Ilvigríp Noche syrup

Patient Information Leaflet

Introduction

Patient Information Leaflet

IlviGrip Night Syrup

paracetamol/dextromethorphan/doxylamine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for use provided 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 further information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Leaflet contents:

1. What IlviGrip Night is and what it is used for
2. What you need to know before taking IlviGrip Night
3. How to take IlviGrip Night
4. Possible side effects
5. Storage of IlviGrip Night
6. Contents of the pack and other information

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

IlviGrip Night is a combination of paracetamol, dextromethorphan hydrobromide, and doxylamine succinate.

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

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

2. What you need to know before taking IlviGrip Night

Do not take IlviGrip Night

• If you are allergic to paracetamol, dextromethorphan hydrobromide, or doxylamine succinate, or to any of the other ingredients 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 must not take this medicine.
• If you have severe kidney or liver impairment.
• If you have asthmatic cough (patients with asthma).
• If you have a productive cough with abundant secretions.
• If you have a severe lung disease.
• If you are currently being treated or have been treated within the previous 2 weeks with monoamine oxidase inhibitors (MAOIs) used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used to treat depression such as fluoxetine and paroxetine; or with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section on use with other medicines).

Warnings and precautions

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

Consult your doctor, pharmacist, or nurse before taking IlviGrip Night:

• Do not take more than the recommended dose indicated in section 3, "How to take".
• Simultaneous use of more than one medicine containing paracetamol may lead to poisoning.
• If you have or have had liver disease (including alcoholic liver disease) or severe kidney disease.
• Chronic alcoholics should take care not to exceed 90 ml of the medicine in 24 hours. Alcohol consumption negatively affects liver function and may increase the risk of hepatotoxicity from paracetamol-containing products.
• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as taking them together may reduce the effectiveness of this medicine and increase the hepatotoxicity risk of paracetamol.
• Doxylamine succinate reduces sweating; therefore, this medicine may worsen symptoms of dehydration and heat stroke.
• This medicine may cause daytime drowsiness.
• Avoid taking sedative medicines while using this medicine.
• If you are taking other medicines such as antidepressants or antipsychotics, IlviGrip Night may interact with them, possibly causing 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
• Do not take IlviGrip Night if you have already taken 4 doses of paracetamol during the day.
• Do not take other medicines containing paracetamol within 6 hours before or after taking IlviGrip Night.

During treatment with IlviGrip Night, 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 with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (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, weakened, or bedridden patients.
• Persistent or chronic cough, such as that due to smoking. Particularly in children, chronic cough may be an early symptom of asthma.
• Atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in childhood in individuals with hereditary allergic predisposition).
• Prolonged QT interval (a heart condition).
• Low blood potassium levels or other blood electrolyte imbalances.
• High blood pressure.
• Chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (a lung disease that impairs breathing).
• Glaucoma (increased eye pressure).
• Urinary retention.
• Prostatic hypertrophy (abnormal enlargement of the prostate).
• Peptic ulcer (erosion of the stomach or duodenal wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), or vesical neck obstruction (a urinary tract disorder).
• Glucose-6-phosphate dehydrogenase deficiency.

Other medicines and paracetamol

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

People aged 65 years and older should consult their doctor before taking this medicine due to increased sensitivity to adverse effects.

Cases of abuse of medicines containing dextromethorphan have been reported among adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section: If you take more IlviGrip Night than you should).

Serotonin syndrome:

Serotonergic effects, including the development of potentially life-threatening serotonin syndrome, have been reported with dextromethorphan when administered concomitantly with serotonergic agents such as selective serotonin reuptake inhibitors (SSRIs), drugs that impair serotonin metabolism (including monoamine oxidase inhibitors (MAOIs) and CYP2D6 inhibitors).

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

Interference with laboratory tests

If you are due to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Doxylamine succinate may interfere with skin allergy tests using allergens. It is recommended to discontinue treatment with IlviGrip Night at least 3 days before such tests.

Paracetamol may alter laboratory test values for uric acid and glucose.

Children and adolescents

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

Taking IlviGrip Night with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as many other medicines may affect liver function and increase the risk of hepatotoxicity.

Before starting this medicine, consult your doctor if you are using any of the following medicines, as dose adjustments or discontinuation of treatment may be necessary:

• Central nervous system depressants (some used to treat: mental disorders, allergies, Parkinson's disease, etc.).
• Medicines for high blood pressure (antihypertensives) with central nervous system effects such as guanabenz, clonidine, or alpha-methyldopa.
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Other anticholinergic drugs such as medicines for depression or Parkinson's disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for mental disorders), atropine-like medicines for treating spasms, or disopyramide (for treating certain heart problems).
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to help you relax or sleep.
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines that increase urine output (some diuretics).
• Medicines for heart arrhythmias: Amiodarone and quinidine.
• Medicines to eliminate phlegm and mucus (expectorants and mucolytics).
• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines for tuberculosis: Isoniazid, rifampicin.
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Medicines for low blood pressure: Epinephrine.
• Medicines acting on the heart, such as those used to treat certain conditions, certain antimalarial drugs, certain medicines used to reduce blood lipids (fats), or certain neuroleptics (medicines for mental disorders).
• Medicines that reduce the elimination of others, such as azole derivatives or macrolides, as they may increase adverse effects of IlviGrip Night.
• If you are taking other medicines that cause ototoxicity, such as carboplatin or cisplatin (cancer medicines), chloroquine (a medicine for treating or preventing malaria), or certain antibiotics (medicines for treating infections) such as erythromycin or injectable aminoglycosides, among others, IlviGrip Night could mask the toxic effects of these medicines, so you should have regular hearing checks.

Do not take this medicine during treatment, or within 2 weeks after treatment with the following medicines, as it may cause serious adverse effects 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 stop smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

Taking IlviGrip Night with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks—beer, wine, liquor—per day) may cause liver damage.

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

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

Taking this medicine with food, except for those mentioned above, 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 effect on the ability to drive and use machines is moderate. This medicine may cause drowsiness, sedation, or blurred vision; therefore, if you experience these symptoms, you should not drive or operate machinery.

IlviGrip Night contains sucrose

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

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

IlviGrip Night contains propylene glycol

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

IlviGrip Night contains sodium benzoate

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

IlviGrip Night contains sodium

This medicine contains 75.2 mg of sodium. Patients on low-sodium diets should be aware 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 intake recommended by the WHO of 2 g of sodium for an adult.

3. How to take IlviGrip Night

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Do not take this medicine if you have already taken 4 doses of paracetamol-containing medicines during the day.

Recommended dose:

Adults and adolescents aged 12 years and older:

Take 30 ml of syrup, administered using the dosing cup, once daily, before going to bed.

This medicine is taken orally.

Shake well before use.

Do not exceed the recommended dose.

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

Exceeding the recommended dose may cause liver damage, especially when used concomitantly with other medicines containing paracetamol. Do not take IlviGrip Night if you have already taken 4 doses of other paracetamol-containing medicines during the day. If in doubt, consult your doctor or pharmacist. This medicine is not intended for long-term use. If your symptoms worsen or do not improve after 3 days, or if you develop 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 Night than you should

This product contains paracetamol. You must consult your doctor or pharmacist immediately. Taking too much paracetamol may cause severe liver damage.

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

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

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

Cases of abuse have been reported with medicines such as IlviGrip Night containing dextromethorphan, which may lead to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), midriasis (dilation of the eye pupil), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), 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 no symptoms are present, as symptoms often do not appear until up to 3 days after the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if initiated within 4 hours of taking the medicine.

Patients undergoing treatment 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 (telephone: 91 562 04 20), indicating the medicine and the amount ingested.

Paediatric population

Serious adverse effects, including neurological disturbances, may occur in children in case of overdose. Caregivers must not exceed the recommended dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 you notice you are bruising or bleeding more easily.

Possible adverse effects of IlviGrip Night may include:

• Frequent adverse effects (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, upper abdominal pain, fatigue, insomnia or nervousness.
• Uncommon adverse effects (may affect up to 1 in 100 people): asthenia (weakness), peripheral edema (swelling of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (drop in blood pressure due to change in posture), diplopia (double vision), dyspepsia (stomach discomfort), feeling of relaxation, nightmares or dyspnea (breathing difficulties).
• Rare adverse effects (may affect up to 1 in 1,000 people): malaise, hypotension (low blood pressure), liver damage, increased blood transaminase levels, agitation (especially in children and elderly), tremor, seizures and blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia or agranulocytosis (reduction in certain blood cells making infections more likely).
• Very rare adverse effects (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood abnormalities (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) or hypoglycemia (low blood sugar), serious skin reactions. If a skin reaction occurs, stop using the medicine and seek medical help immediately.
• Frequency not known (cannot be estimated from available data): A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).
• Other possible side effects with unknown frequency: Poor coordination, hyperactivity.

During the period of use of IlviGrip Night, the following adverse effects have been observed, for which the frequency could not be accurately determined:

• In rarer cases: mental confusion.

People over 65 years of age have a higher risk of experiencing adverse reactions, as they may have other medical conditions or may be taking other medicines simultaneously. These individuals also have an increased risk of falling.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of IlviGrip Night

Keep in the tightly closed container to protect it from light.

Discard one year after first opening the bottle.

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

Do not use this medicine after the expiry date indicated on the bottle after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of IlviGrip Night

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

Nature of the product and contents of the container

IlviGrip Night Syrup is presented as a clear green, slightly viscous liquid with an aniseed odour and taste.

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

The medicine is available in 90 ml, 120 ml and 180 ml bottles, accompanied by a polypropylene dosing cup graduated in 30 ml increments.

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 most recent revision of this leaflet: January 2025

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