CINFATOS DECONGESTANT ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

cinfatós decongestant oral solution

dextromethorphan hydrobromide, pseudoephedrine hydrochloride, triprolidine hydrochloride

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• 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 a doctor if it worsens or does not improve after 5 days.

Package Leaflet Contents

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

1. What cinfatós decongestant is and what it is used for

cinfatós decongestant is an association of pseudoephedrine, dextromethorphan, and triprolidine.

Pseudoephedrine acts as a nasal decongestant, dextromethorphan is a cough suppressant for the relief of non-productive cough (irritative cough, nervous cough), and triprolidine relieves nasal secretion.

It is indicated for the temporary relief of non-productive cough (irritative cough, nervous cough) accompanied by nasal congestion and nasal secretion, associated with the common cold and flu in adults and children over 6 years of age.

You should consult your doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking cinfatós decongestant

This medication may cause dependence. Therefore, treatment should be short-term.

Do not take cinfatós decongestant

• If you are allergic to dextromethorphan, pseudoephedrine, triprolidine, or other sympathomimetic medications, such as antihistamines, or any of the other components of this medication (listed in section 6).
• If you have asthmatic cough.
• If you have cough accompanied by abundant secretions.
• If you have a severe lung disease.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• If you have severe coronary artery disease.
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• If you are in the first trimester of pregnancy.
• If you are or have been treated in the last 2 weeks with other monoamine oxidase inhibitor (MAOI) medications (used to treat depression or Parkinson's disease or other diseases), as an increase in blood pressure may occur.
• If you have an inflammatory bowel disease that manifests with frequent diarrhea (ulcerative colitis).
• If you have glaucoma (elevated eye pressure).
• If you have hyperthyroidism.
• Children under 6 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take cinfatós decongestant.

• If after 5 days of treatment, you do not improve or have a cough accompanied by fever, rash, or persistent headache, you should stop treatment and consult your doctor.
• If you are going to have surgery, you should stop treatment at least 24 hours in advance.
• If you have:

• atopic dermatitis (inflammatory skin disease) or diabetes or cardiovascular disease, mild or moderate hypertension, or predisposition to glaucoma (elevated eye pressure), or prostate enlargement in men, or moderate or severe kidney disease with reduced function, or liver disease with reduced function.

• peptic ulcer (digestive ulcer) or pyloroduodenal ulcer (between the stomach and intestine)
• sedated, debilitated, or bedridden patients

With cinfatós decongestant, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking cinfatós decongestant and contact your doctor or seek immediate medical attention. See section 4.

There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medications containing pseudoephedrine. PRES and RCVS are rare diseases that may involve reduced blood flow to the brain. Stop using cinfatós decongestant immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to learn about the symptoms, see section 4 "Possible side effects").

If you have chronic or persistent cough, such as that caused by smoking or asthma, as it may worsen expectoration and increase respiratory resistance, or when cough is accompanied by large amounts of sputum.

There have been reports of dextromethorphan abuse in adolescents; therefore, this possibility should be taken into account, as serious side effects may occur (see section "If you take more cinfatós decongestant than you should").

It is recommended not to use it at the same time as other medications for cough or nasal congestion. See "Other medications and cinfatós decongestant".

Abdominal pain or rectal bleeding may occur with the use of cinfatós decongestant due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking cinfatós decongestant and contact your doctor or seek immediate medical attention. See section 4.

Children and Adolescents

This medication is contraindicated in children under 6 years of age.

Over 60 years of age

People over 60 years of age may be especially sensitive to the side effects of this medication because it contains pseudoephedrine; pseudoephedrine overdose can cause hallucinations, central nervous system depression, convulsions, and death.

Interference with laboratory tests:

If you are going to undergo any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking/using this medication, as it may alter the results.

Other medications and cinfatós decongestant

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Amiodarone or quinidine (to treat heart arrhythmias).
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib).
• Bupropion (medication used to quit smoking).
• Expectorants or mucolytics (medications used to decrease the density or facilitate the elimination of mucus and phlegm).
• Haloperidol (medication used to treat psychotic disorders).
• Serotonin reuptake inhibitors (medications used to treat depression, such as paroxetine or fluoxetine).
• Urinary alkalizers (sodium bicarbonate, citrates), as they may cause pseudoephedrine to be eliminated more slowly and increase its effect and toxicity.
• Inhaled anesthetics, as they may increase the risk of heart problems.
• Certain medications to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine), as they may decrease the effectiveness of these medications.
• Monoamine oxidase inhibitor (MAOI) medications, including antidepressants like tranylcypromine or moclobemide, medications for Parkinson's disease like selegiline, anticancer medications like procarbazine, or anti-infective medications like linezolid, as they may increase the effects of pseudoephedrine, causing severe hypertension, very high fever, and headache. Concomitant administration of these medications should be avoided, even in the 15 days following the end of MAOI treatment.
• Central nervous system stimulants (amphetamines, xanthines), as they may cause nervousness, irritability, insomnia, or possibly convulsions or cardiac arrhythmias.
• Digitalis glycosides (used for the heart), as they may cause cardiac arrhythmias.
• Thyroid hormones (used for thyroid diseases), as the effects of both hormones and pseudoephedrine may be increased.
• Levodopa (used to treat Parkinson's disease), as it may increase heart rate (arrhythmias).
• Nitrates (used to treat angina pectoris), as their effects may be reduced.
• Cocaine, which, in addition to stimulating the central nervous system, may increase the adverse effects on the heart when used with pseudoephedrine.
• Other medications belonging to the pseudoephedrine group (sympathomimetic medications), as they may potentiate the effects of pseudoephedrine.
• Alcohol or medications that depress the central nervous system (e.g., tricyclic antidepressants, barbiturates, anesthetics, procarbazine, etc.), as the depressant effects of these medications or antihistamines like triprolidine may be potentiated, causing symptoms of overdose.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant) or other medications with anticholinergic action (such as belladonna or belladonna alkaloids): the anticholinergic effects of these medications or antihistamines like triprolidine may be potentiated. If gastrointestinal problems occur, patients should inform their doctor as soon as possible, as paralytic ileus may occur.
• Phenytoin and fosphenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).
• Ototoxic medications: the symptoms of ototoxicity, such as tinnitus, dizziness, and vertigo, may be masked.
• Photosensitizing medications: the photosensitizing effects may be increased.

If you are taking other medications, such as antidepressants or antipsychotics, cinfatós decongestant may interact with these medications, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects, such as body temperature above 38°C, increased heart rate, hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Taking cinfatós decongestant with food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment with this medication, as it may cause drowsiness and increase side effects.

Do not take it with grapefruit or bitter orange juice, as it may increase the side effects of this medication.

Limit the consumption of beverages containing caffeine (coffee, tea, chocolate, and cola-based drinks) while taking this medication.

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 medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

This medication is contraindicated in the first trimester of pregnancy.

This medication is excreted in breast milk; therefore, it should not be used during the breastfeeding period.

Driving and Using Machines

On rare occasions, during treatment, drowsiness and dizziness may occur; if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

cinfatós decongestant contains sorbitol (E-420).

This medication contains 200 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

cinfatós decongestant contains sodium.

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

cinfatós decongestant contains methylparaben (E-219).

It may cause allergic reactions (possibly delayed) because it contains methylparaben.

3. How to take cinfatós decongestant

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years: It is recommended to take 10 ml every 8 hours, 3 times a day.

• If necessary, it can be administered every 6 hours, not exceeding 4 doses in 24 hours.

Children from 6 to 12 years: It is recommended to take 5 ml every 8 hours, 3 times a day.

• If necessary, it can be administered every 6 hours, not exceeding 4 doses in 24 hours.

Severe side effects may occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

• Children under 6 years: The use of this medication is contraindicated in children under 6 years of age.

Over 60 years of age:Your doctor will indicate the amount and when you should take the medication.

How to take it

This medication is taken orally.

cinfatós decongestant is administered orally. To take the correct amount of this medication, use the measuring cup included in the package.

It is recommended to take this medication with meals and drink plenty of water during treatment.

Do not take it with alcoholic beverages, as it may cause side effects.

Do not take it with grapefruit or bitter orange juice, as it may cause a hypertensive crisis.

Limit the consumption of beverages containing caffeine (coffee, tea, chocolate, and cola-based drinks).

If the medication is taken at night, it should be taken a few hours before bedtime to reduce the possibility of insomnia in patients with difficulty sleeping.

You should consult your doctor if it worsens, if the symptoms persist for more than 5 days of treatment, or if they are accompanied by high fever.

If you take more cinfatós decongestant than you should

If you take more cinfatós decongestant than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

In children, very high doses can cause a state of stupor or lethargy, hallucinations, hysteria, facial edema, excitability, nausea, vomiting, and changes in gait. In children and elderly patients, uncontrolled movements, excitement, tremors, mental disorder with altered perception of reality (psychosis), hallucinations, convulsions, difficulty sleeping, and fever may also occur.

Exceptionally, cases of abuse with medications containing dextromethorphan have been reported, particularly by adolescents, with serious side effects, such as rapid heartbeats, lethargy, increased or decreased blood pressure, dilated eye pupils, agitation, dizziness, gastrointestinal upset, hallucinations, slurred speech, involuntary eye movements, fever, rapid breathing, brain damage, uncontrolled movements, convulsions, respiratory depression, loss of consciousness, arrhythmias, and death.

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 medication and the amount ingested.

If you forgot to take cinfatós decongestant

If you forgot to take this medication and the symptoms continue, do not take a double dose to make up for the missed doses. If necessary, restart treatment as indicated in the section "3. How to take cinfatós decongestant".

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe adverse effects (frequency not known): serious diseases that affect the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using cinfatos decongestant immediately and seek urgent medical attention if you experience symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache
• discomfort
• vomiting
• confusion
• seizures
• changes in vision

During the period of use of this medicine, the following adverse effects have been observed, whose frequency could not be established with precision:

• More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremors. Alteration of taste.

• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, somnolence, dilation of the pupils, rapid heartbeats, high blood pressure. Nausea, vomiting, bloody diarrhea. Dermatitis, skin rash. Pain or difficulty urinating. Increased sweating, paleness, and weakness.

• Rarely: hallucinations, nightmares, screaming, and confusion in children, seizures, increased heart rate, slow heartbeats, infarction, breathing difficulties.

• Frequency not known: involuntary movements of the facial muscles, difficulty walking, tingling, blurred vision, double vision (diplopia), dryness of the nose and throat, thickening of mucus, irregular heartbeats, decreased blood pressure, dry mouth, loss of appetite, alterations in taste or smell, diarrhea, constipation, or pain in the upper abdomen, inflammation of the colon due to insufficient blood irrigation (ischemic colitis). Decreased blood flow to the optic nerve (ischemic neuropathy).

If you experience seizures or hallucinations, stop taking this medicine immediately.

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 that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Cinfatos Decongestant

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 this medicine if 6 months have passed since the opening date of the packaging.

Do not store at a temperature above 30°C.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Cinfatos Decongestant

• Active principles (each ml contains)

Dextromethorphan hydrobromide ……………………………………………… 2 mg

Pseudoephedrine hydrochloride ……………………………….……..……………… 6 mg

Triprolidine hydrochloride ………………………………………….….………….. 0.25 mg

• Other components are: citric acid monohydrate (E-330), methyl parahydroxybenzoate sodium (E-219), non-crystallizable liquid sorbitol (E-420), sodium saccharin (E-954), sodium cyclamate, orange flavor, and purified water.

Appearance of the Product and Packaging Content

Cinfatos decongestant is a transparent, colorless, and orange-flavored oral solution, packaged in glass or polyethylene terephthalate (PET) topaz-colored bottles with 125 ml or 200 ml. The packaging includes a graduated dosing cup with measures from 2.5 ml to 15 ml.

Only some package sizes may be marketed.

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 Prospectus:April 2024.

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