CINFATOS NIGHT 1.33 mg/mL + 2 mg/mL ORAL SOLUTION

2. What you need to know before taking cinfatós noche

Do not takecinfatós noche

• if you are allergic to dextromethorphan, diphenhydramine, or any of the other components of this medication (listed in section 6)
• if you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, serotonin reuptake inhibitor medications used to treat depression, bupropion which is a medication used to quit smoking, linezolid which is an antibacterial medication, procarbazine which is a medication used to treat cancer, or selegiline which is used to treat Parkinson's disease
• if you have asthmatic cough or cough accompanied by abundant secretions
• if you have chronic obstructive pulmonary disease (COPD) or other severe lung disease such as pneumonia
• if you have prolonged QT interval (heart disease)
• if you have any liver disease
• if you have porphyria
• breastfeeding women
• children under 12 years of age cannot take this medication.

Warnings and Precautions

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

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

Patients with the following conditions should consult their doctor before using this medication:

• with persistent or chronic cough, such as that caused by smoking
• with kidney disease
• with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition)
• who are sedated, debilitated, or bedridden
• with CYP2D6 polymorphism (genetic alteration that affects the activity of this liver enzyme)
• with prostatic hypertrophy, bladder obstruction, or urinary retention, low potassium levels in the blood with increased eye pressure (glaucoma), hyperthyroidism, cardiovascular diseases, high blood pressure (hypertension), intestinal obstruction, stomach ulcer, or epilepsy due to the presence of diphenhydramine
• under treatment with ear-toxic medications due to the presence of diphenhydramine
• diphenhydramine may increase sensitivity to sunlight and cause excitement in young people
• if you are taking other medications such as antidepressants or antipsychotics, cinfatós noche 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, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea)
• concomitant use with alcohol should be avoided
• cases of abuse with medications containing dextromethorphan have been reported in adolescents, which can cause serious side effects (see section If you take more cinfatós noche than you should)
• this product can also be addictive, so its use at high doses or for a prolonged period can cause tolerance and mental and physical dependence. In patients with a tendency to abuse or dependence, it should only be administered under strict medical control and for short periods of time.

Other Medications and cinfatós noche

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

Do not take this medication during treatment or in the 2 weeks following treatment with the following medications, as it can cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia) or increase the effects of diphenhydramine:

• MAOIs (moclobemide, tranylcypromine)
• Selective serotonin reuptake inhibitors (fluoxetine, sertraline, or paroxetine)
• Bupropion (used to quit smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)

Before taking this medication, you should consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Anti-inflammatory medications such as celecoxib, parecoxib, or valdecoxib
• Medications for treating heart arrhythmias such as amiodarone or quinidine
• Medications used to eliminate phlegm and mucus such as acetilcysteine or guaifenesin
• Concomitant administration with metoprolol (for the treatment of serious heart diseases)
• Central nervous system depressants (alcohol, antihistamines, psychotropics, or medications for Parkinson's disease)
• CYP2D6 inhibitors such as haloperidol (used to treat mental illnesses)

Blood pressure medications, as it may increase drowsiness.

Medications that are metabolized by CYP2D6, such as venlafaxine, and some blood pressure medications.

Betahistine and histamine, as they have opposite actions to diphenhydramine and may cancel its effect.

The sedative effect of medications for treating Parkinson's disease, tricyclic antidepressants, MAOIs, neuroleptics, hypnotics, anxiolytics, barbiturates, antipsychotics, and opioid analgesics, antimuscarinics such as atropine, or alcohol may be enhanced.

Interference with Analytical Tests:

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

Taking cinfatós noche with Food, Drinks, and Alcohol

Alcoholic beverages should be avoided during treatment with this medication, as adverse reactions may occur.

Do not take with grapefruit or bitter orange juice.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Dextromethorphan and diphenhydramine should only be taken during pregnancy after careful evaluation by your doctor or pharmacist.

This medication should not be taken during breastfeeding (see section Do not take cinfatós noche).

Driving and Using Machines

Rarely, during treatment, drowsiness and dizziness may occur, so if you experience these symptoms, you should not drive vehicles or operate hazardous machinery.

cinfatós noche contains Sorbitol

This medication contains 112 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 you 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.

cinfatós noche contains Maltitol

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

cinfatós noche contains Sodium Benzoate

This medication contains 0.60 mg of sodium benzoate per ml.

cinfatós noche contains Sodium

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

3. How to Take cinfatós noche

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

The recommended dose is:

Adults:

Take one 15 ml dose before bedtime.

Repeat after 6 hours, if necessary.

Adolescents from 12 to 18 years:

Take one 15 ml dose before bedtime.

Use in Children

Do not administer to children under 12 years of age.

How to Take:

cinfatós noche is administered orally using the dosing cup included.

If the patient worsens, the cough persists for more than 5 days, or is accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.

If you Take More cinfatós noche than you Should

Due to Dextromethorphan:

If you take more cinfatós noche 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.

Taking very high doses of this medication can cause children to become drowsy, nervous, nauseous, vomit, or have altered gait.

There have been reports of abuse with medications containing dextromethorphan in adolescents, which can cause serious side effects, such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary eye movement), fever, tachypnea (rapid shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

In case of poisoning, you should receive treatment according to the symptoms, which may include intravenous naloxone injection and stomach lavage.

It may also increase the serotonin syndrome.

Due to Diphenhydramine:

If an overdose has occurred, the signs are dryness of membranes, urinary retention, reduced peristalsis, mydriasis (pupil dilation), skin redness, hyperthermia, drowsiness, tachycardia, hallucinations, and convulsions.

Symptoms of depression and stimulation of the central nervous system and hypotension have also been described.

Accidental ingestion of very high doses can cause children to experience aggravated symptoms compared to those described above.

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 Miss a Dose of cinfatós noche

Do not take a double dose to make up for missed doses. If symptoms persist, restart treatment as indicated in section 3.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the use of dextromethorphan and diphenhydramine, the following side effects have been observed:

Very Common(may affect more than 1 in 10 patients): dizziness and drowsiness.

Common(may affect up to 1 in 10 patients): mental confusion, nausea, vomiting, constipation, and fatigue.

Uncommon(may affect up to 1 in 100 patients): blurred vision, diarrhea, dry mouth, and difficulty urinating, more likely in elderly patients.

Rare(may affect up to 1 in 10,000 patients): hallucinations, drug dependence, increased intraocular pressure, glaucoma, blood disorders, allergic reactions, such as skin reactions.

Frequency Not Known(cannot be estimated from available data): allergic reactions such as anaphylactic reaction, angioedema, sweating, hair loss, urticaria, and itching, rash, erythema, and bronchospasm, thicker mucus, headache, fixed drug eruption, dermatitis, tingling sensation on the skin, and sensitivity to sunlight after intense sun exposure. Excitement, vertigo, confused speech, tremors, sleep disturbances, involuntary eye movements, muscle contractions, especially in children, psychomotor impairment, muscle pain. Depression, dizziness, attention disorders, convulsions, breathing difficulties, liver disease, low blood pressure, palpitations, altered heart rhythm, tinnitus, low blood cell count, anemia.

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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of cinfatós noche

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of cinfatós noche

• The active ingredients are dextromethorphan hydrobromide and diphenhydramine hydrochloride. Each ml contains 1.33 mg of dextromethorphan hydrobromide and 2 mg of diphenhydramine hydrochloride.
• The other components (excipients) are: non-crystallizable liquid sorbitol (E-420), liquid maltitol (E-965), glycerol (E-422), sucralose (E-955), orange flavor, citric acid monohydrate, sodium benzoate (E-211), sodium hydroxide, and purified water.

Appearance of the Product and Package Contents

cinfatós noche is a clear, colorless oral solution with an orange flavor.

The medication is presented in:

• A type III amber glass bottle with a contents of 140 ml oral solution, provided with a Pilfer-proof metal cap.

• A topaz polyethylene terephthalate bottle with a contents of 150 ml oral solution, provided with a polypropylene cap.

Each package is provided with a polypropylene dosing cup with graduations ranging from 2.5 ml to 15 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 Package Leaflet: December 2020

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