GRIPPAL with Pseudoephedrine and Dextromethorphan Hard Capsules

Introduction

Package Leaflet: Information for the User

Grippal with Pseudoephedrine and Dextromethorphan Hard Capsules

Paracetamol / Pseudoephedrine Hydrochloride / Dextromethorphan Hydrobromide / 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 exactly.

• 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. See section 4.
• You should consult your doctor if your condition worsens or does not improve after 5 days of treatment (3 days for fever and for adolescents).

Contents of the Package 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. Storage of Grippal
6. Package Contents and Additional Information

1. What Grippal is and what it is used for

Grippal decongestant and antitussive hard capsules arean association of paracetamol that reduces fever and relieves pain, dextromethorphan that is an antitussive, chlorphenamine that helps reduce nasal secretion, and pseudoephedrine that relieves nasal congestion.

This medication is indicated for the symptomatic relief of colds and flu that present with mild or moderate pain such as headache, fever, unproductive cough (irritative cough, nervous cough), and nasal secretion and congestion for adults and adolescents from 12 years old.

You should consult your doctor if your condition worsens or if symptoms persist after 5 days of treatment in adults or 3 days in adolescents, or if the fever persists for more than 3 days, or if the cough is accompanied by rash or persistent headache.

2. What you need to know before taking Grippal

There is a possibility that one of the active ingredients contained in Grippal, pseudoephedrine, may be abused. Large doses of pseudoephedrine can be toxic. Continuous use can lead to tolerance and cause you to take more Grippal than the recommended dose to achieve the desired effect, which could lead to an increased risk of overdose. Do not exceed the maximum recommended dose or treatment duration (see section 3).

Do not take Grippal

• if you are allergic to the active ingredients or to sympathomimetics such as antihistamine medications or to any of the other components of this medication listed in section 6.

• if you have severe hypertension (high blood pressure) or uncontrolled hypertension or severe coronary artery disease.
  • if you are in the first trimester of pregnancy.
  • if you have severe liver disease.
  • if you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
  • if you have respiratory failure, asthmatic cough, or cough accompanied by expectoration.
  • if you are taking or have taken in the last 2 weeks any of the following medications because it could cause an increase in blood pressure (see section 4.5):
    • MAOI Antidepressants
    • SSRI Antidepressants
    • Bupropion
    • Linezolid
    • Procarbazine
    • Selegiline

• children under 7 years old.

Warnings and Precautions

• Do not take more than the recommended dose in section 3. How to take Grippal.
• Chronic alcoholics should be cautious not to take more than 4 capsules per day (2g of paracetamol).
• Patients who habitually consume alcohol (3 or more alcoholic beverages - beer, wine, liquor, ... per day) may experience liver damage when taking this medication.
• While taking this medication, do not take other medications that contain paracetamol, as this could lead to a paracetamol overdose that could damage the liver. Do not use more than one medication that contains paracetamol without consulting your doctor.
• You should also not take other medications that contain nasal decongestants.

You should consult your doctor or pharmacist before starting to take Grippal:

• Patient with kidney, heart, or lung disease and patients with anemia.
• Patient with liver disease (with or without liver failure) or viral hepatitis, as this increases the risk of hepatotoxicity.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to antihistamines, as they may be sensitive to others (such as chlorphenamine).
• Patient with hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, obstruction of the vesical neck, symptomatic prostatic hypertrophy, difficulty urinating, and urinary obstruction or retention.
• Patient with atopic dermatitis.
• Patient with diabetes mellitus.

There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medications containing pseudoephedrine. PRES and RCVS are rare diseases that can involve reduced blood flow to the brain. Stop using Grippal immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to learn about the symptoms, see section 4 "Possible side effects").

Do not take this medication in case of persistent or chronic cough, such as that caused by smoking, as it may worsen expectoration and increase respiratory resistance.

This medication can cause sedation. Avoid consuming alcoholic beverages and certain medications while being treated with this medication, as they can potentiate this effect. See the sections "Taking Grippal with other medications" and "Taking Grippal with food, beverages, and alcohol".

Patient over 60 years old may be especially sensitive to the adverse effects of the medication due to the pseudoephedrine content, which is a sympathomimetic amine. Overdose of sympathomimetic amines in these patients, over 60 years old, can cause hallucinations, CNS depression, convulsions, and death.

Sedated, debilitated, or bedridden patients should not take this medication.

In rare cases, severe skin reactions with redness, blisters, or rashes can occur. If you notice any of these symptoms, stop treatment and consult your doctor.

It is recommended not to take other medications for cough or nasal congestion at the same time. See "Taking Grippal with other medications".

If you are going to have surgery, you should stop treatment with this medication at least 24 hours in advance.

Sudden abdominal pain or rectal bleeding can occur with the use of Grippal decongestant and antitussive hard capsules due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Grippal decongestant and antitussive hard capsules and contact your doctor or seek immediate medical attention. See section 4.

During treatment with Grippal, inform your doctor immediately if:

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or if you 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 12 years old cannot take this medication due to the dose of its active ingredients.

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 treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medications for treating tuberculosis (isoniazid, rifampicin).
• Medications for preventing blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medications used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for treating hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used for treating gout (probenecid).
• Medications used for treating high blood pressure (hypertension) or for promoting urine elimination (such as beta-blockers like propranolol, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine), and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medications for reducing cholesterol levels in the blood (cholestyramine).
• MAOI inhibitors used for treating depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidone). If you are being treated with any of these, you should separate their administration from the administration of Grippal decongestant and antitussive hard capsules by at least 15 days, both before and after. Otherwise, due to the pseudoephedrine content, it can cause a severe increase in blood pressure, very high fever, and headache.
• Other medications for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications for schizophrenia (such as haloperidol).
• Medications that depress the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which, as an adverse effect, produce allergy to light).
• Medications used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Medications that alkalize urine (sodium bicarbonate, citrates).
• Inhaled anesthetic medications.
• Medications that stimulate the nervous system (amphetamines, xanthines).
• Medications used for the heart (digitalis glycosides).
• Medications used for thyroid diseases (thyroid hormones).
• Medication used for Parkinson's disease treatment (levodopa).
• Medications used for treating angina pectoris (nitrates).
• Cocaine, which, in addition to stimulating the nervous system, can increase the effects on the heart when used with pseudoephedrine.
• Other medications belonging to the pseudoephedrine group (sympathomimetic medications), as they can potentiate the adverse effects of pseudoephedrine.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Interference with analytical tests:

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

Taking Grippal with food, beverages, and alcohol

While taking this medication, you cannot 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 habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) can cause liver damage.

Do not take the medication with grapefruit or bitter orange juice, as it may potentiate the adverse effects of some of its components, dextromethorphan and pseudoephedrine.

Pregnancy, lactation, 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 medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

This medication is contraindicated in the first trimester of pregnancy.

The 4 active ingredients of this medication are excreted in breast milk; therefore, breastfeeding women should not take Grippal decongestant and antitussive hard capsules.

Driving and using machines

Grippal decongestant and antitussive hard capsules can cause sedation. If you experience these effects, avoid driving vehicles or using machines.

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 exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: 1 capsule every 6 or 8 hours (3 or 4 times a day), as needed. Preferably take 1 capsule before bedtime. Do not take more than 4 capsules (equivalent to 2g of paracetamol) per day. See "Warnings and Precautions" section.

Adolescents between 12 and 18 years old: 1 capsule every 6 or 8 hours (3 or 4 times a day) as needed. Preferably take 1 dose before bedtime. Do not exceed 4 doses (equivalent to 2g of paracetamol) per day.

Patient with liver insufficiency: Should consult their doctor. The recommended dose is 1 capsule every 8 hours. Do not take more than 4 capsules (equivalent to 2g of paracetamol) per day.

Patient with kidney insufficiency: Should consult their doctor. The recommended dose is 1 capsule every 6 or 8 hours, depending on the degree of insufficiency.

Use in children

Children under 12 years old cannot take this medication due to the dose of its active ingredients.

Use in elderly

People over 60 years old are often more prone to the stimulating effects of one of the components of this medication (pseudoephedrine), so sometimes the dose should be reduced. Consult your doctor.

How to take

It is taken orally.

Take the capsule with the help of a glass of water.

Always use the smallest effective dose.

Treatment will be discontinued as symptoms disappear.

Consult your doctor if your condition worsens or if symptoms persist after 5 days of treatment in adults or 3 days in adolescents or if the fever persists for more than 3 days or if the cough is accompanied by rash or persistent headache.

If you take more Grippal than you should

Go immediately to a medical center, even if there are no symptoms, as they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The most severe effect of an overdose of the medication is liver damage caused by paracetamol. You may feel dizziness, confusion, excitability, restlessness, nervousness, irritability, insomnia, dilation of the pupils, anxiety, agitation, hallucinations, tremors, convulsions, difficulty urinating, gastrointestinal discomfort, abdominal pain, nausea, and vomiting, loss of appetite, rapid breathing, and difficulty breathing, increased blood pressure, palpitations, alteration of heart rhythm (arrhythmias), tachycardia, and reflex bradycardia, visual disturbances, yellowing of the skin and eyes (jaundice). In children, states of sopor or alterations in gait. In more severe cases, it can cause: decreased potassium levels in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, hypertensive crises, arrhythmias, cerebral hemorrhage, myocardial infarction, rhabdomyolysis, and intestinal ischemic infarction.

Treatment of overdose is most effective if started within 4 hours after ingestion of the medication. Patients being treated 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, if not possible, consult the Toxicology Information Service (telephone: 91 562 04 20), indicating the medication and the amount ingested.

4. Possible Adverse Effects

Like all medicines, Grippal can cause adverse effects, although not all people suffer from them.

The most frequent adverse effects are sedation and somnolence.

During the period of use of the association of paracetamol, chlorphenamine, dextromethorphan, and pseudoephedrine, the following other adverse effects have occurred, whose frequency could not be established with precision:

With unknown frequency (cannot be estimated from the available data): serious diseases that affect the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Stop using Grippal immediately and seek urgent medical attention if you experience symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache
• discomfort
• vomiting
• confusion
• seizures
• changes in vision

Inflammation of the colon due to insufficient blood irrigation (ischemic colitis).

More frequently: nervousness, restlessness, difficulty sleeping, anxiety, muscle tremor. Alteration of taste.

Less frequently: hyperactivity, hyperexcitability, dizziness, headache, uncoordinated movements, tremor, pupil dilation, rapid heartbeats, high blood pressure. Nausea, vomiting, bloody diarrhea. Dermatitis, skin rash. Pain or difficulty urinating. Increased sweating, paleness, and weakness.

Rarely, hallucinations, euphoria, nightmares, screaming, and confusion in children and irritability may occur. Heart rhythm disorders and slow heartbeats, breathing difficulties, and urinary retention, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more common in children and the elderly. Dizziness and hypotension, especially in people over 60 years old.

Very rarely, gastrointestinal disorders, such as abdominal pain, diarrhea, nausea, vomiting, and indigestion (dyspepsia), confusion, dizziness, visual disturbances, increased sensitivity to the sun, dry mouth, sore throat, and difficulty urinating. Skin rashes and severe allergic reactions, such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, as well as increased transaminases, have also been described. High doses or prolonged treatments are toxic to the liver. In very rare cases, infarction, and at very high doses, seizures. Very rare cases of severe skin reactions have been reported.

Simultaneous consumption of alcohol during treatment may increase the appearance of adverse effects. Do not ingest alcoholic beverages during the same period.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es.

5. Storage of Grippal

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

Do not store at a temperature above 30°C.

Do not use this medicine after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

The active ingredients are: 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, 15 mg of dextromethorphan hydrobromide, and 2 mg of chlorphenamine maleate (equivalent to 1.40 mg of chlorphenamine).

The other components (excipients) are: pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, gelatin, erythrosine (E127), yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172).

Appearance of the Product and Package Contents

They are hard gelatin capsules of red color that contain a white or white-yellowish powder.

Each package contains 16 capsules.

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

Date of the Last Revision of this Prospectus:February 2025

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