ECHINEEZE ECHINACEA TABLETS
Active substance(s): ECHINACEA ROOT DRY EXTRACT / ECHINACEA ROOT DRY EXTRACT / ECHINACEA ROOT DRY EXTRACT
Echinacea purpurea root extract 70mg
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use this product carefully to get the
best results from it.
Keep this leaflet. 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
4. Possible side effects
2. Before you take this product
5. How to store this product
3. How to take this product
6. Further information
WHAT THE PRODUCT IS AND WHAT IT IS USED FOR
This product is a traditional herbal medicinal product used to relieve the symptoms of the common cold and
influenza type infections based on traditional use only.
Each tablet contains 70mg of extract (as dry extract) from Echinacea purpurea root equivalent to 460 - 530mg
of Echinacea purpurea (L.) Moench root.
Extraction solvent: ethanol 30%v/v.
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:
o If there is a family history of allergic reactions.
o Because Echinacea can trigger auto-immune diseases.
o If your condition worsens, or you get a high fever while using this product, or symptoms continue for more
than 10 days, see your doctor or qualified healthcare practitioner.
o Do not exceed stated dose.
Taking other medicines.
Please tell your doctor or pharmacist if you are taking medicines obtained without a prescription.
Do not take this product if you are already taking immunosuppressant medication such as ciclosporin or methotrexate.
Pregnancy and breastfeeding.
Do not take this product if you are pregnant or breastfeeding, because there is no evidence that it is safe to do so.
PATIENT INFORMATION LEAFLET
HOW TO TAKE THIS PRODUCT
Adults, Elderly and Children over 12 years : Swallow 1 tablet 3 times a day. This means a maximum daily dose
of 210mg Echinacea purpurea extract, equivalent to between 1380mg and 1590mg Echinacea purpurea root.
Start at the first signs of a common cold. Do not use 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 10 days.
Not suitable for children under the age of 12 years.
If you take too much of this product (overdose)
There are no reports of any adverse effects of overdosing, but if you may have taken more than you should and
feel unwell, talk to a doctor or qualified healthcare practitioner as soon as possible.
If you forget to take this product.
Do not take a double dose to make up for a forgotten dose. Take the next dose when it becomes due.
If you stop taking this product.
There are no reported adverse effects associated with stopping this product, however if you feel unwell talk to
a doctor or qualified healthcare practitioner as soon as possible.
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 (anaphalactic shock).
Echinacea can trigger allergic reactions in patients who have a tendency to allergic reactions.
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).
Stop taking the product immediately if you experience any allergic reaction.
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.
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.
HOW TO STORE THIS PRODUCT
Keep out of the reach and sight of children.
Do not store the tablets in a place where the temperature goes above 250C.
Do not use this product after the expiry date which is stated on the side of the label. The expiry date refers to
the last day of that month.
Do not use this product if you notice any unusual discolouring or softening of 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.
Each tablet contains 70mg of dry ethanolic extract equivalent to 460 – 530mg Echinacea purpurea root. It also contains
other non-active ingredients. These ingredients are: Herbal extract: Maltodextrin; Silica colloidal hydrated. Tablet core:
Calcium hydrogen phosphate dihydrate; Cellulose microcrystalline; Silica colloidal hydrated; Crosscarmellose sodium and
Magnesium stearate. This product is available in packs of 30, 60, 90, and 120 tablets (not all sizes may be marketed).
Registration number: THR 33336/0002
Traditional Herbal Registration Holder and Manufacturer:
Natures Aid Ltd., St Georges Park, Preston, Lancs. PR4 2DQ
Tel: 01772 686231; Fax: 01772 671688; e mail: firstname.lastname@example.org
This leaflet was last approved in 02/2014
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.