Gerard House Echinacea Cold And Flu Relief
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Brunei Healthcare Manufacturing Ltd, William Nadin Way Swadlincote, Derbyshire, De11 0BB Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228328
Product: Global Tech Holdings
Echinacea Cold and Flu Relief Leaflet THR 20894/0062
Size: 140mm x 150mm (fold to 39x140mm with 2mm lip size)
Sides: 2 sided
Colour: Black
Code: P10909
Pharmacode: 304
Version: BRU007
Date 27/9/2011
Page 1 of 2
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Read all of this leaflet carefully because it contains important information for you.
This product is available without prescription; however, you still need to use this product carefully to get the best results from it.
Keep this leaflet as you may need to read it again. Ask your doctor, pharmacist or healthcare practitioner if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 10 days.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What the 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 is this product and what is it used for?
This product contains:
• Echinacea purpurea root extract
These tablets are a traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections based on traditional use only.
2. Before you take this product
This product is not suitable for children under 12 years of age.
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
• any of the other ingredients of this product.
(See section 6 further information).
or if you suffer from:
• frequent allergic reactions such as hives (urticaria), eczema, asthma
• the infection: tuberculosis
• connective tissue disease with formation of clumps of cells (sarcoidosis) mainly occurring in the lymph nodes, lungs and liver
• auto-immune diseases such as inflammation of the connective tissue (collagenosis) or multiple sclerosis
• conditions which decrease your natural response to infection (eg HIV infection or AIDS)
• are on therapy to reduce your natural response to infection (immunosuppression eg: chemotherapy or radiotherapy for cancer; history of organ or bone marrow transplant)
• blood disorders involving the white blood cell system such as low white cell count due to bone marrow disorders (agranulocytosis) or blood cell cancer (leukemias)
or if you are already taking immunosuppressant medication such as ciclosporin or methotrexate.
Take special care with this product:
• If there is a family history of allergic reactions.
• Because Echinacea can trigger auto-immune diseases.
Taking other medicines.
Please tell your doctor or pharmacist if you are taking medicines obtained without a prescription.
Pregnancy and breast feeding Do not take this product if you are pregnant or breast feeding, because there is no evidence that it is safe to do so.
3. How to take this product
Start at the first signs of a common cold.
Swallow the tablets whole with water.
Do not chew.
Adults, elderly and children over 12 years:
Take 1-2 tablets, twice a day.
Do not give to children under 12 years.
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Please check this proof on positioning, layout, text & spelling, claims, design issue, colour & size. Please check BBE/EXP positioning, Pcode, Barcode. Please make clear necessary modification.
Brunei Healthcare Manufacturing Ltd cannot be held responsible for errors that have been overlooked once this proof has been Signed for Approval & returned.
ARTWORK CREATED BY: JULIA ROSS ORIGINATION SOFTWARE: CORELDRAW X4
Brunei Healthcare Manufacturing Ltd, William Nadin Way Swadlincote, Derbyshire, De11 0BB Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228328
Product: Global Tech Holdings
Echinacea Cold and Flu Relief Leaflet THR 20894/0062
Size: 140mm x 150mm (fold to 39x140mm with 2mm lip size)
Sides: 2 sided
Colour: Black
Code: P10909
Pharmacode: 304
Version: BRU007
Date 27/9/2011
Page 2 of 2
140mm
<■
A
150mm
A
Do not exceed the stated dose.
Do not take this product for more than 10 days.
If the condition worsens or high fever occurs whilst taking the product or if symptoms persist for more than 10 days, see a doctor or pharmacist. If you take too many tablets by mistake, contact your doctor or pharmacist straight away.
4. Possible side effects
Like all medicines, this product 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
• 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 the product immediately if you experience any allergic reaction.
Association with auto-immune diseases has been reported such as:
• inflammation of the brain and spinal chord (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 eye with kidney tubular dysfunction (Sjogren Syndrome).
A decrease in the number of white blood cells (leucopenia) may occur in long term use (more than 8 weeks).
If you are concerned about any side effect, if a side effect becomes serious, or if you notice a side effect not listed in this leaflet, please tell your doctor, or healthcare practitioner.
5. How to store this product
Keep out of the reach and sight of children.
Do not use these tablets after the expiry date printed on the pack.
Do not store above 25oC.
Store in the original container.
6. Further information
Each film coated tablet contains the active ingredient: 71.5mg of extract (dry extract) from Echinacea purpurea root (6-7:1) (equivalent to 429 mg - 500 mg of Echinacea purpurea (L.) Moench, root)
Also contains: maltodextrin, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose, purified talc, vegetable carbon black (E153), copper chlorophyllin (E141), titanium dioxide (E171).
This product is available in pack sizes of 12, 30, 60, 120 and 180 tablets. Not all pack sizes are marketed.
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 freephone 0808 100 3352 (available 10.00am - 2.00pm Monday - Friday).
To request a copy of this leaflet in Braille,
Large Print or Audio.
Please call 0800 198 5000 (UK only)
Please be ready to give the following:
Product name: Echinacea Cold & Flu Relief Reference No: 20894/0062
THR holder and manufacturer is:
Brunel Healthcare Manufacturing Ltd.,
William Nadin Way, Swadlincote,
Derbyshire, DE11 0BB, U.K.
Text revised: August 2011.
THR 20894/0062
|
COLOUR LIST: |
1 | |
|
Black | ||
RADIUS
CORNERS:
WINDING
DIRECTION:
SUBSTRATE PRODUCT COLOUR
APPROVED:...........................
AMEND
REQUIRED:
DATE:...........................
Please check this proof on positioning, layout, text & spelling, claims, design issue, colour & size. Please check BBE/EXP positioning, Pcode, Barcode. Please make clear necessary modification.
Brunei Healthcare Manufacturing Ltd cannot be held responsible for errors that have been overlooked once this proof has been Signed for Approval & returned.
ARTWORK CREATED BY: JULIA ROSS ORIGINATION SOFTWARE: CORELDRAW X4