Cinfatosnait 1.33Mg/Ml + 2Mg/Ml Oral Solution 150Ml

Cinfatósnait 1.33 mg / ml + 2 mg / ml oral solution

Dextromethorphan hydrobromide / Diphenhydramine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you get side effects, talk to your doctor or pharmacist, including side effects not listed in this leaflet. See section 4.
• You should see a doctor if it worsens or if it does not improve after 5 days.

Package leaflet content

1. What Cinfatósnait is and what it is used for

2. What you need to know before you take Cinfatósnait

3. How to take Cinfatosnait

4. Possible adverse effects

5. How to store Cinfatósnait

6. Contents of the pack and other information

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

You should see a doctor if you get worse or if you do not get better after 5 days of treatment.

Do not take Cinfatosnait

• if you are allergic to dextromethorphan, diphenhydramine or any of the other ingredients of this medicine (listed in section 6)
• if you are being treated or have been in the previous 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 medicine used to stop smoking, linezolid which is an antibacterial medicine, procarbazine which is a medicine used to treat cancer or selegiline which is used to treat Parkinson's
• if you have asthmatic cough or cough accompanied by abundant secretions
• if you have chronic obstructive pulmonary disease (COPD) or other serious lung disease such as pneumonia
• if you have QT interval prolongation (heart disease)
• if you have liver disease
• if you have porphyria
• lactating women
• children under 12 years of age cannot take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cinfatósnait.

This medicine can cause dependency. Therefore the treatment should be of short duration.

Patients should consult their doctor before using this medicine:

• with persistent or chronic cough, such as due to tobacco
• with kidney disease
• with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusting and scaling, beginning in childhood in individuals with hereditary allergic predisposition)
• who are sedated, debilitated, or bedridden
• with CYP2D6 polymorphism (genetic alteration that affects the activity of this liver enzyme)
• with prostate hypertrophy, bladder obstruction or urinary retention, low blood potassium levels with increased eye pressure (glaucoma), hyperthyroidism, cardiovascular disease, high blood pressure (hypertension), bowel obstruction, stomach ulcer or epilepsy due to in the presence of diphenhydramine
• under treatment with drugs toxic to the ear due to the presence of diphenhydramine
• diphenhydramine can increase sensitivity to sunlight and cause arousal in young people
• if you are taking other medicines such as antidepressants or antipsychotics, Cinfatósnait 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 higher than 38º C, increased heart rate, high blood pressure and exaggerated reflexes, muscle stiffness, incoordination, and/or gastrointestinal symptoms (eg, nausea, vomiting, and diarrhea)
• concomitant use with alcohol should be avoided
• Cases of abuse with medicines containing dextromethorphan have been described in adolescents, therefore, this possibility should be taken into account, since serious adverse effects can be caused (see section If you take more Cinfatósnait than you should)
• This product can also be addictive, so its high dose or prolonged use can cause tolerance and mental and physical dependence. In patients with a tendency to abuse or dependence, it will only be administered under strict medical supervision and in short periods of time.

Other medicines and Cinfatósnait

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take this medicine during treatment, or for 2 weeks after treatment, with the following medicines, as excitement, high blood pressure and fever higher than 40°C (hyperpyrexia) may occur or the effects of diphenhydramine may be increased:

• Monoamine oxidase inhibitor 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).

Before taking this medicine you should consult your doctor if you are taking any of the following medicines because it may be necessary to modify the dose of any of them or to stop treatment:

• Anti-inflammatory medications such as celecoxib, parecoxib, or valdecoxib.
• Medicines to treat heart arrhythmias such as amiodarone or quinidine.
• Medications used to remove phlegm and mucus such as (acetylcysteine ​​or guaifenesin).
• Co-administration with metoprolol (for the treatment of serious heart conditions).
• Central nervous system depressants (alcohol, antihistamines, psychotropics, or Parkinson's drugs).
• CYP2D6 inhibitors such as haloperidol (used to treat mental illness).

Antihypertensive drugs, because it could increase tiredness.

Drugs that are metabolized by CYP2D6 such as venlafaxine and/or some blood pressure medications.

Betahistine and histamine, because they have opposite actions to diphenhydramine and its effect would be annulled.

The sedative effect of medications to treat Parkinson's, 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 laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), tell your doctor that you are taking this medicine, as it may alter the results.

Taking Cinfatósnait with food, drinks and alcohol

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

Do not take with grapefruit or bitter orange juice.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

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

This medicine should not be taken during lactation (see section Do not take Cinfatósnait).

Driving and using machines

On rare occasions, mild drowsiness and dizziness may occur during treatment, so if you notice these symptoms you should not drive a car or operate dangerous machinery.

Cinfatósnait contains sorbitol

This medicine contains 112 mg of sorbitol in each ml

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

Cinfatósnait contains maltitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Cinfatósnait contains sodium benzoate

This medicine contains 0.60 mg sodium benzoate in each ml.

Cinfatósnait contains sodium

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults :

Take a measure of 15 ml before going to bed.

Repeat after 6 hours, if necessary.

Adolescents from 12 to 18 years old:

Take a measure of 15 ml before going to bed.

Use in children

Do not administer to children under 12 years of age.

How to drink:

Cinfatósnait is administered orally using the dosing cup that is included.

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

If you take more Cinfatósnait than you should

Due to dextromethorphan:

If you take more Cinfatósnait than directed, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, rapid involuntary eye movements, cardiac disorders (accelerated heartbeat), disturbances of coordination, psychosis with visual hallucinations and hyperexcitability.

Other symptoms in case of massive overdose can be: coma, severe breathing problems and convulsions.

Taking very high amounts of this medication can produce a state of drowsiness, nervousness, nausea, vomiting or changes in the way of walking in children.

There have been cases of abuse with medicines containing dextromethorphan in adolescents, with the possibility of serious side effects, such as tachycardia (accelerated heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil of the eye ), agitation, vertigo, gastrointestinal disturbances, hallucinations, slurred speech, nystagmus (uncontrolled, involuntary movement of the eyes), fever, tachypnea (shallow and rapid 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 above symptoms.

In the event of poisoning, treatment appropriate to the symptoms should be applied, which may include intravenous injection of naloxone and gastric lavage.

It can also increase serotonin syndrome.

Due to diphenhydramine:

If an overdose has been taken, the signs are dry membranes, urinary retention, reduced peristalsis, mydriasis (dilation of the eye's pupil), skin redness, hyperthermia, drowsiness, tachycardia, hallucinations and seizures.

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

Accidental intake of very high doses can produce symptoms in children that are aggravated with respect to the symptoms described above.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Cinfatósnait

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

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Very common (may affect more than 1 in 10 people): dizziness and drowsiness.

Common (may affect up to 1 in 10 people): mental 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, eg paradoxical skin reactions.

unknown frequency(cannot be estimated from the available data): allergic reactions such as anaphylactic reaction, angioedema, sweating, hair loss, urticaria and itching, rash, erythema and bronchospasm, thickened mucus, headache, fixed drug eruption, dermatitis , tingling sensation in the skin and sensitivity to sunlight after intense sun exposure. Excitement, vertigo, slurred speech, tremor, sleep disturbances, involuntary eye movement, involuntary muscle contractions especially in children, psychomotor impairment, muscle pain. Depression, dizziness, disturbance in attention, seizures, shortness of breath, liver disease, low blood pressure, palpitations, heart rhythm disturbance, ringing in the ears, low blood cell count, anemia.

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

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or in the trash. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you don't need. This way you will help to protect the environment.

Composition of Cinfatósnait

• 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 ingredients (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 container

Cinfatósnait is a clear and colorless oral solution with an orange aroma.

The medicine is presented in:

• Type III amber glass bottle containing 140 ml of oral solution with a Pilfer-proof metal stopper.

• 150 ml bottle of amber polyethylene terephthalate with an oral solution content provided with a polypropylene stopper.

Each container is provided with a polypropylene measuring cup with a graduation that ranges from 2.5 ml to 15 ml.

Marketing authorization holder and manufacturer

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Cinfatosnait Leaflet 1.33Mg/Ml + 2Mg/Ml Oral Solution 150Ml