ECHINAFORCE (ECHINACEA DROPS) - summary of medicine characteristics

1. NAME OF THE MEDICINAL PRODUCT

Echinaforce (Echinacea Drops)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml [= 0.905 g] of oral liquid contains:

860 mg of tincture from fresh Echinacea purpurea (L.) Moench herb (1:7.5–14.6).

Extraction solvent: Ethanol 65% v/v

and

45 mg of tincture from fresh Echinacea purpurea (L.) Moench root (1:7.1–12.5). Extraction solvent: Ethanol 65% v/v

1 ml is equivalent to 25 drops.

1 ml of tincture contains approximately 650 mg of ethanol (alcohol) equivalent to 13 ml of beer or 5.42 ml of wine.

For a full list of excipients, see Section 6.1.

Oral drops

Clear, olive-coloured liquid

4.1 Therapeutic indications

Traditional herbal remedy used for symptomatic relief of colds, influenza type infections and similar upper respiratory tract conditions.

4.2 Posology and method of administration

For oral use.

Adults, elderly and children over 12 years: 15 drops (0.6ml) 2–3 times daily in a small amount of water

Not recommended for use in children under 12 years of age (See section 4.4. Special warnings and precautions for use.)

Start at first signs of common cold. Do not use this product 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, to plants of the Asteraceae (Compositae) family or to any of the excipients.

Because of their immunostimulating activity, Echinacea extracts must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g. collangenoses, 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 stated dose.

Not recommended for use in children under 12 years of age because data is not sufficient and medical advice should be sought.

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 before using Echinacea.

This medicinal product contains 65 vol% ethanol (alcohol).

This corresponds to:

348 mg alcohol equivalent to 7.8 ml beer or 3.25 ml wine (15 drops)

162 mg alcohol equivalent to 4 m1 beer or 1.67 m1 wine (7 drops)

Harmful for those suffering from alcoholism. To be taken into account in pregnant, or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.

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.

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

4.6 Fertility, pregnancy and lactation

Data on a limited number (several hundreds) of exposed pregnancies indicate no adverse effects of Echinacea extracts 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.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended unless advised by a doctor.

Studies on the effects on fertility have not been carried out.

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.

This product contains alcohol (see Section 4.4 for details of alcohol content).

4.8 Undesirable effects

Hypersensitive 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 disseminata, erythema nodosum, immunothrombo­cytopenia, Evans Syndrome, Sjorgen 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 pharmacist should be consulted.

4.9 Overdose

5   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Has stimulatory effect on the immune system with increasing number of circulating leucocytes giving an increased phagocytic response for invading organisms.

5.2 Pharmacokinetic properties

No direct references found in literature search.

5.3 Preclinical safety data

Used in folk medicine for many years without any reports of side effects.

6.1. List of Excipients

Ethanol v/v 65%

6.2. Incompatibilities

None.

6.3. Shelf-Life

Unopened 3 years.

6.4 Special precautions for storage

Store below 25°C.

6.5. Nature and Content of Container

Amber glass bottle (type III soda lime glass conforming to Eur. Ph. standards) with:

1) two part dropper dispenser polyethylene tamper proof cap seal and screw cap,

2) three part dropper dispenser polypropylene screw cap with polyethylene tamperproof seal and dropper insert.

(All components comply with the appropriate regulations and with confirmed volume delivery)

Pack sizes: 15ml, 50ml, 100ml and 200ml

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

A.Vogel Ltd

2 Brewster Place,

Irvine

KA11 5DD

8. MARKETING AUTHORISATION NUMBER(S)

PL 13668/0002

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

9th September 1997