Adverse reactions : תופעות לוואי

4.8. Undesirable effects
The evaluation of adverse reactions is based on the following information on frequency: 
Very common:                               Common: more than 1 out of 10 treated persons      less than 1 out of 10 but more than 1 out of 100 treated persons
Uncommon:                                  Rare: less than 1 out of 100 but more than 1 out less than 1 out of 1000 but more than 1 out of 1000 treated persons                    of 10 000 treated persons Very rare: less than 1 out of 10 000 treated persons


There are no verified data on the frequency of the undesirable effects observed during treatment with Ginkgo biloba-containing preparations, since these undesirable effects have become known through single reports from patients, physicians or pharmacists.
According to these reports, the following undesirable effects may occur during treatment with Cerebonin® 120 mg:

- Bleeding from single organs may occur in particular in case of concomitant use of coagulation-inhibiting preparations such as phenprocoumon, acetyl salicylic acid or other non-steroidal antirheumatics (see also 4.5 Interactions). Allergic shock is possible in hypersensitive persons; furthermore, allergic skin reactions (reddening, swelling, itching) may occur.

The following note for the patient is included in the instruction leaflet: “Should any of the above-mentioned adverse reactions occur, please do not take Cerebonin® 120 mg once more and immediately consult your doctor so that he/she may decide on the severity and possibly necessary measures.”

- Furthermore, mild gastrointestinal disturbances, headache, dizziness or enhance- ment of already existing dizziness can occur.

The following note for the patient is included in the instruction leaflet: “Please inform your doctor or pharmacist if you are considerably impaired by one of these undesirable effects.”

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form:
 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectM edic@moh.gov.il