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CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP

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About the medicine

How to use CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Sucrose

Dose

4.5 g

10 ml

2.25 g

5 ml

1.35 g

3 ml

0.9 g

2 ml

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/.

Online doctors for CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP

Discuss questions about CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Dr. Lokchiri’s professional training includes:

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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

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If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
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  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Frequently Asked Questions

Is a prescription required for CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP?
CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP?
The active ingredient in CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP is cloperastine. This information helps identify medicines with the same composition but different brand names.
Who manufactures CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP?
CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP is manufactured by Kern Pharma S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP?
Other medicines with the same active substance (cloperastine) include CINFATUSINA 3.54 mg/ml ORAL SUSPENSION, CLOPERASTINE NORMON 3.54 mg/ml ORAL SUSPENSION, FLUTOX 10 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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