Patient leaflet - Silygalon Milk Thistle capsules
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 disorders as 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 allergic reaction which causes swelling of the face or throat).
The frequency of these side effects occurring 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. Contents of the pack and other information What Silygalon Milk Thistle contains
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 g - 8,215 g of Milk Thistle fruits). This amount of standardised extract corresponds to 108 mg of silymarin, calculated as silibinin.
Extraction solvent: Ethyl acetate > 96.5 % v/v
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:
Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer:
MADAUS GmbH, 51101 Cologne Germany
This leaflet was last revised in February 2019.
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