Summary of medicine characteristics - ROWIREN CREAM
1 NAME OF THE MEDICINAL PRODUCT
Rowiren cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains 100 mg of Rosmarinus officinalis L., aetheroleum (Rosemary oil).
Excipients with known effect:
3 g cetostearyl alcohol (Type A) emulsifying/100 g cream
ethanol (total ethanol content 17.4% V/V)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
White shiny cream with characteristic odour of rosemary oil.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Rowiren is a traditional herbal medicinal product used in adults for the relief of minor muscular and articular pain and minor peripheral circulatory disorders.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use
4.2 Posology and method of administration
Posology
Adults and elderly
Apply approximately 3 – 6 cm of cream 2 to 3 times daily to the affected area and gently massage it into the skin. The amount of cream used will depend on the area being treated.
Paediatric population
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
Method of administration
Cutaneous use.
Before use, pierce the tube by reversing the cap and screwing down to break the seal on the tube.
Duration of use
If the symptoms worsen or persist longer than 4 weeks during the use of the medicinal product, a doctor, qualified healthcare practitioner or pharmacist should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Do not apply to broken or irritated skin.
4.4 Special warnings and precautions for use
Discontinue use if redness, irritation or dry skin occurs.
Articular pain accompanied by swelling of joint, redness or fever should be examined by a doctor.
If there is inflammation of the skin or subcutaneous induration, ulcers, sudden swelling of one or both legs particularly associated with redness and heat, cardiac or renal insufficiency, or a sudden sharp pain in the leg when at rest, a doctor should be consulted.
Contact with eyes should be avoided. Cream should not be applied near mucous membranes.
Wash hands before and after using the cream.
If the cream is accidentally swallowed, a doctor or pharmacist should be contacted for advice.
Paediatric population
The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.
Rowiren contains 0,3 g ethanol (alcohol) in each dose of 2 g cream.
It may cause burning sensation on damaged skin.
Rowiren contains 60 mg cetostearyl alcohol in each dose of 2 g cream.
May cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction None reported.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of Rosemary oil (Rosmarinus officinalis) in pregnant women. Rowiren is not recommended during pregnancy.
Breast-feeding
Safety during lactation has not been established. In the absence of sufficient data, the use during lactation is not recommended.
Fertility
Studies on the effect on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Rowiren has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
The frequency of possible side effects listed below is defined using the using the following convention: very common: (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known: cannot be estimated from the available data.
| Immune system disorders | |
| Not known | Hypersensitivity (contact dermatitis) |
| Respiratory, thoracic and mediastinal disorders | |
| Not known | Hypersensitivity (asthma) |
If other adverse reactions occur, a doctor, qualified healthcare practitioner or pharmacist should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of the traditional herbal medicinal product is important. It allows continued monitoring of the benefit/risk balance of the traditional herbal medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other topical product for joint and muscular pain, ATC code: M02AX
Rowiren is a Traditional herbal medicinal product.
No pharmacodynamic studies have been performed.
5.2 Pharmacokinetic properties
No pharmacokinetic studies have been performed.
5.3 Preclinical safety data
5.3 Preclinical safety dataTests on reproductive toxicity and carcinogenicity have not been performed.
Rosemary oil was shown non-mutagenic in a bacterial reverse mutation assay (Ames test).
6.1
Medium chain triglycerides
Octyldodecanol
Ethanol (96 per cent)
Glycerol (85 per cent)
Emulsifying cetostearyl alcohol (Type A)
Glycerol monostearate 40–55
Trometamol
Dimeticone
Carbomers
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
4 years
Shelf life after first opening: 12 months.
6.4 Special precautions for storage
Store below 25 °C
6.5 Nature and contents of container
Aluminium tube coated internally with an epoxy-phenolic resin and fitted with a HDPE screw cap.
Pack size: 50 g and 90 g cream.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
Medis GmbH
Europaring F15
2345 Brunn am Gebirge
Austria
8 MARKETING AUTHORISATION NUMBER(S)
THR 44194/0003