Package leaflet: Information for the user

Ginkgoherb, 120 mg, coated tablets
Ginkgoherb, 240 mg, coated tablets
Purified and quantified dry extract of leaves of Ginkgo biloba L.
Ginkgonis extractum siccum raffinatum et quantificatum
Medicinal product intended for adult patients
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Contents of the leaflet

What Ginkgoherb is and what it is used for
What you need to know before taking Ginkgoherb
How to take Ginkgoherb
Possible side effects
How to store Ginkgoherb
Contents of the pack and other information

1. What Ginkgoherb is and what it is used for

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

2. Information before taking Ginkgoherb

When not to take Ginkgoherb:

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

Warnings and precautions
If symptoms worsen during treatment with Ginkgoherb, consult a
doctor or pharmacist.
Before starting to take Ginkgoherb, discuss this with a doctor or pharmacist:

if the patient has abnormally increased tendency to bleeding (bleeding diathesis) or if the patient is being treated with blood-thinning medicines;
if the patient has experienced epileptic seizures;
if the patient is scheduled for surgery within the next 3–4 days;
if the patient is taking efavirenz (see "Ginkgoherb and other medicines");
if the patient has been informed by a doctor about intolerance to certain sugars.

Children and adolescents
There are no indications for use of this medicine in children and adolescents.
Ginkgoherb and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take. This also applies to medicines purchased without a prescription. Products containing Ginkgo biloba extracts may affect the action of certain medicines. Therefore, do not take this medicine without consulting a doctor if the patient:

is taking anticoagulants (e.g. phenprocoumon and warfarin) or antiplatelet medicines (e.g. clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs);
is taking dabigatran;
is taking nifedipine.
Concomitant use of preparations containing Ginkgo biloba L. and efavirenz is not recommended. Plasma concentrations of efavirenz may be reduced.

Pregnancy and breastfeeding
There is some evidence suggesting that the tendency to bleeding may increase. Therefore, this medicine should not be taken during pregnancy.
Due to insufficient data, use of this medicinal product is not recommended during breastfeeding.
It is not known whether components of the extract pass into human milk.

Driving and using machines
The doctor will inform the patient whether their medical condition allows them to drive safely and operate machinery.
Appropriate studies evaluating the effect on the ability to drive and operate machinery have not been conducted.

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

3. How to take Ginkgoherb

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Ginkgoherb 120 mg film-coated tablets
The recommended dose for adults and elderly patients is 1 tablet of Ginkgoherb twice daily.
When taking this medicine twice daily, it should be taken in the morning and in the afternoon.
Ginkgoherb 240 mg film-coated tablets
The recommended dose for adults and elderly patients is half a tablet of Ginkgoherb twice daily.
When taking twice daily, the medicine should be taken in the morning and in the afternoon.
Special patient groups
There are no available data regarding dosage recommendations for patients with impaired renal or hepatic function.
Method of administration
Ginkgoherb should be administered orally. Do not take the film-coated tablets while lying on your back. The film-coated tablets should be swallowed whole with 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 if the patient feels worse, contact a doctor. The doctor should assess whether continuing treatment remains justified.
Taking more Ginkgoherb than recommended
No cases of overdose have been reported. Symptoms described in section 4, "Possible side effects", may become more pronounced.
In the event of a significant overdose of Ginkgoherb, contact your doctor or seek medical advice, as medical assistance may be necessary.
If you miss a dose of Ginkgoherb
If you realize you have missed a dose of Ginkgoherb, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Ginkgoherb
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very common (occur in more than 1 in 10 people):

Headache

Common (occur in 1 to 10 in 100 people):

Dizziness, diarrhoea, abdominal pain, nausea, vomiting

Unknown (frequency cannot be estimated from available data):

Bleeding from various organs (eye, nose, cerebral haemorrhage, gastrointestinal haemorrhage), hypersensitivity reactions (anaphylactic shock), allergic skin reactions (erythema, swelling, itching, rash), cardiac arrhythmias, palpitations (sensation of faster, stronger, or irregular heartbeat).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ginkgoherb medicine

Do not store above 30°C.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use Ginkgoherb medicine after the expiry date stated on the outer packaging or label. The expiry date (EXP) refers to the last day of the specified month.

6. Contents of the packaging and other information

What Ginkgoherb contains
The active substance in Ginkgoherb is a dry, purified and quantified extract from the leaves of Ginkgo biloba
(Ginkgonis extractum siccum raffinatum et quantificatum)
One coated tablet contains 120 mg of extract (in the form of a dry, purified and quantified extract) from Ginkgo biloba L., (folium), leaves of Ginkgo biloba (DER 35-67:1), corresponding to:
26.4 mg to 32.4 mg flavonoids, expressed as flavonoid glycosides;
3.36 mg to 4.08 mg ginkgolides A, B and C;
3.12 mg to 3.84 mg bilobalide.
Extraction solvent: 60% (m/m) acetone.

Ginkgoherb 240 mg coated tablets
One coated tablet contains 240 mg of extract (in the form of a dry, purified and quantified extract) from Ginkgo biloba L., (folium), leaves of Ginkgo biloba (DER 35-67:1), corresponding to:
52.8 mg to 64.8 mg flavonoids, expressed as flavonoid glycosides;
6.72 mg to 8.16 mg ginkgolides A, B and C;
6.24 mg to 7.68 mg bilobalide.
Extraction solvent: 60% (m/m) acetone.

Other ingredients are:
Spray-dried liquid glucose

Tablet core ingredients:
Lactose monohydrate
Microcrystalline cellulose type PH 101
Sodium croscarmellose
Anhydrous colloidal silicon dioxide
Magnesium stearate

Coating ingredients:
Opadry II white F 18422 film coating mixture (composition: polyvinyl alcohol, macrogol 3350, titanium dioxide E 171, talc)
Iron oxide yellow E 172

What Ginkgoherb looks like and contents of the pack
Ginkgoherb 120 mg coated tablets
Yellow, oval, coated tablets with a break line on both sides (tablet size: approx. 16.9 mm x 9.0 mm). The tablet can be divided into equal doses.

Ginkgoherb 240 mg coated tablets
Yellow, oblong, coated tablets with a break line on both sides (tablet size: approx. 19.2 mm x 8.2 mm). The tablet can be divided into equal doses.

Ginkgoherb is supplied in packs containing 20, 30, 40, 50, 60, 80, 90, 100, 120, 200 or 500 coated tablets in PVC/PVDC/Aluminium blisters within a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area under the following names:
Germany: Doppelherz Ginkgo 120 mg Filmtabletten
Doppelherz Ginkgo 240 mg Filmtabletten
Poland: Ginkgoherb