KESTRAL DRY THROAT RELIEF PASTILLES - summary of medicine characteristics

Summary of medicine characteristics - KESTRAL DRY THROAT RELIEF PASTILLES

1. NAME OF THE MEDICINAL PRODUCT

Kestrel Dry Throat Relief Pastilles

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Levomenthol 1.07% w/w

Peppermint Oil 0.54% w/w

Myrrh Tincture 1.39% v/w

3 PHARMACEUTICAL FORM

Pastille

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Relief of irritations due to excessive speaking, singing or smoking. Aid in soothing dry irritated throats which so often accompany the common cold.

4.2 Posology and method of administration

Adults, elderly and children over 12 years:-

Dissolve one pastille in the mouth and inhale deeply. Repeat every two hours if required.

Oral administration

4.3 Contraindications

Hypersensitivity to menthol, peppermint, myrrh (Commiphora) or any of the other ingredients

4.4 Special warnings and precautions for use

Keep out of the sight and reach of children.

If symptoms persist, consult your doctor.

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

4.5 Interaction with other medicinal products and other forms of interaction None known

4.6 Pregnancy and lactation

Pregnancy

There is no or inadequate evidence of the safety of menthol, peppermint oil or myrrh tincture in human pregnancy. The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

Lactation

It is not known whether the active ingredients of Vocalzone Throat Pastilles are excreted in human breast milk.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, bronchospasm/asthma, dyspnoea and rash have been reported very rarely with menthol-containing preparations.

Reporting of Side Effects

If you get any side effects, talk to your dentist, doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

4.9 Overdose

Symptoms of overdose are unlikely unless the product is taken grossly in excess of the recommended dose.

Treatment of symptoms and general supportive measures are recommended in case of acute overdose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Soothing and astringent to mucous membranes

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

None

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Glucose, Liquid

Modified Starch (Tapioca, Maize)

Vegetable Oil

Carnauba Wax

Colour E153 (Vegetable Carbon Black, Glucose Syrup, Sodium Benzoate E211)

Liquorice Extract

Purified Water

6.2 Incompatibilities