Ginkgoherb

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: information for the user

Ginkgoherb, 120 mg, coated tablets

Ginkgoherb, 240 mg, coated tablets

Dried, purified, and quantified extract from the leaves of Ginkgo biloba
Ginkgo biloba extractum siccum raffinatum et quantificatum
Medicine intended for adult patients

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ginkgoherb and what is it used for
• 2. Important information before taking Ginkgoherb
• 3. How to take Ginkgoherb
• 4. Possible side effects
• 5. How to store Ginkgoherb
• 6. Package contents and other information

1. What is Ginkgoherb and what is it used for

Ginkgoherb contains a dried extract from the leaves of Ginkgo biloba (Ginkgo biloba L., folium).
Ginkgoherb is a herbal medicinal product used to improve (age-related) cognitive function impairment and quality of life in patients with mild dementia.

2. Important information before taking Ginkgoherb

When not to take Ginkgoherb:

• if the patient is allergic to the dried extract from the leaves of Ginkgo biloba (Ginkgo biloba L., folium) or to any of the other ingredients of this medicine (listed in section 6).
• during pregnancy

Warnings and precautions

In case of worsening symptoms during treatment with Ginkgoherb, the patient should consult a doctor or pharmacist.
Before starting treatment with Ginkgoherb, the patient should discuss the following with their doctor or pharmacist:

• if the patient has an increased tendency to bleeding (coagulopathy) or is being treated with blood-thinning medications;
• if the patient has had seizures;
• if the patient is scheduled to undergo surgery within the next 3-4 days;
• if the patient is taking efavirenz (see "Ginkgoherb and other medicines");
• if the patient has been told by their doctor that they have an intolerance to some sugars.

Children and adolescents

There are no indications for the use of Ginkgoherb in children and adolescents.

Ginkgoherb and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines bought without a prescription. Products containing Ginkgo biloba extracts may affect the action of certain medicines. Therefore, the patient should not take this medicine before consulting their doctor if they:

• are taking anticoagulant medicines (e.g., phenprocoumon and warfarin) or antiplatelet medicines (e.g., clopidogrel, acetylsalicylic acid, and other non-steroidal anti-inflammatory medicines);
• are taking dabigatran;
• are taking nifedipine. It is not recommended to take Ginkgo biloba products and efavirenz at the same time, as efavirenz plasma concentrations may be reduced.

Pregnancy and breastfeeding

There are indications that the tendency to bleeding may increase. Therefore, this medicine should not be taken during pregnancy.
Due to the lack of sufficient data, the use of this medicinal product is not recommended during breastfeeding.
It is not known whether the extract components pass into human milk.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive and use machines safely.
No studies have been conducted to assess the impact on the ability to drive and use machines.

Ginkgoherb contains lactose and glucose.

This medicine contains lactose and glucose. If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Ginkgoherb

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Ginkgoherb 120 mg coated tablets
The recommended dose for adults and elderly patients is 1 Ginkgoherb tablet 2 times a day.
When taking this medicine 2 times a day, it should be taken in the morning and in the afternoon.
Ginkgoherb 240 mg coated tablets
The recommended dose for adults and elderly patients is half a Ginkgoherb tablet 2 times a day.
When taking this medicine 2 times a day, it should be taken in the morning and in the afternoon.
Special patient groups
There are no available data on the dosage instructions for this medicinal product in cases of impaired renal or hepatic function.

Method of administration

Ginkgoherb should be taken orally. The coated tablets should not be taken while lying on the back. The coated tablets should be swallowed whole, with a liquid, preferably a glass of drinking water, with or without food.

Duration of treatment

This medicine should be taken for at least 8 weeks.
If there is no improvement after 3 months or the patient feels worse, they should contact their doctor. The doctor will assess whether continued treatment is justified.

Taking a higher dose of Ginkgoherb than recommended

No cases of overdose have been reported. Enhanced side effects as described in section 4 "Possible side effects" may occur.
In case of significant overdose of Ginkgoherb, the patient should contact their doctor or seek medical advice, as medical attention may be necessary.

Missing a dose of Ginkgoherb

If the patient realizes they have missed a dose of Ginkgoherb, they should wait and take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Ginkgoherb

If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 in 10 people):

• Headache

Common (affects 1 to 10 people in 100):

• Dizziness, diarrhea, abdominal pain, nausea, vomiting

Unknown frequency (cannot be estimated from the available data):

• Bleeding from individual organs (eye, nose, cerebral hemorrhage, and gastrointestinal bleeding), hypersensitivity reactions (anaphylactic shock), allergic skin reactions (flushing, swelling, itching, and rash), heart rhythm disorders (arrhythmia), palpitations (feeling of faster, stronger, or irregular heartbeat).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Ginkgoherb

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use Ginkgoherb after the expiry date stated on the outer packaging or label. The expiry date (EXP) is the last day of the month stated.

6. Package contents and other information

What Ginkgoherb contains

The active substance is a dried, purified, and quantified extract from the leaves of Ginkgo biloba (Ginkgo biloba extractum siccum raffinatum et quantificatum)
One coated tablet contains 120 mg of extract (in the form of dried, purified, and quantified extract) from Ginkgo bilobaL., (folium), Ginkgo biloba leaves (DER 35-67:1), which corresponds to:
26.4 mg to 32.4 mg of flavonoids, calculated as flavonoid glycosides;
3.36 mg to 4.08 mg of ginkgolides A, B, and C;
3.12 mg to 3.84 mg of bilobalide.
Extraction solvent: 60% (m/m) acetone.
Ginkgoherb 240 mg coated tablets
One coated tablet contains 240 mg of extract (in the form of dried, purified, and quantified extract) from Ginkgo bilobaL., (folium), Ginkgo biloba leaves (DER 35-67:1), which corresponds to:
52.8 mg to 64.8 mg of flavonoids, calculated as flavonoid glycosides;
6.72 mg to 8.16 mg of ginkgolides A, B, and C;
6.24 mg to 7.68 mg of bilobalide.
Extraction solvent: 60% (m/m) acetone.
Other ingredients are:
Spray-dried glucose liquid
Core tablet ingredients:
Lactose monohydrate
Microcrystalline cellulose PH 101
Sodium croscarmellose
Silica colloidal anhydrous
Magnesium stearate
Coating ingredients:
Opadry II white F 18422 coating mixture (contains polyvinyl alcohol, macrogol 3350, titanium dioxide E 171, talc)
Yellow iron oxide E 172

What Ginkgoherb looks like and contents of the pack

Ginkgoherb 120 mg coated tablets
Yellow oval coated tablets with a dividing line on both sides (tablet size: approximately 16.9 mm x 9.0 mm). The tablet can be divided into equal doses.
Ginkgoherb 240 mg coated tablets
Yellow elongated coated tablets with a dividing line on both sides (tablet size: approximately 19.2 mm x 8.2 mm). The tablet can be divided into equal doses.
Ginkgoherb is supplied in packages containing 20, 30, 40, 50, 60, 80, 90, 100, 120, 200, or 500 coated tablets in a PVC/PVDC/Aluminum blister pack in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Doppelherz Pharma GmbH
Schleswiger Straße 74
24941 Flensburg
Germany

Manufacturer

Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Swiss Caps GmbH
Grassingerstraße 9
83043 Bad Aibling,
Germany
Queisser Pharma GmbH & Co. KG
Schleswiger Straße 74
24941 Flensburg
Germany

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Germany:
Doppelherz Ginkgo 120 mg Filmtabletten
Doppelherz Ginkgo 240 mg Filmtabletten
Poland:
Ginkgoherb

Date of last revision of the leaflet: