Label: Information for the User

Granulated powder for oral solution

paracetamol / caffeine / brompheniramine maleate

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to 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 not listed in this label. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

Ilvico is an association of paracetamol, which reduces fever and relieves pain,

bromfeniramina, which decreases nasal secretion and congestion, and caffeine, which stimulates the

nervous system.

It is indicated for symptomatic relief in gripal and catarrhal processes that are accompanied by fever, mild or moderate painand nasal secretion.

Consult a doctor if symptoms worsen or do not improve after 5 days.

Do not take Ilvico

• If you are allergic (hypersensitive) to paracetamol, caffeine, bromfeniramine maleate, or any of the other components of this medication (listed in section 6).
• If you suffer from mental alterations that include nervous excitement, epilepsy, anxiety states, and insomnia (sleep problems).
• If you are or have been treated with monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease in the last 14 days.
• If you have asthma and have experienced severe adverse effects on your 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 old 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.
• Avoid taking this medication with other medications that contain paracetamol, as high doses can cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor, as it may cause an overdose.
• Limit your consumption of products that contain caffeine while taking this medication.
• Consult your doctor before taking this medication:
• • If you have anemia, liver disease, kidney disease, lung disease, thyroid disease, or stomach disease;
  • If you have eye problems;
  • If you are taking medications that depress the central nervous system (such as sleep medications);
  • If you are over 65 years old, as it may cause dizziness, sedation, and hypotension;
  • If you have a tumor in the adrenal glands;
  • If you have stomach or intestinal ulcers;
  • If you have or have had heart disease, especially when exercising or at high altitudes;
  • If you are diabetic, as caffeine can raise blood sugar levels;
  • If you are sensitive to theophylline or aminophylline;
  • If you have asthma and are allergic to aspirin;
  • If you have glucose-6-phosphate dehydrogenase deficiency;
  • If you regularly consume alcohol, as this medication can cause liver damage. Avoid drinking alcohol while taking this medication.

Inform your doctor immediately if you experience any of the following during treatment with Ilvico:

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 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 using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include:

Severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Taking Ilvico with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Many other medications can affect liver function and increase the risk of liver toxicity.

Particularly, if you are taking any of the following medications, as it may be necessary to modify the dose of some of them or even discontinue treatment:

• Antidepressants, anticonvulsants
• Other antihistamines
• Anxiety medications
• Sleep medications
• Antibiotics (cloranfenicol) and anti-infectious agents of the quinolone group (e.g., oxolinite acid, ciprofloxacin), linezolid, erythromycin, and terbinafine.
• Oral contraceptives and hormone replacement therapy.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs) or lithium, and other medications for depression and mood disorders: buspirone, phenelzine, fluoxetine, venlafaxine, trazodone, amitriptyline, or nortriptyline.
• Clozapine, used to treat psychosis and bipolar disorders.
• Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Asthma medications (adrenergic bronchodilators and theophylline).
• Medications used to increase urine elimination: diuretics of the loop type, such as furosemide.
• Cimetidine, used to treat stomach ulcers.
• Disulfiram, used to treat chronic alcoholism.
• Idrocilamida, used to treat some muscle contractures and pain.
• Iron supplements for anemia treatment (take 2 hours apart).
• Mexiletine, used to treat arrhythmias.
• Ephedrine, used as a cardiac stimulant.
• Thyroxine, used to treat thyroid diseases.
• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications to treat epilepsy: antiepileptic drugs (lamotrigine, phenytoin, or other hydantoins, phenobarbital, metharbital, primidone, carbamazepine).
• Medications used to treat migraines: ergot alkaloids, triptans, valproic acid.
• Medications to treat tuberculosis: isoniazid, rifampicin.
• Medications to lower cholesterol levels in the blood: cholestyramine. The effect of paracetamol may be reduced).
• Medications used to treat gout: probenecid and sulfinpyrazone.
• Medications used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics).
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used to treat HIV: zidovudine.
• Medications used to treat high blood pressure (hypertension) and arrhythmias: propranolol.
• Substances used for cardiac imaging tests, such as adenosine and dipiridamol. Avoid taking this medication for 24 hours before 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).
• Orange juice.
• Other medications and paracetamol:Inform your doctor or pharmacist if you are taking: flucloxacillin (antibiotic), as there is a serious risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment.

Interference with analytical tests

Inform your doctor if you are to undergo any analytical tests (including blood and urine tests), as this medication may alter the results.

Taking Ilvico with food, drinks, and alcohol

Coffee, tea, chocolate, or cola beverages are sources of caffeine. Therefore, it is recommended to moderate your consumption of these products while taking Ilvico.Consuming up to 400 mg of caffeine per day in healthy adults is considered safe, so it is essential to 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 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 old.

Use in people over 65 years old

Consult your doctor before taking bromfeniramine, as you may experience confusion and may need to take a lower daily dose. People over 65 years old are more prone to adverse effects. Consult your doctorbefore taking this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor or pharmacist before using this medication.

Pregnant or breastfeeding women cannot take this medication.Only consider its use under medical recommendation and strict supervision, if the benefits outweigh the risks.

Driving and operating machinery

This medication may cause drowsiness, dizziness, or blurred vision, especially if you consume alcoholic beverages while taking it. If the medication causes these effects, do not drive or operate hazardous machinery while taking it.

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

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

Patients with diabetes mellitus should note that this medication contains 4.852 g of saccharose per dose.

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

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

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

It may cause asthma, especially in patients allergic to aspirin.

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

The recommended dose is:

Adults

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

Adolescents 12 years of age and older

1 tablet every 8 hours. Do not take more than 3 tablets in 24 hours.

Children under 12 years of age

They cannot take this medication.

This medication is taken orally.

Empty the contents of a tablet into half a glass of water, shake until completely dissolved, and take afterwards.

Discontinue treatment once symptoms have disappeared.

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

If you take more Ilvico than you should

If an overdose has been taken, go quickly to a medical center even if no symptoms are noted, as they often do not manifest until 3 days after the overdose, even in cases of severe poisoning. Taking too much paracetamol can cause severe liver damage.

Overdose symptoms may include: excitement, discomfort, diarrhea, abdominal pain, convulsions, dizziness, nausea, vomiting, loss of appetite, yellow discoloration of the skin and eyes (jaundice), drowsiness, disorientation, and sweating.

The treatment of an overdose is more effective if initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment 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 Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

Like all medications,this medicationcan produce side effects, although not all people will experience them.

Side effects are uncommon with paracetamol.

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

- allergic reactions, p. skin eruptions, itching, urticaria (hives or nettle rash), swelling of lips, tongue or throat, or difficulty breathing, anaphylaxis.

- an increase in the number of nasal bleedings or notice that you are getting bruises or bleeding more easily.

Rare cases of severe skin reactions have been reported. If a skin reaction occurs, discontinue use and seek medical help immediately. –

You must discontinue treatment immediately if you experience dizziness or palpitations (abnormally strong heartbeats).

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

Frequent disorders (observed between 1 and 10 people in every 100):

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

Rare disorders (observed between 1 and 10 people in every 10,000):

- Heart rhythm disorders.

- Decreased blood pressure (hypotension).

- Feeling of fainting.

- Discomfort.

- Convulsions and tremors.

- Liver function alterations.

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

- Decreased levels of some blood cells, which may increase the likelihood of infections or include a type of anemia.

- Decreased blood sugar

- Yellow discoloration of the skin.

-Cloudy urine, burning sensation while urinating.

- Allergy.

- Rare cases of severe skin reactions have been reported. If a skin reaction occurs, discontinue use 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 must discontinue treatment immediately if you feel dizzy or experience palpitations (abnormally strong heartbeats).

Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 30°C.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ilvico

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

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

Appearance of the product and contents of the packaging

Ilvico is an oral granule solution in sachets with6 g. It is presented in boxes with 10 sachets.

Holder of the marketing authorization

Laboratorios Vicks, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid) Spain

Responsible for manufacturing

SoliPharma B.V.

Industrieweg 11a

Oudenbosch – Netherlands

Local representative

Procter & Gamble España, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid) Spain

Revision date of this leaflet: January 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).