GINKGO DOPPELHERZPHARMA

GINKGO DOPPELHERZPHARMA 240 mg film-coated tablets

Important notes (mandatory information)

Ginkgo DoppelherzPharma 240 mg Film-coated tablets. Areas of application: Herbal medicinal product for improving age-related cognitive impairment and quality of life in mild dementia.Warning: Contains lactose and glucose.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ginkgo DoppelherzPharma 240 mg Film-coated tablets, herbal medicinal product for improving age-related cognitive impairment and quality of life in mild dementia for use in adults.
Active ingredient: Ginkgo biloba leaf dry extract

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information.
Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS GINKGO DOPPELHERZPHARMA 240 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GINKGO DOPPELHERZPHARMA 240 MG?
3. HOW TO TAKE GINKGO DOPPELHERZPHARMA 240 MG FILM-COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GINKGO DOPPELHERZPHARMA 240 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS GINKGO DOPPELHERZPHARMA 240 MG AND WHAT IS IT USED FOR?

Ginkgo DoppelherzPharma 240 mg contains a dry extract from Ginkgo biloba leaves.

Ginkgo DoppelherzPharma 240 mg is a herbal medicinal product for improving age-related cognitive impairment and quality of life in mild dementia.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GINKGO DOPPELHERZPHARMA 240 MG?

Ginkgo DoppelherzPharma 240 mg must not be taken:

• if you are allergic to Ginkgo biloba dry extract or any of the other ingredients of this medicine listed in section 6.
• during pregnancy.

Warnings and precautions

Please talk to your doctor or pharmacist if the symptoms worsen while taking Ginkgo DoppelherzPharma 240 mg.

Please talk to your doctor or pharmacist before taking Ginkgo DoppelherzPharma 240 mg:

• if you have an abnormally increased tendency to bleed (haemorrhagic diathesis), as well as during concomitant treatment with blood-thinning medication.
• if you have a known seizure disorder (epilepsy).
• if an operation is planned in the next 3 to 4 days.
• if you are taking efavirenz (see "Taking Ginkgo DoppelherzPharma 240 mg with other medicines").
• if your doctor has told you that you have an intolerance to certain sugars.

Children and adolescents

There is no relevant indication for children and adolescents.

Taking Ginkgo DoppelherzPharma 240 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. This also includes medicines that you have bought without a prescription. Ginkgo can affect the way other medicines work.

Therefore, do not take this medicine before consulting your doctor:

• if you are taking anticoagulant medicines (e.g. phenprocoumon and warfarin) or platelet aggregation inhibitors (e.g. clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory medicines)
• if you are taking dabigatran
• if you are taking nifedipine

The concomitant use of Ginkgo biloba preparations and efavirenz is not recommended; plasma concentrations of efavirenz may be reduced.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Since there are some indications that Ginkgo-containing preparations could increase bleeding tendency, this medicine must not be taken during pregnancy.

This medicine should not be used during breast-feeding, as there are no sufficient studies available. It is not known whether the ingredients of the extract pass into breast milk.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and operate machines. No adequate studies have been conducted on the effects on driving and using machines.

Ginkgo DoppelherzPharma 240 mg contains lactose and glucose.

Please only take Ginkgo DoppelherzPharma 240 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE GINKGO DOPPELHERZPHARMA 240 MG FILM-COATED TABLETS?

Always take this medicine exactly as described in this package leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults and elderly patients is 1/2 Ginkgo DoppelherzPharma 240 mg film-coated tablet twice a day.

The twice-daily intake should be taken in the morning and evening.

Special patient groups

There are no data on dosage in case of impaired renal or hepatic function.

Method of administration

Ginkgo DoppelherzPharma 240 mg should be taken orally. Do not take the film-coated tablets lying on your back. The film-coated tablets should be swallowed whole with liquid, preferably with a glass of drinking water. The intake can be independent of meals.

Duration of use

The treatment should last at least 8 weeks.

If there is no improvement in symptoms after 3 months or if the symptoms of the disease worsen, the doctor should check whether the continuation of treatment is still justified.

If you have taken more Ginkgo DoppelherzPharma 240 mg than you should

No cases of overdose are known. You could experience increased symptoms such as those listed under section 4 "What side effects are possible?". If you have taken an overdose of Ginkgo DoppelherzPharma 240 mg, contact your doctor or seek medical advice, as you may need medical treatment.

If you forget to take Ginkgo DoppelherzPharma 240 mg

If you forget to take your dose of Ginkgo DoppelherzPharma 240 mg, wait and take the next dose at the usual time. Do not take twice the amount to make up for a forgotten dose.

If you stop taking Ginkgo DoppelherzPharma 240 mg

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

Headache

Common (may affect up to 1 in 10 people)

Dizziness, diarrhoea, abdominal pain, nausea, vomiting

Not known (frequency cannot be estimated from the available data)

Bleeding in individual organs (eyes, nose, brain and gastrointestinal bleeding), hypersensitivity reactions (anaphylactic shock), allergic skin reactions (redness, oedema, itching and rash), cardiac arrhythmias, palpitations (feeling of faster or stronger or irregular heartbeats)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GINKGO DOPPELHERZPHARMA 240 MG?
Do not store above 30°C. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister pack after "use by". The expiry date refers to the last day of the month indicated.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Ginkgo DoppelherzPharma 240 mg Film-coated tablets contain

The active ingredient is Ginkgo biloba leaf dry extract. One film-coated tablet contains 240 mg of quantified, refined dry extract from Ginkgo biloba leaves (35 - 67 : 1). The extract is quantified to 52.8 mg - 64.8 mg flavonoids, calculated as flavonol glycosides 6.72 mg - 8.16 mg Ginkgolides A, B and C 6.24 mg - 7.68 mg Bilobalid.

The extract contains a maximum of 5 ppm ginkgolic acids.

Extraction solvent: Acetone 60% (m/m).

The other ingredients are

Tablet core

Croscarmellose sodium, Colloidal silicon dioxide Lactose monohydrate, Magnesium stearate (Ph.Eur.) [vegetable] Microcrystalline cellulose, Spray-dried glucose syrup (Ph.Eur.).

Film coating

Macrogol 3350, Poly(vinyl alcohol), Talc, Titanium dioxide (E171), Iron(III) hydroxide oxide x H2O (E172).

What Ginkgo DoppelherzPharma 240 mg Film-coated tablets look like and contents of the pack:
Ginkgo DoppelherzPharma 240 mg Film-coated tablets are yellow, oblong film-coated tablets with a break notch on both sides (tablet size: approx. 19.2 mm x 8.2 mm). The tablet can be divided into equal doses.

The film-coated tablets are packed in PVC/PVdC/aluminium blister packs with a carton.

Ginkgo DoppelherzPharma 240 mg is available in packs of 30 and 120 film-coated tablets.

Pharmaceutical entrepreneur

Doppelherz Pharma GmbH
Schleswiger Str. 74
24941 Flensburg

Manufacturer

Queisser Pharma GmbH & Co. KG
Schleswiger Str. 74
24941 Flensburg

This package leaflet was last revised in December 2023.

Source: Information from the package leaflet
Status: 01/2025
Areas of application: Herbal medicinal product for improving age-related cognitive impairment and quality of life in mild dementia.Warning: Contains lactose and glucose.