Label: information for the user

Normogrip AntitusivoJunior granulated for oral solution

Paracetamol/Chlorphenamine maleate/Dextromethorphan hydrobromide

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

1. What isNormogrip Antitusivo Juniorand for what it is used

2. What you need to know before starting to takeNormogrip Antitusivo Junior

3. How to takeNormogrip Antitusivo Junior

4. Possible adverse effects

5. Storage ofNormogrip Antitusivo Junior

6. Contents of the package and additional information

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

This medication is indicated for symptomatic relief of colds and flu that are accompanied by mild or moderate pain such as headache, fever, unproductive cough (irritative cough, nervous cough) and nasal secretion in children over 6 years and adolescents.

You should consult your doctor if it worsens or if the symptoms persist after 3 days of treatment.

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

Do not take Normogrip Antitusivo Junior

• If you are allergic to paracetamol, chlorphenamine maleate, dextromethorphan hydrobromide, or any of the other components of this medication (listed in section 6).
• If you have a severe liver or kidney disease.
• If you are being treated with a class of medications called monoamine oxidase inhibitors (MAOIs) or after 2 weeks of having completed treatment with these medications.
• If you have respiratory insufficiency, asthmatic cough, or cough accompanied by expectoration.
• If you are or have been recently treated with other medications, such as antidepressants or Parkinson's disease medications, with linezolid, which is an antibiotic, or with procarbazine, which is a cancer medication (see section "Other medications and Normogrip Antitusivo Junior").
• Children under 6 years old cannot take this medication.

Warnings and precautions

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

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

Taking more than the recommended dose (overdose) may 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 symptoms or signs.

• Chronic alcoholics should ask their doctor if they can take paracetamol, other analgesics, or medications that reduce fever. They should also be careful not to take more than 6 packets a day (2 g of paracetamol).
• While taking this medication, do not take other medications that contain paracetamol, as it may cause a paracetamol overdose that can damage the liver.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

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

• Patients with kidney, heart, or lung diseases, and patients with anemia.
• Patients with liver diseases (with liver insufficiency or without it) or viral hepatitis, as it increases the risk of hepatotoxicity.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to an antihistamine, as they may be sensitive to others (such as chlorphenamine).
• Patients with hypertension (elevated blood pressure), glaucoma (elevated intraocular pressure), hyperthyroidism, urinary obstruction, benign prostatic hyperplasia with residual urine. Elderly patients who may be more sensitive to the side effects of this medication.
• Patients with atopic dermatitis.
• Patients who are slow metabolizers of CYP2D6 or who use CYP2D6 inhibitors.
• Patients with a persistent respiratory condition such as emphysema, chronic bronchitis, asthma, or cough accompanied by excessive secretions, glaucoma, or difficulty urinating due to benign prostatic hyperplasia.

• If you are taking other medications such as antidepressants or antipsychotics, this medication may interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as elevated body temperature, increased heart rate, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

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

You have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have 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 distress with deep and rapid breathing, somnolence, feeling unwell (nausea), and vomiting.

This medication 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 medication.

This medication may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while taking this medication, as they may potentiate this effect. See sections "Other medications and Normogrip Antitusivo Junior" and "Taking Normogrip Antitusivo Junior with food, drinks, and alcohol".

Sedated, weakened, or bedridden patients should not take this medication.

Very rarely, cases of severe skin reactions called acute generalized pustular psoriasis (AGPP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported associated with the use of paracetamol. If you experience the first sign of rash or hypersensitivity, discontinue treatment and consult your doctor.

Other medications and Normogrip Antitusivo Junior

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

In particular, if you are using some of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Medications to treat epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medications to treat tuberculosis (isoniazid, rifampicin).
• Medications to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medications used to increase urine elimination (diuretics of the loop such as those in the furosemide group, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probenecid).
• Medications used to treat high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (arrhythmias), such as amiodarone or quinidine.
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidine). The administration of this medication should be separated from these medications by at least 14 days after completing treatment.
• Other medications to treat depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications to treat schizophrenia (such as haloperidol).
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Medications ototoxic (that cause damage to the ear).
• Medications photosensitizing (that cause allergic reactions to light).
• Medications used to relieve pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Metoprolol, used to treat cardiovascular diseases (hypertension, acute myocardial infarction).
• Isoconazole, used to treat invasive aspergillosis and mucormycosis.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid alteration (called metabolic acidosis) that must be treated urgently (see section 2).

Interference with diagnostic tests:

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

Taking Normogrip Antitusivo Junior with food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as they may potentiate the appearance of adverse effects of this medication.

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

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

The 3 active principles of this medication are excreted in breast milk, so women in the lactation period should not take this medication.

Driving and operating machines

This medication may cause drowsiness, altering mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machines.

Normogrip Antitusivo Junior contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per sachet, which is essentially "sodium-free".

Normogrip Antitusivo Junior contains saccharose

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

Normogrip Antitusivo Juniorcontains yellow-orange S (E-110)

May cause allergic reactions.

Normogrip Antitusivo Junior contains benzyl alcohol

This medication 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 may accumulate in your body and cause adverse effects (metabolic acidosis).

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

Normogrip Antitusivo Junior contains sulfur dioxide (E-220)

Rarely may cause severe hypersensitivity reactions and bronchospasm.

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.

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

The recommended dose is:

Children aged 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 old(weight over 44 kg): 2 sachets every 6 or 8 hours (3 or 4 times a day) as needed.

Preferably take 1 dose before going to bed. Do not exceed 4 doses per day.

This medication is contraindicated in children under 6 years old.

Always use the lower dose that is effective.

Start treatment as soon as the first symptoms appear and discontinue as they disappear.

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

How to take:

This medication is taken orally.

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

If you take more Normogrip Antitusivo Junior than you should

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

If you take more Normogrip Antitusivo Junior than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, involuntary and rapid 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.

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

Cases of abuse with medications containing dextromethorphan have been reported, which may lead to severe adverse effects, such as agitation, confusion, conversion disorders, hallucinations, ataxia (uncoordinated movements), coma, decreased consciousness, dysarthria (speech difficulty), apathy, dystonia, nystagmus (uncontrolled and involuntary eye movements), convulsions, serotonin syndrome, tremor, depression, and central nervous system hyperexcitability, miosis, and mydriasis (pupil constriction and dilation), respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

The symptoms of chlorphenamine overdose may be central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel 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.

The treatment of 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.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience 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 association of paracetamol, dextromethorphan, and chlorphenamine, the following adverse effects occurred, whose frequency could not be established with precision: anaphylactic reaction, hypersensitivity, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more common in children and elderly people.

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

The simultaneous consumption of alcohol during treatment may accentuate the appearance of adverse effects. Do not consume 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 medication.

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

Store below 30°C.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Normogrip Antitusivo Junior

- The active principles are paracetamol, chlorphenamine maleate, and dextromethorphan hydrobromide. Each blister 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), yellow-orange S (E-110), lemon and orange flavor (contains benzyl alcohol and sulfur dioxide (E-220)).

Appearance of the product and content of the packaging

Blister packs containing an orange-colored oral granulate with characteristic flavor and aroma of orange.

Each package contains 10 blister packs.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:February 2025

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