a company of

KLOSTERFRAU

HEALTHCARE CROUP

THFT

Certification

Mark

Patient Information Leaflet

Cypar ®

Milk Thistle Capsules

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 or pharmacist has told you.

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

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not list-⁰ ed in this leaflet. See section 4.

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

What is in this leaflet

1.    What Cypar^® Milk Thistle is and what it is used for

2.    What you need to know before you take Cypar® Milk Thistle

3.    How to take Cypar® Milk Thistle

4.    Possible side effects

5.    How to store Cypar® Milk Thistle

6.    Contents of the pack and other information

1.    What Cypar® Milk Thistle is and what it is used for

This product is a traditional herbal medicinal product containing milk thistle standardised fruit extract. Cypar^® Milk Thistle Capsules is a traditional herbal medicinal product used to relieve the symptoms associated with occasional overindulgence of food and drink such as indigestion and upset stomach based on traditional use only.

2.    What you need to know before you take Cypar® Milk Thistle

Do not take Cypar^® Milk Thistle if

-    You are pregnant or breastfeeding

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

-    You are under 18 years of age

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

3.    How to take Cypar® MilkThistle

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and the elderly.

Take one capsule up to twice daily. Swallow the capsule whole with some water or other liquid. Capsules should not be chewed.

1

2

Do not exceed the stated dose.

Do not give this product to children or adolescents under 18 years old.

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

If you take more Cypar^® Milk Thistle than you should

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 Cypar^® Milk Thistle

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.

4. Possible side effects

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

The following side effects have been reported:

-    Dry mouth, nausea (feeling sick), upset stomach, gastric irritation such as bloated feeling, burning sensation after eating, diarrhoea and headache

If these persist for more than a few days or become more troublesome, stop taking the product. The side effects are usually only temporary.

-    allergic reactions such as dermatitis, itching and/or skin rash, urticaria, hives, pruritus, asthma and anaphylaxis - a severe allergic reaction causing difficulty in breathing, shortness of breath and requires

3

medical attention. If you experience an allergic reaction stop taking the product immediately.

The frequency is not known (frequency cannot be estimated from the available data).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not I isted in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: 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 Cypar® Milk Thistle

Do not use your capsules after the expiry date. The expiry date refers to the last day of that month.

The expiry date is printed on the box and the blister pack.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Q

Do not store above 25° C.

Store in original package.

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

CO

o

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

take them.

co

0

a

=3

O

o

2

6. Contents of the pack and other information What Cypar® Milk Thistle contains

The active substance is 193 mg - 261 mg of standardised extract (as dry extract) from milk thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 3.725 g - 10.818 g of milkthistle fruits). This amount of standardised extract corresponds to 108 mg of silymarin, calculated as silibinin. Extraction solvent: Acetone 95 % v/v.

The other ingredients are:

Extract excipient:

Mannitol

Capsule contents:

Mannitol, cellulose microcrystalline, crosscarmellose sodium, silica colloidal anhydrous, magnesium stearate.

Capsule shell:

Gelatin, purified water, titanium dioxide (E 171), sodium laurylsulfate, iron (III)-oxide (E 172) (red iron oxide), iron oxide hydrate (E 172) (yellow iron oxide).

Each pack contains 30 or 60 hard capsules. The capsules are red opaque.

Traditional Herbal Registration Holder

Cassella-med GmbH & Co.KG Gereonsmuehlengasse 1 50670 Cologne Germany

Manufacturer

Klosterfrau Berlin GmbH Motzener Strasse 41 12277 Berlin Germany

Traditional herbal registration number:

THR 29860/0007

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

Ceuta Healthcare Ltd.,

41 Richmond Hill,

BOURNEMOUTH BH2 6HS,

United Kingdom.

Telephone: 01202 780558

Fax: 01202 780559

Email.: info@ceutahealthcare.com

This leaflet was last revised in July 2016

For a large print, Braille or audio version of this leaflet, call Ceuta Healthcare Ltd. on 08006527150

Cassella-med GmbH is a company of the

KLOSTERFRAU

HEALTHCARE GROUP

4

5

6