Summary of Product Characteristics (SmPC) - Nelsons Rhus Tox cream
1 NAME OF THE MEDICINAL PRODUCT
Nelsons Rhus tox Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains:
Toxicodendron quercifolium (Rhus toxicodendron) 6X (9 % v/w)
Excipients with known effect
Cetostearyl alcohol 2.75% w/w
Propyl parahydroxybenzoate (E216) 0.15% w/w Methyl parahydroxybenzoate (E218).0.30% w/w
(See section 4.4. Special warnings and precautions for use).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A smooth white to off-white cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of rheumatic aches and pains.
4.2 Posology and method of administration
For cutaneous use only
Wash hands before and after use
Adults, the elderly and children over 12 years: Apply to the affected area 3 times a day.
This product is not recommended for use in children under 12 years of age.
If the symptoms worsen, or do not improve after 7 days, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to Rhus toxicodendron or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose
Do not use on broken skin.
Discontinue use if skin becomes red, irritated or sore.
If the symptoms worsen, or do improve after 7 days, a doctor or qualified healthcare practitioner should be consulted.
If joint pain is experienced, accompanied by the swelling of the joints, redness or fever, a doctor or qualified healthcare practitioner should be consulted. This product is not recommended for use in children under 12 years of age and medical advice should be sought.
Contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).
This product contains Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Pregnancy and lactation: There is no evidence of the safety of the product in human pregnancy or lactation, nor is there any evidence from animal studies. Although no adverse events have been observed, the use of this product during pregnancy and lactation should be avoided unless under the guidance of a doctor.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Studies on the effects on the ability to drive or use machinery have not been performed.
4.8 Undesirable effects
None known
If any adverse reactions occur, a doctor or pharmacist should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard
4.9 Overdose
No cases of overdose have been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified Water
Glyceryl monostearate & Macrogol stearate Apricot kernel oil
Theobroma oil
Glycerol
Cetostearyl alcohol & PEG-20 stearate Cetostearyl alcohol
Cetyl palmitate
Glyceryl monocaprylate
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216)
6.2 Incompatibilities
None known
6.3 Shelf life
5 years
Use by 3 months from the date of opening.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original packaging.
6.5 Nature and contents of container
Epoxy phenolic lacquered, collapsible, aluminium tube with a polyethylene screw cap.
Pack size: 30g.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
A Nelson & Co Limited
5-9 Endeavour Way
Wimbledon
London
SW19 8UH
8 MARKETING AUTHORISATION NUMBER(S)
NR 01175/0395
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/07/2017
10 DATE OF REVISION OF THE TEXT
19/07/2017