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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Tradimed® Ginger capsules.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains:

250 mg ginger rhizome (Zingiber officinale ROSCOE)

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Hard capsules.

Light blue capsules

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Traditional herbal medicinal product used:

-    to relieve the symptoms of minor digestive complaints such as indigestion, dyspepsia, feeling of fullness, flatulence and temporary loss of appetite

-    to relieve symptoms of travel sickness based on traditional use only.

4.2    Posology and method of administration

For oral administration.

The capsules should be swallowed whole with 1-2 glasses of water. Do not chew the capsules.

Adults, the elderly and children over 12 years

Digestive complaints:

One capsule to be taken three times a day at mealtimes.

Travel sickness:

2 capsules approximately 30 minutes to one hour before travelling. Do not take more than 8 capsules per day.

Children under 12 years of age

The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

Duration of use

Digestive complaints:

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

Travel sickness:

If the symptoms persist for more than 5 days or worsen during the use of the product, a doctor or a qualified health care practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients Peptic or duodenal ulcer.

Obstruction of the bile duct, cholangitis or gall stones.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Ginger may inhibit platelet aggregation and may decrease platelet thromboxane production thus, theoretically, may increase the risk of bleeding. The product should be discontinued at least 2 weeks prior to elective surgery due to the potential increased risk of bleeding and for potential interactions with medicinal products used during general and regional anaesthesia (see Section 4.5).

The use in children under 12 years age is not recommended due to the lack of data on safety and efficacy.

Digestive complaints:

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

Travel sickness:

If the symptoms persist for more than 5 days or worsen during the use of the product, a doctor or a qualified health care practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Ginger may increase the risk of bleeding when taken with drugs that affect coagulation and bleeding eg. aspirin, anticoagulants such as warfarin, phenprocoumon, heparin, antiplatelet drugs such as clopidogrel, and non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen and naproxen..

4.6 Fertility, Pregnancy and lactation

Safety 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 the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

In some cases patients have experienced drowsiness while taking ginger. Affected patients should not drive or operate machinery.

4.8 Undesirable effects

Minor gastrointestinal complaints including stomach upset, heartburn, eructation, bloating, flatulence, nausea, dyspepsia. Frequency 2-3%. Drowsiness has also been reported.

There is one case report of inhibition of platelet aggregation following chronic consumption of large quantities of ginger marmalade. There is one case report of potential interaction with warfarin (see Section 4.5).

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare 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

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Capsule excipient: Silicon dioxide.

Capsule shell: Gelatin, purified water, titanium dioxide E 171, indigo carmine E 132

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

PVC/PVDC-Al blister strips in cardboard carton.

Packs of 10, 20 or 50 capsules per package. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.