CINFAMAR INFANTIL 25 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

cinfamar infantil 25 mg coated tablets

dimenhidrinato

Read this leaflet 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 leaflet or as 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.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

1. What cinfamar infantil is and what it is used for.
2. What you need to know before taking cinfamar infantil.
3. How to take cinfamar infantil.
4. Possible side effects.
5. Storage of cinfamar infantil.
6. Package contents and additional information.

1. What cinfamar infantil is and what it is used for

Dimenhidrinato is the active ingredient of this medicine and acts against motion sickness caused by means of transportation.

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

2. What you need to know before taking cinfamar infantil

Do not take cinfamar infantil

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

Warnings and precautions

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

In particular, ask them 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 that causes an abnormal increase in thyroid gland activity (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 convulsive movements, with or without loss of consciousness (epilepsy).
• If you are over 65 years old, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are using any medication that produces ear toxicity, as symptoms of those toxic effects, such as ringing in the ears, dizziness, or vertigo, may be masked.
• If you have any liver or kidney disease, stomach or duodenal ulcer, or stomach inflammation (gastritis), you should consult your doctor before taking this medicine.
• You should consult your doctor before taking this medicine 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 consult 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 lamps (UVA rays) while taking this medicine.

Children and adolescents

This medicine should not be administered to children under 2 years old.

Taking cinfamar infantil with other medicines

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

In particular, you should inform them if you are using any of the following medicines; 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.
• Antibiotics of the aminoglycoside group.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian agents.
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity).
• Ototoxic medicines (which can affect the ear) (see section Warnings and precautions).
• Medicines that can cause photosensitivity (skin reactions due to sensitivity to sunlight).

Interference with diagnostic tests

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

Taking cinfamar infantil with food, drinks, and alcohol

It is not recommended to consume alcohol while taking this medicine.

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

Pregnancy, breastfeeding, and fertility

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

This medicine is intended exclusively for administration in children.

Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Women who are breastfeeding should not take this medicine without first consulting their doctor or pharmacist, as this medicine passes into breast milk.

Driving and using machines

Do not drive or operate hazardous machinery, as this medicine can cause drowsiness or decreased reaction capacity at the recommended doses.

3. How to take cinfamar infantil

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

The recommended doses are:

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

Children from 2 to 6 years old: take half a tablet or 1 tablet (corresponding to 12.5 or 25 mg of dimenhidrinato). Repeat the dose every 6 or 8 hours if necessary. Do not administer more than 3 tablets (75 mg of dimenhidrinato) per day, and always divide them into several doses.

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

Patient with liver disease: they should consult their doctor before taking this medicine, 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 not taken previously, the first dose will be taken when symptoms appear. If the motion sickness persists, wait at least 6 hours between one dose and the next.

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

If the symptoms worsen or persist for more than 7 days, consult your 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

.

The symptoms of overdose include mainly: dilated pupils, red face, excitement, hallucinations, confusion, stomach and intestine irritation with nausea, vomiting, and diarrhea, movement alterations, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects are usually mild and transient, especially at the beginning of treatment.

During the use of dimenhidrinato, the following adverse reactions have been observed, whose frequency could not be established with precision:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of cinfamar infantil

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of cinfamar infantil

• The active ingredient is dimenhidrinato. Each tablet contains 25 milligrams of dimenhidrinato.
• The other components are: calcium hydrogen phosphate dihydrate, cornstarch, anhydrous colloidal silica, microcrystalline cellulose, povidone, talc, magnesium stearate, Opadry OY-1141 (hypromellose, titanium dioxide, erythrosine, indigo carmine, iron oxide-hydroxide, macrogol 400), macrogol 6000.

Appearance of the product and package contents

cinfamar infantil are pink, cylindrical, biconvex, and scored on one side.

They are available in packages containing 4 or 10 coated tablets.

Marketing authorization holder and manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

Date of the last revision of this leaflet:January 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/