Ilvigríp Expectorant oral solution powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ilviGrip Expectorant powder for oral solution

paracetamol / guaifenesin / phenylephrine hydrochloride

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

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed 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 adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

Leaflet contents:

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

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

ilviGrip Expectorant contains three active substances:

• Paracetamol, which is well known for its ability to relieve pain (analgesic). It is effective against headaches and sore throat, and can also reduce fever (antipyretic).
• Guaifenesin (an expectorant), which helps loosen mucus, aiding in the relief of productive cough (with phlegm).
• Phenylephrine hydrochloride (a nasal decongestant), which reduces inflammation in the nasal passages, relieving nasal congestion.

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

ilviGrip Expectorant should only be used 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 if your condition worsens after 3 days.

2. What you need to know before taking ilviGrip Expectorant

Do not take ilviGrip Expectorant:

• If you are allergic (hypersensitive) to paracetamol, guaifenesin, phenylephrine hydrochloride, or to any of the components of this medicine (see section 6, Composition of ilviGrip Expectorant).
• If you have a heart disease.
• If you have high blood pressure (hypertension).
• If you suffer from impaired liver function or severe renal insufficiency.
• If you have hyperactivity of the thyroid gland.
• If you are already taking another sympathomimetic medicine (such as pseudoephedrine, oxymetazoline, clonidine, salbutamol, and others).
• If you are diabetic.
• If you have narrow-angle glaucoma (increased pressure in the eye).
• If you have porphyria, which is 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 within the last 14 days.

Warnings and precautions

Important: Contains Paracetamol. Do not take it together with other medicines containing paracetamol.

In case of overdose, consult your doctor immediately, even if you feel well, due to the risk of delayed severe liver damage. Do not take this medicine with other medicines for flu, cold, or nasal congestion.

Talk to your doctor or pharmacist before taking ilviGrip Expectorant:

• If you suffer from alcoholic liver disease or drink alcohol regularly. Regular alcohol consumption affects liver function and may increase the risk of hepatotoxicity from products containing paracetamol.
• If you are male and have an enlarged prostate, making urination more difficult.
• If you have circulatory problems (including Raynaud's syndrome).
• If you have a cough lasting more than one week, a cough producing a lot of mucus (phlegm), or a persistent chronic cough as occurs in asthma, chronic bronchitis, or emphysema.
• If you have severe hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, chronic malnutrition, or if you are dehydrated.

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

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body 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 together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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 of ilviGrip Expectorant with other medicines

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

Inform your doctor if you are taking:

• monoamine oxidase inhibitors (MAOIs) used in the treatment of depression or Parkinson’s disease. Do not take ilviGrip Expectorant if you have been treated with MAO inhibitors within the last 14 days.
• tricyclic antidepressants for depression, such as amitriptyline or imipramine.
• medicines for high blood pressure (antihypertensives), including beta-blockers, or for improving heart function or correcting abnormal heart rhythms (digoxin, lanoxin, digitoxin).
• atropine sulfate, commonly used for eye examinations, to treat low heart rate, or as an antidote for poisoning.
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder called metabolic acidosis requiring 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 (barbiturates).
• medicines 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 medicines for attention deficit/hyperactivity disorder (clonidine, guanfacine), or medicines for spasticity (tizanidine).
• medicines for migraines (ergotamine, dihydroergotamine).
• probenecid or AZT (zidovudine).
• isoniazid or rifampicin (used to treat or prevent tuberculosis).

Taking ilviGrip Expectorant with food, drinks, and alcohol

Do not take this product with alcoholic beverages.

Pregnancy, breastfeeding, and fertility

ilviGrip Expectorant should be used during pregnancy and breastfeeding only 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. ilviGrip Expectorant may be used during pregnancy only if necessary and only if recommended by a doctor or pharmacist. This product should be used during breastfeeding only under medical supervision. Use the lowest possible dose that relieves your pain and/or fever, and use it for the shortest possible time. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.

Driving and using machines

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

ilviGrip Expectorant contains aspartame, sucrose, and sodium:

• Aspartame: This medicine contains 6 mg of aspartame per 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.
• Sucrose: If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
• Sodium: This medicine contains 157 mg of sodium (main component of table salt) per sachet. This corresponds to 7.85% of the maximum recommended daily sodium intake for an adult. Talk to your doctor or pharmacist if you need to take 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 instructions for use provided in this leaflet or those given by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 12 years and older:

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

Do not exceed the recommended dose.

Use in children and adolescents

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

Method of administration

This medicine is a powder that is dissolved in water and taken warm.

Dissolve the contents of one sachet in a cup of hot, but not boiling, water (approximately 250 ml). Allow to cool to a drinkable temperature before taking.

Duration of treatment

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

If you take more ilviGrip Expectorant than you should

Seek immediate medical advice if you accidentally take more than the recommended dose, or if the medicine is accidentally ingested by a child, even if you or the child feel well, due to the risk of delayed severe liver damage.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take ilviGrip Expectorant

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

If you have any further questions about the use of this medicine, ask your pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any of the following serious adverse 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).

• • Very rare cases of serious skin reactions have been reported (may affect up to 1 in 10,000 people). If a skin reaction occurs, stop using the medicine and seek immediate medical help.

• Stevens-Johnson syndrome/Toxic Epidermal Necrolysis may initially appear as red, target-like spots or circular patches, often with central blisters on the trunk. In addition, ulcers may develop in the mouth, throat, nose, genitals and eyes (red and swollen eyes). These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and lead to potentially fatal or life-threatening complications.

• • Certain disorders of blood cells, e.g. in very rare cases an increase in the number of nosebleeds or noticing that you bruise more easily with paracetamol (may affect up to 1 in 10,000 people).

• Other adverse effects

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse reactions, 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 ºC.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of GripaVicks

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

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

Appearance of the product and contents of the container

Ilvigrip Expectorant is a white to off-white powder supplied in single-dose sachets packed in a cardboard box containing either 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 the most recent revision of this leaflet: January 2025

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