Formulatus 1.33 mg/ml honey-flavored syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

FormulaTus 1.33 mg/ml cough syrup with honey flavour

dextromethorphan hydrobromide

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to refer to it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash, or persistent headache, or if there is no improvement after 7 days of treatment.

Contents of the leaflet

1. What FormulaTus is and what it is used for
2. What you need to know before taking FormulaTus
3. How to take FormulaTus
4. Possible side effects
5. How to store FormulaTus
6. Contents of the pack and other information

1. What FormulaTus is and what it is used for

FormulaTus 1.33 mg/ml honey-flavored syrup contains the active substance dextromethorphan hydrobromide, which is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry coughs not accompanied by mucus production (irritant cough and nervous cough) in adults and children aged 6 years and older.

You should consult a doctor if symptoms worsen or 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 to any of the other components of this medicine

(listed in section 6).

• children under 2 years of age must not take this medicine.
• if you have a severe lung disease.
• if you have breathing difficulties
• if you have asthmatic cough
• if you have a cough accompanied by abundant secretions.
• if you are currently being treated or have been treated within the previous 2 weeks with monoamine oxidase inhibitor (MAOI) medicines used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitor medicines used to treat depression such as fluoxetine and paroxetine; or also with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section "Taking other medicines").

Warnings and precautions

This medicine may cause dependence. Therefore, treatment should be short-term.

Consult your doctor or pharmacist or nurse before taking FormulaTus:

• if you have a persistent or chronic cough, such as that caused by smoking. Particularly in children, chronic cough could be an early symptom of asthma.

• if you have liver disease

• if you have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with a hereditary predisposition to allergy)

• if you are sedated, weakened, or bedridden.

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

Cases of abuse of medicines containing dextromethorphan by adolescents have been reported; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section "If you take more FormulaTus than you should").

Other medicines and FormulaTus

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

Do not take this medicine during treatment with, or within 2 weeks after treatment with, the following medicines, 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 stop smoking)
• Isoniazid (used for infections)
• Procarbazine (used to treat cancer)
• Selegiline (used for Parkinson's disease)
• Linezolid (used as an antibacterial)

Before starting to take this medicine, consult your doctor if you are using any of the following medicines, as it may be necessary to adjust the dose or interrupt treatment:

• Haloperidol (used to treat psychiatric disorders)

• Amiodarone and quinidine (used to treat heart arrhythmias)

• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib)

• Central nervous system depressants (some of which are used to treat mental disorders, 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 this may cause adverse effects.

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

Taking food or drinks does not affect the effectiveness of the medicine.

Pregnancy, breastfeeding, and fertility

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

Pregnant or breastfeeding women should not take this medicine without consulting a doctor.

Driving and using machines

Rarely, drowsiness and mild dizziness may occur during treatment; if you experience these symptoms, you should not drive or operate dangerous machinery.

FormulaTus contains ethanol

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

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

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

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

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

FormulaTus contains sucrose and invert sugar (honey)

This medicine contains sucrose and invert sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

May cause dental caries.

Patients with diabetes mellitus should be aware that this medicine contains 370 mg of sucrose per ml.

FormulaTus contains propylene glycol (E-1520)

This medicine contains 99 mg of propylene glycol per ml.

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

If you have liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

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

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

This medicine 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 medicine contains 28.2 mg of sodium (main component of table/cooking salt) in each 15 ml dose. This corresponds to 1.41% of the maximum recommended sodium intake for an adult.

FormulaTus contains phenylalanine

This medicine contains phenylalanine as part of the honey flavor. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take FormulaTus

Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents from 12 years of age:

Take 15 ml three times a day, measured with the dosing cup provided in the package. If necessary, the dose may be repeated every 6 hours.

Use in children:

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

If necessary, the dose may be repeated every 6 hours.

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

Patients with liver problems: Consult your doctor before taking this medicine. The dose should be reduced by half, and under no circumstances should exceed 4 doses per day.

Do not exceed the recommended dose under any circumstances.

How to take

Shake the bottle well before taking the medicine.

FormulaTus is administered orally.

Measure the required dose using the dosing cup.

It can be taken with or without food.

Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section

FormulaTus with food, drinks and alcohol).

Consult a doctor if symptoms worsen, if they are accompanied by high fever, skin rash, or persistent headache, or if there is no improvement 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, disturbances of consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may include: coma, severe breathing difficulties, and seizures.

Taking very high amounts of this medicine may cause children to become drowsy, restless, nauseous, or to vomit, or may cause disturbances in walking.

Cases of abuse have been reported with medications containing dextromethorphan, which may lead to serious adverse effects such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (loss of coordination), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

Contact your doctor or nearest hospital immediately if you experience any of the symptoms listed above, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take FormulaTus

If you forget to take FormulaTus and symptoms persist, do not take a double dose to make up for the missed doses. If necessary, resume taking the medicine as indicated in the section How to take FormulaTus.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, FormulaTus can cause adverse effects, although not everyone will experience them.

During the period of dextromethorphan use, the following adverse effects have been observed, although their frequency could not be established accurately:

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

• More rarely: mental confusion and headache.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Formulatus

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

Do not store above 25°C.

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 must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of FormulaTus

Each millilitre of syrup contains:

• The active substance 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, menthoxipropanediol (TK10), macrogol stearate type I, sodium benzoate (E-211), honey flavour (contains propylene glycol (E-1520), benzyl benzoate, invert sugar, sodium and phenylalanine), verbena flavour (contains ethanol), EDTA (ethylenediaminetetraacetic acid) and purified water.

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

Nature of the product and contents of the container

FormulaTus is supplied in amber glass bottles with a child-resistant closure cap made of polypropylene resin. The medicine is available in 120 ml and 180 ml bottles, each accompanied by a graduated polypropylene dosing cup (5 ml, 10 ml, 15 ml and 30 ml).

Only certain pack sizes may be commercially available.

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 most recent review of this leaflet: November 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/