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Zipvit Echinacea Cold And Flu Tablets

Document: leaflet MAH BRAND_THR 42574-0001 change

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PATIENT

INFORMATION LEAFLET

Healthsense

EchinaSHIELD

COLD AND FLU TABLETS

Health '‘Sense

Echinacea purpurea root extract 70mg

Please read this entire leaflet carefully before you take this product as it contains important information for you. Keep this leaflet. You may need to read it again.

This medicine is available without prescription. However, you still need to use this product carefully to get the best results from it.

If you have further any questions ask your doctor, pharmacist, or qualified healthcare practitioner.

You should consult your doctor or a qualified healthcare practitioner if:-The symptoms worsen during the use of the product, You experience a high fever, You notice any side effects not listed in this leaflet, Any of the side effects listed in this leaflet become serious

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.

1.    What EchinaSHIELD is and what it is used for?

EchinaSHIELD Cold and Flu 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:

•    Are allergic to Echinacea or products from the same plant family: (Asteraceae/Compositae) such as Daisies. Marigolds or Artichokes.

•    Are allergic to any of the other ingredients of this product. (See section 6 further information).

•    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 and liver.

•    Suffer from auto-immune diseases such as inflammation of the connective tissue (collagenosis) or multiple sclerosis.

•    Suffer from conditions which decrease your natural response to infection (e.g. HIV infection or AIDS)

•    Are on therapy to reduce your natural response to infection (immunosuppressant e.g.: chemotherapy or radiotherapy for cancer; history of organ or bone marrow transplant).

•    Suffer from blood disorder involving the white blood cell system such as low white cell count due to bone marrow disorders (agranulocytosis) or blood cell cancer (leukaemias).

•    Are already talking immunosuppressant medication such as ciclosporin or methotrexate.

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

Take special care with EchinaSHIELD:

If there is a family history of allergic reactions, there is a risk of developing serious allergic reactions to Echinacea (e.g. anaphylactic reactions).

Patients should be aware that taking products containing Echinacea can trigger auto-immune diseases.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking medicines obtained without a prescription.

Do not take EchinaSHIELD if you are already taking immunosuppressant medication such as ciclosporin or methotrexate.

Pregnancy and Breast-Feeding

Do not take this product if you are pregnant or breast-feeding., as there is no evidence that it is safe to do so.

THR Certification Mark

3. How To Take This Product

For Oral Use

Adults elderly and children over 12 years: Take 1 tablet three times a day.

Start taking at the first sign of a common cold. Do not take EchinaSHIELD for more than 10 days.

Do not exceed stated dose. See your doctor or qualified healthcare practitioner if your condition worsens, you get a high fever while using this product or symptoms persist for more than 10days.

EchinaSHIELD is not suitable for children under the age of 12 years.

If you take too much EchinaSHIELD (overdose):

if you have taken more than you should and feel unwell, talk to your

doctor or a qualified healthcare practitioner as soon as possible.

If you forget to take this product:

Continue to take your usual dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

4. Possible Side Effects

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

The frequency of the side effects is not known.

The possible side effects include:

•    Allergic reactions such as swelling, hives, or rashes.

•    Swelling of the skin due to fluid

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

•    Swelling of the facial area (Quinke's oedema)

•    Shrinking of the airways of the lungs with obstruction (bronchospasm)

•    Asthma and life threatening reactions (anaphylactic shock)

Echinacea can trigger allergic reactions in patients who have a tendency to allergic reactions.

Stop taking this product immediatley is you experience any allergic reactions.

Association with auto-immune diseases has been reported such as:

•    Inflammation of the brain and spinal chord (disseminated encephalitis)

•    Low Platelet count (immunothrombocytopenia)

•    Painful lumps on the shins (erythema nodosum)

•    Destructionof blood cells by antibodies. (Evans Syndrome)

•    Dryness in the mouth and eye with kidney tubular dysfunction (Sjogren's Syndrome).

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

If any of the side effects become serious, or if you notice a side effect not listed in this leaflet, please tell your doctor, pharmacist or qualified healthcare practitioner.

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 GP's surgery or pharmacy, or call free phone 0808 100 3352 (available 10am-2pm Monday - Friday)

5.    How to Store EchinaSHIELD

Keep out of the reach and sight of children.

Do not store above 25 °C.

Store in Orginal Packaging.

Do not use EchinaSHIELD after the expiry date which is stated on the label after EXP The expiry date refers to the last day of that month.

Do not use this product if you notice a change in appearance in the tablets as this may mean that they have deteriorated.

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.

6.    Further Information

Each flim coated tablet contains 70mg of extract (as dry extract) from Echinacea purpurea root, (equivalent to 420mg to 560mg of Echinacea purpurea (L.) Moench root. )

It also contains other non-active ingredients.

Extract :- Maltodextrin, Colloidal Anhydrous Silica.

Tablet Core :- Calcium hydrogen phosphate, Cellulose Microcrystalline , Magnesium Stearate, Colloidal Anhydrous Silica,

Table Coating:- Hypromellose, Titanium Dioxide E171, Glycerol, Talc.

For Large Print, Braille or audio Formats Please Contact 01253501520 EchinaSHIELD is available in packs of 30, 60, 90 and 120 tablets.

Not All Packs sizes may be marketed.

Registration number: THR 42574/0001

Traditional herbal registration holder and manufacturer:

Nutrition Group,

Olympic Way,

Blackpool,

FY4 4QE, UK Tel: 01253 832650

Distributed By Olympic Way Blackpool,

Lancashire FY4 4QE

This Leaflet was last updated July 2013