Leaflet: information for the patient

Flutox 3.54 mg/ml syrup

Cloperastina fendizoate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

1. What is Flutox and what it is used for

2. What you need to know before starting to take Flutox

3. How to take Flutox

4. Possible side effects

5. Storage of Flutox

6. Contents of the pack and additional information

Thecloperastina,theactiveingredientofthismedication,isanantitussivethatinhibitsthereflexofthelungs.Flutoxisamedicationindicatedforthetreatmentofproductiveformsofcough,irritativeornervouscoughinadultsandchildren2yearsandolder.

-Youshouldconsultadoctorifyouworsenorifyoudonotimproveafter7daysoftreatment.

Do not take Flutox if:

• You are allergic (hypersensitive) to the active ingredient or any of the other components of Flutox.
• You are allergic to allergy medications (antihistamines)
• You are taking medications for depression treatment
• You are pregnant or believe you are pregnant or breastfeeding
• Children under 2 years old cannot take this medication

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flutox:

• If you have high intraocular pressure
• If you have been told you have prostate hypertrophy.
• If your cough persists after 7 days of treatment.

Children

Children under 2 years old cannot take this medication, it is contraindicated.

Flutox with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Flutox may interact with other medications such as:

• Sleeping medications (sedatives, analgesic opioids, barbiturates, hypnotics or benzodiazepines)
• Depression and Parkinson's disease medications because they may potentiate the adverse effects of this medication.
• Expectorants and mucolytics used to eliminate excess mucus and phlegm, because taking them at the same time as a cough medication like Flutox may prevent the elimination of excess mucus and cause choking.

Flutox with food, drinks and alcohol

Do not take alcohol during treatment with Flutox as it may increase the effects of alcohol.

The intake of this medication with food and drinks does not affect its efficacy.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is contraindicated in pregnancy and lactation.

Driving and operating machinery

Flutox may cause drowsiness at usual doses. If so, refrain from driving and operating hazardous machinery.

Flutox contains saccharose, propylparaben and methylparaben, sodium, propylene glycol and ethanol

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains:

This medication may cause allergic reactions (possibly delayed) because it contains propylparaben and methylparaben.

This medication contains less than 23 mg of sodium (1 mmol) per 10 ml dose; it is essentially "sodium-free".

This medication contains 23 mg of propylene glycol in each 10 ml dose.

This medication contains 0.3 mg of alcohol (ethanol) in each 10 ml dose. The amount in 10 ml of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol contained in this medication does not produce any perceptible effect.

Followexactlytheinstructionsfortheadministrationofthemedicationcontainedinthisleafletorthoseindicatedbyyourdoctororpharmacist.Incaseofdoubt,askyourdoctororpharmacist.Therecommendeddoseis:

Inadultsandadolescents12yearsandolder:10ml,3timesaday

Inchildren:Between7and12years:5ml,2timesaday

Between5and6years:3ml,2timesaday.

Between2and4years:2ml,2timesaday.

Flutoxiscontraindicatedinchildrenunder2yearsold.

Howtotake:

Shakethecontainerwellbeforeuse.

Thismedicationistobetakenbymouth

Measuretheamountofmedicationtobetakenwiththedosagecupprovidedinthecontainer.

IfyoutakemoreFlutoxthanyoushould

Thesymptomsofoverdoseare:Excitementanddifficultybreathing.

IfyouhavetakenmoreFlutoxthanyoushould,consultyourdoctororpharmacistimmediatelyorcallthetoxicologyinformationservice9156204020indicatingthemedicationandtheamounttaken.

IfyouforgettotakeFlutox

Donottakeadoubledosetomakeupforthemisseddose.

Thistreatmentissymptomaticifyoudonottakethemedicationandyoudonotreturntotakeit,takethemedicationasindicatedinsection3.HowtotakeFlutox.

.

Like all medicines, Flutox can also produce adverse effects, although not all people will suffer them.

The most common adverse effects that may occur although are relatively infrequent are: dizziness and dry mouth.

The adverse effects that can occur are:

Infrequent (may affect up to 1 in 10,000 patients): dizziness, dry mouth (at high doses).

Rare (may affect up to 1 in 100,000 patients): allergic reaction, urticaria.

If you experience adverse effects, consult your doctor or pharmacist, including if you experience adverse effects that do not appear in this prospectus.

Thismedicationdoesnotrequirespecialstorageconditions.

Keepitoutofsightandreachofchildren.

DonotusethismedicationaftertheexpirationdatethatappearsonthecontainerafterCAD.Theexpirationdateisthelastdayofthemonthindicated.

DisposeofanyremainingmedicationinthetrashanddiscardthecontainerandanyunusedmedicationthatdoesnotrequirethePointSIGREcodefordisposalatthepharmacyorconsultwithyourpharmacistforinstructionsonhowtoproperlydisposeofunusedmedicationsandcontainersinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafedisposalofmedicationsandhouseholdwasteinyourareaorvisityourpharmacistorhealthcareproviderformoreinformationonhowtoproperlydisposeofyourmedicationsandprotecttheenvironmentfromharmfromunwantedmedicationsandhouseholdwasteinyourareaorvisitwww.fda.gov/formoreinformationonsafe6. Contents of the packaging and additional information