Prospecto: information for the user

cinfatós noche1.33 mg / ml + 2 mg / ml oral solution

Dextromethorphan hydrobromide / Diphenhydramine hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

1.What iscinfatós nocheand for what it is used

2.What you need to know before starting to takecinfatós noche

3.How to takecinfatós noche

4.Possible adverse effects

5.Storage ofcinfatós noche

6.Contents of the package and additional information

It is indicated for the relief of unproductive nocturnal cough (irritative cough, nervous cough) associated with colds and flu-like processes in adults and adolescents 12 years of age and older.

Consult a doctor if it worsens or does not improve after 5 days of treatment.

Do not takecinfa-tos night

• if you are allergic to dextromethorphan, diphenhydramine, or any of the other ingredients in this medicine (listed in section 6)
• if you are taking or have taken in the last 2 weeks any monoamine oxidase inhibitor (MAOI) used to treat depression, serotonin reuptake inhibitors used to treat depression, bupropion used to quit smoking, linezolid used as an antibacterial, procarbazine used to treat cancer, or selegiline used to treat Parkinson's disease
• if you have asthma or a cough with a lot of mucus
• if you have chronic obstructive pulmonary disease (COPD) or any other serious lung disease such as pneumonia
• if you have a prolonged QT interval (heart disease)
• if you have liver disease
• if you have porphyria
• if you are breastfeeding
• children under 12 years old cannot take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to takecinfa-tos night.

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

You should consult your doctor before using this medicine the following patients:

• with persistent or chronic cough, such as that due to smoking
• with kidney disease
• with atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition)
• who are sedated, weakened, or bedridden
• with CYP2D6 polymorphism (genetic alteration affecting the activity of this liver enzyme)
• with prostate hypertrophy, urinary obstruction, or urinary retention, low potassium levels in the blood with increased intraocular pressure (glaucoma), hyperthyroidism, cardiovascular diseases, high blood pressure (hypertension), intestinal obstruction, stomach ulcers, or epilepsy due to the presence of diphenhydramine
• on treatment with ototoxic drugs due to the presence of diphenhydramine
• diphenhydramine may increase sensitivity to sunlight and cause excitement in young people
• if you are taking other medicines such as antidepressants or antipsychotics,cinfa-tos nightmay interact with these medicines and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as high body temperature above 38°C, increased heart rate, high blood pressure, and exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea)
• you should avoid concurrent use with alcohol
• cases of abuse with dextromethorphan-containing medicines have been described in adolescents, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section If you take morecinfa-tos nightthan you should)
• this product may also be addictive, so its use at high doses or for a long time may cause 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 medicines andcinfa-tos night

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

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

• monoamine oxidase inhibitors (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 medicine, you should consult your doctor if you are using any of the following medicines, as it may be necessary to modify the dose of one of them or interrupt treatment:

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

Anti-hypertensive medicines, as it may increase drowsiness.

Medicines that are metabolized by CYP2D6 such as venlafaxine and some medicines for hypertension.

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

The sedative effect of medicines used to treat Parkinson's disease, tricyclic antidepressants, MAOIs, neuroleptics, hypnotics, anxiolytics, barbiturates, antipsychotics, and opioid analgesics, antimuscarinics such as atropine, or alcohol may be potentiated.

Interference with analytical tests:

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

Takingcinfa-tos nightwith food, drinks, and alcohol

Alcoholic beverages should be avoided during treatment with this medicine, as it may cause adverse reactions.

Do not take with orange or bitter lemon juice.

Pregnancy, lactation, and fertility

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

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

This medicine should not be taken during lactation (see section Do not takecinfa-tos night).

Driving and operating machinery

In rare cases, during treatment, drowsiness and dizziness may appear, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

cinfa-tos nightcontains sorbitol

This medicine 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 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 medicine.

cinfa-tos nightcontains maltitol

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

cinfa-tos nightcontains sodium benzoate

This medicine contains 0.60 mg of sodium benzoate per ml

cinfa-tos nightcontains sodium

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

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:

Take a 15 ml measure before going to bed.

Repeat after 6 hours, if necessary.

Adolescents 12 to 18 years:

Take a 15 ml measure before going to bed.

Use in children

Do not administer to children under 12 years.

How to take:

Take at nightis 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 eruptions, or persistent headache, consult the doctor.

If you take morecinfatós nochethan you should

Due to dextromethorphan:

If you take morecinfatós nochethan indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, altered 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.

Taking very high doses of this medication may cause in children a state of drowsiness, nervousness, nausea, vomiting, or gait disturbances.

Cases of abuse with medications containing dextromethorphan have been reported in adolescents, which may lead to severe adverse effects, such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, 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 intoxication, appropriate treatments for the symptoms will be applied, which may include intravenous naloxone injection and stomach lavage.

It may also increase serotonin syndrome.

Due to diphenhydramine:

If an overdose has been taken, the signs are dry mucous membranes, urinary retention, reduced peristalsis, mydriasis (pupil dilation), skin erythema, hyperthermia, somnolence, tachycardia, hallucinations, and seizures.

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

Accidental ingestion of very high doses may produce in children more severe symptoms than those described above.

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 takecinfatós noche

Do not take a double dose to compensate for the missed doses. If symptoms persist, restart treatment as indicated in section3.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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

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

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

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

Unknown Frequency(cannot be estimated from available data): allergic reactions such as anaphylactic reactions, angioedema, sweating, hair loss, urticaria, and itching, rash, erythema, and bronchospasm, thicker mucus, headache, fixed drug eruption, dermatitis, skin tingling sensation, and sensitivity to sunlight after intense sun exposure. Excitement,vertigo, confused speech, tremor, sleep disturbances, involuntary eye movements, involuntary muscle contractions, especially in children, psychomotor deterioration, muscle pain. Depression, dizziness, attention alteration, seizures, difficulty breathing, liver disease, low blood pressure, palpitations, arrhythmia, tinnitus, low blood cell count, anemia.

Reporting 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 them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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.

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.

Composition ofcinfatós noche

• The active principles 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 contents of the packaging

cinfatós nocheis a transparent and colorless oral solution with an orange aroma.

The medicine is presented in:

• Amber type III glass bottle with a 140 ml oral solution content provided with a metal Pilfer-proof cap.

• Amber polyethylene terephthalate bottle with a 150 ml oral solution content provided with a polypropylene cap.

Each container is provided with a polypropylene dosing cup with a graduation ranging from 2.5 ml to 15 ml.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: December 2020

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