Cinfatos Noche 1.33 mg/ml + 2 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Cinfatós noche 1.33 mg / ml + 2 mg / ml oral solution
Dextromethorphan hydrobromide / Diphenhydramine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of this medicine 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 further 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 you worsen or do not improve after 5 days.
Contents of the leaflet
- What Cinfatós noche is and what it is used for
- What you need to know before taking Cinfatós noche
- How to take Cinfatós noche
- Possible adverse effects
- How to store Cinfatós noche
- Contents of the pack and other information
1. What Cinfatós noche is and what it is used for
It is indicated for the relief of non-productive nighttime cough (irritant cough, nervous cough) associated with colds and influenza-like illnesses in adults and adolescents aged 12 years and older.
You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment.
2. What you need to know before taking Cinfatós night
Do not take Cinfatós night
- if you are allergic to dextromethorphan, diphenhydramine, or any of the other ingredients of this medicine (listed in section 6)
- if you are currently taking or have taken within the previous 2 weeks any monoamine oxidase inhibitor (MAOI) medicines used to treat depression, serotonin reuptake inhibitors used for depression, bupropion (a medicine used to stop smoking), linezolid (an antibacterial medicine), procarbazine (a medicine used to treat cancer), or selegiline (used to treat Parkinson’s disease)
- if you have asthmatic cough or cough with abundant secretions
- if you have chronic obstructive pulmonary disease (COPD) or another serious lung disease such as pneumonia
- if you have QT interval prolongation (a heart condition)
- if you have liver disease
- if you have porphyria
- women who are breastfeeding
- children under 12 years of age must not take this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cinfatós night.
This medicine may cause dependence. Therefore, treatment should be short-term.
Patients should consult their doctor before using this medicine if they:
- have persistent or chronic cough, such as that caused by smoking
- have kidney disease
- have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with hereditary predisposition to allergy)
- are sedated, debilitated, or bedridden
- have CYP2D6 polymorphism (a genetic alteration affecting the activity of this liver enzyme)
- have prostate hypertrophy, bladder obstruction, urinary retention, low potassium levels in blood with increased ocular pressure (glaucoma), hyperthyroidism, cardiovascular diseases, high blood pressure (hypertension), intestinal obstruction, stomach ulcer, or epilepsy due to the presence of diphenhydramine
- are taking ototoxic medicines (toxic to the ear) due to the presence of diphenhydramine
- diphenhydramine may increase sensitivity to sunlight and cause excitation in young people
- if you are taking other medicines such as antidepressants or antipsychotics, Cinfatós night may interact with these medicines 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, and diarrhea)
- concomitant use with alcohol should be avoided
- cases of abuse of medicines containing dextromethorphan in adolescents have been reported; therefore, this possibility should be considered, as serious adverse effects may occur (see section "If you take more Cinfatós night than you should")
- this product may also be addictive, so its use at high doses or for prolonged periods may lead to tolerance and mental and physical dependence. In patients with a tendency to abuse or dependence, it should only be administered under strict medical supervision and for short periods.
Other medicines and Cinfatós night
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take this medicine during treatment with, or within 2 weeks after stopping, the following medicines, as this may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia), or increase the effects of diphenhydramine:
- MAOI antidepressants (moclobemide, tranylcypromine)
- Selective serotonin reuptake inhibitor antidepressants (fluoxetine, sertraline, or paroxetine)
- Bupropion (used to stop smoking)
- Linezolid (used as an antibacterial)
- Procarbazine (used to treat cancer)
- Selegiline (used to treat Parkinson’s disease)
Before taking this medicine, consult your doctor if you are using any of the following medicines, as it may be necessary to adjust the dose or interrupt treatment:
- Anti-inflammatory medicines such as celecoxib, parecoxib, or valdecoxib
- Medicines for treating heart arrhythmias such as amiodarone or quinidine
- Medicines used to eliminate phlegm and mucus such as (acetylcysteine or guaifenesin)
- Concomitant administration with metoprolol (for the treatment of serious heart conditions)
- Central nervous system depressants (alcohol, antihistamines, psychotropics, or medicines for Parkinson’s disease)
- CYP2D6 inhibitors such as haloperidol (used to treat mental illnesses)
Antihypertensive medicines, as tiredness may increase.
Medicines metabolized by CYP2D6 such as venlafaxine and some blood pressure medicines.
Betahistine and histamine, as they have actions opposite to diphenhydramine and their effect may be canceled.
The sedative effect may be enhanced when taking medicines for Parkinson’s disease, tricyclic antidepressants, MAOIs, neuroleptics, hypnotics, anxiolytics, barbiturates, antipsychotics, opioid analgesics, antimuscarinics such as atropine, or alcohol.
Interference with laboratory tests:
If you are scheduled to have any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.
Taking Cinfatós night with food, drinks, and alcohol
Alcoholic beverages should be avoided during treatment with this medicine, as adverse reactions may occur.
Do not take with grapefruit juice or bitter orange juice.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 must not be taken during breastfeeding (see section "Do not take Cinfatós night").
Driving and use of machines
Rarely, during treatment, mild drowsiness and dizziness may occur. If you experience these symptoms, you should not drive or operate dangerous machinery.
Cinfatós night contains sorbitol
This medicine contains 112 mg of sorbitol per ml.
Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.
Cinfatós night contains maltitol
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Cinfatós night contains sodium benzoate
This medicine contains 0.60 mg of sodium benzoate per ml.
Cinfatós night contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per ml; this is essentially "sodium-free".
3. How to take Cinfatós night
Follow exactly the instructions for use 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:
Take one 15 ml dose at bedtime.
Repeat after 6 hours if necessary.
Adolescents aged 12 to 18 years:
Take one 15 ml dose at bedtime.
Use in children
Do not administer to children under 12 years of age.
How to take:
Cinfatós night is administered orally using the dosing cup provided.
If the patient's condition worsens, if cough persists for more than 5 days, or if it is accompanied by high fever, skin rash, or persistent headache, consult a doctor.
If you take more Cinfatós night than you should
Due to dextromethorphan:
If you take more Cinfatós night 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 (increased heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in case of massive overdose may include: coma, severe breathing problems, and seizures.
Taking very high doses of this medicine may cause children to become drowsy, nervous, nauseous, vomit, or experience disturbances in gait.
Cases of abuse have occurred with medications containing dextromethorphan in adolescents, potentially leading to serious adverse effects such as tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil of the eye), agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary and uncontrollable eye movements), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.
Contact your doctor or hospital immediately if you experience any of the symptoms listed above.
In case of poisoning, appropriate treatments for the symptoms should be administered, which may include intravenous naloxone injection and gastric lavage.
Serotonin syndrome may also be increased.
Due to diphenhydramine:
In case of overdose, signs include dryness of mucous membranes, urinary retention, reduced peristalsis, mydriasis (dilation of the pupil of the eye), skin flushing, hyperthermia, drowsiness, tachycardia, hallucinations, and seizures.
Symptoms of central nervous system depression and stimulation, as well as hypotension, have also been reported.
Accidental ingestion of very high doses may cause children to experience more severe symptoms than those described above.
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 night
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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed during the period of use of dextromethorphan and diphenhydramine:
Very common (may affect more than 1 in 10 people): dizziness and somnolence.
Common (may affect up to 1 in 10 people): confusion, nausea, vomiting, constipation, and fatigue.
Uncommon (may affect up to 1 in 100 people): blurred vision, diarrhoea, dry mouth, and difficulty urinating, more likely in elderly patients.
Very rare (may affect up to 1 in 10,000 people): hallucinations, drug dependence, increased intraocular pressure, glaucoma, blood disorders, allergic reactions, for example, paradoxical reactions in the skin.
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, skin tingling sensation, and photosensitivity after intense sun exposure. Excitation, vertigo, slurred speech, tremor, sleep disturbances, involuntary eye movements, involuntary muscle contractions, especially in children, psychomotor impairment, muscle pain. Depression, dizziness, attention disturbances, seizures, breathing difficulties, liver disease, low blood pressure, palpitations, heart rhythm disturbances, tinnitus, low blood cell count, anaemia.
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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cinfatós noche
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 is the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cinfatós noche
- The active substances 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 flavour, citric acid monohydrate, sodium benzoate (E-211), sodium hydroxide and purified water.
Appearance of the product and contents of the pack
Cinfatós noche is a transparent, colourless oral solution with an orange flavour.
The medicine is available in:
-
Amber glass bottle type III with a content of 140 ml oral solution, supplied with a Pilfer-proof metal cap.
-
Amber polyethylene terephthalate bottle with a content of 150 ml oral solution, supplied with a polypropylene cap.
Each pack includes a polypropylene dosing cup graduated 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 most recent revision of this leaflet: December 2020
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information on 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/85664/P_85664.html
QR code to: https://cima.aemps.es/cima/dochtml/p/85664/P_85664.html