Ginkobil 80 mg hard capsules

Package leaflet: information for the user

Ginkobil 80 mg hard capsules

Refined and quantified dry ginkgo extract

Read all this leaflet carefully before you start taking this medicinal product because it contains important information for you.
Always take this medicinal product exactly as indicated in this leaflet or as directed by your doctor or a pharmacist.

–                                    Keep this leaflet; you may need to read it again.

–                                    If you have any further questions, consult a pharmacist.

–             If you experience side effects (even though these effects are not listed in this leaflet), consult your doctor or a pharmacist. See chapter 4.

–                                    If your condition did not improve within 30 days or even worsened, contact your doctor.

Content of the leaflet:
1. What Ginkobil is and what it is used for
2. What do you need to know before you use Ginkobil
3. How to use Ginkobil
4. Possible side effects
5. How to store Ginkobil
6. Content of the package and other information

1. What Ginkobil is and what it is used for
Ginkobil active substance is ginkgo (Ginkgo biloba L.) leaf dry extract. 

Ginkobil is intended for improvement of age-related cognitive impairment and quality of life in people with mild dementia.

2. What do you need to know before you use Ginkobil? 
Do not use Ginkobil:

-If you are allergic to the ginkgo extract or any excipient of this medicinal product (they are listed in chapter 6);

-During pregnancy.

Warnings and special precautions

Consult your doctor or a pharmacist before you start taking Ginkobil.

–          In the case of pathologically increased bleeding tendencies, also if blood thinners are used (anticoagulants), this medicinal product can be taken only after a consultation with a doctor.

–          Since there is isolated evidence that medicinal products containing ginkgo can increase bleeding tendency, the use of this medicinal product must be terminated before a surgery. Please inform your doctor if you are using ginkgo extract so that he can decide further actions.

If you have epilepsy, consult your doctor before taking this medicinal product.

Children and adolescents

Ginkobil is not intended for children and adolescents.

Other medicinal products and Ginkobil

If you are using or recently used other medicinal products or you are not sure about this, inform your doctor or a pharmacist.

When taking Ginkobil together with antiplatelet agents (e.g.: clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory medicinal products), their effect might be affected.

You should be careful while taking Ginkobil together with dabigatran.

Ginkobil, in combination with nifedipine (a medicinal product used for high blood pressure), has been shown to increase the dizziness and hot flushes in some people.

It is not recommended to use ginkgo medicinal products in combination with efavirenz (for the treatment of HIV) because the levels of efavirenz can decrease.

If you take Ginkobil for a long time, the interaction between this medicinal product and other blood thinners that are used at the same time (e.g. warfarin) might occur.

Pregnancy, breastfeeding and fertility
If you are (possibly) pregnant or breastfeeding, or wish to become pregnant, consult your doctor or pharmacist before taking this medicinal product.

Do not use this medicinal product during pregnancy.

It is unknown whether the substances of the ginkgo extract are passed into breast milk. It is not recommended to take this medicinal product during breastfeeding.

Driving and using machines

There is no sufficient research that would indicate the influence of ginkgo on the ability to drive and use machines.

3. How to use Ginkobil 
Always use this medicinal product exactly as directed by your doctor. If in doubt, consult your doctor or a pharmacist.

For adults and elderly

A single dose is 80–240 mg (1–3 capsules).

A daily dose is 240 mg (3 capsules).

Use this medicinal product for at least 8 weeks.

If the symptoms did not reduce within 3 months or have worsened during the treatment, consult your doctor.
If you feel that the effect of Ginkobil is too strong or too weak, consult your doctor or a pharmacist.

If you forget to take Ginkobil
Do not use a double dose to make up for a forgotten dose.

4. Possible side effects
This medicinal product, like all medicinal products, can cause side effects, although, not everybody experiences them.

Very common side effects (might affect more than 1 in 10 people)

Common side effects (might affect up to 1 in 10 people)

Dizziness, gastrointestinal tract disorders (diarrhoea, abdominal pain, nausea, vomiting).

Frequency is unknown (cannot be estimated from the available data)
Eye, nose, brain and gastrointestinal bleeding, allergic skin reactions (redness, swelling oedema, itchiness, rash).

Reporting of side effects

If you experience side effects, including the effects not indicated in this leaflet, tell your doctor or a pharmacist. You can also report a side effect directly, via the form on www.vvkt.lt website, and submit it: send in writing to the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, Zirmunu str. 139A, LT 09120 Vilnius, phone: 8 800 73568, free fax: (8 800) 20 131; via email: NepageidaujamaR@vvkt.lt, via the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania website (http://www.vvkt.lt). By reporting a side effect, you can help us get more information about the safety of this medicinal product.

5. How to store Ginkobil?
Keep out of the reach and sight of children.
Do not store above 25 ° C. Store in manufacturer’s package to protect the medicinal product from moisture.
Do not use Ginkobil after the expiry date stated on the carton and blister pack. This medicinal product is suitable for use until the last day of the indicated month.
Medicinal products should not be disposed to drainage or with household waste. Ask a pharmacist how to dispose of unnecessary medicinal products. These measures will help protect the environment.

6. Content of the package and other information
Ginkobil composition:
– the active substance is refined and quantified ginkgo dry extract.
Each hard capsule contains 80 mg of refined and quantified dry extract Ginkgo biloba L., folium (ginkgo leaf) (30-40:1) that corresponds to:
– 17.6–21.6 mg flavonoids, expressed on flavone glycosides, 
– 2.24–2.72 mg ginkgolides A, B and C,
– 2.08–2.56 mg bilobalide.
Extraction solvent: 60–65 % (V/V) acetone;

Or

Each hard capsule contains 80 mg of refined and quantified dry extract Ginkgo biloba L., folium (ginkgo leaf) (35-67:1) that corresponds to:
– 17.6–21.6 mg flavonoids, expressed on flavone glycosides, 
– 2.24–2.72 mg ginkgolides A, B and C,
– 2.08–2.56 mg bilobalide.
Primary extraction solvent: 59–65 % (V/V) ethanol.

-Excipients: in the content of the capsule: microcrystalline cellulose, talc, magnesium stearate, anhydrous colloidal silicon dioxide. Casing contains: gelatine, titanium dioxide (E171), red iron oxide (E172).

Ginkobil appearance and amount in the package
Ginkobil hard capsules are chestnut brown, cylindrical, filled with light brown or brownish powder, might contain agglomerates.

Ginkobil is packed in blister packages of 20 capsules. Blister packages are packed in cartons of 40, 60, 80 or 100 hard capsules.
Not all package sizes might be available.

Registrant and producer

UAB Aconitum

Inovaciju str. 4

Biruliskes village

Kaunas district municipality

Lithuania

Phone: +370 37 328008

Fax: +370 37 338487

Email: info@aconitum.lt

If you want more information on this medicinal product, contact the registrant.

This package leaflet was last reviewed: 22/05/2017

Detailed information on this medicinal product is provided on the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania website https://www.vvkt.lt/.