FLUDITEC SYRUP 2% 125ML (INFANTS AND CHILDREN)

ATC code: R05CB03 

Active substances: Carbocisteinum

Vendor, principal: Innotech Intern.. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

FLUDITEC 50MG/1ML 125ML

Package leaflet: Information for the user

FLUDITEC, 50 mg/mL syrup

Carbocisteine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take 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.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

What is in this leaflet

1.   What Fluditec is and what it is used for
2.   What you need to know before you take Fluditec
3.   How to take Fluditec
4.   Possible side effects
5.   How to store Fluditec
6.   Contents of the pack and other information

1. What Fluditec is and what it is used for

Fluditec contains carbocisteine as active substance. Carbocisteine has expectorant and mucolytic effect that means it makes mucus less sticky and then it is easier to cough it up.
Fluditec 50 mg/mL syrup is used for respiratory diseases in adults and adolescents from the age of 15 when there is a lot of mucus in airways.

2. What you need to know before you take Fluditec Do not take Fluditec:

-   if you are allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6);
-   if you have fructose intolerance, glucose and galactose malabsorption or saccharase-isomaltase deficiency, as this medicine contains saccarose.
Do not give Fluditec 50 mg/mL syrup to adolescents under 15 years old. The medicine is not suitable for them due to high active substance content. In children under 15 years Fluditec 20 mg/mL syrup with lower active substance content should be used.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluditec.
The medicine should not be used concomitantly with anti-cough medicines inhibiting cough reflex (for example codeine, dextromethorphan), especially before going to sleep, as such combination of medicines makes it difficult to cough up mucus.
Caution is required in case of peptic or duodenal ulcer.
Fluditec contains 5.25 g of saccharose in one dose (15 mL): this should be taken into account by diabetics.
Methyl parahydroxybenzoate and sunset yellow (E110) can cause allergic reactions.

Other medicines and Fluditec

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use with medicines inhibiting the cough reflex.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As the safety of this medicine during pregnancy and breast-feeding is not established, the use of the medicine should be avoided during these periods, except in the presence of clear indication.

Driving and using machines

Fluditec has no known effect on the ability to drive or use machines.

Fluditec contains saccharose.

Fluditec contains 5.25 g of saccharose in one dose (15 mL): this should be taken into account by diabetics.
Methyl parahydroxybenzoate and sunset yellow (E110) can cause allergic reactions.
This medicine contains 39 mg of sodium in one dose (15 mL). This should be taken into account by patients on restricted sodium content diet.

3. How to take Fluditec

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Fluditec should be used only in adults and adolescents from the age of 15.
15 mL of syrup contains 750 mg of carbocisteine.
The recommended dose is 15 mL 3 times a day, preferably between meals.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
If you feel that the effect of Fluditec is too strong or too weak, talk to your doctor or pharmacist.

If you take more Fluditec than you should

Contact your doctor immediately if you suspect overdose. Take the medicine package with you.

If you forget to take Fluditec

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders (abdominal pain, nausea, diarrhoea) may occur. When these side effects occur dose reduction is recommended.
Uncommonly skin rash and allergic skin reactions (pruritus, inflammatory skin rash, urticaria, local skin oedema) have occurred.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluditec

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Shelf life after first opening: 2 months
Do not use this medicine after the expiry date that is stated on the bottle. The expiry date refers to the last day of that month.
Do not throw away any 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 Fluditec contains

-   The active substance is carbocisteine. One mL of syrup contains 50 mg (5%) of carbocisteine.
-   The other excipients are:
Glycerol, methyl parahydrohybenzoate, saccharose, patent blue V, sunset yellow FCF (E110), sodium hydroxide, caramel aroma and flavouring*, purified water.
Composition of caramel aroma and flavouring: levulinic acid, p-anisaldehyde, veratraldehyde, methyl anisate, ethyl anisate, benzyl cinnamate, 1,2-dimethoxybenzene, ethyl vanillin, coconut extract (ethanol), vanilla extract (propylene glycol), almond oil, 4-methoxy acephone, methyl cyclopentenolone, 6-methylcoumarin, gamma-octolactone, piperonal/heliotropin, propylene glycol, triacetin, gamma-valerolactone, vanillin, 3-hydroxy-2-methyl-4-pyrone.

What Fluditec looks like and contents of the pack

The syrup is a pale green liquid with a brownish glimmer and caramel aroma.
125 mL of syrup in glass bottle with polypropylene graduated measuring cup (20 mL).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratoire INNOTECH INTERNATIONAL 22, AVENUE ARISTIDE BRIAND 94 110 ARCUEIL France
Manufacturer INNOTHERA CHOUZY RUE RENE CHANTEREAU L’ISLE VERT
41150 CHOUZY SUR CISSE France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
OÜ Retlando Aisa 8 80017 Pämu Tel. +372 5136092

This leaflet was last revised in October 2017.