TEBONIN

TEBONIN konzent 240 mg Filmtabletten

Important notes (mandatory information)

Tebonin concentrated 240 mg film-coated tablets. Active ingredient: Ginkgo biloba leaf dry extract. Areas of application: as a herbal medicinal product for the improvement of (age-associated) cognitive impairment and for improving the quality of life in mild dementia.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tebonin concentrated 240 mg film-coated tablets for adults aged 18 and over
Active ingredient: Ginkgo biloba leaf dry extract
Herbal medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Tebonin concentrated 240 mg must be used as directed in order to be effective.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor.

This package leaflet contains

1. WHAT IS TEBONIN CONCENTRATED 240 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING TEBONIN CONCENTRATED 240 MG?
3. HOW SHOULD YOU TAKE TEBONIN CONCENTRATED 240 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD TEBONIN CONCENTRATED 240 MG BE STORED?
6. WHAT DOES TEBONIN CONCENTRATED 240 MG CONTAIN AND WHAT PACK SIZES ARE AVAILABLE?
7. WHO IS THE MARKETING AUTHORISATION HOLDER FOR TEBONIN CONCENTRATED 240 MG?

1. WHAT IS TEBONIN CONCENTRATED 240 MG AND WHAT IS IT USED FOR?

Tebonin concentrated 240 mg contains an extract from ginkgo leaves. Tebonin concentrated 240 mg is used as a herbal medicinal product for the improvement of (age-associated) cognitive impairment and for improving the quality of life in mild dementia.

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING TEBONIN CONCENTRATED 240 MG?

Tebonin concentrated 240 mg must not be taken:

• if you are hypersensitive (allergic) to Ginkgo biloba or any of the other ingredients,
• during pregnancy.

Special care should be taken when taking Tebonin concentrated 240 mg

What should be considered in children?
There is insufficient research on the use of this medicine in this age group. It should therefore not be used in children and adolescents under 18 years of age.

What should you be aware of during pregnancy and breastfeeding?
Since there are some indications that ginkgo-containing preparations could increase bleeding tendency, this medicine must not be taken during pregnancy. This medicine should not be used during breastfeeding, as there is insufficient research. It is not known whether the ingredients of the extract pass into breast milk.

What else should you watch out for?
In the case of abnormally increased bleeding tendency (haemorrhagic diathesis) and simultaneous treatment with anticoagulant medicines, this medicine should only be used after consulting a doctor. Since there are some indications that ginkgo-containing preparations could increase bleeding tendency, this medicine should be discontinued as a precaution before an operation. Please inform your doctor in good time if you have taken Tebonin concentrated 240 mg so that they can decide on the further procedure. If you have a known seizure disorder (epilepsy), please consult your doctor before taking Tebonin concentrated 240 mg.

This medicine contains lactose

Please only take Tebonin concentrated 240 mg after consulting your doctor if you know that you are intolerant to certain sugars.

Interactions with other medicines

If this medicine is taken at the same time as anticoagulant medicines (such as phenprocoumon, warfarin, clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs), their effect cannot be ruled out. As with all medicines, an effect on the metabolism of various other medicines cannot be ruled out for Tebonin concentrated 240 mg either, which could affect the potency and/or duration of action of the medicines concerned. There is insufficient research on this. Please therefore consult your doctor or pharmacist.

When taking Tebonin concentrated 240 mg together with food and drink

There are no special instructions.

3. HOW SHOULD YOU TAKE TEBONIN CONCENTRATED 240 MG?

Always take Tebonin concentrated 240 mg exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Method of administration

For oral use. Unless otherwise prescribed by your doctor, the usual dose is: Adults aged 18 and over should take 1 film-coated tablet once a day (equivalent to 240 mg ginkgo extract per day). Do not take film-coated tablets while lying down. Please take the film-coated tablets whole with sufficient liquid (preferably a glass of drinking water). They can be taken independently of meals. Please talk to your doctor or pharmacist if you have the impression that the effect of this medicine is too strong or too weak.

Children and adolescents

Tebonin concentrated 240 mg is not intended for use in persons under 18 years of age.

How long should you take Tebonin concentrated 240 mg?
The duration of treatment should be at least 8 weeks. After a treatment period of 3 months, the doctor should check whether it is still justified to continue treatment.

If you have taken more Tebonin concentrated 240 mg than you should

Symptoms of overdose are not known to date. The side effects mentioned below may occur more frequently if you have taken a larger amount of Tebonin concentrated 240 mg. Please inform your doctor. They can decide on any necessary measures.

If you forget to take Tebonin concentrated 240 mg

Do not take twice the amount the next time, but continue taking it as prescribed by your doctor or as described in this package leaflet.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can have side effects. The list includes all known side effects under treatment with Ginkgo biloba leaf dry extract, including those under higher dosage or long-term therapy.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

It is not possible to provide reliable information on the frequency of side effects known to occur when taking Ginkgo biloba-containing medicines, as these side effects have become known through individual reports from patients, doctors or pharmacists. According to these reports, the following side effects could occur when taking this medicine: Bleeding may occur in individual organs, especially if anticoagulant medicines such as phenprocoumon, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs are taken at the same time. In hypersensitive persons, severe hypersensitivity reactions (anaphylactic shock) may occur; in addition, allergic skin reactions (reddening of the skin, swelling of the skin, itching) may occur. If you are affected by any of the side effects mentioned above, do not take Tebonin concentrated 240 mg again and contact your doctor immediately so that they can decide on the severity and any necessary measures. Furthermore, mild gastrointestinal complaints, headaches, dizziness or an increase in existing dizziness may occur. Please inform your doctor or pharmacist if any of the side effects listed have a significant impact on you.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD TEBONIN CONCENTRATED 240 MG BE STORED?

Keep out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton or container (blister pack).

6. WHAT DOES TEBONIN CONCENTRATED 240 MG CONTAIN AND WHAT PACK SIZES ARE AVAILABLE?

1 film-coated tablet contains: Active ingredient: 240 mg quantified dry extract from Ginkgo biloba leaves (35-67:1), extraction agent: acetone 60% (m/m). The extract is quantified to 52.8 - 64.8 mg flavonoid glycosides and to 12.96 - 15.84 mg terpene lactones, of which 6.72 - 8.16 mg ginkgolides A, B and C and 6.24 - 7.68 mg bilobalide, and contains less than 1.2 µg ginkgolic acids per film-coated tablet. Other ingredients: croscarmellose sodium; dimethicone 350; highly dispersed silicon dioxide; hypromellose; lactose monohydrate; macrogol 1500; macrogol stearyl ether-5 (Ph. Eur.); magnesium stearate (Ph. Eur.) [vegetable]; maize starch; microcrystalline cellulose; sorbic acid (Ph. Eur.); talc; titanium dioxide E 171; iron(III) hydroxide-oxide E 172.

Tebonin concentrated 240 mg is available in packs of 30 (N1), 60 (N2), 80, 120 (N3) film-coated tablets.

7. WHO IS THE MARKETING AUTHORISATION HOLDER FOR TEBONIN CONCENTRATED 240 MG?

Pharmaceutical entrepreneur and manufacturer

Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Straße 4
76227 Karlsruhe
Telephone: 08000005258
Telefax: 08001009549
www.schwabe.de

This package leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Ginkgo biloba leaf dry extract. Areas of application: as a herbal medicinal product for the improvement of (age-associated) cognitive impairment and for improving the quality of life in mild dementia.