Sinecode Drops x20 ml GlaxoSmithKline

SINECOD / SINECOD DROPS 20ML indications:
SINECODE 0.5% Oral drops, solution contains the active substance butamirate nitrate, which belongs to the group of cough suppressants. SINECODE 0.5% Oral drops, solution is used for the symptomatic treatment of cough of various origins. 
Dosage and administration:
Do not use SINECODE 0.5% Oral drops, solution in children under 2 years of age without a doctor's recommendation. 
Children from 2 months to 1 year – 10 drops 4 times a day. Children from 1 year to 3 years – 15 drops 4 times a day. 
Children over 3 years old – 25 drops 4 times daily. 
Ingredients:
The active substance is butamirate citrate. 
The other ingredients (excipients) are: sorbitol solution 70 % w/w, glycerol. saccharin sodium, benzoic acid, vanillin, sodium hydroxide 30 % w/w, ethanol 96 % v/v. purified water. 
PACKAGE LEAFLET: INFORMATION FOR THE USER SINECOD 0.5% Oral drops, solution Butamirate citrate SINECOD 0.5% Oral drops, solution Butamirate citrate Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them, even if their condition is the same as yours. • If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What this leaflet contains 1. What SINECODE 0.5% Oral drops, solution is and what it is used for 2. What you need to know before you use SINECODE 0.5% Oral drops, solution 3. How to use SINECODE 0.5% Oral drops, solution 4. Possible side effects 5. How to store SINECODE 0.5% Oral drops, solution 6. Contents of the pack and other information 1. What SINECODE 0.5% Oral drops, solution is and what it is used for SINECODE 0.5% Oral drops, solution contains the active substance butamirate nitrate, which belongs to the group of medicines for suppressing cough. SINECODE 0.5% Oral drops, solution is used for the symptomatic treatment of cough of various origins. 2. What you need to know before you use SINECODE 0.5% Oral drops, solution Do not use SINECODE 0.5% Oral drops, solution • If you are allergic to the active substance butamirate citrate or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using SINECODE 0.5% Oral drops, solution. Consult your doctor or pharmacist if the cough persists for more than 7 days. Children Do not give SINECODE 0.5% Oral drops, solution to children under 2 years of age, unless the medicinal product has been prescribed by a doctor. Other medicines and SINECODE 0.5% Oral drops, solution Avoid the simultaneous use of SINECODE 0.5% Oral drops, solution with other antitussives, as this may lead to retention of secretions in your lungs. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines or nutritional supplements obtained without a prescription. Pregnancy and breast-feeding If you are pregnant or breast-feeding, do not use SINECODE 0.5% Oral drops, solution, unless recommended by your doctor. Driving and using machines In rare cases, SINECODE 0.5% Oral drops, solution may reduce alertness in some people compared to normal. If this occurs in you. you should be careful when using this medicine when driving or operating machinery. Your child should avoid riding a bicycle or scooter in traffic when using SINECODE 0.5% Oral drops, solution. SINECODE 0.5% oral drops, solution contains: Sorbitol (E 420): if your doctor has told you that you have an intolerance to some sugars, contact your doctor before using SINECODE 0.5% Oral drops, solution. Ethanol: SINECODE 0.5% Oral drops, solution contains small amounts of ethanol (alcohol), less than 100 mg per dose. 3. How to use SINECODE 0.5% Oral drops, solution Always use SINECODE 0.5% Oral drops, solution exactly as your doctor or pharmacist has told you. Do not use SINECODE 0.5% Oral drops, solution for more than 7 days (one week) without consulting your doctor. Use in children SINECODE 0.5% Oral drops, solution Do not use SINECODE 0.5% Oral drops, solution in children under 2 years of age without a doctor's recommendation. Children from 2 months to 1 year - 10 drops 4 times a day. Children from 1 year to 3 years - 15 drops 4 times a day. Children over 3 years - 25 drops 4 times a day. If you have used more than the required dose of SINECODE 0.5% Oral drops, solution If you have used more than the required dose of SINECODE 0.5% Oral drops, solution, consult your doctor immediately. 4. Possible side effects Like all medicines SINECODE 0.5% Oral drops, solution can cause side effects, although not everyone gets them. The following side effects may occur in rare cases (may affect between 1 and 10 in every 10,000 people) - drowsiness, skin rashes, nausea and diarrhea. These side effects should disappear after reducing the dose or stopping treatment. If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not described in this leaflet. 5. How to store SINECODE 0.5% Oral drops, solution Keep out of the reach of children. Do not use SINECODE 0.5% Oral drops, solution after the expiry date which is stated on the carton. The expiry date corresponds to the last day of that month. Store in the original packaging. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What SINECODE 0.5% Oral drops, solution contains The active substance is butamirate citrate. The other ingredients (excipients) are: sorbitol solution 70 % w/w, glycerol. saccharin sodium, benzoic acid, vanillin, sodium hydroxide 30 % w/w, ethanol 96 % v/v. purified water. What SINECODE 0.5% Oral drops, solution looks like what the pack contains SINECODE is available in the form of oral drops, solution, syrup and prolonged-release tablets. SINECODE 0.5% Oral drops, solution is a clear, colourless, vanilla-flavoured, sweet and slightly bitter solution. It is distributed in a dark glass bottle equipped with a dropper and a cap. Packaging: 20 ml. Marketing Authorization Holder and Manufacturer Novartis Consumer Health GmbH. Zielstattstrasse 40, 81379 Munich, Germany For any information about this medicine, please contact the local representative of the Marketing Authorization Holder: Salvis Pharma Ltd., Sofia 1528. 5 Dimitar Peshev Str., Tel.: +359 882532901