ILVICO COATED TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ilvico coated tablets

paracetamol / caffeine / brompheniramine maleate

Read the entire 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 as 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 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.

Contents of the leaflet:

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 belongs to the group of combination cold medicines.

It is indicated for the symptomatic relief of influenza-like and catarrhal conditions accompanied by 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 starting to take Ilvico

Do not take Ilvico

• If you are allergic (hypersensitive) to paracetamol, caffeine, brompheniramine maleate, or 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 inhibitor (MAOI) medicines used to treat depression or Parkinson’s disease.
• If you have asthma and have previously experienced serious adverse effects in the bronchi and lungs after 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 starting to take Ilvico.

• Do not take more medicine than recommended in section 3, "How to take Ilvico."
• The simultaneous use of this medicine with other medicines containing paracetamol should be avoided, 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.
• You should limit consumption of products containing caffeine while taking this medicine.
• You should consult your doctor before taking this medicine:
  • if you have anaemia, or any liver, kidney, lung, thyroid, or stomach disease;
  • if you have eye discomfort;
  • if you are being treated with central nervous system (CNS) depressants (such as medicines used for sleep);
  • if you are over 65 years of age, as this may cause dizziness, sedation, and hypotension;
  • if you have a tumour of the adrenal glands;
  • if you suffer from stomach or intestinal ulcers;
  • if you have or have had heart conditions or disorders, especially when performing physical exercise or being 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 in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Taking Ilvico with other medicines

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

In particular, if you are using any of the following medicines, dosage adjustments 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 oestrogen 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 those in the furosemide group.
• Cimetidine, used to treat stomach ulcers.
• Disulfiram, a medicine used to treat chronic alcoholism.
• Idrocilamide, used for certain muscle spasms and pain.
• Iron supplements for the treatment of anaemias (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 for 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 for cardiac imaging tests, such as adenosine and dipyridamole. You should avoid taking this medicine 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 (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).
• .

Interference with laboratory tests

If you are scheduled to have 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 and drinks

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 habitually consume alcohol (three or more alcoholic drinks—beer, wine, spirits, etc.—per day) may cause liver damage.

Concurrent consumption 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 you may need a lower daily dose. 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 or breastfeeding women 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 using machines

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

Ilvico contains sodium carboxymethyl starch (type A)

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

3. How to take Ilvico

Follow exactly the instructions for administering the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

2 tablets (650 mg of paracetamol) every 8 hours. Do not take more than 6 tablets in 24 hours. Do not exceed 3 g of paracetamol in 24 hours (see section 2, "Warnings and precautions").

Adolescents aged 12 years and older

1 tablet every 6 or 8 hours. Do not take more than 4 tablets 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.

The tablets should be taken with a little water.

Stop treatment once symptoms have disappeared.

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

If you take more Ilvico than you should

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

Symptoms of overdose may include: restlessness, 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 receiving 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, seek immediate medical attention 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 will experience 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 notice that you bruise easily or bleed more readily.

Very rare cases of serious skin reactions have been reported. If a skin reaction occurs, discontinue use 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 observed for which the frequency could not be established: pupil dilation, dry eyes, constipation, disturbances in intellectual capacity, abdominal pain, fatigue, loss of coordination, confusion, vomiting or digestive problems. Some children may become hyperactive after taking this medicine.

Frequent 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 experience difficulty in urinating (urinary retention).

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

• Heart rhythm disorders.
• Decrease in blood pressure (hypotension).
• Feeling of faintness.

Malaise.

Seizures and tremors.

• Liver disorders.

Very rare disorders (observed in less 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.

• Decreased blood sugar levels.

• Yellowish discoloration 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 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 discontinue 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 blood to become more acidic (called metabolic acidosis) in patients with severe 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 they are possible adverse effects 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 drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ilvico

The active substances are paracetamol 325 mg, caffeine 30 mg and brompheniramine maleate 3 mg.

The other components are microcrystalline cellulose, sodium carboxymethylstarch (type A) (derived from potato starch), crospovidone, hypromellose, powdered cellulose, magnesium stearate, glycerol (E-422), colloidal anhydrous silica, titanium dioxide (E171), macrogol, talc.

Appearance of the medicinal product and contents of the pack

Ilvico are white coated tablets, supplied in blisters and packaged in cartons containing 20 tablets.

Marketing Authorization Holder

Laboratorios Vicks, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid), Spain

Manufacturer

P&G Health Austria GmbH & Co. OG

Hösslgasse 20

9800 Spittal an der Drau

Austria

Local representative

Procter & Gamble España, S.L.U.

Avda. Bruselas, 24

28108 Alcobendas (Madrid), Spain

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

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