Label: information for the user

oral decongestant solution

dextromethorphan hydrobromide, pseudoephedrine hydrochloride, triprolidine hydrochloride

Read this label carefully before taking this medicine, as it contains important information for you.

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

• Keep this label, 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 label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Cinfatós Decongestive is an association of pseudoephedrine, dextromethorphan, and triprolidine.

Pseudoephedrine acts as a nasal decongestant, dextromethorphan is an antitussive for the relief of unproductive cough (irritative cough, nervous cough) and triprolidine relieves nasal secretion.

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

You should consult your doctor if it worsens or does not improve after5 days.

This medication may cause dependence. Therefore, treatment should be of short duration.

Do not take cinfatós decongestant

• If you are allergic to dextromethorphan, pseudoephedrine, triprolidine, other sympathomimetic medications such as antihistamines or any of the other components of this medication (listed in section 6).
• If you have asthma.
• If you have a cough accompanied by abundant secretions.
• If you have a serious lung disease.
• If you have severe high blood pressure (hypertension) or uncontrolled hypertension with your medication.
• If you have a severe coronary artery disease.
• If you have a severe, acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
• If you are in the first trimester of pregnancy.
• If you have been treated with other medications that inhibit monoamine oxidase (MAO) inhibitors (used to treat depression or Parkinson's disease or other diseases (See section Other medications and cinfatós decongestant), as it may cause a significant increase in blood pressure.
• If you have 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 old.

Warnings and precautions

Consult your doctor or pharmacist before starting to takecinfatós decongestant.

• If after 5 days of treatment you do not improve or have a cough accompanied byfever, rashorpersistent headacheyou should stop treatment and consult with your doctor.
• If you are going to be operated on, you should stop taking the treatment at least 24 hours before.
• 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 benign prostatic hypertrophy in men or moderate or severe kidney disease with reduced function or liver disease with reduced function

• peptic ulcer stenosis (stomach ulcer) or duodenal ulcer (between the stomach and the intestine)
• sedated, weakened or bedridden patients

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

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

If you have chronic or persistent cough, such as that due to smoking or asthma, as it may worsen expectoration and increase resistance in the respiratory tract, or when the cough is accompanied by abundant mucus production.

Cases of dextromethorphan abuse have been reported in adolescents, so this possibility should be taken into account, as it may cause severe side effects (see section “If you take more cinfatós decongestant than you should”).

It is recommended not to use at the same time with other medications for cough or nasal congestion. See “Other medications and cinfatós decongestant”.

Cinfatós decongestant may cause sudden abdominal pain or rectal bleeding due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking cinfatós decongestant and contact your doctor or seek medical attention immediately. See section 4.

Children and adolescents

This medication is contraindicated in children under 6 years old.

Seniors over 60 years old

Seniors over 60 years old may be especially sensitive to the side effects of this medication because it contains pseudoephedrine, as pseudoephedrine overdose may cause hallucinations, central nervous system depression, seizures, and death.

Interference with diagnostic tests:

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

Other medications and cinfatós decongestant

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription.

In particular, if you are using any of the following medications, as 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 reduce the density or facilitate the elimination of mucus and phlegm).
• Haloperidol (medication used to treat psychotic disorders).
• Inhibitors of serotonin reuptake (medications to treat depression such as paroxetine, fluoxetine).
• Alkalizing agents (sodium bicarbonate, citrates) as they may make pseudoephedrine eliminate more slowly and increase its effect and toxicity.
• Anesthetics by inhalation as they may increase the risk of heart problems.
• Some medications to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, metildopa, guanetidina) as it may reduce the effectiveness of these medications.
• Medications that inhibit monoamine oxidase (MAO) that include antidepressants such as tranilcipromina, moclobemida, medications for Parkinson's disease such as selegilina, anticancer medications such as procarbazina, or anti-infectious medications such as linezolida: as they may increase the effects of pseudoephedrine, causing severe hypertension, high fever, and headache. It is recommended to avoid concurrent administration of these medications and even in the 15 days following the end of treatment with MAO inhibitors.
• Stimulants of the nervous system (amphetamine, xanthines) as it may cause nervousness, irritability, insomnia, or possibly seizures or alteration of heart rhythm (arrhythmias)
• Digitalis glycosides (used for the heart) as they may cause alterations in heart rhythm.
• 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 nervous system, its use with pseudoephedrine may increase adverse effects on the heart.
• Other medications belonging to the pseudoephedrine group (sympathomimetic medications), as they may potentiate the effects of pseudoephedrine.
• Alcohol or medications that produce depression on the central nervous system (e.g. tricyclic antidepressants, barbiturates, anesthetics, procarbazina, etc.) may potentiate the depressive effects of these medications or antihistamines, such as triprolidine, causing symptoms of overdose.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant) or other medications with anticholinergic action (such as Belladonna or Belladonna alkaloids): may potentiate the anticholinergic effects of these medications or antihistamines such as triprolidine. If gastrointestinal problems appear, inform patients to report them as soon as possible to the doctor, as it may cause paralytic ileus.
• Fosphenytoin and phenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).
• Otototoxic medications: may mask symptoms of ototoxicity such as tinnitus, dizziness, and vertigo.
• Phototoxic medications: may increase phototoxic effects

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 high body temperature, increased heart rate, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea).

Taking cinfatós decongestant with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with this medication as it may cause drowsiness and increase adverse effects.

Do not take with orange or grapefruit juice as it may increase adverse effects of this medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you 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 may be harmful 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, so it should not be used during lactation.

Driving anduse of machines

In rare cases, during treatment, you may experience drowsiness and dizziness, so if you notice these symptoms, you should not drive 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 if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

Sorbitol may cause gastrointestinal discomfort 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 methyl parahydroxybenzoate sodium (E-219).

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate sodium.

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

The recommended dose is:

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

• In case of need, it could be administered every 6 hours without exceeding 4 doses in 24 hours.

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

• In case of need, it could be administered every 6 hours without exceeding 4 doses in 24 hours.

Severe adverse effects may occur in children in case of overdose, including neurological alterations. Caregivers must not exceed the recommended dose.

• Children under 6 years:This product is contraindicated in children under 6 years.

Over 60 years:Your doctor will indicate the amount and when to take the medication.

How to take

This medication is taken orally.

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

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

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

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

Limit the consumption of beverages containing caffeine (coffee, tea, chocolate, and cola 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 symptoms persist for more than 5 days of treatment, or if 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, disturbances of consciousness, involuntary and rapid eye movements, cardiac disturbances (accelerated heart rate), coordination disturbances, psychosis with visual hallucinations and hyperexcitability.

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

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

In children, very high doses may produce a state of somnolence or lethargy, hallucinations, hysteria, facial edema, excitability, nausea, vomiting, and alterations in gait. In children and elderly patients, involuntary movements, excitement, tremors, mental disturbances with altered perception of reality (psychosis), hallucinations, seizures, difficulty sleeping, and fever may also occur.

Exceptionally, cases of abuse with medications containing dextromethorphan have been reported, particularly by adolescents, with severe adverse effects, such as rapid heartbeats, lethargy, increased or decreased blood pressure, pupil dilation, agitation, dizziness, gastrointestinal discomfort, hallucinations, mumbling speech, involuntary eye movements, fever, rapid breathing, brain damage, involuntary movements, seizures, respiratory depression, loss of consciousness, arrhythmias, and death.

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 cinfatós decongestant

If you forgot to take this medication and symptoms continue, do not take a double dose to compensate for the missed doses. If necessary, continue treatment according to the instructions 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects (unknown frequency): serious diseases that affect the blood vessels in the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using this decongestant immediately and seek urgent medical assistance if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden onset of severe headache

• discomfort

• vomiting

• confusion

• seizures

• changes in vision

During the period of use of this medicine, the following side effects have been observed with an unknown frequency:

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

• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, drowsiness, dilated pupils, rapid heart rate, elevated blood pressure. Nausea, vomiting, diarrhea with blood. Dermatitis, skin rash. Pain or difficulty urinating. Increased sweating, pallor, and weakness.

• Rarely: hallucinations, nightmares, screaming, and confusion in children, seizures, increased heart rate, slow heart rate, myocardial infarction, respiratory difficulty.

• Unknown frequency: involuntary facial muscle movements, clumsiness when walking, tingling, blurred vision, double vision (diplopia), dryness of the nose and throat, thickening of mucosities, irregular heartbeats, decreased blood pressure, dry mouth, loss of appetite, alterations of taste or smell, diarrhea, constipation, or abdominal pain in the upper part of the abdomen, ischemic colitis due to inadequate blood supply.Decreased blood flow to the optic nerve (ischemic neuropathy).

In the event of seizures or hallucinations, stop taking this medicine immediately.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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 this medication if it has been 6 months since the packaging was opened.

Do not store at a temperature above 86°F (30°C).

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Cinfa decongestant composition

• Active principles (per ml contains)

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

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

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

• The 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.

Product appearance and packaging contents

Cinfa decongestant is an oral, transparent, colorless solution with an orange aroma, packaged in glass bottles or polyethylene terephthalate (PET) bottles with a topaz color, containing 125 ml or 200 ml. The packaging includes a graduated dosing cup with measurements from 2.5 ml to 15 ml.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: April 2024.

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/