PUNCTO GINKGO ORAL DROPS SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Puncto Ginkgo Oral Drops Solution.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml (20 drops) contains:

40 mg of extract (as dry extract) from Ginkgo biloba L. leaf (35–67:1) Extraction solvent: Acetone 60% v/v.

For a full list of excipients, see section 6.1.

Each 1ml contains 2 mg of dehydrated glucose syrup

3 PHARMACEUTICAL FORM

Oral drops solution

Clear brown solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of Raynaud's syndrome and tinnitus, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

The drops should be taken undiluted or in a glass of water.

Duration of treatment:

If the symptoms worsen, or persist for more than 2 weeks a doctor or qualified health care practitioner should be consulted.

Adults and the Elderly:

Take 20 – 40 drops three times a day.

Children or adolescents under 18 years:

The use in children or adolescents under 18 years of age is not recommended (see Section 4.4 Special warnings and precautions for use).

4.3 Contraindications

Hypersensitivity to Ginkgo preparations or any of the excipients.

4.4 Special warnings and precautions for use

This product is not recommended for children or adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

This product contains dehydrated glucose syrup. Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.

In patients with a pathologically increased bleeding tendency (haemorrhagic diathesis) and concomitant anticoagulant and antiplatelet treatment, the medicinal product should only be used after consultation with a doctor (See section 4.5)

As a precaution gingko should be ceased at least 2 weeks prior to any surgical intervention, or an assessment of clotting parameters carried out prior to surgery

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

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

If the symptoms worsen, or persist for more than 2 weeks, a doctor or a qualified healthcare professional should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

If the medicinal product is taken concomitantly with anticoagulants (e.g. phenprocoumon, warfarin, acenocoumarol, phenindione, apixaban, edoxaban, dabigatran, rivaroxaban heparin, dalteparin, enoxaparin and tinzaparin ) or antiplatelet drugs (e.g. clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs), their effect may be influenced.

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

An interaction study with talinolol indicates that Ginkgo 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 and dabigatran.

One interaction study has indicated that the Cmax of nifedipine may be increased by Ginkgo. In some individuals, increases by up to 100% were observed resulting in dizziness and increased severity of hot flushes.

Concomitant use of Ginkgo preparations and efavirenz is not recommended; plasma concentrations of efavirenz may be decreased because of induction of CYP3A4 (see also section 4.4).

4.6 Fertility, Pregnancy and lactation

Pregnancy

Ginkgo extracts may impair the ability of platelets to aggregate. The tendency for bleeding may be increased. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

The use is in pregnancy is not recommended.

Lactation

It is unknown whether Ginkgo metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded.

In the absence of sufficient data, the use during lactation is not recommended.

Fertility

No specific studies with Ginkgo in humans have been conducted to evaluate effects on fertility. In a study in female mice effects on fertility were seen (see section 5.3).

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been undertaken. Dizziness has been reported with Ginkgo. Affected patients should not drive or use machines.

4.8 Undesirable effects

The following adverse reactions have been reported in association with the use of products containing Gingko extract. The frequency is not known.

Bleeding of individual organs has been reported (eye, nose, cerebral and gastrointestinal haemorrhage).

Gastrointestinal disorders, headaches, dizziness and allergic reactions have been reported. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

4.9 Overdose

No cases of overdose have been reported.

Supportive and symptomatic treatment should be provided as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.

Tests on reproductive toxicity and carcinogenicity have not been performed.

Reproductive toxicity

Only limited information is available on reproductive toxicity of the Ginkgo biloba dry extract. The published data are contradictory. While an older study in rats and rabbits and a newer study in mice revealed no teratogenic, embryotoxic or adverse reproductive effects, another study in mice showed effects on reproductive parameters, such as fertility and reproductive performance and it evoked vaginal bleeding. Also tests with unspecified or slightly different Ginkgo extracts pointed towards effects on fetal development (with and without maternal toxicity) or caused subcutaneous bleeding, hypopigmentation, growth inhibition and anophthalmia in chicken embryos.

Mutagenicity, carcinogenicity

A similar extract was tested in a series of studies for genotoxicity and carcinogenicity. It was positive for gene mutation in bacteria. A peripheral mouse erythrocytes micronucleus test provided a negative result in male and an equivocal result in female animals.

The thyroid gland tumours found in a rat carcinogenicity study and hepatocellular carcinoma found in a mouse carcinogenicity study are considered rodent specific, non-genotoxic response associated (with long-term treatment) with high doses of hepatic enzyme inducers. These types of tumours are not considered relevant to humans. The extract did not induce measurable genotoxic effects in mice up to 2000 mg/kg.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract:

dehydrated glucose syrup

Oral drops:

Propylene glycol

Glycerol 85 %

Saccharin Sodium

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 30°C.

Store in the original package.

6.5 Nature and contents of container

Brown glass bottle 100 ml, PEHD screw cap, PELD dropper.

Packs of 100 and 200 ml (2× 100 ml).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Plantaphile Ltd.

18 Hyde Gardens,

Eastbourne,

East Sussex,

BN21 4PT,

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

THR 32294/0032

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/11/2018