OROFAR tabl x 24
OROFAR tablets * 24
Leaflet: information on how to find it
OROFAR 1 mg/1 mg Lozenges, molded
Benzoxonium Chloride/Lidocaine Hydrochloride
OROFAR 1 mg/1 mg Lozenges
Benzoxonium chloride/Lidocaine hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This medicine is available without a prescription. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. If after 5 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What OROFAR 1 mg/1 mg lozenges is and what it is used for
2. What you need to know before you use OROFAR 1 mg/1 mg lozenges
3. How to use OROFAR 1 mg/1 mg lozenges
4. Possible side effects
5. How to store OROFAR 1 mg/1 mg lozenges
6. Contents of the package and additional information
1. What OROFAR 1 mg/1 mg lozenges is and what it is used for
OROFAR 1 mg/1 mg lozenges contains the antiseptic substance benzoxonium chloride and the anesthetic (local anesthetic) lidocaine hydrochloride.
OROFAR 1 mg/1 mg lozenges fights bacteria, viruses and fungi that cause infections in the mouth and throat. OROFAR 1 mg/1 mg lozenges reduces pain in the mouth and inflammation in the throat.
OROFAR 1 mg/1 mg Lozenges is used to reduce the symptoms associated with infections of the mouth and throat: sore throats with colds, pharyngitis or laryngitis, stomatitis, small mouth ulcers (aftha) or inflamed gums.
OROFAR 1 mg/1 mg lozenges can be used as a maintenance treatment for angina.
OROFAR 1 mg/1 mg lozenges is indicated for the treatment of adults, children and adolescents aged 4 to 18 years.
2. What you need to know before you use OROFAR 1 mg/1 mg lozenges
Do not use OROFAR 1 mg/1 mg lozenges:
• if you are allergic to the active substance benzoxonium chloride or other quaternary ammonium compounds;
• if you are allergic to the active substance lidocaine hydrochloride or other local anesthetics from the amide group;
• if you are allergic to any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before using OROFAR 1 mg/1 mg lozenges if:
• the inflammation of the throat is accompanied by a high temperature or if you have serious difficulty in swallowing;
• symptoms do not improve or last more than 5 days.
OROFAR 1 mg/1 mg lozenges, cast should be used with caution in patients with wounds or lesions of the mouth or throat mucosa.
Children
OROFAR 1 mg/1 mg lozenges is not recommended for use in children under 4 years of age.
Other drugs and OROFAR 1 mg/1 mg Lozenges, molded
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
OROFAR 1 mg/1 mg Lozenges cast with food, drink and alcohol OROFAR 1 mg/1 mg Lozenges cast should not be used during or immediately after consumption of food and drink: the local anesthetic effect of lidocaine may to cause temporary numbness of the mouth and throat and affect swallowing. Avoid eating and drinking while the numbness lasts.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using OROFAR 1 mg/1 mg lozenges.
Driving and using machines
OROFAR 1 mg/1 mg Lozenges, molded does not affect or negligibly affects the ability to drive and operate machines.
Important information about some of the excipients OROFAR 1 mg/1 mg Lozenges, molded contains:
• Sorbitol (E420) - if your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
3. How to use OROFAR 1 mg/1 mg lozenges
Always use this medicine exactly as described in the leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Children from 4 to 11 years
Allow one tablet of OROFAR 1 mg/1 mg Lozenges, molded to melt in the mouth every 2 to 3 hours. Do not use more than 6 tablets in 24 hours.
Adults and children over 12 years old
Allow one tablet of OROFAR 1 mg/1 mg Lozenges, molded to melt in the mouth every 2 to 3 hours. When necessary, in cases of acute inflammation of the throat, you can use 1 tablet every 1 to 2 hours. Do not use more than 10 tablets in 24 hours Aphthous ulcers - allow the tablet to dissolve slowly in contact with the lesion.
Do not chew or swallow the tablets.
Do not exceed the indicated doses.
Use in children
OROFAR 1 mg/1 mg lozenges is not recommended for use in children under 4 years of age.
If you have used more than the required dose of OROFAR 1 mg/1 mg Lozenges
In case of overdose or accidental ingestion of large amounts of OROFAR 1 mg/1 mg lozenges, immediately inform your doctor or pharmacist.
Consult your doctor or pharmacist if you have any other questions related to the use of OROFAR 1 mg/1 mg lozenges.
4. Possible side effects
Like all medicines, OROFAR 1 mg/1 mg Lozenges can cause side effects, although not everybody gets them.
Stop using OROFAR 1 mg/1 mg Lozenges, cast and seek immediate medical attention if you or your child have any of the following symptoms, which may be signs of an allergic reaction:
• Difficulty in breathing and swallowing;
• Swelling of the face, lips, tongue and throat;
• Severe itching of the skin with red rashes and pronounced blisters.
These side effects are very rare (may affect less than 1 in 10,000 people).
Some side effects are common (may affect less than 1 in 10 people)'.
• Irritation or numbness in the mouth and throat.
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.
5. How to store OROFAR 1 mg/1 mg lozenges
• To be stored in a place inaccessible to children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.
• To be stored below 30°C! Keep away from moisture!
• To be stored in the original packaging.
• Do not flush medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What OROFAR 1 mg/1 mg Lozenges, cast contains
The active substances are: benzoxonium chloride and lidocaine hydrochloride.
The other ingredients (excipients) are: sorbitol (E420), corn starch, orange essence, macrogol 6000, cellulose, microcrystalline, sodium chloride, citric acid monohydrate, sodium saccharin, magnesium stearate.
What OROFAR 1 mg/1 mg Lozenges looks like and contents of the pack
OROFAR 1 mg/1 mg lozenges, cast in polyvinyl chloride (PVC)/polyethylene (PE)/polyvinyl chloride (PVDC) blisters with aluminum foil.
OROFAR 1 mg/1 mg Lozenges, molded white to slightly yellow, round lozenges with the inscription “Zyma” on one side and the code “OR” on the other side.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland Producer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstrasse 4, 80339 Munich, Germany
