Leaflet: information for the user

FormulaTus 1.33 mg/ml honey-flavored syrup

dextromethorphan hydrobromide

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist or nurse.

• 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 side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse,if the symptoms are accompanied by high fever, skin eruptions or persistent headache,or if you do not improve after 7 days of treatment.

1. What isFormulaTusand what it is used for

2. What you need to know before starting to takeFormulaTus

3. How to takeFormulaTus

4. Possible side effects

5. Storage ofFormulaTus

6. Contents of the pack and additional information

FormulaTus 1.33 mg/mL syrup with honey flavor contains the active ingredient dextromethorphan hydrobromide, which is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of forms of cough not accompanied by

expectoration (irritative cough and nervous cough) for adults and children aged 6 years and older.

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

Do not take FormulaTus

- If you are allergic to dextromethorphan or any of the other components of this medication

(listed in section 6).

- Children under 2 years old cannot take this medication.

- If you have a serious lung disease.

- If you have difficulty breathing.

- If you have asthma.

- If you have a cough accompanied by abundant secretions.

- If you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used for the treatment of depression such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section Use of other medications).

Warnings and precautions

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

Consult with your doctor or pharmacist or nurse before taking FormulaTus:

- With persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early sign of asthma.

- With liver disease.

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

- If you are sedated, debilitated, or bedridden.

- If you are taking other medications such as antidepressants or antipsychotics, FormulaTus 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, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea).

Cases of abuse with medications containing dextromethorphan by adolescents have been described, therefore, this possibility should be taken into account, as they may produce severe adverse effects (see section If you take more FormulaTus than you should).

Other medications and FormulaTus

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication.

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 high fever above 40°C (hyperpyrexia):

- Monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine)

- Serotonin reuptake inhibitors (paroxetine, fluoxetine)

- Bupropion (used to quit smoking)

- Isoniazid (used for infections)

- Procarbazine (used to treat cancer)

- Selegiline (used to treat Parkinson's disease)

- Linezolid (used as an antibacterial)

Before starting to take this medication, consult with your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

- Haloperidol (used to treat mental disorders)

- Amiodarone and quinidine (used to treat heart arrhythmias)

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

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

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

FormulaTus with food, drinks, and alcohol

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

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

The consumption of food or drinks does not affect the efficacy of the medication.

Pregnancy, breastfeeding, and fertility

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

Pregnant women or breastfeeding women should not take this medication without consulting their doctor.

Driving and operating machinery

In rare cases, during treatment, you may experience mild drowsiness and dizziness, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

FormulaTus contains ethanol

• This medication contains 39mg of alcohol (ethanol) per ml. The amount in each dose of 15ml of this medication is equivalent to less than 15ml of beer or 6ml of wine.

It is unlikelythat theamount of alcohol contained in this medication will have any perceptible effect on adults or adolescents. It may have some effects on young children, such as drowsiness.

The amount of alcohol contained in this medication may alter the effect of other medications. Consult with your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult with your doctor or pharmacist before taking this medication.

If you have a history of alcohol addiction, consult with your doctor or pharmacist before taking this medication.

FormulaTus contains saccharose and invert sugar (honey)

This medication contains saccharose and invert sugar. If your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

It may cause tooth decay.

Patients with diabetes mellitus should note that this medication contains 370mg of saccharose per ml.

FormulaTus contains propylene glycol (E-1520)

This medication contains 99mg of propylene glycol per ml.

If you are pregnant or breastfeeding, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney disease, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

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

FormulaTus contains sodium benzoate (E-211) and benzyl benzoate

This medication contains 1mg of sodium benzoate and up to 0.1mg of benzyl benzoate per ml.

Sodium benzoate and benzyl benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

FormulaTus contains sodium

This medication contains 28.2mg of sodium (main component of table salt/for cooking) per dose of 15ml. This is equivalent to 1.41% of the maximum recommended sodium intake for an adult.

FormulaTus contains phenylalanine

This medication contains phenylalanine as part of the honey aroma. Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older:

Take 15 ml 3 times a day measured with the dosing cup included in the package. If necessary, repeat the dose every 6 hours.

Use in children:

Children between 6 - 11 years::Take 10 ml, every 8 hours, measured with the dosing cup included in the package.

If necessary, repeat the dose every 6 hours.

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

Patients with liver problems:Consult with your doctor before taking this medication. The dose must be reduced to half, not exceeding 4 doses per day.

Do not exceed the recommended dose in any case.

How to take

Shake the bottle well before taking the medication.

FormulaTus is administered orally.

Measure the amount to take with the dosing cup.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see FormulaTus with food, drinks, and alcohol)

You should consult a doctor if it worsens, if symptoms are accompanied by high fever, skin eruptions, or persistent headache, or if it does not improve after 7 days of treatment.

If you take more FormulaTus than you should: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.

Taking very high amounts of this medication may cause in children a state of drowsiness, nervousness, nausea, vomiting, or alterations in 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, 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, loss of consciousness, arrhythmias (irregular heartbeats), and death.

Immediately contact your doctor or hospital if you experience any of the mentioned symptomsor call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take FormulaTus

If you forgot to take FormulaTus and symptoms continue, do not take a double dose to compensate for the missed doses. If necessary, take the medication in the same way as indicated in the section How to take FormulaTus.

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

Like all medications, FormulaTus can produce adverse effects, although not everyone may experience them.

During the period of dextromethorphan use, the following adverse effects have been observed, although their frequency has not been established with precision:

• Somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, and vomiting in some cases.

• Confusion and headache in rare instances.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the medication's safety.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging 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. Dispose of the packaging and the

medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

FormulaTus Composition

Each milliliter of syrup contains

- The active principle is dextromethorphan hydrobromide: 1.33 mg/ml

- The other components are: sucrose, sodium saccharin, propylene glycol (E-1520), ethanol, sodium citrate, citric acid, sodium croscarmellose (carmellose), macrogol, mentoxipropanodiol (TK10), type I macrogol stearate, sodium benzoate (E-211), honey aroma (contains propylene glycol (E-1520), benzyl benzoate, inverted sugar, sodium, and phenylalanine), verbena aroma (contains ethanol), EDTA (ethylenediamine tetraacetic acid), and purified water.

(See also “FormulaTus contains sucrose and inverted sugars, sodium, propylene glycol, sodium benzoate, ethanol, benzyl benzoate, and phenylalanine” in section 2).

Product appearance and packaging contents

FormulaTus is presented in amber glass bottles with a safety cap, child-resistant, made of polypropylene resin. The medication is presented in 120 ml and 180 ml bottles with a polypropylene dosing cup with graduations (5 ml, 10 ml, 15 ml, and 30 ml).

Only some packaging sizes may be commercially available.

Marketing Authorization Holder:

Laboratorios Vicks, S.L.U

Avda. de Bruselas, 24. 28108, Alcobendas. Madrid

Spain

Responsible for Manufacturing:

Procter & Gamble Manufacturing GmbH,

Procter & Gamble Strasse 1,

64521, Gross Gerau, Germany.

Local Representative:

Procter & Gamble España, S.A.U. Avenida de Bruselas 24,

28108 Alcobendas. Madrid. Spain

Last review date of this leaflet: November 2023

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.gob.es/