Package Insert: Information for the User

cinfamar infantil 25 mg coated tablets

dimenhidrinato

Read this entire package insert carefully before you start taking this medicine because it contains important information for you.

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

• Keep this package insert, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

The dimenhidrinate is the active ingredient of this medication and acts against motion sickness caused by transportation.

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

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.

Particularly, ask if you have or have had any of the following circumstances:

• 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 produces ototoxicity, as symptoms of those 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), you should 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 hygienic-dietary measures, such as proper ventilation and hydration.
• Avoid exposure to the sun (even on cloudy days) and ultraviolet lamps (UVA rays) while taking this medication.

Children and adolescents

This medication should not be administered to 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 be taking any other medication.

Particularly, you should inform them 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 a depressant effect on the Central Nervous System.
• Aminoglycoside antibiotics.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian medications.
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity).
• Ototoxic medications (that can affect the ear) (see sectionWarnings 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 results of the test.

Taking Cinfamar infantil with food, drinks, and alcohol

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

It is recommended to take this medication with food or with milk.

Pregnancy, breastfeeding, and fertility

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

This medication is intended exclusively for administration in children.

Consuming 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 first consulting a doctor or pharmacist, as this medication passes into breast milk.

Driving and operating machinery

Do not drive or operate hazardous machinery as this medication causes drowsiness or decreases reaction capacity at the recommended doses.

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 doses are:

Children aged 7 to 12 years:take 1 or 2 tablets (corresponding to 25 or 50 mg of dimenhydrinate). If necessary, repeat the dose every 6 or 8 hours. Do not take more than 6 tablets (150 mg of dimenhydrinate) per day and always divide into several doses.

Children aged 2 to 6 years:take half a tablet or 1 tablet (corresponding to 12.5 or 25 mg of dimenhydrinate). Repeat the dose every 6 or 8 hours if necessary. In no case should more than 3 tablets (75 mg of dimenhydrinate) be administered per day and always divide into several doses.

Children under 2 years:should not be used in this age group.

Patients with liver diseases:should consult their doctor before taking this medication, as it may be necessary to reduce the dose.

cinfamar infantil is taken orally.

The tablet can be divided into equal doses.

It is recommended to take the first dose at least half an hour before starting the trip (preferably 1-2 hours before), and if 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.

cinfamar infantil tablets should be taken without chewing, accompanied by a sufficient amount of liquid. It is recommended to ingest the tablets with food, water, or milk to minimize gastric irritation.

If symptoms worsen, or if they persist for more than 7 days, 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.

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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, movement disorders, convulsions, deep loss of consciousness (coma), sudden decrease in respiratory and heart functions (cardiorespiratory collapse), and death.

The symptoms may take more than 2 hours to appear after the overdose.

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

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

Adverse effects are usually mild and transient, 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.
• Urination 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 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 convulsions.

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 storage 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.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Cinfamar Infantil Composition

-The active ingredient is dimenhydrinate. Each tablet contains 25 milligrams of dimenhydrinate.

• The other components are: calcium dihydrogen phosphate, cornstarch, anhydrous colloidal silica, microcrystalline cellulose, povidone, talc, magnesium stearate, Opadry OY-1141 (hypromellose, titanium dioxide, erythrosine, indigotin, iron oxide-hydroxide, macrogol 400), macrogol 6000.

Product appearance and packaging contents

Cinfamar Infantil are pink-coated, cylindrical, biconvex, and scored on one face tablets.

They are presented in packaging containing 4 or 10 coated tablets.

Marketing authorization holder and manufacturer:

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain.

Last review date of this leaflet:January 2021

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