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Vocalzone Pastilles

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Informations for option: Vocalzone Pastilles, show other option

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Vocalzone Throat Pastilles

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Levomenthol    1.07% w/w

Peppermint Oil    0.54% w/w

Myrrh Tincture    1.3 9% 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.

PHARMACOLOGICAL PROPERTIES

5


5.1    Pharmacodynamic properties

Soothing and astringent to mucous membranes

5.2    Pharmacokinetic properties

Not applicable

5.3    Preclinical safety data

None

Pharmaceutical Particulars 6.1. List of Excipients

Sucrose

Glucose, Liquid Crystal Tex 85 Vegetable Oil Carnauba Wax Vegetable Carbon (E153)

Liquorice Extract Purified Water

6.2    Incompatibilities

None known

6.3    Shelf life

36 months as packaged for sale

6.4    Special precautions for storage

Store below 25°C.

6.5    Nature and contents of container

24 pastilles packed in blisters of 250 p PVC & 20 p aluminium foil.

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Kestrel Medical Limited

Kestrel House

7 Moor Road

Broadstone

Dorset

BH18 8AZ

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 18955/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26th October 2001

10 DATE OF REVISION OF THE TEXT

16/12/2014