Cinfamar Caffeine 50 mg/50 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

cinfamar caffeine 50mg/50mg coated tablets

dimenhydrinate/caffeine

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 provided in this leaflet or those given by your doctor or pharmacist.
• Keep this leaflet, 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 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 caffeine is and what it is used for
2. What you need to know before taking cinfamar caffeine
3. How to take cinfamar caffeine
4. Possible side effects
5. How to store cinfamar caffeine
6. Contents of the pack and other information

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

cinfamar caffeine is a medicine that contains two active substances: dimenhydrinate and caffeine. Dimenhydrinate is an active ingredient that acts against motion sickness caused by various forms of transportation.

Caffeine has a stimulant effect on the central nervous system, thereby counteracting the drowsiness that dimenhydrinate may cause.

cinfamar caffeine 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 adults and children over 12 years of age.

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

2. What you need to know before taking cinfamar caffeine

Do not take cinfamar caffeine

• If you are allergic to dimenhydrinate, diphenhydramine, caffeine (or derivatives thereof, such as aminophylline, theophylline, etc.) or to any of the other components of this medicine (listed in section 6).
• If you have porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrins in urine and feces).
• If you suffer from asthma attacks.
• If you have mental disorders causing nervous excitement or seizures involving convulsive movements, with or without loss of consciousness (epilepsy).
• If you suffer from anxiety states or insomnia (difficulty sleeping).
• If you have severe liver or heart disorders.
• If you have gastric or duodenal ulcers.
• If you have high blood pressure (hypertension).

Warnings and precautions

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

• If you are allergic to any medication used to treat allergies, you may also be allergic to dimenhydrinate.
• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening of secretions may occur and affect expectoration.
• If you have a condition involving abnormal overactivity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), or any disease causing urinary or gastrointestinal tract obstruction.
• 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 ototoxicity (ear toxicity), manifested by symptoms such as ringing in the ears, dizziness, or vertigo, as this medicine may mask the symptoms of such toxic effects.
• Diabetic patients should be aware that caffeine may increase blood glucose levels.
• If you have any liver, kidney, gastric or duodenal ulcer, or stomach inflammation (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 diseases or disorders (cardiac arrhythmia, myocardial ischemia, etc.), especially when performing physical exercise or being at high altitudes.
• If you are sensitive to caffeine or other xanthines such as theophylline, aminophylline, or others, you should consult your doctor before taking this medicine.
• If you suspect you may have appendicitis symptoms such as nausea, vomiting, or abdominal cramps, it is recommended to see a doctor to rule out appendicitis, as dimenhydrinate may complicate the diagnosis of this condition.
• It is recommended to avoid exposure to high temperatures and to follow appropriate hygiene and dietary measures, such as adequate ventilation and hydration.
• Avoid exposure to sunlight (even when cloudy) and UV-A lamps (ultraviolet rays) while taking this medicine.
• Concurrent use of tobacco with the caffeine contained in this medicine may increase caffeine metabolism.

Children

Children under 12 years of age must not take this medicine.

Taking cinfamar caffeine with other medicines

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

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose of cinfamar caffeine or avoid taking it altogether:

Medicines that primarily interact with dimenhydrinate:

• Anesthetics and other substances with central nervous system depressant effects.
• Antibiotics of the aminoglycoside group.
• 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).

Medicines that primarily interact with caffeine:

• Oral contraceptives.
• Anti-infective agents of the quinolone group (e.g., pipemidic acid, ciprofloxacin), linezolid, and erythromycin.
• Barbiturates (used as anticonvulsants).
• Adrenergic bronchodilators and theophylline (used to treat bronchial asthma).
• Calcium.
• Cimetidine (used to treat excessive gastric secretion and gastric ulcers).
• Disulfiram (used in alcohol deterrent therapy).
• Phenytoin (used to treat epilepsy).
• Iron (used to treat anemia. Caffeine reduces iron absorption, so administration should be spaced at least 2 hours apart).
• Lithium (antidepressant).
• Mexiletine: used for heart rhythm disorders (cardiac arrhythmias).
• Procarbazine (anticancer agent).
• Selegiline (used to treat Parkinson's disease).
• Thyroxine (used to treat thyroid disorders).

Interference with diagnostic tests

If you are scheduled to undergo any laboratory tests (blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

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 interference with test results.

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

Taking cinfamar caffeine with food, drinks, and alcohol

Alcohol consumption is not recommended while taking this medicine.

Limit intake of beverages containing caffeine (coffee, tea, chocolate, and cola drinks) while taking this medicine.

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 medicine.

Breastfeeding

Women who are breastfeeding should not take this medicine without first consulting their doctor or pharmacist, as this medicine passes into breast milk.

Driving and using machines

While being treated with this medicine, do not drive or operate dangerous machinery, as this medicine may cause drowsiness or reduced reaction capacity at recommended doses.

cinfamar caffeine contains sodium

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

3. How to take cinfamar caffeine

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years of age

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

Do not take more than 8 tablets per day (equivalent to 400 mg of dimenhydrinate and 400 mg of caffeine).

Patients with liver disease

Must consult their doctor before taking this medicine, as a dose adjustment may be necessary.

Use in children

Children under 12 years of age must not take this medicine.

cinfamar caffeine is administered orally.

The first dose should be taken at least half an hour before starting the journey (preferably 1 or 2 hours beforehand), leaving at least 4 hours between doses. It is recommended to take the tablets with food, water, or milk to minimize gastric irritation.

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

If your condition worsens or symptoms persist for more than 7 days, you should consult your doctor.

If you take more cinfamar caffeine 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, irritation of the stomach and intestines with nausea, vomiting and diarrhea, movement disturbances, convulsions, deep unconsciousness (coma), sudden decrease in respiratory and heart function (cardiorespiratory collapse), and death. Symptoms may not appear until more than 2 hours 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 usually occur at the beginning of treatment.

During the use of dimenhydrinate, the following adverse reactions have been observed, although their frequency cannot be precisely determined:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation.
• 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 photosensitivity after intense sun exposure, possibly causing urticaria, itching, and skin redness.
• Decreased blood levels of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrins in feces and urine).
• Hypotension (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.

In addition, due to caffeine, the following may occur:

• Excitement, restlessness, and/or difficulty sleeping.
• Tinnitus (ringing in the ears).
• Disorientation.
• Rapid breathing.
• Hot flushes.
• Increased urine output.
• Hyperglycemia or hypoglycemia (increased or decreased blood glucose levels).

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 System of Pharmacovigilance of 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 caffeine

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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of cinfamar caffeine

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

Appearance of the product and contents of the pack

cinfamar caffeine are white, coated tablets, cylindrical, biconvex, and scored on one side.

They are available in packs containing 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 most recent revision of this leaflet: December 2020

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