Package Insert: Information for the User

Biodramina Infantil 4 mg/ml Oral Solution

Dimenhidrinate

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 provided 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.

The dimenhydrinate is the active ingredient of this medication and acts against motion sickness caused by transportation.

It 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 dizziness in children aged 2 to 12 years.

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

Do not take Biodramina Infantil

• If you are allergic to dimenhidrinato, difenhidramina, 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.

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 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 a medication that causes ototoxicity, as it may mask symptoms of these toxic effects, such as tinnitus, dizziness, or vertigo.
• If you have any liver or kidney disease, stomach ulcers, or duodenal ulcers, 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, etc.).
• 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 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 Biodramina Infantil with other medications

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

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

• Anesthetics and other substances with central nervous system depressant effects.
• 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 section).
• Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Interference with diagnostic tests:

If you are to undergo any allergy tests: including skin tests, it is recommended to suspend treatment 72 hours before starting the test, to avoid altering the test results.

Taking Biodramina Infantil with food, drinks, and alcohol

It is not recommended to consume alcohol during the time you are taking this medication.

Pregnancy, breastfeeding, and fertility

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 breastfeeding period 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 Infantil contains amaranto (E 123), sacarosa, parahidroxibenzoato de metilo (E 218), alcohol bencílico, propilenglicol (E 1520), and sodium.

• This medication may cause allergic reactions because it contains amaranto (E 123).
• This medication contains sacarosa. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
• This medication may cause allergic reactions (possibly delayed) because it contains parahidroxibenzoato de metilo (E 218).
• This medication contains 150 mg of propilenglicol per ml.

If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propilenglicol or alcohol have been administered.

If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

• This medication contains 0.025 mg of alcohol bencílico per ml. Alcohol bencílico may cause allergic reactions.

Alcohol bencílico has been linked to the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

This medication should not be used for more than a week in children under 3 years old, unless recommended by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of alcohol bencílico may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of alcohol bencílico may accumulate in your body and cause adverse effects (metabolic acidosis).

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

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

The recommended doses are:

Children aged 2 to 6 years:3 to 6 ml of the oral solution per dose (12-24 mg of dimenhydrinate).

If necessary, repeat the dose every 6 to 8 hours. Do not take in any case more than 18 ml of Biodramina Infantil per day (72 mg of dimenhydrinate), divided into several doses.

Children aged 7 to 12 years:6 to 12 ml of the oral solution per dose (24-48 mg of dimenhydrinate). If necessary, repeat this dose every 6 to 8 hours. Do not take in any case more than 36 ml of Biodramina Infantil per day (144 mg of dimenhydrinate), divided into several doses.

Children under 2 years:Should not be used in children under 2 years.

Patients with liver diseases:Should consult a 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 trip (preferably 1-2 hours before), and in case of not having taken it beforehand, the first dose will be taken when the symptoms appear. If the dizziness persists, at least 6 hours should pass between one dose and the next.

It is recommended to take this medication with food, water or milk to minimize gastric irritation.

If symptoms worsen, or if they persist for more than 7 days, you should consult a doctor

Instructions for the correct administration of the medication

Before taking this medication, read the following instructions carefully:

1. Open the bottle by following the instructions indicated on the safety cap. Press on the surface of the same and at the same time unscrew in the opposite direction to the clock hands.

In the first opening, the seal will break.

2. Insert the dosing syringe, pressing on the hole of the perforated cap (seefigure 1).

3. Invert the bottle and remove the dose indicated in the leaflet (seefigure 2).

4. Administer directly with the dosing syringe or place the contents of the dosing syringe in a spoon.

5. The dosing syringe must be washed after each dose and can be sterilized, if necessary, by boiling it in water or immersing it in the sterilizing solution used for bottles.

If you take more Biodramina Infantil than you should

If you have taken Biodramina Infantil 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, 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: 91.5620420), indicating the medication and the amount ingested.

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

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

During the period of use of dimenhidrinato, 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 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.
• Skin allergic reactions and sensitivity to sunlight after intense exposure, which may appear as urticaria, itching, and skin redness.
• Decrease in the blood of the number 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.
• It may cause hyperexcitability, especially in children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even seizures.

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is 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 on the safety of this medication.

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

No special storage conditions are required.

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.

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

Composition of Biodramina Infantil

• The active ingredient is dimehidrinato. Each ml of oral solution contains 4 mg of dimenhidrinato. The other components (excipients) are: propylene glycol (E 1520), methyl parahydroxybenzoate (E218), sucrose, strawberry flavor (contains benzyl alcohol), amaranth (E 123), sodium saccharin (E 954) and purified water.

Appearance of the product and content of the container

Biodramina Infantil is a transparent, red-colored solution with strawberry flavor and odor.

It is presented in a 60 ml bottle with a perforated cap and a 6 ml dosing syringe attached to the cap. The bottle is closed with a safety cap.

Holder of the marketing authorization

URIACH CONSUMER HEALTHCARE S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès (Barcelona - Spain)

Responsible for manufacturing

ITALFARMACO S.A.

San Rafael 3.

28108 Alcobendas (Spain)

Date of the last review 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.”