Flutox 10 mg, film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Flutox 10 mg coated tablets
Cloperastine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for administration of this medicine provided in this leaflet or those given by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Flutox is and what it is used for
- What you need to know before taking Flutox
- How to take Flutox
- Possible adverse effects
- How to store Flutox
- Contents of the pack and other information
1. What Flutox is and what it is used for
Cloperastine, the active substance in this medicine, is an antitussive that inhibits the cough reflex. Flutox is a medicine indicated for the treatment of non-productive forms of cough, such as irritant cough or nervous cough, in adults and adolescents over 12 years of age.
You should consult a doctor if your condition 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 substance or to any of the other components of this medicine (listed in section 6).
- If you are allergic to allergy medications (antihistamines).
- If you are taking medicines for the treatment of depression.
- If you are pregnant or think you may be pregnant, or if you are breastfeeding.
- Children under 12 years of age must not take this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take Flutox:
- If you have urinary bladder obstruction.
- If you have high blood pressure.
- If you have cardiac arrhythmias.
- If you have high intraocular pressure.
- If you have stenosing peptic ulcer, which is a rupture of the stomach's inner lining, or intestinal obstruction.
- If you have been diagnosed with prostate enlargement (prostatic hypertrophy).
- If you have an autoimmune disorder affecting neuromuscular function called myasthenia gravis.
- If you have chronic smoker's cough, pulmonary emphysema (a disease of the lower respiratory tract), or asthma (inflammation and narrowing of the airways), as this medicine may interfere with expectoration and could increase airway resistance.
- If cough persists after 7 days of treatment.
Children
- Children under 12 years of age must not take this medicine.
Other medicines and Flutox
Taking Flutox with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Flutox may interact with other medicines such as:
- Medicines to help you sleep (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
- Medicines for depression or psychosis, and medicines used to treat Parkinson's disease, as they may enhance the adverse effects of this medicine.
- Other medicines used to treat allergic reactions (other antihistamines).
- Expectorant and mucolytic medicines used to eliminate excess mucus and phlegm, because when taken simultaneously with a cough medicine such as Flutox, they may prevent the elimination of excess mucus and cause choking.
Taking Flutox with food, drinks, and alcohol
During treatment with Flutox, alcohol must not be consumed, as it may increase the effects of alcohol.
Taking this medicine with food and drinks does not affect its efficacy.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Flutox is contraindicated during pregnancy and breastfeeding.
Driving and using machines
Flutox may cause drowsiness at usual doses. If this occurs, refrain from driving or operating heavy machinery.
Flutox contains sucrose
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Flutox
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The recommended dose is:
In adults and adolescents over 12 years of age: 1 tablet three times daily.
Flutox is contraindicated in children under 12 years of age.
How to take it:
This medicine is taken orally.
If you take more Flutox than you should
Symptoms of overdose include: excitement and difficulty breathing.
If you have taken more Flutox than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 the missed dose.
If you stop taking Flutox
This treatment is symptomatic. If you do not have a cough, do not take it; if the cough returns, take the medicine as indicated in section 3. How to take Flutox.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects that may occur are:
Uncommon (may affect up to 1 in 100 patients): somnolence, dry mouth (at high doses), dystonia (involuntary muscle contraction), tremors, and dizziness.
Very rare (may affect up to 1 in 10,000 patients): anaphylactic reaction (a severe allergic reaction caused by an immune response, occurring rapidly and frequently presenting with skin reactions, hypotension, nausea, vomiting, or diarrhea) or anaphylactoid reaction (similar to the former but not caused by an immune response), and urticaria.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet.
You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Flutox
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the package and other information
Composition of Flutox coated tablets
The active substance in Flutox is Cloperastine hydrochloride.
The other components (excipients) are for the core: microcrystalline cellulose; colloidal hydrated silica; talc; magnesium stearate. For the coating: hypromellose; povidone; macrogol 4000; talc; sucrose; magnesium carbonate; titanium dioxide (E-171); and erythrosine dye (E-127).
Appearance of the product and contents of the pack
Flutox is presented as round, pink, coated tablets in blisters containing 20 coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Zambon, S.A.U.
Maresme, 5. Polígono Can Bernades-Subirà
08130 Santa Perpètua de Mogoda (Barcelona)
Spain
Manufacturer:
Zambon, S.p.A.
Via della Chimica, 9
Vicenza
Italy
Date of the most recent review of this leaflet: November 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.