GRIPALNORM GRANULADO FOR ORAL SOLUTION

2. What you need to know before taking Gripalnorm

Do not take Gripalnorm

• If you are allergic (hypersensitive) to paracetamol, phenylephrine, chlorphenamine, or any of the other components of the medicine (listed in section 6)
• If you have high blood pressure (arterial hypertension).
• If you have thyroid disease (hyperthyroidism).
• If you have severe liver or kidney disease.
• If you have severe heart or artery disease (such as severe coronary artery disease or angina pectoris).
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat artery diseases) (see: Taking Gripalnorm with other medications).
• If you have glaucoma (increased eye pressure).
• Patients under 18 years of age should not take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Gripalnorm

• Do not take more than the recommended dose in section 3. How to take Gripalnorm
• Chronic alcoholics should not take more than 2 grams of paracetamol per day (more than 2 sachets of Gripalnorm).
• While taking this medicine, you should not take other medications that contain paracetamol, as this could lead to a paracetamol overdose that could damage the liver.
• The following patients should consult their doctor before taking this medicine:
• Patient with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid disease, patients sensitive to the sedative effects of some medications.
• If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (stop of normal movements of a part of the intestine).

• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

During treatment with Gripalnorm, inform your doctor immediately if:

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or 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.

Children and Adolescents

Patients under 18 years of age should not take this medicine.

Taking Gripalnorm with other medications

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

You should avoid taking this medicine simultaneously with other medications that contain paracetamol, such as medications for flu and colds, as high doses may lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or separate the administration by at least 15 days or interrupt treatment:

• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

Medications for treating tuberculosis (isoniazid, rifampicin).

• Medications for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

Medications used to increase urine elimination (diuretics such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for treating hypertension or other conditions).

• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).

Medications used to treat gout (probenecid and sulfinpyrazone).

• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias) (Propranolol).
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine Oxidase Inhibitors (MAOIs)). You should separate the administration of Gripalnorm by at least 15 days after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• Medications used to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetic medications.
• Antihypertensive medications (medications to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides and antiarrhythmics.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases (atropine sulfate).
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of causing allergy to light).

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests:

If you are going to have any analytical tests (including blood, urine, etc...), inform your doctor that you are taking/using this medicine, as it may alter the results.

Taking Gripalnorm with food and drinks

While being treated with this medicine, you should not drink alcoholic beverages, as it may enhance the appearance of side effects of this medicine.

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

The medicine can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

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.

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

This medicine should not be used during breastfeeding, as it may cause side effects in the baby.

Driving and Using Machines

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

Gripalnorm contains yellow-orange colorant (E-110), aspartame, glucose, and sodium

This medicine may cause allergic reactions because it contains yellow-orange colorant (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 30 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

It may cause cavities.

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

3. How to take Gripalnorm

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults over 18 years: 1 sachet every 8 hours as needed (3 sachets per day). Do not take more than 3 grams in 24 hours.

Patient with liver or kidney disease: You should consult your doctor (See section 2 - What you need to know before taking this medicine).

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

Use in Children and Adolescents

This medicine is contraindicated in patients under 18 years of age.

Use in Elderly

Elderly patients should not use this medicine without consulting their doctor.

Because they may be especially affected by some side effects of the medicine, such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the content of phenylephrine and chlorphenamine. They are also more likely to experience side effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration:

It will be taken orally. The contents of the sachet should be dissolved completely in a little liquid, preferably in half a glass of water, before drinking.

Always use the smallest effective dose.

Duration of treatment:

The taking of this medicine is subject to the appearance of symptoms. As they disappear, treatment should be suspended.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen, or other symptoms appear, you should interrupt treatment and consult your doctor.

If you take more Gripalnorm than you should

You should consult your doctor or pharmacist immediately:

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). In prolonged use, it can cause depletion of plasma volume (decrease in blood volume). Overdose can also cause: coagulation disorders (blood clots and bleeding).

Treatment of overdose is more effective if started within 4 hours after taking the overdose of the medicine.

Patient being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible Adverse Effects

Like all medicines, Gripalnormcan cause adverse effects, although not all people suffer from them.

During the period of use of paracetamol, phenylephrine, and chlorphenamine, the following adverse effects have been reported, whose frequency has not been established with precision:

• The adverse effects that may appear more frequently are: Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• The adverse effects that may appear with low frequency (rare) are:

Discomfort, low blood pressure (hypotension) and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increased fluid volume in the lungs) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally with high doses and more frequently in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may appear with low frequency are: chest tension, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach pain or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of the eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood alterations (changes in the blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), alterations in the ears, impotence, menstrual alterations.

• The adverse effects that may appear with very low frequency (very rare) are:

Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowish skin color), blood alterations (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or in prolonged treatments.

• The adverse effects whose frequency of appearance is not known are: Anxiety, irritability, weakness, high blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of the caliber of blood vessels (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disorder), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur. A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

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 it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Gripalnorm

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack (after "CAD"). The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition ofGripalnorm

• The active ingredients are paracetamol 1 g, phenylephrine hydrochloride 10 mg (equivalent to 8.21 mg of phenylephrine) and chlorphenamine maleate 4 mg (equivalent to 2.8 mg of chlorphenamine).
• The other components are: sodium saccharin (E-954), mannitol, orange flavor (contains glucose in maltodextrin from corn and other excipients), yellow-orange colorant (E-110), povidone (E-1201), and aspartame.

Appearance of the Product and Content of the Packaging

Gripalnormis presented in sachets. Each sachet contains white or almost white granules with orange spots.

Gripalnormis presented in a packaging of 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

Other Sources of Information

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.