PATIENT INFORMATION LEAFLET

Tavonin®40 mg

Film-coated tablets

Extract ofGinkgo bilobaEGb 761®

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained 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 side effects, consult your doctor or pharmacist, even if they are 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.

1. What isTavoninand what it is used for

2. What you need to knowbefore starting to takeTavonin

3. Howto takeTavonin

4. Possible side effects

5. Storage ofTavonin

6. Contents of the pack and additional information

Coated tablets with 40 mg ofGinkgo bilobaextract EGb 761®.

This medication improves blood microcirculation.

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

Consult a doctor if symptoms worsen or do not improve after 8 weeks of treatment.

Do not take Tavonin:

If you are allergic to Ginkgo biloba or any of the other components of this medication (listed in section 6).

It should not be administered to children and adolescents under 18 years old.

In case of pregnancy or breastfeeding (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeTavonin.

Do not administer more than 8 weeks consecutively, except by doctor's indication. If symptoms worsen or persist after this period of time, despite regular intake and sufficient dose, you should consult with your doctor, indicating the dose and time you have taken this medication.

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

In case of tinnitus, if no improvement is observed in the 6-8 first weeks of treatment, it is not recommended to continue with the same, since improvement is not expected.

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 a surgical intervention. 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

Since there is not enough clinical experience in the use ofTavoninin children, it is not recommended to use in children and adolescents under 18 years old.

Taking Tavonin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

In case of concomitant treatment ofTavoninwith anticoagulant medications (such as phenprocoumon, warfarin, clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs) it cannot be ruled out that the effect of these preparations is increased.

As with all medications, it cannot be ruled out thatTavoninacts on the metabolism of several other medications which may affect the potency and/or duration of the effect of the medications referred to. There is not enough research available on these effects.

For this reason, please consult with your doctor or pharmacist before takingTavonin.

Also inform your doctor or pharmacist about any suspicion of change in the effects of the medications you are taking at the same time asTavonin.

Taking Tavonin with food and drinks

The intake of the tablets is independent of meals.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.
As a general precaution, and given that isolated cases indicate the possibility that preparations containing Ginkgo may increase the bleeding tendency, this preparation 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 have been described on the ability to drive and operate machines.

Tavonin contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Tavonin contains cornstarch.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

This medication is taken orally.

The recommended dose is:

Adults: 1 tablet three times a day (120 mg), for6 to8 weeks.

If necessary, this dose may be increased up to 4 tablets a day (160 mg).

Seniors:The same as adults.

Do not take the tablets while lying down. The tablets must be swallowed whole with some liquid (preferably with a glass of water).

Use in children and adolescents

It is not recommended for use in children and adolescents under 18 years of age.

If you take more Tavonin than you should:

No cases of overdose have been reported. If you have taken a large amount of Tavonin tablets, you may experience increased adverse reactions as indicated in section 4. Possible side effects. Inform your doctor in this case. He 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 forgot to take Tavonin:

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

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

There are no verified data on the frequency of undesirable 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 withTavonin:

Bleeding from individual organs may occur, particularly in cases of concomitant medication with anticoagulant medications such as phenprocoumon, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (see also section 2. in Taking Other Medications). In people with hypersensitivity, anaphylactic shock or skin allergic reactions (redness, swelling, itching) may occur.

Additionally, mild gastrointestinal disturbances, headaches, dizziness, or exacerbation of existing dizziness may occur.

If any of the aforementioned adverse effects occur, do not take moreTavoninand 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 a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.
Do not use this medication after the expiration date indicated on the packaging after Expiration Date:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at your local pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tavonin 40 mg film-coated tablets:

Each film-coated tablet contains:

The active principle is:40.0 mg of dried leaf extract ofGinkgo bilobaEGb 761®(plant dry matter/extract ratio: 35-67:1), obtained with 60% m/m acetone, quantified at 8.8 - 10.8 mg of flavonoid glycosides and 2.0 - 2.8 mg of terpenic lactones, of which approximately 1.12 – 1.36 mg are ginkgolides A, B, and C, and 1.04 – 1.28 mg are bilobalides and no more than 0.2 micrograms are ginkgolic acids.

The other components (excipients) are: Sodium croscarmellose, dimethicone emulsion, colloidal silicon dioxide, lactose, macrogol, magnesium stearate, cornstarch, hypromellose, microcrystalline cellulose, talc, and colorants: iron(III) oxide / iron(II) oxide hydrate (E-172).

Appearance of the product and contents of the packaging:

Yellow film-coated tablets.

Tavonin film-coated tablets are presented in cardboard boxes containing 60 tablets in blisters.

Holder of the marketing authorization and responsible for manufacturing:

Dr. Willmar Schwabe GmbH & Co.

Willmar-Schwabe-Stra?e 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: April 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.