CLOPERASTINE NORMON 3.54 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Cloperastina Normon 3.54 mg/ml Oral Suspension

cloperastine fendizoate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• 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 side effects not listed in the package leaflet.
• You should consult your doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet:

1. What is Cloperastina Normon and what is it used for
2. What you need to know before taking Cloperastina Normon
3. How to take Cloperastina Normon
4. Possible side effects
5. Storage of Cloperastina Normon
6. Package Contents and Additional Information

1. What is Cloperastina Normon and what is it used for

The active ingredient of this medication, cloperastine, is an antitussive that inhibits the cough reflex.

Cloperastina Normon is a medication indicated for the treatment of non-productive forms of cough, such as irritative 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 Cloperastina Normon

Do not take Cloperastina Normon if

• You are allergic (hypersensitive) to the active ingredient or any of the other components of Cloperastina Normon.
• 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 2 years of age cannot take this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Cloperastina Normon:

• 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 medication; it is contraindicated.

Taking Cloperastina Normon with other medications

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

Cloperastina Normon 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 Cloperastina Normon may prevent the elimination of excess mucus and produce choking.

Taking Cloperastina Normon with food, drinks, and alcohol

During treatment with Cloperastina Normon, 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

Cloperastina Normon may cause drowsiness at usual doses. If so, refrain from driving and operating hazardous machinery.

Cloperastina Normon contains propyl parahydroxybenzoate, methyl parahydroxybenzoate, and sodium

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm, as it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

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

3. How to take Cloperastina Normon

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

For adults and children over 12 years old: 10 ml, 3 times a day

Cloperastina Normon is contraindicated in children under 2 years of age.

How to take

Shake the bottle before use.

This medication is taken orally.

Measure the amount of medication to be taken with the 5 ml graduated syringe with marks at 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml and intermediate marks every 0.5 ml, included in the box.

If you take more Cloperastina Normon than you should

The symptoms of overdose are: excitement and difficulty breathing.

If you have taken more Cloperastina Normon 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.

4. Possible side effects

Like all medications, Cloperastina Normon can cause side effects, although not everyone experiences them.

The most common ones are: drowsiness and dry mouth.

Side effects that may occur are:

Uncommon: may affect up to 1 in 100 patients: drowsiness, dry mouth (at high doses).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cloperastina Normon

This medication does not require special storage conditions.

Keep this medication out of the 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 medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Cloperastina Normon

The active ingredient is cloperastine (as fendizoate). Each ml contains 3.54 mg of cloperastine fendizoate (equivalent to 2 mg of cloperastine hydrochloride).

The other components 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 Package Contents

It is presented as an oral suspension. Each package contains 120 ml or 200 ml of oral suspension and a 5 ml graduated syringe with marks at 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml and intermediate marks 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 Last Revision of this Package Leaflet:

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/.