Cinfamar Infantil 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfamar infantil 25 mg coated tablets

dimenhydrinate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine contained in this leaflet or those provided by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do 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. How to store cinfamar infantil.
6. Contents of the pack and other information.

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

Dimenhydrinate is the active substance in this medicine and acts against motion sickness caused by various modes 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 dizziness in children aged 2 to 12 years.

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 medicine (listed in section 6).
• If you have porphyria (a rare, usually hereditary disorder characterized by excessive excretion of porphyrins in feces and urine).
• If you are experiencing asthma attacks.

Warnings and precautions

Consult your doctor or pharmacist before taking cinfamar infantil.

In particular, ask your doctor if you have or have previously had any of the following conditions:

• Asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening of secretions may occur and impair expectoration.
• A condition involving abnormal overactivity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), hypertension, or any illness causing obstruction of the urinary or gastrointestinal tract.
• Seizures with or without loss of consciousness (epilepsy).
• If you are over 65 years of age, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are taking any medication that causes ototoxicity (ear toxicity), as symptoms of such toxicity (such as tinnitus, dizziness, or vertigo) may be masked.
• If you have any liver or kidney disease, stomach or duodenal ulcer, or inflammation of the stomach (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 conditions (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 appendicitis, as dimenhydrinate may interfere with the diagnosis of this condition.
• It is recommended to avoid exposure to very high temperatures and to follow appropriate hygiene and dietary measures, such as adequate ventilation and hydration.
• Avoid exposure to sunlight (even when cloudy) and ultraviolet lamps (UV-A rays) while taking this medicine.

Children and adolescents

This medicine must not be given to children under 2 years of age.

Taking cinfamar infantil with other medicines

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

In particular, inform your doctor if you are taking any of the following medicines; it may be necessary to adjust the dose of cinfamar infantil or avoid taking it altogether:

• Anaesthetics and other substances with central nervous system depressant effects.
• Aminoglycoside antibiotics.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian agents.
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity).
• Ototoxic medicines (which may affect the ear) (see section Warnings and precautions).
• Medicines that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Interference with diagnostic tests

If you are scheduled to undergo allergy testing, including skin tests, it is recommended to discontinue treatment at least 72 hours before the test to avoid interfering with test results.

Taking cinfamar infantil with food, drinks, and alcohol

Alcohol consumption is not recommended 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is intended exclusively for use in children.

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

Breastfeeding women should not take this medicine without first consulting their doctor or pharmacist, as this medicine passes into breast milk.

Driving and use of machines

Do not drive or operate dangerous machinery, as this medicine may cause drowsiness or reduced reaction ability at recommended doses.

3. How to take cinfamar infantil

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in 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 spread the doses throughout the day.

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. Under no circumstances administer more than 3 tablets (75 mg of dimenhydrinate) per day, and always spread the doses throughout the day.

Children under 2 years of age: this medicine must not be used in this age group.

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

cinfamar infantil is taken orally.

The tablet may be divided into equal doses.

It is recommended to take the first dose at least half an hour before starting the journey (preferably 1–2 hours beforehand). If not taken previously, the first dose should be taken when symptoms appear. If motion sickness persists, wait at least 6 hours between doses.

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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, stomach and intestinal irritation with nausea, vomiting and diarrhea, movement disturbances, seizures, deep unconsciousness (coma), sudden decrease in respiratory and heart function (cardiorespiratory collapse), and death.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

During the period of use of dimenhydrinate, the following adverse reactions have been observed, although their frequency could not be accurately determined:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and vertigo.
• Increased mucus viscosity in the bronchi, making breathing difficult.
• Urinary retention and sexual impotence.
• Glaucoma (increased intraocular pressure of the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic skin reactions and sensitivity to sunlight, following intense exposure, which may result in urticaria, itching, and skin redness.
• Decrease in blood levels of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrin 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, tremor, irritability, euphoria, delirium, palpitations, and even seizures.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of cinfamar infantil

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

Appearance of the product and contents of the container

cinfamar infantil are pink, cylindrical, biconvex, film-coated tablets, scored on one side.

They are available in packs containing 4 or 10 film-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 most recent revision of this leaflet: January 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es/