ILVIGRIP NOCHE JARABE (Syrup)

Introduction

Package Leaflet: Information for the User

IlviGrip Noche Syrup

paracetamol/dextromethorphan/doxylamine

Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you

Follow the instructions for administration of the medicine contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Contents of the Package Leaflet:

1. What is IlviGrip Noche and what is it used for
2. What you need to know before taking IlviGrip Noche
3. How to take IlviGrip Noche
4. Possible side effects

5 Conservation of IlviGrip Noche

1. Contents of the package and additional information

1. What is IlviGrip Noche and what is it used for

IlviGrip Noche is an association of paracetamol, dextromethorphan hydrobromide, and doxylamine succinate.

It is indicated in adults and adolescents from 12 years of age for the symptomatic relief of the common cold and flu that present with pain or fever, nasal congestion, and unproductive cough (irritative cough, nervous cough). It is especially indicated for nighttime treatment.

You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before taking IlviGrip Noche

Do not take IlviGrip Noche

• If you are allergic to paracetamol, dextromethorphan hydrobromide, or doxylamine succinate or to any of the other components of this medicine (listed in section 6).
• If you are allergic to other antihistamines, different from doxylamine succinate.
• If you are pregnant or breastfeeding.
• Children under 12 years of age cannot take this medicine.
• If you have severe kidney or liver failure.
• If you have asthmatic cough (asthmatic patients).
• If you have cough accompanied by abundant secretions.
• If you have a severe lung disease.
• If you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section on use of other medications).

Warnings and precautions

This medicine can cause dependence. Therefore, treatment should be short-term.

Consult your doctor or pharmacist before taking IlviGrip Noche:

• Do not take more than the recommended dose in section 3. How to take.
• Taking more than one medicine that contains paracetamol can cause intoxication.
• You have or have had liver disease (including alcoholic liver disease) or severe kidney disease.
• Chronic alcoholics should take precautions not to take more than 90 ml of the medicine in 24 hours. Alcohol consumption negatively affects liver function and can increase the risk of liver toxicity from products containing paracetamol.
• When being treated with any medication for epilepsy, consult your doctor before taking this medicine, as the efficacy of this medicine may decrease and the liver toxicity of paracetamol may increase when taken together.
• Doxylamine succinate decreases sweating, so this medicine may worsen symptoms of dehydration and heat stroke.
• This medicine can cause drowsiness during the day.
• Avoid taking sedative medications while using this medicine.
• If you are taking other medications such as antidepressants or antipsychotics, IlviGrip Noche may interact with these medications, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
• Do not take IlviGrip Noche if you have taken 4 doses of paracetamol during the day.
• Do not take other medications that contain paracetamol within 6 hours before and after taking IlviGrip Noche.

During treatment with IlviGrip Noche, inform your doctor immediately 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 (an anomaly in the blood and 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 with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea), and vomiting.

Patients with the following conditions should consult a doctor before taking this medicine:

• Asthmatics sensitive to acetylsalicylic acid.
• Kidney, liver, heart, or lung diseases, and patients with anemia.
• Sedated, debilitated, or bedridden patients.
• Persistent or chronic cough, such as that due to smoking. Especially in children, chronic cough could be an early symptom of asthma.
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with a hereditary allergic predisposition).
• Prolongation of the QT interval (a heart problem).
• Low potassium levels in the blood or other electrolyte disorders in the blood.
• High blood pressure.
• Chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (a disease that affects the lungs, making breathing difficult).
• Glaucoma (elevation of eye pressure).
• Urinary retention.
• Prostatic hypertrophy (abnormal increase in the size of the prostate).
• Peptic ulcer (erosion of the stomach or duodenal wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), and obstruction of the bladder neck (disease of the urinary tract).
• Glucose-6-phosphate dehydrogenase deficiency.

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 (see section 2).

People over 65 years of age should consult their doctor before taking this medicine due to their greater sensitivity to the appearance of side effects.

There have been cases of abuse with medications containing dextromethorphan by adolescents, so this possibility should be taken into account, as serious side effects can occur (see section: If you take more IlviGrip Noche than you should).

Serotonin syndrome:

Serotoninergic effects have been reported, including the development of a potentially life-threatening serotonin syndrome for dextromethorphan with concomitant administration of serotoninergic agents, such as selective serotonin reuptake inhibitors (SSRIs), medications that impair serotonin metabolism (including monoamine oxidase inhibitors (MAOIs) and CYP2D6 inhibitors).

The serotonin syndrome can include changes in mental status, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with IlviGrip Noche should be discontinued.

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 medicine, as it may alter the results.

Doxylamine succinate may interfere with skin allergy tests that use allergens. It is recommended to discontinue treatment with IlviGrip Noche at least 3 days before starting such tests.

Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Children and adolescents

This medicine is contraindicated in children under 12 years of age.

Taking IlviGrip Noche with other medications

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

Before starting to take this medicine, consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.).
• Medications for the treatment of high blood pressure (antihypertensives) with an effect on the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• Medications for the treatment of depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Other anticholinergic medications, such as medications for the treatment of depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroleptics (medications for the treatment of mental disorders), atropine-like medications for the treatment of spasms, or disopyramide (for the treatment of certain heart problems).
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to help you relax or sleep.
• Medications for the treatment of epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications that increase urine elimination (some diuretics).
• Medications for the treatment of heart arrhythmias: Amiodarone and quinidine.
• Medications to eliminate phlegm and mucus (expectorants and mucolytics).
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications for the treatment of tuberculosis: Isoniazid, rifampicin.
• Medications used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Medications for the treatment of low blood pressure: Epinephrine.
• Medications with an effect on the heart, such as those used for the treatment of certain medications for malaria, certain medications used to reduce lipids (fat) in the blood, or certain neuroleptic agents (medications for the treatment of mental disorders).
• Medications that decrease the elimination of others, such as azole derivatives or macrolides, as they may increase the adverse effects of IlviGrip Noche.
• If you are taking other medications that produce ear toxicity, such as carboplatin or cisplatin (medications for cancer treatment), chloroquine (medication for the treatment or prevention of malaria), or some antibiotics (medications for infection treatment) such as erythromycin or aminoglycosides injected, among others, IlviGrip Noche could mask the toxic effects of these medications, so you should periodically review the condition of your ears.

Do not take this medicine during treatment or in the 2 weeks following treatment with the following medications, as serious side effects can occur, characterized by excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine).
• Antidepressant serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

Taking IlviGrip Noche with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day) can cause liver damage.

Alcoholic beverages should not be consumed during treatment, as they can increase the adverse effects and cause drowsiness during the day.

Do not take this medicine with grapefruit or bitter orange juice, as they can increase the adverse effects of this medicine.

Taking this medicine with food, except for the aforementioned, does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

The influence on the ability to drive and use machines is moderate. This medicine can cause drowsiness, sedation, or blurred vision, so if you experience these symptoms, you should not drive or operate machines.

IlviGrip Noche contains sucrose

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

Patients with diabetes mellitus should note that this medicine contains 8.250 g of glucose per 30 ml of syrup.

IlviGrip Noche contains propylene glycol

This medicine contains 3000 mg of propylene glycol per adult dose of 30 ml of syrup. It can produce symptoms similar to those of alcohol and may decrease the ability to drive or operate machinery. If you have liver or kidney disease, do not take this medicine unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medicine.

IlviGrip Noche contains sodium benzoate

This medicine contains 30 mg of sodium benzoate per adult dose of 30 ml of syrup.

IlviGrip Noche contains sodium

This medicine contains 75.2 mg of sodium. Patients on low-sodium diets should note that this medicine contains 75.2 mg of sodium (3.268 mmol) per 30 ml of syrup, equivalent to 3.8% of the maximum daily recommended intake by the WHO of 2 g of sodium for an adult.

3. How to take IlviGrip Noche

Follow the administration instructions of the medicine contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. Do not take this medicine if you have already taken 4 doses of medicines containing paracetamol during the day.

The recommended dose is:

Adults and adolescents from 12 years of age:

Take 30 ml of syrup, administered with the dosing cup, once a day, before bedtime.

This medicine is taken orally.

Shake well before use.

Do not exceed the recommended dose.

If symptoms worsen or persist after 3 days of treatment, consult your doctor or pharmacist.

Exceeding the recommended dose can cause liver damage, especially with the concomitant use of other medicines containing paracetamol. Do not take IlviGrip Noche if you have already taken 4 doses of other medicines containing paracetamol during the day. In case of doubt, consult your doctor or pharmacist. This medicine is not designed for long-term use. If your symptoms worsen or do not improve after 3 days, or if you have a high fever, consult your doctor or pharmacist.

Use in children and adolescents

This medicine is contraindicated in children under 12 years of age.

If you take more IlviGrip Noche than you should

It contains paracetamol. You should consult your doctor or pharmacist immediately. Taking too much paracetamol can cause serious liver damage.

If you take more IlviGrip Noche than indicated, you may experience the following symptoms: dizziness, nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, involuntary eye movements, cardiac disorders (acceleration, increase or alteration of heart rate), hyperthermia, coordination disorders, psychosis with visual hallucinations and hyperexcitability, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, excitability, restlessness, nervousness and irritability, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decrease in intestinal tone), redness, increase or decrease in blood pressure, alteration of gait, dizziness, irritability, sedation, and hallucinations. Delirium, decreased respiration, loss of consciousness, and death may occur. A serious complication can be rhabdomyolysis (muscle damage), followed by kidney failure. More severe symptoms may appear after a massive overdose.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

There have been cases of abuse with medicines like IlviGrip Noche that contain dextromethorphan, which can cause serious adverse effects such as: anxiety, panic, memory loss, tachycardia(acceleration of heartbeats), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal disorders, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

If you have ingested an overdose and experience any of the above symptoms, you should go immediately to a medical center, even if you do not notice the symptoms, since they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours after ingestion of the medicine.

Patients being treated with barbiturates 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 (phone: 91 562 04 20), indicating the medicine and the amount ingested.

Pediatric population

Severe adverse effects can occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• allergic reactions, e.g., skin rash, itching, swelling of lips, tongue, or throat, or difficulty breathing, anaphylactic reaction, and anaphylactic shock.
• an increase in the number of nosebleeds or notice that you bruise or bleed more easily.

Possible side effects of IlviGrip Noche may be:

• Frequent adverse effects that may affect up to 1 in 10 people: drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, vertigo, dizziness, headache, pain in the upper abdominal area, fatigue, insomnia, or nervousness.
• Uncommon adverse effects that may affect up to 1 in 100 people: asthenia (fatigue), peripheral edema (inflammation of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to posture changes), diplopia (double vision), dyspepsia (stomach disorders), feeling of relaxation, nightmares, or dyspnea (breathing difficulties).
• Rare adverse effects that may affect up to 1 in 1,000 people: malaise, hypotension (low blood pressure), liver damage, increased levels of transaminases in blood, agitation (especially in children and the elderly), tremors, convulsions, and blood disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (decrease in certain blood cells making infections more likely).
• Very rare adverse effects that may affect up to 1 in 10,000 people: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), or hypoglycemia (low blood sugar), severe skin reactions. If a skin reaction occurs, stop using it and seek medical help immediately.
• Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).
• Other possible side effects with unknown frequency: Poor coordination, hyperactivity.

During the use of IlviGrip Noche, the following adverse effects have been observed, whose frequency cannot be established with precision:

• In rare cases: mental confusion.

People over 65 years of age have a higher risk of suffering from adverse reactions, as they may have other diseases or may be taking other medicines simultaneously. These people also have a higher risk of suffering a fall.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of IlviGrip Noche

Keep in the perfectly closed case to protect it from light.

.

Discard 1 year after opening the bottle for the first time.

Keep this medicine out of sight and reach of children.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that are no longer needed in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package contents and additional information

Composition of IlviGrip Noche

• The active ingredients per 30 ml of syrup are: 600 milligrams of paracetamol, 15 milligrams of dextromethorphan hydrobromide, and 7.5 milligrams of doxylamine succinate.

• The other components (excipients) are: propylene glycol (E-1520), sodium citrate, citric acid monohydrate, macrogol 300, sucrose, glycerol (E-422), potassium sorbate (E-202), sodium benzoate (E-211), anise flavor, quinoline yellow (E-104), brilliant blue FCF (E-133), purified water.

Appearance of the product and package contents

IlviGrip Noche Syrup is presented as a clear green, slightly viscous liquid, with an anise flavor and aroma.

It is presented in a glass bottle with a child-resistant cap.

The medicine is presented in bottles of 90 ml, 120 ml, and 180 ml with a polypropylene dosing cup with a 30 ml graduation.

Marketing authorization holder

LABORATORIOS VICKS S.L.

Avda. de Bruselas, 24

28108 - Alcobendas (Madrid)

Spain

Local representative

PROCTER & GAMBLE ESPAÑA S.A.

Avda. de Bruselas, 24

28108 - Alcobendas (Madrid)

Spain

Manufacturer

PROCTER & GAMBLE MANUFACTURING GMBH

Procter & Gamble Strasse, 1 Gross Gerau

D64521

Germany

Date of the last revision of this prospectus: 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/).