Cinfamar infantil 12,5 mg solucion oral

Leaflet: information for the user

Cinfamar infantil 12.5 mg oral solution

Dimenhidrinato

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you

Follow exactly the administration instructions for 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, consult your pharmacist.

• Ifyou experience any side effects, consult your doctor or pharmacist even if they do not appear in this leaflet. See section 4.

• You should consult a doctor if you get worse or do not improveafter 7 days.

The dimenhidrinate is the active ingredient of this medication and acts against the seasickness produced by means of transportation.

It is indicated for the prevention and treatment of symptoms of seasickness produced by land, sea, or air transportation, such as nausea, vomiting, and/or dizziness for children aged 2 to 12 years.

Consult a doctor if it worsens or does not improve after 7 days.

Do not take Cinfamar infantil

• If you are allergic to dimenhidrinato, difenhidramina, or any of the other components of this medication (listed in section 6).
• If you have porphyria (a rare, usually inherited disorder in which a large amount of porphyrin is eliminated in feces and urine).
• If you have asthma attacks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cinfamar infantil.

• If you have asthma, severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as it may cause thickening of secretions and alter expectoration.
• If you have a disease in which there is an abnormal increase in the activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), hypertension, or any disease that causes obstruction of the urinary or gastrointestinal tract.
• If you have seizures with or without loss of consciousness (epilepsy).
• If you are over 65 years old, it may cause dry mouth, urinary retention, nausea, sedation, confusion, and hypotension.
• If you are using a medication that causes ototoxicity, as symptoms of these toxic effects may be masked, such as tinnitus, dizziness, or vertigo.
• If you have any liver or kidney disease, stomach ulcer or duodenal ulcer, or stomach inflammation (gastritis), consult your doctor before taking this medication.
• You should consult your doctor before taking this medication if you have or have had heart diseases (cardiac arrhythmia, myocardial ischemia, etc.).
• If you suspect you may have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended to see a doctor to rule out the presence or absence of appendicitis, as dimenhidrinato may make it difficult to diagnose this disease.
• It is recommended to avoid exposure to very high temperatures and follow adequate hygiene and dietary measures, such as proper ventilation and hydration.
• Avoid exposure to the sun (even on cloudy days), and ultraviolet radiation lamps (UVA rays) while taking this medication.

Children

Do not use this medication in children under 2 years old.

Taking Cinfamar infantil with other medications

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

Particularly, if you are using any of the following medications, it may be necessary to modify the dose of Cinfamar infantil or not take it:

• Anesthetics and other substances with central nervous system depressant action
• Aminoglycoside antibiotics
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs)
• Antiparkinsonian medications
• Neuroleptics (used to calm agitation and hyperactivity)
• Ototoxic medications (that can affect the ear) (see Warnings and precautions)
• Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight)

Interference with diagnostic tests

If you are to undergo any allergy test: including skin tests, it is recommended to suspend treatment 72 hours before starting the test, to avoid altering the test results.

Taking Cinfamar infantil with food, drinks, and alcohol

It is not recommended to consume alcohol during the time you are taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Women in the breastfeeding period should not take this medication without consulting their doctor or pharmacist, as this medication passes into breast milk.

Driving and operating machinery

Do not drive or operate hazardous machinery as this medication may cause drowsiness or decreased reaction time at recommended doses.

Cinfamar infantil contains parahydroxybenzoate of methyl, sodium salt, and parahydroxybenzoate of propyl, sodium salt

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl, sodium salt, and parahydroxybenzoate of propyl, sodium salt.

Cinfamar infantil contains sorbitol

This medication contains 714.30 mg of sorbitol in each 5 ml.

Sorbitol is a source of fructose. If your doctor has indicated 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 medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Cinfamar infantil contains sodium

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

Cinfamar infantil contains propylene glycol

This medication contains 330 mg of propylene glycol in each 5 ml.

If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

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

The recommended doses are:

• Children aged 7 to 12 years:2 or 4 single-dose packets (corresponding to 25 or 50 mg of dimenhydrinate). If necessary, repeat this dose every 6 to 8 hours. Do not take in any case more than 12 single-dose packets per day (150 mg of dimenhydrinate), divided into several doses.

• Children aged 2 to 6 years:1 or 2 single-dose packets (corresponding to 12.5 or 25 mg of dimenhydrinate). If necessary, repeat this dose every 6 to 8 hours. Do not take in any case more than 6 single-dose packets per day (75 mg of dimenhydrinate), divided into several doses.

• Children under 2 years:This medication should not be used in children under 2 years.

• Patients with liver disease:Should consult a doctor before taking this medication, as it may be necessary to reduce the dose.

This medication is taken orally.

It is recommended to take the first dose at least half an hour before starting the journey (preferably 1 or 2 hours before), and in case it has not been taken beforehand, the first dose will be taken when symptoms appear. If the dizziness persists, at least 6 hours should pass between one dose and the next.

It is recommended to take this medication with food, water, or milk to minimize gastric irritation.

If symptoms worsen, or if they persist for more than 7 days, you should consult a doctor.

If you take more Cinfamar Infantil than you should

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.

The symptoms of an overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, irritation of the stomach and intestines with nausea, vomiting, and diarrhea, alterations in movement, convulsions, deep loss of consciousness (coma), sudden decrease in respiratory and heart functions (cardiorespiratory collapse), and death. Symptoms may take more than 2 hours to appear after an overdose.

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

Adverse effects are usually mild and temporary, especially at the beginning of treatment.

During the period of use of dimenhidrinate, the following adverse reactions have been observed, whose frequency has not been established with precision:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and dizziness.
• Increased mucus viscosity in the bronchi, making breathing difficult.
• Urinary retention and impotence.
• Glaucoma (increase in intraocular pressure of the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which may appear as urticaria, itching, and skin redness.
• Decrease in the blood of the number of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (rare disorder, usually inherited, in which a large amount of porphyrin is eliminated in feces and urine).
• Hypertension or hypotension (increase or decrease in blood pressure).
• Tachycardia, palpitations, and/or cardiac arrhythmias.
• It may cause hyperexcitability, especially in children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even seizures.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of 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.

This medication does not require special conservation conditions.

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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of cinfamar infantil

• Each single-dose sachet contains 12.5 milligrams of dimenhydrinate as the active ingredient.

• The other components are: glycerol (E-422), propylene glycol (E-1520), raspberry flavor (triacetate of glycerol (E-1518) and natural flavoring agents), methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), citric acid monohydrate (E-330), sodium chloride, sodium saccharin (E-954), potassium acesulfame (E-950), sodium citrate (E-331), sorbitol (E-420), hydroxyethylcellulose, and purified water.

Appearance of the product and contents of the packaging

cinfamar infantil is a transparent, colorless, or slightly yellowish oral solution with a raspberry odor.

It is presented in packaging containing 6 or 12 single-dose sachets of 5ml.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:December 2020

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