NORMOGRIP COUGH SUPPRESSANT ORAL SOLUTION GRANULES

Introduction

Prospective:information for the user

Normogrip Antitussivegranules for oral solution

Paracetamol/Chlorphenamine maleate/Dextromethorphan hydrobromide

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly.

• Keep this prospectus, 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 prospectus. 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).

Contents of the prospectus

1. What Normogrip Antitussive is and what it is used for
2. What you need to know before starting to take Normogrip Antitussive
3. How to take Normogrip Antitussive
4. Possible adverse effects
5. Storage of Normogrip Antitussive
6. Package contents and additional information

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

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

This medication 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), nasal secretion, and sneezing for adults and adolescents from 14 years old.

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

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

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

Do not takeNormogrip Antitussive

• 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 disease.
• If you have severe renal insufficiency or are undergoing hemodialysis.
• If you are being treated with a class of medicines called monoamine oxidase inhibitors (MAOIs) or after two weeks of finishing treatment with these medicines.
• If you have respiratory insufficiency, asthmatic cough, and cough accompanied by expectoration.
• If you are or have recently been treated with other medications, such as medications for depression or Parkinson's disease, with linezolid, which is an antibiotic, or with procarbazine, which is a medication for cancer (see section "Other medications and Normogrip Antitussive"). Children under 6 years old cannot take this medication due to the dose of its active ingredients.

Warnings and precautions

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

• Do not take more than the recommended dose in section 3. "How to take Normogrip Antitussive". Taking more than the recommended dose (overdose) can result in liver damage. In case of overdose, seek medical help immediately. Rapid 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 medications. Additionally, they should be cautious not to take more than 3 sachets per day (2 g of paracetamol).
• While taking this medication, you cannot take other medications that contain paracetamol because a paracetamol overdose could occur, which could damage the liver. Do not use more than one medication that contains paracetamol without consulting your doctor.

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

• 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 vesical neck, prostate hyperplasia with urine formation. Elderly patients who may be more sensitive to the side effects of this medication.
• 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 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 body temperature above 38°C, increased heart rate, arterial hypertension, and exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia).

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

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 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 of discomfort (nausea) and vomiting.

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

This medication can cause drowsiness. Avoid consuming alcoholic beverages and certain medications while being treated with this medication, as they can potentiate this effect. Consult the sections "Other medications and Normogrip Antitussive" and "Taking Normogrip Antitussive with food, beverages, and alcohol".

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

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

Cases of abuse with medications containing dextromethorphan have been described in adolescents; therefore, this possibility should be taken into account, as serious adverse effects can occur (see section "If you take more Normogrip Antitussive than you should").

Other medications and Normogrip Antitussive

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt 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 (loop diuretics such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for treating 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 (cardiac arrhythmias), such as amiodarone or quinidine.
• Medications 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, furazolidone). This medication should be administered at least 14 days after finishing treatment with these medications.
• Other medications for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications for schizophrenia (such as haloperidol).
• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of producing allergy to light).
• Medications used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Metoprolol, used to treat cardiovascular system diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used to treat invasive aspergillosis and invasive mucormycosis.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that should 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/using this medication, as it may alter the results.

Taking Normogrip Antitussive with food, beverages, and alcohol

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

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consuming medications during pregnancy can 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 ingredients of this medication are excreted in breast milk; therefore, breastfeeding women should not take this medication.

Driving and using machines

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

Normogrip Antitussive contains sodium

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

Normogrip Antitussive contains sucrose

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

Normogrip Antitussive contains orange yellow S (E-110)

It may cause allergic reactions.

Normogrip Antitussive contains benzyl alcohol

This medication 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 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 contains sulfur dioxide (E-220)

It can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Normogrip Antitussive

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

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

The recommended dose is:

Adults and adolescents from 14 years old

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

Patient 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.

Patient with renal insufficiency

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

Use in children

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

Always use the lowest effective dose.

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

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

How to take:

This medication is taken orally.

Pour 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. At night, take preferably before bedtime.

If you take more Normogrip Antitussive than you should

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

The most serious effect of an overdose of this medication is liver damage caused by paracetamol. You may feel dizzy, vomit, confused, excited, restless, nervous, irritable, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, states of stupor or alterations in gait. The overdose can also cause: coagulation disorders (blood clots and bleeding).

If you take more Normogrip Antitussive 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.

Cases of abuse with medications containing dextromethorphan have been described in adolescents, and serious adverse effects can occur, 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 noises), 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 after ingestion of the medication. Patients treated with barbiturics 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 medication and the amount ingested.

4. Possible Adverse Effects

Like all medicines, this medicine may 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.

The following adverse reactions occurred with an 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 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 enhance 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 Medicines Surveillance System 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 Antitussive

Keep this medicine out of the 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. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Normogrip Antitussive

• The active ingredients are paracetamol, chlorphenamine maleate, and dextromethorphan hydrobromide. Each sachet 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), 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 and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).