Gripalnorm granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gripalnorm granules for oral solution

Paracetamol/Phenylephrine hydrochloride/Chlorpheniramine maleate

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Gripalnorm is and what it is used for
2. What you need to know before taking Gripalnorm
3. How to take Gripalnorm
4. Possible adverse effects
5. How to store Gripalnorm
6. Contents of the pack and other information

1. What Gripalnorm is and what it is used for

Gripalnorm 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 associated with colds or influenza, such as pain, fever, nasal congestion, and nasal discharge in adults.

You should consult your doctor if your condition worsens or 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 Gripalnorm

Do not take Gripalnorm

• If you are allergic (hypersensitive) to paracetamol, phenylephrine, chlorpheniramine, or any of the other ingredients of the 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 severe 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 inhibitor (MAOI) drugs (such as certain antidepressants or drugs used to treat Parkinson's disease).
• If you are being treated with sympathomimetic drugs (drugs used to treat asthma or drugs that increase heart rate).
• If you are being treated with beta-blockers (drugs for heart conditions or arterial diseases) (see: Taking Gripalnorm with other medicines).
• If you have glaucoma (increased intraocular pressure).
• Children under 18 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Gripalnorm:

• Do not take more medicine than the recommended dose stated in section 3, "How to take Gripalnorm".

• Chronic alcoholics should take care not to take more than 2 g of paracetamol per day (more than 2 sachets of Gripalnorm).

• While taking this medicine, do not take other medicines containing paracetamol, as this could lead to paracetamol overdose and possible liver damage.

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

• Patients with kidney, liver, heart, or lung disease, or 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 being treated with drugs for: prostate enlargement, bronchial asthma, very slow heartbeat, 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 drugs 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 Gripalnorm, 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 in these situations when paracetamol is used at regular doses 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, malaise (nausea), and vomiting.

Children and adolescents

Children under 18 years of age must not take this medicine.

Taking Gripalnorm with other medicines

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

The simultaneous use of this medicine with other medicines containing paracetamol (e.g., cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

In particular, if you are taking any of the following medicines, dose adjustments, a minimum 15-day separation between administrations, or discontinuation of treatment may be necessary:

• 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 potassium-depleting diuretics (such as diuretics used to treat hypertension or other conditions).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used to treat 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 Gripalnorm should 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 anesthetics.
• 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 (atropine sulfate).
• Medicines that cause central nervous system depression (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 (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Interference with laboratory 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.

Taking Gripalnorm with food and drinks

While being treated with this medicine, you must not drink alcoholic beverages, as they may increase the risk of adverse effects of this medicine.

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

This medicine may 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 or operating machinery.

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

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

This medicine contains 30 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in individuals 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 with him before taking this medicine.

It may cause dental caries.

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

3. How to take Gripalnorm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

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

Patients with liver or kidney disease: You must consult your doctor (see section 2 – What you need to know before taking this medicine).

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

Use in children and adolescents

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

Use in elderly patients

Elderly individuals must not use this medicine without first consulting a doctor.

This is because they may be particularly affected by certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorpheniramine. They may also be more likely to experience adverse effects such as sedation, confusion, hypotension, or agitation, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration:

For oral use. The contents of the sachet must be completely dissolved in a small amount of liquid, preferably half a glass of water, before drinking.

Always use the lowest effective dose.

Duration of treatment:

This medicine should be taken only while symptoms are present. 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, discontinue treatment and consult your doctor.

If you take more Gripalnorm than you should

Consult your doctor or pharmacist immediately.

If you have ingested 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, 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, fainting sensation, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (fast or irregular heartbeats), palpitations, reduced urine output. Metabolic acidosis (decreased alkaline reserve in the blood). With prolonged use, depletion of plasma volume (reduced blood volume) may occur. Overdose may also cause: coagulation disorders (blood clots and bleeding).

Treatment for overdose is most effective if started within 4 hours after ingestion.

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 (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Gripalnorm may produce adverse effects, although not everyone will experience them.

During the period of use of paracetamol, phenylephrine, and chlorpheniramine, the following adverse effects have been reported, although their frequency has not been precisely 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 levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses and more frequently in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even seizures. 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 as 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 drugs related to chlorpheniramine. Blood disorders (changes in blood cell counts, 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 infrequently (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 of occurrence is unknown are: Anxiety, irritability, weakness, increased blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduction in blood vessel diameter (peripheral vasoconstriction), reduced cardiac performance especially affecting elderly patients and those with poor cerebral or coronary circulation, possible induction or worsening of heart disease, urinary retention, pallor, piloerection (goosebumps), increased blood sugar (hyperglycaemia), low potassium levels in the blood, metabolic acidosis (a metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling faint (hypotension). With high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; prolonged use may lead to decreased blood volume. A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use 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 Pharmacovigilance System for 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 Gripalnorm

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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 drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Gripalnorm

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

Appearance of the product and contents of the pack

Gripalnorm is presented in sachets. Each sachet contains a white or almost white granule with orange specks.

Gripalnorm is available in a pack containing 10 sachets.

Marketing Authorization Holder and Manufacturer

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

Date of the most recent revision 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.