of the other components of this medication (listed in section 6).
- Due to the lack of clinical experience in the use of Tebofortan in children, its use is not recommended 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.
If symptoms worsen or persist during the use of the medication, you should consult your doctor.
In case of increased bleeding tendency (hemorrhagic diathesis) and simultaneous treatment with anticoagulant medications, this medication should only be taken after consulting your doctor. Isolated reports indicate that preparations containing Ginkgomay increase the tendency to bleed. This medication should be discontinued before surgery. Inform your doctor in due time that you have taken Tebofortan so that they can decide how to proceed.
If you suffer from epilepsy, consult your doctor before starting treatment with Tebofortan.
Children and adolescents:
It should not be administered to children and adolescents under 18 years of age.
Taking Tebofortan with other medications:
No clinically relevant interactions are known to date.
Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
Taking Tebofortan with food and beverages:
Do not take the tablets while lying down. The tablets should be swallowed without chewing with some liquid (preferably with a glass of water). The intake of the medication should be done separately from meals.
Pregnancy, breastfeeding, and fertility:
If you are pregnant, think you may be pregnant, or plan 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.
There are no clinical data on its use during breastfeeding, so the use of this medication is not recommended during this period.
Driving and using machines:
No effects on driving and using machines have been described.
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3. How to take Tebofortan
This medication is used orally.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.
Adults over 18 years: The recommended dose is 1 tablet per day (240 mg of Ginkgo bilobaextract 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, you should consult your doctor about the convenience of continuing it.
If you take more Tebofortan than you should:
No cases of overdose are known. If you have taken a large amount of Tebofortan tablets, the adverse reactions indicated in section 4, Possible side effects, may be increased.
In this case, inform your doctor. They will decide what measures to take.
In cases of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Tebofortan:
Do not take a double dose to make up for forgotten doses.
If you stop taking Tebofortan:
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, Tebofortan can cause side effects, although not everyone will experience them.
There are no verified data on the frequency of side effects observed during treatment with Ginkgo bilobapreparations, as these effects are only known through individual reports from patients, doctors, or pharmacists. According to these reports, the following side effects may occur during treatment with Tebofortan:
In people with hypersensitivity, allergic shock or skin allergic reactions (redness, swelling, itching) may occur.
The adverse reactions mainly consist of gastrointestinal problems such as diarrhea, abdominal pain, and nausea, but headache, dizziness, and vertigo have also been described.
There are isolated reports indicating bleeding from individual organs, although no causal relationship with Tebofortan has been established.
The frequency of the aforementioned side effects is unknown.
In case any of the above-mentioned side effects occur, do not take more Tebofortan and consult your doctor so that they can decide on the severity and, possibly, the necessary measures to take.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Tebofortan
Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date shown on the label and carton after Expiration Date:. The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
No special storage conditions are required.
6. Package contents and additional information:
Composition of Tebofortan per tablet:
The active ingredient is 240.0 mg of dry extract of Ginkgo bilobaleaves EGb 761® (plant dry extract ratio: 35-67:1), obtained with 60% w/w acetone, quantified to 52.8 -64.8 mg of flavonoids calculated as flavonoid glycosides and to 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:
Core of the tablet: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, and precipitated silica.
Tablet coating: microcrystalline cellulose, 6 mPa.s hypromellose, 15 mPa.s hypromellose, red iron oxide (E 172), yellow iron oxide (E 172), stearic acid, and talc.
Appearance of the product and package contents:
Film-coated tablets, oval and brown in color. Tebofortan 240 mg is presented in cardboard boxes containing 10, 15, 30, 45, or 60 tablets in blisters.
Title 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:
SCHWABE FARMA IBÉRICA, S.A.U.
Avenida de la Industria, 4. Edificio 2, escalera 1, 2ª planta. 28108 Alcobendas, Madrid
Date of the last revision of this package leaflet: October 2021.
Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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