Cloperastine Kern Pharma 3,54 mg/ml syrup

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cloperastina Kern Pharma 3.54 mg/ml syrup

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 reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or do not improve after 7 days.

Contents of this leaflet:

1. What Cloperastina Kern Pharma is and what it is used for
2. What you need to know before taking Cloperastina Kern Pharma
3. How to take Cloperastina Kern Pharma
4. Possible side effects
5. How to store Cloperastina Kern Pharma
6. Contents of the pack and other information

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

Cloperastine, the active substance of this medicine, is an antitussive 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, 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 starting to take Cloperastina Kern Pharma

Do not take Cloperastina Kern Pharma

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to antiallergy 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

Talk to your doctor or pharmacist before taking Cloperastina Kern Pharma if:

• You have high intraocular pressure.
• You have been diagnosed with prostate enlargement (prostatic hypertrophy).
• Your cough persists for more than one week; consult your doctor.

Children

Cloperastina Kern Pharma is contraindicated in children under 2 years of age.

Other medicines and Cloperastina Kern Pharma

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

Cloperastina may interact with other medicines such as:

• Medicines for 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.
• Expectorants and mucolytics used to eliminate excess mucus and phlegm, because taking them at the same time as a cough medicine such as Cloperastina Kern Pharma may prevent the elimination of excess mucus and cause choking.

Taking Cloperastina Kern Pharma with food, drinks, and alcohol

Do not consume alcohol during treatment with cloperastine, 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 during pregnancy and breastfeeding.

Driving and use of machines

Observe how you react to the medication, because Cloperastina may cause drowsiness at usual doses. If this occurs, refrain from driving or operating dangerous machinery.

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

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware 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 parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (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 contained in this medicine does not produce any perceptible effect.

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

3. How to take Cloperastine Kern Pharma

Follow exactly the administration instructions for Cloperastine provided in this leaflet or those indicated by your doctor. In case of 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, 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 using the dosing cup provided in the package.

If you take more Cloperastine Kern Pharma than you should

Symptoms of overdose include: Excitation and difficulty breathing.

If you have taken more Cloperastine than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Cloperastine Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, Cloperastine may cause adverse effects, although not everyone experiences them.

The most commonly occurring adverse effects, although infrequent, are: drowsiness and dry mouth.

The possible adverse effects are:

Uncommon (may affect up to 1 to 10 in 1000 patients): drowsiness, dry mouth (at high doses).

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

After opening the bottle, the contents should be used within a maximum period of 12 months.

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

6. Contents of the pack and other information

Composition of Cloperastine Kern Pharma

• The active substance is cloperastine fendizoate. Each ml of syrup 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), microcrystalline cellulose-sodium carmellose, polysorbate 80, sucrose, banana flavour (containing propylene glycol (E-1520) and ethanol), and purified water.

Appearance of the medicinal product and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the most recent revision of this leaflet: March 2022

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