Tradimed Vapour & Muscle Rub Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tradimed Vapour & Muscle Rub cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 g cream contains:
0.625 g peppermint oil (essential oil of Mentha x piperita L.)
0.625 g eucalyptus oil (essential oil of Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker)
0.40 g rosemary oil (essential oil of Rosmarinus officinalis L.)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous cream
White with characteristic odour of peppermint, eucalyptus and rosemary
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of
• nasal congestion and coughs due to colds,
• muscular aches and pains, stiffness, based on traditional use only.
4.2 Posology and method of administration
For cutaneous use only.
Adults, the Elderly and Children over 12 years:
Nasal congestion and coughs due to colds
Apply approximately 6 cm of cream 3 to 5 times daily to the chest, throat and back and massage thoroughly into the skin. Leave nightclothes loose for easy inhalation.
Muscular aches and pains stiffness
Apply approximately 6 cm of cream 3 to 5 times daily gently to the affected area and massage thoroughly into the skin.
Children under 12 years:
The use in children under 12 years of age is not recommended (see Section 4.4 Special warnings and precautions for use.
Duration of use:
Nasal congestion and coughs due to colds
If the symptoms worsen or persist for more than one week a doctor or qualified health care practitioner should be consulted.
Muscular aches and pains, stiffness
If the symptoms worsen or persist for more than 2 weeks a doctor or qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients, to menthol or any of the excipients. Patients with
• obstruction of the bile duct or intestinal tract,
• cholangitis,
• liver disease,
• gallstones and any other biliary disorders
4.4 Special warnings and precautions for use
Do not exceed the stated dose. For cutaneous use only.
This medicine is not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.
If the condition worsens, or if symptoms persist for more than one week (nasal congestion and coughs) or more than two weeks (muscular aches and pains, stiffness), a doctor or qualified healthcare practitioner should be consulted.
Do not swallow or place in nostrils. Avoid contact with eyes and mucous membranes. Do not apply to broken or irritated skin. Discontinue use if redness, irritation or dry skin occurs.
Eye contact with unwashed hands after the application of peppermint oil may potentially cause irritation.
If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.
If articular pain accompanied by swelling of joint redness or fever are present a doctor or a qualified healthcare practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been undertaken.
4.8 Undesirable effects
The following adverse reactions have been reported:
• allergic reactions, e.g., skin rash, skin reddening, blistering, hives, swelling, contact dermatitis, asthma
• irritation of skin or mucous membranes as well as bronchial spasms
• inhalation of essential oils containing cineol may cause coughing
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner 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.
Over dosage may result in skin irritation. Accidental swallowing of the cream might cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea.
Supportive and symptomatic treatment should be provided as appropriate.
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
The preclinical toxicology data available are limited.
Monoterpenes contained in the preparation pass the placental barrier. Small amounts of essential oils may pass into the breast milk.
Peppermint oil was negative in two validated tests of genotoxicity, the Ames test and the mouse lymphoma assay. Weak and inconsistent genotoxic responses in other non-validated tests are probably toxicologically inconsequential. There is more evidence for genotoxicity potential of menthol and there seems to be a discrepancy between peppermint oil and its most important constituent menthol. However, the present evidence points to a very weak or totally absent genotoxicity of peppermint oil.
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Medium-chain triglycerides Hard fat (Softisan 378)
Glyceryl stearate citrate (Imwitor 370)
Partial glycerides of saturated vegetable fatty acids (glyceryl cocoate, Imwitor 928)
Cetyl palmitate Xanthan gum White beeswax Octyldodecanol Water, purified
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 package.
6.5 Nature and contents of container
Aluminium tubes of 10 g, 40 g and 100 g.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Grunwalder Gesundheitsprodukte GmbH, Ruhlandstr. 5, 83646 Bad Tolz, Germany.
MARKETING AUTHORISATION NUMBER(S)
THR 18457/0014
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/08/2013
10
DATE OF REVISION OF THE TEXT
06/05/2015