PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE WINADOL ORAL SOLUTION

Introduction

Patient Information Leaflet:

Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol

Oral Solution EFG

Read the entire 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 leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this 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, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

Contents of the Leaflet

1. What Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol is and what it is used for
2. What you need to know before taking Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol
3. How to take Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol
4. Possible side effects
   1. Storage of Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol

1. Package contents and additional information

1. What Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol is and what it is used for

Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol is indicated for the symptomatic relief of catarrhal and flu processes.

This medication contains three active ingredients.

• Paracetamol is an analgesic and reduces your temperature when you have a fever.
• Guaifenesina is an expectorant that thins mucus and helps eliminate phlegm.
• Fenilefrina hydrochloride is a nasal decongestant that reduces inflammation of the nasal passages, relieving nasal congestion.

You should consult a doctor if your condition worsens or does not improve after 3 days. You should only use Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol if you have mild or moderate pain, fever, nasal congestion, and phlegm.

2. What you need to know before taking Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol

Do not takeParacetamol/Guaifenesina/Fenilefrina Hydrochloride Winadolif:

• You have ever had an allergic reaction to paracetamol, guaifenesina, fenilefrina hydrochloride, or any of the other components (listed in section 6)
• You have severe kidney or liver problems, hyperthyroidism, diabetes, high blood pressure (hypertension), or heart disease
• You have pheochromocytoma or narrow-angle glaucoma.
• You have porphyria, a hereditary disorder characterized by an excessive amount of pigments in the urine.
• You are taking beta-blockers, tricyclic antidepressants (or if you have taken monoamine oxidase inhibitors (MAOIs) in the last two weeks, prescribed for depression or Parkinson's disease
• You are taking medications to lower blood pressure or treat angina pectoris

Warnings and precautions

Important: Contains paracetamol. Do not take it with other medications that contain paracetamol. In case of overdose, consult your doctor immediately, even if you feel well, due to the risk of late severe liver damage. Do not take this medication with any other medications for flu, cold, nasal congestion, or cough suppression.

Be especially careful withParacetamol/Guaifenesina/Fenilefrina Hydrochloride Winadolif:

• You have any liver problems.
• You are a man and have an enlarged prostate, which makes it more difficult to urinate.
• You have circulation problems (including Raynaud's syndrome).
• You have chronic or persistent cough, as occurs with asthma, chronic bronchitis, or emphysema
• You have severe hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, chronic nutritional disorder, or if you are dehydrated.

Consult your doctor or pharmacist before starting to take Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol.

During treatment with Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol, inform your doctor immediately if:

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Do not administer Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol to children under 12 years of age.

Other medications andParacetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol

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

• medications that contain paracetamol or other decongestants for colds and flu. If you are taking them, do not take Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol
• monoamine oxidase inhibitors(MAOIs) used in the treatment of depressionor Parkinson's disease. Do not takeParacetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol if you have been treated with MAOIs in the last 14 days.
• tricyclic antidepressantsfor depression, such as amitriptyline or imipramine.
• medications for high blood pressure(antihypertensives), including beta-blockers, or to improve heart function or correct abnormal heart rhythms (digoxin, lanoxin, digitoxin).
• phenothiazines (which are also used as antipsychotic medications to treat diseases such as schizophrenia or paranoia, or to prevent nausea and vomiting.
• medications for nausea and vomiting(such as metoclopramide or domperidone).
• medications to thin the blood(anticoagulants), such as warfarin or other coumarins.
• medications for high cholesterol(such as colestyramine).
• sedatives (barbiturics).
• probenecid or AZT (zidovudine).
• isoniazid (used to treat or prevent tuberculosis).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that must be treated urgently.

Use ofParacetamol/Guaifenesina/Fenilefrina Hydrochloride Winadolwith food, beverages, and alcohol

Do not drink alcoholic beverages while using Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol.

Pregnancy and breastfeeding

It is not recommended to take Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol during pregnancy and breastfeeding.

IMPORTANT FOR WOMEN:

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.

In case of necessity, Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Driving and using machines

This product may cause dizziness or confusion. Do not drive or operate heavy machinery

Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadolcontains ethanol, sorbitol, and sunset yellow (E-110):

This medication contains 19% ethanol (alcohol), which corresponds to an amount of 3.062 g per dose, equivalent to 76 ml of beer or 32 ml of wine. This medication is harmful to people with alcoholism. The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy. The amount of alcohol in this medication may alter the effects of other medications. The amount of alcohol in this medication may decrease the ability to drive or operate machinery.

This medication contains 6.7 g of sorbitol in each 20 ml sachet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medication may cause allergic reactions because it contains sunset yellow (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol

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

The recommended dose is:

Adults, elderly patients, and children over 12 years: Fill the measuring cup to the 20 ml mark. Take a 20 ml dose every 4 hours as needed.

• Do not take more frequently than every 4 hours.
• Do not take more than 4 doses every 24 hours.
• Do not take more than the recommended dose.
• Do not take it for more than 3 days without consulting your doctor.

Use in children:

Do not administer to children under 12 years of age.

If you take moreParacetamol/Guaifenesina/Fenilefrina Hydrochloride Winadolthan you should

If you take too much of this medication, talk to a doctor immediately, even if you feel well. Since too much paracetamol can cause severe liver damage over time. If symptoms persist, consult your doctor.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. If you experience any of the following serious side effects, stop taking the medication immediately and seek urgent medical attention.

• Very rare cases of severe skin reactions have been reported. Rarely, severe allergic reactions (anaphylaxis), wheezing, or breathing difficulties may occur.

(Rare: affects less than 1 in 1,000 people, but more than 1 in 10,000. Very rare: affects less than 1 in 10,000 people).

• Very rarely, certain alterations in blood cells and pancreatitis (inflammation of the pancreas) with paracetamol (affects less than 1 in 10,000 people) may occur.

Other side effects:

Frequent (may affect up to 1 in 10 people): Loss of appetite, nausea, or vomiting.

Rare (may affect up to 1 in 1,000 people): Mild allergic reactions (such as skin rashes or hives), stomach pain, diarrhea, headache, dizziness, rapid heartbeat (palpitations), high blood pressure, difficulty sleeping (insomnia), nervousness, tremors (shaking), irritability, restlessness, confusion, or anxiety.

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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 does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Validity period once opened: 6 months

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofParacetamol/Guaifenesina/Fenilefrina Hydrochloride Winadol

• The active ingredients are: each 20 ml dose contains 500 mg paracetamol, 200 mg guaifenesina, and 10 mg fenilefrina hydrochloride.
• The other components (excipients) are liquid sorbitol (E-420), glycerol (E-422), 96% ethanol, propylene glycol, sodium cyclamate, acesulfame potassium (E-950), sodium citrate, anhydrous citric acid, xanthan gum, sucralose (E-955), fruit flavor 502874/A7, sunset yellow (E-110), and purified water.

Appearance of the product and package contents

Orange-yellow solution, free of foreign substances and with a characteristic fruit flavor.

160 ml and 240 ml packaging: Amber glass bottle with a child-resistant safety cap made of polypropylene (PP) and low-density polyethylene (LDPE). It contains a graduated dosing cup (20 ml) made of polypropylene (PP) for the correct administration of the medication.

Marketing authorization holder and manufacturer

Marketing authorization holder

Nutra Essential OTC, S.L.

C/ La Granja, 1. 3ª Planta.

1. Alcobendas (Madrid)

Spain

Manufacturer

Farmalider S.A.

C/ Aragoneses 2

28108 Alcobendas, Madrid

Spain

or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117,

46191 Villamarchante, Valencia

Spain

Date of the last revision of this leaflet:February 2025

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.es/