Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Care Agnus Castus PMS Relief Capsules

⚠ This medicine appears to have been discontinued

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.

Active substance: Agnus castus
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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

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 160 x 256mm

6

Dimensions

Proof No.

Date

20196901 IG Code

6

60's

Proof No.

Leaflet

160 x 256mm

Pack Size

Dimensions

10pt

Component

Do not take this product:

  • if you are allergic to Agnus Castus or any of the other ingredients of this medicine (listed in section 6).
  • if you are under 18 years of age.
  • if you are pregnant, trying to become pregnant or are breastfeeding.
  • if you have a current pituitary disorder. MHRA Header Boxprecautions: Warnings and Talk to your doctor or pharmacist taking thisColours product: Used Fonts Used Care Agnus Castus PMSbefore Capsules •Product if you Title suffer from, or have suffered from, an oestrogen-sensitive cancer. Arial MT Process Black
  • if you have suffered from a pituitary disorder. Leaflet •Component if you are taking any of the following medicines: Size -Pack Dopamine agonists or antagonists 60's -IGOestrogens Code 20196901
  • Antioestrogens

Care Agnus Castus PMS Capsules

BEFORE YOU TAKE CARE AGNUS CASTUS CAPSULES

Point Sizes Used Min Max

9pt

MHRA Header Box

2.

Product Title

1.

1. What Care Agnus Castus Capsules are and what they are used for.

Arial MT

Fonts Used

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 3 months.

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Point Sizes Used Min Max

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

  • Component Each hard capsule contains 400mg Agnus Castus fruit (Vitex agnus-castus L.). Leaflet
  • The capsule shell is made from hypromellose. Pack Size 60's Castus Capsules look like and contents of the pack What Care Agnus Agnus Castus PMS Relief Capsules are hard, clear, oblong capsules containing a brown Care IG Code 20196901 powder. 160 x 256mm Dimensions The product is available in packs of 30, 60, 90 and 120 capsules (not all sizes may be Proof No. Date 30.10.2017 marketed). 6 Registration number: THR 33336/0009 Traditional Herbal Registration Holder and Manufacturer: Natures Aid Ltd, St Georges Park, Preston, Lancs., PR4 2DQ, UK Distributed by: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK. This leaflet was last revised in November 2017. For a large print, braille or audio version of this leaflet please call 01484 848164 20196901

Leaflet

Fonts Used

Point Sizes Used Min Max

9pt

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CONTENTSCare OFAgnus THECastus PACK AND OTHER INFORMATION Colours Used PMS Capsules

Product Title

Pack Size

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

6.

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Colours Used

Possible side effects

Care Agnus Castus PMS Capsules

4.

Point Sizes Used Min Max

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.

10pt

How to store it

CARE AGNUS CASTUS CAPSULES

Component

5.

Fonts Used

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.

  • menstrual disorders.
  • nausea.
  • abdominal pain.
  • headaches.
  • dizziness.
  • allergic skin reactions, such as a rash or red itchy spots.
  • acne. If you find these effects troublesome, stop using the product. Speak to your doctor if you are at all concerned, if a side effect becomes serious, or you notice an effect not mentioned in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.

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Frequently asked questions about Care Agnus Castus PMS Relief Capsules

How do I take Care Agnus Castus PMS Relief Capsules?

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.

What is the active substance in Care Agnus Castus PMS Relief Capsules?

The active substance in Care Agnus Castus PMS Relief Capsules is agnus castus.

Where does this information come from?

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.

Can I get Care Agnus Castus PMS Relief Capsules without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Agnus castus (2 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

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.

4.2. Posology and method of administration

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').

4.3. Contraindications

Hypersensitivity to Agnus castus or hypromellose.

Patients with a pituitary disorder.

Pregnancy or lactation.

4.4. Special warnings and precautions for use

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.

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 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.

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, 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.

4.9. Overdose

No case of overdose has been reported.

🇷🇴 Known in Romania as

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.

  • FEMIPLANTE over the counter partial — not the same combinationPLANTE (VITEX AGNUS CASTUS) · taken by mouth

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 →

🇵🇱 Known in Poland as

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.

  • MastodynonAgnus castus + Caulophyllum thalictroides + Cyclamen D4 + Ignatia D6 + Iris D2 + Lilium tigrinum D3

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 about this leaflet

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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