Normogrip Forte granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

normogrip forte granules for oral solution

Paracetamol/Phenylephrine hydrochloride/Chlorpheniramine maleate

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

Always follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens, does not improve, or if fever persists for more than 3 days or pain for more than 5 days (2 days for sore throat).

Contents of the leaflet:

1. What normogrip forte granules for oral solution is and what it is 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. How to store normogrip forte granules for oral solution
6. Contents of the pack and other information

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

normogrip forte granules for oral solution is a combination of paracetamol (an analgesic that reduces pain and fever), chlorpheniramine (an antihistamine that relieves nasal discharge), and phenylephrine (which acts to reduce nasal congestion).

This medicine is indicated for the relief of symptoms in catarrhal or influenza-like conditions associated with pain (mild or moderate), fever, nasal congestion, and nasal discharge in adults and adolescents aged 14 years and older.

You should consult your doctor if your condition worsens, does not improve, or if fever persists for more than 3 days or pain for more than 5 days.

2. What you need to know before taking normogrip forte oral solution granules

Do not take normogrip forte oral solution granules

• If you are allergic (hypersensitive) to paracetamol, phenylephrine, chlorpheniramine, or any of the other components of this medicine (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 a serious heart or arterial disease (such as severe coronary heart disease or angina pectoris).
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressant medicines, or medicines used to treat Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma, or medicines that increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see: Taking normogrip forte oral solution granules with other medicines).
• If you have glaucoma (increased intraocular pressure).
• Children under 14 years of age must not take this medicine due to the dose of paracetamol.

Warnings and precautions

Consult your doctor or pharmacist before taking normogrip forte oral solution granules.

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

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).
• Patients who are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between stomach and intestine), thyroid disorders, or patients sensitive to the sedative effects of certain medicines.
• If you are being treated with tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, you must stop taking this medicine and consult a doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

During treatment with normogrip forte oral solution granules, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Chronic alcoholics should take care not to exceed 2 g (3 sachets) of paracetamol per day.

Do not take more medicine than recommended in section 3 (How to take normogrip forte oral solution granules).

Avoid using this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Children and adolescents

Due to the amount of paracetamol it contains, this medicine must not be taken by children under 14 years of age.

Interference with diagnostic tests:

If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking/using this medicine, as it may alter test results.

Chlorpheniramine may interfere with allergy test results. If you are scheduled for such tests, it is recommended to stop taking the medicine at least 3 days beforehand.

Taking normogrip forte oral solution granules with other medicines

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

In particular, if you are using any of the following medicines, dosage adjustments may be necessary, administration should be separated by at least 15 days, or treatment may need to be discontinued:

• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis (isoniazid, rifampicin).
• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics causing potassium loss (such as diuretics used to treat hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias) (propranolol).
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Administration of normogrip forte oral solution granules must be separated by at least 15 days after stopping MAOI treatment.
• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat blood pressure or other conditions (alpha-adrenergic blocking agents).
• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• Medicines used to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetic agents.
• Antihypertensives (medicines to lower blood pressure).
• Medicines used for heart conditions such as cardiac glycosides and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart disease or digestive disorders (sulfate atropine).
• Medicines that depress the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medicines (those with adverse effects damaging the ear).
• Photosensitizing medicines (those with adverse effects causing light allergy).

Inform your doctor or pharmacist if you are taking:

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

Taking normogrip forte oral solution granules with food and drinks

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

In addition, using medicines containing paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

In chronic alcoholics, care should be taken not to exceed 2 g of paracetamol (3 sachets per day), divided into several doses.

This 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 must not be used during breastfeeding, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving vehicles or operating machinery.

Normogrip forte oral solution granules contains orange-yellow dye (E-110), aspartame, glucose, and sodium

This medicine may cause allergic-type reactions because it contains orange-yellow dye (E-110).

This medicine contains 30 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

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

It may harm teeth.

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

3. How to take normogrip forte granules for oral solution

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

Do not exceed 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).

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

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

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

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

Use in children under 14 years of age:

Children under 14 years of age must not take this medicine due to the amount of paracetamol it contains.

Use in elderly people:

Elderly individuals should not use this medicine without consulting a doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorpheniramine. They are also more likely to experience adverse effects such as dizziness, sedation, confusion, hypotension, or agitation, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration

This medicine is taken orally.

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

Duration of treatment:

This medicine should be taken only as long as symptoms persist. As symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, stop treatment and consult your doctor.

If you take more normogrip forte granules for oral solution than you should

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose has been taken, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine output. Metabolic acidosis (decrease in the blood's alkaline reserve). With prolonged use, plasma volume depletion (reduction in blood volume) may occur. Overdose may also cause: coagulation disorders (blood clots and hemorrhages).

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

Patients undergoing treatment 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of paracetamol, phenylephrine, and chlorpheniramine. Their frequency has not been accurately established:

• Adverse effects that may occur more frequently are:

Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2–3 days of treatment. Difficulty in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision, or other visual disturbances.

• Adverse effects that may occur less frequently (rare) are:

Malaise, low blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary oedema (increased fluid volume in the lungs), and cerebral haemorrhage (at high doses or in sensitive patients).

Nervous excitation (usually at high doses and more frequently in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may occur less frequently are: chest tightness, lung sounds, rapid or irregular heartbeat (usually 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 heartbeat, itching, swelling of the eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorpheniramine. Blood disorders (changes in blood cell count, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, oedema (swelling), ear disturbances, impotence, menstrual disorders.

• Adverse effects that may occur very rarely (very rare) are:

Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Very rare cases of serious skin reactions have been reported.

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

• Adverse effects for which the frequency is unknown are: Anxiety, irritability, weakness, increased blood pressure (hypertension, usually at high doses and in sensitive patients), headache (at high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduction in blood vessel diameter (peripheral vasoconstriction), reduced cardiac performance, particularly affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, pallor, piloerection (goosebumps), increased blood sugar (hyperglycaemia), low blood potassium, metabolic acidosis (metabolic disturbance), cold extremities (arms or legs), flushing, feeling of faintness (hypotension). At high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; prolonged use may lead to decreased blood volume. A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Normogrip Forte Granules for Oral Solution

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and on the blister (after “EXP”). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of normogrip forte oral solution granules

• The active substances 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 flavour (containing glucose in maltodextrin derived from maize and other excipients), orange-yellow colour (E-110), povidone (E-1201) and aspartame (E-951).

Appearance of the product and contents of the pack

normogrip forte oral solution granules is presented in sachets. Each sachet contains white or almost white granules with orange specks.

normogrip forte oral solution granules is available in a pack of 10 sachets.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: February 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/