PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE BENEL ORAL SOLUTION

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

Do not takeParacetamol/Guaifenesina/Fenilefrina Hydrochloride Benelif:

• If you have ever had an allergic reaction to paracetamol, guaifenesina, fenilefrina hydrochloride, or any of the other components (listed in section 6)
• If you have severe kidney or liver problems, hyperthyroidism, diabetes, high blood pressure (hypertension), or heart disease
• If you have pheochromocytoma or narrow-angle glaucoma
• Porphyria, which is a hereditary disorder characterized by an excessive amount of pigments in the urine.
• If 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 to 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 medicine with any other medications for flu, cold, nasal congestion, or cough suppression.

Be especially careful withParacetamol/Guaifenesina/Fenilefrina Hydrochloride Benelif:

• 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 a chronic or persistent cough, such as when you suffer from 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 Benel.

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

If you have severe illnesses, 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 Benel to children under 12 years of age.

Other Medicines andParacetamol/Guaifenesina/Fenilefrina Hydrochloride Benel

Tell your doctor if you are taking, have recently taken, or might take any other medicine; particularly:

• medicines that contain paracetamol or other decongestants for colds and flu. If you are taking them, do not take Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Benel.
• monoamine oxidase inhibitors(MAOIs) used in the treatment of depressionor Parkinson's disease. Do not takeParacetamol/Guaifenesina/Fenilefrina Hydrochloride Benel if you have been treated with MAOIs in the last 14 days.
• tricyclic antidepressantsfor depression, such as amitriptyline or imipramine.
• medicines 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 drugs to treat diseases such as schizophrenia or paranoia, or to prevent nausea and vomiting.
• medicines for nausea and vomiting(such as metoclopramide or domperidone).
• medicines to thin the blood(anticoagulants), such as warfarin or other coumarins.
• medicines 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 blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

UsingParacetamol/Guaifenesina/Fenilefrina Hydrochloride Benelwith Food, Drinks, and Alcohol

Do not drink alcohol while using Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Benel.

Pregnancy and Breastfeeding

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.

It is not recommended to take Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Benel during pregnancy and breastfeeding. If necessary, Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Benel 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 medicine more frequently.

Driving and Using Machines

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

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

This medicine 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 medicine 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 medicine may alter the effects of other medicines. The amount of alcohol in this medicine may reduce the ability to drive or operate machinery.

This medicine contains 6.7 g of sorbitol in each 20 ml dose. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you 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 medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

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

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

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. 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 Benelthan you should

If you take too much of this medicine, 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 immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any of the following serious side effects, stop taking the medicine immediately and seek urgent medical help.

• Very rare cases of severe skin reactions have been reported. Rarely, serious 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 side effects, consult your doctor or pharmacist, even if they are not listed 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 help provide more information on the safety of this medicine.

5. Storage of Paracetamol/Guaifenesina/Fenilefrina Hydrochloride Benel

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

Do not use this medicine after the expiration date that appears 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.

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

6. Contents of the Pack and Further Information

Composition ofParacetamol/Guaifenesina/Fenilefrina Hydrochloride Benel

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

Appearance of the Product and Contents of the Pack

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Nutra Essential OTC, S.L.

C/ La Granja, 1. 3rd Floor.

1. Alcobendas (Madrid)

Spain

Manufacturer

Farmalider S.A.

C/ Aragoneses 2

28108 Alcobendas, Madrid

Spain

or

Edefarm, S.L.

Enchilagar del Rullo Industrial Estate, 117,

46191 Villamarchante, Valencia

Spain

Date of the Last Revision of this Leaflet:February 2025

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