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Puncto Ginkgo Oral Drops Solution

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SUMMARY OF PRODUCT 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 4 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.

There are isolated case reports of spontaneous bleeding in association with the use of products containing Ginkgo extracts. Although no causal link has been established care should be taken by patients who have a pre-existing bleeding disorder. 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

Concomitant anti-coagulant, non-steroidal anti-inflammatory, phenytoin or valproic acid use should be avoided due to potential interactions (see section 4.5).

4.5 Interaction with other medicinal products and other forms of interaction

Specific studies have not been conducted to determine whether drug interactions occur with this product and its active constituents.

Due to a potential interaction with CYP2C19 a medical practitioner should be consulted prior to the concomitant use of drugs which are known substrates, such as proton pump inhibitors.

There have been isolated case reports of decreased serum concentrations of both valproic acid and phenytoin resulting in seizures. Caution is advised in such cases and a medical practitioner should be consulted.

Concomitant administration of gingko and anticoagulants such as coumarins (warfarin or heparin) or non-steroidal anti-inflammatory drugs (including ibuprofen, and acetylsalicylic acid) should be avoided due to potential effects on bleeding time prolongation. There have been isolated case reports but this has not been substantiated in pharmacokinetic trials.

There is limited evidence of in-vitro effects of gingko on CYP1A2, CYP2C9, CYP2D6 and CYP1E2 but clinical studies have found no clinically relevant effects.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

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.

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.

Body as a whole: general disorders

Allergy.

Central and peripheral nervous system disorders

Headache.

Gastrointestinal system disorders

Nausea,

Vomiting,

Diarrhoea.

Skin and subcutaneous tissue disorders

Pruritis

Rash.

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

There are reports of bleeding disorders in patients who have been taking preparations containing Ginkgo extract. The causality in these cases is not established.

If any other adverse effects are experienced, a doctor, pharmacist or qualified health care practitioner should be consulted.

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

The preclinical toxicology data available are limited. Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

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

Unopened: 36 months,

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 (2x 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

Grunwalder Gesundheitsprodukte GmbH Ruhlandstr. 5, 83646 Bad Tolz, Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 18457/0018

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/07/2012

10    DATE OF REVISION OF THE TEXT

25/08/2015