Grippal with pseudoephedrine and dextromethorphan hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Grippal with Pseudoephedrine and Dextromethorphan hard capsules

Paracetamol / Pseudoephedrine hydrochloride / Dextromethorphan hydrobromide / 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 as indicated 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 effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if you do not improve after 5 days of treatment (3 days for fever and for adolescents).

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 adverse 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 decongestant and antitussive hard capsules is a combination of paracetamol, which reduces fever and relieves pain; dextromethorphan, an antitussive; chlorpheniramine, which helps reduce nasal secretions; and pseudoephedrine, which relieves nasal congestion.

This medicine is indicated for the symptomatic relief of colds and flu associated with mild to moderate pain such as headache, fever, dry cough (irritative cough, nervous cough), and nasal secretion and congestion, in adults and adolescents aged 12 years and older.

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

2. What you need to know before taking Grippal

One of the active substances in Grippal, pseudoephedrine, may be subject to abuse. High doses of pseudoephedrine can be toxic. Prolonged use may lead to tolerance and result in taking more Grippal than the recommended dose to achieve the desired effect, which could increase the risk of overdose. Do not exceed the maximum recommended dose or the recommended duration of treatment (see section 3).

Do not take Grippal

• if you are allergic to the active substances or to sympathomimetic drugs such as antihistamines, or to any of the other components of this medicine listed in section 6.

• if you have severe hypertension (high blood pressure) or uncontrolled hypertension by medication, or severe coronary artery disease.

  • if you are in the first trimester of pregnancy.
  • if you have severe liver disease.
  • if you have severe acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
  • if you have respiratory insufficiency, asthmatic cough, or cough with expectoration.
  • if you are taking or have taken within the last 2 weeks any of the following medicines, as they may cause an increase in blood pressure (see section 4.5):
  • MAOI antidepressants
  • Serotonin reuptake inhibitor antidepressants (SSRIs)
  • Bupropion
  • Linezolid
  • Procarbazine
  • Selegiline

• children under 7 years of age.

Warnings and precautions

• Do not take more than the recommended dose stated in section 3. How to take Grippal.
• Chronic alcoholics should take care not to take more than 4 capsules per day (2 g of paracetamol).
• Patients who regularly consume alcohol (3 or more alcoholic drinks - beer, wine, spirits, etc. - per day) may experience liver damage when taking this medicine.
• While taking this medicine, do not take other medicines containing paracetamol, as this could lead to a paracetamol overdose that may damage the liver. Do not use more than one medicine containing paracetamol without consulting your doctor.
• You should also avoid taking other medicines containing nasal decongestants.

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

• have kidney, heart, or lung disease, or if you have anemia.
• have liver disease (with or without hepatic insufficiency) or viral hepatitis, as this increases the risk of hepatotoxicity.
• are asthmatic and sensitive to acetylsalicylic acid.
• are sensitive (allergic) to an antihistamine, as you may also be sensitive to others (such as chlorpheniramine).
• have hypertension (high blood pressure), glaucoma (increased eye pressure), hyperthyroidism, bladder neck obstruction, symptomatic prostatic hypertrophy, difficulty urinating, or urinary obstruction or retention.
• have atopic dermatitis.
• have diabetes mellitus.

Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Grippal immediately and seek immediate medical attention if you experience symptoms that could be signs of RPES or RCVS (see section 4 "Possible side effects" for symptoms).

Do not take this medicine for persistent or chronic cough such as that caused by smoking, as it may impair expectoration and thereby increase airway resistance.

This medicine may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while being treated with this medicine, as they may enhance this effect. See the sections “Taking Grippal with other medicines” and “Taking Grippal with food, drinks and alcohol”.

Patients over 60 years of age may be especially sensitive to the adverse effects of the medicine due to its content of pseudoephedrine, a sympathomimetic amine. Overdose of sympathomimetic amines in these patients over 60 years of age may cause hallucinations, central nervous system depression, seizures, and death.

Sedated, weakened, or bedridden patients should not take this medicine.

Rarely, severe skin reactions may occur, including redness, blisters, or rashes. If you notice any of these symptoms, stop treatment and consult your doctor.

It is recommended not to take other cough or nasal decongestant medicines at the same time. See “Taking Grippal with other medicines”.

If you are scheduled for surgery, you must stop treatment with this medicine at least 24 hours beforehand.

Sudden abdominal pain or rectal bleeding may occur with the use of Grippal decongestant and antitussive hard capsules due to inflammation of the colon (ischaemic colitis). If these gastrointestinal symptoms occur, 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:

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 if you 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 12 years of age must not take this medicine due to the dosage of its active substances.

Taking Grippal with other medicines

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

In particular, if you are using any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• Medicines to treat epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines to treat tuberculosis (isoniazid, rifampicin).
• Medicines used to prevent blood clots (oral anticoagulants) such as 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 others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid).
• Medicines used to treat high blood pressure (hypertension) or to promote urine elimination (such as beta-blockers like propranolol, ACE inhibitors, rauwolfia alkaloids such as reserpine, methyldopa, guanethidine), and for cardiac arrhythmias, such as amiodarone or quinidine.
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Monoamine oxidase inhibitor (MAOI) medicines used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson’s disease (selegiline), or other conditions such as cancer (procarbazine), infections (linezolid, furazolidone). If you are being treated with any of these, administration of Grippal decongestant and antitussive hard capsules must be separated by at least 15 days before and after. Otherwise, because it contains pseudoephedrine, it may cause severe increase in blood pressure, very high fever, and headache.
• Other medicines used to treat depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for schizophrenia (such as haloperidol).
• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety, for Parkinson’s disease, or for allergies).
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which cause light allergy as an adverse effect).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Urine-alkalinizing medicines (sodium bicarbonate, citrates).
• Inhalational anesthetics.
• Central nervous system stimulants (amphetamines, xanthines).
• Medicines used for heart conditions (digitalis glycosides).
• Medicines used for thyroid disorders (thyroid hormones).
• Medicine used to treat Parkinson’s disease (levodopa).
• Medicines used to treat angina pectoris (nitrates).
• Cocaine, which, in addition to stimulating the central nervous system, when used with pseudoephedrine may increase effects on the heart.
• Other medicines belonging to the pseudoephedrine group (sympathomimetic medicines), as they may enhance its adverse effects.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Interference with diagnostic tests:

If you are scheduled to undergo any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Grippal with food, drinks, and alcohol

While taking this medicine, you must not consume alcoholic beverages, as they may increase the likelihood of adverse effects from this medicine.

In addition, the use of medicines containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic drinks—beer, wine, liquor, etc.—per day) may cause liver damage.

Do not take this medicine together with grapefruit juice or bitter orange juice, as they may enhance the adverse effects of some of its components, dextromethorphan and pseudoephedrine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

This medicine is contraindicated during the first trimester of pregnancy.

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

Driving and operating machinery

Grippal decongestant and antitussive hard capsules may cause drowsiness. If you experience this effect, avoid driving vehicles or operating machinery.

3. How to take Grippal

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:

Adults: 1 capsule every 6 or 8 hours (3 or 4 times daily), as needed. Preferably take 1 capsule before going to bed. Do not exceed 4 capsules (equivalent to 2 g of paracetamol) per day. See section “Warnings and precautions”.

Adolescents aged 12 to 18 years: 1 capsule every 6 or 8 hours (3 or 4 times daily), as needed. Preferably take 1 dose before going to bed. Do not exceed 4 doses (equivalent to 2 g of paracetamol) per day.

Patients with hepatic impairment: Must consult their doctor. The recommended dose is 1 capsule every 8 hours. Do not exceed 4 capsules (equivalent to 2 g of paracetamol) per day.

Patients with renal impairment: Consult your doctor. The recommended dose is 1 capsule every 6 or 8 hours, depending on the degree of renal impairment.

Use in children

Children under 12 years of age must not take this medicine due to the dose of its active ingredients.

Use in elderly people

Individuals over 60 years of age are often more susceptible to the stimulant effects of one of the components of this medicine (pseudoephedrine), so the dose may sometimes need to be reduced. Consult your doctor.

How to take

Take orally.

Swallow the capsule with a glass of water.

Always use the lowest effective dose.

Treatment should be discontinued as symptoms resolve.

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

If you take more Grippal than you should

Seek immediate medical attention, even if you have no symptoms, as symptoms often do not appear until 3 days after overdose ingestion, even in cases of severe poisoning.

The most serious effect of overdose is liver damage caused by paracetamol. You may experience dizziness, confusion, excitability, restlessness, nervousness, irritability, insomnia, pupil dilation, anxiety, agitation, hallucinations, tremor, seizures, difficulty urinating, gastrointestinal discomfort, abdominal pain, nausea and vomiting, loss of appetite, rapid and difficult breathing, increased blood pressure, palpitations, heart rhythm disturbances (arrhythmias), tachycardia and reflex bradycardia, visual disturbances, yellowing of the skin and eyes (jaundice). In children, drowsiness or disturbances in gait may occur. In more severe cases, the following may occur: decreased potassium levels in the blood (hypokalaemia), mental disorder with altered perception of reality (psychosis), seizures, coma, hypertensive crises, arrhythmias, cerebral haemorrhage, myocardial infarction, rhabdomyolysis, and ischaemic intestinal infarction.

Treatment of overdose is most effective if started within 4 hours of ingestion of the medicine. 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, seek immediate medical attention or, if not possible, contact the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount ingested.

4. Possible adverse effects

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

The most common adverse effects are sedation and somnolence.

During the period of use of the combination of paracetamol, chlorpheniramine, dextromethorphan, and pseudoephedrine, the following other adverse effects have occurred, whose frequency could not be established accurately:

Frequency not known (cannot be estimated from available data): serious conditions affecting the blood vessels of the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS). A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

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

• sudden, severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

Ischaemic colitis (inflammation of the colon due to insufficient blood supply).

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

Less frequently: hyperactivity, hyperexcitability, dizziness, headache, uncoordinated movements, tremor, dilated pupils, rapid heartbeat, elevated blood pressure. Nausea, vomiting, bloody diarrhoea. Dermatitis, skin rash. Pain or difficulty urinating. Increased sweating, pallor, and weakness.

Rarely, hallucinations, euphoria, nightmares, shrieking, and confusion in children and irritability may occur. Cardiac rhythm disturbances and slow heartbeats, breathing difficulties, urinary retention, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more common in children and elderly patients. Dizziness and hypotension, especially in patients over 60 years of age.

Very rarely, gastrointestinal discomfort such as abdominal pain, diarrhoea, nausea, vomiting, and indigestion (dyspepsia), confusion, dizziness, visual disturbances, increased sensitivity to sunlight, dry mouth, sore throat, and difficulty urinating. Skin rashes and serious allergic reactions have also been reported, such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, as well as increased transaminase levels. High doses or prolonged treatment are hepatotoxic. In very rare cases, myocardial infarction, and at very high doses, seizures. Very rare cases of serious skin reactions have also been reported.

Concomitant consumption of alcohol during treatment may increase the occurrence of adverse effects. Do not consume alcoholic beverages during treatment.

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es.

5. Storage of Grippal

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging 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. Unused containers and medicines should be handed in at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

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

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

Appearance of the product and contents of the pack

Hard red gelatin capsules containing a white or yellowish-white powder.

Each pack contains 16 capsules.

Marketing Authorization Holder

Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

Manufacturer responsible for manufacturing

Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain

Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/