PATIENT INFORMATION LEAFLET

Food Supplement Company Cold & Flu Echinacea Tablets

Echinacea purpurea root extract 75 mg

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 qualified healthcare practitioner.

What is in this leaflet?

1.    What Food Supplement Company Cold & Flu Echinacea is and what it is used for

2.    Before you take Food Supplement Company Cold & Flu Echinacea

3.    How to take Food Supplement Company Cold & Flu Echinacea

4.    Possible side effects

5.    How to store Food Supplement Company Cold & Flu Echinacea

6.    Further information

1. What Food Supplement Company Cold & Flu Echinacea is and what it is used for

What Food Supplement Company Cold & Flu Echinacea Is

This product is a traditional herbal medicinal product containing Echinacea purpurea root extract. Each film coated tablet contains 75 mg of extract (as dry extract) from Echinacea purpurea root (equivalent to 225mg-450mg of Echinacea purpurea (L.) Moench, root). Extraction Solvent: Ethanol 45% w/w.

What Food Supplement Company Cold & Flu Echinacea Is used for

Food Supplement Company Cold & Flu Echinacea Is a traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza (flu) type infections based on traditional use only.

2. Before you take Food Supplement Company Cold & Flu Echinacea

X Do not take this product if you:

•    Are pregnant or breastfeeding

•    Are allergic to Echinacea or products from the same plant family: (Asteraceae/Compositae) such as daisies, marigolds or artichokes or any of the other ingredients of this product (see section 6 further information).

•    Are under the age of 12 years

•    Suffer from frequent allergic reactions such as hives (urticaria) eczema, 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 conditions such as inflammation of the connective tissue (collagenoses), or multiple sclerosis

•    Suffer from conditions which decrease your resistance to infection (eg HIV or AIDS)

•    Are undergoing therapy to decrease your natural response to infection eg 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)

Take special care with this product:

•    If there is a family history of allergic reactions

•    As it may trigger an autoimmune response Taking other medicines:

Tell your doctor or pharmacist before use if you are taking any other medicines, including those obtained without a prescription or you have any autoimmune conditions.

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

3. How to take Food Supplement Company Cold & Flu Echinacea

Adults (over the age of 12 years) and the elderly:

Take 1-2 tablets twice a day. Start at the first signs of a common cold.

Swallow the tablet whole with some water or other liquid. Do not chew.

Do not take this medicine for more than 10 days. If your symptoms worsen, if high fever develops or if symptoms persist for more than 10 days, consult your doctor or 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. Do not take a double dose to make up for it.

4. Possible side effects

Like all medicines, this product can have 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 this product Immediately If you experience any allergic reaction.

Association with autoimmune diseases has been reported 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 (Sjorgen’s syndrome)

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

If you experience any side effect not mentioned above, or any side effect mentioned above becomes serious, please tell your doctor or pharmacist.

5. How to store Food Supplement Company Cold & Flu Echinacea

X Do not use your tablets after the expiry date.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. The expiry date is printed on the box and the blister.

! Keep the tablets out of the sight and reach of children.

✓    Do not store above 25°C. Store in the original packaging.

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

6. Further information

Active ingredient: Each film coated tablet contains 75 mg of extract (as dry extract) from Echinacea purpurea root (equivalent to 225mg-450mg of Echinacea purpurea (L.) Moench, root). Extraction Solvent: Ethanol 45% w/w.

This product also contains the following ingredients:

Herbal extract: Maltodextrin, Colloidal Anhydrous Silica.

Tablet core: Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Anhydrous Silica, Magnesium Stearate, Stearic Acid.

Tablet coating: Hypromellose, Iron Oxide Red (E172), Iron Oxide Black (E172), Titanium Dioxide (E171), Purified Talc.

What these tablets look like

Food Supplement Company Cold & Flu Echinacea tablets are pale pink circular biconvex film coated tablets. This product is blister packed and available in 30, 60, 90 pack sizes. Not all pack sizes may be marketed.

Registration holder for this product:

The Herbal Research Company Limited, 27 Old Gloucester Street, London WC1N 3XX

Traditional Herbal Registration Number: THR 02231/0001 Manufacturer of this product:

Honeywood Ltd., Edmonds Close, Denington Industrial Estate, Wellingborough, Northants, NN8 2QY.

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

FSC Food Supplement Company, Lancaster Road, Carnaby, Bridlington, East Yorkshire, Y015 3QY Email: info@beehealth.com Tel. +44 (0)1262 607890 and Fax. +44(0)1262 424012

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday-Friday).

For large print, Braille or audio version of this leaflet call 01262 607890.

This leaflet was last revised in September 2010.

THR’

Certification Mark fsc-pci29

Meclica

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