GRIPPAL with Phenylephrine ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Grippal® with Phenylephrine Granules for Oral Solution

Paracetamol / Phenylephrine Bitartrate / Chlorphenamine Maleate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.
• You should consult your doctor if your symptoms worsen or do not improve, or if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the Package Leaflet:

1. What is Grippal and what is it used for
2. What you need to know before taking Grippal
3. How to take Grippal
4. Possible side effects
5. Storage of Grippal
6. Package Contents and Additional Information

1. What is Grippal and what is it used for

It is an association of 3 active ingredients, paracetamol, chlorphenamine, and phenylephrine. Paracetamol is an analgesic that reduces pain and fever. Chlorphenamine is an antihistamine that relieves nasal secretion, and phenylephrine acts by reducing nasal congestion.

It is indicated in adults and adolescents from 15 years old for the relief of symptoms of colds and flu that occur with fever or mild to moderate pain, congestion, and nasal secretion.

You should consult your doctor if your symptoms worsen or do not improve, or if the fever persists for more than 3 days or the 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 ingredients or to any of the other components of this medication (listed in section 6).
• If you have arterial hypertension.
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: Taking Grippal with other medications).
• If you have glaucoma (high eye pressure).
• 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 old cannot take this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication.

• Do not take more medication than recommended in section 3: How to take Grippal.

• Avoid simultaneous use of this medication with other medications that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

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

• Patients with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.

• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

• Patient sensitive (allergic) to an antihistamine, because they may be sensitive to other antihistamines (such as chlorphenamine).

• Patient who are being treated with medications for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patients sensitive to the sedative effects of some medications.

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

During treatment with Grippal, inform your doctor immediately if:

If you have serious 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 are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and Adolescents

Children under 15 years old cannot take this medication.

Taking Grippal with other medications

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

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

• Medications for tuberculosis: (isoniazid, rifampicin).

• Medications for convulsions and depression (barbiturics), used as hypnotics, sedatives, and anticonvulsants.

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

• Medications used to increase urine elimination (diuretics such as furosemide and others) and other diuretics that cause potassium loss (such as diuretics for hypertension and others).

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

• Medications used to treat gout (probenecid and sulfinpyrazone).

• Medications used to treat high blood pressure and heart rhythm disorders (propranolol).

• Medications used to lower cholesterol levels in the blood (cholestyramine).

• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). Grippal and these medications should be taken at least 15 days apart.

• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).

• Alpha and beta-adrenergic blocking medications (labetalol and carvedilol) used for the heart or to treat arterial diseases.

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

• Medications used for general anesthesia.

• Antihypertensive medications used to lower blood pressure.

• Medications used for the heart, such as cardiac glycosides and antiarrhythmics.

• Medications containing thyroid hormones (used to treat thyroid diseases).

• Medications used for heart diseases or digestive diseases, such as atropine sulfate.

• Medications that produce depression of the central nervous system, such as those used for insomnia or anxiety.

• Ototoxic medications (which have the adverse effect of damaging the ear).

• Photosensitizing medications (which have the adverse effect of producing allergy to light).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that should be treated urgently (see section 2).

Interference with analytical tests:

If you are going to have any analytical test (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Grippal with food, drinks, and alcohol

While being treated with this medication, you should not consume alcoholic beverages, as it may enhance the appearance of adverse effects of this medication.

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

The medication 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 taking this medication.

This medication should not be taken during pregnancy unless your doctor considers it strictly necessary.

This medication should not be taken by mothers during breastfeeding, as it may produce adverse effects in the baby.

Driving and Using Machines

This medication may cause drowsiness. If you experience drowsiness during treatment with this medication, avoid driving vehicles or using machines.

Warnings about Excipients

Grippal contains Mannitol (E-421).

This medication may produce a mild laxative effect because it contains mannitol.

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

3. How to take Grippal

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 15 years old: 1 sachet (650 mg of paracetamol) every 6-8 hours as needed (3 or 4 sachets per day).

Do not take more than 3 grams of paracetamol every 24 hours (see section: Warnings and Precautions).

Patient with liver or kidney disease: Should consult their doctor (see section 2: What you need to know before taking Grippal).

Use in Children

This medication is contraindicated in children under 15 years old.

Use in Elderly

Elderly people cannot use this medication without consulting their doctor, as some adverse effects of the medication, such as slow heartbeats (bradycardia) or reduced cardiac output, due to phenylephrine and chlorphenamine, may affect them especially. It is also more likely that they may experience adverse effects such as sedation, confusion, hypotension, or excitement, 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 little liquid, preferably half a glass of water, and then drink.

Always take the smallest effective dose.

Treatment with this medication is subject to the appearance of symptoms. As they disappear, you should suspend treatment.

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

If you take more Grippal than you should

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice 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 (the latter especially in children). Dry mouth, nose, or throat. You may also notice effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, decreased urine output, metabolic acidosis (decrease in blood alkaline reserve). In case of prolonged use, a decrease in blood volume may occur.

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

Patient treated with barbiturics 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 medication and the amount ingested.

4. Possible Side Effects

Like all medications, Grippal may produce side effects, although not all people 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 more 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 tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

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

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

Nervous excitement (usually with high doses, and more frequent 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 pain or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of the eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood disorders (changes in the blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disorders, impotence, menstrual disorders.

• The side effects that may appear with very low frequency (very rare) are:Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

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

Very rare cases of severe skin reactions have been reported.

• The side effects whose frequency of appearance is not known 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 (severe bradycardia), reduction of peripheral blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that especially affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium levels in the blood, metabolic acidosis (alteration of metabolism), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; in prolonged use, a decrease in blood volume may occur. A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

5. Storage of Grippal

Keep out of sight and reach of children.

Do not use Grippalafter the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Grippal Composition

Each sachet contains:

• As active ingredients: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).
• The other components (excipients) are: Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor (containing maltodextrin, which is a corn starch derivative) and povidone.

Product Appearance and Package Contents

Grippal is a white or yellowish-white oral solution granulate with an orange flavor, presented in sachets packaged in cardboard boxes 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 leaflet was approved in February 2025.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/