Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Agnus castus may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR Care Agnus Castus PMS Relief Capsules are 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. Each hard capsule contains 400mg Agnus Castus fruit (Vitex agnus-castus L.)
Date
30.10.2017
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Approved by Date
GKE
Artwork No. 901053 CRN
13875
Reason for Change
New product introduction
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Issued by Date MHRA/IMB submission required
Yes
9pt
30.10.2017 160 x 256mm
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20196901 IG Code
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60's
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Do not take this product:
Care Agnus Castus PMS Capsules
BEFORE YOU TAKE CARE AGNUS CASTUS CAPSULES
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1. What Care Agnus Castus Capsules are and what they are used for.
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Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
10pt
Agnus Castus fruit 400mg
PCP Header Box Operator
Approved by Date
GKE
Artwork No. 901053 CRN
13875
Reason for Change
New product introduction
Suffix
C
Issued by Date MHRA/IMB submission required
Yes
9pt
30.10.2017 20196901
160 x 256mm
6
IG Code
Dimensions
Proof No.
Date
10pt
60's
What Care Agnus Castus Capsules contain Arial MT Process Black
Leaflet
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9pt
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CONTENTSCare OFAgnus THECastus PACK AND OTHER INFORMATION Colours Used PMS Capsules
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Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package. Do not use this product after the expiry date which is stated on the side of the label after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. MHRA Header Box
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Care Agnus Castus PMS Capsules
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Adults: Women experiencing premenstrual symptoms: Take one capsule twice a day, morning and night. Swallow whole with a glass of water. Do not take more than the label tells you to. As the effects of this product may not occur immediately, the capsules should be taken continuously for three months. If your symptoms persist or worsen or do not improve after 3 months, consult your doctor or qualified healthcare practitioner. If you take more of this product than you should If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner. Take this leaflet with you. If you forget to take this product Do not take a double dose to make up for a forgotten dose. Take the next dose when it becomes due. If you have any questions or are not sure how to use this product, consult your doctor or qualified healthcare practitioner.
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CARE AGNUS CASTUS CAPSULES
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Like all medicines, this product can cause side effects, although not everybody gets them. The frequency of effects is not known. Possible side effects include: Severe allergic reactions such as swelling of the face, breathlessness or difficulty swallowing. If you experience these effects, seek medical advice immediately.
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Care Agnus Castus PMS Relief Capsules comes as capsule. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Care Agnus Castus PMS Relief Capsules is agnus castus.
This leaflet reproduces the patient information leaflet approved for Care Agnus Castus PMS Relief Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
A traditional herbal medicinal product used to help relieve premenstrual symptoms such as: irritability; mood swings; breast tenderness; bloating and menstrual cramps, base on traditional use only.
For oral use only. For women experiencing premenstrual symptoms.
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 for up to three months continuously. Maximum daily dose: 2 capsules.
If symptoms persist, worsen, or do not improve after 3 months use, a doctor or qualified healthcare practitioner should be consulted.
Women suffering from a pituitary disorder should not take this 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').
Hypersensitivity to Agnus castus or hypromellose.
Patients with a pituitary disorder.
Pregnancy or lactation.
Do not exceed the stated dose.
Patients who suffer from 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 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 persist, or worsen during the use of the product, or do not improve after 3 months of using the 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.
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.
There is no indication for the use in pregnancy.
Data from reproductive studies suggest that extracts of the fruits may affect lactation. The use during lactation is not recommended.
Due to the potential for Agnus castus fruits to have hormone-like actions, use should be avoided by women who are trying to get pregnant.
No studies on the effect on fertility have been performed.
No studies on the effect on the ability to drive and use machines have been performed.
Severe allergic reactions with face swelling, dypsnoea 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 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 of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.
No case of overdose has been reported.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Agnus castus. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Care Agnus Castus PMS Relief Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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