GURGELLÖSUNG-

GURGELLÖSUNG-ratiopharm

Important notes (mandatory information)

Gurgellösung-ratiopharm. Active ingredient: Dequalinium chloride 0.01%. Areas of application: for the supportive treatment of bacterial inflammation of the mucous membrane of the mouth and throat. Warning: Contains propylene glycol and macrogolglycerol hydroxystearate.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Gurgellösung-ratiopharm
Active ingredient: Dequalinium chloride 0.01%

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Gurgellösung-ratiopharm must be used as directed in order to be as effective as possible.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 3 days, you must see a doctor.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

This package leaflet includes

1. WHAT IS GURGELLÖSUNG-RATIOPHARM AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING GURGELLÖSUNG-RATIOPHARM?
3. HOW TO USE GURGELLÖSUNG-RATIOPHARM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GURGELLÖSUNG-RATIOPHARM?
6. FURTHER INFORMATION

1. WHAT IS GURGELLÖSUNG-RATIOPHARM AND WHAT IS IT USED FOR?

Gurgellösung-ratiopharm is an oral and throat therapeutic. Gurgellösung-ratiopharm is used for the supportive treatment of bacterial inflammation of the mucous membrane of the mouth and throat.

2. What you need to know before using Gurgellösung-ratiopharm?

Gurgellösung-ratiopharm must not be used:

• if you are hypersensitive (allergic) to dequalinium chloride, propylene glycol, cinnamon (cinnamaldehyde) or any of the other ingredients of Gurgellösung-ratiopharm. This also applies if you are hypersensitive to Peruvian balsam (cross-allergy).
• in infants and toddlers under 2 years of age (risk of laryngeal spasm).
• if you suffer from bronchial asthma or other respiratory diseases that are associated with pronounced hypersensitivity of the respiratory tract. Inhalation of Gurgellösung-ratiopharm can lead to shortness of breath or trigger an asthma attack.

Special care must be taken when using Gurgellösung-ratiopharm

If your symptoms are accompanied by fever or do not subside significantly after 3 days at the latest, you should see a doctor, as there may be a tonsillitis that requires treatment, which can trigger serious secondary diseases of the heart and kidneys. Avoid getting the gargle solution in your eyes. If you suffer from contact allergies, you should not use the gargle solution, as sensitization is possible.

When using Gurgellösung-ratiopharm with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Dequalinium chloride is inactivated by protein, serum and pus in the presence of common soaps as well as by anionic, surface-active substances, materials such as porous substances (rubber, cotton, cork) and plastic materials (polyvinyl chloride, polyethylene), phospholipids and other lipid-containing substances.

Pregnancy and

breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicine.

Pregnancy

Even if data on a limited number of pregnant women treated do not suggest any harmful effects of Gurgellösung-ratiopharm on pregnancy or the health of the unborn child or newborn, you should only use Gurgellösung-ratiopharm during pregnancy after careful consideration of the benefits and risks by your doctor.

Breastfeeding

You should only use Gurgellösung-ratiopharm during breastfeeding after careful consideration of the benefits and risks by your doctor. Important information about certain other ingredients of Gurgellösung-ratiopharm: Propylene glycol, macrogolglycerol hydroxystearate and cinnamon (cinnamaldehyde) can cause skin irritation.

3. HOW TO USE GURGELLÖSUNG-RATIOPHARM?

Always use Gurgellösung-ratiopharm exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Gurgellösung-ratiopharm is a ready-to-use gargle solution and should therefore be used undiluted. Rinse or gargle with 1 tablespoon of Gurgellösung ratiopharm for 15 - 30 seconds in the morning and evening after meals. The medicine should not be used long-term without medical or dental advice. Discontinue Gurgellösung-ratiopharm a few days after the symptoms have subsided.

If you have used more Gurgellösung-ratiopharm than you should

Local skin damage (skin necrosis and ulcers) has been described after improper use on intertriginous skin areas (skin regions that are adjacent to each other over a large area and rub against each other easily and frequently when moving) or in the anal and genital area as well as under tightly occlusive dressings (occlusive dressings). In such cases, you should see a doctor. Gurgellösung-ratiopharm is harmless, even if it is accidentally swallowed while gargling.

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Gurgellösung-ratiopharm can have side effects, although not everybody gets them.

• Contact allergies have been described, occasionally also with swelling of the pharyngeal mucosa and obstruction of the respiratory tract
• Mucosal irritation and itching
• Delayed wound healing when applied to wounds
• Sensitization is possible

Peppermint oil can cause laryngeal spasm in infants and toddlers up to 2 years of age, resulting in severe respiratory distress.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GURGELLÖSUNG-RATIOPHARM?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton and label. The shelf life after opening is 12 months. Store the bottle in the outer carton in order to protect the contents from light.

6. FURTHER INFORMATION

What Gurgellösung-ratiopharm contains

The active ingredient is dequalinium chloride. 100 ml contain 10 mg dequalinium chloride. The other ingredients are: propylene glycol, peppermint flavour (including peppermint oil and cinnamaldehyde), patent blue V, macrogolglycerol hydroxystearate (Ph.Eur.), poloxamer 188, sodium lauryl sarcosinate (30% solution), sodium cyclamate, sodium dihydrogen phosphate dihydrate, sodium hydroxide, purified water.

Contents of the pack

Gurgellösung-ratiopharm is available in bottles of 200 ml.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This leaflet was last revised in December 2014.

Source: Package leaflet information
Status: 12/2017
Active ingredient: Dequalinium chloride 0.01%. Areas of application: for the supportive treatment of bacterial inflammation of the mucous membrane of the mouth and throat. Warning: Contains propylene glycol and macrogolglycerol hydroxystearate.