Biodramina Infantil 4 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Biodramina Infantil 4 mg/ml Oral solution

Dimenhydrinate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of this medicine as described in this leaflet or as directed 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 get worse or do not improve after 7 days.

Contents of this leaflet:

1. What Biodramina Infantil is and what it is used for
2. What you need to know before taking Biodramina Infantil
3. How to take Biodramina Infantil
4. Possible side effects
5. How to store Biodramina Infantil
6. Contents of the pack and other information

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

Dimenhydrinate is the active ingredient in this medicine and acts against motion sickness caused by various modes of transportation.

It 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 children aged 2 to 12 years.

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

2. What you need to know before taking Biodramina Infantil

Do not take Biodramina Infantil

• If you are allergic to dimenhydrinate, diphenhydramine, or any of the other ingredients of this medicine (listed in section 6).
• If you have porphyria (a rare disorder, usually hereditary, in which large amounts of porphyrins are excreted in faeces and urine).
• If you are experiencing asthma attacks.

Warnings and precautions

• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening of secretions may occur and may impair expectoration.
• If you have a condition characterized by abnormally increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), hypertension, or any disease causing obstruction of the urinary or gastrointestinal tract.
• If you suffer from seizures with or without loss of consciousness (epilepsy).
• 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), as symptoms of such toxic effects (such as tinnitus, dizziness, or vertigo) may be masked.
• If you have any liver or kidney disease, stomach or duodenal ulcer, or inflammation of the stomach (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 conditions (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 appendicitis, as dimenhydrinate may make diagnosis of this condition more difficult.
• It is recommended to avoid exposure to high temperatures and to follow appropriate hygienic-dietary measures, such as adequate ventilation and hydration.
• Avoid exposure to sunlight (even when cloudy) and to ultraviolet lamps (UV-A rays) while taking this medicine.

Children

Do not use this medicine in children under 2 years of age.

Taking Biodramina Infantil with other medicines

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

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

• Anaesthetics and other substances with central nervous system depressant effects
• Aminoglycoside antibiotics
• 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).

Interference with diagnostic tests:

If you are to undergo any allergy testing, including skin tests, it is recommended to discontinue treatment 72 hours before the test to avoid interfering with test results.

Taking Biodramina Infantil with food, drinks, and alcohol

Alcohol consumption is not recommended while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be supervised by your doctor.

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 use of machines

Do not drive or operate heavy machinery, as this medicine may cause drowsiness or reduced reaction capacity at the recommended doses.

Biodramina Infantil contains amaranth (E 123), sucrose, methyl parahydroxybenzoate (E 218), benzyl alcohol, propylene glycol (E 1520), and sodium.

• This medicine may cause allergic-type reactions because it contains amaranth (E 123).
• This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
• This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E 218).
• This medicine contains 150 mg of propylene glycol per ml.

If the child is under 5 years of age, consult your doctor or pharmacist, especially if other medicines containing propylene glycol or alcohol have been administered.

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

If you have hepatic or renal insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

• This medicine contains 0.025 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

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

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

3. How to take Biodramina Infantil

Follow exactly the instructions for administering this medicine as stated in this leaflet or as directed 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 oral solution per dose (12–24 mg of dimenhydrinate).
If necessary, repeat the dose every 6 to 8 hours. Under no circumstances should more than 18 ml of Biodramina Infantil be taken per day (72 mg of dimenhydrinate), divided into several doses.

Children aged 7 to 12 years: 6 to 12 ml of oral solution per dose (24–48 mg of dimenhydrinate).
If necessary, repeat this dose every 6 to 8 hours. Under no circumstances should more than 36 ml of Biodramina Infantil be taken per day (144 mg of dimenhydrinate), divided into several doses.

Children under 2 years: This medicine must not be used in children under 2 years of age.

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

This medicine is taken by mouth.

It is recommended to take the first dose at least half an hour before starting travel (preferably 1–2 hours beforehand). If not taken previously, the first dose should be taken when symptoms appear. If nausea persists, wait at least 6 hours between doses.

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

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

Instructions for correct administration of the medicine

Before taking this medicine, carefully read the following instructions:

1. Open the bottle by following the instructions on the safety cap. Press down on the surface of the cap while simultaneously unscrewing it counterclockwise.

On first opening, the seal will break.

2. Insert the dosing syringe into the pierced opening in the cap (see figure 1).
3. Invert the bottle and draw up the dose indicated in the leaflet (see figure 2).
4. Administer directly using the dosing syringe, or transfer the contents of the syringe into a teaspoon.
5. The dosing syringe should be washed after each use and, if necessary, may be sterilized by boiling in water or immersing it in the sterilizing solution used for baby bottles.

If you take more Biodramina Infantil than you should

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

Symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, stomach and intestinal irritation with nausea, vomiting and diarrhoea, movement disturbances, seizures, deep unconsciousness (coma), sudden decrease in respiratory and heart function (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 Toxicology Information Service (telephone: 91.5620420), indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, Biodramina Infantil can have adverse effects, although not everyone will experience them.

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

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

• Nausea, vomiting, constipation, diarrhoea, 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 in the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic skin reactions and photosensitivity after intense sun exposure, which may result in urticaria, itching, and skin redness.
• Decrease in 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 faeces and urine).
• Hypertension or hypotension (increase or decrease in 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.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for 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 Biodramina Infantil

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the box and label after EXP. The expiry date is the last day of the month indicated.

Medicines should 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 have any questions, 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 Biodramina Infantil

• The active substance is dimenhydrinate. Each ml of oral solution contains 4 mg of dimenhydrinate.
  The other components (excipients) are: propylene glycol (E 1520), methylparahydroxybenzoate (E 218), sucrose, strawberry flavour (contains benzyl alcohol), amaranth (E 123), sodium saccharin (E 954) and purified water.

Appearance of the product and contents of the pack

Biodramina Infantil is a red, transparent solution with strawberry flavour and odour.

It is supplied in a 60 ml bottle with a perforated cap and a 6 ml dosing syringe that attaches to the cap. The bottle is closed with a child-resistant cap.

Marketing Authorization Holder

URIACH CONSUMER HEALTHCARE S.L.
Av. Generalitat 163-167
08174 Sant Cugat del Vallès (Barcelona - Spain)

Manufacturer

ITALFARMACO S.A.
San Rafael 3.
28108 Alcobendas (Spain)

Date of the most recent revision of this leaflet: October 2013

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