FLUTOX 3.54 mg/ml SYRUP

Introduction

Package Leaflet: Information for the Patient

Flutox 3.54 mg/ml Syrup

Cloperastine Fendizoate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package 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

Cloperastine, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex. Flutox is a medicine indicated for the treatment of non-productive forms of cough, such as irritative cough or nervous cough for adults and children from 2 years of age.

• 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 to any of the other components of Flutox.
• You are allergic to allergy medicines (antihistamines)
• You are taking medicines for the treatment of depression
• You are pregnant or think you may be pregnant or are breastfeeding
• Children under 2 years of age cannot take this medicine

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 2 years of age cannot take this medicine, it is contraindicated.

Taking Flutox with other medicines

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

Flutox may interact with other medicines such as:

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

Taking Flutox with food, drinks, and alcohol

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

Taking this medicine 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 medicine.

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, propyl hydroxybenzoate, and methyl hydroxybenzoate, sodium, propylene glycol, and ethanol

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

Patient with diabetes mellitus should note that this medicine contains:

This medicine may cause allergic reactions (possibly delayed) because it contains propyl hydroxybenzoate and methyl hydroxybenzoate.

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

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

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

The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to take Flutox

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

In adults and adolescents over 12 years:10 ml, 3 times a day

In children:Between 7 and 12 years: 5 ml, 2 times a day

Between 5 and 6 years: 3 ml, 2 times a day.

Between 2 and 4 years: 2 ml, 2 times a day.

Flutox is contraindicated in children under 2 years of age.

How to take:

Shake the bottle before use.

This medicine is taken orally

Measure the amount of medicine to be taken with the measuring cup included in the package.

If you take more Flutox than you should

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 91 562 04 20 indicating the medicine and the amount taken.

If you forget to take Flutox

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 medicine as indicated in section 3. How to take Flutox.

4. Possible side effects

Like all medicines, Flutox can cause side effects, although not everyone gets them.

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

Side effects that may occur are:

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 package leaflet.

5. Storage of Flutox

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Flutox

The active ingredient of Flutox is Cloperastine Fendizoate.

The other components (excipients) are sucrose; microcrystalline cellulose-carboxymethylcellulose sodium; polyoxyethylene-40-stearate; methyl hydroxybenzoate (E-218); propyl hydroxybenzoate (E-216); banana flavor (containing propylene glycol E-1520, ethanol) and purified water

Appearance of the Product and Package Contents

Flutox is presented as a white opaque syrup, in 120 and 200 ml bottles.

Other Presentations

Flutox 10 mg, coated tablets

Marketing Authorization Holder and ManufacturerMarketing Authorization Holder:

ZAMBON S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda – Barcelona

Spain

Manufacturer:

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza (Italy)

Date of the Last Revision of this Package Leaflet: July 2019

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