Normogrip antitussive granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Normogrip Antitussive 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.

Follow exactly the instructions for use provided 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 further 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 your doctor if you worsen or do not improve after 5 days (3 days for fever and in adolescents).

Contents of the leaflet

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

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

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

This medicine is indicated for the symptomatic relief of colds and flu accompanied by mild to moderate pain such as headache, fever, non-productive cough (irritating cough, nervous cough), nasal discharge, and sneezing, in adults and adolescents aged 14 years and older.

You should consult your doctor if your condition worsens or if symptoms persist for more than 5 days in adults or 3 days in adolescents, or if fever persists for more than 3 days.

2. What you need to know before taking Normogrip Antitussive

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

Do not take Normogrip Antitussive

• If you are allergic to paracetamol, chlorpheniramine maleate, dextromethorphan hydrobromide, or any of the other components of this medicine (listed in section 6).
• If you have severe liver disease.
• If you have severe renal failure or are undergoing hemodialysis.
• If you are being treated with a class of medicines called monoamine oxidase inhibitors (MAOIs), or within two weeks after stopping such treatment.
• If you have respiratory insufficiency, asthmatic cough, or productive cough with expectoration.
• If you are currently or have recently been treated 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”). Children under 6 years of age must not take this medicine due to the dose of its active ingredients.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• Do not exceed the recommended dose stated in section 3, “How to take Normogrip Antitussive”. 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 alcohol users should consult their doctor before taking paracetamol, other analgesics, or antipyretic medicines. They should also take care not to exceed 3 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 potential liver damage. Do not use more than one paracetamol-containing medicine without consulting your doctor.

The following patients should consult their doctor or pharmacist before starting treatment:

• Patients with kidney, heart, or lung diseases, or those with anemia.
• Patients with liver diseases (with or without hepatic insufficiency) or viral hepatitis, as this increases the risk of hepatotoxicity.
• Patients with aspirin-sensitive asthma.
• Patients who are sensitive (allergic) to an antihistamine, as they may also react to others (such as chlorpheniramine).
• Patients with hypertension (high blood pressure), glaucoma (elevated intraocular pressure), hyperthyroidism, bladder neck obstruction, prostate hyperplasia with urinary retention.
• Elderly patients, who may be more sensitive to the side effects of this medicine.
• Patients with atopic dermatitis.
• Patients who are poor metabolizers of CYP2D6 or who are 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 prostate 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).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

During treatment with Normogrip Antitussive, 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 for prolonged periods or when taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), vomiting.

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

This medicine may cause drowsiness. Avoid consuming alcoholic beverages and certain medicines during treatment, as they may increase this effect. See sections “Other medicines and Normogrip Antitussive” and “Taking Normogrip Antitussive with food, beverages, and alcohol”.

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

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

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

Other medicines and Normogrip Antitussive

Inform 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, dosage adjustments or discontinuation 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 output (loop diuretics such as furosemide, or other diuretics), and other potassium-wasting diuretics (such as those used for hypertension or other conditions).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid).
• Medicines used for high blood pressure (hypertension), such as propranolol, or 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, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson’s disease (selegiline), or other conditions such as cancer (procarbazine), infections (linezolid, furazolidone). Administration of this medicine should be separated by at least 14 days after stopping such treatment.
• Other antidepressants, 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 that may damage the ear).
• Photosensitizing medicines (those that may cause light allergy).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Metoprolol, used for cardiovascular conditions (hypertension, acute myocardial infarction).
• Isavuconazole, used for the treatment of invasive aspergillosis and mucormycosis.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) requiring urgent treatment (see section 2).

Interference with laboratory 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/using this medicine, as it may alter test results.

Taking Normogrip Antitussive with food, beverages, and alcohol

Do not consume alcoholic beverages while taking this medicine, as it 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—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 of this medicine are excreted in breast milk; therefore, breastfeeding women 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 contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; hence, it is essentially “sodium-free”.

Normogrip Antitussive contains sucrose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It contains 4.45 g of sucrose per sachet, which should be considered in patients with diabetes mellitus.

Normogrip Antitussive contains sunset yellow FCF (E-110)

May cause allergic reactions.

Normogrip Antitussive contains benzyl alcohol

This medicine contains 0.026 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 contains sulfur dioxide (E-220)

Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

3. How to take Normogrip Antitussive

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.

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

Recommended dose:

Adults and adolescents aged 14 years and older

1 sachet every 6 to 8 hours (3 or 4 times daily), as needed. Preferably take 1 sachet at bedtime. Do not take more than 4 sachets (equivalent to 2.6 g of paracetamol) per day. See section “Warnings and precautions”.

Patients with hepatic impairment

1 sachet every 8 hours. Do not take more than 3 sachets (equivalent to 1.95 g of paracetamol) per day. Consult your doctor.

Patients with renal impairment

This medicine must not be used due to the 650 mg dose of paracetamol.

Use in children

This medicine is contraindicated in children under 14 years of age due to the dosage of its active ingredients.

Always use the lowest effective dose.

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

If symptoms do not improve or worsen after 5 consecutive days of treatment (3 days for fever or in adolescents), consult your doctor. (See section 1. “What Normogrip Antitussive is and what it is used for”).

How to take:

This medicine is taken orally.

Empty the contents of one sachet into half a glass of water and stir until dissolved. Sugar or honey may be added according to personal preference. At night, it is preferable to take it before going to bed.

If you take more Normogrip Antitussive than you should

Seek immediate medical attention at a healthcare facility, even if you have no symptoms, as symptoms often do not appear until 3 days after overdose, even in cases of severe poisoning.

The most serious effect of overdose 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 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 listed above.

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

Symptoms of chlorpheniramine overdose 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 experiencing 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. Patients receiving treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects 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 may cause adverse effects, although not everyone experiences them.

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

The following adverse reactions were reported with unknown frequency (cannot be estimated from the available data): anaphylactic reaction, hypersensitivity, insomnia, nervousness and restlessness (psychomotor hyperactivity), abdominal pain, diarrhea, nausea, vomiting, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin eruptions, skin lesions after taking the medicine (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 who use paracetamol (see section 2).

Concomitant consumption of alcohol during treatment may intensify 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

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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Normogrip Antitussive

• The active substances are paracetamol, maleate chlorphenamine, and dextromethorphan hydrobromide. Each sachet contains 650 mg of paracetamol, 4 mg of maleate chlorphenamine, and 20 mg of dextromethorphan hydrobromide.
• The other components (excipients) are polysorbate 80, povidone, citric acid, anhydrous sodium citrate, sucrose, sodium saccharin, sodium cyclamate, titanium dioxide (E-171), sunset yellow FCF (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 granular powder for oral solution with a characteristic orange flavour and odour.

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 the most recent revision of this leaflet: February 2025

Detailed and up-to-date 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/).