SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

HRI Ginger Tablets

HRI Travel and Digestion Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 250 mg Zingber officinale Roscoe rhizome

Each tablet also contains 128 mg sucrose.

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Coated tablet Grey tablet.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of travel sickness and minor digestive complaints such as nausea, indigestion, dyspepsia, or flatulence based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly, and children over 12 years For relief of travel sickness:

One or two tablets approximately 30 minutes to one hour before travelling.

Minor digestive complaints: One tablet three times a day at mealtimes with 1-2 glasses of water.

Children under 12 years

Not recommended for children under 12 years (See Section 4.4 Special warnings and precautions for use).

If symptoms worsen or persist for more than 5 days in the case of travel sickness or 2 weeks in cases of digestive upsets, a doctor or a qualified healthcare 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.

The use of this product in children under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.

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).

This product contains sucrose. Each tablet contains 128 mg sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

If symptoms worsen or persist for more than 5 days in the case of travel sickness or 2 weeks in cases of digestive upsets, a doctor or a qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

There is one case report of ginger interacting with warfarin.

Ginger may increase the risk of bleeding when taken with drugs that affect coagulation and bleeding such as aspirin, anticoagulants such as warfarin, phenprocoumon and 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 human pregnancy and lactation had not been established.

In the absence of sufficient data the use in 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 performed.

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

4.8 Undesirable effects

Minor gastrointestinal complaints including stomach upset, heartburn, eructation, bloating, flatulence, nausea, dyspepsia and drowsiness have been reported.

There has been one case report of inhibition of platelet aggregation following chronic consumption of large quantities of ginger marmalade.

If other adverse reactions not mentioned above occur, a doctor, pharmacist or qualified healthcare practitioner should be consulted

4.9 Overdose

No cases of overdose have been reported.

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

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet Core Dicalcium phosphate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Stearic acid Magnesium stearate

Tablet Coating Shellac

Titanium dioxide (E171)

Calcium carbonate light

Sucrose

Acacia powder

Talc

Black iron oxide (E172) Wax polish (solids)

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Amber glass bottle with foil tamper evident seal and white polypropylene screw cap. Pack sizes: 10, 15. 20, 30, 40, 50, 60, 80, 90, 100

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

The Herbal Research Company Limited (trading as Jessup Marketing)

27 Old Gloucester Street

London

WC1N 3XX

8    MARKETING AUTHORISATION NUMBER(S)

THR 02231/0009

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/03/2013

10    DATE OF REVISION OF THE TEXT

21/03/2013