Leaflet: information for the user

IlviGrip Night Syrup

paracetamol/dextromethorphan/doxylamine

Read this leaflet carefully before you start taking thismedicine, because it contains important informationfor you

Follow exactly the administration instructions for the medicine contained 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.

• Ifyou experience any 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 you get worse or do not improveafter 3 days.

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

2.What you need to knowbeforestarting totake IlviGrip Night

3.How to take IlviGrip Night

4.Possible side effects

5Storage of IlviGrip Night

6.Contents of the pack and additional information

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

It is indicated in adults and adolescents aged 12 years and older for symptomatic relief of common cold and flu that are accompanied by pain or fever, nasal congestion, and non-productive cough (irritative cough, nervous cough). It is especially indicated for nighttime treatment.

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

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 medication (listed in section 6).
• If you are allergic to other antihistamines, other than doxylamine succinate.
• If you are pregnant or breastfeeding.
• Children under 12 years old cannot take this medication.
• If you have severe kidney or liver disease.
• If you have asthma (asthmatic patients).
• If you have a cough accompanied by abundant secretions.
• If you have a severe lung disease.
• If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other medications that inhibit serotonin reuptake used for the treatment of 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 medication may cause dependence. Therefore, treatment should be of short duration.

Consult your doctor or pharmacist or nurse before taking IlviGrip Noche:

• Do not take more medication than recommended in section 3. How to take.
• The simultaneous use of more than one medication containing paracetamol may cause intoxication.
• You have or have had liver disease (including alcoholic liver disease) or severe kidney disease.
• Chronic alcoholics should be careful not to take more than 90 ml of the medication in 24 hours. Alcohol consumption negatively affects liver function and may increase the risk of liver toxicity due to paracetamol-containing products.
• When taking any medication for epilepsy, consult your doctor before taking this medication, as when taken together, it may reduce the effectiveness of the medication and increase the toxicity of paracetamol for the liver.
• Doxylamine succinate reduces sweating, so this medication may exacerbate dehydration and heatstroke symptoms.
• This medication may cause drowsiness during the day.
• Avoid taking sedatives while using this medication.
• 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 high body temperature, increased heart rate, high blood pressure, and exaggeration of reflexes, muscle rigidity, 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 containing paracetamol within 6 hours before and after taking IlviGrip Noche.

During treatment with IlviGrip Noche, immediately inform your doctor if:

• You have severe diseases, such as severe kidney disease or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or if you 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 difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

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

• Asthmatics sensitive to acetylsalicylic acid.
• Liver, kidney, heart, or lung diseases, and patients with anemia.
• Debilitated, sedated, or bedridden patients.
• Persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough may be an early sign of asthma.
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• Prolongation of the QT interval (a heart problem).
• Low levels of potassium in the blood or other electrolyte abnormalities in the blood.
• High blood pressure.
• Chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (disease affecting the lungs, making it difficult to breathe).
• Glaucoma (elevated eye pressure).
• Urinary retention.
• Prostatic hypertrophy (abnormal enlargement of the prostate).
• Peptic ulcer (erosion of the stomach wall or beginning of the intestine), pyloric obstruction (difficulty passing food from the stomach to the intestine), and urethral stricture (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 old should consult their doctor before taking this medication due to their increased sensitivity to the appearance of adverse effects.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents, so this possibility should be taken into account, as it may cause severe adverse effects (see section: If you take more IlviGrip Noche than you should).

Serotonin syndrome:

Serotonin syndrome, including potentially fatal syndrome, has been reported with dextromethorphan administration concomitantly with serotoninergic agents, such as selective serotonin reuptake inhibitors (SSRIs), medications that impair serotonin metabolism (including monoamine oxidase inhibitors (MAOIs) and CYP2D6 inhibitors).

Serotonin syndrome may include changes in mental state, instability of autonomic function, 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 to undergo any analytical test (including blood, urine, etc...), inform your doctor that you are taking this medication, 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 these tests.

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

Children and adolescents

This medication is contraindicated in children under 12 years old.

Taking IlviGrip Noche with other medications

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

Before starting to take this medication, 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 discontinue treatment:

• Depressants of the central nervous system (some of which are used to treat: mental illnesses, allergies, Parkinson's disease, etc).
• Medications for the treatment of high blood pressure (anti-hypertensives) with a central nervous system effect, such as guanabenz, clonidine, or alpha-methyldopa.
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Other anticholinergic medications, such as medications for treating depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroleptics (medications for mental disorders), atropinic medications for treating spasms, or disopyramide (for treating certain heart problems).
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications for lowering cholesterol levels in the blood (colestiramine).
• Medications used to treat gout (probencid and sulfinpyrazone).
• Medications used to help you relax or sleep.
• Medications for treating epilepsy: Antiepileptic medications (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications that increase the elimination of urine (some diuretics).
• Medications for treating heart arrhythmias: Amiodarone and quinidine.
• Medications for eliminating mucus and phlegm (expectorants and mucolytics).
• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase the elimination of urine (diuretics of the loop, such as those in the furosemide group).
• Medications for treating tuberculosis: Isoniazid, rifampicin.
• Medications used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.
• Medications for treating low blood pressure: Epinephrine.
• Medications with a heart effect, such as those used to treat certain malaria medications, certain medications used to lower lipids (fat) in the blood, or certain neuroleptic medications (medications for mental disorders).
• Medications that decrease the elimination of other medications, such as azole derivatives or macrolides, which may increase the adverse effects of IlviGrip Noche.
• If you are taking other medications that cause ototoxicity, such as carboplatin or cisplatin (medications for cancer), chloroquine (medication for malaria treatment or prevention), and some antibiotics (medications for infections) such as erythromycin or aminoglycosides, IlviGrip Noche may mask the toxic effects of these medications, so you should regularly check your ear status.

Do not take this medication during treatment, or in the 2 weeks following treatment, with the following medications, as it may cause severe adverse effects, characterized by excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Antidepressants that inhibit monoamine oxidase (MAOIs) (moclobemide, tranilcipromine).
• Antidepressants that inhibit serotonin reuptake (paroxetine, fluoxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial medication).
• 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 regularly consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

Do not consume alcoholic beverages during treatment, as they may increase the adverse effects and drowsiness during the day.

Do not take it with orange or grapefruit juice, as it may increase the adverse effects of this medication.

Taking this medication with food, except for those mentioned above, does not affect its efficacy.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The influence on the ability to drive and operate machinery is moderate. This medication may cause drowsiness or sedation or blurred vision, so if you notice these symptoms, you should not drive or operate machinery.

IlviGrip Noche contains saccharose

This medication contains saccharose. 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 note that this medication contains 8.250 g of glucose per 30 ml of syrup.

IlviGrip Noche contains propylene glycol

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

IlviGrip Noche contains sodium benzoate

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

IlviGrip Noche contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.Do not take this medication if you have already taken 4 doses of medications containing paracetamol during the day.

The recommended dose is:

Adults and adolescents 12 years of age and older:

Take30 ml of syrup, administered with the measuring cup, once a day, before going to bed.

This medication is taken orally.

Shake well before use.

Do not exceed the recommended dose.

Ifit worsens or if symptoms persistafter3 days of treatment, consult your doctor or pharmacist.

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

Use in children and adolescents

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

If you take more IlviGrip Noche than you should

Contains paracetamol. You must consult your doctor or pharmacist immediately. Taking too much paracetamol can cause severe 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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (acceleration, increase or alterations in heart rhythm), hyperthermia, coordination disturbances, 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, decreased intestinal tone), redness, , increased or decreased blood pressure, , gait disturbances, dizziness, irritability, sedation, and hallucinations. Severe complications may include rhabdomyolysis (muscle injury), followed by renal 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.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

There have been cases of abuse with medications such asIlviGrip Nochecontaining dextromethorphan, which may cause severe 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 disturbances, mumbling speech, nystagmus (uncontrolled and involuntary eye movements), 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 must immediately go to a medical center, even if you do not notice the symptoms, as they often do not manifest until 3 days after ingestion, even in cases of severe poisoning.

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

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

Incase of overdose or accidental ingestion, immediately go to a medical center or call the Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.

Pediatric population

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

Like all medicines, this medicine may 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 rashes, itching, swelling of lips, tongue or throat, or difficulty breathing, anaphylactic reaction and anaphylactic shock.

- an increase in the number of nasal bleedings or notice that you get bruises or bleed more easily.

The possible side effects ofIlviGrip Nochemay be:

• Frequent side effectsthat may affect up to1 in 10 people: drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, dizziness, nausea, headache, upper abdominal pain, fatigue, insomnia or nervousness.
• Infrequent side effectsthat may affect up to1 in 100 people: asthenia (fatigue), peripheral edema (inflammation of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (noise in the ears), orthostatic hypotension (decrease in blood pressure due to changes in posture), diplopia (double vision), dyspepsia (stomach disorders), feeling of relaxation, nightmares or dyspnea (respiratory difficulties).
• Rare side effects that may affect up to 1 in 1,000 people: discomfort, hypotension (low blood pressure), liver damage, increase in blood transaminase levels,agitation (especially in children and the elderly), tremors, convulsions and blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia or agranulocytosis (decrease in certain blood cells making infections more likely).
• Very rare side effects that may affect up to 1 in 10,000 people:kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) or hypoglycemia (low blood sugar), severe skin reactions. If a skin reaction occurs, stop using it and seek medical help immediately.
• Unknown frequency(cannot be estimated from available data): A serious disease that may make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).
• Other possible side effects with unknown frequency: Poor coordination, hyperactivity.

During the period of use ofIlviGrip Noche,the following side effects have been observed whose frequency has not been established with precision:

• In rare cases: mental confusion.

People over 65 years old have a higher risk of experiencing adverse reactions, as they may have other diseases or be taking other medications simultaneously. These people also have a higher risk of falling.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

.

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe bottleafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, please ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of IlviGrip Noche

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

• Theother 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 aroma, quinoline yellow (E-104), brilliant blue FCF (E-133), purified water.

Appearance of the product and contents of the packaging

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

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.

Holder of the marketing authorization

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

Responsible for manufacturing

Procter & Gamble Manufacturing GmbH

Procter & Gamble Strasse, 1 Gross Gerau

D-64521

Germany

Last review 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/).