Leaflet: information for the user

Gripalnorm granulated for oral solution

Paracetamol/Fenilefrine hydrochloride/Chlorphenamine maleate

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

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

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

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

1. What is Gripalnorm and what it is used for

2. What you need to know before starting to take Gripalnorm

3. How to take Gripalnorm

4. Possible side effects

5. Storage of Gripalnorm

6. Contents of the pack and additional information

Gripalnormis an association of paracetamol (a pain reliever that reduces pain and fever), chlorphenamine (an antihistamine that alleviates nasal secretion) and phenylephrine (which acts by reducing nasal congestion).

This medication is indicated for the relief of symptoms of catarrhal or flu-like processes that are accompanied by pain, fever, congestion, and nasal secretion in adults.

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.

Do not take Gripalnorm

- 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 a thyroid disease (hyperthyroidism)

- If you have a severe liver or kidney disease

- If you have a 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 taking a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease)

- If you are taking sympathomimetic medications (medications used to treat asthma or to increase heart rate)

- If you are taking beta-blocker medications (medications for the heart or to treat artery diseases) (see: Taking Gripalnorm with other medications)

- If you have glaucoma (elevated eye pressure)

- Children under 18 years old cannot take this medication

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gripalnorm

- Do not take more medication than recommended in the section 3. How to take Gripalnorm

- Chronic alcoholics should be careful not to take more than 2 g of paracetamol per day (more than 2 packs of Gripalnorm)

- While taking this medication, do not take other medications that contain paracetamol, as it may cause a paracetamol overdose that can damage the liver

- 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 acetylsalicylic acid

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

- Patients taking medications for: benign prostatic hyperplasia, asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer disease, pyloric obstruction, thyroid diseases, patients sensitive to the sedative effects of some medications

- If you are taking tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, stop taking this medication and consult your 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 Gripalnorm, 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

Children and adolescents

Children under 18 years old cannot take this medication

Taking Gripalnorm with other medications

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

You should 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 take more than one medication that contains paracetamol without consulting your doctor

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

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

- Medications for tuberculosis (isoniazid, rifampicin)

- Medications for 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 (MAOIs)). You should separate the administration of Gripalnorm by at least 15 days after completing the treatment

- Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure or other diseases (alpha-blockers)

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

- Medications for 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 can damage the ear)

- Photosensitizing medications (that can cause an allergic reaction to light)

Inform your doctor or pharmacist if you are taking:

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

Interference with laboratory tests:

If you are having any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking/using this medication, as it may alter the results

Taking Gripalnorm with food and drinks

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

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

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 machinery

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

Gripalnorm 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). It may cause asthma, especially in patients allergic to acetylsalicylic acid

This medication contains 30 mg of aspartame in each pack. 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

This medication may cause tooth decay

This medication contains less than 23 mg of sodium (1 mmol) per pack, which is essentially "sodium-free"

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

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

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

You should avoid using high daily doses of paracetamol for prolonged periods of time as this increases the risk of adverse effects such as liver damage.

Use in children and adolescents

This medication is contraindicated in children under 18 years.

Use in older adults

Older adults cannot use this medication without consulting a doctor.

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

Administration form:

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

Always use the smallest effective dose.

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 if the pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

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 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 somnolence), 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, reduced 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 (Telephone 91 562 04 20), indicating the medication and the amount ingested.

Like all medications,Gripalnormmay 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 paresthesias, 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, dryness of the nose and throat, 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 (increase in lung volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Excitement (usually with 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 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) with related chlorphenamine medications. Blood disorders (changes in blood cell formula, 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 alterations.

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

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

Very rarely, severe skin reactions have been reported.

The 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 with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), reduction of peripheral blood vessel diameter (vasoconstriction), reduction of heart function that affects especially 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 disorder), coldness in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With 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 it is about 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 about possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of 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 medication.

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

Do not store at a temperature above 86°F (30°C).

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofGripalnorm

- The active principles 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 aroma (contains glucose in maltodextrin from corn and other excipients), yellow-orange dye (E-110), povidone (E-1201) and aspartame.

Appearance of the product and contents of the packaging

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

Gripalnormis 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)

Date of the last review 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.