Package Insert: Information for the User

Biodramina Caffeine Coated Tablets

Dimenhydrinate/Caffeine/Pyridoxine Hydrochloride

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

Follow exactly the medication administration instructions 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.

Dimenhydrinate acts against motion sickness caused by modes of transportation.

Caffeine has a stimulating effect on the nervous system, thus countering the somnolence effect that dimenhydrinate may cause.

Piridoxine, through its action on the central nervous system, is used in cases of nausea and dizziness, such as those caused by movement.

Biodramina cafeina 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 it worsens or does not improve after 7 days.

Do not take Biodramina Cafeína:

• If you are allergic to dimenhidrinato, difenhidramina, caffeine (or derivatives such as aminofilina, teofilina…), piridoxina hidrocloruro, 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 feces and urine).
• If you have asthma attacks.
• If you have mental alterations that cause nervous excitement, seizures with or without loss of consciousness (epilepsy), anxiety, 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 may cause thickening of secretions and alter expectoration.
• If you have a disease that causes 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, it may cause dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension).
• If you are using a medication that causes ototoxicity (toxicity in the ear), as it may mask symptoms of these effects, such as tinnitus, dizziness, or vertigo.
• If you are diabetic, be aware that caffeine may increase blood sugar levels.
• If you have liver, kidney, stomach ulcer, or duodenal disease, or stomach inflammation (gastritis), consult your doctor before taking this medication.
• Consult your doctor before taking this medication if you have or have had heart diseases (cardiac arrhythmia, myocardial ischemia,…), especially when exercising or at high altitudes.
• If you are sensitive to other xanthines such as theophylline, aminophylline, consult your doctor before taking this medication.
• If you suspect you may have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, consult 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 high temperatures and follow proper hygiene and dietary measures, such as adequate ventilation and hydration.
• Avoid exposure to the sun (even on cloudy days) and UV-A lamps while taking this medication.
• The simultaneous use of tobacco with the caffeine in this medication increases the degradation of caffeine.

Interference with diagnostic tests:

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

If you are to undergo an 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 may 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 taken recently, 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 central nervous system depressant action.
• Aminoglycoside antibiotics.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian medications.
• Neuroleptics (used to calm agitation and hyperactivity).
• Ototoxic medications (that can affect the ear) (see Warnings and Precautions).
• Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Medications that primarily interfere with caffeine:

• Oral contraceptives.
• Quinolone antibiotics (such as pipemidic acid, ciprofloxacin), linezolid, and erythromycin.
• Barbiturates (used as anticonvulsants).
• Adrenergic bronchodilators and theophylline (used to combat asthma).
• Calcium.
• Cimetidine (used to treat excessive stomach secretion and stomach ulcers).
• Disulfiram (used in alcohol withdrawal treatments).
• Phenobarbital and phenytoin (used to treat epilepsy).
• Iron (used to treat anemia) (caffeine reduces iron absorption, so it is recommended to take it 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).

Medications that primarily interfere with piridoxina hidrocloruro:

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

Taking Biodramina Cafeína with food, drinks, and alcohol

Do not consume alcohol while taking this medication.

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

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

Pregnancy, lactation, and fertility

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

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

Women who are breastfeeding should not take this medication without consulting their doctor or pharmacist, 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 decreased reaction time at recommended doses.

Biodramina Cafeína contains yellow-orange lake S (E110).

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

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:1-2 tablets (50-100 mg of dimenhydrinate, 50-100 mg of caffeine, and 15-30 mg of pyridoxine hydrochloride). If necessary, repeat the dose every 4-6 hours. Do not administer more than 4 tablets (200 mg of dimenhydrinate, 200 mg of caffeine, and 60 mg of pyridoxine hydrochloride) per day.

Use in children

Children under 12 years should not take this medication.

Patients with liver disease: should consult their doctor before taking this medication, as it may be necessary to adjust the dose.

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 half an hour before starting the trip (preferably 1-2 hours before), leaving at least 4 hours between one dose and the next. Do not take the last dose within 6 hours of going to bed, to avoid possible insomnia, especially in patients with difficulty sleeping.

If symptoms worsen or persist for more than 7 days, consult a doctor.

If you take more Biodramina Caffeine than you should

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

The symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, irritation of the stomach and intestines with nausea, vomiting, and diarrhea, movement disorders, seizures, 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, go immediately to a medical center or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

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

Like all medications, Biodramina Caffeine may have adverse effects, although not everyone will experience them.

Adverse effects are usually mild and temporary, especially at the beginning of treatment.

During the period of use of dimenhydrinate, 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.
• Sleep and sedation (drowsiness)
• Headache, dizziness, and dizziness.
• Increased mucus viscosity 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).
• Hypertension or hypotension (increase or decrease in blood pressure).
• Tachycardia, palpitations, and/or cardiac arrhythmias.
• 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,
• Hot flashes,
• Abundant urination.
• Hypoglycemia or hyperglycemia (increase or decrease in blood glucose)

The administration of pyridoxine hydrochloride may cause the following adverse effects:

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

If you experience adverse effects, consult your doctor or pharmacist, even if it is about adverse effects that do not appear in this prospectus.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in the 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 about the safety of this medication.

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

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging afterCAD.The expiration date is the last day of the month indicated.

Medicines 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.In case of 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 Biodramina Caffeine

• The active principles are dimenhydrinate, caffeine, and pyridoxine hydrochloride. Each tablet contains 50 mg of dimenhydrinate, 50 mg of caffeine, and 15 mg of pyridoxine hydrochloride.
• The other components (excipients) are methylcellulose, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose A (from potato), ammonium methacrylate copolymer Type A, talc, titanium dioxide (E171), yellow-orange lake S (E110), triethyl citrate, polyethylene glycol 6000, dimethicone. See section 2 “ Biodramina Caffeine contains yellow-orange lake S (E110)."

Appearance of the product and contents of the packaging

biodramina caffeine are round, orange-coated tablets with a notch on one face.

They are presented in containers containing 4 and 12 tablets.

Marketing Authorization Holder:

URIACH CONSUMER HEALTHCARE, S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona – Spain)

Responsible for manufacturing:

Noucor Health, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans

(Barcelona-Spain)

Last review date of this leaflet : October 2013

“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.gob.es.”