TAVONIN 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tavonin® 120 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 Tavonincarefully to get 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 8 weeks of treatment.

Contents of the Package Leaflet

1. What is Tavonin and what is it used for
2. What you need to know before taking Tavonin
3. How to take Tavonin
4. Possible side effects
5. Storage of Tavonin
6. Package Contents and Additional Information

1. What is Tavonin and what is it used for

They are film-coated tablets containing 120 mg of Ginkgo 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 feeling of cold in the legs).

You should consult a doctor 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 any of the other components of this medication (listed in section 6).
• Due to the lack of clinical experience in the use of Tavonin in children, its use is not recommended in children and adolescents under 18 years of age.
• In case of pregnancy (see Pregnancy and Breastfeeding).

Warnings and Precautions:

Consult your doctor or pharmacist before starting to take Tavonin.

Do not administer for more than 12 consecutive weeks, except as indicated by your doctor. If symptoms worsen or persist after this period, despite regular intake and sufficient dosage, you should consult your doctor, indicating the dosage and time you have taken this medication.

In case of increased tendency to bleeding (hemorrhagic diathesis) and simultaneous treatment with anticoagulant medications, this medication should only be taken after consulting your doctor. Isolated reports indicate that preparations containing Ginkgo may increase the tendency to bleed. This medication should be discontinued before surgery. Inform your doctor in due time that you have taken Tavoninso that they can decide how to proceed.

If you suffer from epileptic seizures, consult your doctor before starting treatment with Tavonin.

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 recently taken, or may need to take any other medication.

Taking Tavonin 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 or 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 during breastfeeding is not recommended.

Driving and Use of Machines:

No effects on driving and use of machines have been described.

Tavonin contains lactose:

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

Tavonin contains corn starch.

3. How to take Tavonin

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 (120 mg of Ginkgo bilobaextract per day).

If necessary, the dose may be increased to 2 tablets per day (240 mg of Ginkgo bilobaextract per day).

Duration of Treatment:

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

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

If the symptoms of the disease worsen or aggravate during treatment, you should consult your doctor about the convenience of continuing it.

If you take more Tavonin than you should:

No cases of overdose are known. If you have taken a large amount of Tavonin 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 Tavonin:

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Tavonin:

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

4. Possible Side Effects

Like all medications, Tavonin can cause side effects, although not everyone experiences them.

There are no verified data on the frequency of side effects observed during treatment with preparations containing Ginkgo biloba, 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 Tavonin:

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 also headache, dizziness, and vertigo or worsening of existing vertigo.

Isolated reports indicate the possibility of bleeding from individual organs.

In case any of the above-mentioned side effects occur, do not take more Tavonin and consult your doctor so that they can decide on the severity and, possibly, the necessary measures to take.

Reporting of 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 national reporting system. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tavonin

Keep this medication out of the 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 Tavonin per tablet:

The active ingredient is 120.0 mg of dry extract of Ginkgo biloba leaves EGb 761® (plant dry extract ratio: 35-67:1), obtained with 60% w/w acetone, quantified to 26.4 – 32.4 mg of flavonoids calculated as flavonoid glycosides and to 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 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, corn starch, microcrystalline cellulose, dimethicone, alpha-octadecyl-omega-hydroxypoly(oxyethylene)5, sorbic acid (E-200), talc, and red iron oxide colorant (E-172).

Appearance of the Product and Package Contents:

Red, round, film-coated tablets.

Tavonin 120 mg is presented 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

You can request more information about this medication by contacting 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

Date of the Last Revision of this Package Leaflet: September 2024

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/.