PHARMAGRIP TOS Y CONGESTIÓN ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the Patient

Pharmagrip Cough and Congestionpowder for oral solution

Paracetamol / Pseudoephedrine sulfate / Dextromethorphan hydrobromide

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

Follow the instructions for administration of the medicine contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

Contents of the Package Leaflet

1. What is Pharmagrip Cough and Congestion and what is it used for
2. What you need to know before you start taking Pharmagrip Cough and Congestion
3. How to take Pharmagrip Cough and Congestion
4. Possible side effects
5. Storage of Pharmagrip Cough and Congestion
6. Contents of the pack and further information

1. What is Pharmagrip Cough and Congestion and what is it used for

Paracetamol belongs to the group of medicines called analgesics and antipyretics, which reduces pain and fever. Pseudoephedrine belongs to the group of medicines called nasal decongestants. Dextromethorphan belongs to the group of medicines called antitussives.

This medicine is indicated for the symptomatic relief of colds and flu that are accompanied by pain, fever, nasal congestion, and unproductive cough (irritative and nervous). For individuals over 12 years of age.

You should consult a doctor if your symptoms worsen or do not improve or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

2. What you need to know before you start taking Pharmagrip Cough and Congestion

This medicine can cause dependence. Therefore, treatment should be of short duration.

There is a possibility that one of the active ingredients in Pharmagrip Cough and Congestion, pseudoephedrine, may be abused. Large doses of pseudoephedrine can be toxic. Continuous use can lead to tolerance and may cause you to take more Pharmagrip Cough and Congestion 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 takePharmagrip Cough and Congestion

• If you are allergic to paracetamol, pseudoephedrine, dextromethorphan, or any of the other components of this medicine (listed in section 6).
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• If you have a serious heart or coronary disease.
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• If you have angle-closure glaucoma (nerve damage with high eye pressure).
• If you have hyperthyroidism.
• If you have any serious lung disease.
• If you have chronic or persistent cough due to diseases such as emphysema or asthma, or if you have a cough accompanied by excessive secretions.
• If you are being treated or have been treated in the past 2 weeks with certain medicines called monoamine oxidase inhibitors (MAOIs) (such as some antidepressants or medicines for Parkinson's disease, etc.) (see "Other medicines and Pharmagrip Cough and Congestion").
• If you are pregnant and in the first trimester of pregnancy.
• If you have respiratory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pharmagrip Cough and Congestion.

Due to its Paracetamolcontent:

• Do not take more than the recommended dose of medicine. See section 3, "How to take Pharmagrip Cough and Congestion".
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• The following patients should consult their doctor before taking this medicine:
• patients with anemia, heart, lung, kidney, or liver disease, as prolonged treatment is not recommended (in the case of liver disease, occasional use is acceptable, but prolonged administration of high doses may increase the risk of adverse effects);
• asthmatic patients sensitive to acetylsalicylic acid;
• patients who habitually consume alcohol (3 or more alcoholic beverages per day), as this medicine can cause liver damage.
• Chronic alcoholic patients should not take more than 2 grams of paracetamol per day (4 sachets).
• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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.

Due to its Pseudoephedrinecontent:

• Do not take this medicine with other medicines that contain nasal decongestants.
• Consult your doctor before taking this medicine if you have:

• cardiovascular disease, such as arrhythmias or cardiac ischemia (narrowing of an artery reducing oxygen supply to the heart);
• diabetes mellitus (may increase blood glucose levels);
• high eye pressure (glaucoma or predisposition to it);
• enlarged prostate (may increase urine retention);
• kidney disease;
• a tumor of the adrenal gland that produces hormones affecting heart rate and blood pressure (pheochromocytoma).

With Pharmagrip Cough and Congestion, blood flow to the optic nerve may be reduced. If you experience sudden loss of vision, stop taking Pharmagrip Cough and Congestion and contact your doctor or seek immediate medical attention. See section 4.

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

• Patient over 60 years of age may be especially sensitive to the adverse effects of sympathomimetic amines (medicines for the treatment of depression). Overdose of these amines in patients over 60 years of age can cause hallucinations, central nervous system depression, convulsions, and death.

Sudden abdominal pain or rectal bleeding may occur with the use of Pharmagrip Cough and Congestion due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Pharmagrip Cough and Congestion and contact your doctor or seek immediate medical attention. See section 4.

Due to its Dextromethorphancontent:

• Do not administer in case of sedated, debilitated, or bedridden patients.
• Consult your doctor before taking this medicine:
• patients with liver disease, as dextromethorphan metabolism may be altered, to establish the most suitable dosage regimen;
• patients with persistent or chronic cough, such as that caused by smoking, as dextromethorphan may prevent the expulsion of mucus;
• patients with atopic dermatitis (allergic skin disease characterized by itching, redness, or other lesions, often in individuals with a hereditary predisposition);
• if you are taking other medicines such as antidepressants or antipsychotics, Pharmagrip Cough and Congestion may interact with these medicines, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Cases of abuse with medicines containing dextromethorphan have been described in adolescents. Therefore, this possibility should be taken into account, as serious adverse effects may occur (see "If you take more Pharmagrip Cough and Congestion than you should").

Children and adolescents

Do not use in children under 12 years of age.

Other medicines andPharmagrip Cough and Congestion

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

Interactions due to paracetamol

• oral anticoagulants (acenocoumarol, warfarin)
• antiepileptics (lamotrigine, phenytoin, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• ethanol
• oral contraceptives and estrogen treatments
• antibiotics (chloramphenicol)
• antituberculars (isoniazid, rifampicin)
• barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• activated charcoal used for diarrhea or gas treatment
• cholestyramine (used to decrease blood cholesterol levels)
• medicines used for gout treatment (probenecid and sulfinpyrazone)
• certain medicines used to increase urine elimination (loop diuretics such as furosemide)
• medicines used for relief of stomach, intestine, and bladder spasms or contractions (anticholinergics)
• metoclopramide and domperidone (used to prevent nausea and vomiting)
• propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).

Also, inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Interactions due to pseudoephedrine

Do not take this medicine during treatment or in the 2 weeks following treatment with medicines of the type of monoamine oxidase inhibitors (MAOIs) such as those listed below, as adverse effects such as severe hypertension, arrhythmias, vomiting, and headache may occur:

• antidepressants such as moclobemide or tranylcypromine
• linezolid (used as an antibacterial)
• procarbazine (used to treat cancer)
• selegiline (used to treat Parkinson's disease).

Do not take this medicine with other medicines for relieving nasal congestion.

If you are using any of the following medicines, it may be necessary to modify the dose of one of them or interrupt treatment:

• urinary alkalinizers (sodium bicarbonate, citrates)
• medicines used for the heart (digitalis glycosides)
• central nervous system stimulants (amphetamines, xanthines)
• inhalation anesthetics
• certain medicines used to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, methyldopa, guanethidine, rauwolfia alkaloids such as reserpine)
• thyroid hormones (used for thyroid diseases)
• levodopa (used to treat Parkinson's disease)
• nitrates (used to treat angina pectoris)
• cocaine
• other sympathomimetics.

Interactions due to dextromethorphan

Do not take this medicine during treatment or in the 2 weeks following treatment with medicines of the type of:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide or tranylcypromine, procarbazine (used to treat cancer), selegiline (used to treat Parkinson's disease), or linezolid (used as an antibacterial)
• serotonin reuptake inhibitor antidepressants (SSRIs) such as fluoxetine and paroxetine
• serotonergic drugs such as bupropion or sibutramine (used to treat obesity)
• as serious adverse effects such as high blood pressure (hypertension), excitement, and sweating, among other symptoms, may occur.

If you are using any of the following medicines, it may be necessary to modify the dose of one of them or interrupt treatment:

• medicines that produce central nervous system depression (some used for mental illnesses, allergies, Parkinson's disease, etc.)
• anti-inflammatory medicines (celecoxib, parecoxib, valdecoxib)
• antiarrhythmic medicines for treating heart arrhythmias (amiodarone or quinidine)
• haloperidol (used to treat mental disorders)
• mucolytic expectorants.

Interference with laboratory tests:

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

TakingPharmagrip Cough and Congestionwith food, drinks, and alcohol

Limit the consumption of beverages containing caffeine (coffee, tea, chocolate, and cola-based drinks) while taking this medicine.

Do not consume alcoholic beverages during treatment, as this may increase the occurrence of adverse reactions.

Do not take with grapefruit or bitter orange juice.

Pregnancy and breastfeeding

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.

Do not use Pharmagrip Cough and Congestion, due to pseudoephedrine, during the first trimester of pregnancy, as it may cause malformations of the digestive system and face of the newborn, with a higher risk in smoking women, and during the remaining months of pregnancy, only under medical prescription.

Breastfeeding women should not take this medicine, as paracetamol passes into breast milk and pseudoephedrine also in small amounts, which may cause adverse effects in the infant.

Driving and using machines

On rare occasions, during treatment, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

Pharmagrip Cough and Congestioncontains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Pharmagrip Cough and Congestion contains sorbitol (E-420)

This medicine contains 10 mg of sorbitol (E-420) in each sachet.

Pharmagrip Cough and Congestion contains amaranth (E-123)

This medicine may cause allergic reactions because it contains amaranth (E-123). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Pharmagrip Cough and Congestioncontains sodium

This medicine contains 60.84 mg of sodium (main component of table salt) in each sachet. This is equivalent to 3% of the maximum recommended daily intake of sodium for an adult.

3. How to take Pharmagrip cough and congestion

Follow the administration instructions of the medicine contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:the recommended dose is 1 sachet every 4, 6, or 8 hours (6, 4, or 3 times a day) as needed. Do not take more than 3 grams of paracetamol (6 sachets) in 24 hours. See the "Warnings and precautions" section.

Adolescents (from 12 years old) weighing over 43 kg:the recommended dose is 1 sachet 3 or 4 times a day, as needed. The doses should be spaced at least 4 hours apart. Do not exceed 5 sachets every 24 hours.

Patients with liver or kidney disease: must consult their doctor before taking this medicine. If your doctor prescribes this medicine, you should wait at least 8 hours between two doses.

People over 60 years old: the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

Use in children and adolescents

This medicine is not indicated for children under 12 years old.

This medicine is administered orally.

Pour the contents of a sachet into a half glass of water and stir until it is completely dissolved.

Take once dissolved.

If the medicine is taken at night, it should be taken a few hours before bedtime to reduce the possibility of insomnia in patients with difficulty sleeping.

The administration of this medicine is subject to the appearance of pain or fever. As these disappear, this medication should be suspended.

If the fever persists for more than 3 days, the pain for more than 5 days, or the symptoms worsen or others appear such as high fever, skin rash, or persistent headache, you should consult a doctor.

If you take morePharmagrip cough and congestionthan you should

You should consult your doctor or pharmacist immediately.

The symptoms of paracetamol overdose can be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and kidney and liver disorders.

If you have taken an overdose, you should go to a medical center immediately, even if you do not notice the symptoms, since they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

The symptoms of pseudoephedrine overdose include stimulation of the nervous system and heart: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, convulsions, hallucinations, irregular heartbeats (slow or fast) severe or continuous, increased blood pressure, severe or continuous breathing difficulties, and difficulty urinating. In elderly patients, serious adverse effects such as hallucinations, central nervous system depression, or convulsions have been reported. In more severe cases, it can cause: decreased potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crises.

In the case of a dextromethorphan overdose, you may experience confusion, excitability, nervousness, and restlessness, among other effects, depending on the dose.

In children, the accidental ingestion of very high doses can cause hallucinations (visions or hearings that are not present), hysteria, facial inflammation, nausea, vomiting, drowsiness, nervousness, and gait disturbances, among other symptoms.

There have been cases of abuse with medicines containing dextromethorphan in adolescents, which can cause serious adverse effects, such as: mental and emotional changes, which can include anxiety, depression, and psychosis (mental illness).

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

If you take more Pharmagrip cough and congestion than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forgot to takePharmagrip cough and congestion

Do not take a double dose to make up for the forgotten doses. If necessary, take the medicine again as indicated in section 3. "How to take Pharmagrip cough and congestion".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects due to Paracetamol:

Rare (may affect up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare (may affect up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Frequency not known (cannot be estimated from the available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Very rare cases of serious skin reactions have been reported.

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

Side effects due to Pseudoephedrine:

During the period of use of pseudoephedrine, the following side effects have been reported, whose frequency cannot be established with precision:

Severe side effects (frequency not known): serious diseases that affect the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

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

• severe headache of sudden onset
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision

More frequently, the following may occur: symptoms of central nervous system stimulation, including sleep disorders, nervousness, restlessness, muscle tremors, anxiety, and taste distortion.

Less frequently, the following may occur: hyperactivity, hyperexcitability, dizziness, headache, ataxia (movement disorder), tremors, dilated pupils, tachycardia, palpitations, hypertension (mainly in hypertensive patients), nausea, vomiting, intestinal inflammation with frequent diarrhea (ischemic colitis), red hardened skin rashes with itching, skin inflammation, difficulty or pain when urinating, increased sweating, unusual paleness, and weakness.

In rarer cases, the following may occur: hallucinations (more frequent with high doses), nightmares, screaming, and confusion in children, convulsions, arrhythmias, and bradycardia (very rapid or very slow heartbeats, more frequent with high doses), myocardial infarction (very rare), breathing difficulties.

Frequency not known(cannot be estimated from the available data): colon inflammation due to insufficient blood irrigation (ischemic colitis), decreased blood flow to the optic nerve (ischemic optic neuropathy).

Side effects due to Dextromethorphan:

During the period of use of dextromethorphan, the following side effects have been observed, whose frequency cannot be established with precision:

• In some cases, the following may occur: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• In rarer cases, the following may occur: mental confusion and headache.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pharmagrip cough and congestion

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

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

Do not store at a temperature above 25°C.

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

6. Package contents and additional information

Composition of Pharmatusgrip

• The active ingredients are paracetamol, pseudoephedrine sulfate, and dextromethorphan hydrobromide. Each sachet contains 500 mg of paracetamol, 30 mg of pseudoephedrine sulfate, and 15 mg of dextromethorphan hydrobromide.

• The other components are: anhydrous citric acid, sucrose, sodium saccharin, sorbitol (E-420), sodium citrate (E-331), strawberry flavor (composed of natural flavorings, natural-identical flavorings, maltodextrin, propylene glycol (E-1520), and alpha-tocopherol (E-307)), and amaranth (E-123).

Appearance of the product and package contents

Pharmatusgrip powder for oral solution is a pink powder for oral solution with a strawberry flavor.

Each package contains 10 or 20 single-dose sachets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 (Alcobendas) Madrid

Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/ Aragoneses, 2

28108 Alcobendas, Madrid (Spain)

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

Lamp San Prospero SPA

Via della Pace, 25/A,

41030, San Prospero (Modena)

Italy

Date of the last revision of this prospectus:March 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/