Discussion in Working Party on Community monographs and Community list (MLWP)

January 2010 March 2010

Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation

15 March 2010

End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

15 August 2010

Rediscussion in Working Party on Community monographs and Community list (MLWP)

Adoption by Committee on Herbal Medicinal Products (HMPC)

Well-established use

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended

Juniperus communis L., aetheroleum (juniper oil)

i)    Herbal substance Not applicable.

ii)    Herbal preparations

Essential oil obtained by steam distillation from the ripe, non-fermented berry cones.

Well-established use

Traditional use

Herbal preparation in liquid dosage forms for oral and cutaneous use.

The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Well-established use

Traditional use

Oral use

Indication 1)

Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the

Well-established use

Traditional use

urinary tract as an adjuvant in minor urinary tract complaints.

Indication 2)

Traditional herbal medicinal product for symptomatic relief of digestive disorders such as dyspepsia and flatulence.

Cutaneous use

Indication 3)

Traditional herbal medicinal product as adjuvant in the relief of minor muscle and articular pain.

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Well-established use

Traditional use

Posology Oral use

Adults

Average daily dose

60-100 mg to be taken in 1-3 doses.

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').

Cutaneous use

Adolescents, adults

Bath additive 3-4 times weekly 1-1.5 g juniper oil full bath for 10-20 min at 35-38°C

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

If symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Method of administration

Well-established use

Traditional use

Oral use. Cutaneous use.

Well-established use

Traditional use

Hypersensitivity to the active substance.

Severe renal disease including infectious interstitial nephritis, pyelitis and pyelonephritis.

Indication 1)

Conditions where reduced fluid intake is recommended (e.g. severe cardiac diseases).

Well-established use

Traditional use

Oral use

The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.

Cutaneous use

The use in children under 12 years of age has not been established due to lack of adequate data.

Indications 1) and 2)

If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Indication 1)

Appropriate fluid intake is recommended.

If complaints or symptoms such as fever, dysuria, spasms or blood in the urine occur during the use of the medicinal product, a doctor or a qualified health care professional should be consulted.

The use of this product is not recommended in case of oedema due to limited heart and kidney function.

Indication 3)

In cases of hypertension, a full bath should be used with caution.

Well-established use

Traditional use

None reported.

Well-established use

Traditional use

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Well-established use

Traditional use

No studies on the effect on the ability to drive and use machines have been performed.

Well-established use

Traditional use

Allergic skin reactions have 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.

Well-established use

Traditional use

In case of prolonged oral use and overdose, urine will smell of violets. There may be renal irritation and kidney pain, strong diuresis, albuminuria, haematuria, purplish urine, gastrointestinal upsets, increased heartbeat and blood pressure. Rarely symptoms of central stimulation like convulsions occur as well as metrorrhagia and abortion.

Well-established use

Traditional use

Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended.

There is limited evidence from non-clinical studies that juniper may influence glucose levels in diabetes

Well-established use

Traditional use

Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended.

Well-established use

Traditional use

Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

Well-established use

Traditional use

Not applicable.