Ginkyo® 50 mg film coated tablets
Product Characteristics
Read all of this leaflet carefully because it contains important information for you.This medicine is available without prescription. However, you still need to take Ginkyo® 50mg exactly as directed to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
Ginkyo® 50mg
LI 1370
Active substance: The active pharmaceutical ingredient is a dry extract of Ginkgo biloba leaves.
1 film-coated tablet contains:
50 mg dry extract of Ginkgo biloba leaves (35-67:1). Extraction solvent: acetone 60% (m/m).
The extract is quantified to 22-27% flavonoids, calculated as flavonoid glycosides, and 5.0-7.0% terpene lactones, including 2.8-3.4% ginkgolides A, B, and C, and 2.6-3.2% bilobalides; it contains less than 5 ppm ginkgolic acids.
The other ingredients are:
highly dispersed silicon dioxide, lactose monohydrate, microcrystalline cellulose, citric acid monohydrate, talcum, magnesium stearate, basic butyl methacrylate copolymer (Ph. Eur.), saccharin sodium, vanillin, iron oxide hydrate (E 172), castor oil.
Ginkyo® 50 mg is available in packs of 50 film-coated tablets (N2), 100 film-coated tablets (N3), or 1,000 (10 x 100) film-coated tablets (hospital pack).
1. WHAT Ginkyo® 50mg IS AND WHAT IT IS USED FOR
1.1 Ginkyo® 50 mg contains an extract of Ginkgo leaves.
1.2 From: Lichtwer Healthcare GmbH & Co. KG, Wallenroder Straße 8-10, 13435 Berlin, Germany
1.3 Ginkyo® 50 mg is used:
a) for symptomatic treatment of brain-related performance disorders within the scope of an overall therapeutical concept in case of a decrease or loss of acquired mental capacities (dementia syndrome), involving the following primary complaints: impaired memory, impaired concentration, depressive mood disorders, dizziness, ear noises, headaches.
Patients' individual response to medication cannot be predicted.
Before starting treatment with this medicine, it should be investigated whether the complaints are not caused by an underlying illness that requires a specific form of treatment.
b) for increasing pain-free walking distance in arterial occlusive disease of the limbs, intermittent claudication of FONTAINE Stage II within the scope of physical therapy, in particular walking training.
c) in case of dizziness caused by circulation disorders or age-related involution (vertigo of vascular and involutive origin).
d) for supportive treatment of ear noises (tinnitus). Any frequent recurrence of dizziness and ear noises must be thoroughly investigated by a doctor. If you experience a sudden impairment or loss of hearing, you should see a doctor immediately.
2. BEFORE YOU TAKE Ginkyo® 50mg
2.1 Do not take Ginkyo® 50mg
if you are allergic (hypersensitive) to the active substance or to any of the other ingredients.
2.2 Take special care with Ginkyo® 50mg
if you have a pathologically increased propensity for bleeding (hemorrhagic diathesis), or if you are concurrently being treated with anticoagulant drugs, you should consult a doctor before using this medicine.
Using Ginkyo® 50 mg in children
No adequate studies have been conducted on using this medicine in children. It should therefore not be used by children under 12 years of age.
What to keep in mind during pregnancy and breast-feeding
Experimental studies showed no evidence of any teratogenic effects of the ginkgo extract contained in this medicine.
However, as there is no practical experience with the use of this medicine in humans, and its use during pregnancy is not justified, the benefits of a treatment during pregnancy have to be carefully weighed against the potential risks involved.
It is not known whether the constituents of the Ginkgo extract pass into breast milk.
What else to keep in mind
As there is some evidence suggesting that preparations containing Ginkgo can increase the propensity for bleeding, this medicine has to be discontinued before any surgical procedure. Please notify your doctor in time, so he/she may decide on the further course of action as appropriate.
Please observe the information given in sections 1.3 and 3.2.
Important information about some of the ingredients of Ginkyo® 50mg
This medicine contains lactose. Therefore, if you know that you are suffering from a sugar intolerance, please consult your doctor before taking Ginkyo® 50mg.
2.3 Taking other medicines
When this medicine is taken concurrently with anticoagulants (e.g. phenprocoumon, acetylsalicylic acid, or other non-steroidal antirheumatics), their effects may be increased.
2.4 Taking Ginkyo® 50mg with food and drink
No special precautions are required.
3. HOW TO TAKE Ginkyo® 50mg
Always take Ginkyo® 50mg exactly as directed in this package leaflet. You should check with your doctor or pharmacist if you are not sure.
3.1 Method of administration
For oral use.
3.2 Unless otherwise prescribed by your doctor, the usual dosage is as follows:
a) for symptomatic treatment of brain-related performance disorders, adults and adolescents from 12 years of age should take 1 film-coated tablet 3 times per day or 2 film-coated tablets twice per day (equivalent to 150 or 200 mg of Ginkgo extract per day, respectively).
b) for increasing pain-free walking distance in arterial occlusive disease of the limbs, adults and adolescents from 12 years of age should take 1 film-coated tablet 3 times per day (equivalent to 150 mg of Ginkgo extract per day).
c)/d) in case of dizziness and for supportive treatment of ear noises, adults and adolescents from 12 years of age should take 1 film-coated tablet 3 times per day (equivalent to 150 mg of Ginkgo extract per day).
Do not take the film-coated tablets while you are lying down.
Please swallow the film-coated tablets whole with a sufficient amount of liquid (preferably a glass of plain drinking water).
If you are supposed to take 3 doses per day, you should take them in the morning, at noon, and in the evening; if you are supposed to take 2 doses per day, you should take them in the morning and evening. The tablets may be taken independently of your regular meals.
Please consult your doctor or pharmacist if you feel that the effect of this medicine is too strong or too weak.
How long to take Ginkyo® 50 mg
a) In case of brain-related performance disorders, the minimum treatment period should be 8 weeks.
After a treatment period of 3 months, your doctor should check whether further treatment is still warranted.
b) In case of arterial occlusive disease of the limbs:
A minimum treatment period of 6 weeks is required to achieve an improvement in walking distance.
c) In case of dizziness:
Treatment periods in excess of 6-8 weeks will not improve the outcome.
d) In case of ear noises:
Supportive treatment should be maintained for a minimum period of 12 weeks. If no improvement is seen after 6 months, it is not to be expected after that even if treatment is continued.
3.3 If you take more Ginkyo® 50mg than you should
There might be an increased occurrence of the side effects listed below; in this case please notify a doctor. He/she may then decide what measures have to be taken.
3.4 If you forget to take Ginkyo® 50mg
Do not take a double dose to make up for a forgotten dose, but continue taking Ginkyo® 50mg as prescribed by your doctor, or as described in this package leaflet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects.
The listing includes all side effects reported under treatment with Ginkgo leaf extract, including those that occurred at higher doses or during long-term therapy.
Some vary rare instances of bleeding (in the brain, in the gastrointestinal tract, in the eye) may occur during treatment with medicines that contain Ginkgo biloba, in particular when anticoagulants such as phenprocoumon, acetylsalicylic acid, or other non-steroidal antirheumatics are used concurrently.
Very rare instances of mild gastrointestinal complaints, headaches, or allergic skin reactions (redness, swelling, itching) have been observed following the use of this medicine.
If you experience any of the side effects mentioned above, please tell a doctor, who will then determine the degree of severity, as well as any action that may have to be taken.
At the first signs of a hypersensitivity reaction or bleeding, you must stop taking this medicine.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Ginkyo® 50 mg
Keep out of the reach and sight of children.
Do not use Ginkyo® 50mg after the expiry date which is stated on the carton/container.
Storage:
Do not store above 25°C.
This leaflet was last approved in:
February 2006.
For sale in pharmacies only
Marketing authorisation No.: 26370.00.00
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