0® Do's & Don'ts

2. Before you take this product

Do not use this product

For children 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 in this product (see section 6)

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 breast-feeding.

If you are taking another medicine which is affected by alcohol.

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)

You should also know

This medicinal product contains 65 vol °/o ethanol (alcohol), i.e. up to 348 mg per 15 drop dose, eguivalent to 7.8 ml beer (less than a tablespoon) or 3.25 ml wine (less than a teaspoon).

If you suffer from alcoholism the alcohol content of this product may be harmful.

If you are in a high risk group (patients with liver disease or epilepsy) you should consider the alcohol content before taking this product.

^ Using

3. How to take this product

Adults, elderly and children over 12 years: Take 15 drops (0.6 ml) in a little water 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.

•    Overdose of this product may result in alcohol intoxication and should be treated accordingly (see section 2 'You should also know').

If you forget to take this product

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

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 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 frequency 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.

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. Store below 25°C.

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

It should be a clear liquid that is olive in colour.

6.    Further Information

What this product contains

1 ml of oral liquid contains the tinctures of:

Fresh Echinacea herb    860 mg

(Echinaceapurpurea (L.) Moench) (1:7.514.6). Extraction solvent: ethanol 65% v/v Fresh Echinacea root    45 mg

(Echinacea purpurea (L.) Moench) (1:7.112.5). Extraction solvent: ethanol 65% v/v 1 ml of Echinaforce is equivalent to 25 oral drops.

The other ingredients used for the liquid are ethanol.

What this product looks like and the contents of the pack

Echinaforce Echinacea Drops is a clear liquid that is olive in colour.

This product is available in 15 ml, 50 ml and 100 ml bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder and Batch Release:

Bioforce (UK) Ltd,

2 Brewster Place,

Irvine, Ayrshire, UK KA11 5DD Manufacturer:

Bioforce AG, CH-9325, Roggwil Switzerland

PL No. 13668/0002

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 Echinacea Drops.

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).

Echinaforce Drops PIL UK variation RFI Aug 2012.indd 2