Leaflet: information for the user

Tavonin120 mg

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 useTavoninwith 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 8 weeks of treatment.

1. What isTavoninand what it is used for

2. What you need to know before starting to takeTavonin

3. How to takeTavonin

4. Possible adverse effects

5. Storage ofTavonin

6. Contents of the pack and additional information

Coated tablets with 120 mg of Ginkgo biloba extract EGb 761.

This medication improves blood microcirculation.

This medication is indicated for the symptomatic treatment of alterations in cerebral microcirculation (such as vertigo and tinnitus) or symptoms associated with circulatory insufficiency in the extremities (such as cramps and cold sensation in the legs).

Consult a doctor if it worsens or does not improve.

Do not take Tavonin:

- 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 in the use of Tavonin in children, it is not recommended for use in children and adolescents under 18 years of age.

- During pregnancy (see Pregnancy and breastfeeding).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Tavonin.

Do not take more than 12 consecutive weeks, except on the advice of your doctor. If symptoms worsen or persist after this period of time, despite regular intake and sufficient dosage, you should consult your doctor, informing them of the dosage and the time you have taken this medication.

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 surgery. Inform your doctor in due time that you have takenTavoninso that they can decide how to proceed.

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

Children and adolescents:

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

Taking Tavonin 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 need to take any other medication.

Taking Tavonin 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, in the 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.

Tavonin contains lactose:

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

Tavonin contains cornstarch.

This medication is taken orally.

Follow exactly the administration instructions 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 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).

Treatment duration:

In the treatment of vertigo, administration for more than 8 weeks does not provide therapeutic benefit.

In the case of tinnitus, the recommended treatment duration is 12 weeks. If no improvement is observed in the first 8 weeks of treatment, it is not recommended to continue with the same, as improvement is not expected.

If the symptoms of the disease worsen or intensify during treatment, consult the doctor about the advisability of continuing it.

If you take more Tavonin than you should:

No cases of overdose are known. If you have taken a large number of Tavonin tablets, you may see increased adverse reactions indicated in section 4.Possible side effects.

Inform your doctor. 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 Tavonin:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tavonin:

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Tavonin 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. In accordance with these reports, the following secondary effects may occur during treatment with Tavonin:

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 secondary effects mentioned above occur, do not take more Tavonin 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 national notification system. 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 thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

No special storage conditions are required.

Composition of Tavonin per tablet:

The active principle is 120.0 mg of dry extract of Ginkgo biloba 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:

Coated tablets, round in shape, and red in color.

Tavonin 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

For more information about this medication, please contact 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

Last review date of this leaflet: September 2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) at http://www.aemps.gob.es/.