CINFATOS DECONGESTANT ORAL SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cinfatós decongestant oral solution

Dextromethorphan hydrobromide, Pseudoephedrine hydrochloride, Triprolidine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days.

Contents of the leaflet

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 adverse effects
5. How to store Cinfatós decongestant
6. Contents of the pack and other information

1. What Cinfatós Decongestant Is and What It Is Used For

Cinfatós decongestant is a combination of pseudoephedrine, dextromethorphan, and triprolidine.

Pseudoephedrine acts as a nasal decongestant, dextromethorphan is an antitussive used to relieve non-productive cough (irritative cough, nervous cough), and triprolidine helps relieve nasal discharge.

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

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

2. What you need to know before starting Cinfatós decongestant

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

Do not take Cinfatós decongestant

• If you are allergic to dextromethorphan, pseudoephedrine, triprolidine, other sympathomimetic medicines such as antihistamines, or any of the other components of this medicine (listed in section 6).
• If you have asthmatic cough.
• If you have cough accompanied by abundant secretions.
• If you have a serious lung disease.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension not managed by your medication.
• If you have severe coronary artery disease.
• If you have severe, acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
• If you are in the first trimester of pregnancy.
• If you are currently or have been treated in the last 2 weeks with other medicines such as monoamine oxidase inhibitors (MAOIs) (used to treat depression, Parkinson's disease, or other conditions) (see section "Other medicines and Cinfatós decongestant"), as this may cause an increase in blood pressure.
• If you suffer from inflammatory bowel disease causing frequent diarrhea (ulcerative colitis).
• If you have glaucoma (increased 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 if your cough is accompanied by fever, rash, or persistent headache, you should stop treatment and consult your doctor.

• If you are due to undergo surgery, you must stop treatment at least 24 hours beforehand.

• If you suffer from:

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

• stenosing peptic ulcer (digestive ulcer) or pyloroduodenal ulcer (between stomach and 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 immediate medical attention. See section 4.

Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Cinfatós decongestant immediately and seek immediate medical help if you experience symptoms that could indicate RPES or RCVS (see section 4 "Possible side effects" for symptoms).

If you have chronic or persistent cough, such as that caused by smoking or asthma, as it may impair expectoration and increase airway resistance, or when cough is accompanied by excessive phlegm production.

Cases of dextromethorphan abuse in adolescents have been reported; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section “If you take more Cinfatós decongestant than you should”).

It is recommended not to use this medicine simultaneously with other cough or nasal decongestant medicines. See “Other medicines and Cinfatós decongestant”.

Abdominal pain or rectal bleeding may occur with 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 medicine is contraindicated in children under 6 years of age.

Patients over 60 years old

Patients over 60 years of age may be especially sensitive to the adverse effects of this medicine because it contains pseudoephedrine. Overdose of pseudoephedrine may cause hallucinations, central nervous system (CNS) depression, seizures, and death.

Interference with diagnostic tests:

If you are scheduled to undergo any diagnostic tests (including blood or urine tests, skin allergy tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Other medicines and Cinfatós decongestant

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

In particular, if you are using any of the following medicines, dosage adjustment or discontinuation of treatment may be necessary:

• Amiodarone or quinidine (used to treat heart arrhythmias).
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib).
• Bupropion (a medicine used to quit smoking).
• Expectorants or mucolytics (medicines used to reduce mucus thickness or facilitate mucus expulsion).
• Haloperidol (a medicine used to treat psychotic disorders).
• Serotonin reuptake inhibitors (medicines used to treat depression such as paroxetine, fluoxetine).
• Urinary alkalinizers (sodium bicarbonate, citrates), as they may slow down the elimination of pseudoephedrine, increasing its effect and toxicity.
• Inhalational anesthetics, as they may increase the risk of heart problems.
• Some medicines to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine), as they may reduce the effectiveness of these medicines.
• Monoamine oxidase inhibitors (MAOIs), including antidepressants such as tranylcypromine, moclobemide; medicines for Parkinson's disease such as selegiline; anticancer drugs such as procarbazine; or anti-infectives such as linezolid: these may increase the effects of pseudoephedrine, causing severe high blood pressure, very high fever, and headache. Concomitant administration of these medicines should be avoided, including within 15 days after stopping MAOI treatment.
• Central nervous system stimulants (amphetamines, xanthines), as they may cause nervousness, irritability, insomnia, or possibly seizures or heart rhythm disturbances (arrhythmias).
• Digitalis glycosides (used for heart conditions), as they may cause disturbances in heart rhythm.
• Thyroid hormones (used for thyroid diseases), as the effects of both the hormones and pseudoephedrine may be enhanced.
• 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 adverse cardiac effects when used with pseudoephedrine.
• Other medicines belonging to the pseudoephedrine group (sympathomimetic medicines), as they may enhance its effects.
• Alcohol or medicines causing central nervous system depression (e.g., tricyclic antidepressants, barbiturates, anesthetics, procarbazine, etc.), as their depressant effects or those of antihistamines such as triprolidine may be enhanced, possibly causing overdose symptoms.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant), or other medicines with anticholinergic action (such as Belladonna or belladonna alkaloids): anticholinergic effects of these medicines or antihistamines such as triprolidine may be enhanced. If gastrointestinal problems occur, patients should be advised to inform their doctor immediately, as paralytic ileus may occur.
• Phenytoin and fosphenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).
• Ototoxic medicines: symptoms of ototoxicity such as tinnitus, dizziness, and vertigo may be masked.
• Photosensitizing medicines: photosensitizing effects may be increased.

If you are taking other medicines such as antidepressants or antipsychotics, Cinfatós decongestant may interact with them, 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, high blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Taking Cinfatós decongestant with food, drinks, and alcohol

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

Do not take this medicine with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.

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

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. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

This medicine is contraindicated during the first trimester of pregnancy.

This medicine is excreted in breast milk and therefore should not be used during breastfeeding.

Driving and use of machines

Rarely, during treatment, mild drowsiness or dizziness may occur. If you experience these symptoms, you should not drive or operate dangerous machinery.

Cinfatós decongestant contains sorbitol (E-420).

This medicine contains 200 mg of sorbitol per ml.

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

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Cinfatós decongestant contains sodium.

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

Cinfatós decongestant contains sodium methyl parahydroxybenzoate (E-219).

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

3. How to take Cinfatós decongestant

Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years of age: 10 ml every 8 hours, 3 times a day.

• If necessary, it may be administered every 6 hours, without exceeding 4 doses in 24 hours.

Children aged 6 to 12 years: 5 ml every 8 hours, 3 times a day.

• If necessary, it may be administered every 6 hours, without exceeding 4 doses in 24 hours.

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

• Children under 6 years of age: Use is contraindicated in children under 6 years of age.

Patients over 60 years of age: Your doctor will determine the appropriate dose and timing for taking the medicine.

How to take

This medicine is taken orally.

Cinfatós decongestant is administered orally. To ensure the correct dosage, use the measuring cup provided in the package.

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

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

Do not take together with grapefruit juice or bitter orange juice, as this may trigger a hypertensive crisis.

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

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

You should consult your doctor if your condition worsens, if 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, disturbances of consciousness, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include: coma, severe breathing difficulties, and seizures.

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

In children, very high doses may cause drowsiness or lethargy, hallucinations, hysteria, facial swelling, excitability, nausea, vomiting, and disturbances in gait. In children and elderly patients, uncontrolled movements, excitement, tremors, mental disturbances with altered perception of reality (psychosis), hallucinations, seizures, difficulty sleeping, and fever may also occur.

Rarely, cases of abuse of medicines containing dextromethorphan have been reported, particularly among adolescents, resulting in serious adverse effects such as rapid heartbeat, lethargy, increased or decreased blood pressure, pupil dilation, agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, involuntary eye movements, fever, rapid breathing, brain damage, uncontrolled 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cinfatós decongestant

If you forget to take this medicine and your symptoms persist, do not take a double dose to make up for the missed doses. If continuing treatment is necessary, restart as indicated in section “3. How to take Cinfatós decongestant”.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects (frequency not known): serious diseases affecting the blood vessels in the brain, known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Cinfatos descongestivo immediately and seek urgent medical attention if you experience symptoms that could be signs of reversible posterior encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden, severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

During the use of this medicine, the following adverse effects have been observed, for which the frequency could not be accurately determined:

• More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremor, taste disturbance.

• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, somnolence, pupil dilation, rapid heartbeat, elevated blood pressure. Nausea, vomiting, bloody diarrhea. 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 heartbeat, heart attack, breathing difficulties.

• Frequency not known: involuntary facial muscle movements, unsteady gait, tingling, blurred vision, double vision (diplopia), dryness of nose and throat, thickening of mucus, irregular heartbeat, decreased blood pressure, dry mouth, loss of appetite, taste or smell disturbances, diarrhea, constipation or upper abdominal pain, inflammation of the colon due to insufficient blood supply (ischemic colitis). Reduced blood flow to the optic nerve (ischemic neuropathy).

If seizures or hallucinations occur, 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinfatós descongestivo

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not use this medicine if 6 months have passed since the container was opened.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cinfatós Decongestant

• Active ingredients (each ml contains):

Dextromethorphan hydrobromide……………………………………………… 2 mg
Pseudoephedrine hydrochloride……………………………………………… 6 mg
Tripolidine hydrochloride…………………………………………………… 0.25 mg

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

Appearance of the product and contents of the container

Cinfatós Decongestant is a transparent, colorless oral solution with an orange aroma, packed in amber-colored glass or polyethylene terephthalate (PET) bottles containing 125 ml or 200 ml. The package includes a graduated dosing cup with markings from 2.5 ml to 15 ml.

Only certain pack 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 most recent revision of this leaflet: April 2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72689/P_72689.html

QR code to: https://cima.aemps.es/cima/dochtml/p/72689/P_72689.html