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TAVONIN 40 mg FILM-COATED TABLETS

TAVONIN 40 mg FILM-COATED TABLETS

Ask a doctor about a prescription for TAVONIN 40 mg FILM-COATED TABLETS

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use TAVONIN 40 mg FILM-COATED TABLETS

Introduction

PROSPECTUS: INFORMATION FOR THE PATIENT

Tavonin®40 mg

Coated tablets

Extract ofGinkgo bilobaEGb 761®

Read the entire prospectus carefully before starting to take this medication because it contains important information for you.

Follow exactly the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist.

  • Keep this prospectus, 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 they are adverse effects that do not appear in this prospectus. See section 4.
  • You should consult a doctor if you worsen or do not improve after 8 weeks of treatment.

Contents of the prospectus:

  1. What is Tavonin and what is it used for
  2. What you need to know before starting to take Tavonin
  3. How to take Tavonin
  4. Possible adverse 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 with 40 mg of Ginkgo bilobaEGb 761® extract.

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 feeling of cold in the legs).

You should consult a doctor if you worsen or do 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 medication (included in section 6).

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tavonin.

Do not administer for more than 8 weeks in a row, except as indicated by the doctor. If the symptoms worsen or persist after this period, despite regular and sufficient intake, you should consult 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 first 6-8 weeks of treatment, it is not recommended to continue with the same, as improvement is not expected.

In case of increased bleeding tendency (hemorrhagic diathesis) and simultaneous treatment with anticoagulant medications, this medication should only be taken after consulting a doctor.

Isolated reports indicate the possibility that preparations containing Ginkgo may increase the tendency to bleed.

This medication should be discontinued before surgery. Inform your doctor in due course that you have taken Tavoninso that they can decide how to proceed.

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

Children and adolescents

Since there is not enough clinical experience in the use of Tavoninin children, its use is not recommended in children and adolescents under 18 years of age.

Taking Tavonin with other medications

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

In case of concomitant treatment with Tavoninand anticoagulant medications (such as fenprocoumon, warfarin, clopidogrel, acetylsalicylic acid, and other non-steroidal anti-inflammatory drugs), it cannot be excluded that the effect of these preparations may be increased.

As with all medications, it cannot be excluded that Tavoninmay affect the metabolism of various other medications, which may affect the potency and/or duration of the effect of the medications in question. There is not enough research available on these effects.

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

Also, inform your doctor or pharmacist about any suspected change in the effects of the medications you are taking at the same time as Tavonin.

Taking Tavonin with food and drinks

Intake of the tablets is independent of meals.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 tendency to bleed, this preparation 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 using machines

No effects on the ability to drive and use 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 cornstarch.

3. How to take Tavonin

Follow exactly the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist.

This medication is used 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 to 4 tablets per day (160 mg).

Elderly: Same as adults.

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

Use in children and adolescents

The use of this medication is not recommended in children and adolescents under 18 years of age.

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 adverse 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 Toxicological 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.

4. Possible adverse effects

Like all medications, this medication can 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 only known through individual reports from patients, doctors, or pharmacists. According to these reports, the following side effects may occur during treatment with Tavonin:

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

Additionally, mild gastrointestinal disorders, headaches, vertigo, or worsening of existing vertigo may occur.

In case any of the above-mentioned side effects occur, do not take more Tavoninand consult your doctor so that they can decide on the severity and, possibly, the necessary 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 that does not appear in this prospectus. You can also report them directly through the Spanish Medication Pharmacovigilance System for Human Use. http://www.notificaram.es. By reporting adverse 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.

It does not require special storage conditions. Do not use this medication after the expiration date indicated on the packaging after Expiration:. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in 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.

6. Package contents and additional information

Composition of Tavonin 40 mg film-coated tablets:

Each film-coated tablet contains:

The active ingredient is: 40.0 mg of dry extract of Ginkgo bilobaEGb 761®(plant dry extract ratio: 35-67:1), obtained with 60% w/w acetone, quantified to 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 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 oxide (III) / iron hydroxide (E-172).

Appearance of the product and package contents:

Yellow film-coated tablets.

Tavonin film-coated tablets are presented 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

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 prospectus: April 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/.

Alternatives to TAVONIN 40 mg FILM-COATED TABLETS in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to TAVONIN 40 mg FILM-COATED TABLETS in Poland

Dosage form: Tablets, 40 mg
Active substance: Ginkgo folium
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Manufacturer: Biofarm Sp. z o.o.
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Alternative to TAVONIN 40 mg FILM-COATED TABLETS in Ukraine

Dosage form: tablets, 120 mg tablets in blister
Active substance: Ginkgo folium
Prescription not required
Dosage form: tablets, 40 mg
Active substance: Ginkgo folium
Manufacturer: BOFUR IPSEN INDUSTRI
Prescription not required
Dosage form: solution, 40 mg/ml; 30 ml in a bottle
Active substance: Ginkgo folium
Manufacturer: BOFUR IPSEN INDUSTRI
Prescription required
Dosage form: capsules, 40mg
Active substance: Ginkgo folium
Prescription not required
Dosage form: drops, 40 mg/ml in 40 ml bottle
Active substance: Ginkgo folium
Prescription not required
Dosage form: tablets, 10 tablets in a blister
Active substance: Ginkgo folium
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