Package leaflet: Information for the user

Silygalon Milk Thistle capsules

Milk Thistle Standardised fruit extract

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

-    Keep this leaflet. You may need to read it again.

-    Ask your doctor, qualified healthcare practitioner or pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor, qualified healthcare practitioner or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to a doctor or qualified healthcare practitioner if you do not feel better, or if you feel worse after 1 week.

What is in this leaflet

1.    What Silygalon Milk Thistle is and what it is used for

2.    What you need to know before you take Silygalon Milk Thistle

3.    How to take Silygalon Milk Thistle

4.    Possible side effects

5.    How to store Silygalon Milk Thistle

6.    Further information

1. What Silygalon Milk Thistle is and what it is used for

This product is a traditional herbal medicinal product containing Milk Thistle standardised fruit extract. Each capsule contains 173.0 mg - 186.7 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertn.) (equivalent to 6,228 mg - 8,215 mg of Milk Thistle fruits)corresponding to 108 mg of silymarin, calculated as silibinin.

Extraction solvent: Ethyl acetate

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

2. What you need to know before you take Silygalon Milk Thistle Do not take Silygalon Milk Thistle:

-    if you are allergic to Milk Thistle, other plants of the Asteraceae (Compositae) family, such as daisies, marigolds or artichokes or to any of the other ingredients of this medicine (listed in section 6).

-    if you are under 18 years of age

-    if you are pregnant or breast feeding

Before you take this medicine

Talk to your doctor or pharmacist before taking Silygalon Milk Thistle if you suffer from active liver disease.

Other medicines and Silygalon Milk Thistle

Tell your doctor, qualified healthcare practitioner or pharmacist if you are taking, or have recently taken any other medicines, including any bought without a prescription.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines..

3.    How to take Silygalon Milk Thistle

Always take this medicine exactly as described in this leaflet or as your doctor, qualified healthcare practitioner or pharmacist has told you. Check with your doctor, qualified healthcare practitioner or pharmacist if you are not sure.

For oral use only.

Adults and the elderly

The recommended dose is 1 capsule 3 times daily.

Do not exceed the stated dose.

The capsules should be swallowed whole with water or some other liquid.

Duration of use

If your symptoms worsen, or do not improve after 1 week, you should consult your doctor or qualified healthcare practitioner.

If you take more Silygalon Milk Thistle than you should:

If you take too many tablets, consult your doctor or qualified healthcare practitioner as soon as possible.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you miss a dose

If you miss a dose, take the next dose when it’s due. Do not take a double dose.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects:

-    Gastrointestinal symptoms e.g. dry mouth, nausea (feeling sick), upset stomach, gastric irritation (such as bloated feeling, burning sensation after eating) and diarrhoea

-    Headache

-    Allergic reactions such as dermatitis, raised itchy rash, skin rash, pruritus (itching), asthma and anaphylaxis (serious allergicreaction which causes swelling of the face or throat).

The frequency of these side effects ocurring is not known.

In case of allergic reactions you should stop taking Silygalon Milk Thistle capsules and consult a doctor as soon as possible..

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 to 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 Silygalon Milk Thistle

Keep this medicine out of the sight and reach of children.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the blister/carton after “EXP”. The expiry date refers to the last day of that month.

6. Further information

What Silygalon Milk Thistle contains Each hard capsule contains:

-    The active substance is: 173.0 - 186.7 mg of standardised extract (as dry extract) from Milk Thistle fruits

(Silybum marianum (L.) Gaertner) (equivalent to 6,228 mg - 8,215 mg of Milk Thistle fruits). corresponding to 108 mg of silymarin, calculated as silibinin. Extraction solvent: Ethyl acetate

-    The other ingredients are:

Capsule contents: Microcrystalline cellulose, sodium starch glycolate, maize starch, magnesium stearate, sodium lauryl sulphate

Capsule shell: Gelatin, red iron oxide E 172, titanium dioxide E 171, black iron oxide E 172

What Silygalon Milk Thistle looks like and contents of the pack

Original packs of 30, 60 and 100 brown capsules. Not all pack sizes may be marketed.

Traditional Herbal Registration Holder:

Tenlec Pharma Ltd.

Hailsham, East Sussex BN271PQ United Kingdom

Manufacturer:

MADAUS GmbH, 51101 Cologne Germany

This leaflet was last revised in July 2016.

State details for providing a leaflet in large font or in Braille. THR logo and certification mark

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