FLUTOX 10 mg FILM-COATED TABLETS

Introduction

Leaflet:informationforthepatient

Flutox10mgcoatedtablets

Cloperastine hydrochloride

Readtheentireleafletcarefullybeforetakingthismedication,asitcontainsimportantinformationforyou

Follow the administration instructions for the medication contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

1. What is Flutox and what is it used for
2. What you need to know before taking Flutox
3. How to take Flutox
4. Possible side effects
5. Storage of Flutox
6. Package contents and additional information

1. What is Flutox and what is it used for

The active ingredient of this medication, cloperastine, is an antitussive that inhibits the cough reflex. Flutox is a medication indicated for the treatment of non-productive forms of cough, such as irritative or nervous cough for adults and adolescents over 12 years old.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before taking Flutox

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 the treatment of depression
• You are pregnant or think you may be pregnant or 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 the cough persists after 7 days of treatment

Children

• Children under 12 years old cannot take this medication

Taking Flutox with other medications

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

Flutox may interact with other medications such as:

• Medications to help you sleep (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines)
• Medications for depression and medications for the treatment of Parkinson's disease, as they may potentiate the adverse effects of this medication
• Expectorant and mucolytic medications used to eliminate excess mucus and phlegm, as taking them at the same time as a cough medication like Flutox may prevent the elimination of excess mucus and produce choking.

Taking Flutox with food, drinks, and alcohol

During treatment with Flutox, do not consume alcohol, as it may increase the effects of alcohol.

Taking this medication with food and drinks does not affect its efficacy.

Pregnancy and breastfeeding

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

It is contraindicated in pregnancy and breastfeeding.

Driving and using machines

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

Flutox contains sucrose

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

3. How to take Flutox

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. The recommended dose is:

Inadultsandadolescentsover12yearsold: 1 tablet 3 times a day

Flutox is contraindicated in children under 12 years old.

How to take:

This medication is taken orally

IfyoutakemoreFlutoxthanyoushould

The symptoms of overdose are: excitement and difficulty breathing.

If you have taken more Flutox than you should, consult your doctor or pharmacist immediately or call the toxicology information service at 91 562 04 20, indicating the medication and the amount taken.

IfyouforgettotakeFlutox

Do not take a double dose to make up for forgotten doses.

This treatment is symptomatic. If you do not have a cough, do not take it, and if it returns, take the medication as indicated in section 3. How to take Flutox.

4. Possible side effects

Like all medications, Flutox may cause side effects, although not everyone may experience them.

The most common side effects, although rare, are: drowsiness and dry mouth.

Possible side effects include:

Uncommon (may affect up to 1 in 1000 patients): drowsiness, dry mouth (at high doses)

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

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Flutox

Do not store above 25°C.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Flutox coated tablets

The active ingredient of Flutox is Cloperastine 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, sucrose, magnesium carbonate, titanium dioxide (E-171), and erythrosine (E-127) coloring.

Appearance of the product and package contents

Flutox is presented in the form of round, pink, coated tablets in blisters of 20 coated tablets.

Other presentations

Flutox 3.54 mg / ml syrup

Marketing authorization holder and manufacturer

Marketing authorization holder:

Zambon, S.A.U.

Maresme, 5. Can Bernades-Subirà Industrial Estate

08130 Sta. Perpètua de Mogoda – Barcelona

Manufacturer:

Zambon, S.p.A.

Via della Chimica, 9.

Vicenza, Italy

Date of the last revision of this leaflet: April 2013

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.