Premherb Pms Relief Tablets
Out of date information, search anotherPremHerb PIL 2014 5940-01 11/04/2014 15:19 Page 1
6: Further information
Each film-coated tablet contains 4mg of extract (as dry extract) from Agnus castus fruit (Vitex agnus castus L.) (7-13:1) (equivalent to 28-52mg of Agnus castus). Extraction solvent: Ethanol 60% v|v.
This product also contains the following ingredients:
Tablet core: Liquid glucose, silica colloidal anhydrous, lactose monohydrate, magnesium stearate, maize starch, cellulose microcrystalline, sodium starch glycolate (type A).
Film-coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), iron (lll)-oxide (E 172).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
Each film-coated tablet contains 124mg of lactose and 36mg of liquid glucose. Each pack contains 30 film-coated tablets.
Registration holder for this product
Schwabe Pharma (UK) Ltd
Alexander House, Mere Park, Dedmere Road, Marlow, Bucks SL7 1FX
Manufacturer of this product
Certification
Mark
Wiewelhove GmbH,
Gildestrasse 39, 49477 Ibbenbiiren, Germany
Traditional herbal registration number:
THR 23056/0002
If you would like further information about this product, please contact:
Schwabe Pharma (UK) Ltd, Alexander House, Mere Park, Dedmere Road,
Marlow, Bucks SL7 1FX
Telephone: 01628 401980
Email: info@schwabepharma.co.uk
This leaflet was revised 04/2014.
Fora large print, Braille or audio version of this leaflet, call 01628 401980 o
Patient Information Leaflet
PremHerb PMS Relief tablets
Agnus castus fruit extract 4mg
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about PremHerb® PMS Relief.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or
qualified healthcare practitioner.
1: What this product is and what it is used for............................page 1
2: Before you take this product..............................................page 2
3: How to take this product..................................................page 2
4: Possible side-effects ......................................................page 3
5: How to store this product..................................................page 3
6: Further information ........................................................page 4
1: What this product is and what it is used for
This product is a traditional herbal medicinal product containing Agnus castus fruit. Each film-coated tablet contains 4mg of extract (as dry extract) from Agnus castus fruit (Vitex agnus castus L.) (7-13:1) (equivalent to 28-52mg of Agnus castus). Extraction solvent: Ethanol 60% v|v.
PremHerb PMS Relief is a traditional herbal medicinal product used to help relieve symptoms of premenstrual syndrome such as irritability, mood swings, breast tenderness, bloating and menstrual cramps.
This usage is based on traditional use only.
2: Before you take this product
DO NOT TAKE this product if you are: d lactose-intolerant (react badly to lactose or milk)
□ pregnant or trying to become pregnant
□ breast-feeding
d allergic to any of the ingredients (see section 6)
□ suffering from a pituitary disorder
□ under 18 years of age
Tell your doctor before taking this product if you have:
□ an intolerance to some sugars (see section 6)
□ had a pituitary disorder in the past
If you are taking a dopamine-receptor antagonist or agonist-type drug, there is a theoretical risk that this product may affect the way they work.
3: How to take this product
For women experiencing premenstrual symptoms Take 1 tablet daily.
Try to take the tablets at the same time each day, either in the morning or evening. Swallow the tablets whole with some water or other liquid. Do not chew the tablets. You can take the tablets with or without food. The maximum beneficial effect of this product may take up to 3 months to develop in some women.
Do not exceed the stated dose.
Do not give to children or adolescents under 18 years old.
If you take too much of this product (overdose)
If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you. A small overdose (up to 8 tablets) may not cause any symptoms. In the event of a large overdose (more than 8 tablets) advice should be sought from a doctor.
If you forget to take this product
Continue to take your usual dose at the usual time, it does not matter if you have missed a dose.
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If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.
4: Possible side-effects
Like all medicines this product can have side-effects. Any side-effects are usually mild and disappear in a few days. Side-effects that have been reported are listed below:
Side-effects
If these persist for more than a few days, or become troublesome, stop taking this product. These common side-effects are often only temporary.
□ nausea or feeling sick
□ indigestion
□ digestive upsets such as wind, bloating or diarrhoea
□ headache
Stop taking this product immediately if you experience any allergic skin reaction.
□ allergic skin reactions itch and/or rash of the skin
Other side-effects
Tell your doctor or pharmacist if you notice any other side-effect.
You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme atwww.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP's surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am-2pm Monday - Friday).
5: How to store this product
Do not use your tablets after the expiry date.
Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.
This medicinal product does not require any special storage conditions. Keep the tablets out of the reach and sight of children.
Keep your tablets in the blister pack until it is time to take them.