SUMMARY OF PRODUCT CHARACTERISTICS

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).

Excipient with known effect:

3 g cetostearyl alcohol (Type A) emulsifying/100 g

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. Wash hands before and after use.

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’).

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.

Method of administration Cutaneous use.

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

The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.

If symptoms worsen or persist longer than 4 weeks during the use of the medicinal product, a doctor, qualified healthcare practitioner or a pharmacist should be consulted.

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.

If the cream is accidentally swallowed, a doctor or pharmacist should be contacted for advice.

Rowiren contains cetostearyl alcohol (Type A), emulsifying, which may cause local skin reactions (e.g. contact dermatitis).

Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Fertility, pregnancy and lactation

Pregnancy

Safety during pregnancy has not been established. In the absence of sufficient data, the use during pregnancy is not recommended.

Breastfeeding

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 a 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

Website: www.mhra.gov.uk/yellowcard.

4.9    Overdose

No case of overdose has been reported.

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 and carcinogenicity have not been performed. Rosemary oil was shown non-mutagenic in a bacterial reverse mutation assay (Ames test).

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Triglycerides, medium chain

Octyldodecanol

Ethanol (96 per cent)

Glycerol (85 per cent)

Cetostearyl alcohol (Type A) emulsifying

Glycerol monostearate 40-55

Trometamol

Dimeticone

Carbomers

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months

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: 90 g cream.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Medis GmbH

St. Veiter StraBe 34/III

9020 Klagenfurt am Worthersee

Austria

8    MARKETING AUTHORISATION NUMBER(S)

THR 44194/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/06/2016

10    DATE OF REVISION OF THE TEXT

16/06/2016