Cloperastine Normon 3.54 mg/ml oral suspension
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- **Cloperastine Normon 3.54 mg/ml oral suspension**
- 1. What Cloperastine Normon is and what it is used for
- 2. What you need to know before taking Cloperastine Normon
- 3. How to take Cloperastine Normon
- 4. Possible adverse effects
- 5. Storage of Cloperastine Normon
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Cloperastine Normon 3.54 mg/ml oral suspension
cloperastine fendizoate
Read this 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 your doctor if you worsen or do not improve after 7 days.
Leaflet contents:
- What Cloperastine Normon is and what it is used for
- What you need to know before taking Cloperastine Normon
- How to take Cloperastine Normon
- Possible adverse effects
- How to store Cloperastine Normon
- Package contents and additional information
1. What Cloperastine Normon is and what it is used for
Cloperastine, the active ingredient in this medicine, is an antitussive that inhibits the cough reflex.
Cloperastine Normon 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 symptoms worsen or do not improve after 7 days of treatment.
2. What you need to know before taking Cloperastine Normon
Do not take Cloperastine Normon if
- You are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6). You are allergic to antiallergy medicines (antihistamines).
- You are taking medicines for the treatment of depression.
- 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
Consult your doctor or pharmacist before taking Cloperastine Normon:
- If you have increased intraocular pressure.
- If you have been diagnosed with prostate enlargement (benign prostatic hyperplasia).
- If you experience difficulty in urination.
- If you suffer from hypertension.
- If you have heart problems.
- If you have a muscle degenerative disorder called myasthenia gravis.
- If you have any type of gastric or intestinal obstruction, including peptic ulcer.
- If you have chronic cough due to smoking, lung disease, or asthma.
- If your cough persists after 7 days of treatment.
Children
Cloperastine Normon is contraindicated in children under 2 years of age.
Other medicines and Cloperastine Normon
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Cloperastine Normon may interact with other medicines such as:
- Medicines used to help you sleep (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
- Medicines for depression and medicines used to treat Parkinson's disease, as they may enhance the adverse effects of this medicine.
- Expectorant and mucolytic medicines used to eliminate excess mucus and phlegm, because when taken simultaneously with a cough medicine such as Cloperastine Normon, they may prevent the elimination of mucus and cause choking.
Taking Cloperastine Normon with food, drinks and alcohol
Alcohol must not be consumed during treatment with Cloperastine Normon, as it may enhance 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.
Cloperastine Normon is contraindicated during pregnancy and breastfeeding.
Driving and using machines
Cloperastine Normon may cause drowsiness at usual doses. If this occurs, refrain from driving or operating dangerous machinery.
Cloperastine Normon contains propyl parahydroxybenzoate, methyl parahydroxybenzoate and sodium
May cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).
This medicine contains less than 1 mmol of sodium (23 mg) per ml; hence, it is essentially "sodium-free".
3. How to take Cloperastine Normon
Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
In adults and children over 12 years of age: 10 ml, 3 times a day.
In children: | Between 7 and 12 years: 5 ml, twice daily. Between 5 and 6 years: 3 ml, twice daily. Between 2 and 4 years: 2 ml, twice daily. |
Cloperastine Normon is contraindicated in children under 2 years of age.
Shake the bottle before use.
This medicine is taken orally.
Measure the required dose using the 5 ml graduated syringe included in the package, which has markings at 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml, with intermediate markings every 0.5 ml.
If you take more Cloperastine Normon than you should
Symptoms of overdose include: excitement and difficulty breathing.
If you have taken more Cloperastine Normon 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 Cloperastine Normon
Do not take a double dose to make up for forgotten doses.
This treatment is symptomatic; do not take it if you do not have a cough. If your cough returns, take the medicine as indicated in section 3, "How to take Cloperastine Normon".
4. Possible adverse effects
Like all medicines, Cloperastine Normon can cause adverse effects, although not everyone experiences them.
The most commonly occurring adverse effects, although infrequent, are: drowsiness and dry mouth.
The following adverse effects may occur:
Uncommon: may affect up to 1 in 100 patients: drowsiness, dry mouth (at high doses), movement disorders, tremors, and dizziness.
Very rare: may affect up to 1 in 10,000 patients: allergic reaction, urticaria.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Cloperastine Normon
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
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. Unwanted medicines and their containers should be taken to a pharmacy’s SIGRE Point. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cloperastine Normon
The active substance is cloperastine (as fendizoate). Each ml contains 3.54 mg of cloperastine fendizoate (equivalent to 2 mg of cloperastine hydrochloride).
The other components (excipients) are: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), xanthan gum (E-415), glycerin (E-422), Carbopol 974P, macrogol 40 stearate, sodium saccharin (E-954), banana flavor, and purified water.
Appearance of the product and contents of the pack
It is presented as an oral suspension. Each container contains 120 ml or 200 ml of oral suspension and a graduated 5 ml dosing syringe with markings at 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml, and intermediate markings every 0.5 ml.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)
Date of the most recent revision of this summary: February 2026
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.