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Herbal Classics Echinacea Cold Relief Film-Coated Tablets

Document: leaflet MAH BRAND_THR 15525-0009 change

Patient Information Leaflet

EchinaBoost tablets

Echinacea purpurea root extract 30 mg

Please read this leaflet carefully before you start taking these tablets.

It contains some important information about EchinaBoost tablets.

Keep this leaflet with the tablets.

You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

What is in this leaflet:

1.

What this product is and what it is used for

Page 1

2.

Before you take this product

Page 1-2

3.

How to take this product

Page 2

4.

Possible side-effects

Page 3

5.

How to store this product

Page 3

6.

Further information

Page 4

1.

What this product is and what it is used for

This product is a traditional herbal medicinal product containing an extract of Echinacea purpurea root. Each film-coated tablet contains 30 mg of extract (as dry extract)(6.5:1) equivalent to 243-279 mg Echinacea purpurea root (Echinacea purpurea L. Moench). Extraction solvent: Ethanol 45% v/v.

EchinaBoost tablets 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. used to relieve the symptoms of common cold and influenza type infections based on traditional use only.

2. Before you take this product

DO NOT TAKE this product if you:

•    Are allergic to any of the ingredients or to plants of the Asteraceae/Compositae family such as daisies, marigolds or artichokes (see section 6)

•    Have a tendency to allergies such as hives, allergic eczema or asthma.

•    Are lactose intolerant (react badly to lactose or milk)

•    Are intolerant to some sugars - this product contains lactose monohydrate, glucose and isomalt

•    Are pregnant or breastfeeding

•    Suffer from the infection tuberculosis

•    Suffer from connective tissue disease such as sarcoidosis

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

•    Suffer from conditions which reduce your immunity to infection such as HIV

•    Are on therapy which reduces your resistance to infection in conditions such as cancer or radiotherapy, history of organ or bone marrow transplant

•    Suffer from blood disorders involving the white blood cells count due to bone marrow disorders (agranulocytosis) or leukaemia

•    Are taking immunosuppressant medicines such as ciclosporin or methotrexate.

TAKE SPECIAL CARE with this product

•    Do not exceed the stated dose

•    If you are prone to allergies, there is a risk of developing serious allergic reactions to Echinacea eg. anaphylactic reactions

•    Taking Echinacea containing products may trigger auto-immune diseases.

Echinaboost contains glucose, lactose monohydrate and isomalt

Echinaboost contains glucose, lactose monohydrate and isomalt. If you have been told by your doctor that you have an intolerance to some sugars, do not take this medicinal product.

3.    How to take this product

Adults, elderly and children over 12

Take 2-3 tablets 3 times daily. Chew the tablet or swallow it whole with water. Start taking at the first sign of cold or flu. Do not take for longer than 10 days.

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

If you take too much of this product (overdose)

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 of this product may cause diarrhoea.

If you forget to take this product

Do not take a double dose to make up for a forgotten dose. It doesn’t matter if you miss a dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4.    Possible side effects

Like all medicines, EchinaBoost tablets can have side effects, although not everyone gets them. Stop taking EchinaBoost and check with your doctor, pharmacist or qualified healthcare practitioner if any of the following side-effects occur:

Allergic (hypersensitive) reactions such as:

•    Rash

•    Hives

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

•    Swelling of the skin due to fluid

•    Swelling of the facial area (Quincke’s oedema).

•    Shrinking of the airways in 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

Association with autoimmune 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 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). The frequency is not known.

After taking this product

You must see a doctor or a qualified healthcare practitioner if your symptoms worsen, if you experience a high fever or your symptoms persist after 10 days.

If any of these side-effects become troublesome, or if you notice side-effects not listed in this leaflet, please tell your doctor, pharmacist or qualified 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.

5.    How to store this product

Do not use your tablets after the expiry date.

Return any outof-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Store the tablets in a cool dry place.

Do not store the tablets in a place where the temperature goes above 25°C.

Keep the tablets out of the sight and reach of children.

Keep the tablets in the blister pack until it is time to take them.

6.    Further information

Each film-coated tablet contains 30 mg of extract (as dry extract) (6.5:1) equivalent to 243-279 mg of Echinacea purpurea root (Echinaceapurpurea L. Moench). Extraction solvent: Ethanol 45% v/v.

This product also contains the following ingredients:

Isomalt, liquorice dry extract, glucose (in liquorice dry extract), talc, microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, , hypromellose, cellulose, levomenthol, eucalyptus oil, anise oil, fennel oil, macrogol, clove oil.

Each pack contains 40, 60 or 80 film-coated tablets.

Not all pack sizes may be marketed.

Registration holder for this product

Pharbio Medical International AB, Box 715, SE 194 27 Upplands Vasby, Sweden.

THR Logo and Certification Mark Manufacturer for this product

Cederroth International Production Paramedical A/S, Vassingerodvej 3-7, DK-3540 Lynge, Denmark. Traditional herbal registration number: THR 15525/0009

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