LEAFLET SPEC

PATIENT INFORMATION LEAFLET

HOLLAND ft BARRETT

ECHINACEA COLD & FLU RELIEF EFFERVESCENT TABLETS Dried juice of Echinacea purpurea herb I76mg

Important notes

U Please read this leaflet carefully before you start taking these tablets: It contains some important information about Holland & Barrett Echinacea Cold & Flu Relief effervescent tablets.

U 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 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

U Suffer from conditions which reduce your immunity to infection such as HIV infection or AIDS

U Are on therapy which reduces your resistance to infection such as cancer drug treatment or radiotherapy, history of organ or bone marrow transplant U Suffer from blood disorders involving the white blood cells count due to bone marrow disorders (agranulocytosis) or leukaemia

U Are taking immunosuppressant medicines such as ciclosporin or methotrexate U Are under 12 years of age

TAKE SPECIAL CARE with this product U Do not exceed the stated dose U If you are prone to allergies, there is a risk of developing serious allergic reactions to Echinacea e.g. anaphylactic reactions U Taking Echinacea containing products may trigger autoimmune diseases U This product contains I7.05mmol (or 392mg) sodium per tablet. This should be taken into consideration by patients on a sodium controlled diet

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

This product is a traditional herbal medicinal product containing Echinacea purpurea herb.

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

2 - Before you take this product

Do not take this product if you:

U Are allergic to any of the ingredients or to plants of the Asteraceae/ Compositae family such as daisies, marigolds or artichokes (see section 6)

U Have a tendency to allergies such as hives, allergic eczema or asthma U Are pregnant or breastfeeding U Suffer from the infection tuberculosis U Suffer from connective tissue disease such as sarcoidosis

U Suffer from autoimmune diseases such as inflammation of the connective tissue (collagenoses) or multiple sclerosis

3 - How to take this product

Adults, elderly and children over 12 years of age: Take 1-2 effervescent tablets daily, dissolved in a glass of water (about 200ml). The dissolved tablet should be drunk immediately.

Start taking at the first sign of a cold or flu.

Do not take for longer than 10 days.

This product is not suitable for children under 12 years of age.

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: Do not

take a double dose to make up for a forgotten dose. It doesn’t matter if you miss a dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4 - Possible side-effects

Like all medicines, this product can have side-effects, although not everyone gets them. Stop taking this product and check with your doctor, pharmacist or qualified healthcare practitioner if any of the following side-effects occur:

Allergic (hypersensitive) reactions such as:

U Rash U Hives

U Inflammatory disorder of the skin (Stevens-Johnson Syndrome)

U Swelling of the skin due to fluid U Swelling of the facial area (Quincke’s oedema) U Shrinking of the airways in the lungs with obstruction (bronchospasm)

U Asthma and life-threatening allergic reactions (anaphylactic shock)

Echinacea can trigger allergic reactions in patients who have a tendency to develop allergic conditions. Association with autoimmune diseases has been reported such as:

U Inflammation of the brain and spinal cord (disseminated encephalitis)

U Painful lumps on the shins (erythema nodosum)

U Low blood platelet count (immunothrombocytopenia)

U Destruction of blood cells by antibodies (Evans Syndrome)

U 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. You must see your doctor or a qualified healthcare practitioner if your symptoms worsen, if you experience a high fever or your symptoms persist after 10 days. If any of these side-effects become troublesome, or if you notice side-effects not listed in this leaflet, please tell a doctor, pharmacist or qualified healthcare practitioner.

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.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5    - How to store this product

U Do not use your tablets after the expiry date U Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the tube and outer carton

U You can use these tablets up to 7 months after first opening the packaging U Store the tablets in a cool dry place U Keep the tablets out of the reach and sight of children

U Keep your tablets in the tube until it is time to take them

6    - Further information

Each effervescent tablet contains I76mg of dried pressed juice from fresh flowering Echinacea purpurea (L.) Moench herb (20-28:1) (equivalent to 3520 -4928mg of fresh flowering Echinacea purpurea (L.) Moench herb), which is the active ingredient.

This product also contains the following ingredients: Herbal preparation: Maltodextrin, precipitated silicon dioxide, citric acid monohydrate.

Tablet: Citric acid anhydrous, sodium hydrogen carbonate, maltodextrin, saccharin sodium, sodium cyclamate, ascorbic acid and citric flavour Permaseal 84260-51.

Each original pack contains 20 effervescent tablets.

Registration holder for this product

Swiss Caps GmbH,

Grassingerstrasse 9,

D-83043 Bad Aibling, Germany

Manufactured for:

NBTY Europe Limited by:

Swiss Caps GmbH, Grassingerstrasse 9,

D-83043 Bad Aibling, Germany Traditional herbal registration number:

THR 18397/0004

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

NBTY Europe Limited Regulatory Services Department Samuel Ryder House, Barling Way, Nuneaton Warwickshire, CVI0 7RH, United Kingdom Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 215 400

Fax: +44 (0) 2476 215 452

Email: customerservices@NBTYeurope.com

This leaflet was prepared on: 07/08/2014

CERTIFICATION MARK

HB ECHINACEA COLD & FLU LEAFLET

LEAFLET SIZE: 140mm x 180mm (flat)

45mm x 140mm (folded)

BLEED: N/A BULK: N/A ISSUE: 00A BARCODE: N/A

CHANGES FROM LAST PRINT: None

COLOURS:

K

P364

FONTS:

Gil Sans

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CAUTION: It is the vendors responsibility to print a scannable UPC code from either our artwork or your alternative UPC method

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More information on back panel