Information

Important things you need to know

This product is used to relieve the symptoms of cold and flu.

Don't take this product if you are allergic to any of the ingredients: see section 6.

Before you take this product:

read section 2.

Dosage instructions: see

section 3.

Talk to your doctor if your symptoms worsen or do not improve within 10 days.

Side effects can rarely occur when using this product: see section 4.

Now read the rest of this leaflet carefully. Keep this leaflet. You may need to read it again.

1. What this product is for

Echinaforce Chewable is a traditional herbal medicinal product used to relieve the symptoms of:

Cold

Flu

This is based on traditional use only.

Echinaforce Chewable PIL UK Variation Submission Aug 2012.indd 1

2. Before you take this product

Do not take this product

If you are allergic to

Echinacea or plants of the daisy (Asteraceae/ Compositae) family Echinacea is a member of the daisy family

If you have a tendency to allergies such as hives, allergic eczema or asthma consult your doctor before use. This product may not be suitable for you.

If you are pregnant or breastfeeding.

If you are having treatment to reduce the response of your immune system (immunosuppression) e.g. chemotherapy, radiotherapy.

If you are taking dclosporin or methotrexate, or any other immunosuppressant medicine.

If you have had an organ or bone marrow transplant.

If you suffer from

TB (the infection tuberculosis)

Sarcoidosis (a connective tissue disease which causes the formation of clumps of cells mainly in the lymph nodes, lungs and liver)

An autoimmune disease such as collagenoses (inflammation of the connective tissue) or multiple sclerosis HIV, AIDS or any other condition which decreases your resistance to infection A disorder which affects your white blood cells such as agranulocytosis (low white blood cell count due to bone marrow disorders) or leukemia (blood cell cancer)

See your doctor first

If you have been told you have an intolerance to some sugars.

This product contains sorbitol and sucrose and may not be suitable for you.

(7 Using

3. How to take this product

Adults, the elderly and children over 12 years: Chew 2 tablets two to three times daily.

Not for use in children under 12.

Start taking this product at the first signs of a cold.

For oral use only. Do not take more than the recommended dose.

Do not take this product for a cold or flu for more than 10 days.

If you take too much

If you take too much and feel ill, talk to your doctor. Taking too much is unlikely to be harmful.

If you forget to take this product

Don't worry about the missed dose. Take the next dose as usual.

Please turn over...

If you feel this product isn't working

Stop taking this product and see your doctor:

If you have a high temperature (fever)

If your symptoms worsen or if you don't feel an improvement within 10 days

Adverse events not mentioned in the patient information leaflet occur

XXX

III

Echinaforce Chewable PIL UK

4. Possible side effects

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

Side effects

Allergic reactions

If you already suffer from allergies you may be more likely to get them. Allergic reactions which may occur are:

Skin rash

Red, itchy skin (hives)

Swelling of the skin due to fluid

(angioedema) or swelling of the face (Quincke's oedema)

Blistering of the skin and mucous membranes (Stevens-Johnson syndrome)

Difficulty in breathing (bronchospasm with obstruction)

Asthma or anaphylactic shock (a life-threatening allergic reaction)

Stop taking this product immediately if any of these occur. Seek medical advice and take this leaflet with you.

There have been isolated reports suggesting an association between Echinacea products and autoimmune diseases such as:

Inflammation 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 (Sjogren Syndrome)

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

The freguency is not known. This means it is not known how often these reactions occur as there has not been enough reports to allow this information to be calculated.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Information

5.    How to store this product

Keep out of the reach and sight of children.

Do not use this product after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Use within 2 months of opening.

Store in the original container to protect from moisture.

Do not use this product if you notice a change in appearance.

The tablets should be speckled and green in colour.

6.    Further Information

What this product contains

1 tablet contains 380 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench herb (1:12) and 20 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench root (1:11). Extraction solvent: ethanol 65% v/v.

The other ingredients used for the tablet are sorbitol, betadex, anhydrous colloidal silica, magnesium stearate and orange flavouring (containing sucrose).

What this product looks like and the contents of the pack

The tablets are round, speckled and green in colour. This product is available in packs containing 40, 80 and 120 tablets. Not all pack sizes may be marketed.

Traditional Herbal Registration Holder and Manufacturer

Traditional Registration Holder and Batch Release:

Bioforce (UK) Ltd,

2 Brewster Place,

Irvine, Ayrshire, UK KA11 5DD

Manufacturer:

Bioforce AG, CH-9325, Roggwil Switzerland

THR No. 13668/0015

Certification Mark

This leaflet was revised on 08/2012

What is Echinacea?

Echinacea is a plant which is native to America. The herb and root extracts of the Echinacea species, Echinacea purpurea, are combined to make Echinaforce Chewable.

You should also know

Bioforce runs a helpline by phone and email which can provide you with further information.

Email: enquiries@avogel.co.uk

Phone: 0845 608 5858

You can help to 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 doctor's surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday-Friday).

You can get a larger print or audio version of this leaflet.

Call this number:

0845 608 5858.

22/08/2012 11:56