Biodramina infantil 12,5 mg solucion oral
Jak stosować Biodramina infantil 12,5 mg solucion oral
Introduction
Package Insert: Information for the User
Biodramina Infantil 12.5 mg Oral Solution
Dimenhidrinato
Read this entire package insert carefully before starting to take this medication, as it contains important information for you
Follow exactly the administration instructions for the medication 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 of treatment.
1. What is Biodramina Infantil and what is it used for
The dimenhidrinate is the active ingredient of this medication and acts against motion sickness caused by transportation.means of locomotion.
It is indicated in children from 2 to 12 years old for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air transportation, such as nausea, vomiting, and/or dizziness.
2. What you need to know before starting Biodramina Infantil
Do not take Biodramina Infantil if:
- You are allergic (hypersensitive) to dimenhidrinato, difenhidramina, or any other component of this medication (listed in section 6).
- You have porphyria (a rare, usually inherited disorder in which a large amount of porphyrin is eliminated in feces and urine).
- You have asthma attacks.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Biodramina Infantil:
- 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 low blood pressure (hypotension).
- If you are using a medication that causes ototoxicity, as it may mask symptoms of these toxic effects, such as ringing in the ears, dizziness, or vertigo.
- If you have any liver or kidney disease, stomach or duodenal ulcer, or stomach inflammation (gastritis), consult your doctor before taking this medication.
- If you have or have had heart diseases (cardiac arrhythmia).
- 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.
You may experience cross-sensitivity (allergy) with other antihistamines.
In some patients, sedation or somnolence may occur.
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 ultraviolet radiation lamps (UVA rays) while taking this medication.
Children
Do not use this medication in children under 2 years old.
Other medications and Biodramina Infantil
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
In particular, if you are using any of the following medications, it may be necessary to modify the dose of Biodramina Infantil or not take it:
- Substances with a depressant effect on the Central Nervous System, such as anesthetics, barbiturates, benzodiazepines, opioid analgesics, as dimenhidrinato may potentiate their sedative effect.
- Aminoglycoside antibiotics and other medications that cause ototoxicity (see "Warnings and precautions").
- Tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), antiparkinsonian medications, and neuroleptics (for treating schizophrenia), as dimenhidrinato may potentiate the adverse effects of these medications. Monitor for the appearance of gastrointestinal symptoms, as it may cause paralytic ileus (absence of intestinal movements).
- Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight).
Interference with diagnostic 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 of the test.
Taking Biodramina Infantil with food, drinks, and alcohol
Do not consume alcohol during the time you are taking this medication.
Pregnancy and lactation
If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.
This medication is intended exclusively for administration in children.
The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.
Women in the lactation period should not take this medication without first consulting a doctor or pharmacist, as this medication passes into breast milk and may inhibit milk production.
Driving and operating machinery
Do not drive or operate hazardous machinery, as this medication may cause drowsiness or decrease reaction time at recommended doses.
Biodramina Infantil contains parahydroxybenzoate of methyl (E-218), saccharose, propylene glycol (E-1520), and sodium
-This medication may cause delayed allergic reactions because it contains parahydroxybenzoate of methyl (E-218).
-This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.
-This medication contains 200 mg of propylene glycol (E-1520) in each sachet.If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.
-This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".
3. How to Take Biodramina Infantil 12.5 mg Oral Solution
Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
- Children aged 2 to 6 years:1 to 2 sachets (12.5-25 mg of dimenhydrinate). If necessary, repeat the dose every 6 to 8 hours. Do not take in any case more than 6 sachets a day (75 mg of dimenhydrinate in 24 hours).
- Children aged 7 to 12 years:2 to 4 sachets (25-50 mg of dimenhydrinate). If necessary, repeat the dose every 6 to 8 hours. Do not take in any case more than 12 sachets a day (150 mg of dimenhydrinate in 24 hours).
- Children under 2 years:Should not be used in children under 2 years.
- Patients with liver disease:Should consult their 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 journey (preferably 1 or 2 hours before), and if not taken beforehand, the first dose will be taken when 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, the patient should consult their doctor.
If you take more Biodramina Infantil than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.
The symptoms of an 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.
4. Possible Adverse Effects
Like all medications, Biodramina Infantilmay produce adverse effects, although not all people will experience them.
Adverse effects are usually mild and transient, especially at the beginning of treatment.
During the period of use of dimenhidrinate, 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.
- 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 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 young children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even seizures.
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 this 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.
5. Conservation of Biodramina Infantil 12.5 mg oral solution
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and the packaging after CAD. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Biodramina Infantil
- The active ingredient is dimenhidrinato. Each 2.5 ml sachet contains 12.5 mg of dimenhidrinato.
- The other components (excipients) are: propylene glycol (E-1520), methyl parahydroxybenzoate (E-218), sucrose, sodium saccharin (E-954), sodium cyclamate (E-952), tutti frutti flavor, sodium chloride, and purified water.
Appearance of the product and contents of the packaging
Biodramina Infantil is a transparent, colorless or slightly yellowish oral solution, with a tutti frutti odor and taste.
It is presented in packaging containing 12 sachets of 2.5 ml.
Holder of the marketing authorization
URIACH CONSUMER HEALTHCARE S.L.
Generalitat 163-167 Avenue
08174 Sant Cugat del Vallès
(Barcelona-Spain)
Responsible for manufacturing
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares
Madrid
Last review date of this leaflet:April 2021
The 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.es/
- Kraj rejestracji
- Substancja czynna
- Wymaga receptyNie
- Producent
- SkładPropilenglicol (200 mg mg), Parahidroxibenzoato de metilo (e-218) (1,25 mg mg), Sacarosa (1200 mg mg), Sacarina sodica (2,5 mg mg), Ciclamato de sodio (12,5 mg mg), Cloruro de sodio (3,5 mg mg)
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