Ficha técnica de Flutox 10 mg, comprimidos recubiertos – Espanha

Como usar Flutox 10 mg, comprimidos recubiertos

Introduction

Label:informationforthepatient

Flutox10mgtablets

Cloperastinahydrochloride

Readthelabelcarefullybeforeyoustarttakingthismedication,becauseitcontainsimportantinformationforyou.

Followexactlytheinstructionsfortheadministrationofthismedicationcontainedinthislabelorthosegivenbyyourdoctororpharmacist.

Keepthislabel,andreaditagainwhenyouneedtotakethismedication.
Ifyouneedadviceorinformation,consultyourdoctororpharmacist.
Ifyouexperienceanyadverseeffects,consultyourdoctororpharmacist,eveniftheyarenotlistedinthislabel.

Youshouldconsultadoctorifyoudonotimproveorifyourconditionworsensafter7days.

1. WhatisFlutoxandwhatisitusedfor

2. WhatyouneedtoknowbeforestartingtotakeFlutox

3. HowtotakeFlutox

4. Possibleadverseeffects

5. StorageofFlutox

6. Contentsofthepackageandadditionalinformation

1. What is Flutox and what is it used for

Thecloperastina,theactiveingredientofthismedication,isananticholinergicagentthatinhibitsthereflexofthebladder.Flutoxisamedicationindicatedforthetreatmentofproductiveformsofurinarybladderirritationornervousbladderinadultsandadolescents12yearsofageorolder.

Youshouldconsultadoctorifyouworsenorifyoudonotimproveafter7daysoftreatment.

2. What you need to know before starting Flutox

Do not take Flutox if:

You are allergic (hypersensitive) to the active ingredient or to 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 may be pregnant or if you are breastfeeding.
Children under 12 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 12 years old cannot take this medication.

Flutox with other medications

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

Flutox may interact with other medications such as:

Sleeping medications (sedatives, opioid analgesics, barbiturates, hypnotics or benzodiazepines).
Depression medications 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 produce choking.

Flutox with food, drinks and alcohol

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

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

Pregnancy and breastfeeding

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 breastfeeding.

Driving and operating machinery

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

Flutox contains saccharose

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

3. How to Take Flutox

Followexactlytheinstructionsfortheadministrationofthismedicationasindicatedinthisprospectusorasprescribedbyyourdoctororpharmacist.Incaseofdoubt,askyourdoctororpharmacist.Therecommendeddoseis:

Inadultsandadolescents12yearsofageandolder:1comprimido3timesaday

Flutoxiscontraindicatedinchildren12yearsofageandyounger.

Howtotake:

Thismedicationistobetakenbymouth

IfyoutakemoreFlutoxthanyoushould

Thesymptomsofoverdoseare:excitementanddifficultybreathing.

IfyouhavetakenmoreFlutoxthanyoushould,consultyourdoctororpharmacistimmediatelyorcallthetoxicologyinformationservice915620420indicatingthemedicationandtheamounttaken.

IfyouforgettotakeFlutox

Donottakeadoubledosetomakeupforthemisseddose.

Thistreatmentissymptomatic.Ifyoudonothavesymptoms,donottakethemedicationandifthesymptomsreturn,takethemedicationindicatedinsection3.HowtotakeFlutox.

4. Possible Adverse Effects

Likeallmedicines,Flutoxmayalsoproduceadverseeffects,althoughnotallpeoplewillsufferthem.

Theadverseeffectsthataremostlikelytooccur,althoughtheyarerelativelyinfrequent,are:drowsinessanddrymouth.

Theadverseeffectsthatcanoccurare:

Infrequent (may affect up to 1 to 10 of every 1000 patients): drowsiness, dry mouth (at high doses)

Very rare (may affect up to 1 of every 10,000 patients): allergic reaction, urticaria.

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

5. Conservation of Flutox

Do not store at a temperature above25°C.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Flutox coated tablets

The active ingredient of Flutox is Cloperastina hydrochloride.

The other components (excipients) are for the core: microcrystalline cellulose; hydrated colloidal silica; talc; magnesium stearate. For the coating: hypromellose; povidone; macrogol 4000, talc, saccharose, magnesium carbonate, titanium dioxide (E-171) and erythrosine (E-127) colorant.

Appearance of the product and contents of the packaging

Flutox is presented in the form of coated, round, pink tablets, in a blister pack containing 20 coated tablets.

Other presentations

Flutox 3.54 mg / ml syrup

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Zambon, S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda – Barcelona

Responsible for manufacturing:

Zambon, S.p.A.

Via della Chimica, 9.

Vicenza. Italy

Date of the last review of this leaflet: April 2013

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.