Package Insert: Information for the Patient

Cloperastina Normon 3.54 mg/mL Oral Suspension

Cloperastina Fendizoate

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

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

• Keep this package insert, as you may need to refer to 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 not listed in the package insert.
• You should consult your doctor if your condition worsens or does not improve after 7 days.

1. What is Cloperastina Normon and how is it used

2. What you need to know before starting to take Cloperastina Normon

3. How to take Cloperastina Normon

4. Possible adverse effects

5. Storage of Cloperastina Normon

6. Contents of the package and additional information

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

Cloperastina Normon is a medication indicated for the treatment of unproductive forms of cough, such as irritative cough or nervous cough in adults and children aged 2 years and above.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not takeCloperastina 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 depression treatment.
• You are pregnant or think you may be pregnant or breastfeeding.
• Children under 2 years old 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 your cough persists after 7 days of treatment.

Children

Children under 2 years old cannot take this medication, it is contraindicated.

Taking Cloperastina Normon with other medications

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

Cloperastina Normonmay interact with other medications such as:

• Sleeping medications (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
• Depression medications and Parkinson's disease medications because they may potentiate the adverse effects of this medication.
• Expectorants and mucolytics used to eliminate excess mucus and phlegm, because taking them at the same time as a cough medication like Cloperastina Normon may prevent the elimination of excess mucus and cause choking.

Taking Cloperastina Normon with food, drinks, and alcohol

Do not take alcohol during treatment with Cloperastina Normon as it may increase the effects of alcohol.

The taking of this medication with food and drinks does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is contraindicated in pregnancy and breastfeeding.

Driving and operating machinery

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

Cloperastina Normon contains parahydroxybenzoic acid propyl ester, parahydroxybenzoic acid methyl ester, and sodium

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm because it contains parahydroxybenzoic acid propyl ester (E-216) and parahydroxybenzoic acid methyl ester (E-218).

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

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

Cloperastina Normon is contraindicated in children under 2 years.

How to take

Shake the bottle before using it.

This medication is taken orally.

Measure the amount of medication you need to take with the 5 ml syringe with markings at 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml, and intermediate markings every 0.5 ml, included in the box.

If you take moreCloperastina Normonthan you should

The symptoms of overdose are: excitement and difficulty breathing.

If you have taken moreCloperastina Normonthan you should, consult your doctor or pharmacist immediately or call the toxicology information service 91 562 04 20 indicating the medication and the amount taken.

Like all medications,Cloperastina Normonmay cause adverse effects, although not all people will experience them.

The most common ones are: drowsiness and dry mouth.

The adverse effects that may occur are:

Rare: 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not require special conservation conditions.

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

Do not use this medication after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way,you will help protect the environment.

Cloperastina Normon Composition

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

The other components are:parahydroxybenzoate of methyl (E-218),parahydroxybenzoate of propyl (E-216), xanthan gum (E-415), glycerin (E-422), Carbopol 974P, macrogol 40 stearate, sodium saccharin (E-954), banana flavor and purified water.

Product appearance and packaging contents

It is presented in the form of an oral suspension. Each package contains 120 ml or 200 ml of oral suspension and a graduated dosing syringe of 5 mlwith markings at 1 ml, 2 ml, 3 ml, 4 ml and 5 ml and intermediate markings every 0.5 ml.

Marketing authorization holder and responsible manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6- 28760 Tres Cantos- Madrid (SPAIN)

Last review date of this leaflet:

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.