LAITOS 3 mg/ml SYRUP

Introduction

• PROSPECTUS: INFORMATION FOR THE USER –

LAITOS 3 mg/ml Syrup

Dextromethorphan hydrobromide

Read this prospectus carefully because it contains important information for you.

This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If the symptoms worsen, if they persist for more than 7 days, or if they are accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Contents of the prospectus

1. What LAITOS 3 mg/ml Syrup is and what it is used for
2. Before taking LAITOS 3 mg/ml Syrup
3. How to take LAITOS 3 mg/ml Syrup
4. Possible side effects
5. Storage of LAITOS 3 mg/ml Syrup
6. Additional information

1. What LAITOS 3 mg/ml Syrup is and what it is used for

Dextromethorphan, the active ingredient of this medication, is a cough suppressant that inhibits the cough reflex.

It is indicated for the symptomatic treatment of forms of cough that are not accompanied by expectoration (irritative cough, nervous cough).

2. Before taking LAITOS 3 mg/ml Syrup

This medication can 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 medication
• 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 during the previous 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used for the treatment of depression or Parkinson's disease or other diseases (see section on Use of other medications).

Be careful with LAITOS:

Patients with the following conditions should consult their doctor before using this medication:

• chronic or persistent cough, such as that caused by smoking
• liver disease
• atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition)
• those who are sedated, debilitated, or bedridden.

There have been reports of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious adverse effects can occur (see section on If you take more LAITOS than you should).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Do not take this medication during treatment or in the 2 weeks following treatment with the following medications, as excitement, high blood pressure, and fever above 40°C (hyperpyrexia) may occur:

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine)
• Antidepressant serotonin reuptake inhibitors (paroxetine, fluoxetine)
• Bupropion (used to quit 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 using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• Amiodarone or quinidine (to treat heart arrhythmias)
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)
• Central nervous system depressants (some used for mental illnesses, allergies, Parkinson's disease, etc.)

Expectorants and mucolytics (used to eliminate phlegm and mucus).

Consult your doctor or pharmacist before taking LAITOS:

Taking LAITOS with food and drinks

Alcoholic beverages should not be consumed during treatment, as they may cause adverse reactions.

Do not take with grapefruit or bitter orange juice, as they may increase the adverse effects of this medication.

Use in children

Do not administer to children under 2 years of age.

Pregnancy

Consult your doctor or pharmacist before taking any medication.

Important for women

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should not take this medication without consulting their doctor.

Driving and using machines

Rarely, during treatment, a decrease in reaction capacity or drowsiness and mild dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate machines.

Important information about some of the components of LAITOS

This medication contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may produce a mild laxative effect because it contains 0.4 g of sorbitol per ml. Caloric 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 doubts.

The dose to take is:

Over 12 years: take 5 ml (15 mg) depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. You can also take 10 ml (30 mg) every 6 or 8 hours. The maximum amount that can 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 intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. You can also take 5 ml (15 mg) every 6 or 8 hours.

The maximum amount that can 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 intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours. You can also take 2.5 ml (7.5 mg) every 6 or 8 hours.

The maximum amount that can be taken in 24 hours is 10 ml (30 mg), divided into several doses.

Severe adverse effects can occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

LAITOS is administered orally. Measure the amount to take with the dosing spoon included in the package.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section on Taking LAITOS with food or drinks).

It is recommended to drink plenty of water during treatment.

If the cough worsens, if it persists for more than 7 days, or if it 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 notice: 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, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

Taking very high amounts of this medication can cause children to enter a state of stupor (drowsiness), nervousness, nausea, vomiting, or alterations in gait.

There have been reports of abuse with medications containing dextromethorphan, which can cause serious adverse effects, such as anxiety, panic, memory loss, tachycardia (accelerated heart rate), lethargy (drowsiness), hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the eye pupil), agitation, vertigo, gastrointestinal discomfort, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression (difficulty breathing), loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 915620420), indicating the medication and the amount ingested. It is recommended to bring the packaging and prospectus of the medication to the healthcare professional.

If you forget to take LAITOS

If you forget to take LAITOS and the symptoms continue, do not take a double dose to make up for the forgotten dose. If necessary, take the medication again as indicated in section 3. HOW TO TAKE LAITOS.

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

4. Possible side effects

Like all medications, LAITOS can have side effects, although not everyone will experience them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency cannot be established with precision:

• In some cases, the following have occurred: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting
• In rarer cases: mental confusion and headache.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of LAITOS

Keep out of the reach and sight of children.

Keep the container perfectly closed and protected from light. Do not freeze.

Expiration date

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Ask your pharmacist how to dispose of the packaging and medications 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 ingredient.
• The other components (excipients) are sodium benzoate (E-211), sodium carmellose, sorbitol (E-420), glycerol (E-422), citric acid monohydrate, sodium saccharin (E-954), strawberry flavor, and purified water.

Appearance of the product and packaging content

LAITOS is a colorless syrup with a strawberry odor and flavor, for oral administration.

It is presented in containers that contain 125 ml or 200 ml of syrup and a dosing spoon with marks to measure 1.25, 2.5, and 5 ml.

Marketing authorization holder and manufacturer

LAINCO, S.A.

Avda. Bizet, 8-12

08191 Rubí (Barcelona)

SPAIN

This prospectus was approved in November 2021