ILVIGRIP EXPECTORANT ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

ilviGrip Expectorant powder for oral solution

paracetamol / guaifenesina / phenylephrine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this leaflet, 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, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the package leaflet:

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

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

ilviGrip Expectorant contains three active substances:

• 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).
• Guaifenesina (an expectorant) thins mucus, helping to relieve productive cough (with phlegm).
• Phenylephrine hydrochloride (a nasal decongestant) reduces the inflammation of the nasal passages, relieving nasal congestion.

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

You should only use ilviGrip Expectorant 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 it does not improve or worsens after 3 days.

2. What you need to know before taking ilviGrip Expectorant

Do not takeilviGrip Expectorant if:

• You are allergic (hypersensitive) to paracetamol, guaifenesina, phenylephrine hydrochloride, or any of the components of this medicine (see section 6 composition of ilviGrip Expectorant).
• You have heart disease.
• You have high blood pressure (hypertension).
• You have altered liver function or severe kidney failure.
• You have hyperthyroidism.
• You are already taking another sympathomimetic medicine (such as pseudoephedrine, oxymetazoline, clonidine, salbutamol, and others).
• You are diabetic.
• You have glaucoma (increased pressure in the eye) of the narrow-angle type.
• You have porphyria, a hereditary disorder characterized by an excessive amount of pigments in the urine.
• You are taking tricyclic antidepressants.
• You are taking beta-blockers.
• 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 medicines 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 other medicines for flu, cold, or nasal congestion.

Talk to your doctor or pharmacist before takingilviGrip Expectorant if:

• You have liver disease or drink alcohol regularly. Regular alcohol consumption affects liver function and may increase the risk of liver toxicity from products containing paracetamol.
• 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 cough that lasts more than a week, a cough that produces a lot of mucus (phlegm), or chronic persistent cough as occurs when suffering from asthma, chronic bronchitis, or emphysema.
• You have severe hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, chronic nutritional disorder, or are dehydrated.

During treatment with ilviGrip Expectorant, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in 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 and adolescents

ilviGrip Expectorant is not intended for children under 12 years of age.

Use ofilviGrip Expectorant with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Tell your doctor if you are taking:

• monoamine oxidase inhibitors(MAOIs) used in the treatment of depressionor Parkinson's disease. Do not takeilviGrip Expectorant 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).
• atropine sulfate commonly used for eye exams, to treat low heart rate, and as an antidote for poisoning.
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly called metabolic acidosis that requires urgent treatment (see section 2).

• 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).
• medicines to control epilepsy, e.g., lamotrigine and barbiturics.
• 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).
• medicines for migraines(ergotamine, dihydroergotamine).
• probenecid or AZT (zidovudine).
• isoniazid or rifampicin (used to treat or prevent tuberculosis).

Taking ilviGrip Expectorantwith food, drinks, and alcohol.

Do not take this product with alcoholic beverages.

Pregnancy, breastfeeding, and fertility

Taking ilviGrip Expectorant during pregnancy and breastfeeding should only be done if recommended by your doctor or pharmacist.

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. If necessary and only if recommended by a doctor or pharmacist, ilviGrip Expectorant can be used during pregnancy. This product should only be used during breastfeeding under medical supervision. You should 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 medicine more frequently.

Driving and using machines

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

ilviGrip Expectorant contains aspartame, sucrose, and sodium:

• Aspartame: This medicine contains 6 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• Sucrose: If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• Sodium: This medicine 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 per day for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to take ilviGrip Expectorant

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

In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years of age:

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 medicine should not be used in children under 12 years of age.

Method of administration

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

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

Duration of treatment

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 medicine was accidentally ingested by a child, even if you or the child feel 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 medicine and the amount taken.

If you forget to takeilviGrip Expectorant

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

If you have any other doubts about the use of this medicine, ask your pharmacist.

4. Possible side effects

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

• • Serious allergic reactions (anaphylaxis), e.g., in rare cases, a skin rash, itching, swelling of the lips, tongue, throat, face, wheezing, or difficulty breathing (can affect up to 1 in 1,000 people).
• • Very rare cases of serious skin reactions (can affect up to 1 in 10,000 people) have been reported. If a skin reaction occurs, stop using it and seek medical help immediately.
• The Stevens-Johnson syndrome/Toxic Epidermal Necrolysis can initially appear as reddish spots in a target shape or circular patches, often with central blisters on the trunk. Additionally, ulcers can occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These serious skin reactions are usually preceded by fever and/or flu-like symptoms. The rashes can progress to cause widespread skin peeling and potentially fatal or life-threatening complications.
• • Certain blood cell disorders, e.g., in very rare cases, an increase in the number of nosebleeds or noticing that you bruise more easily with paracetamol (can affect up to 1 in 10,000 people).

• Other side effects

Reporting of side effects:

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ilviGrip Expectorant

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 is the last day of the month indicated.

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

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 the 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 of ilviGrip Expectorant

The active substances are paracetamol, guaifenesina, and phenylephrine hydrochloride.Each sachet of this medicine provides a single dose that contains the following active substances: 500 mg of paracetamol, 200 mg of guaifenesina, and 10 mg of phenylephrine hydrochloride.

Other components(excipients) are: sucrose, citric acid, tartaric acid, sodium citrate, aspartame (E951), acesulfame potassium (E950), menthol powder flavor, lemon flavor, lemon juice flavor, quinoline yellow (E104). See the end of section 2.

Appearance of the product and pack contents

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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, Hessen

Germany

Local representative

Procter & Gamble España, S.A.U.

Avenida de Bruselas, 24, 28108 Alcobendas, Madrid

Date of last revision of this leaflet:January 2025

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