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Echinaboost Film-Coated Tablets

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EchinaBoost Tablets PIL 2015 (5986-03) 25/02/2015 19:52 Page 1

5: How to store this product

Do not use your tablets after the expiry date.

Return any out-of-date tablets to your pharmacist who will dispose of them for you.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 your 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) equivalent to 243-279 mg Echinacea purpurea root (Echinacea purpurea L. Moench). Extraction solvent: Ethanol 45% V/V.

This product also contains the following ingredients:

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 oi Tablet coating: hypromellose, macrogol.

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

Not all pack sizes may be marketed.

Registration holder for this product

Certification

Mark


Pharbio Medical International AB, Box 715,

THR'


SE 194 27 Upplands, Vasby, Sweden

Manufacturer for this product

Cederroth International Production Paramedical A/S,

Vassingerodvej 3-7, DK-3540 Lynge, Denmark.

Traditional herbal registration number: THR 15525/0009

If you would like further information about this product, please contact the UK distributor:

Schwabe Pharma (UK) Ltd

Alexander House, Mere Park, Dedmere Road, Marlow, Bucks SL7 1FX Telephone: 01628 401980 Email: info@schwabepharma.co.uk This leaflet was revised 02/2015

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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.

1: What this product is and what it is used for............................page 1

2: Before you take this product..........................................pages 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) 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.

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 autoimmune 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 e.g. anaphylactic reactions

Taking Echinacea containing products may trigger autoimmune 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.

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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 allergic reactions (anaphylactic shock). Echinacea can trigger allergic reactions in patients who have a tendency to develop allergic conditions

Association with autoimmune 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 (immunothrombocytopenia)

Destruction of blood cells by antibodies (Evans Syndrome)

Dryness in the mouth and eyes with renal 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 your 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 mentioned 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.