BIODRAMINA CAFFEINE COATED TABLETS

Introduction

Leaflet: Information for the user

Biodramina Cafeína Coated Tablets

Dimenhidrinato/Cafeína/Piridoxina hydrochloride

Read the entire 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 leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. (See section 4).
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the leaflet:

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

1. What Biodramina Cafeína is and what it is used for

Dimenhidrinato acts against motion sickness caused by means of transportation.

Caffeine has a stimulating effect on the nervous system, which counteracts the drowsiness effect that dimenhidrinato may cause.

Piridoxina, due to its action on the central nervous system, is used in cases of nausea and motion sickness.

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

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Biodramina Cafeína

Do not take Biodramina Cafeína:

• If you are allergic to dimenhidrinato, difenhidramina, caffeine (or its derivatives, such as aminophylline, theophylline...), piridoxina hydrochloride, or any other component of this medication (listed in section 6).
• If you have porphyria (a rare, usually hereditary disorder in which a large amount of porphyrin is eliminated in feces and urine).
• If you have asthma attacks.
• If you have mental disorders that cause nervous excitement, crises with convulsive movements, with or without loss of consciousness (epilepsy), anxiety states, and insomnia (difficulty sleeping).
• If you have severe liver, heart, stomach ulcer, duodenum, or high blood pressure.
• If you are being treated with levodopa (a medication used for Parkinson's disease).

Warnings and precautions

• If you have asthma, severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as it can cause thickening of secretions and alter expectoration.
• If you have a disease in which there is an abnormal increase in thyroid gland activity (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), or any disease that causes obstruction of the urinary or gastrointestinal tract.
• If you are over 65 years old, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are using 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 are diabetic, you should be aware that caffeine can raise blood sugar levels.
• If you have any liver or kidney disease, stomach ulcer, or duodenum, 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,...), especially when engaging in physical exercise or being in high-altitude areas.
• If you are sensitive to other xanthines, such as theophylline or aminophylline, you should consult your doctor before taking this medication.
• If you suspect you may have appendicitis symptoms, 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 can 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 UVA lamps (ultraviolet rays) while taking this medication.
• The simultaneous use of tobacco with the caffeine contained in this medication increases the degradation of caffeine.

Interference with diagnostic tests:

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

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

Children

Do not use this medication in children under 12 years old.

Taking Biodramina Cafeína 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 using any of the following medications, it may be necessary to modify the dose of Biodramina Cafeína or not take it:

Medications that primarily interfere with dimenhidrinato:

• Anesthetics and other substances with a depressant effect on the central nervous system.
• Antibiotics of the aminoglycoside group.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian agents.
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity).
• Ototoxic medications (which can affect the ear) (see Warnings and precautionssection).
• Medications that can cause photosensitivity (skin reactions due to sun sensitivity).

Medications that primarily interfere with caffeine:

• Oral contraceptives.
• Anti-infectious agents of the quinolone group (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 decreases iron absorption, so it should be taken at least 2 hours apart).
• Lithium (antidepressant).
• Mexiletine used for heart rhythm disorders (cardiac arrhythmias).
• Procarbazine (anticancer).
• Selegiline (used to treat Parkinson's disease).
• Thyroxine (used to treat thyroid diseases).

Medications that primarily interfere with piridoxina hydrochloride:

• Levodopa (medication used for Parkinson's disease).
• Phenobarbital and phenytoin (medications used for epilepsy).
• Amiodarone (medication for the heart).
• Altretamine and cyclophosphamide (medications used for cancer).
• Penicillamine (medication used for rheumatic diseases).
• Hydralazine (medication used for hypertension).
• Antitubercular agents (isoniazid, cycloserine, ethionamide).
• Oral contraceptives.
• Immunosuppressants (such as corticosteroids, cyclosporine, azathioprine, etc.) used in organ transplantation.

Taking Biodramina Cafeína with food, beverages, and alcohol

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

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

The administration of piridoxina with food delays the absorption of piridoxina.

Pregnancy, breastfeeding, and fertility

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.

Women who are breastfeeding 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 the recommended doses.

Biodramina Cafeína contains yellow orange S (E110).

This medication can cause allergic reactions because it contains yellow orange S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Biodramina Cafeína

Follow the administration instructions for the medication contained in this 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 old: 1-2 tablets (50-100 mg of dimenhidrinato, 50-100 mg of caffeine, and 15-30 mg of piridoxina hydrochloride). If necessary, repeat the dose every 4-6 hours. Do not take more than 4 tablets (200 mg of dimenhidrinato, 200 mg of caffeine, and 60 mg of piridoxina hydrochloride) per day.

Use in children

Children under 12 years old should not take this medication.

Patient with liver disease: should consult their doctor before taking this medication, as a dose adjustment may be necessary.

This medication is taken orally.

It is recommended to take the tablets with food, water, or milk to minimize gastric irritation.

The first dose should be taken at least 30 minutes before starting the trip (preferably 1-2 hours before), leaving at least 4 hours between doses. The last dose should not be taken in the 6 hours before bedtime to avoid possible insomnia, especially in patients with difficulty sleeping.

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

If you take more Biodramina Cafeína than you should

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

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

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, Biodramina Cafeína can have side effects, although not everyone experiences them.

The 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 cannot be established with precision:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Lack of appetite and dry mouth.
• Sleepiness and sedation (drowsiness).
• Headache, dizziness, and vertigo.
• Increased viscosity of mucus in the bronchi, making breathing difficult.
• Urinary retention and impotence.
• Glaucoma (increased intraocular pressure).
• Dilated pupils, blurred vision, or double vision.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which can cause urticaria, 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 a large amount of porphyrin is 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.

Additionally, due to caffeine, the following may appear:

• Excitement, agitation, and/or difficulty sleeping.
• Ringing in the ears.
• Disorientation.
• Accelerated breathing.
• Hot flashes.
• Abundant urine elimination.
• Hyperglycemia or hypoglycemia (increased or decreased blood sugar).

The administration of piridoxina hydrochloride may cause the following side effects:

• Decrease in platelets in the blood.
• Allergic reactions, including skin allergic reactions and sensitivity to sunlight.
• Folic acid deficiency.
• Headache, tingling sensation, and numbness in feet and hands, drowsiness, insomnia, and memory alteration.
• Breathing difficulties (apnea, dyspnea).
• Nausea.
• Suppression of lactation, breast pain, and breast enlargement.
• Liver enzyme alterations.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in the leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Biodramina Cafeína

Keep this medication out of the sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date shown on the packaging after EXP.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 unused medications at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Biodramina Cafeína

• The active ingredients are dimenhidrinato, caffeine, and piridoxina hydrochloride. Each tablet contains 50 mg of dimenhidrinato, 50 mg of caffeine, and 15 mg of piridoxina hydrochloride.
• The other components (excipients) are methylcellulose, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose (potato), ammonio methacrylate copolymer Type A, talc, titanium dioxide (E171), yellow orange S (E110), triethyl citrate, polyethylene glycol 6000, and dimethicone. See section 2 "Biodramina Cafeína contains yellow orange S (E110)".

Appearance of the product and package contents

Biodramina Cafeína are round, orange, coated tablets with a score on one side.

They are available in packages containing 4 and 12 tablets.

Marketing authorization holder:

URIACH CONSUMER HEALTHCARE, S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona, Spain)

Manufacturer:

Noucor Health, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans

(Barcelona, Spain)

Date of the last revision of this leaflet:October 2013

"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.gob.es."