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 Echinacea or any of the other ingredients of this product.

•    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 Echinaforce Hot Drink Concentrate is and what it is used for

Echinaforce Hot Drink Concentrate is a traditional herbal medicinal product used to relieve the symptoms of cold and flu. This is based on traditional use only.

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2. What you need to know before you take Echinaforce Hot Drink Concentrate

Do not take Echinaforce Hot Drink Concentrate

•    If you are under 12 years of age.

•    If you are allergic to

Echinacea or plants of the daisy (Asteraceae/ Compositae) family.

Echinacea is a member of the daisy family.

Any of the other ingredients of this product (listed in section 6).

•    If you have a tendency to allergies such as hives, allergic eczema or asthma see your doctor before taking this product. It 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 ciclosporin 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 disorder 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)

Echinaforce Hot Drink Concentrate contains sucrose and ethanol

•    If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this product.

•    This product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

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3. How to take Echinaforce Hot Drink Concentrate

To be made into a hot drink by diluting in hot water before use.

If you take more Echinaforce Hot Drink Concentrate than you should

•    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 Echinaforce Hot Drink Concentrate

•    Do not worry about a missed dose. Take the next dose as usual.

If you feel Echinaforce Hot Drink Concentrate is not working

Stop taking this product and see your doctor:

•    If you have a high temperature (fever).

•    If your symptoms worsen or if you do not feel an improvement within 10 days.

•    Side effects not mentioned in this leaflet occur.

If you have any further questions on the use of this product ask your doctor or pharmacist.

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Side effects

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 spots (hives)

These are often short-lived and should go away by themselves. However if they are troubling you, talk to your doctor or pharmacist.

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 of the above side effects is not known. This means it is not known how often these reactions occur as there have 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.

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 via the Yellow Card Scheme at: www. m h ra .g ov. u k/y el I o wca rd

By reporting side effects you can help provide more information on the safety of this medicine.

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Echinaforce Hot Drink P!L UK Variation Apr 2016.indd 2

Information

5.    How to store Echinaforce Hot Drink Concentrate

Keep this product out of the sight and reach of children.

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

Store below 25 C.

Use within 1 month of opening.

After opening, store in the refrigerator (below 8 C).

Do not use this product if you notice a change in appearance. The oral solution should be dark red to dark violet in colour.

6.    Contents of the pack and other information

What Echinaforce Hot Drink Concentrate contains

5 ml of concentrate contains 1,140 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench herb (1:12-13) and 60 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench root (1:11-12). Extraction solvent: Ethanol 65% V/V.

The other ingredients used are sucrose, purified water, concentrated elderberry juice, citric acid monohydrate, modified starch, medium-chain triglycerides, potassium sorbate and ethanol.

What Echinaforce Hot Drink Concentrate looks like and contents of the pack

Echinaforce Hot Drink Concentrate is a dark red to dark violet viscous liguid. It is available in 100 ml bottles.

Traditional Herbal Registration Holder and Manufacturer

Traditional Registration Holder and Batch Release:

Bioforce (UK) Ltd,

2 Brewster Place,

Irvine, Ayrshire, KA11 5DD - UK Tel: 01294 277344 enguiries@avogel.co.uk

Manufacturer:

Bioforce AG, CH-9325, Roggwil Switzerland

THR 13668/0031

This leaflet was revised on 04/2016.

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 Hot Drink Concentrate.

You should also know

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

E-mail: enquiries@avogel.co.uk Phone: 0845 608 5858

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

Call this number: 0845 608 5858.

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