Prospecto:Information for the User

Normogrip AntitusivoGranulated Oral Solution

Paracetamol/Chlorphenamine maleate/Dextromethorphan hydrobromide

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

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

• Keep this prospect, 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 prospect. See section 4.
• You should consult your doctor if your condition worsens or does not improve after 5 days(3 days for fever and for adolescents).

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

This medication is indicated for symptomatic relief of colds and flu that are accompanied by mild or moderate pain such as headache, fever, non-productive cough (irritative cough, nervous cough), nasal secretion, and sneezing for adults and adolescents 14 years and older.

You should consult your doctor if symptoms worsen or persist after 5 days of treatment in adults or 3 days in adolescents or if fever persists for more than 3 days.

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

Do not takeNormogrip Antitusivo

• 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 a severe liver disease.
• If you have severe kidney failure or are undergoing hemodialysis.
• If you are being treated with a class of medicines called monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping treatment with these medicines.
• If you have respiratory insufficiency, asthma, or cough with expectoration.
• If you are or have been recently treated with other medicines, such as antidepressants or Parkinson's disease medicines, with linezolid, which is an antibiotic, or with procarbazine, which is a cancer medicine (see section "Other medicines and Normogrip Antitusivo"). Children under 6 years old cannot take this medicine due to the dose of its active principles.

Warnings and precautions

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

• Do not take more than the recommended dose in section 3. "How to take Normogrip Antitusivo". Taking more than the recommended dose (overdose) may cause 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 medicines that reduce fever. They should also be careful not to take more than 3 packets a day (2 g of paracetamol).
• While taking this medicine, do not take other medicines that contain paracetamol, as it may cause a paracetamol overdose that can damage the liver. Do not use more than one medicine that contains paracetamol without consulting your doctor.

You should consult your doctor or pharmacist before starting to take this medicine:

• 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 tract obstruction, benign prostatic hyperplasia with urinary retention. Elderly patients may be more sensitive to the side effects of this medicine.
• 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 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 these medicines and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
• In case of G6PD deficiency (may cause hemolytic anemia).

Inform your doctor immediately if you have:

Severe diseases, such as severe kidney failure 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, 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 taking this medicine, as they may potentiate this effect. See sections "Other medicines and Normogrip Antitusivo" and "Taking Normogrip Antitusivo with food, drinks, and alcohol".

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

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.

Cases of abuse with dextromethorphan-containing medicines have been reported in adolescents, so this possibility should be taken into account, as it may cause severe adverse effects (see section "If you take more Normogrip Antitusivo than you should").

Other medicines and Normogrip Antitusivo

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

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

• Medicines for treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines for treating tuberculosis (isoniazid, rifampicin).
• Medicines for preventing blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medicines used to increase urine elimination (thiazide diuretics such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used to treat gout (probencid).
• Medicines used to treat high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (arrhythmias), such as amiodarone or quinidine.
• Medicines used 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, furazolidine). The administration of this medicine should be separated from these medicines by at least 14 days after stopping treatment.
• Other medicines for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for schizophrenia (such as haloperidol).
• Medicines that cause depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medicines (that cause damage to the ear).
• Phototoxic medicines (that cause allergy to light).
• Medicines used to relieve pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medicines 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 serious risk of blood and fluid alteration (metabolic acidosis) that must be treated urgently (see section 2).

Interference with analytical 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/using this medicine, as it may alter the results.

Taking Normogrip Antitusivo with food, drinks, and alcohol

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

Additionally, the use of medicines 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 medicine 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 medicine.

The consumption of medicines during pregnancy may 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 women in the lactation period should not take this medicine.

Driving and operating machines

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

Normogrip Antitusivo contains sodium

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

Normogrip Antitusivo contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine. It contains 4.45 g of saccharose per sachet, which should be taken into account in patients with diabetes mellitus.

Normogrip Antitusivo contains Yellow No. 5 (E-110)

It may cause allergic reactions.

Normogrip Antitusivo 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 Antitusivo contains sulfur dioxide (E-220)

Rarely, it 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 granule contained in the Normogrip Antitusivo sachets is for oral administration.

The recommended dose is:

Adults and adolescents 14 years and older

1 sachet every 6 or 8 hours (3 or 4 times a day), as needed. Preferably take 1 sachet before going to bed. Do not take more than 4 sachets (equivalent to 2.6 g of paracetamol) per day. See the "Warnings and precautions" section.

Patients with liver insufficiency

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 insufficiency

You cannot take this medication due to the paracetamol dose of 650 mg.

Use in children

This medication is contraindicated in children under 14 years old, due to the dose of its active principles.

Always use the lowest effective dose.

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

If you do not improve or worsen after 5 consecutive days of treatment (3 for fever or adolescents), you should consult your doctor. (See section 1. "What is Normogrip Antitusivo and what is it used for").

How to take:

This medication is taken orally.

Empty the contents of a sachet into a half glass of water and stir until dissolved. You can add sugar or honey according to your preferences. Take preferably before going to bed at night.

If you take more Normogrip Antitusivo than you should

Go immediately to a medical center, even if you do not have symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe intoxication.

The most severe effect of an overdose of this medication 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 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 dextromethorphan-containing medications have been reported in adolescents, 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, tremors, 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 an overdose is more effective if initiated within 4 hours after 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, consult your doctor or pharmacist immediately 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.

The following adverse reactions were reported with unknown frequency (cannot be estimated from available data): anaphylactic reaction, hypersensitivity, insomnia, nervousness, and restlessness (psychomotor hyperactivity), abdominal pain, diarrhea, nausea, vomiting, angioedema (swelling of certain skin areas), pruritus, urticaria, rash, pruritic rash, skin eruptions, 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 exacerbate the appearance 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 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 the packaging and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist howto dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Normogrip Antitusivo

• The active principles are paracetamol, chlorphenamine maleate, and dextromethorphan hydrobromide. Each tablet contains 650 mg of paracetamol, 4 mg of chlorphenamine maleate, 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), yellow-orange S (E-110), lemon flavor, and orange flavor (contains benzyl alcohol and sulfur dioxide (E-220)).

Appearance of the product and contents of the packaging

Blister packs containing an orange-colored oral granule solution 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 and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).