Boxs Herbals Period Relief
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