Summary of Product Characteristics (SmPC) - Periagna
1 NAME OF THE MEDICINAL PRODUCT
PERIAGNA
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400mg of Agnus Castus fruit (Vitex agnus castus L.)
For list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Clear size 0 hard capsules.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
PERIAGNA is a traditional herbal medicinal product used to help relieve premenstrual symptoms such as irritability, mood swings, breast tenderness, bloating and menstrual cramps, based on traditional use only.
4.2 Posology and method of administration
For oral use only. For women experiencing premenstrual symptoms.
For the temporary relief of symptoms associated with premenstrual syndrome. Take 1 capsule 2 times a day, morning and night, swallowed with water.
As treatment effects may not be apparent immediately, the product may need to be taken up to 3 months continuously. Maximum daily dose:- 2 capsules.
Duration of use:-
If symptoms persist, worsen or do not improve after 3 months use of PERIAGNA, a doctor or a qualified healthcare practitioner should be consulted.
Women suffering a pituitary disorder should not take the product (see section 4.3).
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
4.3 Contraindications
Hypersensitivity to Agnus castus or any of the excipients.
Women with a pituitary disorder.
4.4 Special warnings and precautions for use
Patients who suffer or suffered from an oestrogen-sensitive cancer should consult their doctor before using the product. Patients who are using dopamine agonists, dopamine antagonists, oestrogens and antioestrogens should consult
their doctor before using the product (see section 4.5 ‘Interactions with other medicinal products and other forms of interaction’).
The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Vitex agnus-castus fruits are thought to act on the pituitary-hypothalamic axis and therefore patients with a history of a pituitary disorder should consult with a doctor before using this product. In cases of prolactin secreting tumours of the pituitary gland the intake of Vitex agnus-castus fruits can mask symptoms of the tumour.
4.5 Interaction with other medicinal products and other forms of interaction
Because of the possible dopaminergic and oestrogenic effects of Vitex agnus-castus fruits interactions with dopamine agonists, dopamine antagonists, oestrogens and antioestrogens cannot be excluded.
4.6 Fertility, Pregnancy and lactation
There is no indication for the use during pregnancy.
Data from reproductive studies suggest that extracts of the fruits may affect lactation. The use during 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
Severe allergic reactions with face swelling, dyspnoea and swallowing difficulties.
(Allergic) skin reactions (rash and urticaria), headache, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), acne, menstrual disorders 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 are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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
Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100,TA 1535 and TA 1537) and E.Coli strain WP2 uvrA mutation assays with or without metabolic activation.
Adequate tests on reproductive toxicity and carcinogenicity have not been performed.
Limited data from reproductive studies suggest that extracts of the fruits influence lactation.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hypromellose (capsule shell)
6.2 Incompatibilities
Not Applicable
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C in the original package.
6.5 Nature and contents of container
Duma 110ml HDPE plastic container and tamper evident threaded Duma cap. Duma 200ml HDPE plastic container and tamper evident Duma cap. PERIAGNA pack contains 60 or 120 Capsules.
6.6 Special precautions for disposal
There are no special precautions for disposal of PERIAGNA capsules.
7 MARKETING AUTHORISATION HOLDER
Bio-Health Limited,
Culpeper Close,
Medway City Estate,
Rochester,
Kent
ME2 4HU
8 MARKETING AUTHORISATION NUMBER(S)
THR 15817/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/08/2019
10 DATE OF REVISION OF THE TEXT
29/08/2019