Label: Information for the Patient

Pharmagrip for Cough and CongestionOral Solution Powder

Paracetamol / Pseudoephedrine Sulfate / Dextromethorphan Hydrobromide

Read this label carefully before taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those given by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if you worsen, 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.

Paracetamol belongs to a group of medicines called analgesics and antipyretics, which reduces pain and fever. Pseudoephedrine belongs to a group of medicines called Nasal Decongestants. Dextromethorphan belongs to a group of medicines called Cough Suppressants.

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

Consult a doctor if symptoms worsen, do not improve, or if fever persists for more than 3 days or pain or other symptoms persist for more than 5 days.

This medication may cause dependence. Therefore, treatment should be of short duration.

The possibility of abuse of one of the active ingredients it contains, pseudoephedrine, exists. Large doses of pseudoephedrine can be toxic. Continuous use may cause tolerance and lead to taking more Pharmagrip tos and congestión 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 duration of treatment (see section 3).

Do not takePharmagrip tos and congestión

• If you are allergic to paracetamol, pseudoephedrine, dextromethorphan, or any of the other components of this medication (listed in section 6).
• If you have severe high blood pressure (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 (eye nerve damage with high eye pressure).
• If you have hyperthyroidism.
• If you have a 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 abundant secretions.
• If you are being treated or have been treated in the past two weeks with a medication of the type of monoamine oxidase inhibitors (MAOIs) (such as some antidepressants or medications for Parkinson's disease, or others) (see "Other medications and Pharmagrip tos and congestión").
• If you are pregnant and are in the first trimester of pregnancy.
• If you have respiratory insufficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pharmagrip tos and congestión.

Due to its content in Paracetamol:

• Do not take more medication than recommended in section 3. "How to take Pharmagrip tos and congestión".
• Avoid simultaneous use of this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Consult your doctor before taking this medication:
• patients with anemia, heart, lung, or kidney disease, or liver disease, as it is recommended to avoid long-term treatments (in the latter case, 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 regularly consume alcohol (3 or more alcoholic beverages per day) as this medication may cause liver damage.
• Patients with chronic alcoholism should not take more than 2 g of paracetamol per day (4 packets).
• If you have severe diseases, such as severe kidney disease or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Due to its content in Pseudoephedrine:

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

• cardiovascular disease, such as arrhythmias or ischemic heart disease (narrowing of an artery reducing oxygen delivery to the heart);
• diabetes mellitus (may increase blood glucose concentration);
• high eye pressure (glaucoma or predisposition to it);
• prostate enlargement (prostatic hypertrophy) (may increase urine retention);
• kidney disease;
• adrenal gland tumor producing hormones affecting heart rate and blood pressure (pheochromocytoma).

With Pharmagrip tos and congestión, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Pharmagrip tos and congestión and seek medical attention immediately. See section 4.

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

• Patients over 60 years old may be especially sensitive to the adverse effects of sympathomimetic amines (medications for depression treatment). Overdose of these amines in patients over 60 years old may cause hallucinations, central nervous system depression, seizures, and death.

Abdominal pain or rectal bleeding may occur with the use of Pharmagrip tos and congestión due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Pharmagrip tos and congestión and seek medical attention immediately. See section 4.

Due to its content in Dextromethorphan:

• Do not administer in patients who are sedated, weakened, or bedridden.
• Consult your doctor before taking this medication:
• patients with liver disease, as it may alter the metabolism of dextromethorphan, to establish the most suitable dosage regimen;
• patients with persistent or chronic cough, such as that due to smoking, as dextromethorphan may prevent mucus discharge;
• patients with atopic dermatitis (allergic skin disease characterized by itching, redness, or other lesions, often in individuals with hereditary predisposition);
• if you are taking other medications such as antidepressants or antipsychotics,Pharmagrip tos and congestiónmay interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Cases of abuse with medications containing dextromethorphan in adolescents have been reported. Therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section "If you take more Pharmagrip tos and congestión than you should").

Children and adolescents

Do not use in children under 12 years old.

Other medications and Pharmagrip tos and congestión

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

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
• colestiramine (used to reduce blood cholesterol levels)
• medications used to treat gout (probencid and sulfinpyrazone)
• diuretics of the loop type (such as furosemide)
• anticholinergic medications used to relieve spasms or contractions of the stomach, intestines, and bladder
• metoclopramide and domperidone (used to prevent nausea and vomiting)
• propranolol used to treat high blood pressure and arrhythmias

Also inform your doctor or pharmacist if you are taking:

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

Interactions due to pseudoephedrine

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

• 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 medication with other medications to relieve nasal congestion.

If you are using any of the following medications, you may need to modify the dose of one of them or discontinue treatment:

• alkalinizing urinary medications (sodium bicarbonate, citrates)
• medications used to treat the heart (digitalis glycosides)
• stimulants of the nervous system (amphetamine, xanthines)
• inhalation anesthetics
• some medications to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, metildopa, guanetidine, rauwolfia alkaloids such as reserpine)
• thyroid hormones (used to treat 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 medication during treatment, or in the two weeks following treatment with medications of the type of monoamine oxidase inhibitors (MAOIs) such as those listed below, as severe adverse effects may occur such as high blood pressure, excitement, and sweating, among other symptoms:

• antidepressants such as moclobemide or tranylcypromine, procarbazine (used to treat cancer), selegiline (used to treat Parkinson's disease), or linezolid (used as an antibacterial)
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and paroxetine
• serotoninergic medications such as bupropion or sibutramine (used to treat obesity)

If you are using any of the following medications, you may need to modify the dose of one of them or discontinue treatment:

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

Interference with analytical tests:

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

Pharmagrip tos and congestiónwith food, drinks, and alcohol

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

Do not consume alcoholic beverages during treatment as it may increase the risk of adverse reactions.

Do not take this medication with orange bitter juice.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not usePharmagrip tos and congestión, due to pseudoephedrine, during the first trimester of pregnancy because it may cause birth defects in the digestive system and face of the newborn, with a higher risk in smoking women, and during the rest of the pregnancy only under medical prescription.

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

Driving and operating machinery

In rare cases, during treatment, drowsiness and dizziness may occur, so if you experience these symptoms, you should not drive or operate hazardous machinery.

Pharmagrip tos and congestióncontains saccharose

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Pharmagrip tos and congestióncontains sorbitol (E-420)

This medication contains 10 mg of sorbitol (E-420) in each packet.

Pharmagrip tos and congestióncontains amaranth (E-123)

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

Pharmagrip tos and congestióncontains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:The recommended dose is 1 tablet 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 tablets) in 24 hours. See the “Warnings and precautions” section.

Adolescents (12 years and older) weighing more than 43 kg:The recommended dose is 1 tablet 3 or 4 times a day, as needed. Doses should be spaced at least 4 hours apart. Do not exceed 5 tablets in 24 hours.

Patients with liver or kidney disease: Consult your doctor before taking this medication. If your doctor prescribes this medication, wait at least 8 hours between doses.

Patients 60 years and older: Dosage should be established by your doctor, as there may be a need to reduce the usual dose.

Use in children and adolescents

This medication is not indicated for children under 12 years.

This medication is administered orally.

Empty the contents of one tablet into a half glass of water and shake until completely dissolved.

Swallow once dissolved.

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

Administration of this medication is dependent on the appearance of pain or fever. As these symptoms disappear, this medication should be discontinued.

If fever persists for more than 3 days, pain for more than 5 days, or if symptoms worsen or other symptoms such as high fever, skin eruptions, or persistent headache appear, consult your doctor.

If you take morePharmagrip tos and congestiónthan you should

Consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, go to a medical center immediately, even if you do not notice symptoms, as these often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Patients on barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

The symptoms of pseudoephedrine overdose include stimulation of the nervous and cardiovascular systems: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, convulsions, hallucinations, irregular heartbeats (slow or rapid), severe or continuous hypertension, severe or continuous respiratory difficulty, and urinary difficulty. In elderly patients, there have been reports of severe adverse effects such as hallucinations, depression of the central nervous system, or convulsions. In more severe cases, there may be: decreased potassium in the blood (hypokalemia), altered perception of reality (psychosis), convulsions, coma, and hypertensive crises.

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

In children, accidental ingestion of very high doses may produce hallucinations (visions or sounds not present), hysteria, facial inflammation, nausea, vomiting, drowsiness, nervousness, and alterations in gait, among other symptoms.

There have been cases of abuse with medications containing dextromethorphan in adolescents, which may lead to severe adverse effects, such as: mental and emotional changes, which may include anxiety, depression, and psychosis (mental illness).

The treatment of an overdose is more effective if initiated within 4 hours of medication ingestion.

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

Other symptoms in cases of massive overdose may include: 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 medication and the amount ingested.

If you forget to takePharmagrip tos and congestión

Do not take a double dose to compensate for the missed dose. If necessary, take the medication as indicated in the section 3. “How to take Pharmagrip tos and congestión”.

Like all medicines, this medicine may 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:unpleasantness, 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 diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

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

Severe skin reactions have been reported very rarely.

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

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 affecting the blood vessels of the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop usingPharmatusgripimmediately and seek urgent medical assistance if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache of sudden onset

• unpleasantness

• vomiting

• confusion

• convulsions

• changes in vision

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

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

Rarely, the following symptoms may occur: hallucinations (more frequent with high doses), nightmares, screaming, and confusion in children, convulsions, arrhythmias, and bradycardia (very fast or very slow heartbeats, more frequent with high doses), myocardial infarction (very rare), respiratory difficulty.

Frequency not known(cannot be estimated from available data): ischemic colitis, optic neuropathy due to insufficient blood flow (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 rare 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Pharmatusgrip

• The active principles 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, identical natural flavorings, maltodextrin, propylene glycol (E-1520), and alpha-tocopherol (E-307)) and amaranth (E-123).

Appearance of the product and content of the container

Pharmatusgrip oral powder is an oral powder, pink in color and with a strawberry flavor.

Each container contains 10 or 20 single-dose sachets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing:

FARMALIDER, S.A.

Aragoneses Street, 2

28108 (Alcobendas) Madrid

Spain

or

TOLL MANUFACTURING SERVICES S.L.

Aragoneses Street, 2

28108 Alcobendas, Madrid (Spain)

or

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

or

Lamp San Prospero SPA

Pace Street, 25/A,

41030, San Prospero (Modena)

Italy

Last review date of this prospectus:March 2025

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