What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: .

GeloRevoice Throat Lozenges

PATIENT INFORMATION LEAFLET

GeloRevoice Throat Lozenges

Dear Patient,

Please read the following leaflet carefully, as it contains important information that you should keep in mind, when using this medical device. If you have any questions, please contact your doctor or pharmacist.

In this leaflet:

1. Instructions for use
2. Intended purpose
3. Mode of action
4. Contraindications and warnings
5. Side effects
6. Method and duration of administration
7. Notes and information on shelf life

Instructions for use

GeloRevoice Throat Lozenges contain:

xanthan, carbomer, sodium hyaluronate.

Other ingredients: mannitol, sodium hydrogen carbonate, xylitol, citric acid, macrogol, aspartame, flavour (cherry, menthol), potassium monohydrogen phosphate, zinc stearate, silica.

Contents: 20 lozenges

Intended purpose:

GeloRevoice Throat Lozenges provide effective protection of the mouth and throat lining (mucous membranes), which can be irritated by many factors, including:

  • voice overuse,
  • impaired nasal breathing (e.g. due to colds),
  • dry air caused by heating or air-conditioning systems,
  • pollen allergy (hay fever),
  • smoking.

Such factors may result in hoarseness, throat irritation, tickly throat and dry mucous membranes, leading to a sore throat. GeloRevoice Throat Lozenges provide a coating that protects the mucous membranes from further irritants.

Mode of action:

When dissolved, GeloRevoice Throat Lozenges form a special hydrogel complex containing hyaluronic acid. This complex adheres well to the mucous membranes, where it forms a protective film over irritated areas. Due to their special composition of minerals and a slight effervescent effect, the lozenges cause intense stimulation of saliva flow. This is very important to provide a constant distribution of the hydrogel complex within the mouth and throat region. Irritated areas can regenerate, thereby alleviating symptoms such as hoarseness, throat irritation, tickly throat and dry mucous membranes, which lead to sore throat. GeloRevoice Throat Lozenges have a pleasantly mild cherry and menthol flavour.

Contraindications and warnings:

Do not use GeloRevoice Throat Lozenges, if you are allergic to any of the ingredients. The lozenges are not recommended for use in patients suffering from severely impaired saliva flow (e.g. Sjoegren’s syndrome). Patients suffering from phenylketonuria (a hereditary metabolic disorder), should keep in mind that GeloRevoice Throat Lozenges contain aspartame as a sweetening agent. Do not consume GeloRevoice Throat Lozenges simultaneously with other medicines used in the mouth and throat region. Do not use the lozenges while lying down, e.g. at bedtime, due to the risk of choking.

Points to consider in children:

Do not use in children below 6 years of age.

Points to consider during pregnancy and breast-feeding:

There is no data available, contradicting the use of GeloRevoice Throat Lozenges during pregnancy and breast-feeding.

Other points to consider in certain patient groups:

Patients on a low-salt diet should remember that 1 GeloRevoice Throat Lozenge contains 3.2 mmol sodium.

Side effects:

If used excessively, GeloRevoice Throat Lozenges may have a laxative effect and/or cause gastrointestinal complaints.

Method and duration of administration:

Instructions for using GeloRevoice Throat Lozenges:

Let GeloRevoice Throat Lozenges dissolve slowly until completely disintegrated, in order to ensure the entire development of the hydrogel complex as well as its complete dispersion. The lozenges must not be chewed or swallowed whole.

How often should you use GeloRevoice Throat Lozenges?

You can take one GeloRevoice Throat Lozenge several times a day as needed, e.g. every 2 – 3 hours. Up to 6 tablets a day can be used. We recommend consuming GeloRevoice Throat Lozenges after some food.

How long can you use GeloRevoice Throat Lozenges?

GeloRevoice Throat Lozenges can be used over prolonged periods or for intermittent therapy. If your acute symptoms (e.g. fever, swollen throat, aching limbs) get worse or do not improve within 3 days, please consult your doctor.

Notes and information on shelf life:

Do not use GeloRevoice Throat Lozenges after the expiry date.

Storage instructions:

Store GeloRevoice Throat Lozenges below 25°C in a dry place. Always carefully reseal the aluminium tube after removing the lozenges.

Store medical devices in a safe place. Keep out of the reach and sight of children.

G. Pohl-Boskamp GmbH & Co. KG
Kieler Strasse 11
25551 Hohenlockstedt
Germany
Tel.:+49 (0)48 26 / 59-0
Fax:+49 (0)48 26 / 59-109
Website:www.pohl-boskamp.de

Date of information: June 2011

225780025/1