Pharmagrip Tos y Congestion oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pharmagrip cough and congestion oral suspension

Paracetamol / Dextromethorphan hydrobromide / Pseudoephedrine hydrochloride

Read this 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 refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse 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 condition worsens, or if symptoms persist for more than 5 days (3 days for fever, if present), or if new symptoms appear such as high fever, skin rash, or persistent headache.

Contents of the leaflet

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

Pharmagrip Cough and Congestion is a combination of paracetamol, dextromethorphan, and pseudoephedrine.

Paracetamol is effective in reducing pain and fever.

Dextromethorphan has antitussive action (inhibits the cough reflex).

Pseudoephedrine is effective in reducing nasal congestion.

It is indicated for the symptomatic relief of influenza-like conditions and the common cold associated with mild to moderate pain, fever, non-productive cough (irritative cough, nervous cough), and nasal congestion, in adults and adolescents aged 12 years and older.

You should consult a doctor if your condition worsens, or if symptoms persist for more than 5 days (3 days for fever, if present), or if new symptoms develop, such as high fever, skin rash, or persistent headache.

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

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

There is a potential for abuse of one of the active ingredients in Pharmagrip Cough and Congestion, pseudoephedrine. High doses of pseudoephedrine can 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 duration of treatment (see section 3).

Do not take Pharmagrip Cough and Congestion

• If you are allergic to paracetamol, dextromethorphan, pseudoephedrine, other nasal decongestants, or any of the other components of this medicine (listed in section 6).

• If you have a serious lung disease. You have asthmatic cough or cough with abundant secretions.

• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension due to your medication.

• If you have serious heart or blood vessel diseases.

• If you have severe, acute (sudden) or chronic (long-term) kidney disease, or kidney failure.

• If you have been diagnosed with hyperthyroidism.

• If you are currently being treated or have been treated within the previous 2 weeks with:

• any monoamine oxidase inhibitor (MAOI) medicines used to treat depression, as this may cause an increase in blood pressure.

• any medicines for Parkinson’s disease or other conditions, as well as other serotonin reuptake inhibitors used to treat depression such as fluoxetine and paroxetine.

• bupropion, a medicine used to stop smoking.

• linezolid, an antibacterial medicine (see section “Other medicines and Pharmagrip Cough and Congestion”).

• If you are pregnant and are in the first trimester of pregnancy.

Warnings and precautions

Do not take more medicine than the recommended dose stated 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.

Sudden abdominal pain or rectal bleeding may occur while taking 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.

With Pharmagrip Cough and Congestion, blood flow to the optic nerve may be reduced. 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 assistance if you experience symptoms that could indicate RPES or RCVS (for symptoms, see section 4 "Possible side effects").

Consult your doctor or pharmacist before starting Pharmagrip Cough and Congestion if you are a patient with:

• Kidney, liver, heart, or lung diseases, or if you have anemia.
• Treatment with any medicine for epilepsy. You should consult your doctor before taking this medicine, as simultaneous use may reduce efficacy and increase hepatotoxicity of one of the active ingredients.
• Aspirin-sensitive asthma.
• Diabetes.
• Cardiovascular disease, hypertension.
• High eye pressure (glaucoma).
• Difficulty urinating, urinary obstruction.
• Persistent or chronic cough, such as that caused by smoking. In children, chronic cough could be an early sign of asthma.
• Atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in infancy in individuals with hereditary allergic predisposition).
• If you are sedated, weakened, or bedridden.
• Chronic alcoholics should take care not to exceed the recommended amount of this medicine stated in section 3. “How to take Pharmagrip Cough and Congestion.” If diarrhea occurs during treatment, stop taking this medicine immediately and consult your doctor.
• 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).
• 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 in these situations when paracetamol is used regularly 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, feeling unwell (nausea), and vomiting.

Cases of abuse of medicines containing dextromethorphan in adolescents have been reported; therefore, this possibility should be considered, as serious adverse effects may occur (see section “If you take more Pharmagrip Cough and Congestion than you should”).

Do not take this medicine if you are taking other medicines containing nasal decongestants.

Treatment should be discontinued at least 24 hours before undergoing surgery.

Concomitant use of cocaine with pseudoephedrine may increase cardiovascular effects and the risk of adverse reactions.

Children and adolescents

Do not administer to children under 12 years of age.

Elderly patients

Elderly individuals are more sensitive to adverse effects; therefore, dose adjustment may be necessary. Consult your doctor.

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 medicines.

In particular, if you are using any of the following medicines or substances with pharmacological effects listed below, it may be necessary to adjust the dose or discontinue treatment:

• Urinary alkalinizing agents (sodium bicarbonate, citrates), as they may slow the elimination of pseudoephedrine, increasing its effect and toxicity.
• Inhalation anesthetics, as they may increase the risk of heart problems.
• Monoamine oxidase inhibitors (MAOIs) 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 should be separated from that of Pharmagrip Cough and Congestion by at least 15 days, both before and after. Otherwise, due to its pseudoephedrine content, you may experience severe increase in blood pressure, high fever, and headache.
• Medicines for treating depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines for treating epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Levodopa (used to treat Parkinson’s disease), as it may increase heart rate (arrhythmias).
• Central nervous system stimulants (amphetamines, xanthines), as they may cause nervousness, irritability, insomnia, or possibly seizures or heart rhythm disturbances (arrhythmias), since they may enhance the effects of pseudoephedrine, causing severe increase in blood pressure, high fever, and headache.
• Cocaine, which, in addition to stimulating the central nervous system, when used with pseudoephedrine may increase adverse effects on the heart.
• Central nervous system depressants (some used to treat: mental disorders, allergies, Parkinson’s disease, etc.).
• Some medicines to lower blood pressure, treat heart rhythm disorders, or promote urine elimination (such as beta-blockers e.g., propranolol, ACE inhibitors, loop diuretics such as furosemide, rauwolfia alkaloids such as reserpine, amiodarone, and quinidine), as they may reduce the effectiveness of these medicines.
• Digitalis glycosides (used for heart conditions), as they may cause disturbances in heart rhythm.
• Nitrates (used to treat angina pectoris), as their effects may be reduced.
• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to lower blood cholesterol levels: cholestyramine.
• Thyroid hormones (used for thyroid disorders), as the effects of both the hormones and pseudoephedrine may be increased.
• Medicines used to treat tuberculosis: isoniazid, rifampicin.
• Medicines used to treat gout: probenecid and sulfinpyrazone.
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Anti-inflammatory medicines: celecoxib, parecoxib, or valdecoxib.
• Expectorants and mucolytics (used to clear phlegm and mucus).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) requiring urgent treatment (see section 2).

Do not take this medicine during treatment or within 2 weeks after treatment with the following medicines, as it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Monoamine oxidase inhibitor (MAOI) antidepressants: moclobemide, tranylcypromine.
• Serotonin reuptake inhibitor antidepressants: paroxetine, fluoxetine.
• Bupropion (used to stop smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson’s disease).

Interference with diagnostic tests

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

Taking Pharmagrip Cough and Congestion with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with this medicine, as it may cause serious adverse reactions.

Do not take together with grapefruit juice or bitter orange juice. Other foods and drinks do not affect the medicine’s effectiveness.

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.

Pharmagrip Cough and Congestion is contraindicated during the first trimester of pregnancy due to the presence of pseudoephedrine.

Paracetamol and pseudoephedrine pass into breast milk; therefore, breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and use of machines

Rarely, drowsiness and mild dizziness may occur during treatment. If you experience these symptoms, do not drive or operate dangerous machinery.

Pharmagrip Cough and Congestion contains sodium methyl parahydroxybenzoate (E-219) and sodium propyl parahydroxybenzoate (E-217), aspartame (E-951), maltitol (E-965), sodium, propylene glycol (E-1520), and ethanol

It may cause allergic reactions (possibly delayed) because it contains sodium methyl parahydroxybenzoate (E-219) and sodium propyl parahydroxybenzoate (E-217).

This medicine contains 1.8 mg of aspartame (E-951) per ml. Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains maltitol (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may have a mild laxative effect. Calorific value: 2.3 kcal/g maltitol.

This medicine contains less than 1 mmol of sodium (23 mg) per ml; thus, it is essentially “sodium-free.”

This medicine contains 5.45 mg of propylene glycol (E-1520) per ml. If the infant is less than 4 weeks old, consult your doctor or pharmacist, especially if the infant has been administered other medicines containing propylene glycol or alcohol.

This medicine contains 1.64 mg of alcohol (ethanol) per ml, equivalent to 0.16% (w/v). The amount in 10 ml of this medicine is equivalent to less than 1 ml of beer or wine.

The small amount of alcohol in this medicine does not produce any perceptible effect.

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping control tests.

3. How to take Pharmagrip Cough and Congestion

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

The recommended dose is:

Adults and adolescents over 12 years of age: 10 ml (one 10 ml measure) every 6–8 hours (3–4 times daily). Do not exceed 3 g of paracetamol in any 24-hour period (see section “Warnings and precautions”).

Patients with liver or kidney disease: must consult their 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: dosage must be determined by a doctor, as a reduction from the usual dose may be necessary.

Use in children and adolescents

This medicine is indicated only for adolescents aged 12 years and older. Children under 12 years of age must not take this medicine.

How to take:

This medicine is for oral use.

Shake the bottle well before use.

Measure the required dose using the dosing cup provided with the bottle. After use, wash the dosing cup.

If taking the medicine at night, take it a few hours before going to bed to reduce the risk of insomnia in patients who have difficulty sleeping.

This medicine should only be taken when all symptoms are present. As symptoms improve, treatment should be discontinued.

If your condition worsens, or if symptoms persist for more than 5 days (3 days for fever, if present), or if new symptoms such as high fever, skin rash, or persistent headache appear, consult your doctor.

If you take more Pharmagrip Cough and Congestion than you should

If you have taken more Pharmagrip Cough and Congestion than recommended, symptoms such as dizziness, vomiting, loss of appetite, jaundice (yellowing of the skin), and abdominal pain may occur. Seizures, respiratory disturbances, hallucinations, increased blood pressure, irregular heartbeat, excitability, tremors, palpitations, and difficulty urinating may also occur.

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 of consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

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

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

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

If an overdose has been ingested, go immediately to a medical center even if no symptoms are present, as symptoms often do not appear until up to 3 days after the overdose, even in cases of severe poisoning.

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

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

Cases of abuse have been reported with medicines containing dextromethorphan, particularly among adolescents, which may lead to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (increased heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil of the eye), agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Stop using Pharmagrip cough and congestion 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

Rare adverse effects (may affect up to 1 in 1,000 people):

• Malaise
• Drop in blood pressure (hypotension)
• Increased blood transaminase levels

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Kidney disorders, cloudy urine
• Skin rashes with or without irritation, itching, skin inflammation (dermatitis), jaundice (yellowing of the skin), severe skin reactions
• Blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia) and hypoglycaemia (low blood sugar)

Adverse effects with unknown frequency (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 taking paracetamol (see section 2).
• Changes in heart rate (tachycardia, bradycardia, and arrhythmias), palpitations, difficulty breathing (dyspnoea).
• Symptoms of excitement, sleep disturbances, restlessness, dizziness, vertigo, headache, seizures, hallucinations, and mental confusion. If seizures or hallucinations occur, stop taking this medicine immediately.
• Involuntary eyelid closure (blepharospasm), light phobia, and tearing
• Nausea, vomiting, gastrointestinal discomfort, intestinal inflammation causing frequent diarrhoea (ulcerative colitis), and constipation
• Colon inflammation due to insufficient blood supply (ischaemic colitis)
• Urine retention in men, pain or difficulty urinating
• Tremor, pallor, weakness, and increased sweating
• Reduced blood flow to the optic nerve (ischaemic optic neuropathy)

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

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pharmagrip Cough and Congestion

The active substances are paracetamol, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride. Each ml of oral suspension contains:

Paracetamol 50 mg
Dextromethorphan hydrobromide 2 mg
Pseudoephedrine hydrochloride 6 mg

The other components (excipients) are: maltitol (E-965), glycerol (E-422), sodium citrate, citric acid monohydrate, hypromellose, xanthan gum, sodium methyl parahydroxybenzoate (E-219), aspartame (E-951), ammonium glycyrrhizinate, sodium propyl parahydroxybenzoate (E-217), orange flavour (containing propylene glycol (E-1520) and ethanol), orange juice flavour, masking flavour, and purified water.

Nature of the product and contents of the container

Pharmagrip Cough and Congestion is a homogeneous suspension, white-beige or camel-coloured, with an orange odour.

It is supplied in amber glass bottles containing 125 ml of oral suspension, fitted with a metal cap with Pilfer Proof seal. Each pack includes a dosing cup with markings corresponding to 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain

Date of the latest revision of this package leaflet: February 2025.

Other sources of information

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/61068/P_61068.html

QR code to: https://cima.aemps.es/cima/dochtml/p/61068/P_61068.html