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PATIENT INFORMATION LEAFLET

digestive relief tablets

Milk Thistle standardised fruit extract 300 mg

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 qualified healthcare practitioner.



What is in this leaflet?

1.    What Principle Healthcare digestive relief is and what it is used for

2.    Before you take Principle Healthcare digestive relief

3.    How to take Principle Healthcare digestive relief

4.    Possible Side Effects

5.    How to store Principle Healthcare digestive relief

6.    Further Information

1. What Principle Healthcare digestive relief is and what it is used for

What Principle Healthcare digestive relief is

This product is a traditional herbal medicinal product containing Milk Thistle standardised fruit extract.

Each film-coated tablet contains 300 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 7200mg - 8100mg of Milk Thistle fruits) corresponding to 174mg of silymarin, calculated as silibinin. Extraction solvent: Acetone 95% v/v.

What Principle Healthcare digestive relief is used for

Principle Healthcare digestive relief 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 Principle Healthcare digestive relief
X Do not take if you:

•    are under the age of 18 years

•    are pregnant or breastfeeding

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

Tell your doctor before taking this product if you are currently suffering from active liver disease.

Taking other medicines

Tell your doctor or pharmacist before use if you are taking any other medicines, including those obtained without prescription.

3. How to take Principle Healthcare digestive relief
Adults and the elderly

The recommended dosage is 1 or 2 tablets daily. The tablets must be swallowed whole with a little water. Do not chew the tablets. Do not exceed the stated dose.

This product is not recommended for children or adolescents under 18 years of age.

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.

If your condition worsens or if symptoms persist one week after taking this product or if side effects become serious or if side effects not mentioned in the patient information leaflet occur, consult a doctor or a qualified healthcare practitioner. 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 although the frequency is not known. These are listed below.

•    Nausea ( feeling sick)

•    Upset stomach

•    Diarrhoea

•    Headache

•    Mild allergic reactions such as itching and or skin rash, urticaria, anaphylaxis, hives, pruritus. If you experience an allergic reaction, stop taking this product and consult your doctor.

If side effects become serious or if you notice any side effects not mentioned above after taking this medicine, a doctor or qualified healthcare practitioner should be consulted.


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5. How to Store Principle Healthcare digestive relief

* Do not use your tablets after the expiry date. 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. 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 the reach and sight of children. s Keep your tablets in the blister pack until it is time to take them.


6. Further Information

Active Ingredients: Each film-coated tablet contains 300 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 7200mg - 8100mg of Milk Thistle fruits) corresponding to 174mg of silymarin, calculated as silibinin. Extraction solvent: Acetone 95% v/v.

This product also contains the following ingredients:

Tablet core: Calcium Carbonate, Pregelatinised Starch, Sodium Croscarmellose, Silicon Dioxide, Magnesium Stearate, Stearic Acid.

Tablet coating: Hypromellose, Purified Talc, Spectracoat Purple (Anthocyanin (E163), Titanium Dixoide (E171), Hypromellose, Citric Acid).

What these tablets look like

Principle Healthcare digestive relief tablets are pale purple oval biconvex film coated tablets. This product is available in 30, 60, 90 pack sizes.

Not all pack sizes may be marketed.


Traditional Herbal Registration Number: THR 02231/0004 Registration holder for this product:

The Herbal Research Company Limited, 27 Old Gloucester Street, London WC1N 3XX

Manufacturer of this product:

Honeywood Ltd, Edmonds Close, Denington Industrial Estate, Wellingborough, Northants, NN8 2QY

If you would like further information about this product please contact: Principle Healthcare Ltd., Millennium Road,

Airedale Business Centre, Skipton, North Yorkshire BD23 2TZ.

Email: enquiries@principlehealthcare.com. Tel. +44 (0) 1756 792600.


You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard Alternatively you can get a paper yellow card form from your GP’s surgery or pharmacy, or call free phone 0808 100 3352 (available 10am - 2pm Monday to Friday).

For a large print, Braille or audio version of this leaflet call 01756 792600.

This leaflet was last revised in August 2011.


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