Normogrip Antitussive Junior granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Normogrip Antitussive Junior granules for oral solution

Paracetamol/Chlorpheniramine maleate/Dextromethorphan hydrobromide

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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.

Contents of the 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. How to store Normogrip Antitussive Junior
6. Contents of the pack and other information

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

Normogrip Antitussive Junior is a combination of paracetamol, which reduces fever and relieves pain; dextromethorphan, which is an antitussive; and chlorpheniramine, which helps reduce nasal secretions.

This medicine is indicated for the symptomatic relief of colds and flu accompanied by mild to moderate pain such as headache, fever, unproductive cough (irritant cough, nervous cough), and runny nose in children over 6 years of age and adolescents.

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

2. What you need to know before starting to take Normogrip Antitussive Junior

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

Do not take Normogrip Antitussive Junior

• If you are allergic to paracetamol, chlorpheniramine maleate, dextromethorphan hydrobromide, or to 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 within 2 weeks after stopping treatment with these medicines.
• If you have respiratory failure, asthmatic cough, or productive cough (cough with phlegm).
• If you are or have recently been receiving treatment with other medicines, such as antidepressants or medicines for Parkinson’s disease, linezolid (an antibiotic), or procarbazine (a cancer medicine) (see section “Other medicines and Normogrip Antitussive Junior”).
• Children under 6 years of age must not take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Normogrip Antitussive Junior.

• Do not exceed the recommended dose stated in section 3, “How to take Normogrip Antitussive Junior”.

Taking more than the recommended dose (overdose) may result in liver damage. In case of overdose, seek immediate medical help. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

• Chronic alcoholics should consult their doctor before taking paracetamol or other painkillers or fever-reducing medicines. They should also take care not to exceed 6 sachets per day (2 g of paracetamol).
• While taking this medicine, do not take other products containing paracetamol, as this could lead to paracetamol overdose and possible liver damage.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

Patients should consult their doctor or pharmacist before starting Normogrip Antitussive Junior if they have:

• Kidney, heart, or lung disease, or anemia.

• Liver disease (with or without hepatic insufficiency) or viral hepatitis, as this increases the risk of hepatotoxicity.

• Asthma sensitive to acetylsalicylic acid.

• Hypersensitivity (allergy) to an antihistamine, as they may also be sensitive to others (such as chlorpheniramine).

• Hypertension (high blood pressure), glaucoma (increased intraocular pressure), hyperthyroidism, bladder neck obstruction, or benign prostatic hyperplasia with residual urine. Elderly patients may be more sensitive to the side effects of this medicine.

• Atopic dermatitis.

• Poor metabolizers of CYP2D6 or those taking CYP2D6 inhibitors.

• Patients with chronic respiratory conditions such as emphysema, chronic bronchitis, bronchial asthma, or cough with excessive secretions, glaucoma, or difficulty urinating due to benign prostatic hyperplasia.

• If you are taking other medicines such as antidepressants or antipsychotics, this medicine may interact with them and you may experience changes in mental status (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).

During treatment with Normogrip Antitussive Junior, 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 under these conditions when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

This medicine may increase the sedative effects of central nervous system (CNS) depressants, including alcohol, sedatives, and tranquilizers. Therefore, it is recommended to avoid alcohol or 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 enhance this effect. See sections “Other medicines and Normogrip Antitussive Junior” and “Taking Normogrip Antitussive Junior with food, drinks, and alcohol”.

Sedated, weakened, or bedridden patients must not take this medicine.

Very rarely, serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported with paracetamol use. At the first sign of a skin rash or hypersensitivity, stop treatment and consult your doctor.

Other medicines and Normogrip Antitussive Junior

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are using any of the following medicines, dose adjustments or discontinuation of treatment may be necessary:

• Medicines for epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines for 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 potassium-depleting diuretics (such as diuretics used for hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used for gout (probenecid).
• Medicines used for high blood pressure (hypertension), such as propranolol, and for heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression (moclobemide, tranilcipromine, fluoxetine, paroxetine, bupropion), Parkinson’s disease (selegiline), or other conditions such as cancer (procarbazine), infections (linezolid, furazolidone). Administration of this medicine must be separated by at least 14 days after stopping treatment.
• Other medicines for depression, known as tricyclic and tetracyclic antidepressants (e.g., maprotiline).
• Medicines for schizophrenia (e.g., haloperidol).
• Medicines causing central nervous system depression (such as those used for insomnia or anxiety, Parkinson’s disease, or allergies).
• Ototoxic medicines (those with adverse effects damaging the ear).
• Photosensitizing medicines (those causing adverse effects such as light allergy).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Metoprolol, used for cardiovascular diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used for invasive aspergillosis and invasive mucormycosis.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with diagnostic tests:

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

Taking Normogrip Antitussive Junior with food, drinks, and alcohol

While taking this medicine, do not consume alcoholic beverages, as they may enhance the adverse effects of this medicine.

Additionally, using paracetamol-containing medicines in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Do not take this medicine with grapefruit juice or bitter orange juice, as they may enhance 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 may be harmful 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 three active ingredients in this medicine are excreted in breast milk; therefore, women who are breastfeeding should not take this medicine.

Driving and using machines

This medicine may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

Normogrip Antitussive Junior contains sodium

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

Normogrip Antitussive Junior contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine. It contains 4.1 g of sucrose per sachet, which should be considered in patients with diabetes mellitus.

Normogrip Antitussive Junior contains Sunset Yellow FCF (E-110)

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

Normogrip Antitussive Junior contains sulfur dioxide (E-220)

Rarely may cause severe hypersensitivity reactions and bronchospasm.

3. How to take Normogrip Antitussive Junior

Follow exactly the dosing instructions for this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

Recommended dose:

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 daily), as needed.

Individuals over 12 years of age (weight over 44 kg): 2 sachets every 6 or 8 hours (3 or 4 times daily), as needed.

It is preferable to take one dose before going to bed. Do not exceed 4 doses per day.

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

Always use the lowest effective dose.

Begin treatment at the onset of first symptoms and discontinue as symptoms subside.

This 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 one sachet into half a glass of water and stir until dissolved.

If you take more Normogrip Antitussive Junior than you should

Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must not exceed the recommended dose. Seek immediate medical attention even if no symptoms are present, as symptoms often do not appear until 3 days after the overdose has been ingested, even in cases of severe intoxication. The most serious effect of overdose with this medicine is liver damage caused by paracetamol. You may experience 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, drowsiness or disturbances in gait may occur. Overdose may also cause: coagulation disorders (blood clots and hemorrhages).

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

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

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

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

Symptoms of overdose with chlorpheniramine may include central nervous system (CNS) depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or arrhythmias. Patients with prolonged agitation, coma, or seizures may rarely develop rhabdomyolysis and renal failure.

Treatment of overdose is most effective if initiated within 4 hours of ingestion of 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

During the period of use of the combination of paracetamol, dextromethorphan, and chlorphenamine, the following adverse effects have occurred, although their frequency could not be precisely determined: anaphylactic reaction, hypersensitivity, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more commonly observed in children and elderly individuals.

Similarly, with frequency not known (cannot be estimated from available data): gastrointestinal disturbances such as abdominal pain, diarrhea, nausea, vomiting, and indigestion (dyspepsia), angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin rash, skin lesions following drug intake (fixed drug eruption), as well as increased transaminases. A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Concurrent consumption of alcohol during treatment may worsen the occurrence of adverse effects. Do not consume alcoholic beverages during treatment.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Normogrip Antitussive Junior

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging 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 containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Normogrip Cough Junior

• The active substances are paracetamol, maleate chlorpheniramine, and dextromethorphan hydrobromide. Each sachet contains 300 mg of paracetamol, 2 mg of maleate chlorpheniramine, 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 flavour, and orange flavour (containing benzyl alcohol and sulfur dioxide (E-220)).

Appearance of the product and contents of the pack

Sachets containing an orange-coloured granulate with a characteristic orange flavour and odour for oral solution.

Each pack contains 10 sachets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of latest revision of this leaflet: February 2025

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