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Ginkobil (Ginkgo biloba extract) 80 mg capsules

Effectively reduces:
• dizziness and ringing in the ears;
• legs pain raised of circulatory disorders;
• memory and attention disorders.

PACKAGE LEAFLET: INFORMATION FOR USERS

Ginkobil 80 mg hard capsules
Refined and quantified dry extract of Ginkgo

Read the whole leaflet carefully before you start taking this medicine.
- Ginkobil can be purchased without a prescription and for a best effect use it as directed.
- Keep this leaflet, it may be necessary to read it later.
- If you want to know more or to get consultation ask your pharmacist.
- If the symptoms worsen or do not improve over 20-30 days seek medical advice.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Ginkobil is and what it is used for?
2. What you should know before you take Ginkobil?
3. How to take Ginkobil?
4. Possible side effects.
5. How to store Ginkobil?
6. Futher information.

1. WHAT GINKOBIL IS AND WHAT IT IS USED FOR?
There is Ginkgo (Ginkgo biloba) leaves dry extract in the Ginkobil.

Ginkobil used for:
• Symptomatic treatment of mild to moderate brain blood flow insufficiency, manifested weakened memory and concentration, ringing and tinnitus in the ears, dizziness or headache.
• For improvement of pain-free walking distance in peripheral arterial occlusive disease in Stage II according to Fontaine (intermittent claudication), through physical and therapeutic measures, in particular walking exercise.
• Dizziness, tinnitus caused by the senile changes and vascular damage.

The cause of frequent dizziness and tinnitus should always be investigated by a doctor. In the case of sudden hearing disturbance or hearing loss, the patient should seek immediate medical attention.

2. WHAT SHOULD YOU KNOW BEFORE TAKING GINKOBIL?

Do not take Ginkobil in the following cases:
- if you are alergic (hypersensitive) to active substance or to any excipient of Ginkobil.

Take special care with Ginkobil
- special precautionary measures are not necessary.

Taking other medicines
Taking Ginkobil for a long time can cause interaction between Ginkobil and other drugs that inhibit blood clotting.

Taking Ginkobil with food and drink
-

Pregnancy and breast-feeding

Consult your doctor before you take any medicine.

During studies with animals ginkgo extract did not cause toxicity to the fetus or embryo, however there is no treatment experience with pregnant women, it is not recommended to use medicinal product.

It is unknown whether the extract containing substances get in the breast-feeding milk. It is not recommended to take medicine during breastfeeding.

Driving and using machines
Ginkobil does not affect ability to drive or to operate machines.

Other information on some Ginkobil excipients
-

3. HOW TO USE GINKOBIL?

Take Ginkobil exactly as your doctor has told you. In case of doubt, please consult your doctor or pharmacist.

Symptomatic treatment of brain activity disorders of organic origin
Take 1 capsule 2 – 3 times per day (corresponds to 160 – 240 mg daily dose).

To increase walking distance without leg pain, if peripheral arterial occlusion is present. To reduce of tinnitus and dizziness caused by vascular damage or senile changes.
Take 1 capsule 2 times per day (corresponds to 160 mg ginkgo extract daily dose).

Ginkobil is used after a meal, not chewable, with liquid.
Treatment duration of the brain function organic disorder depends on the severity of the disease. If the disease is a chronic one, medicine should be taken for at least 8 weeks.
After taking Ginkobil for three months, it is necessary to determine whether it is worth to continue the treatment.
If vascular damage and other causes of dizziness and tinnitus do not decrease during the 6-8 weeks, it is pointless to take medicine any longer.

If you think that Ginkobil is too strong or too weak, consult with your doctor or pharmacist.

If you took more Ginkobil then you should
If you have taken too much Ginkobil accidentally, please seek for your doctor or turn to emergency room of the nearest hospital.

If you forgot to take Ginkobil
Do not take a double dose of medicine to compensate for the forgotten one.

If you stop taking Ginkobil
Undetermined

If you have any further questions about the use of this medicine consult your physician or pharmacist.

4. POSSIBLE SIDE EFFECTS

Ginkobil, as any other medicine, can cause side effects, although not everybody experiences them.

There are very rare cases of some scanty gastrointestinal disorders, headache or allergic skin reaction. In addition, there were bleeding cases for patients who took product for a long time and were prone to bleeding or took blood coagulation medicine. There is no determined connection between taking medicine and bleeding.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please, inform your doctor or pharmacist.

5. HOW TO STORE GINKOBIL?
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Do not use Ginkobil after the expiry date indicated on the blister and the outer package. For the expiry date the last day of month applies.
Medicine should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6. FUTHER INFORMATION
What Ginkobil contains
- Actyve substance is refined and quantified ginkgo dry extract.
Each hard capsule contains 80 mg Ginkgo biloba L., folium (ginkgo leaves) refined and quantified dry extract (30-40:1), equivalent to:
- 17,6 – 21,6 mg flavonoids, expressed in accordance with flavones glycosides,
- 2,24 – 2,72 mg ginkgolides A, B and C,
- 2,08 – 2,56 mg bilobalid.
Extraction solvent: 60 -65 % (V/V) of acetone.
- The excipients are microcrystalline cellulose, talc, magnesium stearate, anhydrous colloidal silica dioxide, in the body of the capsule – gelatine, titanium dioxide (E171), red iron oxide (E172).

What Ginkobil looks like and contents of the pack

Ginkobil capsules are auburn cylindrical capsules filed with light brown powder.

Ginkobil is packed in blister packages of 20 capsules. Blister package are packed in carton box containing 20, 40, 60, 80 or 100 capsules.

Not all sizes of cartons may be available for supply.

Marketing Authorization Holder
JSC Aurantijus
Taikos av.102
LT-51195 Kaunas
Lithuania
Tel. +370 37 328008
Fax .+370 37 338487
E.mail This email address is being protected from spambots. You need JavaScript enabled to view it.

Manufacturer
JSC Aconitum
Taikos av. 102
Kaunas LT-51195
Lithuania

Consult marketing authorization holder, if you want more information about this medicine.

The latest date of approval of this package information leaflet is 2011-01-17

The latest review of the package information leaflet is available online at the website of State Medicines Control Agency (SMCA) under the Ministry of Health of the Republic of Lithuania http://www.vvkt.lt/

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