Leaflet: information for the user

ilviGrip Expectorant powder for oral solution

paracetamol / guaifenesin / phenylephrine hydrochloride

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 3 days.

1. What is ilviGrip Expectorant and what it is used for

2. What you need to know before starting to take ilviGrip Expectorant

3. How to take ilviGrip Expectorant

4. Possible side effects

5. Storage of ilviGrip Expectorant

6. Contents of the pack and additional information

ilviGrip Expectorante contains three active ingredients:

• Paracetamol is well known for its ability to relieve pain (analgesic). It is effective against headaches and sore throats and can also reduce fever (antipyretic).
• Guaifenesin (an expectorant) thins out mucus, helping to relieve productive cough (with mucous).
• Phenylephrine hydrochloride (a nasal decongestant) reduces nasal passage inflammation, relieving nasal congestion.

ilviGrip Expectorante is indicated for the short-term relief of symptoms of catarrhal and influenza processes (mild to moderate pain, fever, nasal congestion, with expectorant effect on productive cough) in adults and adolescents 12 years and older.

Only use ilviGrip Expectorante if you have a combination of cold and flu symptoms, such as pain and/or fever, nasal congestion, and productive cough.

Consult your doctor if you do not improve or worsen after 3 days.

Do not takeilviGrip Expectorante:

• If you are allergic (hypersensitive) to paracetamol, guaifenesina, phenylephrine hydrochloride, or any of the components of this medication (see section 6 composition of ilviGrip Expectorante).
• If you have a heart disease.
• If you have high blood pressure (hypertension).
• If you have altered liver function or severe renal insufficiency.
• If you have hyperthyroidism.
• If you are already taking another sympathomimetic medication (such as pseudoephedrine, oxymetazoline, clonidine, salbutamol, and others).
• If you are diabetic.
• If you have glaucoma (increased eye pressure) of the narrow-angle type.
• If you have porphyria, a hereditary disorder characterized by excessive amounts of pigments in the urine.
• If you are taking tricyclic antidepressants.
• If you are taking beta-blockers.
• If you are taking monoamine oxidase inhibitors (MAOIs) - used in the treatment of depression or Parkinson's disease - or have taken them in the last 14 days.

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 other medications for the flu, cold, or nasal congestion.

Consult your doctor or pharmacist before takingilviGrip Expectorante:

• If you have alcoholic liver disease or regularly drink alcohol. Regular alcohol consumption affects liver function and may increase the risk of paracetamol toxicity.
• If you are a man with an enlarged prostate, making it difficult to urinate.
• If you have circulation problems (including Raynaud's syndrome).
• If you havecough that lasts more than a week, cough that produces a lot of mucus (phlegm), or persistent chronic cough as occurs in asthma, chronic bronchitis, or emphysema.
• If you have severe hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, chronic nutritional disorder, or are dehydrated.

During treatment with ilvigrip expectorant, immediately inform your doctor if:

You have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

ilviGrip Expectorante is not intended for children under 12 years old.

Use ofilviGrip Expectorantewith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are taking:

• .

• monoamine oxidase inhibitors(MAOIs) used in the treatment ofdepressionor Parkinson's disease.Do not takeilviGrip Expectorante if you have been treated with MAOIs in the last 14 days.
• tricyclic antidepressantsfordepression, such as amitriptyline or imipramine.
• medications forhigh blood pressure(anti-hypertensives), including beta-blockers, or to improve heart function or correct abnormal heart rhythms (digoxin, lanoxin, digitoxin).
• sulfate of atropine commonly used for eye exams, to treat low heart rate, and as an antidote for poisoning
• flucloxacillin (antibiotic), due to a severe risk of a blood and fluid anomaly called metabolic acidosis that requires urgent treatment (see section 2),

• medications fornausea and vomiting(such as metoclopramide or domperidone).
• medications forthinning the blood(anticoagulants), such as warfarin or other coumarins.
• medications forhigh cholesterol(such as cholestyramine).

• sedatives (barbiturates).
• medications to control epilepsy, e.g. lamotrigine and barbiturates
• acetylsalicylic acid and other salicylates used to reduce pain, fever, and blood clots.
• alpha-adrenergic agonists, such as medications for attention deficit hyperactivity disorder (clonidine, guanfacine), medications for spasticity (tizanidine)
• medications for migraines (ergotamine, dihydroergotamine)
• probencid or AZT (zidovudine).
• isoniazid or rifampicin (used to treat or prevent tuberculosis).

Taking ilviGrip Expectorante with food, drinks, and alcohol

Do not take this product with alcoholic beverages.

Pregnancy, breastfeeding, and fertility

The use of ilviGrip Expectorante during pregnancy and breastfeeding should only be used if recommended by your doctor or pharmacist.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. If necessary and only if recommended by a doctor or pharmacist, ilviGrip Expectorante may be used during pregnancy. This product should only be used during breastfeeding under medical supervision. Use the lowest possible dose that reduces your pain and/or fever and use it for the shortest possible time. Contact your doctor if the pain and/or fever do not decrease or if you need to take the medication more frequently.

Driving and operating machines

This medication may cause dizziness or confusion. If you experience drowsiness or dizziness, do not drive or operate machines.

ilviGrip Expectorantecontains aspartame, saccharose, and sodium:

• Aspartame: This medication contains 6 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• Saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.
• Sodium: This medication contains 157 mg of sodium (main component of cooking / table salt) in each sachet. This is equivalent to 7.85% of the maximum recommended daily intake of sodium for an adult. Talk to your doctor or pharmacist if you need 3 or more sachets a day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older:

The recommended dose is one sachet, which can be taken up to four times a day as needed, with an interval of at least 4 hours between doses. Do not take more than 4 sachets in 24 hours.

Do not exceed the indicated dose.

Use in children and adolescents

This medication should not be used in children under 12 years.

Administration form

This medication is a powder that dissolves in water and is taken hot.

Dissolve the contents of one sachet in a cup with hot water, but not boiling (approx. 250 ml). Let cool until a temperature that can be drunk.

Treatment duration

If symptoms worsen or persist for more than 3 days, consult your doctor.

If you take moreilviGrip Expectorantthan you should

Consult your doctor immediatelyif you accidentally take more than you should or if the medication was accidentally ingested by a child,even if you or the child feels well, due to the risk of late severe liver damage.

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 medication and the amount taken.

If you forgot to takeilviGrip Expectorant

Do not take a double dose to compensate for the missed doses.

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

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

• • Severe allergic reactions (anaphylaxis), e.g. in rare cases, skin rash, itching, swelling of lips, tongue, throat, face, wheezing, or difficulty breathing (may affect up to 1 in 1,000 people).
• • Rare cases of severe skin reactions (may affect up to 1 in 10,000 people) have been reported. If a skin reaction occurs, stop using it and seek immediate medical help.
• Steven Johnson Syndrome/ Toxic Epidermal Necrolysis may initially appear as red spots in the shape of a bull's eye or circular patches, often with central blisters on the trunk. Additionally, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin reactions are usually preceded by fever and/or flu-like symptoms. The rash may progress to cause widespread skin peeling and potentially fatal or life-threatening complications.
• • Certain blood disorders, e.g. in very rare cases, an increase in nasal bleeding or noticing that bruises appear more easily with paracetamol (may affect up to 1 in 10,000 people).

• Other side effects

Reporting of 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 System for Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Duration after reconstitution: The reconstituted solution is stable for 90 minutes.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of GripaVicks

The active principles are paracetamol, guaifenesina and hydrochloride phenylephrine.Each sachet of this medication provides a single dose containing the followingactive principles: 500 mg of paracetamol, 200 mg of guaifenesina and 10 mg of hydrochloride phenylephrine.

Theother components(excipients) are: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate, aspartame (E951), potassium acesulfame (E950), powdered menthol aroma, lemon aroma, lemon juice aroma, yellow quinoline (E104). See end of section 2.

Appearance of the product and contents of the packaging

GripaVicks Expectorant is a white powder that is presented in single-dose sachets in a cardboard box, which is packaged in a box of 5 or 10 sachets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Vicks Laboratories, S.L.U.

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

Spain

Responsible for manufacturing

Procter & Gamble Manufacturing GmbH

Procter & Gamble Strasse 1

64521Gross-Gerau, Hessen

Germany

Local representative

Procter & Gamble España, S.A.U.

Avenida de Bruselas, 24, 28108 Alcobendas, Madrid

Date of the last review of this prospectus:January 2025

“Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”