SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

PHYTOVEIN

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 350 mg of Butcher’s Broom rhizome (Ruscus aculeatus L., rhizome)

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, hard

Clear, size 0 hard capsules.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Traditional herbal medicinal product used to relieve symptoms of discomfort and heaviness of the legs related to minor venous circulatory disturbances, based on traditional use only.

Traditional herbal medicinal product used to relieve symptoms of itching and burning associated with haemorrhoids, based on traditional use only.

4.2 Posology and method of administration

Oral use.

Adults and the elderly:

1 capsule, 3 times daily during meals, with a large glass of water.

Children and adolescents

The use in children or 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 persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose

There is no relevant use in children and adolescents under 18 years of age.

If there is inflammation of the skin or subcutaneous induration, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted.

If diarrhoea develops, treatment should be discontinued.

If rectal bleeding occurs a doctor should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established.

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

No studies on the effects on fertility have been performed.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Nausea, gastrointestinal complaints, diarrhoea, lymphocytic colitis may occur. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a 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 and patients are asked to report any suspected adverse reactions via the Yellow Card Reporting Scheme; www.yellowcard.mhra.gov.uk

4.9 Overdose

No case of overdose has been reported.

Symptomatic and supportive measure should be taken 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.

Pharmacokinetic properties

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

5.3 Preclinical safety data

Reverse mutation assays (Ames test) on bacteria indicated that Butcher’s Broom powder contained in the product was not mutagenic in Salmonella typhimurium (strains TA 1535, TA 1537, TA98, TA 100 and TA102) mutation assays with or without metabolic activation.

Tests on reproductive toxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Colloidal hydrated silica Magnesium stearate Hypromellose (capsule shell).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 30°C. Keep the bottle tightly closed.

6.5 Nature and contents of container

Brown polyvinyl chloride bottle of 45 capsules, with a security cap made of low density polyethylene.

6.6 Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

LABORATOIRES ARKOPHARMA Lid de Carros Le Broc-1^er avenue, 2709 m 06510 CARROS FRANCE

Tel.: +33 (0)4 93 29 11 28 Fax.:+33 (0)4 93 29 11 62

Trading as :

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES Lid de Carros Le Broc-1^er avenue, 2709 m 06510 CARROS FRANCE

8    MARKETING AUTHORISATION NUMBER(S)

THR 12297/0015

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 08/07/2016

10 DATE OF REVISION OF THE TEXT

08/07/2016