SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

PHYTOCALM

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 capsule contains 300 mg Passion Flower herb (Passiflora incarnata L., herba). For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, hard.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety and to aid sleep based on traditional use only.

4.2 Posology and method of administration

For oral short term use only

Adults and the elderly:

2 capsules after evening meal and 2 capsules before going to sleep, with a large glass of water.

Maximum dose: Up to 6 capsules daily if necessary.

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

The patient should consult a doctor or a qualified healthcare practitioner if symptoms worsen or do not improve after 4 weeks.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens, or symptoms persist after 4 weeks of using the product, a doctor or a qualified healthcare practitioner should be consulted.

The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

4.5 Interaction with other medicinal products and other forms of interaction

Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.

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

May cause drowsiness and impair the ability to drive and operate machines. If affected, do not drive or operate machines.

4.8 Undesirable effects

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported. 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 measures 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.

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

A reverse mutation assay on bacteria indicated that Passion flower powder contained in the product was not found to be mutagenic in Salmonella typhimurium (strains TA 1535, TA 1537, TA98, TA 100) and Escherichia coli (strain WP2 pKM101/uvrA) 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

Hypromellose (capsule shell)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

5 years.

6.4 Special precautions for storage

Store below 30°C Store in the original package

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^ere avenue, 2709 m 06510 CARROS France

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

Trading as:

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES LID de Carros Le Broc - 1^ere avenue, 2709 m 06510 CARROS France

8    MARKETING AUTHORISATION NUMBER(S)

THR 12297/0014

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11/07/2016

10    DATE OF REVISION OF THE TEXT

11/07/2016