GINKOBIL-

GINKOBIL-ratiopharm 120 mg film-coated tablets

Important notes (mandatory information)

Ginkobil ratiopharm 120 mg film-coated tablets. Active ingredient: Ginkgo biloba leaf dry extract. Areas of application: for the symptomatic treatment of organic brain disorders as part of a therapeutic overall concept in the case of a decrease or loss of acquired mental abilities (dementia syndrome) with the main symptoms: memory disorders, concentration disorders, depressive mood, dizziness, tinnitus, headaches; for extending the pain-free walking distance in the case of arterial occlusive disease in the limbs, so-called "intermittent claudication" (Claudicatio intermittens in stage II according to FONTAINE) as part of physical-therapeutic measures, in particular gait training; in the case of dizziness due to circulatory disorders or age-related regression processes (vertigo of vascular and involutional origin); for the supportive treatment of tinnitus due to circulatory disorders or age-related regression processes (tinnitus of vascular and involutional origin).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ginkobil ratiopharm 120 mg film-coated tablets 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, to achieve the best possible treatment results, Ginkobil ratiopharm 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 GINKOBIL RATIOPHARM 120 MG AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING GINKOBIL RATIOPHARM 120 MG?
3. HOW TO TAKE GINKOBIL RATIOPHARM 120 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD GINKOBIL RATIOPHARM 120 MG BE STORED?
6. HOW IS GINKOBIL RATIOPHARM 120 MG COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?
7. WHO IS GINKOBIL RATIOPHARM 120 MG FROM?

1. WHAT IS GINKOBIL RATIOPHARM 120 MG AND WHAT IS IT USED FOR?

Ginkobil ratiopharm 120 mg contains an extract from ginkgo leaves.

Ginkobil ratiopharm 120 mg is used:

• for the symptomatic treatment of organic brain disorders as part of a therapeutic overall concept in the case of a decrease or loss of acquired mental abilities (dementia syndrome) with the main symptoms: memory disorders, concentration disorders, depressive mood, dizziness, tinnitus, headaches. The individual response to the medication cannot be predicted. Before starting treatment with this medicine, it should be clarified whether the symptoms of the disease are not due to a specific underlying disease that needs to be treated.
• for extending the pain-free walking distance in the case of arterial occlusive disease in the limbs, so-called "intermittent claudication" (Claudicatio intermittens in stage II according to FONTAINE) as part of physical-therapeutic measures, in particular gait training.
• in the case of dizziness due to circulatory disorders or age-related regression processes (vertigo of vascular and involutional origin).
• for the supportive treatment of tinnitus due to circulatory disorders or age-related regression processes (tinnitus of vascular and involutional origin). Frequent dizziness and tinnitus generally require clarification by a doctor. In the case of sudden hearing loss or a loss of hearing, a doctor should be consulted immediately.

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING GINKOBIL RATIOPHARM 120 MG?

Ginkobil ratiopharm 120 mg must not be taken:

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

Special care must be taken when taking Ginkobil ratiopharm 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) as well as during 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 Ginkobil ratiopharm 120 mg so that he/she can decide on the further procedure. If you have a known seizure disorder (epilepsy), please consult your doctor before taking Ginkobil ratiopharm 120 mg.

This medicine contains lactose

Therefore, please only take Ginkobil ratiopharm 120 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

This medicine contains sodium

Ginkobil ratiopharm 120 mg contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it is virtually "sodium-free".

Interactions with other medicines

When 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 Ginkobil ratiopharm 120 mg either, which could affect the efficacy and/or duration of action of the medicines concerned. Sufficient studies on this are not available. Therefore, please consult your doctor or pharmacist.

No special features need to be observed when taking Ginkobil ratiopharm 120 mg together with food and drinks.

3. HOW TO TAKE GINKOBIL RATIOPHARM 120 MG?

How should Ginkobil ratiopharm 120 mg be taken?
Always take Ginkobil ratiopharm 120 mg exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not quite sure.

Method of administration

For oral use.

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

• For the symptomatic treatment of organic brain disorders: Adults aged 18 and over should take 1 film-coated tablet twice a day (corresponding to 120 mg Ginkgo extract twice a day).
• For extending 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 Ginkgo extract 1 to 2 times a day).
• In the case of 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 Ginkgo extract 1 to 2 times a day).

When taken twice a day, the medicine should be taken in the morning and evening, and when taken once a day, it should be taken 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 medicine 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

Ginkobil ratiopharm 120 mg is not intended for use in persons under 18 years of age.

How long should you take Ginkobil ratiopharm 120 mg?

• In the case of organic brain disorders: 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.
• In the case of peripheral arterial occlusive disease: An improvement in walking distance requires a treatment period of at least 6 weeks.
• In the case of dizziness: Use for a period longer than 6 to 8 weeks does not improve the treatment result.
• In the case of tinnitus: The supportive treatment should be carried out over a period of at least 12 weeks. If no success has been achieved after 6 months, it is no longer to be expected even with longer treatment.

If you have taken a larger amount of Ginkobil ratiopharm 120 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 Ginkobil ratiopharm 120 mg. Please inform your doctor. He/she can decide on any necessary measures.

If you forget to take Ginkobil ratiopharm 120 mg

Do not take twice the amount the next time, but continue taking the medicine 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 evaluate 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.

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 (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 Ginkobil ratiopharm 120 mg again and contact your doctor immediately so that he/she 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 notice any side effects, contact 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 about the safety of this medicine.

5. HOW SHOULD GINKOBIL RATIOPHARM 120 MG 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 GINKOBIL RATIOPHARM 120 MG COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?

1 film-coated tablet contains: Active ingredient: 120 mg quantified, refined 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 flavonol glycosides, 3.36 - 4.08 mg Ginkgolides A, B and C, 3.12 - 3.84 mg Bilobalid, 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.); Maize starch; Microcrystalline cellulose; Simeticon-alpha-hydro-omega-octadecyloxypoly(oxyethylene)-5-sorbic acid(Ph. Eur.)-water; Talc; Titanium dioxide; Iron(III) oxide.

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

7. WHO IS GINKOBIL RATIOPHARM 120 MG FROM?

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

Marketing authorisation holder

Bioplanta Arzneimittel GmbH
Postfach 226
76256 Ettlingen

This package leaflet was last revised in February 2020.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Ginkgo biloba leaf dry extract. Areas of application: for the symptomatic treatment of organic brain disorders as part of a therapeutic overall concept in the case of a decrease or loss of acquired mental abilities (dementia syndrome) with the main symptoms: memory disorders, concentration disorders, depressive mood, dizziness, tinnitus, headaches; for extending the pain-free walking distance in the case of arterial occlusive disease in the limbs, so-called "intermittent claudication" (Claudicatio intermittens in stage II according to FONTAINE) as part of physical-therapeutic measures, in particular gait training; in the case of dizziness due to circulatory disorders or age-related regression processes (vertigo of vascular and involutional origin); for the supportive treatment of tinnitus due to circulatory disorders or age-related regression processes (tinnitus of vascular and involutional origin).