Tavonin 40 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Tavonin®40 mg

Film-coated tablets

Extract of Ginkgo biloba EGb 761®

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

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 further information, consult your pharmacist.
• If you experience any adverse reactions, 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.

Leaflet contents:

1. What Tavonin is and what it is used for
2. What you need to know before taking Tavonin
3. How to take Tavonin
4. Possible adverse effects
5. How to store Tavonin
6. Contents of the pack and other information

1. What Tavonin is and what it is used for

These are film-coated tablets containing 40 mg of Ginkgo biloba extract EGb 761®.

This medicine 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 limbs (such as cramps and cold sensation in the legs).

You should consult a doctor if your condition worsens or does not improve after 8 weeks of treatment.

2. What you need to know before starting to take 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).

It must not be administered to children and adolescents under 18 years of age.

During pregnancy or breastfeeding (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tavonin.

Do not take for longer than 8 consecutive weeks, unless otherwise directed by your doctor. If symptoms worsen or persist after this time, despite regular use and adequate dosage, consult your doctor and inform them of the dose and duration of treatment with this medicine.

In the treatment of vertigo, administration beyond 8 weeks does not provide additional therapeutic benefit.

In cases of tinnitus, if no improvement is observed within the first 6–8 weeks of treatment, continuation is not recommended, as improvement is unlikely.

If you have an increased tendency to bleeding (hemorrhagic diathesis) or are taking anticoagulant medications simultaneously, 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 they can determine the appropriate course of action.

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

Children and adolescents

Due to insufficient clinical experience with the use of Tavonin in children, its use is not recommended in children and adolescents under 18 years of age.

Taking Tavonin with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

When Tavonin is taken concomitantly with anticoagulant medicines (such as phenprocoumon, warfarin, clopidogrel, acetylsalicylic acid, and other non-steroidal anti-rheumatic agents), an increased effect of these preparations cannot be ruled out.

As with all medicines, it cannot be excluded that Tavonin may affect the metabolism of various other medicines, thereby influencing their potency and/or duration of effect. There is insufficient research available on these interactions.

For this reason, please consult your doctor or pharmacist before taking Tavonin.

Also inform your doctor or pharmacist about any suspected changes in the effects of medicines you are taking concurrently with Tavonin.

Taking Tavonin with food and drink

The tablets may be taken independently of meals.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. As a general precaution, and given that isolated cases suggest preparations containing Ginkgo may increase the tendency to bleeding, this preparation 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 the ability to drive or operate machinery have been reported.

Tavonin contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Tavonin contains maize starch.

3. How to take Tavonin

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist.

This medicine is taken orally.

The recommended dose is:

Adults: 1 tablet three times a day (120 mg), for 6 to 8 weeks.

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

Elderly: Same as for adults.

Do not take the tablets while lying down. The tablets should be swallowed whole with liquid (preferably with a glass of water), without chewing.

Use in children and adolescents

Use in children and adolescents under 18 years of age is not recommended.

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 this 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 missed doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets 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, physicians, or pharmacists. According to these reports, the following side effects may occur during treatment with Tavonin:

Bleeding from individual organs may occur, particularly when co-medicated with anticoagulant drugs such as phenprocoumon, acetylsalicylic acid, or other non-steroidal anti-rheumatic agents (see also section 2. Taking other medicines). In individuals with hypersensitivity, allergic shock or skin allergic reactions (redness, swelling, itching) may occur.

In addition, mild gastrointestinal disturbances, headache, dizziness, or worsening of pre-existing dizziness may occur.

If any of the above-mentioned side effects occur, do not take any more Tavonin and consult your doctor so that the severity can be assessed and, if necessary, appropriate measures taken.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. 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.

No special storage conditions required.

Do not use this medicine after the expiry date stated on the container after Exp.: The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tavonin 40 mg film-coated tablets:

Each film-coated tablet contains:

The active substance is: 40.0 mg of dry extract from leaves of Ginkgo biloba EGb 761® (ratio of dry plant to extract: 35-67:1), obtained with 60% m/m acetone, quantified as 8.8 - 10.8 mg of flavonoid glycosides and 2.0 - 2.8 mg of terpene lactones, of which approximately 1.12 – 1.36 mg are ginkgolides A, B, and C, and 1.04 – 1.28 mg are bilobalides, and not more than 0.2 micrograms are ginkgolic acids.

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

Appearance of the product and contents of the pack:

Yellow film-coated tablets.

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

Marketing Authorization Holder and Manufacturer:

Dr. Willmar Schwabe GmbH & Co.

Willmar-Schwabe-Straße 4

76227 Karlsruhe / Germany

Further information on this medicinal product is available upon request to 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 review of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.