Package Insert: Information for the User

cinfamar 50 mg coated tablets

dimenhidrinato

Read this 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 you worsen or do not improve after 7 days.

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

It is indicated for the prevention and treatment of symptoms of motion sickness produced by land, sea, or air transportation, such as nausea, vomiting, and/or dizziness in adults and children over 12 years old.

Consult a doctor if symptoms worsen or do not improve after 7 days.

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 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.

• 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 any 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).
• 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 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 medication.

Children

Do not use this medication in children under 2 years old.

Taking Cinfamar with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may 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 or not take it:

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 test results.

Taking Cinfamar 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 milk.

Pregnancy and breastfeeding

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

The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Women in the lactation period should not take this medication without consulting their doctor or pharmacist first, as this medication passes into breast milk.

Driving and operating machinery

Do not drive or operate hazardous machinery as this medication may cause drowsiness or decrease reaction time at recommended doses.

Cinfamar contains sodium

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

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

The recommended doses are:

• Adults and children over 12 years:1 or 2 tablets (50 - 100 mg of dimenhydrinate) per dose. If necessary, repeat the dose every 4-6 hours. Do not administer more than 8 tablets (400 mg of dimenhydrinate) per day, divided into several doses.
• Children from 2 to 12 years:This medication is not suitable for children aged 2-12 years. There are more suitable presentations for children in this age range, such as Cinfamar infantil 25 mg coated tablets or Cinfamar infantil 12.5 mg oral solution.
• Children under 2 years:It should not be used in children under 2 years.
• Patients with liver diseases:They 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 journey (preferably 1-2 hours before), and if it has not been taken beforehand, the first dose should be taken when symptoms appear. If the dizziness persists, at least 4 or 6 hours should pass between one dose and the next.

It is recommended to take the tablets with food, water, or milk to minimize gastric irritation. If symptoms worsen, or if they persist for more than 7 days, the patient should consult their doctor.

If you take more Cinfamar than you should

If you have taken Cinfamar in excess, consult your doctor or pharmacist immediately.

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

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.

Like all medications,,this medicationcan produce adverse effects, although not all people 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:

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does 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 box and label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of cinfamar

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

Appearance of the product and contents of the packaging

White, cylindrical, biconvex, and scored tablets on one face.

It is presented in packaging with 4 or 10 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:December 2020

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