ECHINAFORCE SORE THROAT SPRAY - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Echinaforce Sore Throat Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

863.3 mg of tincture from fresh Echinacea purpurea (L.) Moench herb (1:12–13). Extraction solvent: Ethanol 65% V/V.

45.5 mg of tincture from fresh Echinacea purpurea (L.) Moench root (1:11–12). Extraction solvent: Ethanol 65% V/V.

430.0 mg of tincture from fresh Sage leaves (Salvia officinalis L. folium) (1:17–18). Extraction solvent: Ethanol 68% V/V.

1 spray □ 0.22 ml

Excipients:

1 ml contains a maximum of 407 mg sorbitol, 370 mg ethanol (alcohol), 20 mg of soy lecithin and 5 mg sucrose laurate.

For a full list of excipients, see section 6.1.

Oromucosal spray, solution.

Brown to yellow-green, clear liquid

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve sore throats associated with coughs, colds and flu, based on traditional use only.

4.2 Posology and method of administration

For oromucosal administration

Adults and the elderly:

2 sprays six to ten times daily to the back of the throat.

The use in children and adolescents under 18 years of age is not recommended (see section 4.3 ‘Contraindica­tions’).

Method of administration:

Remove the cap from the bottle and fit the nozzle onto the cap. Replace the cap gently but firmly onto the bottle.

Before using the product for the first time activate the spray by pressing the pump 2–3 times.

To use the spray, shake the bottle well, place the nozzle just inside the mouth and point it towards the back of the throat. Press the pump to spray.

Do not use the product for more than 7 days. If symptoms worsen during the use of the product or persist for more than 7 days, a doctor or qualified healthcare practitioner should be consulted (see section 4.4 ‘Special warnings and precautions for use’).

4.3 Contraindications

Hypersensitivity to the active substances, plants of the Asteraceae (Compositae) family or to any of the excipients.

Patients with a history of significant allergy or difficulties swallowing or breathing.

This product contains soy lecithin. If you are allergic to peanut or soya, do not take this product. Refer to Section 2, Qualitative and Quantitative Composition for soya content.

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), immunodeficiences (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).

Children and adolescents under 18 years.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Do not use and consult your doctor if you have difficultly swallowing or breathing, if sore throat is severe and is accompanied by high fever, headache, nausea or vomiting.

Avoid contact with eyes.

If the symptoms worsen during the use of the product, or if symptoms persist for more than 7 days, a doctor or qualified healthcare practitioner should be consulted.

There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should not use this product.

This product contains 38 – 42 vol % ethanol (alcohol).

This corresponds to:

Up to 163 mg alcohol equivalent to 3.7 ml beer or 1.5 ml wine (2 sprays)

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

This product contains soy lecithin and should not be used by patients who are allergic to peanut or soya.

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Refer to Section 2, Qualitative and Quantitative Composition for sorbitol content.

4.5 Interaction with other medicinal products and other forms of interaction The product should not be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate.

The intake of Sage leaf preparations might influence the effect of medicinal products acting via GABA receptor (e.g. barbiturates, benzodiazepines), even if not seen clinically. Therefore the concomitant use with such medicinal products is not recommended.

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

The safety of this product during pregnancy and lactation has not been established, therefore 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.

Safety during pregnancy and lactation has not been established for Salvia extracts.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

4.8 Undesirable effectsCommon (>1/100 to <1/10)

4.9 Overdose

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 carcinogenicity have not been performed with Echinaforce Sore Throat Spray.

Echinacea purpurea showed no toxicity in single dose toxicity (rodents) and repeated-dose toxicity (rodents).

The Echinaforce extract contained in Echinaforce Sore Throat Spray has been shown to be non-mutagenic in Salmonella typhimurium reverse mutation assay up to a dose of 5000 pg/plate. Tests on reproductive toxicity and carcinogenicity have not been performed.

The Sage extract contained in Echinaforce Sore Throat Spray has also been shown to be non-mutagenic in Salmonella typhimurium reverse mutation assay up to a dose of 5000 pg/plate. Tests on reproductive toxicity and carcinogenicity have not been performed.

6.1 List of excipients

Sucrose laurate

Soy lecithin

Ethanol

Peppermint oil

Sorbitol, liquid (non crystallising)

6.2 Incompatibilities

Not known.

6.3 Shelf life

Unopened:

30 months

After first opening the container:

2 months

6.4 Special precautions for storage

This product does not require any special storage conditions.