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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Lane’s Original Composition Essence Napiers Warming Cold and Flu Elixir

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains:-

0.033 ml extract (as liquid extract) from Capsicum fruit (Capsicum frutescens L.) (1:3)

Extraction solvent Ethanol 60% v/v

0.032 ml extract (as liquid extract) from Ginger rhizome (Zingiber officinale) (1:2) Extraction solvent Ethanol 90% v/v 0.25 ml of extract (as liquid extract) from Oak Bark (Quercus robur L.) (1:1) Extraction solvent: Ethanol 21 % v/v

5 ml of oral liquid contains approximately 0.525 ml of ethanol and 0.1g of sucrose. (See section 4.4 ‘Special warnings and precautions for use’.)

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral Liquid.

A dark brown liquid

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of colds, sore throats, chills and flu-type symptoms, based on traditional use only.

4.2 Posology and method of administration

For oral use.

Start at the first signs of a common cold.

Adults and the Elderly: One or two 5 ml teaspoonfuls in a glass of hot water or milk, every two hours when required.

Maximum daily dose: 12 doses (120 ml)

Children and adolescents over 12 years of age: One 5 ml teaspoonful in warm water every three hours if required.

Maximum daily dose: 8 doses (40 ml)

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:

Not to be taken for more than 7 days

If the symptoms worsen or persist for more than 7 days during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

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

Obstruction of the bile duct, cholangitis or galls stones.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms worsen or persist for more than 7 days during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

If symptoms worsen or if dyspnoea, fever or purulent sputum occurs during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

Absorption of concomitantly administered medicines with Oak bark preparations may be delayed. Therefore the product, should be taken 1 hour or more before or after intake of other medicinal products.

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 anesthesia (see Section 4.5)

The use in children under 12 years is not recommended because data are insufficient and medical advice should be sought.

This medicinal product contains 10.5 % v/v ethanol (alcohol), i.e. up to 420 mg per dose, equivalent to 10.5 ml beer, 4.37 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-glactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No studies have been carried out to determine if drug interactions occur with this product.

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

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

Studies on the effect on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effect of this product on the ability to drive or use machinery have been performed.

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

This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section 4.4 ‘Special warnings and precautions for use’.)

4.8 Undesirable effects

Minor gastrointestinal complaints, particularly stomach upset, eructation, dyspepsia and nausea have been reported with Ginger. Frequency: common (>1/100 and <1/10). Drowsiness has also been reported.

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

Allergic reactions have been reported with Oak bark preparations. The frequency is not known.

If other adverse reaction occurs, a doctor or a qualified health care practitioner should be consulted.

4.9 Overdose

No cases have been reported with this product.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (8.4 g in 100 ml; 12.6 g in 150 ml: equivalent to 0.35 or 0.525 large glasses of wine respectively may result in intoxication and should be treated accordingly.

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.

Reproductive and developmental toxicity has been investigated in 3 studies in rats. One study demonstrated advanced skeletal development and increased embryo resorption with the administration of ginger tea (20 g/l and 50 g/l) during gestation days 6-15. Another study using dried powder extract in dosages of 500 and 1000 mg/kg/day during gestation days 5-15 found increased embryo resorption. No maternal toxicity or gross foetal toxicity or defects were observed.

One repeated dose toxicity study in rats (600 mg/kg per day of an aqueous extract of ginger root for 6 days) demonstrated increased testicular weight and increased levels of testosterone in the testes. Another study, in which rats were administered ginger rhizome powder in daily dosages of 50 and 100 mg/kg for 20 days, did not demonstrate any changes in morphology or weight of testes compared to control rats. Chronic toxicity studies have not raised suspicion of other organ changes.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol Cassia oil Clove oil Pimento oil Glycerol Caramel E150 Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25^oC. Store in the original container.