GINKGO ADGC

GINKGO ADGC 120 mg film-coated tablets

Important notes (mandatory information)

Ginkgo-ADGC 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 risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ginkgo-ADGC 120 mg film-coated tablets, for use in adults and adolescents over 12 years of age
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 prescription. However, to achieve the best possible treatment results, Ginkgo-ADGC 120 mg must be used as directed.

• 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 in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS GINKGO–ADGC 120 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GINKGO–ADGC 120 MG?
3. HOW SHOULD GINKGO–ADGC 120 MG BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD GINKGO–ADGC 120 MG BE STORED?
6. FURTHER INFORMATION

1. WHAT IS GINKGO-ADGC 120 MG AND WHAT IS IT USED FOR?

Ginkgo-ADGC 120 mg contains an extract from ginkgo leaves. Ginkgo-ADGC 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 signs of illness are not based on a specific underlying disease that needs to be treated. Frequently occurring feelings of dizziness and tinnitus generally require clarification by a doctor. In the event of sudden hearing loss or hearing impairment, a doctor should be consulted immediately.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GINKGO-ADGC 120 MG?

Ginkgo-ADGC 120 mg must not be taken if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients.

Special care should be taken when taking Ginkgo-ADGC1 120 mg:

• in the case of a pathologically increased tendency to bleed (hemorrhagic diathesis) and in the case of simultaneous treatment with anticoagulant drugs, this medicine should only be used after consulting a doctor. Since there are indications that ginkgo-containing preparations can increase the risk of bleeding, this medicine must be discontinued before an operation. Please inform your doctor in good time, who will decide on the further procedure. Please note the text under 1. "What is Ginkgo–ADGC 120 mg and what is it used for?" and 3. "How should Ginkgo–ADGC 120 mg be taken?".
• in children: There are no sufficient studies on the use of this medicine in children. It should therefore not be used in children under 12 years of age.
• in pregnancy and breastfeeding: Experimental studies have shown no evidence of a harmful effect on the fetus of the ginkgo extract contained in this medicine. However, since there is no experience in humans and the use during pregnancy is also not justified, the benefit of treatment during pregnancy must be carefully weighed against the possible risks. It is not known whether the ingredients of the ginkgo extract pass into breast milk.

When taking Ginkgo-ADGC 120 mg with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. When this medicine is taken at the same time as anticoagulant medicines (such as phenprocoumon, acetylsalicylic acid and other non-steroidal anti-rheumatic drugs), their effect may be increased.

When taking Ginkgo-ADGC 120 mg together with food and drink, there are no special precautions to be taken.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Ginkgo-ADGC1120 mg

This medicine contains lactose and glucose. Therefore, please only take Ginkgo-ADGC 120 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD GINKGO-ADGC 120 MG BE TAKEN?

Always take Ginkgo-ADGC 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: Adults and adolescents aged 12 years and over should take 1/2 - 1 film-coated tablet twice a day (corresponding to 120 - 240 mg ginkgo extract per day). Do not take the film-coated tablets while lying down. Please take the film-coated tablets whole with sufficient liquid (preferably a glass of drinking water). The application is carried out twice a day, in the morning and in the evening. 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.

Duration of use

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 the continuation of treatment is still justified.

If you have taken more Ginkgo-ADGC 120 mg than you should

The side effects listed below may be more pronounced; in this case, please notify a doctor. He can decide on any necessary measures.

If you forget to take Ginkgo-ADGC 120 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.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Ginkgo-ADGC 120 mg can have side effects, although not everybody gets them.

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.

Possible side effects

Very rarely, bleeding occurs when taking ginkgo biloba-containing medicines, especially if anticoagulant medicines such as phenprocoumon, acetylsalicylic acid or other non-steroidal anti-rheumatic drugs are taken at the same time (cerebral hemorrhages, bleeding in the gastrointestinal tract, bleeding in the eye). Very rarely, mild gastrointestinal complaints, headaches or allergic skin reactions (redness of the skin, swelling of the skin, itching) have been observed after taking this medicine.
If you observe any of the above side effects, please inform a doctor so that he can decide on the severity and any necessary measures. At the first signs of a hypersensitivity reaction or bleeding, this medicine must not be taken again.

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, Dept. 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 GINKGO-ADGC 120 MG BE STORED?

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

Storage conditions

Do not store above 25°C.

6. FURTHER INFORMATION

What Ginkgo-ADGC 120 mg contains

The active ingredient is: Ginkgo biloba leaf dry extract. 1 film-coated tablet contains: 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. The other ingredients are: spray-dried glucose syrup, highly dispersed, hydrophobic silicon dioxide, lactose, microcrystalline cellulose, citric acid, talc, magnesium stearate (Ph. Eur.), basic butyl methacrylate copolymer (Ph. Eur.) (Eudragit E 100), saccharin sodium, vanillin, iron(III) hydroxide oxide x H20 (E 172), hydrogenated castor oil.

What Ginkgo-ADGC 120 mg looks like and contents of the pack

Ginkgo-ADGC 120 mg are oval, yellow-brown film-coated tablets with a breaking groove on both sides. Ginkgo-ADGC 120 mg is available in original packs of 20 film-coated tablets, 60 film-coated tablets and 120 film-coated tablets. Hospital packs with 600 (10 x 60) film-coated tablets are also available for hospital use.

Pharmaceutical entrepreneur

KSK-Pharma Vertriebs AG
Finkenstraße 1
76327 Pfinztal-Berghausen
Phone: 0721/20 190-0
Fax: 0721/20 190-11
E-mail: info@ksk-pharma.de

Manufacturer

Artesan Pharma GmbH & Co. KG
Wendlandstraße 1
D-29439 Lüchow

This package leaflet was last revised in October 2018.

Source: Information from the package leaflet
Status: 11/2019
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.