OROFAR tabl x 24 / OROFAR lozenges
OROPHAR 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 includes any possible side effects not listed in this leaflet. If you do not feel better after 5 days or your condition gets worse, you should seek medical advice.
What this leaflet contains:
1. What OROFAR 1 mg/1 mg Lozenges are and what they are 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 pack and other information
1. What OROFAR 1 mg/1 mg lozenges are and what they are used for
OROPHAR 1 mg/1 mg Lozenges contain 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 mouth pain and throat inflammation.
OROPHAR 1 mg/1 mg Lozenges are used to reduce symptoms associated with mouth and throat infections: sore throat with colds, pharyngitis or laryngitis, stomatitis, small mouth ulcers (aphthae) or inflamed gums.
OROFAR 1 mg/1 mg Lozenges can be used as a maintenance treatment for angina.
OROPHAR 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 OROPHAR 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 OROPHAR 1 mg/1 mg Lozenges if:
• the sore throat is accompanied by a high fever or if you have serious difficulty swallowing;
• symptoms do not improve or persist for more than 5 days.
OROFAR 1 mg/1 mg Lozenges, molded should be used with caution in patients with wounds or lesions of the lip or throat mucosa.
Children
OROPHAR 1 mg/1 mg Lozenges are not recommended for use in children under 4 years of age.
Other medicines and OROFAR 1 mg/1 mg Lozenges, molded
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
OROFAR 1 mg/1 mg Lozenges, molded with food, drinks and alcohol OROFAR 1 mg/1 mg Lozenges, molded should not be used during or immediately after consumption of food and drinks: the local anesthetic effect of lidocaine may cause temporary numbness of the mouth and throat and affect swallowing. Avoid taking food and drinks while the numbness persists.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using OROPHAR 1 mg/1 mg Lozenges.
Driving and using machines
OROFAR 1 mg/1 mg lozenges, molded has no or negligible influence on the ability to drive and use machines.
Important information about some of the excipients OROPHAR 1 mg/1 mg Lozenges, molded contains:
• Sorbitol (E420) - if your doctor has told you that you have an intolerance to some sugars, contact him before taking this product.
3. How to use OROFAR 1 mg/1 mg Lozenges
Always use this medicine exactly as described in this 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 old
Allow one tablet of OROPHAR 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 OROPHAR 1 mg/1 mg Lozenges, molded to dissolve in the mouth every 2 to 3 hours. When necessary, in cases of acute sore 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
OROPHAR 1 mg/1 mg Lozenges are not recommended for use in children under 4 years of age.
If you use more OROPHAR 1 mg/1 mg lozenges than you should
In case of overdose or accidental ingestion of large quantities of OROPHAR 1 mg/1 mg Lozenges, inform your doctor or pharmacist immediately.
Consult your doctor or pharmacist if you have any other questions related to the use of OROPHAR 1 mg/1 mg Lozenges.
4. Possible side effects
Like all medicines, OROPHAR 1 mg/1 mg Lozenges can cause side effects, although not everybody gets them.
Stop using OROPHAR 1 mg/1 mg Lozenges, molded and seek medical help immediately if you or your child have any of the following symptoms, which may be signs of an allergic reaction:
• Difficulty 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 tingling in the mouth and throat.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store OROFAR 1 mg/1 mg Lozenges
• Keep out of the reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Store below 30°C! Protect from moisture!
• Store in the original packaging.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What OROPHAR 1 mg/1 mg lozenges, molded contain
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, saccharin sodium, magnesium stearate.
What OROFAR 1 mg/1 mg lozenges, molded, look like and contents of the pack
OROPHAR 1 mg/1 mg lozenges are molded in blisters of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinyl chloride (PVDC) with aluminum foil.
OROPHAR 1 mg/1 mg Lozenges, molded are white to slightly yellow, round lozenges with the inscription “Zyma” on one side and the code “OR” on the other side.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland Manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstrasse 4, 80339 Munich, Germany
