Ratiopharm Ginkgobene 240 mg 30 film-coated tablets

Ginkgobene contains a dry extract of Ginkgo biloba leaves.

Ginkgobene is a herbal medicine to improve the (age-related) cognitive impairment and to increase the quality of life in mild dementia

Contraindications

Ginkgobene 240 mg must not be taken,

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

interactions

Other medicines and Ginkgobene 240 mg Tell
your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This includes medicines 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 antiplatelet medicines (e.g. clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs).
• if you take dabigatran
• if you are taking nifedipine

Concomitant use of Ginkgo biloba preparations and efavirenz is not recommended; Efavirenz plasma concentrations may be decreased.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Since there is some evidence that preparations containing ginkgo could increase the tendency to bleed, this medicine must not be taken during pregnancy (see section 2. "Do not take Ginkgobene 240 mg").

Use during lactation is not recommended due to insufficient data. It is not known whether the components of the extract are excreted in breast milk.

application

Always take this medicine exactly as described in this 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 half a Ginkgobene 240 mg film-coated tablet twice a day or one Ginkgobene 240 mg film-coated tablet once a day.

The tablet is divisible into equal doses.

The film-coated tablet should be taken twice a day in the morning and in the afternoon.

Use in children and adolescents
There is no relevant indication for children and adolescents.

Special patient
groups There are no data on dosing in the event of impaired renal or hepatic function.

Method of
administration Ginkgobene 240 mg is to be taken orally. Do not take the tablets lying on your back. The tablets should not be chewed and swallowed with liquid, preferably with a glass of drinking water. It can be taken independently of meals.

Duration of use
The treatment should last at least 8 weeks

If the symptoms have not improved after 3 months or if the symptoms of the disease worsen, the doctor must check whether the continuation of the treatment is still justified.

side effects

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, diarrhea, abdominal pain, nausea, vomiting

Not known (cannot be estimated from the available data)

• Bleeding in individual organs (eyes, nose, cerebral and gastrointestinal bleeding), hypersensitivity reactions (allergic shock), allergic skin reactions (skin redness, edema, itching and rash)

composition

Each film-coated tablet contains 240 mg extract (dry extract) of Ginkgo biloba L, folium (Ginkgo biloba leaves) (35-67:1).

The extract is quantified to
22.0 - 27.0% flavonoids, calculated as flavonoid glycoside
2.8 - 3.4% ginkgolides A, B and C
2.6 - 3.2% bilobalide
and contains less than 5 ppm ginkgolic acid.
First extraction agent: acetone 60% (m/m).

The other ingredients are:
Tablet core: croscarmellose sodium, colloidal anhydrous silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, glucose, liquid, spray-dried Film-
coating: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide E171, iron oxide yellow E172