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Vitabiotics Milk Thistle Tablets

Document: leaflet VITABIOTICS_THR 20894-0071 change

Patient Information Leaflet Milk Thistle Standardised Fruit Extract 500mg


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VITABIOTICS

milk thistle

tablets

P13277


30 Tablets

VITABIOTICS

milk thistle


sfr[Kracdt 500mg tablets


WHAT IS IN THIS LEAFLET

1.    What this product is and what it is used for

2.    Before you take this product

3.    How to take this product

4.    Possible side effects

5.    How to store this product

6.    Further information

Please read this information carefully before you start taking these tablets. It contains some important information about this product. Keep this leaflet with the tablets. You may want to read it again or show it to your doctor, pharmacist or refer to a qualified healthcare practitioner.


1.    WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR

This product is a traditional herbal medicinal product used to relieve the symptoms associated with occasional over indulgence of food and drink such as indigestion and upset stomach based on traditional use only.

2.    BEFORE YOU TAKE THIS PRODUCT
3. HOW TO TAKE THIS PRODUCT Adults and the elderly:

Take 1 tablet daily, before a meal. Swallow the tablets whole with water. Do not chew.

Children and adolescents under 18 years old:

This medicine is not recommended for children and adolescents under 18 years of age.

Do not exceed the stated dose.

Do not take this product if you:

•    Are under the age of 18 years

•    Are allergic to Milk Thistle or to plants of the Asteraceae/Compositae family such as daisies, marigolds or artichokes or to any of the ingredients (see section 6).

Take special care with this product:

If you are suffering from active liver disease.

Please consult your doctor before taking this

product, as Milk Thistle may alter the way that

certain drugs are broken down by the liver.

Taking other medicines:

You must speak to a qualfied healthcare practitioner if your symptoms worsen, or persist for more than one week, or if you notice any side effects not mentioned in the leaflet.

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.

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.

Tell your doctor or pharmacist before taking this medicine if you are taking other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding:

Do not take this product if you are pregnant or breast-feeding, because there is no evidence that it is safe to do so.

Driving or operating machines:
4. POSSIBLE SIDE EFFECTS

Like all medicines, this product can have possible side effects. These are listed below:

•    Gastrointestinal reactions (nausea, upset stomach, diarrhoea)

•    Headaches

•    Allergic reactions (urticaria [raised itchy rash], skin rash, pruritus [itching], anaphylaxis)

No studies on the effects on the ability to drive and Stop taking this product immediately if you use machines have been performed.    experience any allergic skin reactions.

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4.    POSSIBLE SIDE EFFECTS (CONTINUED)

The frequency of these possible side effects is not known. If any of the effects become troublesome or if you experience any other unexpected effects not listed in this leaflet, consult your doctor or a pharmacist.

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.

By reporting side effects you can help provide more information on the safety of this medicine.

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. The expiry date is printed on the box and the blister pack. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original packaging. Keep the tablets out of sight and reach of children.

Keep your tablets in the packaging until it is time to take them.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    FURTHER INFORMATION

Each film coated tablet contains 500mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner). (Equivalent to 10.0 - 20.0g of Milk Thistle fruits) corresponding to 250 - 300mg of silymarin calculated as silibinin. Extraction Solvent:

Ethyl acetate 100% v/v.

This product also contains the following ingredients:

Tablet core:

Calcium Carbonate, Maltodextrin, Croscarmellose Sodium, Microcrystalline Cellulose, Colloidal Anhydrous Silica, Magnesium Stearate.

Tablet coating:

Hypromellose, Purified Talc.

Each pack contains film coated pale yellow caplet shaped tablets.

This product is available in pack sizes of 30, 60 or 120 tablets. Not all pack sizes are marketed.

If you would like further information about this product or for large print, Braille or audio version please contact:

Vitabiotics Ltd, 1 Apsley Way, London NW2 7HF Telephone: 020 8955 2662 Traditional Herbal Registration Holder and Manufacturer:

Brunel Healthcare Manufacturing Ltd, William Nadin Way, Swadlincote Derbyshire, DE11 0BB.

Traditional Herbal Registration Number:

THR 20894/0071

This leaflet was revised in May 2014.

THR


Certification Mark


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VITABIOTICS