Leaflet: information for the user

Normogrip forte granulated for oral solution

Paracetamol/Fenilefrina hydrochloride/Chlorphenamine maleate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4

- You should consult a doctor if it worsens or does 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).

1. What is normogrip forte granulated for oral solution and what it is used for

2. What you need to know before starting to take normogrip forte granulated for oral solution

3. How to take normogrip forte granulated for oral solution

4. Possible side effects

5. Storage of normogrip forte granulated for oral solution

6. Contents of the pack and additional information

Normogrip Forte Granulado for Oral Solutionis an association of paracetamol (an analgesic 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 are accompanied by pain (mild or moderate), fever, congestion, and nasal secretion in adults and adolescents 14 years of age and older.

Consult a doctor if symptoms worsen, do not improve, or if fever persists for more than 3 days or pain for more than 5 days.

Do not take Normogrip Forte Granulado for Oral Solution

- If you are allergic (hypersensitive) to paracetamol, pheniramine, 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) (such as certain antidepressants or medications for Parkinson's disease).

- If you are being treated with sympathomimetic medications (medications used to treat asthma or medications to increase heart rate).

- If you are being treated with beta-blockers (medications for the heart or to treat artery disease) (see: Taking Normogrip Forte Granulado for Oral Solution with other medications).

- If you have glaucoma (elevated eye pressure).

- Children under 14 years old cannot take this medication due to the paracetamol dosage.

Warnings and Precautions

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

You should consult your doctor before taking this medication:

- Patients with kidney, liver, heart, or lung diseases and patients with anemia.

- Asthmatic patients sensitive to aspirin.

- Patients sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).

- Patients being treated with medications for: benign prostatic hyperplasia, asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer disease, pyloric obstruction, thyroid diseases, patients sensitive to the sedative effects of certain medications.

- If you are being treated with tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, stop taking this medication and consult a doctor immediately, as you may develop paralytic ileus (detention of normal intestinal movements).

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

During treatment with Normogrip Forte Granulado for Oral Solution, inform your doctor immediately 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 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.

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

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

Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may 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 old cannot take this medication.

Interference with Analytical Tests:

Inform your doctor if you are taking/using this medication, as it may alter test results.

Chlorphenamine may interfere with allergy test results. If you are to undergo any tests, it is recommended to stop taking the medication at least 3 days before.

Taking Normogrip Forte Granulado 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.

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

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

- Medications for treating tuberculosis (isoniazid, rifampicin).

- Medications for treating seizures 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 of the loop, such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for hypertension or others).

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

- Medications used to treat gout (probencid and sulfinpyrazone).

- Medications used to treat high blood pressure and heart rhythm disorders (arritmias cardiacas) (Propranolol).

- Medications to lower cholesterol levels in the blood (colestiramine).

- Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine oxidase inhibitors (IMAO)). You should separate the administration of Normogrip Forte Granulado for Oral Solution by at least 15 days after completing the treatment.

- Medications used to treat migraines; medications taken for childbirth; medications taken for hypertension or other diseases (alpha-adrenergic blockers).

- Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).

- Medications for treating depression (tricyclic antidepressants and tetracyclic antidepressants).

- General anesthetics.

- Anti-hypertensives (medications to lower blood pressure).

- Medications used for the heart, such as cardiac glycosides and anti-arrhythmics.

- 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 (that cause damage to the ear).

- Photosensitizing medications (that cause allergic reactions to light).

Inform your doctor or pharmacist if you are taking:

- Flucloxacillin (antibiotic), due to a severe risk of blood and fluid alteration (metabolic acidosis) that must be treated urgently (see section 2).

Taking Normogrip Forte Granulado for Oral Solution with Food and Drinks

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

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

Chronic alcoholics should be careful not to take more than 2 g of paracetamol (3 sachets per day) divided into several doses.

This medication can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you 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 adverse effects in the baby.

Driving and Operating Machines

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

Normogrip Forte Granulado for Oral Solution contains Yellow Orange Colorant (E-110), Aspartame, Glucose, and Sodium

This medication may cause allergic reactions due to the presence of Yellow Orange Colorant (E-110).

This medication contains 30 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in cases 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."

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

Dosage

Adults: The usual dose is 1 tablet every 6-8 hours (3-4 tablets a day).

Do not take more than 3 grams in 24 hours..

Adolescents 14 years and older: The usual dose is 1 tablet every 6-8 hours (3-4 tablets a day).

Patients with liver disease: In case of hepatic insufficiency, do not exceed 2 g of paracetamol (3 tablets a day) and the minimum interval between doses will be 8 hours.

Patients with kidney disease: This medication is not indicated for patients with renal insufficiency due to the paracetamol dose.

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

It is recommended to avoid the use of high daily doses of paracetamol for prolonged periods of time as it increases the risk of adverse effects such as liver damage.

Use in children under 14 years:

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

Use in elderly people:

Elderly people should not use this medication without consulting their doctor because they may be especially affected by some adverse effects of the medication such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the content of phenylephrine and chlorphenamine. They may also be more likely to present adverse effects such as dizziness, sedation, confusion, hypotension or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Administration form

This medication is taken orally

Empty the contents of the sachet into approximately half a glass of water. Shake and drink.

Treatment duration:

The taking of 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, treatment should be interrupted and the doctor consulted.

If you take more Normogrip Forte Granulated for Oral Solution than you should

If you have ingested an overdose, you should go immediately to a medical center, even if you do not feel the 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 (this last especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduction of urine production. Metabolic acidosis (decrease in blood alkalinity reserve). In prolonged use, depletion of plasma volume (decrease in blood volume) may occur. Overdose can also cause: coagulation disorders (blood clots and hemorrhages).

The treatment of overdose is more effective if it is initiated within 4 hours of taking the overdose of the medication.

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, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines,this medicinemay cause side effects, although not everyone will experience them.

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

-The side effects that may appear most frequently are:

Mild drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and paresthesia, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, nasal and throat dryness, thickening of mucosities, sweating, blurred vision or other visual disturbances.

-The side effects that may appear with low frequency (rare) are:

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

Excitement (usually at high doses and more frequently in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other side effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (usually with overdose), liver disturbances (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-reactivity (allergy) with related chlorphenamine medications. Blood alterations (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear alterations, impotence, menstrual disturbances.

-The side effects that may appear with very low frequency (very rare) are:

Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood alterations (neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Very rarely, severe skin reactions have been reported

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

-The side effects whose frequency of appearance is unknown are:

Anxiety, irritability, weakness, high blood pressure (hypertension, usually at high doses and in sensitive patients), headache (at high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), peripheral vasoconstriction, reduced heart function that affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium levels in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of fainting (hypotension). At high doses, vomiting, palpitations, psychotic states with hallucinations may occur; in prolonged use, a decrease in blood volume may occur. A severe disease that may make the blood more acidic (denominated metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Normogrip Forte Granulated for Oral Solution

- The active principles 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 dye (E-110), povidone (E-1201) and aspartame (E951).

Appearance of the product and contents of the packaging

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

Normogrip ForteGranulated for Oral Solutionis presented in a pack of 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:February 2025

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/