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Relieves symptoms of over-indulgence of drink and food

image descriptionThisilyn Milk Thistle Maximum Strength Capsules

193-261mg standardised fruit extract

30 capsules

Traditionally used for:

  • Over-indulgence of drink & food
  • Indigestion
  • Upset stomach
4.25 out of 5 based on 4 customer ratings
Rated 4.25 stars See reviews
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Thisilyn Milk Thistle is a traditional herbal medicinal product used to relieve the symptoms associated with occasional over indulgence of drink and food such as indigestion and upset stomach, exclusively based upon long-standing use as a traditional remedy. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal active
Milk Thistle (Silybum marianum (L.) Gaertner)
Strength
193-261mg of dried fruit extract (equivalent to 3.725-10.818 g of Milk Thistle fruits, corresponding to 108mg of silymarin calculated as silibinin)
Dose
One capsule up to twice daily

Thisilyn contains Milk Thistle, sometimes called Silybum marianum, an annual or biannual plant and member of the Asteraceae family. This fairly typical thistle has red to purple flowers and shiny pale green leaves with white veins. Originally a native of Southern Europe through to Asia, it is now found throughout the world.

A licensed herbal medicine means a safe, high quality product

Thisilyn Milk Thistle Maximum Strength Capsules have been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • Thisilyn is a regulated herbal product and meets specific standards of safety and quality
  • Thisilyn is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. Thisilyn’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that Thisilyn has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

Each pharmaceutical grade hard capsule is foil blister packed to retain its freshness and maintain its potency.

Adults and the elderly should take one capsule up to twice daily. Swallow the capsules whole with some water or other liquid. Do not chew the capsules. Not suitable for people under 18 years of age.

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

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe for more information about our company.

Also available from…

Boots, Holland & Barrett, Waitrose and other leading independent pharmacies and health food stores nationwide

About Milk Thistle

Milk Thistle is an extremely prickly plant. Its thorns or needles are reminiscent of sewing needles but are even thinner and sharper.

Visit Vitfacts.co.uk

About over-indulgence

Milk thistle is a well known herb in the UK and is used by people before, during and after heavy eating and drinking sessions.

Take a health check

Check out your dietary lifestyle using this simple questionnaire and get some useful tips on what might help.

What this product is and what it is used for

This product is a traditional herbal medicinal product containing Milk Thistle standardised fruit extract. Each capsule of this product contains 193mg – 261mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertn.) (equivalent to 3.725g – 10.818g of Milk Thistle fruits). This amount of standardised extract corresponds to 108mg of silymarin, calculated as silibinin. Extraction solvent : Acetone 95% v/v.

Thisilyn® Maximum Strength Milk Thistle is a traditional herbal medicinal product used to relieve the symptoms associated with occasional overindulgence of drink and food such as indigestion and upset stomach. This usage is based on traditional use only.

Before you take this product

DO NOT TAKE this product if you are:

  • under 18 years of age
  • pregnant or breast-feeding
  • allergic to any of the ingredients or to plants of the Asteraceae/Compositae family such as daisies, marigolds or artichokes (see section 6)

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

How to take this product

Adults and the elderly

Take 1 capsule up to twice daily. Swallow the capsules whole with some water or other liquid. Do not chew the capsules.

Do not exceed the stated dose.

Do not give this product 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 your 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 you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

Possible side-effects

Like all medicines, this product can have side-effects, although the frequency is not known. These are listed below.

  • nausea or feeling sick
  • diarrhoea
  • upset stomach
  • headache
  • mild allergic skin reactions itching and/or skin rash, urticaria, hives, pruritis itching, anaphylaxis.

If these persist for more than a few days, or become troublesome, stop taking this product. These side-effects are often only temporary.

Stop taking this product immediately if you experience any allergic skin reaction.

Tell your doctor or pharmacist if you notice any other side-effect not mentioned.

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after one week, or if side-effects not mentioned in this leaflet occur.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. 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).

How to store this product

Do not use your capsules after the expiry date.

Return any out-of-date capsules to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Store the capsules in a cool dry place below 25° C.

Keep the capsules out of the reach and sight of children.

Keep your capsules in the blister pack until it is time to take them.

Further information

Each hard capsule of this product contains 193 mg – 261 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertn.) (equivalent to 3.725 g – 10.818 g of Milk Thistle fruits).
This amount of standardised extract corresponds to 108 mg of silymarin, calculated as silibinin. Extraction solvent: Acetone 95% v/v.

This product also contains the following ingredients:

Extract excipients: mannitol

Capsule contents: mannitol, cellulose microcrystalline, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate.

Capsule shell: gelatin, purified water, titanium dioxide E171, sodium lauryl sulphate, iron (III)-oxide E172 (= red iron oxide), iron oxide hydrate E172 (= yellow iron oxide).

Each pack contains 21, 28, 30, 56, 60 or 90 hard capsules.

Not all pack sizes may be marketed.

Registration holder for this product

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park, Dedmere Road, Marlow, Bucks SL7 1PD
Manufacturer of this product
Wiewelhove GmbH,
Dörnebrink19, 49479 Ibbenbüren, Germany

Traditional herbal registration number:

THR 23056/0010

If you would like further information about this product, please contact:

SchwabePharma(UK)Ltd
AlexanderHouse, Mere Park, Dedmere Road, Marlow, Bucks, SL7 1PD
Telephone: 01628 401 980
Email:info@schwabepharma.co.uk

This leaflet was prepared in August 2010

1 Name of the medicinal product

  • Thisilyn® Maximum Strength Milk Thistle capsules
  • Higher Nature Milk Thistle capsules
  • boots Max Strength Digestion Relief Milk Thistle capsules
  • Healthspan Milk Thistle Capsules

2 Qualitative and quantitative composition

Each hard capsule contains:

193 mg – 261 mg of extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner)(equivalent to 3.725 g – 10.818 g of Milk Thistle fruits) corresponding to 108 mg of silymarin, calculated as silibinin.

Extraction solvent: Acetone 95% v/v.
For full list of excipients, see section 6.1

3 Pharmaceutical form

Hard capsule.
Red, opaque, hard gelatin capsule.

4 Clinical particulars

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly
Take 1 capsule up to twice daily. The capsules should be swallowed whole with some water or other liquid. The capsules should not be chewed.

Children and adolescents under 18 years of age
This medicine is not recommended for children and adolescents under 18 years of age (see Section 4.4 Special warnings and precautions for use).

4.3 Contraindications

Hypersensitivity to Milk Thistle or to plants of the Asteraceae (Compositae) family or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Patients suffering from active liver disease should consult their doctor before taking the product.

Milk Thistle may alter the way that certain drugs are broken down by the liver (see Section 4.5 Interaction with other medicinal products and other forms of interaction).

The use in children and adolescents under 18 years of age is not recommended as there is no relevant indication.

If symptoms worsen or persist a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

In vitro, Milk Thistle extract resulted in inhibition of CYP isoenzymes. However, the clinical relevance of these findings is not established.

4.6 Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

No studies of the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Gastrointestinal reactions (nausea, upset stomach, diarrhoea), headache, allergic reactions (urticaria, skin rash, pruritis, anaphylaxis).

The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

No cases of overdose have been reported.
Supportive and symptomatic treatment should be provided as appropriate.

5 Pharmacological properties

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Milk Thistle extract was not mutagenic in the mammalian murine micronucleus
test.

Tests on reproductive toxicity and carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

Extract excipients
Mannitol

Capsule contents:
Capsule filling mass:
Mannitol
Cellulose microcrystalline
Croscarmellose sodium
Silica, colloidal anhydrous
Magnesium Stearate

Capsule shell:
Gelatin
Purified water
Titanium dioxide E171
Sodium lauryl sulphate
Iron (III)-oxide E172 (= red iron oxide)
Iron oxide hydrate E172 (= yellow iron oxide)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Thisilyn Maximum Strength Milk Thistle capsules are packed in PVC/ PVDCaluminium blisters and inserted into a carton.

Original packages contain 21, 28, 30, 56, 60 or 90 hard capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 Registration holder

Schwabe Pharma (UK) Ltd
Alexander House
Mere Park
Dedmere Road
Marlow
Buckinghamshire
SL7 1PD

8 Registration number

THR 23056/0010

9 Date of first registration authorisation

1st October 2010

10 Date of revision of the text

5th April 2011

4 reviews for Thisilyn Milk Thistle Maximum Strength Capsules

  1. 5 out of 5

    :

    Relieved my swollen ankles within 6 weeks.

  2. 3 out of 5

    :

    It is very good for liver protection.

  3. 5 out of 5

    :

    Brilliant – I’ve been taking this product for just 4 days and feel a whole lot better.

  4. 4 out of 5

    :

    I find taking Thisilyn Max Strength during the Christmas party season very helpful in relieving upset stomach caused by over-doing it!

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