What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: THR 23056/0002.


Boots PMS Relief Agnus Castus Tablets

Information for the user

Boots PMS Relief Agnus Castus Tablets

Agnus Castus fruit extract 4 mg

Read all of this leaflet carefully because it contains important information for you.

This medicine is a traditional herbal medicinal product available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

  • Keep this leaflet, you may need to read it again
  • Ask your pharmacist if you need more information or advice

What this medicine is for

This traditional herbal medicinal product contains Agnus Castus fruit extract, which has been traditionally used to help relieve symptoms associated with premenstrual syndrome such as irritability, mood swings, breast tenderness, bloating and menstrual cramps, based on traditional use only.

Before you take this medicine

This medicine can be taken by women aged 18 years and over. However, some women should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

  • If you are under 18 years
  • If you are allergic to any of the ingredients (see “What is in this medicine”)
  • If you have a pituitary disorder
  • If you are pregnant, trying to get pregnant or breastfeeding

Tell your doctor before taking this product if you:

  • have an intolerance to some sugars (this medicine contains lactose and glucose)
  • have had a pituitary disorder in the past
  • suffer from, or have suffered from, an oestrogen-sensitive cancer
  • are taking any of the following: dopamine receptor antagonist or agonist type medicine, oestrogens or antioestrogens or any other medicines including any bought without a prescription.

If you are not sure that your medicine is on the list, or are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor or medicine you have bought yourself.

How to take this medicine

Check the foil is not broken before use.

If it is, do not take that tablet.

Women aged 18 years and over experiencing premenstrual symptoms: take one tablet, once daily, at the same time of day, if possible (morning or evening)

Swallow the tablet whole with water or liquid. Do not chew the tablet.

As the effects of this product may not occur immediately, the tablets should be taken continuously for three months.

If symptoms worsen, or do not improve after 3 months, a doctor or qualified healthcare practitioner should be consulted.

Do not give to children or adolescents under 18 years.

Do not take more than the label/leaflet tells you to take.

If symptoms do not go away talk to your doctor.

If you take too many tablets: Talk to a doctor, pharmacist or qualified healthcare professional and take this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these side effects, stop taking the tablets:

Severe allergic reactions such as swelling of the face, breathlessness or difficulty swallowing. If you experience these effects, seek medical attention immediately.

These other effects may happen. If they bother you talk to a pharmacist:

  • nausea or feeling sick
  • abdominal pain
  • menstrual disorders
  • acne
  • dizziness
  • headache
  • allergic skin reactions such as itching and/or rash of the skin

If any side effect becomes severe, lasts more than a few days, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Reporting of side effects:

If you get any side-effects, talk to your doctor, pharmacist or qualified healthcare practitioner. 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.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard. Keep your tablets in the blister pack until it is time to take them.

Use by the date on the base of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.

This medicinal product does not require any special storage conditions. Store in the original packaging.

What is in this medicine

Each film-coated tablet contains 4 mg of extract (as dry extract) from Agnus castus fruit (Vitex agnus castus L.) (7-13:1). This is equivalent to 28 – 52 mg of Agnus castus. The extraction solvent is ethanol 60% v/v.

As well as the active ingredient, the tablet core also contains glucose, colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, sodium starch glycolate (type A).

The tablet coating contains lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171), red iron oxide (E172).

The pack contains 30 salmon-pink, round convex, scored film-coated tablets.

Who makes this medicine

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by

Wiewelhove GmbH
Gildestrasse 39
49477 Ibbenbűren
Germany

Traditional Herbal Registration held by

Schwabe Pharma (UK) Ltd
Alexander House Mere Park
Dedmere Road
Marlow
Buckinghamshire
SL7 1FX

Leaflet revised 06/2018

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots PMS Relief Agnus Castus Tablets

Reference number: THR 23056/0002

This is a service provided by the Royal National Institute of Blind People.

WBAG324519 C