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Boxs Herbals Cold And Flu Relief

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Napiers Herbal Cold and Flu Away Box's Herbals Cold and Flu Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of oral liquid contains: -

0.1 ml of extract (as liquid extract) from Elder flowers (Sambucus nigra. L.) (1:1) (equivalent to 0.1g Elder Flowers)

Extraction Solvent: Water

0.05 ml of extract (as liquid extract) from Bayberry bark (Myrica cerifera L.) (1:1) (equivalent to 0.5g Bayberry Bark)

Extraction Solvent: Ethanol 45% v/v

0.1 ml of extract (as liquid extract) from Hemlock Spruce bark (Tsuga canadensis Carr.) (1:1) (equivalent to 0.1g Hemlock Spruce)

Extraction Solvent: Ethanol 45% v/v

5ml of oral liquid contains approximately 0.27 ml of ethanol and 2.38g 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 red brown liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of cold

and flu, sore throats and chills, 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, the elderly and children over 12 years: Two 5 ml teaspoonfuls in a third of a cup of warm or hot water three times a day.

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

Duration of use: Not to be taken for more than 1 week.

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 or any of the excipients.

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.

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

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

This medicinal product contains 5 % v/v ethanol (alcohol), i.e. up to 400 mg per 10ml dose, equivalent to 10 ml beer, 4.2 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding 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.

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.

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

None known.

If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

Overdose

4.9


No cases have been reported with this product.

Overdose of this products may result in alcohol intoxication; the amount of alcohol in a full bottle (4g in 100 ml, 6g in 150 ml, 8g in 200 ml: equivalent to 0.16, 0.25 or 0.33 large glasses of wine respectively) may result in intoxication and should be treated accordingly.

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

Peppermint oil Cassia oil Pimento oil Clove oil

Stronger Capsicum tincture (ethanol, water, capsicum) Strong Ginger tincture (ethanol, ginger root)

Capsicum oleoresin

Ethanol

Syrup (sucrose)

Acacia powder Beetroot powder (E162)

Caramel (E150a)

Viscarin (carrageenan (E407), glucose (dextrose)) Water

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 container.

6.5    Nature and contents of container

Amber glass bottle with polypropylene child-resistant safety cap contained in a cardboard carton: 100ml, 150 ml and 200 ml.

6.6    Special precautions for disposal

There are no special precautions for disposal.

7


MARKETING AUTHORISATION HOLDER

Highland Herbs Limited 10 Payne Street Glasgow

G4 0LF


8    MARKETING AUTHORISATION NUMBER(S)

THR 43751/0008

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/03/13

10    DATE OF REVISION OF THE TEXT

20/01/2015