Fluditek 2% Syrup for children x125 ml Innotech International

FLUDITEC syrup 2% 125 ml. children
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluditec 20 mg/ml syrup carbocisteine Fluditec 20 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 is in this leaflet 1. What Fluditec 20 mg/ml syrup is and what it is used for 2. What you need to know before you take Fluditec 20 mg/ml syrup 3. How to take Fluditec 20 mg/ml syrup 4. Possible side effects 5. How to store Fluditec 20 mg/ml syrup 6. Contents of the pack and other information
1. WHAT FLUDITEC 20 mg/ml SYRUP IS AND WHAT IT IS USED FOR
The name of your medicine is Fluditec 20 mg/ml syrup. This medicine belongs to the group of medicines called „mucolytics”. It is intended for the treatment of bronchial secretion disorders, especially in cases of acute lung diseases: acute bronchitis and acute bronchopneumonia crises in children over 2 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUDITEC 20 mg/ml SYRUP
Do not take Fluditec 20 mg/ml syrup and tell your doctor if: • you are allergic (hypersensitive) to: the active ingredient of this medicine or any of the other ingredients of Fluditec 20 mg/ml syrup (listed in section 6 What Fluditec 20 mg/ml syrup contains), especially methyl parahydroxybenzoate. Do not use in babies (under 2 years of age) due to the risk of worsening bronchial congestion. If you think any of these conditions apply to you, or are in any doubt, consult your doctor or pharmacist before treatment with Fluditec 20 mg/ml syrup. Take special care with Fluditec 20 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 expectoration. - a bronchial modifying agent such as Fluditec 20 mg/ml syrup should not be combined with cough suppressant and/or cough-drying products. - due to the presence of sugar, Fluditec 20 mg/ml syrup is contraindicated for people with congenital fructose intolerance, glucose/galactose malabsorption syndrome or sugar/isomaltase 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 3.5g in 5 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 20 mg/ml syrup has no known drug interactions. However, always tell your doctor or pharmacist about the medicines your child is taking.
Pregnancy and lactationNot applicable
Driving and using machines Not applicable.
Important information about some of the ingredients of Fluditec 20 mg/ml syrup If your doctor has told you that your child has an intolerance to some sugars, contact your doctor before your child takes this product.
The presence of methyl parahydroxybenzoate and sunset yellow FCF may cause allergic reactions (possibly delayed).
H.HOW TO TAKE FLUDITEC 20 mg/ml SYRUP
Always give your child Fluditec 20 mg/ml syrup exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is taken orally (by mouth).
One measuring cup filled to the 5 ml mark contains 100 mg of carbocysteine.
Children over 5 years: one measuring cup filled to the 5 ml mark, 3 times daily, preferably between meals.
Children from 2 to 5 years: one measuring cup filled to the 5 ml mark, 2 times a day, preferably between meals.
The recommended duration of treatment is 8-10 days. For longer treatment, consult a doctor.
Follow your doctor's instructions throughout the entire treatment period.
If you have given more Fluditec 20 mg/ml syrup than you should: In case of overdose, stop the treatment and immediately consult a doctor or go to the nearest emergency room. Take the medicine with you. This will help the doctor understand exactly what you have given your child.
If you forget to take Fluditec 20 mg/ml syrup • give Fluditec 20 mg/ml syrup to your child as your doctor has told you • Do not give more than your child's prescribed daily dose • Do not give a double dose to make up for a forgotten 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 20 mg/ml syrup can cause side effects, although not everybody gets them. - Risk of bronchial congestion in babies, - Skin allergic reactions such as pruritus, erythematous rashes, urticaria and angioedema, - Digestive disorders (gastralgia, nausea or vomiting or diarrhoea) are possible. If any of the side effects become serious or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FLUDITEC 20 mg/ml SYRUP Keep out of the reach of children. Do not use Fluditec 20 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. PACKAGE CONTENTS AND OTHER INFORMATION
What does Fluditec 20 mg/ml syrup contain? • The active substance is: carbocysteine. • Each dose (5 ml) of the syrup contains 100 mg of carbocysteine. The other ingredients are: glycerol, methyl parahydroxybenzoate (E218), sucrose, dyes - sunset yellow FCF (E110), sodium hydroxide, banana essence, purified water.
What Fluditec 20 mg/ml syrup looks like and what the package contains Fluditec 20 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 INNOTECH INTERNATIONAL 22 Avenue Aristide Briand. BP 32 94111 Arcueil CEDEX,France
ManufacturerINNOTHERA CHOUZYRue Ren6 Chantereau – Chouzy-sur-Cisse41150 VALLOIRE-SUR-CISSE – France
Representative Office for Bulgaria1113 Sofia, Iztok District, 22 Dr. Lyuben Rusev St., 1st floor, apt. 3tel. 02/ 87 00 462, e-mail: [email protected]
Date of last approval of the leaflet: 12/2018