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Ilvigrip Night Syrup 180 ml

Ilvigrip Night Syrup 180 ml

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Ilvigrip Noche Jarabe is an effective treatment designed to relieve cold and flu symptoms at night. Perfect to include in your first aid kit during cold seasons.

Precio: €11.67

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Description

Ilvigrip Night Syrup 180 ml

Paracetamol/Dextromethorphan/Doxylamine

Read the entire package insert carefully before starting to take this medicine, because it contains important information for you

Follow the instructions for use of the medicine exactly, either those contained in this package insert or those indicated by your doctor or pharmacist.

- Keep this leaflet, as you may need to read it again.

- Ask your pharmacist if you need advice or more information.

- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you experience worsening or no improvement after 3 days.

Contents of the package leaflet:

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

2. What you need to know before you start taking IlviGrip Night

3. How to take IlviGrip Night

4. Possible side effects

5. Storing IlviGrip Night

6. Contents of the pack and other information

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

IlviGrip Noche is a combination 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 with pain or fever, nasal congestion and non-productive cough (irritating cough, nervous cough). Especially suitable for night-time treatment.

Consult a doctor if symptoms worsen or if there is no improvement after 3 days of treatment.

2. What you need to know before you start taking IlviGrip Night

Do not take IlviGrip Night

- If you are allergic to paracetamol, dextromethorphan hydrobromide or doxylamine succinate or any of the other ingredients of this medicine (listed in section 6).

- If you are allergic to antihistamines other than doxylamine succinate.

- If you are pregnant or breastfeeding.

- Children under 12 years of age should not take this medicine.

- If you have severe kidney or liver failure.

- If you have asthmatic cough (asthmatic patients).

- If you have a cough accompanied by profuse secretions.

- If you have a serious lung disease.

- If you are being treated or have been treated in the previous 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease or other illnesses, 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 drug. (See section on use of other medications).

Warnings and precautions

This medication can cause dependence. Therefore, treatment should be of short duration.

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

- Do not take more of the medicine than the amount recommended in section 3. How to take it.

- The simultaneous use of more than one medicine containing paracetamol can cause poisoning.

- 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 medicine in 24 hours. Alcohol consumption negatively affects liver function and can increase the risk of liver toxicity from paracetamol-containing products.

- When you are being treated with any medication for epilepsy, you should consult your doctor before taking this medication, because when taken at the same time, it decreases the effectiveness of this medication and increases the liver toxicity of paracetamol.

- Doxylamine succinate reduces sweating, so this medicine can aggravate the symptoms of dehydration and heat stroke.

- This medicine can cause drowsiness during the day.

- If you are taking other medications such as antidepressants or antipsychotics, IlviGrip Night 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 38ºC, 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 Night if you have taken 4 doses of paracetamol during the day.

- Do not take other medicines containing paracetamol within 6 hours before and after taking IlviGrip Night.

- Other medicines and paracetamol: Tell your doctor or pharmacist if you are taking: flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbance (metabolic acidosis with high anion gap) that must be treated urgently and that can occur particularly in case of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used. organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used.

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

- Asthmatics sensitive to acetylsalicylic acid.

- Patients with kidney, liver, heart or lung disease and patients with anemia.

- Sedated, debilitated or bedridden patients.

- Persistent or chronic cough, such as that caused by tobacco. Especially in children, chronic cough could be an early symptom of asthma.

- Atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, scabbing and scaling, which begins in childhood in individuals with a hereditary allergic predisposition).

- Prolongation of the QT interval (a heart problem).

- Low blood potassium levels or other electrolyte disturbances in the blood.

- High blood pressure.

- Chronic bronchitis (persistent inflammation of the bronchial tubes) and pulmonary emphysema (a disease that affects the lungs making it difficult to breathe).

- Glaucoma (raised pressure in the eyes).

- Urinary retention.

- Prostatic hypertrophy (abnormal increase in the size of the prostate).

- Peptic ulcer (erosion of the stomach wall or beginning of the intestine), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine) and bladder neck obstruction (urinary tract disease).

People over 65 years of age should consult their doctor before taking this medicine because of their increased sensitivity to the appearance of adverse effects.

There have been cases of abuse of medications containing dextromethorphan by teenagers, so this possibility should be taken into account, as it can lead to serious adverse effects (see section: If you take more IlviGrip Night than you should).

Serotonin syndrome:

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

Serotonin syndrome can include changes in mental state, instability of autonomy, 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 going to have any kind of test (including blood tests, urine tests, etc.), tell your doctor that you are taking this medicine, as it may alter the results.

Doxylamine succinate may interfere with skin allergy tests using allergens. It is recommended that you stop taking IlviGrip Night at least 3 days before starting such tests.

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

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 that you are taking, have recently taken or might have 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 medication, you should consult your doctor if you are using any of the following medications because it may be necessary to modify the dose of any of them or interrupt the treatment:

- Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.).

- Drugs for the treatment of high blood pressure (antihypertensives) with an effect on the central nervous system such as guanabenz, clonidine or alpha-methyldopa.

- Medicines to treat depression and convulsions: Barbiturates (used as hypnotics, sedatives and anticonvulsants).

- Other anticholinergic drugs such as medicines for the treatment of depression or Parkinson's disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for the treatment of mental disorders), atropine medicines for the

treatment of spasms, or disopyramide (for the treatment of certain heart problems).

- Anti-inflammatories (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 to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Medicines that increase urine output (some diuretics).

- Medicines to treat cardiac arrhythmia: Amiodarone and quinidine.

- Medicines to eliminate phlegm and mucus (expectorants and mucolytics).

- Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

- Medicines used to increase urine output (loop diuretics such as those in the furosemide group).

- Medicines to treat tuberculosis: Isoniazid, rifampicin.

- Medicines used to treat high blood pressure (hypertension) and heart rhythm disturbances (cardiac arrhythmias): Propranolol.

- Medicines to treat low blood pressure: Epinephrine.

- Medicines with an effect on the heart such as those used to treat certain malaria drugs, certain medicines used to reduce lipids (fat) in the blood or certain neuroleptic agents (medicines for the treatment of mental disorders).

- Medicines that decrease the elimination of others such as azole or macrolide derivatives as they could increase the adverse effects of IlviGrip Night.

- If you are taking other medicines that produce toxicity in the ear, such as carboplatin or cisplatin (medicines to treat cancer), chloroquine (medicine for the treatment or prevention of malaria) and some antibiotics (medicines to treat infections) such as erythromycin or injected aminoglycosides, among others, Ilvi Noche could mask the toxic effects of these medicines , so you should check the condition of your ears periodically.

Do not take this medicine during treatment, or for 2 weeks after treatment with the following medicines, as serious adverse effects may occur, characterized by excitement, high blood pressure and fever higher than 40 ºC (hyperpyrexia):

- Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine).

- Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine).

- Bupropion (used to help people quit smoking).

- Linezolid (used as an antibacterial).

- Procarbazine (used to treat cancer).

- Selegiline (used to treat Parkinson's disease).

Take IlviGrip Night with food, drink and alcohol.

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages, beer, wine, spirits, etc. per day) can cause liver damage.

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

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

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

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine has a moderate influence on the ability to drive and use machines. This medicine may cause drowsiness or sedation, so you should not drive or operate machinery if you experience these symptoms.

IlviGrip Night contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor 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 can produce alcohol-like symptoms, which can impair your ability to drive or operate machinery. If you suffer from liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional checks 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 a low sodium diet should take this into account. 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 the instructions for use exactly, either those contained in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. Do not take this medicine if you have already taken 4 doses of paracetamol-based medicines during the day.

The recommended dose is:

Adults and adolescents from 12 years of age:

Take 30 ml of syrup, administered with the measuring cup, once a day, before going to bed.

This medicine is taken orally.

Shake well before use.

The recommended dose should not be exceeded.

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

Use in children and adolescents

This medicine is not recommended for children under 12 years of age.

If you take more IlviGrip Night than you should

You should immediately consult your doctor or pharmacist.

If you take more IlviGrip Night than indicated, you may experience the following symptoms: dizziness, nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, impaired consciousness, involuntary and rapid eye movements, cardiac disorders (acceleration, increase or alterations in heart rate), coordination disorders, psychosis with visual hallucinations and hyp erexcitability, 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), flushing, increased or decreased blood pressure, altered gait, dizziness dizziness, irritability, sedation, and hallucinations. Delirium, decreased breathing, loss of consciousness, and death may occur. A serious complication can be rhabdomyolysis (a muscle injury), followed by kidney failure.

Other symptoms in the event of a massive overdose can include coma, serious respiratory problems and convulsions.

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

There have been cases of abuse with medications such as IlviGrip Night that contain dextromethorphan, and serious adverse effects may appear such as: anxiety, panic, memory loss, tachycardia (acceleration of the heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the eye pupil), agitation, vertigo, gastrointestinal discomfort, , stuttering speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat) and death.

If you have taken an overdose, you should go immediately to a medical center even if you do not notice the symptoms, as they often do not manifest until 3 days after taking the overdose, even in cases of severe intoxication.

Overdose treatment is more effective if started within 4 hours of taking the medication.

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 may occur in children in the event of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

4. Possible adverse effects

As with all medicines, this medicine can cause adverse effects, although not everybody gets them.

The possible adverse effects of IlviGrip Nighttime are:

- Common side 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, upper abdominal pain, fatigue, insomnia or nervousness.

- Uncommon side effects that may affect up to 1 in 100 people: asthenia (tiredness), peripheral edema (swelling of the arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (drop in blood pressure due to changes in posture), diplopia ( double vision), dyspepsia (stomach problems), feeling of relaxation, nightmares or dyspnoea (breathing difficulties).

Rare adverse effects that may affect up to 1 in 1,000 people: malaise, hypotension (low blood pressure), increased blood transaminase levels, agitation (especially in children and the elderly), tremor, convulsions and blood problems such as hemolytic anemia, thrombocytopenia, leukopenia or agranulocytosis (decrease in certain blood cells).

Very rare adverse effects that can affect up to 1 in 10,000 people: kidney disease, cloudy urine, allergic dermatitis (rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia) or hypoglycemia (low blood sugar ), severe skin reactions.

During the period of use of IlviGrip Night, the following adverse effects have been observed, the frequency of which cannot be accurately established:

- More rarely: mental confusion.

People over 65 are at greater risk of adverse reactions, as they may have other illnesses or may be taking other medications at the same time. These people are also at greater risk of falling.

Reporting of adverse effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of IlviGrip Noche

Keep in the box, perfectly closed to protect 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 which is stated on the bottle after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What IlviGrip Noche contains

- 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 ingredients (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 flavoring, quinoline yellow (E -104), brilliant blue FCF (E-133), purified water.

Appearance of the product and contents of the container.

IlviGrip Noche Syrup comes as a clear green liquid, slightly viscous, with an aniseed aroma and flavor.

It comes in a glass bottle with a child-resistant cap.

The medicine comes in 90 ml, 120 ml and 180 ml bottles with a 30 ml polypropylene measuring cup.

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