- PROSPECTO : INFORMATION FOR THE USER –

LAITOS 3 mg/ml Syrup

Dextromethorphan hydrobromide

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

This medicine can be purchased without a prescription. However, for 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 symptoms worsen, persist for more than 7 days, or are accompanied by high fever, skin eruptions, or persistent headache, you should consult a doctor.

- If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

1. What isLAITOS 3 mg/ml Syrupand for what it is used

2. Before takingLAITOS 3 mg/ml Syrup

3. Howto takeLAITOS 3 mg/ml Syrup

4. Possible adverse effects

5. Storage ofLAITOS 3 mg/ml Syrup

6. Additional information

The active ingredient dextromethorphan in this medication is a cough suppressant that inhibits the cough reflex.

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

This medication may cause dependence. Therefore, treatment should be of short duration.

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 serious lung disease

- If you have asthma cough

- If you have a cough accompanied by abundant secretions

- If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression or Parkinson's disease or other diseases (see section on Use of other medications).

Be especially careful with LAITOS:

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

- Persistent or chronic cough, such as that caused by smoking

- Liver disease

- Atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition)

- Sedated, weakened, or bedridden individuals.

Cases of abuse with medications containing dextromethorphan in adolescents have been described, therefore this possibility should be taken into account, as it may cause severe adverse effects (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 it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

- Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine)

- Serotonin reuptake inhibitor antidepressants (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 discontinue treatment:

- Amiodarone or quinidine (used to treat heart arrhythmias)

- Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)

- Central nervous system depressants (some used to treat mental illnesses, allergies, Parkinson's disease, etc)

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

Consult your doctor or pharmacist before taking LAITOS:

- If you are taking other medications such as antidepressants or antipsychotics, LAITOS may interact with these medications and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea).

LAITOS with food and beverages

Do not consume alcoholic beverages during treatment, as it may cause adverse reactions.

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

Use in children

Do not administer to children under 2 years.

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 consumption of medications during pregnancy may 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 operating machinery

In rare cases, during treatment, a decrease in reaction capacity or mild dizziness and dizziness may appear, therefore, if you notice these symptoms, you should not drive or operate machinery.

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 cause a mild laxative effect because it contains 0.4 g of sorbitol per ml. Caloric value: 2.6 kcal/g of sorbitol.

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:

Over 12 years old: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 dose that can be taken in 24 hours is 40 ml (120 mg), divided into several doses.

Children between 6 - 12 years old: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 dose that can be taken in 24 hours is 20 ml (60 mg), divided into several doses.

Children between 2 - 5 years old: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 dose that can be taken in 24 hours is 10 ml (30 mg), divided into several doses.

Severe adverse effects may occur in children in case of overdose, including neurological alterations. Caregivers must not exceed the recommended dose.

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

It can be taken with or without food.

Do not take with orange or bitter lemon juice or with alcoholic beverages (see section 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 eruptions, 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, excitement, 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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (accelerated heart rate), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

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

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

Taking very high doses of this medication may cause children to become drowsy, nervous, nauseous, vomiting, or have altered gait.

Cases of abuse with medications containing dextromethorphan have been reported, which may lead to severe adverse effects, such as anxiety, panic, memory loss, tachycardia (rapid heart rate), lethargy (drowsiness), hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), fever, tachypnea (rapid and shallow 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone: 915620420), indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forgot to take LAITOS:

If you forgot to take LAITOS and symptoms persist, do not take a double dose to compensate for the missed dose. If necessary, take the medication in the same way as indicated in the section "How to take Laitos."

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

Like all medications, 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, but their frequency has not been established with precision:

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting

• In rare instances: mental confusion and headache.

If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

Expiration Date

Do not use this medication after the expiration date that appears on the container 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. Ask your pharmacist how to dispose of containers and medications that you no longer need.By doing so, you will help protect the environment.

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 caramel, sorbitol (E-420), glycerol (E-422), citric acid monohydrate, sodium saccharin (E-954), strawberry flavor, and purified water.

Appearance of the Product and Contents of the Package

LAITOS is an odorless and colorless syrup with a strawberry taste, for oral administration.

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

Holder of the Marketing Authorization and Responsible for Manufacturing

LAINCO, S.A.

Avda. Bizet, 8-12

08191 Rubí (Barcelona)

SPAIN

This leaflet was approved in November 2021