Package Insert: Information for the User

cinfatusina 3.54 mg/ml oral suspension

Cloperastina fendizoate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Cloperastine, the active ingredient of this medication, is an antitussive that inhibits the cough reflex. Cinfatusina 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 cinfatusina

• If you are allergic to cloperastina fendizoate or 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 treatment.
• If you are pregnant or believe you may be pregnant or if you 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 experience difficulty urinating.
• If you are hypertensive.
• If you have heart problems.
• If you have a degenerative muscle disease called myasthenia gravis.
• If you have any type of gastrointestinal or intestinal obstruction, including ulcers.
• If you have chronic cough due to smoking, respiratory problems, or asthma.
• If the cough persists after 7 days of treatment.

Children

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

Other medications and cinfatusina

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

Cinfatusina may interact with other medications such as:

• Sleeping medications (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
• Depression medications and Parkinson's disease medications 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 cinfatusina may prevent the elimination of excess mucus and cause choking.

Taking cinfatusina with food, drinks, and alcohol

During treatment with cinfatusina, do not consume alcohol as it may increase the effects of alcohol.

The taking of this medication with food and drinks does not affect its efficacy.

Pregnancy and lactation

If you are pregnant or breastfeeding, or believe you may be pregnant, consult your doctor or pharmacist before using this medication.

It is contraindicated in pregnancy and lactation.

Driving and operating machinery

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

Cinfatusina contains parahydroxybenzoate of methyl and parahydroxybenzoate of propyl.

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

Cinfatusina contains sodium.

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

Follow exactly the administration instructionscontainedin this leaflet or those 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: 10 ml, 3 times a day.

For children:Between 7 and 12 years: 5 ml, 2 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.

Cinfatusina is contraindicated in children under 2 years.

Shake the bottle before using it.

This medication is taken orally.

To administer correctly, use the dropper or dosing cup included in the packaging.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take cinfatusina

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. If you cough again, take the medication as indicated in section 3. How to take Cinfatusina.

Like all medications, this medication 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 in 100 patients): drowsiness, dry mouth (at high doses), movement alterations, tremors, and dizziness.

Very rare (may affect up to 1 in 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.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use cinfatusina after eighteen months of the packaging opening date.

Medicines should not be thrown down the drain or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Cinfatusina Composition

The active principle 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.

Product appearance and packaging contents

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

Marketing authorization holder and manufacturer responsible

Cinfa Laboratories, S.A

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:February 2021

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