Flutox 3.54 mg/ml syrup
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Flutox 3.54 mg/ml syrup
Cloperastine fendizoate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- 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 children from 2 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 to the active substance or to any of the other ingredients 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 2 years of age must not take this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking 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 inner lining of the stomach, or intestinal obstruction.
-
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 airways), or asthma (inflammation and narrowing of the airways), as this medicine may affect mucus clearance and could increase airway resistance.
-
If you have been diagnosed with prostate enlargement (benign prostatic hyperplasia).
-
If your cough persists for more than 7 days of treatment.
Children
This medicine is contraindicated in children under 2 years of age.
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 clear excess mucus and phlegm, because 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, 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 dangerous machinery.
Flutox contains sucrose, propyl parahydroxybenzoate and methyl parahydroxybenzoate, 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 him or her before taking this medicine.
Patients with diabetes mellitus should take into account that this medicine contains:
Sucrose | Dosage |
4.5 g | 10 ml |
2.25 g | 5 ml |
1.35 g | 3 ml |
0.9 g | 2 ml |
This medicine may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate and methyl parahydroxybenzoate.
This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml dose, i.e., 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 contained in this medicine does not produce any perceptible effect.
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: 10 ml, 3 times daily
In children:
Between 7 and 12 years: 5 ml, 2 times daily
Between 5 and 6 years: 3 ml, 2 times daily
Between 2 and 4 years: 2 ml, 2 times daily
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 using the dosing cup provided in the package.
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, consult 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 missed doses.
If you stop taking Flutox
This treatment is symptomatic; if you do not have a cough, do not take it, and if your 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 possible adverse effects 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, rapidly occurring 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 the adverse effects are not listed in this leaflet.
You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 sight and reach of children.
This medicine does not require any special storage conditions.
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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Flutox
The active substance in Flutox is Cloperastine fendizoate.
The other components (excipients) are sucrose; microcrystalline cellulose-sodium carboxymethylcellulose; polyoxy-40-stearate; methyl p-hydroxybenzoate (E-218); propyl p-hydroxybenzoate (E-216); banana flavour (containing propylene glycol E-1520, ethanol); and purified water.
Appearance of the medicine and contents of the pack
Flutox is presented as an opaque white syrup, in bottles of 120 ml and 200 ml.
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
36100 Vicenza
Italy
Date of the most recent revision of this package leaflet: November 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.