ILVICO GRANULADO FOR ORAL SOLUTION

2. What you need to know before taking Ilvico

Do not take Ilvico

• If you are allergic (hypersensitive) to paracetamol, caffeine, brompheniramine maleate, or any of the other components of this medication (listed in section 6).
• If you suffer from mental disorders that occur with nervous excitement, epilepsy, anxiety states, and insomnia (sleep problems).
• If you are or have been in treatment, in the last 14 days, with monoamine oxidase inhibitor (MAOI) medications used to treat depression or Parkinson's disease.
• If you have asthma and have suffered severe 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 prostate enlargement
• Children under 12 years of age cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ilvico:

• Do not take more medication than recommended in section 3. How to take Ilvico.
• It should be avoided to use this medication simultaneously with other medications that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor, as it may cause an overdose.
• You should limit the consumption of products that contain caffeine when you are being treated with this medication.
• You should consult your doctor before taking this medication:
• • ;

During treatment with Ilvico, inform your doctor immediately if:

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), 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 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.

Taking Ilvico with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. As many other medications can affect liver function and increase the risk of liver toxicity.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or even interrupt treatment:

• Antidepressants, anticonvulsants
• Other antihistamines
• Anxiety medications
• Sleep medications
• Antibiotics (chloramphenicol) and anti-infective quinolones (such as oxolinic acid, ciprofloxacin), linezolid, erythromycin, and terbinafine.
• Oral contraceptives and estrogen treatments.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs) or lithium, and other medications for depression and mood: buspirone, phenelzine, fluoxetine, venlafaxine, trazodone, amitriptyline, or nortriptyline.
• Clozapine, used for the treatment of psychosis and bipolar disorders.
• Barbituric medications (used as hypnotics, sedatives, and anticonvulsants).
• Asthma medications (adrenergic bronchodilators and theophylline).
• Medications used to increase urine elimination: loop diuretics such as furosemide.
• Cimetidine, used to treat stomach ulcers.
• Disulfiram, a medication used for the treatment of chronic alcoholism.
• Hydrocylamide, used for some muscle contractions and pains.
• Iron supplements for the treatment of anemia (should be taken 2 hours apart).
• Mexiletine, used for heart rhythm disorders.
• Ephedrine, a medication used as a cardiac stimulant.
• Thyroxine, a medication used in the treatment of thyroid diseases.
• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications used to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications used to treat migraines: ergot alkaloids, triptans, valproic acid.
• Medications used to treat tuberculosis: isoniazid, rifampicin.
• Medications used to lower cholesterol levels in the blood: cholestyramine. The effect of paracetamol may decrease). Medications used to treat gout: probenecid and sulfinpyrazone.
• Medications used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics).
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used for the human immunodeficiency virus (HIV): zidovudine.
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias), such as propranolol.
• Substances used for heart imaging tests, such as adenosine and dipyridamole. You should avoid taking this medication 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 down stomach emptying.
• St. John's Wort (Hypericum perforatum).
• Grapefruit juice.
• Other medications and paracetamol: Inform your doctor or pharmacist if you are taking: flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis that requires urgent treatment.

Interference with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Ilvico with food, drinks, and alcohol

Coffee, tea, chocolate, or cola drinks are sources of caffeine. Therefore, it is recommended to moderate the consumption of these products while taking Ilvico. Taking up to 400 mg of caffeine per day in healthy adults is considered safe, so it is important that you consider the total caffeine content in other foods or products while taking this medication.

Taking Ilvico by patients who regularly consume alcohol (three or more alcoholic beverages, - beer, wine, liquor... - per day) may cause liver damage.

The simultaneous consumption of Ilvico with alcoholic beverages may increase its adverse effects.

Taking this medication with food does not affect its efficacy.

Use in children

Do not administer to children under 12 years of age.

Use in adults over 65 years

Talk to your doctor before taking brompheniramine, as it is more likely to cause confusion, and you may need to take a lower daily dose. Elderly people are more likely to experience side effects. Consult your doctor before taking this medication.

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 medication.

Pregnant or breastfeeding women cannot take this medication. Its use will only be considered in case of medical recommendation and under strict supervision, if the benefits outweigh the risks.

Driving and using machines

This medication may cause drowsiness, dizziness, or blurred vision, especially if you drink alcoholic beverages while being treated with this medication. If the medication causes these effects, do not drive or operate hazardous tools or machines while being treated.

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

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

This medication contains less than 1 mmol of sodium (23 mg) per sachet, which is essentially 'sodium-free'.

This medication may cause allergic reactions because it contains orange yellow (E-110).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Ilvico

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

1 sachet (500 mg of paracetamol) every 8 hours. If necessary, it can be taken every 6 hours (4 times a day). Do not take more than 4 sachets in 24 hours. Do not take more than 3 g of paracetamol every 24 hours (see section "Warnings and precautions" in section 2).

Adolescents from 12 years of age

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

Children under 12 years of age

Cannot take this medication.

This medication is taken orally.

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

Suspend treatment once symptoms have disappeared.

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

If you take more Ilvico than you should

If you have taken an overdose, go quickly to a medical center, even if you do not notice symptoms, as they often do not manifest until 3 days after taking the overdose, even in cases of severe poisoning. Taking too much paracetamol can cause severe liver damage.

The symptoms of overdose may be: excitement, discomfort, diarrhea, abdominal pain, convulsions, dizziness, nausea, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), drowsiness, disorientation, and sweating.

Treatment of the overdose is more effective if started within 4 hours after taking the medication.

Patients being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

4. Possible side effects

Like all medications, this medication can cause side 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 rashes, 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 or bleed more easily.

Very rare cases of severe skin reactions have been reported. If a skin reaction occurs, stop using it and seek medical help immediately.

You should interrupt treatment immediately if you experience dizziness or palpitations (unusually strong heartbeats).

The following side effects have been observed for which the exact frequency cannot be established: pupil dilation, dry eyes, constipation, alterations in intellectual capacity, abdominal pain, fatigue, loss of coordination, confusion, vomiting, or digestion problems. Some children may become hyperactive after taking this medication.

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 prostate enlargement, may have problems urinating (urinary retention).

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

• Heart rhythm disorders.
• Decreased blood pressure (hypotension).
• Fainting sensation.
• Discomfort.
• Seizures and tremors.
• Liver alterations.

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

• Decrease in the number of some blood cells, which can increase the likelihood of infections or include a type of anemia.
• Decrease in blood sugar
• Yellowing of the skin.
• Cloudy urine, burning sensation when urinating.
• Allergy.
• Very rare cases of severe skin reactions have been reported. If a skin reaction occurs, stop using it and seek medical help immediately.

.

Other side effects related to caffeine have been observed, for which the exact frequency cannot 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 should suspend treatment immediately if you feel dizziness or palpitations (unusually strong heartbeats).

Frequency not known (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting side effects:

If you experience any type of side effect, consult 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 Medications: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ilvico

Do not store above 30 °C.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Ilvico Composition

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

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

Product Appearance and Packaging Content

Ilvico is an oral solution granule in sachets with 6 g. It is presented in boxes with 10 sachets.

Marketing Authorization Holder

Laboratorios Vicks, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid) Spain

Manufacturer

SoliPharma B.V.

Industrieweg 11a

Oudenbosch – Netherlands

Local Representative

Procter & Gamble España, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid) Spain

Date of the Last Revision of this Leaflet: January 2025

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