Vocalzone Pastilles
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
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
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
29/06/2016