Orophar Oral mucosa spray x30 ml Stada

OROFAR SPRAY 30 ML reduces mouth pain and throat inflammation. It relieves pain and fights bacteria, viruses and fungi that cause infections in the mouth and throat.
OROFAR 0.2%/0.15% Oral mucosa spray contains the antiseptic substance benzoceonium chloride and the anesthetic (local anesthetic) lidocaine chloride. OROFAR 0.2%/0.15% Spray for mouth and throat infections: sore throat with colds, pharyngitis or laryngitis, stomatitis, small mouth ulcers (aphthae) or inflamed gums. For maintenance treatment of angina. OROFAR 0.2%/0.15% Oral mucosa spray is indicated for the treatment of adults, children and adolescents aged 4 to 18 years. 
OROFAR SPRAY 30ML dosage and application:
Children 4 to 11 years: Spray 2 or 3 times OROFAR 0.2%/0.15% Oral Mucosa Spray into the mouth or back of the mouth on the affected area. Repeat 3 to 6 times daily as needed. The interval should be at least 2 to 3 hours between each dose. OROFAR 0.2%/0.15% Oral Mucosa Spray should be administered to children under parental supervision. OROFAR 0.2%/0.15% Oral Mucosa Spray should not be administered to children who cannot hold their breath during the spray. 
Adults and children over 12 years: Spray 2 to 4 times OROFAR 0.2%/0.15% Oral Mucosa Spray into the mouth or back of the mouth on the affected area. Repeat 3 to 6 times daily as needed, with an interval of at least 2 to 3 hours between each dose. 
How to use: • Remove the protective cap. • Place the applicator on the pump and press firmly. • Before first use, activate the pump by pressing the applicator several times until a spray appears in the air. • Hold the bottle upright and spray into the mouth or back of the mouth. Hold your breath while spraying. • Clean and dry the applicator after use and place it in the carton until next use. • To avoid possible spread of infections, the applicator should be used by one patient only. • The medicinal product should not be used if the applicator is damaged. 
Use in children OROPHAR 0.2%/0.15% Oral mucosa spray is not recommended for use in children under 4 years of age. 
OROFAR SPRAY 30ML ingredients:
The active substances are: benzoxonium chloride and lidocaine hydrochloride. The other ingredients (excipients) are: glyceryl, ethanol 94% (w/w), hydrochloric acid 0.1N (for pH adjustment), peppermint oil, levomenthol, purified water. 
OROPHAR 0.2%/0.15% Oral spray, solution 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 can be obtained without a prescription. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • If you need any 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 listed in this leaflet. • If you do not feel better after 5 days or your condition worsens, you should seek medical advice. What this leaflet contains: 1. What OROFAR 0.2%/0.15% Oral mucosa spray is and what it is used for 2. Before you use OROFAR 0.2%/0Л5% Oral mucosa spray 3. How to use OROFAR 0.2%/0.15% Oral mucosa spray 4. Possible side effects 5. How to store OROFAR 0.2%/0.15% Oral mucosa spray 6. Contents of the pack and other information 1. What OROFAR 0.2%/0.15% Oral mucosa spray is and what it is used for OROFAR 0.2%/0.15% Oral mucosa spray contains the antiseptic substance benzoceonium chloride and anesthetic (local anesthetic) lidocaine chloride. OROFAR 0.2%/0.15% Oral mucosa spray fights bacteria, viruses and fungi that cause infections in the mouth and throat. OROFAR 0.2%/0.15% Oral mucosa spray reduces pain in the mouth and throat. OROFAR 0.2%/0.15% Oral mucosa spray is used to reduce symptoms associated with mouth and throat infections: sore throats during colds, pharyngitis or laryngitis, stomatitis, small mouth ulcers (aphthae) or inflamed gums. OROFAR 0.2%/0.15% Oral mucosa spray can be used as a maintenance treatment for angina. OROFAR 0.2%/0.15% Oral spray 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 0.2%/0.15% Oral spray Do not use OROFAR 0.2%/0.15% Oral spray: • 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 0.2%/0.15% Oral Mucosa Spray if: • sore throat is accompanied by a high fever or if you have serious difficulty swallowing; • symptoms do not improve or last more than 5 days. • Be careful not to spray OROFAR 0.2%/0.15% Oral Mucosa Spray into the eyes and do not inhale it (hold your breath while spraying). OROFAR 0.2%/0.15% Oral Mucosa Spray should be used with caution in patients with wounds or lesions on the lip or throat mucosa. Children OROFAR 0.2%/0.15% Oral Mucosa Spray is not recommended for use in children under 4 years of age. Other medicines and OROFAR 0.2%/0.15% Oral Spray Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. OROFAR 0.2%/0.15% Oral Spray with food, drink and alcohol OROFAR 0.2%/0.15% Oral Spray should not be used during or immediately after eating or drinking: the local anesthetic effect of lidocaine may cause temporary numbness of the mouth and throat and affect swallowing. Avoid eating or drinking while the numbness persists. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using OROFAR 0.2%/0.15% Oral Mucosal Spray. Driving and using machines OROFAR 0.2%/0.15% Oral Mucosal Spray has no or negligible influence on the ability to drive and use machines. Important information about some of the excipients OROFAR 0.2%/0.15% Oromucosal Spray contains: • Butanol: this medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose (one pump actuation delivers 140 microliters ± 25%, containing 13.132 mg ± 25% ethanol and the maximum dose per application is 4 sprays.) 3. How to use OROFAR 0.2%/0.15% Oromucosal Spray 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 Spray 2 or 3 times OROFAR 0.2%/0.15% Oral Mucosa Spray into the mouth or back of the mouth on the affected area. Repeat 3 to 6 times daily as needed. The interval should be at least 2 to 3 hours between each dose. OROFAR 0.2%/0.15% Oral Mucosa Spray should be administered to children under parental supervision. OROFAR 0.2%/0.15% Oral Mucosa Spray should not be administered to children who cannot hold their breath during the spray. Adults and children over 12 years Spray 2 to 4 times OROFAR 0.2%/0.15% Oral Mucosa Spray into the mouth or back of the mouth on the affected area. Repeat 3 to 6 times daily as needed, with an interval of at least 2 to 3 hours between each dose. Method of administration: • Remove the protective cap. • Place the applicator on the pump and press firmly. • Before first use, activate the pump by pressing the applicator several times until a spray appears in the air. • Hold the bottle upright and spray into the mouth or back of the mouth. Hold your breath while spraying. • Clean and dry the applicator after use and place it in the carton until next use. • To avoid possible spread of infections, the applicator should be used by one patient only. • The medicinal product should not be used if the applicator is damaged. Use in children OROFAR 0.2%/0.15% Oromucosal Spray is not recommended for use in children under 4 years of age. If you use more OROFAR 0.2%/0.15% Oral Spray than you should In case of overdose or accidental ingestion of large amounts of OROFAR 0.2%/0.15% Oral Spray, inform your doctor or pharmacist immediately. Consult your doctor or pharmacist if you have any further questions on the use of OROFAR 0.2%/0.15% Oral Spray. 4. Possible side effects Like all medicines, OROFAR 0.2%/0.15% Oral Spray can cause side effects, although not everybody gets them. Stop using OROPHAR 0.2%/0.15% Oral Mucosa Spray 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, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 5. How to store OROFAR 0.2%/0.15% Oral spray • 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. • Store in the original packaging. • Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What OROFAR 0.2%/0.15% Oral spray contains The active substances are: benzoxonium chloride and lidocaine hydrochloride. The other ingredients (excipients) are: glyceryl, ethanol 94% (w/w), hydrochloric acid 0.1N (for pH adjustment), peppermint oil, levomenthol, purified water. What OROFAR 0.2%/0.15% Oral Mucosa Spray looks like and what the package contains OROFAR 0L%/0.15% Oral Mucosa Spray is in a high-density polyethylene (HDPE) bottle with a low-density polyethylene (LDPE) dosing spray pump and a protective cap. The buccal applicator is made of polypropylene (PP) and is located in the cardboard packaging. OROFAR 0.2%/0.15% Oral Mucosa Spray is a colorless, clear solution. Marketing Authorisation Holder and Manufacturer Novartis Consumer Health GmbH, Zielstattstrasse 40, 81379 München, Germany