Puncto Ginkgo Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Puncto Ginkgo Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet 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 tablet contains 120 mg lactose monohydrate and 2 mg dehydrated glucose syrup.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, convex, oblong film-coated tablets.
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 tablets should be swallowed whole with a glass of water. Do not chew the tablets.
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 1-2 tablets 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 medicine 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 lactose monohydrate and dehydrated glucose syrup. Patients with rare hereditary problems of galactose and/or fructose intolerance, the Lapp lactase deficiency 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 Puncto Ginkgo 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
Tablet core:
Lactose monohydrate Cellulose, microcrystalline Maize starch Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate
Tablet coating:
Hypromellose Iron oxide yellow E172 Polysorbate 80 Talc
Titanium dioxide E171
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
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
PVC/PE/PVDC-Al blister strips in cardboard carton.
Packs of 30, 60, 120 and 200 film-coated tablets.
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, UK
8 MARKETING AUTHORISATION NUMBER(S)
THR 32294/0006
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/07/2012
10 DATE OF REVISION OF THE TEXT
30/07/2012