Laitos 3 mg/ml syrup
SpainTable of Contents
Package leaflet: Information for the user
Introduction
- PACKAGE LEAFLET: INFORMATION FOR THE USER –
LAITOS 3 mg/ml Syrup
Dextromethorphan hydrobromide
Read the entire leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, to achieve the best results, it must be used appropriately.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen, persist for more than 7 days, or are accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.
- If you consider any of the side effects you experience to be severe or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Contents of the leaflet
- What LAITOS 3 mg/ml Syrup is and what it is used for
- Before taking LAITOS 3 mg/ml Syrup
- How to take LAITOS 3 mg/ml Syrup
- Possible side effects
- How to store LAITOS 3 mg/ml Syrup
- Further information
1. What LAITOS 3 mg/ml Syrup is and what it is used for
Dextromethorphan, the active substance in this medicine, is an antitussive that suppresses the cough reflex.
It is indicated for the symptomatic treatment of dry cough forms not accompanied by expectoration (irritative cough, nervous cough).
2. Before taking LAITOS 3 mg/ml Syrup
This medicine may cause dependence. Therefore, treatment should be short-term.
Do not take LAITOS:
- If you are allergic (hypersensitive) to dextromethorphan or to any of the other components of this medicine
- If you have a severe lung disease
- If you have asthmatic cough
- If you have cough accompanied by abundant secretions
- If you are being treated or have been treated within the previous 2 weeks with a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other conditions (see section "Use with other medicines").
Take special care with LAITOS:
Patients should consult a doctor before using this medicine if they:
- Have persistent or chronic cough, such as that caused by smoking
- Have liver disease
- Have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with hereditary predisposition to allergy)
- Are sedated, weakened, or bedridden
Cases of abuse of medicines containing dextromethorphan in adolescents have been reported; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section "If you take more LAITOS than you should").
Use with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not requiring a prescription.
Do not take this medicine during treatment with, or within 2 weeks after treatment with, the following medicines, as it may cause excitation, high blood pressure, and fever above 40°C (hyperpyrexia):
- Monoamine oxidase inhibitor antidepressants (MAOIs) (moclobemide, tranylcypromine)
- Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
- Bupropion (used to stop smoking)
- Linezolid (used as an antibacterial)
- Procarbazine (used to treat cancer)
- Selegiline (used to treat Parkinson's disease)
- Sibutramine (used to treat obesity)
If you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:
- Amiodarone or quinidine (used to treat heart arrhythmias)
- Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib)
- Central nervous system depressants (some used for mental disorders, allergies, Parkinson's disease, etc.)
-Expectorants and mucolytics (used to eliminate phlegm and mucus).
Consult your doctor or pharmacist before taking LAITOS:
- If you are taking other medicines such as antidepressants or antipsychotics, LAITOS may interact with these medicines and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
Taking LAITOS with food and drinks
Do not consume alcoholic beverages during treatment, as they may cause adverse reactions.
Do not take together with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.
Use in children
Do not administer to children under 2 years of age.
Pregnancy
Consult your doctor or pharmacist before taking any medicine.
Important for women
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.
Breast-feeding
Consult your doctor or pharmacist before taking any medicine.
Women who are breast-feeding should not take this medicine without consulting their doctor.
Driving and using machines
Rarely, during treatment, a decreased ability to react, drowsiness, or mild dizziness may occur. If you experience these symptoms, you should not drive or operate machinery.
Important information about some of the components of LAITOS
This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine. It may produce a mild laxative effect because it contains 0.4 g of sorbitol per ml. Calorific value: 2.6 kcal/g of sorbitol.
3. How to take LAITOS 3 mg/ml Syrup
Follow these instructions unless your doctor has given you different ones.
Consult your doctor or pharmacist if you have any doubts.
The dose to take is:
Adults and children over 12 years: take 5 ml (15 mg), depending on the severity of cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. Alternatively, 10 ml (30 mg) may be taken every 6 or 8 hours. The maximum amount to be taken in 24 hours is 40 ml (120 mg), divided into several doses.
Children between 6 - 12 years: take 2.5 ml (7.5 mg), depending on the severity of cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. Alternatively, 5 ml (15 mg) may be taken every 6 or 8 hours.
The maximum amount to be taken in 24 hours is 20 ml (60 mg), divided into several doses.
Children between 2 - 5 years: take 1.25 ml (3.75 mg), depending on the severity of cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. Alternatively, 2.5 ml (7.5 mg) may be taken every 6 or 8 hours.
The maximum amount to be taken in 24 hours is 10 ml (30 mg), divided into several doses.
Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must not exceed the recommended dose.
LAITOS is administered orally. Measure the amount to be taken using the dosing spoon provided in the package.
It can be taken with or without food.
Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section "Taking Laitos with food or drinks").
It is advisable to drink plenty of water during treatment.
If cough worsens, persists for more than 7 days, or is accompanied by high fever, skin rash, or persistent headache, consult your doctor.
If you take more LAITOS than you should:
If you take more Laitos than recommended, you may experience: confusion, excitability, restlessness, nervousness, and irritability.
If you take more LAITOS than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in case of massive overdose may include: coma, severe respiratory problems, and seizures.
Contact your doctor or hospital immediately if you experience any of the symptoms listed above.
Taking very high amounts of this medicine may cause children to become drowsy (sedated), nervous, nauseous, vomit, or have difficulty walking.
Cases of abuse with medications containing dextromethorphan have been reported, potentially leading to serious adverse effects such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy (drowsiness), hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression (difficulty breathing), loss of consciousness, arrhythmias (irregular heartbeats), and death.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 915620420), indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.
If you forget to take LAITOS
If you forget to take LAITOS and symptoms persist, do not take a double dose to make up for the missed dose. If necessary, take the medicine again as indicated in section 3. HOW TO TAKE LAITOS.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, LAITOS may have adverse effects, although not everyone will experience them.
During the period of use of dextromethorphan, the following adverse effects have been observed, although their frequency could not be established with accuracy:
- In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting
- In rarer cases: mental confusion and headache.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
5. Storage of LAITOS
Keep out of the reach and sight of children.
Keep the container tightly closed and store protected from light. Do not freeze.
Expiry
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Additional information
Composition of LAITOS 3 mg/ml Syrup
- Each ml contains 3 milligrams of dextromethorphan hydrobromide as the active substance.
- The other components (excipients) are sodium benzoate (E-211), sodium carmellose, non-crystallizable liquid sorbitol (E-420), glycerol (E-422), citric acid monohydrate, sodium saccharin (E-954), strawberry flavouring, and purified water.
Appearance of the product and contents of the pack
LAITOS is a colourless syrup with a strawberry odour and taste, for oral administration.
It is supplied in containers containing 125 ml or 200 ml of syrup, with a dosing spoon marked for measuring 1.25, 2.5 and 5 ml.
Marketing Authorization Holder and Manufacturer
LAINCO, S.A.
Avda. Bizet, 8-12
08191 Rubí (Barcelona)
SPAIN
This leaflet was approved in November 2021