GINKGO BILOBA Film coated tablet Ref.[8178] Active ingredients: Ginkgo biloba

The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

There are rare cases of spontaneous bleeding in association with use of products containing Ginkgo bilobaextracts. Although no exact causal link has been established, care should be taken by patients who are at an increased risk of bleeding such as those with bleeding disorders or those being treated with anti-platelet agents or anticoagulants. It is advisable that Ginkgo-Biloba Pharma Nord is discontinued at least 2 weeks prior to surgery.

In patients with epilepsy, onset of further seizures – promoted by intake of Ginkgo preparations – cannot be excluded.

Concomitant use of Ginkgo biloba containing products and efavirenz is not recommended (see section 4.5).

Appropriate studies have not been conducted to determine whether drug interactions occur with Ginkgo-Biloba Pharma Nord and its active constituents.

Products containing Ginkgo biloba have been observed in some studies to cause moderate induction of drug metabolizing enzymes, such as CYP3A4, CYP2C9 and CYP2C19. It may not be excluded that other enzymes may be induced as well. Because induction causes increased synthesis of these enzymes, it can result in slight to moderate decreases in plasma concentrations of drugs metabolized by these enzymes. Induction generally varies widely among individuals. The results reported from different studies are somewhat contradictory, however. Besides induction, weak inhibition of CYP3A4 has also been observed. Since the enzyme-inducing and -inhibiting effects of Ginkgo biloba are quite small, they are unlikely to be of clinical relevance for most drugs. However, it may be relevant for drugs with a narrow therapeutic index and in certain patients.

Concomitant use of Ginkgo biloba preparations and efavirenz is not recommended; plasma concentrations of efavirenz may be decreased because of induction of CYP3A4.

Available studies with warfarin do not indicate that there is an interaction between warfarin and Ginkgo biloba products, but adequate monitoring is advised when starting Ginkgo biloba, when changing Ginkgo biloba dose, when ending Ginkgo biloba intake or if changing product.

An interaction study with talinolol indicates that Ginkgo biloba may inhibit P-glycoprotein at the intestinal level. This may give rise to increased exposure of drugs markedly affected by P-glycoprotein in the intestine such as dabigatran etexilate. Caution is advised if combining Ginkgo biloba and dabigatran.

Limited clinical data suggest that Ginkgo biloba may raise nifedipine levels and increase its effects. In some individuals this may result in dizziness and increased severity of hot flushes.

Pregnancy

There are no or limited amount of data from the use of Ginkgo biloba in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Ginkgo-Biloba Pharma Nord should not be used during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

It is unknown whether Ginkgo biloba/active metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. Ginkgo-Biloba Pharma Nord should not be used during breast-feeding.

Fertility

No studies with Ginkgo biloba in humans have been conducted to evaluate the effects on fertility.

Specific studies to determine the potential effect of Ginkgo biloba extract on the ability to drive or operate machinery have not been carried out.

The follow adverse reactions have been reported rarely in association with the use of products containing Ginkgo biloba extract.

Immune system disorders: Allergy

Nervous system disorders: Headache, Dizziness

Gastrointestinal system disorders: Nausea, Vomiting, Diarrhoea, Abdominal pain

Skin and subcutaneous tissue disorders: Pruritus, Rash

There have been very rare case reports of Stevens-Johnson syndrome associated with the use of Ginkgo biloba extract.

There are sporadic case reports of bleeding disorders in patients who have been taking preparations containing Ginkgo biloba extract; the causality has not been established.

In patients with epilepsy, onset of further seizures – promoted by the intake of Ginkgo preparations – cannot be excluded

Reporting of suspected adverse reactions

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance Website: www.hpra.ie.

Not applicable.