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Package Leaflet: Information for The User

Esberelief ® t ablets

Wild indigo root,

Echinacea purpurea root,

Echinacea pallida root,

White cedar tips and leaves

In this leaflet:

1.    What Esberelief® is and what it is used for

2.    Before you take Esberelief®

3.    How to take Esberelief®

4.    Possible side effects

5.    How to store Esberelief®

6.    Further information

1. What Esberelief® is and what it is used for

Esberelief^® is a traditional herbal medicinal product used to relieve the symptoms of the common cold, such as cough, catarrh, sore throat, runny or blocked nose, based on traditional use only.

2. Before you take Esberelief®

2.1 Do not take Esberelief® if you

•    are allergic to any of the active ingredients or plants of the Asteraceae/Compositae family such as daisies, marigolds or artichokes

•    are allergic to any of the other ingredients (see section 6)

•    are under 12 years of age _ • are pregnant or breast feeding

^u • suffer from frequent allergic reactions such as _m hives (urticaria), eczema, asthma

•    suffer from the infection tuberculosis

^a • suffer from connective tissue disease with formation of clumps of cells (sarcoidosis) mainly ^u occurring in the lymph nodes, lungs and liver

•    suffer from auto-immune diseases such as inflammation of the connective tissues (collagenosis) or multiple sclerosis

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

•    suffer from 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)

•    are already taking immunosuppressant medication such as ciclosporin or methotrexate

•    are on therapy to reduce your natural response to infection (immunosuppression) e.g. chemotherapy or radiotherapy for cancer, history of organ or bone marrow transplant

While you take this medicine, see your doctor if you

experience shortness of breath, high temperature

or discoloured sputum.

Tell your doctor before you take this product if you have an intolerance to some sugars (see section 6).

2.2    Take special care with Esberelief^®

•    if there is a family history of allergic reactions

•    because Echinacea can trigger auto-immune diseases

If your symptoms last for more than 10 days or get worse you must see your doctor.

2.3    Taking other medicines

Please tell your doctor, pharmacist or qualified healthcare practitioner if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without prescription.

2.4    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.

2.5    Driving and using machines

This product is not likely to affect your ability to drive or use machines.

2.6    Important information about some of the ingredients of Esberelief^®

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each tablet contains 170.6 mg lactose monohydrate and 91.5 mg of sucrose.

3. How to take Esberelief®

Remember to always take this medicine with a glass of water. The tablets should be swallowed whole and not chewed. You should check with your doctor, pharmacist or qualified healthcare practitioner if you are not sure.

3.1 How much Esberelief^® to take

The usual treatment time is 10 days. If your symptoms worsen or persist for more than 10 days, see your doctor or pharmacist.

3.2    Adults, the elderly and children over 12 years

Take 5 tablets three times a day. Start at the first signs of a common cold. The tablets should be taken at regular intervals, in the morning, in the middle of the day and in the evening. You do not need to take the tablets with meals. Do not give to children under 12 years of age. Do not exceed the stated dose.

3.3    If you take more Esberelief® than you should

This usually will not have any side effects. Continue to take the usual dose at the usual time. If you have accidentally taken a lot of this medicine you may get more side effects or any side effects may get worse. You must talk to your doctor.

3.4 If you forget to take Esberelief®

Continue to take your usual dose at the usual time. Never take a double dose to make up for a missed dose. If you have any further questions about taking this medicine, please ask your doctor, pharmacist or qualified healthcare practitioner.

4. Possible side effects

Like all medicines, Esberelief® can cause side effects,

although not everybody gets them. The frequency

is not known. Possible side effects are:

•    Allergic reactions such as swelling, hives or rashes

•    Swelling of the skin due to fluid

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

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

•    Asthma and life threatening allergic reactions (anaphylactic shock)

•    Gastrointestinal disorders (abdominal pain, vomiting, diarrhoea, nausea)

•    Dizziness

Echinacea can trigger allergic reactions in patients who have a tendency to allergic reactions. Stop taking the product immediately if you experience an allergic reaction.

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

•    inflammation of the brain and spinal cord (disseminated encephalitis)

•    painful lumps on the shins (erythema nodosum)

•    low blood platelet count (immunothrombo-cytopenia)

•    destruction of blood cells by antibodies (Evans syndrome)

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

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

5. How to store Esberelief®

Keep out of the reach and the sight of children. Do not use the tablets after the expiry date on the carton and the blister strip. The expiry date is the last day of that month. Store the tablets in a cool, dry place below 30° C. Keep them in the blister package until it is time to take them.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6. Further Information

What Esberelief® contains

Each tablet contains:

3.2 mg of extract (as dry extract) (4-9:1) from Wild indigo root (Baptisia tinctoria (L.) R.Br.), Echinacea purpurea root (Echinacea purpurea (L.) Moench), Echinacea pallida root (Echinacea pallida (Nutt.) Nutt. White cedar tips and leaves (Thuja occidental's L.) (4.92:1.85:1.85:1). Extraction solvent: ethanol 30 % v/v.

The other ingredients are:

Lactose monohydrate, Magnesium stearate, Macrogol 6000, Sucrose

What Esberelief® looks like and contents of the pack

Esberelief® is a beige-brown, round tablet. Esberelief® comes in blister packs of 60, 100 or 200 tablets.

Not all pack sizes may be marketed.

Traditional Herbal Registration Holder and Manufacturer

Traditional Herbal Registration Holder:

Schaper & Brummer GmbH & Co.KG,

Bahnhofstr. 35, 38259 Salzgitter, Germany.

Manufacturer:

Schaper & Brummer GmbH & Co.KG,

Bahnhofstr. 35, 38259 Salzgitter, Germany.

UK and Channel Islands Distributor:

tml:health Hamilton House PO Box 8014 Reading RG6 9DB

info@esberelief.co.uk

This leaflet was last revised in October 2014.

Stop taking this product immediately if you experience allergic reactions.

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.

For a large print, Braille or audio version of this leaflet, please contact:

Schaper & Brummer GmbH & Co.KG, Bahnhofstrasse 35, 38259 Salzgitter, Germany

THR 26548/0002 certification mark