Fluditec 5% Syrup for adults x125 ml

FLUDITEC syrup 5% 125 ml for adults
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluditec 50 rng/ml syrup carbocisteine Fluditec 50 mg/ml syrup carbocisteine
Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to get the best results from your treatment, you should carefully follow the instructions for use of the medicinal product. 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 listed in this leaflet. See section 4. If you do not feel better or your condition gets worse, you should seek medical advice.
What this leaflet contains 1. What Fluditec 50 mg/ml syrup is and what it is used for 2. What you need to know before you take Fluditec 50 mg/ml syrup 3. How to take Fluditec 50 mg/ml syrup 4. Possible side effects 5. How to store Fluditec 50 mg/ml syrup b. Contents of the pack and other information
1. WHAT FLUDITEC 50 mg/ml SYRUP IS AND WHAT IT IS USED FOR
The name of your medicine is Fluditec 50 mg/ml syrup. This medicine belongs to the group of medicines called „mucolytics”. It is intended for adults and children over 15 years of age for the treatment of respiratory diseases accompanied by difficulty in expectoration, for coughing up bronchial secretions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUDITEC 50 mg/ml SYRUP
Do not take Fluditec 50 mg/ml syrup and tell your doctor if: • you are allergic (hypersensitive) to:

the active ingredient of this medicine or related ones,
some other ingredients of Fluditec 50 mg/ml syrup (described in section 6 What Fluditec 50 mg/ml syrup contains), especially methyl parahydroxybenzoate.

If you think any of these conditions apply to you, or if you are in any doubt, consult your doctor or pharmacist before treatment with Fluditec 50 mg/ml syrup.
Take special care when treating with Fluditec 50 mg/ml syrup. You need medical advice in case of: - productive cough with purulent discharge, - chronic disease of the bronchial passages or lungs, - treatment should be discontinued in case of exacerbation of symptoms. In such a case, consult your doctor to reassess the treatment. - productive cough is a major part of the body's protective bronchopulmonary system and it must be well maintained, especially in chronic patients with difficulty in expectorating, - a bronchial modifying agent such as Fluditec 50 mg/ml syrup should not be combined with cough suppressant and/or cough-drying products, - due to the presence of sugar, Fluditec 50 mg/ml syrup is contraindicated for people with congenital fructose intolerance, glucose/galactose malabsorption syndrome or sugar/maltase deficiency, - it should be used with caution in patients with gastric and duodenal ulcers, - the sugar content should be taken into account in patients with diabetes or on a diet requiring reduced sugar intake. The sugar content is 5.25g in 15 ml of syrup. - This medicine contains methyl parahydroxybenzoate (E 218) and the azo dye sunset yellow FCF and may cause allergic reactions (possibly delayed).
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Fluditec 50 mg/ml syrup has no known drug interactions. However, always tell your doctor or pharmacist about any other medicines you are taking.
Pregnancy and breastfeeding The use of Fluditec 50 mg/ml syrup during pregnancy or breastfeeding should be avoided. Always consult your doctor or pharmacist before starting to take any other medicine.
Driving and using machines: No effect of this medicinal product on the ability to drive or use machines has been described.
Important information about some of the ingredients of Fluditec 50 mg/ml syrup If your doctor has told you that you have an intolerance to some sugars, contact him before taking this product. The presence of methyl parahydroxybenzoate and sunset yellow FCF may cause allergic reactions (possibly delayed).
H. HOW TO TAKE FLUDITEC 50 mg/ml SYRUP
Always take Fluditec 50 mg/ml syrup exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Take this medicine orally (by mouth).
15 ml of syrup in the dosing cup contains 750 mg of carbocysteine.
Adults and children over 15 years: 3 times daily 15 ml in the dosing cup, preferably between meals. The recommended duration of treatment is 5 days.
Children under 15 years of age: Fluditec 50 mg/ml is not recommended for children under 15 years of age. A syrup with a lower concentration of the active substance, called Fluditec 20 mg/ml, is available for them. Follow the instructions given by your doctor during the entire treatment period.
If you take more Fluditec 50 mg/ml syrup than you should In case of overdose, stop treatment and consult a doctor immediately or go to the nearest emergency room. Take the medicine with you. This will help the doctor understand exactly what you have taken.
If you forget to take Fluditec 50 mg/ml syrup • take Fluditec 50 mg/ml syrup as your doctor has told you • Do not take more than your prescribed daily dose • Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS Like all medicines, Fluditec 50 mg/ml syrup can cause side effects, although not everybody gets them.
Adverse reactions are rare and mainly manifest as gastrointestinal disturbances: - stomach pain, - nausea, - diarrhea, which disappears after reducing the dose.
If any of the side effects gets serious or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FLUDITEC 50 mg/ml SYRUP

Keep out of the reach of children.
Do not use Fluditec 50 mg/ml syrup after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
Store below 25°C.
Store in the original packaging.

Shelf life after first opening: 2 months Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Fluditec 50 mg/ml syrup contains • The active substance is: carbocysteine. • Each dose (15 ml) of the syrup contains 750 mg of carbocysteine.
The other ingredients are: glycerol, methyl parahydroxybenzoate (E218), sucrose, dyes - sunset yellow FCF (E110) and patent blue (E131), sodium hydroxide, caramel essence, purified water.
What Fluditec 50 mg/ml syrup looks like and what the package contains Fluditec 50 mg/ml syrup is available in the form of syrup, placed in transparent, colorless glass bottles of 125 ml with a measuring cup.
Marketing Authorisation Holder
LABORATOIRE INNOTES INTERNATIONAL 22 Avenue Aristide Briand. BP 32 94111 Arcueil CEDEX, France
ManufacturerJNNOTHERA CHOUZYRue Rend Chantereau – Chouzy-sur-Cisse41150 VALLOIRE-SUR-CISSE - France
Representative office for Bulgaria1113 Sofia, Iztok district, 22′ Dr. Lyuben Rusev Str., 1st floor, apt. 3 tel.: 02/ 87 00 462, e-mail: [email protected]
Date of last approval of the leaflet: 08/2018