Leaflet: information for the user

Cloperastina Kern Pharma 3.54 mg/ml syrup

cloperastina fendizoate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in the leaflet. See section 4.
• You should consult your doctor if you get worse or do not improve after 7 days.

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

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you are allergic to allergy medications (antihistamines).
• If you are taking medications for depression (monoamine oxidase inhibitors).
• If you are pregnant, or think you may be pregnant, or if you are breastfeeding.
• Children under 2 years old cannot take this medication.

Warnings and precautions

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

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

Children

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

Other medications and Cloperastina Kern Pharma

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

Cloperastina may interact with other medications such as:

• Sleeping medications (sedatives, analgesic opioids, barbiturates, hypnotics, or benzodiazepines).
• Depression medications and medications for Parkinson's disease treatment 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 Kern Pharma may prevent the elimination of excess mucus and cause choking.

Cloperastina Kern Pharma with food, drinks, and alcohol

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

The taking of this medication 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

This is contraindicated in pregnancy and breastfeeding.

Driving and operating machinery

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

Cloperastina Kern Pharma contains saccharose, propylparaben (E-216), methylparaben (E-218), propylene glycol (E-1520), and ethanol

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

This medication may cause allergic reactions (possibly delayed) because it contains propylparaben (E-216) and methylparaben (E-218).

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

This medication contains 3.6 mg of alcohol (ethanol) in each dose of 10 ml. The amount in 10 ml of this medication is equivalent to less than 1 ml of beer or wine. The small amount of alcohol contained in this medication does not produce any perceptible effect.

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

Follow exactly the administration instructions for Cloperastina contained in this leaflet or those 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 medication is contraindicated in children under 2 years

Shake the bottle before using it.

This medication is taken orally.

Measure the amount of medication you need to take with the dosing cup included in the package.

If you take more Cloperastina Kern Pharma than you should

The symptoms of overdose are: Excitement and difficulty breathing.

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

If you forgot to take Cloperastina Kern Pharma

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Cloperastina may produce adverse effects, although not all people will experience them.

The adverse effects that may occur, although they are infrequent, are: drowsiness and dry mouth.

The adverse effects that may occur are:

Infrequent(may affect up to 1 to 10 of every 1000 patients): drowsiness, dry mouth (at high doses).

Very Rare(may affect up to 1 of every 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 prospectus. 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 packaging. 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.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Cloperastina Kern Pharma

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

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

Appearance of the product and contents of the packaging

Cloperastina Kern Pharma is presented in the form of a white syrup, in 120 ml or 200 ml PET (plastic) or dark glass bottles with a metal cap and a dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this leaflet:March 2022

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