TEBONIN

TEBONIN intens 120 mg film-coated tablets

Important notes (mandatory information)

Tebonin intens 120 mg film-coated tablets. Active ingredient: Ginkgo biloba leaf dry extract. Areas of application: for the symptomatic treatment of mental performance deficits caused by organic brain damage. The application takes place within the framework of a therapeutic overall concept for progressive decline or loss of acquired mental abilities (dementia syndrome) with the main symptoms: memory disorders, concentration disorders, depression, dizziness, tinnitus, headaches; for extending the pain-free walking distance in arterial occlusive disease in the limbs, so-called "intermittent claudication" (Claudicatio intermittens in stage II according to FONTAINE) within the framework of physical-therapeutic measures, in particular gait training; for dizziness due to circulatory disorders or age-related involution processes (vertigo of vascular and involutional origin); for the supportive treatment of tinnitus due to circulatory disorders or age-related involution processes (tinnitus of vascular and involutional origin).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tebonin intens 120 mg film-coated tablet for adults aged 18 and over
Active ingredient: Ginkgo biloba leaf dry extract

Read the entire package leaflet carefully because it contains important information for you. This medicine is also available without a doctor's prescription. However, in order to achieve the best possible treatment result, Tebonin intens 120 mg must be used as prescribed.

• 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 INTENS 120 MG AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING TEBONIN INTENS 120 MG?
3. HOW TO TAKE TEBONIN INTENS 120 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD TEBONIN INTENS 120 MG BE STORED?
6. HOW IS TEBONIN INTENS 120 MG COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?
7. WHO IS TEBONIN INTENS 120 MG FROM?

1. WHAT IS TEBONIN INTENS 120 MG AND WHAT IS IT USED FOR?

Tebonin intens 120 mg contains an extract from ginkgo leaves. Tebonin intens 120 mg is used for the symptomatic treatment of mental performance deficits caused by organic brain damage. The application takes place within the framework of a therapeutic overall concept for progressive decline or loss of acquired mental abilities (dementia syndrome) with the main symptoms: memory disorders, concentration disorders, depression, dizziness, tinnitus, headaches. The individual response to the medication cannot be predicted. Before starting treatment with this medicine, it should be clarified whether the signs of illness are not based on a specific underlying disease that needs to be treated. To extend the pain-free walking distance in arterial occlusive disease in the limbs, so-called "intermittent claudication" (Claudicatio intermittens in stage II according to FONTAINE) within the framework of physical-therapeutic measures, in particular gait training. For dizziness due to circulatory disorders or age-related involution processes (vertigo of vascular and involutional origin). For the supportive treatment of tinnitus due to circulatory disorders or age-related involution processes (tinnitus of vascular and involutional origin). Frequent dizziness and tinnitus generally require clarification by a doctor. If sudden hearing loss or hearing loss occurs, a doctor should be consulted immediately.

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING TEBONIN INTENS 120 MG?

Tebonin intens 120 mg must not be taken:

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

Special care is required when taking Tebonin intens 120 mg

What should be considered in children?
There are no sufficient studies 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 do you need to consider 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 are no sufficient studies. It is not known whether the ingredients of the extract pass into breast milk.

What else do you need to watch out for?
In the case of a pathologically increased bleeding tendency (hemorrhagic diathesis) and simultaneous treatment with anticoagulant drugs, this medicine should only be used after consultation with 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 intens 120 mg so that he can decide on the further procedure. If you have a known seizure disorder (epilepsy), please consult your doctor before taking Tebonin intens 120 mg.

This medicine contains lactose

Please only take Tebonin intens 120 mg after consulting your doctor if you know that you suffer from an intolerance 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 influence on the metabolism of various other medicines cannot be ruled out for Tebonin intens 120 mg either, which could affect the strength and/or duration of action of the medicines concerned. Sufficient studies on this are not available. Therefore, please consult your doctor or pharmacist.

When taking Tebonin intens 120 mg together with food and drink

There are no special features to be observed.

3. HOW TO TAKE TEBONIN INTENS 120 MG?

Always take Tebonin intens 120 mg exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Method of application

For oral use.

Unless otherwise prescribed by your doctor, the usual dose is:

• For the symptomatic treatment of mental disorders caused by organic brain damage: Adults aged 18 and over should take 1 film-coated tablet twice a day (corresponding to 120 mg of ginkgo extract twice a day).
• To extend the pain-free walking distance in peripheral arterial occlusive disease: Adults aged 18 and over should take 1 film-coated tablet 1 to 2 times a day (corresponding to 120 mg of ginkgo extract 1 to 2 times a day).
• For dizziness and for the supportive treatment of tinnitus: Adults aged 18 and over should take 1 film-coated tablet 1 to 2 times a day (corresponding to 120 mg of ginkgo extract 1 to 2 times a day).

The intake is taken twice a day in the morning and evening, once a day in the morning. Do not take film-coated tablets while lying down. Please take the film-coated tablets unchewed with sufficient liquid (preferably a glass of drinking water). The intake can take place 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 intens 120 mg is not intended for use in persons under 18 years of age.

How long should you use Tebonin intens 120 mg?

• For mental disorders caused by organic brain damage: The duration of treatment should be at least 8 weeks. After a treatment period of 3 months, the doctor should check whether the continuation of treatment is still justified.
• For peripheral arterial occlusive disease: Improvement in walking distance requires a treatment period of at least 6 weeks.
• For dizziness: Use for a period longer than 6 to 8 weeks does not improve the treatment result.
• For tinnitus: The supportive treatment should be carried out over a period of at least 12 weeks. If no success has occurred after 6 months, this is no longer to be expected even with longer treatment.

If you have taken more Tebonin intens 120 mg than you should

Overdose symptoms are not known so far. The side effects mentioned below may occur more frequently if you have taken a larger amount of Tebonin intens 120 mg. Please notify your doctor. He can decide on any necessary measures.

If you forget to take Tebonin intens 120 mg

Do not take double the amount next time, but continue taking it as prescribed by your doctor or as described in this 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 treated persons out of 100
Uncommon:	1 to 10 treated persons out of 1,000
Rare:	1 to 10 treated persons out of 10,000
Very rare:	less than 1 treated person out of 10,000
Not known:	Frequency cannot be estimated from the available data.

The following side effects have been reported with the use of Ginkgo biloba-containing medicines

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 (see also under Interactions). In hypersensitive persons, severe hypersensitivity reactions (anaphylactic shock) may occur; in addition, allergic skin reactions (redness, swelling, itching) may occur. If you are affected by one of the above side effects, do not take Tebonin intens 120 mg again and contact your doctor immediately so that he 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 listed side effects affect you significantly.

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 provide more information about the safety of this medicine.

5. HOW SHOULD TEBONIN INTENS 120MG BE STORED?

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

6. HOW IS TEBONIN INTENS 120MG COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?

1 film-coated tablet contains

Active ingredient: 120 mg dry extract from Ginkgo biloba leaves (35-67:1), extraction agent: acetone 60% (m/m). The extract is quantified to 26.4 - 32.4 mg flavonoids, calculated as flavonoid glycosides, and 6.0 - 8.4 mg terpenlactones, of which 3.36 - 4.08 mg ginkgolides A, B and C and 3.12 - 3.84 mg bilobalide, and contains less than 0.6 µg ginkgolic acids per film-coated tablet. Other ingredients: croscarmellose sodium; highly dispersed silicon dioxide; hypromellose; lactose monohydrate; macrogol 1500; magnesium stearate (Ph. Eur.); corn starch; microcrystalline cellulose; simethicone-alpha-hydro-omega-octadecyloxypoly(oxyethylene)-5-sorbic acid(Ph. Eur.)-water; talc; titanium dioxide; iron(III) hydroxide oxide x H2O.

Tebonin intens 120 mg is available in packs of 30 (N1), 60 (N2), 120 (N3), 200 film-coated tablets.

7. WHO IS TEBONIN INTENS 120 MG FROM?

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 February 2014.

Active ingredient: Ginkgo biloba leaf dry extract. Areas of application: for the symptomatic treatment of mental performance deficits caused by organic brain damage. The application takes place within the framework of a therapeutic overall concept for progressive decline or loss of acquired mental abilities (dementia syndrome) with the main symptoms: memory disorders, concentration disorders, depression, dizziness, tinnitus, headaches; for extending the pain-free walking distance in arterial occlusive disease in the limbs, so-called "intermittent claudication" (Claudicatio intermittens in stage II according to FONTAINE) within the framework of physical-therapeutic measures, in particular gait training; for dizziness due to circulatory disorders or age-related involution processes (vertigo of vascular and involutional origin); for the supportive treatment of tinnitus due to circulatory disorders or age-related involution processes (tinnitus of vascular and involutional origin).