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VITABIOTICS

echinacea

tablets

WHAT IS IN THIS LEAFLET

1.    What this product is and what it is used for

2.    Before you take this product

3.    How to take this product

4.    Possible side effects

5.    How to store this product

6.    Further information

1. WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR

This is a traditional herbal medicinal product used to relieve symptoms of common cold and influenza type infections. This is based on traditional use only.

2. before you take this product

Do not take this product if you:

•    Are pregnant or breast-feeding

•    Are allergic to any of the ingredients (see section 6) or to Echinacea or any other members of the Asteraceae (Compositae) family such as daisies, marigolds or artichokes

•    Are under the age of 12 years

•    Have a tendency to hives, allergic eczema or asthma

•    Suffer from the infection tuberculosis

•    Suffer from connective tissue disease with formation of clumps of cells (sarcoidosis), mainly occurring in the lymph nodes, lungs or liver

•    Suffer from autoimmune diseases such as inflammation of the connective tissue (collagenosis), or multiple sclerosis

•    Suffer from conditions which decrease your resistance to infection (e.g. HIV or AIDS)

•    Are undergoing therapy to decrease your natural response to infection e.g. chemotherapy or radiotherapy for cancer; history of organ or bone marrow transplant

•    Suffer from blood disorders involving the white blood count system such as low white blood cell count due to bone marrow disorders (agranulocytosis) or blood cell cancers (leukaemia)

•    Do not use this product if you are taking any immunosuppressant medication such as ciclosporin or methotrexate.

Take special care with this product:

•    If there is a family history of allergic reactions, as it may trigger an autoimmune response.

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 refer to a qualified healthcare practitioner.

Taking other medicines:

• Tell your doctor or pharmacist before taking this medicine if you are taking other medicines.

3. how to take this product

Adults, the elderly and children over 12 years:

Take 1 to 2 tablets per day. Swallow the tablets whole with some water or other liquid. Do not chew. Start at the first signs of a common cold.

Do not take this product for more than 10 days.

If symptoms worsen, or persist for more than ten days, or you get a high fever, consult your doctor or a qualified healthcare practitioner.

Do not exceed the stated dose.

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.

4. possible side effects

Like all medicines, this product can have possible side effects. These are listed below:

•    Allergic skin reactions like swelling, hives or rashes

•    Swelling of the facial area (Quincke’s Oedema)

•    Swelling of the skin due to fluid

•    Shrinking of the airways in the lungs with obstruction (bronchospasm)

•    Asthma and life threatening allergic reactions (anaphylactic shock)

•    Echinacea can trigger allergic reactions in people with a tendency to develop allergic conditions. Stop taking the

product if you experience

any allergic reaction. VITABIOTICS

There have been reports suggesting an association with Echinacea and autoimmune diseases such as:

•    I nflammation of the brain and spinal cord (disseminated encephalitis)

•    Painful lumps on the shins (erythema nodosum)

•    Low blood platelet count (immunothrombocytopenia)

•    Destruction of blood cells by antibodies (Evans syndrome)

•    Dryness in the mouth and eyes with renal tubular dysfunction (Sjorgen’s syndrome)

A decrease in the number of white blood cells (leucopenia) may occur in long term use (longer than 8 weeks).

If any of the effects become troublesome or if you experience any other unexpected effects not listed in this leaflet, consult your doctor or a pharmacist.

You must speak to a qualfied healthcare practitioner if your symptoms worsen, if they do not improve after ten days, if you develop a high fever, or if any of the side effects become serious, or if you notice any side effects not mentioned in the leaflet.

If you would like further information about this product or for large print, Braille or audio version please contact:

Traditional Herbal Registration Holder:

Vitabiotics Ltd, 1 Apsley Way, London NW2 7HF Telephone: 020 8955 2662

Manufacturer:

Thompson & Capper Ltd, Hardwick Road,

Astmoor, Runcorn, Cheshire WA7 1PH.

Traditional Herbal Registration Number: THR 00387/0058

You can help 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 0800 100 3352 (available 10am - 2pm Monday - Friday).

This leaflet was revised in March 2012.

5.    how to store this product

Do not use your tablets after the expiry date. Return any out of date tablets to your pharmacist who will dispose of them. 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 sight and reach of children.

Keep your tablets in the packaging until it is time to take them.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    further information

Each film coated tablet contains 200mg of extract (as dry extract) from Echinacea purpurea root. (Equivalent to 1200mg - 1600mg of Echinacea purpurea (L.) Moench, root). Extraction Solvent: Ethanol 75% v/v

This product also contains the following ingredients:

Tablet core

Maltodextrin, Microcrystalline cellulose, Sodium croscarmellose, Stearic Acid, Magnesium Stearate, Colloidal Anhydrous Silica.

Tablet coating

Hypromellose, Glycerol, Titanium Dioxide (E171), Copper chlorophyllin.

Each pack contains green film coated oval biconvex tablets.

This product is available in 30, 60 and 90 film coated tablets. Not all pack sizes are marketed.