NORMOGRIP ANTITUSSIVE JUNIOR ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Normogrip AntitussiveJunior Granules for Oral Solution

Paracetamol/Chlorphenamine Maleate/Dextromethorphan Hydrobromide

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package 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 Normogrip Antitussive Junior is and what it is used for
2. What you need to know before taking Normogrip Antitussive Junior
3. How to take Normogrip Antitussive Junior
4. Possible side effects
5. Storage of Normogrip Antitussive Junior
6. Package Contents and Additional Information

1. What Normogrip Antitussive Junior is and what it is used for

Normogrip Antitussive Junior is an association of paracetamol that reduces fever and relieves pain, dextromethorphan that is an antitussive, and chlorphenamine that helps reduce nasal secretion.

This medicine is indicated for the symptomatic relief of colds and flu that present with mild or moderate pain such as headache, fever, unproductive cough (irritative cough, nervous cough), and nasal secretion for children over 6 years and adolescents.

You should consult your doctor if your symptoms worsen or persist after 3 days of treatment.

2. What you need to know before taking Normogrip Antitussive Junior

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

Do not take Normogrip Antitussive Junior

• If you are allergic to paracetamol, chlorphenamine maleate, dextromethorphan hydrobromide, or any of the other components of this medicine (listed in section 6).
• If you have severe liver or kidney disease.
• If you are being treated with a class of medicines called monoamine oxidase inhibitors (MAOIs) or after 2 weeks of finishing treatment with these medicines.
• If you have respiratory failure, asthmatic cough, and cough accompanied by expectoration.
• If you are being treated with other medicines, such as those for depression or Parkinson's disease, with linezolid, which is an antibiotic, or with procarbazine, which is a medicine for cancer (see the section "Other Medicines and Normogrip Antitussive Junior").
• Children under 6 years of age cannot take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Normogrip Antitussive Junior.

• Do not take more than the recommended dose in section 3. "How to take Normogrip Antitussive Junior".

Taking more than the recommended dose (overdose) can result in liver damage. In case of overdose, seek medical help immediately. Prompt medical attention is critical for adults, as well as for children, even if you do not perceive any signs or symptoms.

• Chronic alcoholics should ask their doctor if they can take paracetamol, other analgesics, or fever-reducing medicines. Additionally, they should be cautious not to take more than 6 sachets per day (2g of paracetamol).
• While taking this medicine, you cannot take other medicines that contain paracetamol because a paracetamol overdose could occur, which could damage the liver.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia).

You should consult your doctor or pharmacist before starting to take Normogrip Antitussive Junior:

• Patient with kidney, heart, or lung disease and patients with anemia.
• Patient with liver disease (with or without liver failure) or viral hepatitis, as it increases the risk of hepatotoxicity.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to others (such as chlorphenamine).
• Patient with hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, obstruction of the neck of the bladder, prostate hyperplasia with residual urine formation. Elderly patients who may be more sensitive to the side effects of this medicine.
• Patient with atopic dermatitis.
• Patient slow metabolizers of CYP2D6 or using CYP2D6 inhibitors.
• Patient with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough accompanied by excessive secretions, glaucoma, or difficulty urinating due to prostate hyperplasia.

• If you are taking other medicines such as antidepressants or antipsychotics, this medicine may interact with these medicines, 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, arterial hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

During treatment with Normogrip Antitussive Junior, inform your doctor immediately if:

If you have severe diseases, such as severe renal 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 serious disease called metabolic acidosis (an anomaly in 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 unwell (nausea), and vomiting.

This medicine may increase the sedative effects of central nervous system depressants, including alcohol, sedatives, and tranquilizers. Therefore, it is recommended to avoid drinking alcohol or taking CNS depressants (barbiturates, tranquilizers, MAOIs) while taking this medicine.

This medicine may cause drowsiness. Avoid consuming alcoholic beverages and certain medicines while being treated with this medicine, as they may potentiate this effect. Consult the sections "Other Medicines and Normogrip Antitussive Junior" and "Taking Normogrip Antitussive Junior with Food, Beverages, and Alcohol".

Sedated, debilitated, or bedridden patients should not take this medicine.

Very rarely, cases of severe skin reactions called acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported, associated with the use of paracetamol. At the first symptom of skin rash or hypersensitivity, discontinue treatment and consult your doctor.

Other Medicines and Normogrip Antitussive Junior

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicines for treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines for treating tuberculosis (isoniazid, rifampicin).
• Medicines to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for treating hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid).
• Medicines used in the treatment of high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines to lower cholesterol levels in the blood (cholestyramine).
• Medicines used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidone). This medicine should be administered at least 14 days after finishing treatment.
• Other medicines for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for schizophrenia (such as haloperidol).
• Medicines that produce depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which have the adverse effect of producing allergy to light).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Metoprolol, used for the treatment of cardiovascular system diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used in the treatment of invasive aspergillosis and invasive mucormycosis.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that must be treated urgently (see section 2).

Interference with analytical tests:

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Taking Normogrip Antitussive Junior with Food, Beverages, and Alcohol

While taking this medicine, you cannot drink alcoholic beverages, as it may potentiate the appearance of adverse effects of this medicine.

Additionally, the use of medicines containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) may cause liver damage.

Do not take the medicine with grapefruit or bitter orange juice, as it may potentiate the effects of one of its components (dextromethorphan).

Pregnancy and Breastfeeding

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.

Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

This medicine should not be taken during pregnancy unless your doctor considers it strictly necessary.

The 3 active principles of this medicine are excreted in breast milk, so breastfeeding women should not take this medicine.

Driving and Using Machines

This medicine may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Normogrip Antitussive Junior contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., it is essentially "sodium-free".

Normogrip Antitussive Junior contains Sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It contains 4.1 g of sucrose per sachet, which should be taken into account in patients with diabetes mellitus.

Normogrip Antitussive Junior contains Orange Yellow S (E-110)

It may cause allergic reactions.

Normogrip Antitussive Junior contains Benzyl Alcohol

This medicine contains 0.022 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).

Normogrip Antitussive Junior contains Sulphur Dioxide (E-220)

It may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Normogrip Antitussive Junior

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The granules contained in the sachets of Normogrip Antitussive Junior are for oral administration.

The recommended dose is:

Children from 6 to 12 years (weight between 21.5 kg and 43 kg): 1 sachet every 6 or 8 hours (3 or 4 times a day) as needed.

Over 12 years (weight over 44 kg): 2 sachets every 6 or 8 hours (3 or 4 times a day) as needed.

Preferably take 1 dose before bedtime. Do not exceed 4 doses per day.

This medicine is contraindicated in children under 6 years of age.

Always use the smallest effective dose.

Start treatment when the first symptoms appear and suspend as they disappear.

The medication should not be used for more than 3 consecutive days without consulting a doctor. (See section 1. "What Normogrip Antitussive Junior is and what it is used for").

How to take:

This medicine is taken orally.

Pour the contents of a sachet into a half glass of water and stir until dissolved.

If you take more Normogrip Antitussive Junior than you should

Severe side effects can occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose. Go immediately to a medical center, even if there are no symptoms, as they often do not manifest until 3 days after ingestion, even in cases of severe poisoning. The most severe effect of an overdose of this medicine is liver damage caused by paracetamol. You may feel dizziness, vomiting, confusion, excitability, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, states of stupor or changes in gait. Overdose can also cause: coagulation disorders (blood clots and bleeding).

If you take more Normogrip Antitussive Junior than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

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 containing dextromethorphan, which can cause severe side effects, such as agitation, confusion, conversion disorders, hallucinations, ataxia (uncoordinated movements), coma, decreased consciousness, dysarthria (difficulty speaking), apathy, dystonia, nystagmus (involuntary and uncontrolled eye movements), convulsions, serotonin syndrome, tremor, depression, and central nervous system excitement, miosis, and mydriasis (contraction and dilation of the eye pupil), respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

The symptoms of an overdose of chlorphenamine can be central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased intestinal sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, convulsions, or arrhythmias. Patients with prolonged agitation, coma, or convulsions may rarely develop rhabdomyolysis and renal failure.

Treatment of overdose is more effective if started within 4 hours of taking 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects were reported in at least 1 in 100 subjects during clinical trials with chlorphenamine: drowsiness, dry mouth, dizziness, restlessness, pharyngitis, and dyspepsia.

During the period of use of the paracetamol, dextromethorphan, and chlorphenamine combination, the following adverse effects have occurred, whose frequency could not be established with precision: anaphylactic reaction, hypersensitivity, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more common in children and the elderly.

In the same way, with unknown frequency (cannot be estimated from the available data): gastrointestinal disorders, such as abdominal pain, diarrhea, nausea, vomiting, and indigestion (dyspepsia), angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin eruption, skin lesions after taking the medicine (fixed drug eruption), as well as increased transaminases. A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Simultaneous consumption of alcohol during treatment may accentuate the appearance of adverse effects. Do not ingest alcoholic beverages during the same period.

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

5. Storage of Normogrip Antitusivo Junior

Keep this medicine out of sight and reach of children.

Store below 30°C.

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

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Normogrip Antitusivo Junior

• The active ingredients are paracetamol, chlorphenamine maleate, and dextromethorphan hydrobromide. Each sachet contains 300 mg of paracetamol, 2 mg of chlorphenamine maleate, and 15 mg of dextromethorphan hydrobromide.
• The other components (excipients) are polysorbate 80, citric acid, sucrose, sodium saccharin, sodium cyclamate, titanium dioxide (E-171), orange yellow S (E-110), lemon flavor, and orange flavor (contains benzyl alcohol and sulfur dioxide (E-220)).

Appearance of the Product and Package Contents

Sachets containing an orange-colored granulate for oral solution with a characteristic flavor and odor of orange aroma.

Each package contains 10 sachets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the Last Revision of this Prospectus:February 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/).