SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Healthsense EchinaSHIELD Cold and Flu Tablets Zipvit Echinacea Cold and Flu Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains 70mg of extract (as dry extract) from Echinacea purpurea Root, (equivalent to 420 to 560mg of Echinacea purpurea (L.) Moench root.)

Extraction Solvent: Ethanol 75% v/v.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet.

White, round, biconvex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2 Posology and method of administration

For oral administration

Adults, elderly and children over 12 years: take one tablet three times a day.

The use in children or adolescents under 18 years of age in not recommended (see section 4.4 special warnings and precautions for use)

Swallow tablets whole with water

Start at first signs of common cold.

Duration of Use

Do not use the medicinal product for more than 10 days.

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

4.3 Contraindications

Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family or to any other 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, leukaemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

The use of this product in children or adolescents under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.

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

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 Fertility, 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.

Studies on fertility have not been preformed

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 edema, bronchospasm with obstruction, asthma and anaphylactic shock) may occur.

Echinacea can trigger allergic reactions in atopic patients.

Association with autoimmune diseases (encephalitis disseminate, 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.

Overdose

No case of overdose has been reported.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Not Required as per article 16c(1)(a)(iii) of directive 2001/83EC as Amended

5.2    Pharmacokinetic properties

Not Required as per article 16c(1)(a)(iii) of directive 2001/83EC as Amended

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Herbal Extract

Maltodextrin

Colloidal Anhydrous Silica Tablet Core

Calcium hydrogen phosphate Cellulose Microcrystalline Magnesium Stearate Colloidal Anhydrous Silica

Tablet Coating

Hypromellose

Titanium Dioxide (E171)

Glycerol

Talc

Incompatibilities

None known.

6.3 Shelf life

3 Years

6.4 Special precautions for storage

Do not store above 25 °C.

Store in the original packaging

6.5 Nature and contents of container

White PET Pot with heat-seal and a white tamper evident LDPE closure in a printed cardboard outer carton containing patient information leaflet.

Pack sizes of 30, 60, 90, and 120.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Nutrition Group plc Olympic Way BLACKPOOL FY44QE UK

8    MARKETING AUTHORISATION NUMBER(S)

THR 42574/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/11/2011

10    DATE OF REVISION OF THE TEXT

01/10/2015