Boxs Herbals Rheumatox Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Joint Ability Herbal Remedy Box's Herbals Rheumatox Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral liquid contains: -
1ml of extract (as liquid extract) from White Willow Bark (Salix alba L.) (1:1) (equivalent to 1 gm White Willow)
Extraction Solvent: Water
0.075ml of extract (as liquid extract) from Black Cohosh Root (Cimicifuga racemosa Nutt.) (1:1) (equivalent to 75 mg Black Cohosh)
Extraction Solvent: Ethanol 90 % v/v
0.15 ml of extract (as liquid extract) from Scullcap herb (Scutellaria laterifolia L.) (1:1) (equivalent to 150 mg Scullcap)
Extraction solvent Water
0.5ml of extract (as liquid extract) from Yarrow Herb (Achilliea millefolium L.) (1:1) (equivalent to 500 mg Yarrow)
Extraction Solvent: Water
0.5ml of extract (as liquid extract) from Burdock Root (Articum lappa L.)
(1:1) (equivalent to 500 mg Burdock Root)
Extraction Solvent: Water
5 ml of oral liquid contains approximately 0.52 ml ethanol, 0.056 ml of glucose and 0.38 ml of sucrose and 0.03 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.
A dark brown liquid.
4
CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults and the Elderly: Take one 5ml teaspoonful three times a day.
The use in children and adolescents under 18 years of age is not recommended (See Section 4.4. ‘Special warnings and precautions for use’.)
If symptoms get worse or persist for more than 4 weeks during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
Hepatic and renal impairment
The safety of Black Cohosh extract has not been studied in patients with hepatic and/or renal impairment. This product should not be taken by patients who have hepatic impairment or renal impairment.
4.3 Contraindications
Hypersensitivity to the active ingredients, plants of the Asteraceae (Compositae) family or any of the excipients.
Hypersensitivity to salicylates or to other NSAIDs (e.g. history of angiodema, bronchial spasm or chronic urticaria in response to salicylates or other NSAIDs.
Asthma
Patients who have active liver disease or a history of liver damage, severe renal dysfunction, coagulation disorders, gastric/duodenal ulcer, active peptic ulcer and glucose-6-phosphate dehydrogenase deficiency.
Women who are pregnant or breast feeding or in women who could become pregnant unless contraception is used.
Patients currently receiving treatment for or have a history of an oestrogen dependant tumour.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms get worse or persist for more than 4 weeks during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
If articular pain accompanied by swelling of joint, redness or fever are present, a doctor should be consulted.
The use of this product in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
Women of childbearing potential should use effective contraception.
This product is not intended to be used in cases of acute arthritis as this condition requires medical advice.
Concomitant use with salicylates and other NSAIDs is not recommended without medical advice.
There have been rare cases of hepatic reactions associated with the use of Black Cohosh. Patients taking this product should be informed to immediately stop the use of the product and consult their doctor if they develop signs and symptoms suggestive of liver dysfunction. (Fatigue, anorexia, yellowing of the skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine).
Advice should be sought from a doctor if the patient has a family history of an oestrogen dependent tumour.
Oestrogens may only be taken simultaneously with this product under medical supervision, as their effect may be intensified by Black Cohosh.
Contains glucose, sucrose and sorbitol. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains 10.38 % v/v ethanol (alcohol), i.e. up to 409 mg per dose, equivalent to 10.38 ml beer, 4.32 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.
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).
Willow bark may increase the effects of anticoagulants such as coumarin derivatives.
4.6 Fertility, Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established and salicylates cross the placenta and appear in breast milk. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Additionally because of the potential for Black cohosh to have hormone-like actions, the product should be avoided by women who could become pregnant unless contraception is used.
Studies on the effects on fertility have not been performed.
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
Allergic reactions such as rash, pruritis, urticaria, asthma,exanthema, and gastrointestinal symptoms such as nausea, vomiting , abdominal pain, dyspepsia, heartburn and diarrhoea have been reported with Willow bark. The frequency is not known.
Hypersensitivity reactions of the skin have been reported with Yarrow herb. The frequency is not known.
Anaphylactic shock has been reported with Burdock root. The frequency is not known.
In rare cases Black Cohosh may cause liver reactions (including hepatitis, jaundice and disturbances in liver function tests). Skin reactions (urticaria, itching, exanthema), facial oedema, peripheral oedema and gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhoea), weight gain and increase in liver enzymes (transaminases) have also been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
4.9 Overdose
In the event of an overdose advice should be sought from a doctor. Treatment should be symptomatic and supportive in nature.
Older herbal texts state that doses of over 5g unprocessed Black Cohosh may produce symptoms of nausea, vomiting, dizziness, visual and nervous disturbances, reduced pulse rate and increased perspiration.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (8.18 g in 100 ml; 16.36 g in 200 ml: equivalent to 0.34 or 0.69 large glasses of wine respectively or 0.83 or1.66 glasses of beer, respectively) may result in intoxication and should be treated accordingly.
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.
For Black cohosh: In a six-month study in rats the no-observed- effect-level (NOEL) for the isopropanolic extract (Granulate) was defined with 21.06 mg native extract/kg bodyweight.
Evidence from in-vitro and in-vivo pharmacological studies suggests that Cimicifuga extracts do not influence the latency or development of breast cancer.
However, contradictory results have been obtained in other in-vitro experiments.
In Cimicifuga-treated (isopropanolic black cohosh extract equivalent to 40 mg of root and rhizome), tumour-bearing, female transgenic mice, the percentage of mice with detectable metastatic lung tumours at necropsy was increased compared to those on the control diet. However, in the same experimental model, no increase in primary breast tumour was seen. Influence on breast cancer or other hormonedepending tumours cannot be completely excluded.
A genotoxicity study (AMES-test) of the ethanolic extract (4.5-8.5:1, ethanol 60% (V/V)) was performed to a concentration of 1 mg/plate. The test does not fulfil the recent criteria of such testing and therefore the relevance of these results for safety assessment is doubtful.
There are no conclusive studies on carcinogenicity and reproductive toxicity.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glucose Liquid Syrup (sucrose)
Glycerol
Cardamon Tincture, Compound (Cardamom oil, Caraway oil, Cinnamon oil, Beetroot powder, glycerol, ethanol and water)
Nutmeg oil
Clove oil Cinnamon oil
Liquorice liquid extract (liquorice root, ethanol, water) Ethanol
Caramel E150a
Water
Sorbitol
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25oC. 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: 100ml, 200ml and 500ml.
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 LTD
10 PAYNE STREET, GLASGOW G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0006
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/04/2013
10 DATE OF REVISION OF THE TEXT
19/01/2015