Grippal with phenylephrine granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Grippal ® with phenylephrine granules for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorpheniramine maleate

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

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects not listed in this leaflet.
• 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.

Contents of the leaflet:

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

1. What Grippal is and what it is used for

Grippal is a combination of three active substances: paracetamol, chlorpheniramine, and phenylephrine. Paracetamol is an analgesic that reduces pain and fever. Chlorpheniramine is an antihistamine that relieves nasal discharge, and phenylephrine works by reducing nasal congestion.

It is indicated in adults and adolescents aged 15 years and older for the relief of symptoms of colds and flu accompanied by fever or mild to moderate pain, nasal congestion, and nasal discharge.

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 Grippal

Do not take Grippal

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have hyperthyroidism.
• 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 to increase heart rate).
• If you are being treated with beta-blockers (medicines for heart conditions or to treat arterial diseases) (see: Taking Grippal with other medicines).
• If you have glaucoma (high pressure in the eye).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).
  • If you have a serious liver or kidney disease.

Children under 15 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

• Do not take more medicine than the recommended dose stated in section 3: How to take Grippal.

• Avoid using this medicine together with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

• Chronic alcoholics should take care not to take more than 3 sachets per day of Grippal.

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

• Patients with kidney, liver, heart, or lung diseases, 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 chlorphenamine).

• Patients who are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heartbeat, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between the 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).

During treatment with Grippal, 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 imbalance 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

Children under 15 years of age must not take this medicine.

Taking Grippal 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 taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• 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.

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

• Medicines used to increase urine elimination (loop diuretics such as furosemide, or others) and other diuretics that cause potassium loss (such as diuretics used to treat hypertension or others).

• 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 (propranolol).

• Medicines used to lower blood cholesterol levels (cholestyramine).

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Grippal and these medicines must be taken at least 15 days apart.

• 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 blocking agents (labetalol and carvedilol) used for heart conditions or arterial diseases.

• Medicines used to treat depression of the tricyclic and tetracyclic antidepressant type.

• Medicines used for general anesthesia.

• Antihypertensive medicines used to lower blood pressure.

• Medicines for the heart such as cardiac glycosides and antiarrhythmics.

• Medicines containing thyroid hormones (used to treat thyroid disorders).

• Medicines used for heart conditions or digestive disorders such as atropine sulfate.

• Medicines that cause central nervous system depression, such as those used for insomnia or anxiety.

• Ototoxic medicines (those that have the adverse effect of damaging the ear).

• Photosensitizing medicines (those that cause light allergy as an adverse effect).

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap), which requires urgent treatment (see section 2).

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Grippal with food, drinks, and alcohol

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

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 are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

This medicine must not be taken during pregnancy unless your doctor considers it strictly necessary.

Breastfeeding mothers must not take this medicine, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness. If you experience drowsiness during treatment with this medicine, avoid driving or operating machinery.

Warnings about excipients

Grippal contains mannitol (E-421).

This medicine may produce a mild laxative effect due to the presence of mannitol.

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

3. How to take Grippal

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 and adolescents aged 15 years and older: 1 sachet (650 mg of paracetamol) every 6–8 hours as needed (3 or 4 sachets per day).

Do not exceed 3 grams of paracetamol in any 24-hour period (see section: Warnings and precautions).

Use in children

This medicine is contraindicated in children under 15 years of age.

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 heart rate (bradycardia) or reduced cardiac output, due to phenylephrine and chlorpheniramine. They are also 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.

How to take

Grippal is taken orally. Dissolve the contents of the sachet completely in a small amount of liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

This medicine should only be taken when symptoms appear. As symptoms subside, treatment should be discontinued.

If fever persists for more than 3 days of treatment, or pain or other symptoms last more than 5 days, or worsen or new symptoms appear, consult your doctor.

If you take more Grippal than you should

If you have taken an overdose, you must go immediately to a medical center even if you do not feel any 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 (the latter especially in children). Dryness of the mouth, nose, or throat. You may also experience effects such as high blood pressure, arrhythmias (fast or irregular heartbeat), palpitations, decreased urine output, metabolic acidosis (decreased blood alkaline reserve). With prolonged use, a reduction in blood volume may occur.

Treatment of overdose is most effective if started within 4 hours after the overdose has been taken.

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, Grippal may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported during the use of paracetamol, phenylephrine, and chlorpheniramine, although their frequency has not been precisely established:

• The 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.

• The 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 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 common 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 rales, 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 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 count, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disorders.

• The 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 hypoglycemia (low blood sugar).

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

Very rare cases of serious skin reactions have been reported.

• Adverse effects whose frequency is unknown are: Anxiety, irritability, weakness, increased blood pressure (hypertension, generally with 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 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 (hyperglycemia), low blood potassium, metabolic acidosis (a metabolic disturbance), cold extremities (arms or legs), flushing, sensation of fainting (hypotension). At high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur. A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness taking 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.

5. Storage of Grippal

Keep out of the sight and reach of children.

Do not use Grippal after the expiry date shown on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Grippal

Each sachet contains:

• Active substances: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine), and 4 mg of chlorpheniramine maleate (equivalent to 2.8 mg of chlorpheniramine).
• Other components (excipients): Mannitol (E-421), sodium saccharin, colloidal anhydrous silica, orange flavour (containing maltodextrin, a derivative of maize starch), and povidone.

Appearance of the medicinal product and contents of the pack

Grippal is an oral granular formulation for solution, white or slightly yellowish-white in colour, with an orange flavour. It is supplied in sachets, packed in cardboard packs containing 10 sachets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid), Spain

This summary of product characteristics was approved in February 2025.

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/