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., pseudo-fructus (juniper berry)

i) Herbal substance Cone berries

ii) Herbal preparations

Comminuted cone berries

Liquid extract with 25% ethanol (1:1 V/V)

Tincture with 45% ethanol (1:5 V/V)

Well-established use

Traditional use

Herbal substance or herbal preparations in solid or liquid dosage forms or as herbal tea for oral use.

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

Well-established use

Traditional use

a)    Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary tract complaints.

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

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

i)    Herbal substance Indication a)

Cone berries:

To start on day 1 with 5 cone berries, increasing the number every day by 1 coneberry (well chewed) up to 15 cone berries, then decrease the number (1 per day less) until 5 coneberries. So the duration of the therapy is 21 days, the maximum daily dose 15 cone berries.

ii)    Herbal preparations Indications a) and b)

Infusion:

2    g crushed or comminuted herbal substance for tea preparation with boiling water, infusion time 10 minutes: 2-3 times a day

Liquid extract (1:1 in 25% ethanol): 2-4 ml

3    times daily

Tincture (1:5 in ethanol 45%): 1-2 ml 3 times daily

Not to be used in children and adolescents under 18 years of age (see section 4.4 ‘Special warnings and precautions for use’).

Duration of use

Not to be used for more than 3 weeks without consulting a doctor or a qualified health care practitioner.

Method of administration

Oral use.

Indication a)

For preparations other than tea preparations, ensure appropriate fluid intake.

Well-established use

Traditional use

Hypersensitivity to the active substance.

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

Indication a)

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

Well-established use

Traditional use

Not to be used in children and adolescents under 18 years of age since no data on the safe use in children and adolescents are available.

Appropriate fluid intake is recommended.

If complaints of 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.

Concomitant treatment with synthetic diuretics is not recommended.

For preparations containing ethanol the appropriate labelling for ethanol, taken from the ‘Guideline on excipients in the label and package leaflet of medicinal products for human use’, must be included.

Well-established use

Traditional use None reported.

Well-established use

Traditional use

Safety during pregnancy and lactation has not been established.

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

Seizures and kidney damage have been reported in individuals who took more than 10 g of Juniper per day or who took high doses of Juniper for longer than 4 weeks.

In case of prolonged use and overdose, urine will smell of violets. There may be renal irritation and pain in and near the kidney, strong diuresis, albuminuria, haematuria, purplish urine, gastrointestinal upsets, accelerated 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 preclinical 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.

Based on the results of preclinical investigations it can be concluded that Juniperus communis extract has anti-fertility and abortifacient effects in rats.

As no specific investigations were done on the foetuses, there are no data on genotoxicity, reproductive toxicity or carcinogenicity available for Juniperus communis or its preparations.

Well-established use

Traditional use Not applicable.