Ilvico granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ilvico granules for oral solution

paracetamol / caffeine / brompheniramine maleate

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

Follow exactly the instructions for use provided in this leaflet or those given 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 or pharmacist, 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 5 days.

Leaflet contents:

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

1. What Ilvico is and what it is used for

Ilvico is a combination of paracetamol, which reduces fever and relieves pain,
brompheniramine, which reduces nasal secretion and congestion, and caffeine, which stimulates the
nervous system.

It is indicated for the symptomatic relief of influenza-like and cold conditions associated with fever, mild to moderate pain, and nasal discharge.

You should consult a doctor if your condition worsens or does not improve after 5 days.

2. What you need to know before taking Ilvico

Do not take Ilvico

• If you are allergic (hypersensitive) to paracetamol, caffeine, brompheniramine maleate, or to any of the other components of this medicine (listed in section 6).
• If you suffer from mental disorders associated with nervous excitement, epilepsy, anxiety states, or insomnia (difficulty sleeping).
• If you are currently or have been treated within the last 14 days with monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease.
• If you have asthma and have experienced serious adverse effects in the bronchi and lungs when taking allergy medications.
• If you have any brain injury.
• If you have glaucoma.
• If you have severe liver disease.
• If you have difficulty urinating and/or an enlarged prostate.
• Children under 12 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Ilvico:

• Do not take more medicine than recommended in section 3, How to take Ilvico.
• Avoid using this medicine simultaneously with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor, as this may lead to overdose.
• Limit consumption of products containing caffeine while being treated with this medicine.
• You should consult your doctor before taking this medicine:
  • if you have anemia, or any liver, kidney, lung, thyroid, or stomach disease;
  • if you experience eye discomfort;
  • if you are taking central nervous system (CNS) depressants (such as medicines used for sleep);
  • if you are over 65 years old, as this may cause dizziness, sedation, and hypotension;
  • if you have a tumor of the adrenal glands;
  • if you suffer from stomach or intestinal ulcers;
  • if you have or have had heart conditions, especially during physical exertion or at high altitudes;
  • if you are diabetic, as caffeine may increase blood sugar levels;
  • if you are sensitive to theophylline or aminophylline;
  • if you are asthmatic and allergic to acetylsalicylic acid (aspirin);
  • if you have glucose-6-phosphate dehydrogenase deficiency;
  • if you regularly consume alcohol, as this medicine may cause liver damage. You should avoid drinking alcohol while taking this medicine.

During treatment with Ilvico, 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 under these conditions when paracetamol is used at regular doses over a prolonged period or when taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Taking Ilvico with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine. Many other medicines may affect liver function and increase the risk of hepatotoxicity.

In particular, if you are taking any of the following medicines, a dose adjustment or discontinuation of treatment may be necessary:

• Antidepressants, anticonvulsants
• Other antihistamines
• Medicines for anxiety
• Medicines to help you sleep
• Antibiotics (chloramphenicol) and anti-infectives of the quinolone group (e.g., oxolinic acid, ciprofloxacin), linezolid, erythromycin, and terbinafine.
• Oral contraceptives and estrogen treatments.
• Antidepressants such as monoamine oxidase inhibitors (MAOIs) or lithium, and other medicines for depression and mood: buspirone, phenelzine, fluoxetine, venlafaxine, trazodone, amitriptyline, or nortriptyline.
• Clozapine, used for the treatment of psychosis and bipolar disorders.
• Barbiturate medicines (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to treat asthma (adrenergic bronchodilators and theophylline).
• Medicines used to increase urine elimination: loop diuretics such as furosemide.
• Cimetidine, used to treat stomach ulcers.
• Disulfiram, a medicine used to treat chronic alcoholism.
• Idrocilamide, used for certain muscle spasms and pains.
• Iron supplements for treating anemias (intake should be spaced at least 2 hours apart).
• Mexiletine, used for heart rhythm disorders.
• Ephedrine, a medicine used as a cardiac stimulant.
• Thyroxine, a medicine used in the treatment of thyroid disorders.
• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines used to treat migraine: ergot alkaloids, triptans, valproic acid.
• Medicines used to treat tuberculosis: isoniazid, rifampicin.
• Medicines to lower blood cholesterol levels: cholestyramine. (The effect of paracetamol may be reduced.)
• Medicines used to treat gout: probenecid and sulfinpyrazone.
• Medicines used to relieve spasms or contractions of the stomach, intestine, and bladder (anticholinergics).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used for human immunodeficiency virus (HIV): zidovudine.
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias), such as propranolol.
• Substances used in cardiac imaging tests, such as adenosine and dipyridamole. This medicine should not be taken during the 24 hours prior to the test.
• Amphetamines, as well as analgesics such as cyclobenzaprine, fentanyl, meperidine, or tramadol.
• Activated charcoal, and other products that slow gastric emptying.
• St. John’s wort (Hypericum perforatum).
• Grapefruit juice.
• Other medicines and paracetamol: Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis), which requires urgent treatment.

Interference with laboratory tests

If you are scheduled to undergo any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Ilvico with food, drinks, and alcohol

Coffee, tea, chocolate, and cola drinks are sources of caffeine. Therefore, it is recommended to moderate consumption of these products while taking Ilvico. Consuming up to 400 mg of caffeine per day in healthy adults is considered safe; thus, it is important to consider the total caffeine content from other foods or products while taking this medicine.

Taking Ilvico in patients who regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits—per day) may cause liver damage.

Concurrent use of Ilvico with alcoholic beverages may increase adverse effects.

Taking this medicine with food does not affect its efficacy.

Use in children

Do not administer to children under 12 years of age.

Use in people aged 65 years and older

Talk to your doctor before taking brompheniramine, as confusion is more likely and a lower daily dose may be needed. Elderly individuals are more prone to adverse effects. Consult your doctor before taking this medicine.

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.

Pregnant women or those who are breastfeeding must not take this medicine. Its use will only be considered under medical recommendation and strict supervision if the benefits outweigh the risks.

Driving and use of machines

This medicine may cause drowsiness, dizziness, or blurred vision, especially if alcoholic beverages are consumed during treatment. If you experience these effects, do not drive or operate dangerous tools or machinery while on this medicine.

Ilvico contains sucrose, sorbitol, sodium cyclamate, sodium saccharin, and orange yellow (E-110)

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 4.852 g of sucrose per sachet.

This medicine contains 5.85 mg of sorbitol syrup (as part of the orange flavor) in each sachet.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., essentially “sodium-free.”

This medicine may cause allergic reactions as it contains orange yellow (E-110).

It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Ilvico

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 again.

The recommended dose is:

Adults

1 sachet (500 mg of paracetamol) every 8 hours. If necessary, it may be taken every 6 hours (4 times a day). Do not take more than 4 sachets in 24 hours. Do not exceed 3 g of paracetamol in any 24-hour period (see section 2, “Warnings and precautions”).

Adolescents aged 12 years and older

1 sachet every 8 hours. Do not take more than 3 sachets in 24 hours.

Children under 12 years of age

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

This medicine is for oral use.

Empty the contents of one sachet into half a glass of water, shake until completely dissolved, and take immediately.

Stop treatment once symptoms have disappeared.

If symptoms worsen or persist for more than 5 days of treatment, you must consult your doctor.

If you take more Ilvico than you should

In case of overdose, go immediately to a medical centre even if you do not experience symptoms, as symptoms often do not appear until 3 days after the overdose has been taken, even in cases of severe poisoning. Taking too much paracetamol may cause serious liver damage.

Symptoms of overdose may include: agitation, malaise, diarrhoea, abdominal pain, seizures, dizziness, nausea, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), drowsiness, disorientation, and sweating.

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical centre or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Side effects are uncommon with paracetamol.

Stop taking the product and contact your doctor immediately if you notice:

• allergic reactions, e.g. skin rash, itching, urticaria (hives or nettle rash), swelling of lips, tongue or throat, or difficulty breathing, anaphylaxis.
• an increase in the number of nosebleeds or you notice you are bruising easily or bleeding more readily.

Very rare cases of serious skin reactions have been reported. If a skin reaction occurs, stop using the product and seek immediate medical help.

You must immediately stop treatment if you experience dizziness or palpitations (unusually strong heartbeats).

The following adverse effects have been reported, for which the exact frequency could not be established: pupil dilation, dry eyes, constipation, intellectual impairment, abdominal pain, fatigue, loss of coordination, confusion, vomiting, or digestive problems. Some children may become hyperactive after taking this medicine.

Common disorders (observed in 1 to 10 people out of 100):

• Drowsiness, headache, blurred vision, increased respiratory secretions, dry mouth, stomach pain. Some patients, particularly those with enlarged prostate, may have difficulty urinating (urinary retention).

Rare disorders (observed in 1 to 10 people out of 10,000):

• Heart rhythm disorders.
• Decrease in blood pressure (hypotension).
• Feeling faint.
• Malaise.
• Seizures and tremors.
• Liver disorders.

Very rare disorders (observed in fewer than 1 in 10,000 people):

• Decrease in the number of certain blood cells, which may increase the likelihood of infections or include a type of anaemia.
• Decrease in blood sugar levels.
• Yellowing of the skin.
• Cloudy urine, burning sensation when urinating.
• Allergy.
• Very rare cases of serious skin reactions have been reported. If a skin reaction occurs, stop using the product and seek immediate medical help.

Other adverse effects related to caffeine have been observed, for which the exact frequency could not be established. The most commonly observed effects have been: insomnia, restlessness, nervousness, irritability, excitement, and disorientation. Nausea, vomiting, and stomach irritation have also been observed.

You must immediately stop treatment if you experience dizziness or palpitations (unusually strong heartbeats).

Frequency not known (cannot be estimated from available data): A serious illness that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who are using paracetamol (see section 2).

Reporting of adverse effects:

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

5. Storage of Ilvico

Do not store above 30 ºC.

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

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ilvico

The active substances are paracetamol 500 mg, caffeine 30 mg and brompheniramine maleate 3 mg.

The other components are citric acid, orange yellow (E-110), orange flavour, sodium cyclamate, macrogol, sodium saccharin, anhydrous colloidal silica, sucrose.

Appearance of the product and contents of the pack

Ilvico is an oral granulate in sachets of 6 g. It is available in cartons containing 10 sachets.

Marketing Authorization Holder

Laboratorios Vicks, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid), Spain

Manufacturer

SoliPharma B.V.

Industrieweg 11a

Oudenbosch – The Netherlands

Local representative

Procter & Gamble España, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid), Spain

Date of the most recent revision of this leaflet: January 2025

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