CINFAMAR 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

cinfamar 50 mg coated tablets

dimenhidrinato

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

1. What cinfamar is and what it is used for

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

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

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

Do not take cinfamar:

• 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 hereditary disorder in which large amounts of porphyrin are eliminated in feces and urine).
• If you have asthma.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take cinfamar.

• 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), prostate enlargement (prostatic hypertrophy), hypertension, or any disease that causes obstruction of the urinary tract 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 hypotension may occur.
• If you are taking 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 medication.
• You should consult your doctor before taking this medication if you have or have had heart diseases (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 dimenhidrinato may hinder the diagnosis of 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

Do not use this medication in children under 2 years of age.

Taking cinfamar 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 taking any of the following medications, it may be necessary to modify the dose of Cinfamar or not take it:

• Anesthetics and other substances with central nervous system depressant action.
• Antibiotics of the aminoglycoside group.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian medications.
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity).
• Ototoxic medications (which 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 suspend treatment 72 hours before starting the test to avoid altering the results.

Taking cinfamar with food, drinks, and alcohol

Alcohol consumption is not recommended during the time you are taking this medication.

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

Pregnancy and breastfeeding

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.

Breastfeeding women 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 capacity at recommended doses.

Cinfamar contains sodium

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

3. How to take cinfamar

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:

• Adults and children over 12 years: 1 or 2 tablets (50-100 mg of dimenhidrinato) per dose. If necessary, repeat the dose every 4-6 hours. Do not take more than 8 tablets (400 mg of dimenhidrinato) per day, divided into several doses.
• Children from 2 to 12 years: This medication is not suitable for children from 2-12 years. There are more suitable presentations for children between 2-12 years, such as cinfamar infantil 25 mg coated tablets or cinfamar infantil 12.5 mg oral solution.
• Children under 2 years: Do not use in children under 2 years.
• 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 half an hour before starting the trip (preferably 1-2 hours before), and if not taken beforehand, the first dose will be taken when symptoms appear. If motion sickness persists, wait at least 4 or 6 hours between doses.

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 than you should

If you have taken Cinfamar more than you should, consult your doctor or pharmacist immediately.

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

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.

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 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 number of red blood cells, white blood cells, leukocytes, and platelets in the blood.
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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

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 shown on the box and label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of cinfamar

• Each tablet contains 50 mg of dimenhidrinato as the active ingredient.
• The other components are:
• • Core: calcium hydrogen phosphate dihydrate, corn starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (potato), povidone, talc, and magnesium stearate.
  • Coating: Hypromellose 606, hypromellose 615, macrogol 6000, and purified water.

Appearance of the product and package contents

White, cylindrical, biconvex, and scored coated tablets.

Available in packages of 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 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.es/