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Boxs Herbals Period Relief

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Napiers Monthly Cramp Relief Box's Herbals Period Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains: -

0.265 ml of extract (as liquid extract) from Scullcap herb (Scutellaria laterifolia L.) (1:1)

Extraction Solvent: Water

0.175 ml of extract (as liquid extract) from Helionas root (Chamaelirium luteum) (1:1)

Extraction Solvent: Ethanol 45% v/v

0.1ml of extract (as liquid extract) from Jamaican Dogwood bark (Piscidia piscipula) (1:1)

Extract Solvent: Ethanol 60% v/v

0.265ml of extract (as liquid extract) from Motherwort herb (Leonurus cardiaca) (1:1)

Extract Solvent: Water

0.555 ml of extract (as liquid extract) of Buchu leaf (Agathosma betulina (Berg) Pillans) (1:2.5)

Extract solvent: Ethanol 25% v/v

5 ml of oral liquid contains approximately 710 mg of ethanol, 435 mg of sucrose, 29 mg glucose and 0.001 ml sorbitol (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.

Dark brown slightly viscous liquid.

CLINICAL PARTICULARS

4


4.1 Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of menstrual cramps, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Women experiencing menstrual cramps: Take one 5ml teaspoonfuls four times a day. Elderly: There is no relevant indication

The use in children and adolescent under 18 years is not recommended (see section

4.4 ‘Special warnings and precautions for use’).

If symptoms worsen or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients to any of the excipients. Not to be used in pregnancy.

4.4 Special warnings and precautions for use

Do not exceed the sated dose.

The use is not recommended in children and adolescent under 18 years of age due to the lack of adequate data.

If symptoms worsen or do not improve after one week, consult a doctor or a qualified healthcare practitioner.

This medicinal product contains 18% v/v ethanol (alcohol), i.e. up to 710 mg per dose, equivalent to 18ml beer, 7.5 ml wine per dose. 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.

Contains sucrose, glucose and sorbitol. Patients with rare hereditary problems of fructose intolerance, glucose-galactose 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 therefore be avoided in patients taking other medication known to interact with alcohol (e.g. Metronidazole).

4.6 Fertility, Pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. Furthermore due to the presence of Motherwort, the product is contraindicated in pregnancy ( see section 4.3) and should not be used if pregnancy is suspected.

In the absence of sufficient data, the use during lactation is not recommended. Studies on the effects on fertility have not been carried out.

4.7 Effects on ability to drive and use 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

None known.

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

4.9 Overdose

Treatment should be symptomatic and supportive.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (10.65g in 75ml; 14.2g in 100 ml; 21.3g in 150 ml: equivalent to 0.45 or 0.6 or 0.9 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

Syrup (sucrose)

Glycerol

Tincture Cardamon Co (Cardamom oil, Caraway oil, Cinnamon oil, Beetroot powder, glycerol, ethanol and water)

Nutmeg oil Clove oil Cinnamon oil

Liquorice liquid extract (Liquorice, ethanol, sorbitol and water)

Ethanol

Caramel E150a

Water

Sorbitol

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 child-resistant polypropylene cap packed in a cardboard box: 75ml, 100ml 150ml, 200ml and 250ml.

Not all pack sizes may be marketed.

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 43751/0010

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/04/2013

10    DATE OF REVISION OF THE TEXT

16/01/2015