CINFATUSINA 3.54 mg/ml ORAL SUSPENSION

Introduction

Leaflet: information for the user

cinfatusina 3.54 mg/ml oral suspension

Cloperastine fendizoate

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

Follow the administration instructions of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

1. What cinfatusina is and what it is used for.
2. What you need to know before taking cinfatusina.
3. How to take cinfatusina.
4. Possible side effects.
5. Storage of cinfatusina.
6. Package contents and additional information.

1. What cinfatusina is and what it is used for

Cloperastine, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex. Cinfatusina 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 old.

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 cinfatusina

Do not take cinfatusina

• If you are allergic to cloperastine fendizoate or 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.
• If you are pregnant or think you may be pregnant or are breastfeeding.
• Do not administer cinfatusina to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfatusina:

• If you have high intraocular pressure.
• If you have been told you have prostate hypertrophy.
• If you have difficulty urinating.
• If you have high blood pressure.
• If you have heart problems.
• If you have a degenerative muscle disease called myasthenia gravis.
• If you have any type of gastric or intestinal obstruction, including ulcers.
• If you have chronic cough due to smoking, lung problems, or asthma.
• If the cough persists after 7 days of treatment.

Children

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

Other medicines and cinfatusina

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Cinfatusina may interact with other medicines such as:

• Medicines to help you sleep (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
• Medicines for depression and medicines for the treatment of Parkinson's disease because they may potentiate the adverse effects of this medicine.
• Expectorant and mucolytic medicines used to eliminate excess mucus and phlegm, because taking them at the same time as a cough medicine like cinfatusina may prevent the elimination of excess mucus and produce choking.

Taking cinfatusina with food, drinks, and alcohol

During treatment with Cinfatusina, 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 and breastfeeding

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.

It is contraindicated in pregnancy and breastfeeding.

Driving and using machines

Cinfatusina may cause drowsiness at usual doses. If so, avoid driving and operating hazardous machinery.

Cinfatusina contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Cinfatusina contains sodium.

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

3. How to take cinfatusina

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

For adults and adolescents over 12 years old: 10 ml, 3 times a day.

For children: Between 7 and 12 years old: 5 ml, 2 times a day.

Between 5 and 6 years old: 3 ml, 2 times a day.

Between 2 and 4 years old: 2 ml, 2 times a day.

Cinfatusina is contraindicated in children under 2 years old.

Shake the bottle before use.

This medicine is taken orally.

For correct administration, use the measuring cup or dosing syringe included in the package.

If you take more cinfatusina than you should

The symptoms of overdose are: excitement and difficulty breathing.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take cinfatusina

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 Cinfatusina.

4. Possible side effects

Like all medicines, this medicine 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 may occur are:

Uncommon (may affect up to 1 in 100 patients): drowsiness, dry mouth (at high doses), movement disorders, tremors, and dizziness.

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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of cinfatusina

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

This medicine does not require special storage conditions.

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

Do not use cinfatusina after 18 months from the opening date of the package.

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

6. Package contents and additional information

Composition of cinfatusina

The active ingredient of cinfatusina is cloperastine fendizoate. Each ml of oral suspension 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), Xanthan gum (E-415), Glycerol (E-422), Carbomers (Carbopol 974 P), Macrogol stearate, Banana flavor, Sodium saccharin (E-954), and Purified water.

Appearance of the product and package contents

It is presented as an oral suspension. Each package contains 120 ml or 200 ml of oral suspension and a measuring cup with measures from 2.5 to 15 ml, as well as a dosing syringe with measures from 0.25 ml to 5 ml.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this leaflet:February 2021

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