FORMULATUS 1.33 mg/ml SYRUP HONEY FLAVORED

Introduction

Package Leaflet: Information for the User

FormulaTus 1.33 mg/ml Honey-Flavored Syrup

dextromethorphan hydrobromide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

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

Contents of the Package Leaflet

1. What is FormulaTus and what is it used for
2. What you need to know before taking FormulaTus
3. How to take FormulaTus
4. Possible side effects
5. Storage of FormulaTus
6. Package Contents and Additional Information

1. What is FormulaTus and what is it used for

FormulaTus 1.33 mg/ml honey-flavored syrup contains the active ingredient dextromethorphan hydrobromide, which 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 and nervous cough) for adults and children from 6 years of age.

You should consult a doctor if your symptoms worsen or if they do not improve after 7 days of treatment.

2. What you need to know before taking FormulaTus

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 of age cannot take this medication.
• if you have a severe lung disease.
• if you have breathing difficulties
• if you have asthma
• if you have a cough accompanied by abundant secretions.
• if you are being treated or have been treated during the 2 weeks prior to taking this medication with certain monoamine oxidase inhibitor (MAOI) medications used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section on Use of Other Medications).

Warnings and Precautions

This medication can cause dependence. Therefore, treatment should be short-term.

Consult your doctor, 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 symptom of asthma.

• with liver disease
• with atopic dermatitis (inflammatory skin disease characterized by redness, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition)

• who 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 body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea)

There have been reports of abuse of medications containing dextromethorphan by adolescents, so this possibility should be taken into account, as they can produce serious side effects (see section on If you take more FormulaTus than you should).

Other Medications and FormulaTus

Inform your doctor or pharmacist if you are using, have recently used, 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 they can cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• MAOIs (moclobemide, tranilcipromine)
• 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 medication)

Before starting to take this medication, consult 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 phlegm and mucus).

Taking FormulaTus with Food, Drinks, and Alcohol

Do not consume alcoholic beverages during treatment, as they can cause side effects.

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

Taking 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 your doctor or pharmacist before using this medication.

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

Driving and Using Machines

On rare occasions, during treatment, you may experience drowsiness and dizziness, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

FormulaTus contains ethanol

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

It is unlikely that the amount of alcohol in this medication will have any noticeable effect on adults or adolescents. It may have some effects on young children, such as drowsiness.

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

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

If you have an alcohol addiction, consult your doctor or pharmacist before taking this medication.

FormulaTus contains sucrose and inverted sugar (honey)

This medication contains sucrose and inverted sugar. If your doctor has told you that you have an 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 370 mg of sucrose per ml.

FormulaTus contains propylene glycol (E-1520)

This medication contains 99 mg 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 of age, consult your doctor or pharmacist, especially if they have been given other medications that contain propylene glycol or alcohol.

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

This medication contains 1 mg of sodium benzoate and up to 0.1 mg 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 of age).

FormulaTus contains sodium

This medication contains 28.2 mg of sodium (main component of table salt/cooking salt) per 15 ml dose. 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 flavor. Phenylalanine can be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take FormulaTus

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years of age:

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

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

Patient with liver problems: consult your doctor before taking this medication. The dose should be reduced by half, not exceeding 4 daily doses in any case.

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 section on FormulaTus with Food, Drinks, and Alcohol)

You should consult a doctor if your symptoms worsen, if they are accompanied by high fever, skin rash, or persistent headache, or if they do not improve after 7 days of treatment.

If you take more FormulaTus than you should:you may experience the following symptoms: nausea and vomiting, muscle contractions, agitation, confusion, drowsiness, disorders 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 be:coma, severe respiratory problems, and convulsions.

Taking very high amounts of this medication can cause a state of stupor, nervousness, nausea, vomiting, or gait disturbances in children.

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

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take FormulaTus

If you forget to take FormulaTus and your symptoms continue, do not take a double dose to make up for the missed doses. If necessary, take the medication again as indicated in the section on How to take FormulaTus.

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

4. Possible Side Effects

Like all medications, FormulaTus can cause 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 certainty:

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

• In rarer cases: mental confusion and headache.

Reporting Side Effects:

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

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5. Storage of FormulaTus

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 shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of FormulaTus

Each milliliter of syrup contains

• The active ingredient 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, menthoxypropanediol (TK10), macrogol stearate type I, sodium benzoate (E-211), honey flavor (contains propylene glycol (E-1520), benzyl benzoate, inverted sugar, sodium, and phenylalanine), verbena flavor (contains ethanol), EDTA (ethylenediaminetetraacetic 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).

Appearance of the Product and Package 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 dosing cup made of polypropylene with graduations (5 ml, 10 ml, 15 ml, and 30 ml).

Not all package sizes may be marketed.

Marketing Authorization Holder:

Laboratorios Vicks, S.L.U.

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

Spain

Manufacturer:

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

Date of the Last Revision of this Package Leaflet: November 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/