Tavonin 120 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tavonin® 120 mg
film-coated tablets
Ginkgo biloba extract EGb761®
Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you. This medicine can be obtained without a prescription, for the treatment of minor conditions without the intervention of a doctor. However, you should use Tavonin carefully to achieve the best results. 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 adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 8 weeks of treatment.
Contents of the leaflet
- What Tavonin is and what it is used for
- What you need to know before taking Tavonin
- How to take Tavonin
- Possible adverse effects
- How to store Tavonin
- Contents of the pack and other information
1. What Tavonin is and what it is used for
These are film-coated tablets containing 120 mg of Ginkgo biloba extract EGb 761®.
This medicinal product improves blood microcirculation.
This medicine is indicated for the symptomatic treatment of disturbances in cerebral microcirculation (such as vertigo and tinnitus) or of symptoms associated with circulatory insufficiency in the extremities (such as leg cramps and cold sensation in the legs).
You should consult a physician if your condition worsens or does not improve.
2. What you need to know before taking Tavonin:
Do not take Tavonin:
- 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 regarding the use of Tavonin in children, its use is not recommended in children and adolescents under 18 years of age.
- During pregnancy (see Pregnancy and breastfeeding).
Warnings and precautions:
Talk to your doctor or pharmacist before starting to take Tavonin.
Do not administer for longer than 12 consecutive weeks, except on medical advice. If symptoms worsen or persist beyond this period, despite regular intake and adequate dosage, consult your doctor, informing him of the dose and duration for which you have taken this medicine.
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 procedures. Inform your doctor promptly that you have been taking Tavonin so that he can determine the appropriate course of action.
If you suffer from epileptic seizures, consult your doctor before starting treatment with Tavonin.
Children and adolescents:
This medicine should not be administered to children under 18 years of age.
Taking Tavonin 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 Tavonin 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 or 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 its use during breastfeeding; therefore, the use of this medicine is not recommended during this period.
Driving and using machines:
No effects on driving and using machines have been reported.
Tavonin contains lactose:
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Tavonin contains corn starch.
3. How to take Tavonin
This medicine is for oral use.
Always follow exactly the instructions provided in this leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Adults over 18 years of age: The recommended dose is 1 tablet per day (120 mg of Ginkgo biloba extract per day).
If necessary, the dose may be increased to 2 tablets per day (240 mg of Ginkgo biloba extract per day).
Duration of treatment:
In the treatment of vertigo, administration beyond 8 weeks does not provide additional therapeutic benefit.
For tinnitus, the recommended treatment duration is 12 weeks. If no improvement is observed within the first 8 weeks of treatment, continuation is not recommended, as improvement is unlikely.
If your symptoms worsen or intensify during treatment, consult your doctor regarding the appropriateness of continuing treatment.
If you take more Tavonin than you should:
There are no known cases of overdose. If you have taken a large amount of Tavonin 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 Tavonin:
Do not take a double dose to make up for forgotten doses.
If you stop taking Tavonin:
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Tavonin may cause adverse effects, although not everyone experiences 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 Tavonin:
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, 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 Tavonin and consult your doctor so they can assess the severity and, if necessary, determine the appropriate measures to take.
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 national reporting system. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tavonin
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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.
No special storage conditions are required.
6. Contents of the pack and other information
Composition of Tavonin 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 using 60% m/m acetone, quantified to contain 26.4 – 32.4 mg of flavonoids expressed as flavonic 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 not more than 0.6 micrograms are ginkgolic acids.
The other components are croscarmellose sodium, colloidal anhydrous silica, hypromellose, lactose monohydrate, macrogol 1500, magnesium stearate, corn starch, microcrystalline cellulose, dimethicone, alpha- octadecyl omega hydroxypoly(oxietilen)5, sorbic acid (E-200), talc, and red iron oxide pigment (E-172).
Appearance of the medicinal product and contents of the pack:
Red, round, film-coated tablets.
Tavonin 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Local representative:
SCHWABE FARMA IBÉRICA, S.A.U.
Avenida de la Industria, 4. Building 2, staircase 1, 2nd floor
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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.