


Ask a doctor about a prescription for CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP
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.
Contents of the Package Leaflet:
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.
Do not take Cloperastine Kern Pharma
Warnings and Precautions
Consult your doctor or pharmacist before starting to take Cloperastine Kern Pharma
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:
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".
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:
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.
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.
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.
Composition of Cloperastine Kern Pharma
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/.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for CLOPERASTINE KERN PHARMA 3.54 mg/ml SYRUP – subject to medical assessment and local rules.