SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Echinaboost film-coated tablets

Herbal Classics Echinacea Cold Relief film-coated tablets EchinaCold Echinacea Cold & Flu Relief tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains:

30 mg of extract (as dry extract) equivalent to 243-279 of Echinacea purpurea root (Echinacea purpurea L. Moench).

Extraction solvent: Ethanol 45% V/V.

Excipient(s): One tablet contains lactose monohydrate 7 mg, glucose 16-19 mg and isomalt 371.5 mg

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablets

Round, biconvex, beige to brown tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of common cold and influenza type infections based on traditional use only.

4.2    Posology and method of administration

For oral short term use only.

The tablets can be chewed or swallowed whole.

Adults, elderly and children over 12 years:

2 to 3 tablets 3 times a day.

Maximum: 9 tablets per day.

Paediatric population

This tablet formulation is not recommended for children below 12 years.

Start at first signs of common cold.

Echinaboost should not be used for more than 10 days.

If symptoms worsen during the use of the product or persist for more than 10 days, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or to other plants of the Asteraceae (Compositae) family or to any of the excipients.

Because of its immunostimulating activity, Echinacea must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g.: collagenoses, multiple sclerosis), immunodeficiencies (e.g.: HIV infection, AIDS), immunosuppression (e.g.: oncological cytostatic therapy, history of organ or bone marrow transplant), diseases of the white blood cell system (e.g.: agranulocytosis, leukemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms worsen or high fever occurs during the use of the product, or if symptoms persist for more than 10 days, a doctor or qualified healthcare practitioner should be consulted.

There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea.

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

Since the tablet contains lactose monohydrate, glucose and isomalt (see section 6.1) patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate.

4.6 Pregnancy and lactation

In the absence of sufficient data the use in pregnancy and lactation is not recommended.

Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date, no other relevant epidemiological data are available. The potential risk for humans is unknown.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Hypersensitivity reactions (rash, urticaria, Stevens-Johnson Syndrome, angioedema of the skin, Quincke oedema, bronchospasm with obstruction, asthma and anaphylactic shock) may occur (see section 4.4). Echinacea can trigger allergic reactions in atopic patients.

Association with autoimmune diseases (encephalitis disseminata, erythema nodosum immunothrombocytopenia, Evans Syndrome, Sjogren syndrome with renal tubular dysfunction) has been reported. Leucopenia may occur in long-term use (more than 8 weeks).

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No case of overdose has been reported. However, due to the isomalt content, overdoses may result in diarrhoea.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2    Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3    Preclinical safety data

Tests on reproductive toxicity, genotoxicity and on carcinogenicity have not been performed with Echinacea purpurea root extracts.

6.1 List of excipients

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

Do not store above 25 °C

Nature and contents of container

Each cardboard    carton    of 40    tablets consists    of 2 x    20    foil    strip blister packs

Each cardboard    carton    of 60    tablets consists    of 3 x    20    foil    strip blister packs

Each cardboard    carton    of 80    tablets consists    of 4 x    20    foil    strip blister packs

Not all pack sizes may    be marketed.

6.6 Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

PHARBIO MEDICAL INTERNATIONAL AB BOX 715

SE-194 27 UPPLANDS VASBY SWEDEN

8    MARKETING AUTHORISATION NUMBER(S)

THR 15525/0009

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 19/11/2010

10 DATE OF REVISION OF THE TEXT

25/03/2015