FORMULAEXPEC 13.33 mg/ml SYRUP HONEY FLAVORED

Introduction

Package Leaflet: Information for the User

FormulaExpec 13.33 mg/ml Honey-Flavored Syrup

Guaifenesina

Read the entire package leaflet carefully before starting to take this medication,

as it contains important information for you.

• 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 or pharmacist or nurse, even if they are side effects 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 FormulaExpec and what is it used for
2. What you need to know before taking FormulaExpec
3. How to take FormulaExpec
4. Possible side effects
5. Storage of FormulaExpec
6. Package Contents and Additional Information

1. What is FormulaExpec and what is it used for

Guaifenesina, the active ingredient of this medication, belongs to the group of medications called expectorants.

This medication is indicated to relieve productive cough by reducing phlegm (mucus), making it easier to expel for adults and children from 6 years of age.

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

2. What you need to know before taking FormulaExpec

Do not take FormulaExpec:

• if you are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have porphyria, a metabolic disorder.
• children under 6 years of age cannot take this medication.

Warnings and Precautions

Consult your doctor or pharmacist or nurse before starting to take this medication if:

• you have had a cough for more than 7 days or if your cough is recurrent or accompanied by fever, rash, or persistent headache.
• you have chronic or persistent cough, such as that associated with asthma, smoking, chronic bronchitis, and emphysema (severe lung disease)
• you have a cough with a large amount of mucus (phlegm)
• you have severe liver or kidney problems.
• you are diabetic or have difficulty digesting certain sugars

Interference with Laboratory Tests

If you are going to undergo any diagnostic tests (including blood or urine tests...), it is important that you inform your doctor or nurse that you are taking or have recently taken this medication, as it may alter some results.

Inform your doctor and stop taking this medication 48 hours before undergoing

the determination of 5-hydroxyindoleacetic acid (5-HIAA) and vanilmandelic acid (VMA) in urine, which are specific tests for tumors.

Children and Adolescents

Children under 6 years of age cannot take this medication because it is contraindicated.

Taking FormulaExpec with Other Medications

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

• It is not recommended to take this medication with other medications to

stop coughing (antitussives or cough suppressants)

Taking FormulaExpec with Food, Drinks, and Alcohol

You can take this medication with or without food.

Do not drink alcohol while being treated with this medication.

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 medication.

This medication should not be used during pregnancy unless advised by a doctor.

Do not take this medication if you are breastfeeding unless advised by a doctor.

Driving and Using Machines

It is not expected that FormulaExpec will affect your ability to drive or use machines.

However, if you experience dizziness, do not drive or use machines.

FormulaExpec contains saccharose, ethanol, sodium, propylene glycol, and sodium benzoate:

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. Patients with diabetes mellitus should be aware that this medication contains 5.55 g of saccharose per dose.

This medication contains 5.256% v/v ethanol (alcohol), which corresponds to an amount of 597 mg per 15 ml. The amount in each 15 ml dose of this medication is equivalent to less than 12 ml of beer and 5 ml of wine. The small amount of alcohol in this medication will not have any noticeable effect.

This medication contains 27.9 mg of sodium (main component of cooking/table salt) in each dose (15 ml). This is equivalent to 1.40% of the maximum recommended daily sodium intake for an adult.

This medication contains 1,650 mg of propylene glycol in each dose, which is equivalent to 1,650 mg per 15 ml. If you are pregnant or breastfeeding, do not take this medication unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medication. If you have liver or kidney failure, do not take this medication unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

This medication contains 15 mg of sodium benzoate in each dose, equivalent to 15 ml.

3. How to Take FormulaExpec

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

Adults and adolescents from 12 years: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. Do not exceed 6 doses in 24 hours. The maximum amount that can be taken in 24 hours is 90 ml, divided into several doses.

Use in Children and Adolescents

Children between 6 and 11 years:Take 10 ml 3 times a day, measured with the dosing cup included in the package. If necessary, the dose can be repeated every 6 hours. Do not exceed 5 doses in 24 hours. The maximum amount that can be taken in 24 hours is 45 ml, divided into several doses.

Children under 6 years: Do not administer this medication to children under 6

years.

How to take this medication

Shake the bottle well before taking this medication.

FormulaExpec is taken orally.

Measure the amount to be taken with the dosing cup.

Do not exceed the recommended dose.

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 FormulaExpec than you should

If you take more FormulaExpec than you should, you may experience stomach upset, nausea, and

drowsiness.

In case of overdose or accidental ingestion, go to a center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the

amount ingested.

If you forget to take FormulaExpec

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medications, this medication can cause side effects,

although not everyone experiences them.

The following may occur: nausea, vomiting, and diarrhea; stomach upset, headache

and dizziness.

If you experience any of the following side effects, stop taking this

medication and consult a doctor immediately:

• Allergic reactions, including skin rash (which can be severe, including blisters, abrasion, and peeling of the skin) itchingand

redness. Difficulty breathing, swelling of the face, lips, tongue, or

throat.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Reporting Side Effects

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

5. Storage of FormulaExpec

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 "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages

and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt

ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of FormulaExpec

• The active ingredient is guaifenesina 13.33 mg/ml.
• The other components are: saccharose, propylene glycol, ethanol, sodium citrate,

carmellose sodium, citric acid, macrogol stearate, honey and ginger flavor, verbena flavor, sodium benzoate (E-211), polyethylene oxide, sodium saccharin, menthol,

water.

(See also "FormulaExpec contains saccharose, ethanol, sodium, propylene glycol, and sodium benzoate" in section 2).

Appearance of the Product and Package Contents

FormulaExpec is presented in amber glass bottles with a child-resistant closure. The medication is presented in 120 ml and 180 ml bottles, of pale yellow liquid, with a polypropylene dosing cup 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

Local Representative:

Procter & Gamble España, S.A.

Avenida de Bruselas, 24,

28108 Alcobendas. Madrid.

Spain

Manufacturer:

Procter & Gamble Manufacturing GmbH

Procter & Gamble Strasse 1,

64521, Gross Gerau

Germany

This package leaflet was approved in: November 2023

Detailed information about this medication is available on the

website of the Spanish Agency for Medicines and Health Products (AEMPS).

http://www.aemps.gob.es/