Echinaboost Film-Coated Tablets
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Herbal Classics Echinacea Cold Relief film-coated tablets
Echinacea purpurea root extract 30 mg
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Echinacea Cold Relief carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor or qualified healthcare practitioner if your symptoms worsen or do not improve after 1 0 days.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or qualified healthcare practitioner.
In this leaflet:
1. What Echinacea Cold Relief is and what it is used for
2. Before you take Echinacea Cold Relief
3. How to take Echinacea Cold Relief
4. Possible side effects
5. How to store Echinacea Cold Relief
6. Further information
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1. What Echinacea Cold Relief is and what it is used for
Echinacea Cold Relief is a traditional herbal medicinal product used to relieve the symptoms of common cold and influenza type infections, based on traditional use only.
The tablets contain an extract of Echinacea purpurea root.
For full details see section 6.
2. Before you take Echinacea Cold Relief
This product is not suitable for
Children under 12 years of age.
Do not take Echinacea Cold
Relief 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 Echinacea Cold Relief (listed in Section 6 below).
Or if:
• You have frequent allergic reactions such as hives, eczema or asthma.
• You have tuberculosis infection.
• You have a connective tissue disease with formation of clumps of cells (sarcoidosis) mainly occuring in the lymph nodes, lungs and liver.
• You have auto-immune diseases such as inflammation of the connective tissue (collagenosis) or multiple sclerosis.
• You have conditions which decrease your natural response to infection such as HIV infection or AIDS.
• You are on any treatment which lowers your natural response to infection (immunosuppression) such as chemotherapy or radiotherapy for cancer; or have had organ or bone marrow transplantation.
• You have any blood disorders involving the white blood cell system such as low white cell count due to bone marrow disorders (agranulocytosis) or blood cell cancer (leukaemia).
• You are already taking other medicines which lower your immune system (immunosuppressants) such as ciclosporin or methotrexate.
This product contains lactose monohydrate, glucose and isomalt. If you have been told by your doctor that you have an intolerance to some sugars do not take Echinacea Cold Relief.
Take special care with Echinacea Cold Relief
• If there is a family history of allergic reactions.
• Because echinacea can trigger auto-im-mune diseases.
Taking other medicines
Please tell your doctor or qualified healthcare practitioner if you are taking any other medicines.
Pregnancy and breast-feeding Do not take Echinacea Cold Relief if you are pregnant or breast-feeding, because there is no evidence that it is safe to do so. Ask your doctor or pharmacist for advice before taking any medicine.
3. How to take Echinacea Cold Relief
For oral short term use only.
Take Echinacea Cold Relief as advised in this leaflet. You should check with your doctor or qualified healthcare practitioner if you are not sure.
Do not exceed the stated dose.
Chew the tablet or swallow it whole with water.
Adults, elderly and children over 12 years
Take 2 to 3 tablets 3 times a day.
Do not take more than 9 tablets a day.
This tablet formulation is not intended for children under 12 years.
Start your treatment at the first signs of common cold.
Do not use for more than 1 0 days.
Contact your doctor or qualified healthcare practitioner if your symptoms worsen or do not improve after 1 0 days, or if a high fever occurs.
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If you take more Echinacea Cold Relief than you should
If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you. Because of the sugar content taking too much Echinacea Cold Relief may cause diarrhoea.
If you forget to take Echinacea Cold Relief
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 forgotten tablets.
If you have any further questions on the use of this product, ask your doctor or a qualified healthcare practitioner.
4. Possible side effects
Like all medicines, Echinacea Cold Relief
can cause side effects, although not everybody gets them.
The frequency of the side effects is not
known.
The possible side effects include:
• Skin rash.
• Red, itchy skin (hives).
• Swelling of the skin due to fluid (angioedema).
• Swelling of the face (Quincke's oedema).
• Blistering of the skin and mucous membranes (Stevens-Johnson Syndrome).
• Difficulty in breathing (broncospasm with obtruction).
• Asthma and life threatening reactions
(anaphylactic shock).
Echinacea Cold Relief can trigger allergic reactions in patients who have a tendency to allergic reactions.
Stop taking Echinacea Cold Relief immediately if you experience any allergic reaction.
Association with diseases of the immune system (autoimmune diseases) have been reported with the use of echinacea such as:
• Inflammation of the brain and spinal chord (disseminated encephalitis).
• Painful lumps on the shins (erythema nodosum).
• Low blood platelet count (immuno-thrombocytopenia).
• Destruction of blood cells by antibodies (Evans Syndrome).
• Dryness in the mouth and eyes 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).
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 Echinacea Cold Relief
Do not store above 25°C.
Keep out of the reach and sight of children.
Do not use Echinacea Cold Relief after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Take medicines no longer required to your pharmacist who will dispose of them. These measures will help to protect the environment.
6. Further information
What Echinacea Cold Relief contains
• Each film-coated tablet contains 30 mg of extract (as dry extract) equivalent to 243-279 mg of Echinacea purpurea root [Echinacea purpurea
L. Moench).
Extraction solvent: Ethanol 45% V/V.
• The other ingredients are:
Extract excipients: lactose monohydrate, cellulose, colloidal anhydrous silica. Tablet core: isomalt, liquorice dry extract, talc, glucose (in liquorice dry extract), microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, levomenthol, eucalyptus oil, anise oil, fennel oil, clove oil.
Tablet coating: hypromellose, macrogol.
What Echinacea Cold Relief looks like and contents of the pack
The film-coated tablets are round, biconvex and beige to brown.
Pack sizes: 40, 60, 80 tablets in blisters. Not all pack sizes may be marketed.
Traditional Herbal Registration Holder
Pharbio Medical International AB,
Box 715, SE-194 27 Upplands Vasby, Sweden.
Telephone: +46 8 590 963 00 E-mail: regulatory@cederroth.com
Manufacturer
Cederroth International Production Paramedical A/S,
Vassingerodvej 3-7, DK-3540 Lynge, Denmark.
Manufactured for
NBTY Europe Limited,
Nuneaton, Warwickshire CV10 7RH, UK
This leaflet was last approved in February 2015
CERTIFICATION MART