NORMOGRIP FORTE ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Normogrip Forte Granules for Oral Solution

Paracetamol/Phenylephrine Hydrochloride/Chlorphenamine Maleate

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

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

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve, or if the fever persists for more than 3 days or the pain for more than 5 days (2 days for throat pain).

Contents of the Package Leaflet:

1. What Normogrip Forte Granules for Oral Solution are and what they are used for.
2. What you need to know before taking Normogrip Forte Granules for Oral Solution.
3. How to take Normogrip Forte Granules for Oral Solution.
4. Possible side effects.
5. Storage of Normogrip Forte Granules for Oral Solution.
6. Package Contents and Additional Information.

1. What Normogrip Forte Granules for Oral Solution are and what they are used for.

Normogrip Forte Granules for Oral Solutionis an association of paracetamol (a pain reliever that reduces pain and fever), chlorphenamine (an antihistamine that relieves nasal secretion), and phenylephrine (which acts by reducing nasal congestion).

This medication is indicated for the relief of symptoms in catarrhal or flu-like processes that occur with pain (mild or moderate), fever, congestion, and nasal secretion in adults and adolescents from 14 years of age.

You should consult your doctor if your symptoms worsen or do not improve, or if the fever persists for more than 3 days or the pain for more than 5 days.

2. What you need to know before taking Normogrip Forte Granules for Oral Solution.

Do not take Normogrip Forte Granules for Oral Solution

• If you are allergic (hypersensitive) to paracetamol, phenylephrine, chlorphenamine, or any of the other components of the medication (listed in section 6).
• If you have high blood pressure (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 (used to treat asthma or to accelerate heart rate).
• If you are being treated with beta-blocker medications (used for heart conditions or to treat artery diseases) (see: Taking Normogrip Forte Granules for Oral Solution with other medications).
• If you have glaucoma (increased eye pressure).
• Children under 14 years of age cannot take this medication due to the paracetamol dose.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Normogrip Forte Granules for Oral Solution.

The following patients should consult their doctor before taking this medication:

• Patient with kidney, liver, heart, or lung diseases, 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 diseases, patient sensitive to 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 medication and consult a doctor immediately, as you may develop paralytic ileus (stop of normal bowel movements).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

During treatment with Normogrip Forte Granules for Oral Solution, inform your doctor immediately if:

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 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.

Chronic alcoholics should be cautious not to take more than 2 grams (3 sachets) of paracetamol per day.

Do not take more medication than recommended in section 3 (How to take Normogrip Forte Granules for Oral Solution).

Avoid simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, as high doses can cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

Children and Adolescents

Due to the amount of paracetamol in this medication, children under 14 years of age cannot take this medication.

Interference with analytical tests:

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

Chlorphenamine may interfere with the results of allergy tests. If you are going to have any, it is recommended to stop taking the medication at least 3 days in advance.

Taking Normogrip Forte Granules for Oral Solution with other medications

Inform your doctor or pharmacist if you are taking or 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 separate the administration by a minimum of 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 (barbiturics), 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).

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

Medications used in the treatment of gout (probenecid and sulfinpyrazone).

• Medications used in the treatment of high blood pressure and heart rhythm disorders (arrhythmias) (Propranolol).
• Medications to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine Oxidase Inhibitors (MAOIs)). Normogrip Forte Granules for Oral Solution administration should be separated by a minimum of 15 days after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken for blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or to treat artery diseases).
• Medications for treating depression (tricyclic and tetracyclic antidepressants).
• General anesthetic medications.
• Antihypertensive medications (medications to lower blood pressure).
• Medications used for heart conditions, 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 light allergy).

Inform your doctor or pharmacist if you are taking:

-Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that should be treated urgently (see section 2).

Taking Normogrip Forte Granules for Oral Solution with food and beverages

While being treated with this medication, you should not consume alcoholic beverages, as it may increase the risk of side effects.

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.

In chronic alcoholics, caution should be taken not to take more than 2 grams of paracetamol (3 sachets per day) divided into several doses.

The medication 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 medication.

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

This medication cannot be used during breastfeeding, as it may cause side effects in the baby.

Driving and Using Machines

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

Normogrip Forte Granules for Oral Solution contains orange yellow colorant (E-110), aspartame, glucose, and sodium

This medication may cause allergic reactions because it contains orange yellow colorant (E-110).

This medication contains 30 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

It may harm teeth.

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

3. How to take Normogrip Forte Granules for Oral Solution

Follow the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Dosage

Adults: The usual dose is 1 sachet every 6-8 hours (3-4 sachets per day).

Do not take more than 3 grams in 24 hours.

Adolescents from 14 years of age: The usual dose is 1 sachet every 6-8 hours (3-4 sachets per day).

Patient with liver disease: in case of liver failure, do not exceed 2 grams of paracetamol (3 sachets per day) and the minimum interval between doses will be 8 hours.

Patient with kidney disease: this medication is not indicated for patients with renal failure due to the paracetamol dose.

(See section 2: What you need to know before taking this medication).

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 under 14 years:

Children under 14 years of age cannot take this medication due to the amount of paracetamol it contains.

Use in elderly patients:

Elderly patients should not use this medication without consulting their doctor, as some side effects of the medication, such as slow heart rate (bradycardia) or reduced cardiac output, due to the phenylephrine and chlorphenamine content, may affect them especially. They are also more likely to experience side effects such as dizziness, sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration

This medication is taken orally.

Pour the entire contents of the sachet into approximately half a glass of water. Stir and drink.

Duration of treatment:

Taking this medication is subject to the appearance of symptoms. As they disappear, treatment should be discontinued.

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 Normogrip Forte Granules for Oral Solution than you should

If you have ingested an overdose, you should go to a medical center immediately, 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). Prolonged use may cause plasma volume depletion (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 medication.

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

In case of overdose or accidental ingestion, go to a medical center 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 can 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:

• 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 discomfort (which may decrease if the medicine 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.

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

Discomfort, lowering of blood pressure (hypotension) and increase in blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung fluid volume) 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 tightness, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood disorders (changes in blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; lowering or rising blood pressure, edema (swelling), alterations in the ears, impotence, menstrual alterations.

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

Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowish skin discoloration), blood disorders (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.

• Adverse effects whose frequency of appearance is not known are: Anxiety, irritability, weakness, increase in 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 blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, increase in blood sugar (hyperglycemia), decrease in 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 severe 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 medicine.

5. Conservation of Normogrip Forte Granulate for Oral Solution

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine 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 medicines that 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 medicines that you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of Normogrip Forte Granulate for Oral Solution

• The active ingredients are paracetamol 650 mg, 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 (E951).

Appearance of the Product and Content of the Packaging

Normogrip ForteGranulate for Oral Solutionis presented in sachets. Each sachet contains white or almost white granulate with orange spots.

Normogrip ForteGranulate for Oral Solutionis 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/