CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP

Introduction

Package Leaflet: Information for the User

Cloperastine Kern Pharma 3.54 mg/ml Syrup

cloperastine fendizoate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

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

• 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 not listed in this package leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet:

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

1. What is Cloperastine Kern Pharma and what is it used for

Cloperastine, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex. Cloperastine Kern Pharma is a medicine indicated for the treatment of non-productive forms of cough, such as irritative cough or nervous cough for adults and children from 2 years of age.

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

2. What you need to know before taking Cloperastine Kern Pharma

Do not take Cloperastine Kern Pharma

• If you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6).
• If you are allergic to allergy medicines (antihistamines).
• If you are taking medicines for the treatment of depression (monoamine oxidase inhibitors).
• If you are pregnant, think you may be pregnant, or are breastfeeding.
• Children under 2 years of age must not take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Cloperastine Kern Pharma

• If you have high intraocular pressure.
• If you have been told you have prostate hypertrophy (enlargement of the prostate).
• If the cough persists for more than a week, consult your doctor.

Children

Children under 2 years of age must not take this medicine, it is contraindicated.

Other Medicines and Cloperastine Kern Pharma

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

Cloperastine may interact with other medicines such as:

• Sleeping medicines (sedatives, opioid analgesics, barbiturics, hypnotics, or benzodiazepines).
• Medicines for depression and medicines for the treatment of Parkinson's disease, as they may enhance the adverse effects of this medicine.
• Expectorant and mucolytic medicines used to eliminate excess mucus and phlegm, as taking them at the same time as a cough medicine like Cloperastine Kern Pharma may prevent the elimination of excess mucus and cause choking.

Taking Cloperastine Kern Pharma with Food, Drinks, and Alcohol

During treatment with cloperastine, do not drink alcohol, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is contraindicated in pregnancy and breastfeeding.

Driving and Using Machines

Observe your response to the medication, as Cloperastine may cause drowsiness at usual doses. If so, refrain from driving and operating hazardous machinery.

Cloperastine Kern Pharma contains sucrose, propyl hydroxybenzoate (E-216), methyl hydroxybenzoate (E-218), propylene glycol (E-1520), and ethanol

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 4.5 g of sucrose per 10 ml dose.

This medicine may cause allergic reactions (possibly delayed) because it contains propyl hydroxybenzoate (E-216) and methyl hydroxybenzoate (E-218).

This medicine contains 26.4 mg of propylene glycol (E-1520) in each 10 ml dose.

This medicine contains 3.6 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 wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml dose; i.e., it is essentially "sodium-free".

3. How to take Cloperastine Kern Pharma

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

The recommended dose is:

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

For children:

• Between 7 and 12 years: 5 ml, 3 times a day
• Between 5 and 6 years: 3 ml, 2 times a day
• Between 2 and 4 years: 2 ml, 2 times a day

This medicine is contraindicated in children under 2 years of age.

Shake the bottle before use.

This medicine is taken orally.

Measure the amount of medicine to be taken with the measuring cup included in the package.

If you take more Cloperastine Kern Pharma than you should

The symptoms of overdose are: Excitement and difficulty breathing.

If you have taken more Cloperastine than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Cloperastine Kern Pharma

Do not take a double dose to make up for forgotten doses.

This treatment is symptomatic. If you do not have a cough, do not take it, and if it returns, take the medicine as indicated in section 3. How to take Cloperastine Kern Pharma.

4. Possible side effects

Like all medicines, Cloperastine can cause side effects, although not everyone gets them.

The most common side effects, although rare, are: drowsiness and dry mouth.

The side effects that can occur are:

Uncommon (may affect up to 1 in 1000 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 Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cloperastine Kern Pharma

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Once the bottle is opened, the contents must be used within a maximum period of 12 months.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Cloperastine Kern Pharma

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

• The other ingredients are: methyl hydroxybenzoate (E-218), propyl hydroxybenzoate (E-216), microcrystalline cellulose-carmellose sodium, polysorbate 80, sucrose, banana flavor (contains propylene glycol (E-1520) and ethanol), and purified water.

Appearance of the Product and Package Contents

Cloperastine Kern Pharma is presented as a white syrup, in 120 ml or 200 ml PET (plastic) or dark glass bottles, with a metal cap and a measuring cup.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the Last Revision of this Package Leaflet:March 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.