Package Insert: Information for the User

cinfamar caffeine 50mg/50mg coated tablets

dimenhydrinate/caffeine

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

• Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.
• Keep this package insert, as you may need to refer to 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 your condition worsens or does not improve after 7 days.

Cinfamar Caffeine is a medication that contains two active substances: dimenhidrinato and caffeine.The dimenhidrinato is an active principle that acts against motion sickness caused by means of transportation.

Caffeine has a stimulating effect on the nervous system, so it counteracts the somnolence effect that dimenhidrinato may cause.

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

You should consult a doctor if it worsens or does not improve after 7 days.

Do not take cinfamar with caffeine

• If you are allergic to dimenhidrinato, difenhidramina, caffeine (or derivatives such as aminofilina, teofilina, etc.) or any other component 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 urine and feces).
• If you have asthma attacks.
• If you have mental disorders that cause nervous excitement or seizures with or without loss of consciousness (epilepsy).
• If you have anxiety or insomnia (difficulty sleeping).
• If you have severe liver or heart disorders.
• If you have stomach or duodenal ulcers.
• If you have high blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfamar with caffeine.

Children

Children under 12 years old should not take this medication.

Taking cinfamar with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medication.

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of cinfamar or not be able to take it:

Medications that primarily interfere with dimenhidrinato:

• Anesthetics and other substances with central nervous system depressant action.
• Aminoglycoside antibiotics.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian drugs.
• Neuroleptics (used to calm agitation and hyperactivity of the neuromuscular system).
• Ototoxic medications (that can affect the ear) (see Warnings and Precautions section).
• Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Medications that primarily interfere with caffeine:

• Oral contraceptives.
• Quinolone antibiotics (e.g. pipemidic acid, ciprofloxacin), linezolid and erythromycin.
• Barbiturates (used as anticonvulsants).
• Adrenergic bronchodilators and theophylline (used to combat bronchial asthma).
• Calcium.
• Cimetidine (used to treat excessive gastric secretion and stomach ulcers).
• Disulfiram (used in alcohol detoxification treatments).
• Phenytoin (used to treat epilepsy).
• Iron (used to treat anemia. Caffeine reduces iron absorption, so it should be taken at least 2 hours apart).
• Lithium (antidepressant).
• Mexiletine: used to treat cardiac arrhythmias.
• Procarbazine (anticancer medication).
• Selegiline (used to treat Parkinson's disease).
• Thyroxine (used to treat thyroid diseases).

Interference with diagnostic tests

If you are to undergo any analytical test (blood or urine analysis, etc.), inform your doctor that you are taking this medication, as it may alter the results of these 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 results of the test.

Additionally, diabetic patients should be aware that caffeine may increase blood glucose levels.

Taking cinfamar with food, drinks and alcohol

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

Limit the consumption of drinks containing caffeine (coffee, tea, chocolate and cola drinks) while taking this medication.

Pregnancy and breastfeeding

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

Breastfeeding

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

Driving and operating machinery

While taking this medication, do not drive or operate hazardous machinery, as this medication may cause drowsiness or decreased reaction time at recommended doses.

cinfamar contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, 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 dose is:

Adults and children over 12 years old

1 or 2 tablets per dose. If necessary, repeat the dose every 4-6 hours.

Do not take more than 8 tablets a day (corresponding to 400 mg of dimenhidrinato and 400 mg of caffeine).

Patients with liver disease

They must consult their doctor before taking this medication, as it may be necessary to adjust the dose.

Use in children

Children under 12 years old should not take this medication.

Cinfamar Caffeine is administered orally.

The first dose should be taken at least 30 minutes beforestarting the trip (preferably 1 or 2 hours before), leaving at least 4 hours between one dose and the next. It is recommended to take the tablets with food, water, or milk to minimize gastric irritation.

The last dose should not be taken in the 6 hours before bedtime, to avoid possible insomnia, especially in patients with difficulty sleeping.

If it worsens or if symptoms persist for more than 7 days, consult a doctor.

If you take more Cinfamar Caffeine than you should

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..

The symptoms of an overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, irritation of the stomach and intestines 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.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects usually occur 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:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and dizziness.
• Increased viscosity of mucus in the bronchi, making breathing difficult.
• Urinary retention and impotence.
• Glaucoma (increase in intraocular pressure of the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic reactions on the skin and sensitivity to sunlight after intense exposure, which may appear as urticaria, itching, and skin redness.
• Decrease in the blood of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (rare disorder, usually inherited, in which a large amount of porphyrin is eliminated in feces and urine).
• Hypotension (decrease in blood pressure).
• Tachycardia, palpitations, and/or arrhythmias.
• It may cause hyperexcitability, especially in children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even convulsions.

Additionally, due to caffeine, the following may appear:

• Excitement, agitation, and/or difficulty sleeping.
• Tinnitus.
• Disorientation.
• Accelerated breathing.
• Sweating.
• Abundant urine elimination.
• Hyperglycemia or hypoglycemia (increase or decrease in blood glucose).

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 packaging, 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 collection point at the 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 caffeine

• Each tablet contains 50 milligrams of dimenhydrinate and 50 milligrams of caffeine as active principles.
• The other components are:
• • Core: Cornstarch, anhydrous colloidal silica, microcrystalline cellulose, dihydrate calcium phosphate, magnesium stearate, sodium carboxymethylcellulose (from potato) (type A), povidone, talc.
  • Coating: Macrogol 6000, hypromellose 606, hypromellose 615.

Appearance of the product and content of the packaging

cinfamar caffeineare coated white, cylindrical, biconvex, and scored tablets on one face.

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:December 2020

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