VITABIOTICS ECHINACEA TABLETS - summary of medicine characteristics

Vitabiotics Echinacea Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains 200 mg of extract (as dry extract) from Echinacea purpurea root. (Equivalent to 1200–1600 mg of Echinacea purpurea (L.) Moench, root).

Extract Solvent Ethanol 75% v/v

For full list of excipients, see section 6.1.

Film coated tablet

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

Start at first signs of a common cold.

Adults, elderly and children over 12 years:

Take 1 tablet twice a day.

Swallow the tablets whole with some water or other liquid.

Do not chew the tablets.

Do not take this product for more than ten days.

If symptoms worsen, or persist for more than ten days or you get a high fever, consult your doctor or qualified healthcare practitioner.

This product is not recommended for use in children under 12 years (see section 4.4 special warnings and precautions for use)

4.3 Contraindications

Hypersensitivity to the active substance or to 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 condition worsens 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.

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

There is a possible risk of allergic reactions in sensitive individuals. Those patients should consult their doctor before using Echinacea.

This product is not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.

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 the effects on fertility have not been performed

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 (skin rash, urticaria, swelling of the face) may occur. Cases of severe hypersensitivity reactions such as Stevens-Johnson Syndrome, angioedema of the skin, Quincke edema, bronchospasm with airway obstruction, asthma and anaphylactic shock) may occur.

Echinacea can trigger allergic reactions in atopic patients.

Association with autoimmune diseases (encephalitis disseminata, erythema nodosum, immunothrombo­cytopenia, Evans Syndrome, Sjögren syndrome with renal tubular dysfunction) cannot be excluded.

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 (www.mhra.gov.uk/yellowcard).

4.9 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 2001/83/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

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.

Tests on reproductive toxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract

Maltodextrin

Colloidal anhydrous silica

Tablet Core

Maltodextrin

Microcrystalline cellulose

Sodium croscarmellose

Stearic Acid

Magnesium Stearate

Colloidal Anhydrous Silica

Tablet Coating

Hypromellose

Glycerol

Titanium Dioxide (E171)

Copper chlorophyllin

6.2 Incompatibilities

None known.

6.3 Shelf life

2 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

Tablets are packed into PVC foil backed blisters

Pack sizes: 30’s, 60’s, 90’s

Not all pack sizes may be marketed

6.6 Special precautions for disposal No special requirements.

7 MARKETING AUTHORISATION HOLDER

Vitabiotics Limited

1 Apsley Way

London

NW2 7HF

8 MARKETING AUTHORISATION NUMBER(S)

THR 00387/0058