CINFAMAR INFANTIL 12.5 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Cinfamar Infantil 12.5 mg Oral Solution

Dimenhydrinate

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 side effects not listed in this package leaflet. See section 4.

• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package 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. Contents of the pack and further information

1. What Cinfamar Infantil is and what it is used for

Dimenhydrinate 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 travel, such as nausea, vomiting, and/or dizziness in children from 2 to 12 years old.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Cinfamar Infantil

Do not take Cinfamar Infantil

• If you are allergic to dimenhydrinate, diphenhydramine, or any of the other components of this medication (listed in section 6).
• If you have porphyria (a rare, usually hereditary disorder in which large amounts of porphyrin are 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 that causes abnormal increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), enlarged prostate (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 taking any medication that causes 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 ulcers, 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 or disorders (cardiac arrhythmia, myocardial ischemia, ...).
• 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 dimenhydrinate 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 recently taken, or may need to take any other medication.

In particular, 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
• Antibiotics of the aminoglycoside group
• 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 Warnings and Precautions section)
• Medications that can cause photosensitivity (skin reactions due to sensitivity to sunlight)

Interference with diagnostic tests

If you are going to undergo any allergy test, including skin tests, it is recommended to discontinue 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 medication.

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 medication.

Taking medications 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 medication without first consulting their doctor or pharmacist, as this medication passes into breast milk.

Driving and using machines

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

Cinfamar Infantil contains methyl parahydroxybenzoate, sodium salt, and propyl parahydroxybenzoate, sodium salt

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt, and propyl parahydroxybenzoate, 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 told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset 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 it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney failure, do not take this medication unless it is 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.

3. How to take Cinfamar Infantil

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

The recommended doses are:

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

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

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

• Patient with liver disease: should consult their 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 30 minutes before starting the trip (preferably 1 or 2 hours before), and if not taken previously, the first dose will be taken when symptoms appear. If motion sickness persists, wait at least 6 hours 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 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 medication and the amount ingested.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

During the use of dimenhydrinate, 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, dizziness, and vertigo.
• Increased viscosity of mucus in the bronchi, making breathing difficult.
• Urinary retention and impotence.
• Glaucoma (increased intraocular pressure).
• Dilated pupils, 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 large amounts of porphyrin are 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 side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cinfamar Infantil

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 stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Cinfamar Infantil

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

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

Appearance of the product and contents of the pack

Cinfamar Infantil is a clear, colorless or slightly yellowish oral solution with a raspberry flavor.

It is presented in packs containing 6 or 12 single-dose units of 5 ml.

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 package leaflet:December 2020

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