Pharmagrip Cough and Congestion powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pharmagrip cough and congestion oral solution powder

Paracetamol / Pseudoephedrine sulfate / Dextromethorphan hydrobromide

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 directed 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 a doctor if your condition worsens, does not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

Leaflet contents

1. What Pharmagrip cough and congestion is and what it is used for
2. What you need to know before taking Pharmagrip cough and congestion
3. How to take Pharmagrip cough and congestion
4. Possible side effects
5. How to store Pharmagrip cough and congestion
6. Contents of the pack and other information

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

Paracetamol belongs to a group of medicines called analgesics and antipyretics, therefore it reduces pain and fever. Pseudoephedrine belongs to the group of medicines known as nasal decongestants. Dextromethorphan belongs to the group of medicines known as antitussives.

This medicine is indicated for the symptomatic relief of colds and flu accompanied by pain, fever, nasal congestion, and non-productive cough (irritating and nervous cough). For use in individuals over 12 years of age.

You should consult a doctor if symptoms worsen, do not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

2. What you need to know before starting to take Pharmagrip cough and congestion

This medicine may cause dependence. Therefore, treatment should be short-term.

There is a risk of abuse of one of the active ingredients in Pharmagrip cough and congestion, pseudoephedrine. High doses of pseudoephedrine may be toxic. Continuous use may lead to tolerance and result in taking more Pharmagrip cough and congestion 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 Pharmagrip 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, acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
• If you have closed-angle glaucoma (optic 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 conditions such as emphysema or asthma, or if your cough is accompanied by abundant secretions.
• If you are currently being treated or have been treated within the last 2 weeks with monoamine oxidase inhibitors (MAOIs), such as certain antidepressants or medications for Parkinson's disease (see "Other medicines and Pharmagrip cough and congestion").
• If you are pregnant and in the first trimester of pregnancy.
• If you suffer from respiratory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pharmagrip cough and congestion.

Due to its content in Paracetamol:

• Do not take more medicine than recommended in section 3, "How to take Pharmagrip cough and congestion".
• Avoid using this medicine simultaneously with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• The following patients should consult their doctor before taking this medicine:
• Patients with anemia, or heart, lung, kidney, or liver disease, as long-term treatment should be avoided (in the latter case, occasional use is acceptable, but prolonged administration of high doses may increase the risk of adverse effects);
• Asthmatic patients who are sensitive to acetylsalicylic acid;
• Patients who regularly consume alcohol (3 or more alcoholic drinks—beer, wine, liquor—per day), as this medicine may damage the liver.
• Chronic alcoholics should not take more than 2 g of paracetamol per day (4 sachets).
• 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 are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Due to its content in Pseudoephedrine:

• Do not take this medicine with other medicines containing nasal decongestants.

• You should 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 (benign prostatic hyperplasia) (may increase urinary retention);

• Kidney disease;

• A tumor of the adrenal gland producing hormones that affect heart rate and blood pressure (pheochromocytoma).

Pharmagrip cough and congestion may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking Pharmagrip cough and congestion and contact your doctor or seek immediate medical attention. See section 4.

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 Pharmagrip cough and congestion immediately and seek immediate medical help if you experience symptoms that could be signs of RPES or RCVS (for symptoms, see section 4, "Possible side effects").

• Patients over 60 years of age may be particularly sensitive to the adverse effects of sympathomimetic amines (medicines used to treat depression). Overdose of these sympathomimetic amines in patients over 60 years of age may cause hallucinations, central nervous system (CNS) depression, seizures, 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 occur, stop taking Pharmagrip cough and congestion and contact your doctor or seek immediate medical attention. See section 4.

Due to its content in Dextromethorphan:

• Do not administer to sedated, weakened, or bedridden patients.
• The following patients should consult their doctor before taking this medicine:
• Patients with liver disease, as dextromethorphan metabolism may be altered, requiring the most appropriate 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 (an allergic skin disease characterized by itching, redness, or other lesions, often in individuals with 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Cases of abuse of medicines containing dextromethorphan in adolescents have been reported. Therefore, this possibility should be considered, as it may lead to serious adverse effects (see section "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 and Pharmagrip cough and congestion

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

Interactions due to paracetamol

• Oral anticoagulants (acenocoumarol, warfarin)
• Antiepileptics (lamotrigine, phenytoin, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Ethyl alcohol
• Oral contraceptives and estrogen treatments
• Antibiotics (chloramphenicol)
• Antituberculosis medicines (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal used for diarrhea or treatment of gas
• Cholestyramine (used to lower blood cholesterol levels)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Some medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used to treat 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 blood and fluid imbalance (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Interactions due to pseudoephedrine

Do not take this medicine during treatment or within 2 weeks after treatment with 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 used to relieve nasal congestion.

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

• Urinary alkalinizing agents (sodium bicarbonate, citrates)
• Medicines used for the heart (digitalis glycosides)
• Central nervous system stimulants (amphetamines, xanthines)
• Inhaled anesthetics
• Some medicines 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 within 2 weeks after treatment with medicines such as:

• 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 inhibitors (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), excitation, and sweating, among other symptoms, may occur.

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

• Medicines that cause central nervous system depression (sedation) (some used for mental illnesses, allergies, Parkinson's disease, etc.)
• Anti-inflammatory medicines (celecoxib, parecoxib, valdecoxib)
• Antiarrhythmics used to treat heart arrhythmias (amiodarone or quinidine)
• Haloperidol (used to treat psychiatric disorders)
• Mucolytic expectorants

Interference with laboratory tests:

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

Taking Pharmagrip cough and congestion with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day) may cause liver damage.

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

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

Do not take together with grapefruit juice (bitter orange juice).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 because it may cause malformations of the digestive system and face in the newborn, with higher risk in women who smoke. During the remaining months of pregnancy, it should only be used under medical prescription.

Breastfeeding women should not take this medicine, because paracetamol passes into breast milk and pseudoephedrine also passes in small amounts, potentially causing adverse effects in the infant.

Driving and use of machines

Rarely, during treatment, mild drowsiness and dizziness may occur; therefore, if you experience these symptoms, you should not drive cars or operate dangerous machinery.

Pharmagrip Cough and Congestion contains sucrose

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

Pharmagrip Cough and Congestion contains sorbitol (E-420)

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

Pharmagrip Cough and Congestion contains amaranth (E-123)

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

Pharmagrip Cough and Congestion contains sodium

This medicine contains 60.84 mg of sodium (main component of table/cooking salt) per sachet. This corresponds to 3% of the maximum daily recommended sodium intake for an adult.

3. How to take Pharmagrip Cough and Congestion

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. In case of doubt, consult 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, respectively), as needed. Do not exceed 3 grams of paracetamol (6 sachets) in 24 hours. See section “Warnings and precautions”.

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

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

Patients over 60 years of age: The dosage should be determined by the physician, as a reduction of the usual dose may be necessary.

Use in children and adolescents

This medicine is not indicated for children under 12 years of age.

This medicine is administered orally.

Empty the contents of one sachet into half a glass of water and stir until completely dissolved.

Take once dissolved.

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

This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

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

If you take more Pharmagrip Cough and Congestion than you should

Contact your doctor or pharmacist immediately.

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

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose has occurred—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.

Symptoms of pseudoephedrine overdose include stimulation of the nervous system and heart: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, seizures, hallucinations, irregular (slow or fast) severe or persistent heartbeats, increased blood pressure, severe or persistent breathing difficulties, and difficulty urinating. In elderly patients, serious adverse effects such as hallucinations, central nervous system depression, or seizures have been reported. In more severe cases, the following may occur: low blood potassium levels (hypokalemia), mental disorders with altered perception of reality (psychosis), seizures, 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 cause hallucinations (seeing or hearing things that are not present), hysteria, facial swelling, nausea, vomiting, drowsiness, nervousness, and disturbances in walking, among other symptoms.

Cases of abuse of medications containing dextromethorphan have occurred in adolescents, potentially leading to serious adverse effects such as mental and emotional changes, including anxiety, depression, and psychosis (mental illness).

Treatment of overdose is most effective if initiated within 4 hours after ingestion of 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, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination problems, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pharmagrip Cough and Congestion

Do not take a double dose to make up for missed doses. If necessary, resume taking the medicine as indicated in section 3, “How to take Pharmagrip Cough and Congestion”.

4. Possible adverse effects

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

Adverse effects due to Paracetamol:

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

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

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Very rare cases of serious skin reactions have been reported.

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

Adverse effects due to Pseudoephedrine:

During the period of use of pseudoephedrine, the following adverse effects have been reported, whose frequency could not be precisely established:

Serious adverse effects (frequency not known): serious disorders affecting the blood vessels in the brain, known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Pharmatusgrip 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

More commonly observed: symptoms of central nervous system stimulation including sleep disturbances, nervousness, restlessness, muscle tremor, anxiety, and taste disturbances.

Less commonly observed: hyperactivity, hyperexcitability, dizziness, headache, ataxia (movement disorder), tremor, pupil dilation, tachycardia, palpitations, hypertension (mainly in hypertensive patients), nausea, vomiting, intestinal inflammation leading to frequent diarrhoea (ischaemic colitis), red, hardened, itchy skin rashes, skin inflammation, difficulty or pain during urination, increased sweating, unusual paleness, and weakness.

Rarely observed: hallucinations (more frequent with high doses), nightmares, screaming, confusion in children, seizures, arrhythmias and bradycardia (very fast or very slow heartbeat, more frequent with high doses), myocardial infarction (very rare frequency), breathing difficulties.

Frequency not known (cannot be estimated from available data): inflammation of the colon due to insufficient blood supply (ischaemic colitis), reduced blood flow to the optic nerve (ischaemic optic neuropathy).

Adverse effects due to Dextromethorphan:

During the use of dextromethorphan, the following adverse effects have been observed, whose frequency could not be precisely established:

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pharmagrip cough and congestion

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

6. Contents of the pack and other information

Composition of Pharmatusgrip

• The active substances 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 flavour (composed of natural flavourings, flavourings identical to natural ones, maltodextrin, propylene glycol (E-1520), and alpha tocopherol (E-307)), and amaranth (E-123).

Appearance of the medicinal product and contents of the pack

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

Each pack contains 10 or 20 unit-dose sachets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: March 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/