PHARMAGRIP TOS Y CONGESTION ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Pharmagrip Cough and Congestion Suspensionoral

Paracetamol/Dextromethorphan Hydrobromide/Pseudoephedrine Hydrochloride

Read the entirepackage leaflet carefullybefore starting to take this medication,asitcontainsimportantinformationforyou.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen, or if they persist for more than 5 days (3 days for fever, if present), or if other symptoms such as high fever, skin rash, or persistent headache appear.

Contents of thepackage 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. Storage of Pharmagrip Cough and Congestion
6. Package contents and additional information

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

Pharmagrip Cough and Congestion is an association of paracetamol, dextromethorphan, and pseudoephedrine.

Paracetamol is effective in reducing pain and fever.

Dextromethorphan has an antitussive action (inhibits the cough reflex).

Pseudoephedrine is effective in reducing nasal congestion.

It is indicated for the symptomatic relief of flu and common cold processes that occur with mild or moderate pain, fever, unproductive cough (irritative cough, nervous cough), and nasal congestion for adults and adolescents from 12 years old.

You should consult a doctor if your symptoms worsen, or if they persist for more than 5 days (3 days for fever, if present), or if other symptoms such as high fever, skin rash, or persistent headache appear.

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

This medication can cause dependence. Therefore, treatment should be short-term.

There is a possibility of abuse of one of the active ingredients contained in Pharmagrip Cough and Congestion, pseudoephedrine. High doses of pseudoephedrine can be toxic. Continuous use can lead to tolerance and taking 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, dextromethorphan, pseudoephedrine, or any other component of this medication (listed in section 6).
• If you have a severe lung disease. You have asthmatic cough or cough accompanied by abundant secretions.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• If you have severe heart or blood vessel diseases.
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• If you have been diagnosed with hyperthyroidism.
• If you are being treated or have been treated in the last 2 weeks with:

• any monoamine oxidase inhibitor (MAOI) medication used to treat depression, as it can cause a significant increase in blood pressure.
• any medication for Parkinson's disease or other diseases, as well as other medications that inhibit serotonin reuptake used to treat depression, such as fluoxetine and paroxetine.
• bupropion, which is a medication used to quit smoking.
• linezolid, which is an antibacterial medication (see the section "Other medications and Pharmagrip Cough and Congestion").

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

Warnings and precautions

Do not take more medication than recommended in section 3 "How to take Pharmagrip Cough and Congestion".

Avoid simultaneous use of this medication with other medications that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

Sudden abdominal pain or rectal bleeding may occur with the use of Pharmagrip Cough and Congestion due to colon inflammation (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.

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 posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medications containing pseudoephedrine. PRES and RCVS are rare diseases that can 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").

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

• Kidney, liver, heart, or lung disease, and patients with anemia.
• Treatment with any medication for epilepsy. You should consult your doctor before taking this medication because, when used at the same time, the efficacy is decreased and the hepatotoxicity of one of the active ingredients is potentiated.
• Asthma sensitive to acetylsalicylic acid.
• Diabetes.
• Cardiovascular disease, hypertension.
• High eye pressure (glaucoma).
• Difficulty urinating, urinary obstruction.
• Persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition).
• Those who are sedated, debilitated, or bedridden.
• Chronic alcoholics should be cautious not to exceed the recommended amount of this medication in section 3. "How to take Pharmagrip Cough and Congestion". If diarrhea occurs during treatment, stop taking this medication immediately and consult your doctor.
• If you are taking other medications such as antidepressants or antipsychotics, Pharmagrip Cough and Congestion may interact with these medications, 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).
• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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.

Cases of abuse with medications containing dextromethorphan have been described in adolescents; therefore, this possibility should be taken into account, as serious side effects can occur (see the section "If you take more Pharmagrip Cough and Congestion than you should").

If you are taking other medications that contain nasal decongestants, you should not take this medication.

Treatment should be suspended at least 24 hours before surgery.

The simultaneous use of cocaine with pseudoephedrine can increase cardiovascular effects and the risk of side effects.

Children and adolescents

Do not administer to children under 12 years old.

Elderly patients

Elderly people are more sensitive to side effects, so a dose adjustment may be necessary. Consult your doctor.

Other medications and Pharmagrip Cough and Congestion

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

In particular, if you are using any of the following medications or substances with pharmacological effects listed below, it may be necessary to modify the dose of one of them or interrupt treatment:

• Urinary alkalizers (sodium bicarbonate, citrates) as they can cause pseudoephedrine to be eliminated more slowly and increase its effect and toxicity.
• Inhaled anesthetics as they can increase the risk of heart problems. Monoamine oxidase inhibitor (MAOI) medications used to treat depression (moclobemide, tranilcipromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidone). If you are being treated with any of them, you should separate their administration from the administration of Pharmagrip Cough and Congestion by at least 15 days, both before and after. If not, because it contains pseudoephedrine, it could cause a significant increase in blood pressure, very high fever, and headache.
• Medications for treating depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Levodopa (used for Parkinson's treatment) as it can increase heart rate (arrhythmias).
• Central nervous system stimulants (amphetamines, xanthines) as they can cause nervousness, irritability, insomnia, or possibly convulsions or alteration of heart rhythm (arrhythmias), as they can increase the effects of pseudoephedrine, causing a significant increase in blood pressure, very high fever, and headache.
• Cocaine, which, in addition to stimulating the central nervous system, its use with pseudoephedrine can increase the risk of side effects on the heart.
• Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.).
• Certain medications for lowering blood pressure and treating heart rhythm disorders or for promoting 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 it can decrease the efficacy of these medications.
• Digitalis glycosides (used for the heart) as they can produce alterations in heart rhythm.
• Nitrates (used for the treatment of angina pectoris) as the effects of nitrates can be reduced.
• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications to lower cholesterol levels in the blood: colestyramine.
• Thyroid hormones (used for thyroid diseases) as the effects of both hormones and pseudoephedrine can be increased.
• Medications for treating tuberculosis: isoniazid, rifampicin.
• Medications used for the treatment of gout: probenecid and sulfinpyrazone.
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Anti-inflammatory medications: celecoxib, parecoxib, or valdecoxib.
• Expectorants and mucolytics (used to eliminate phlegm and mucus).
• Flucloxacillin (antibiotic) due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not take this medication during treatment or in the 2 weeks following treatment with the following medications, as it can cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Monoamine oxidase inhibitor (MAOI) antidepressants: moclobemide, tranilcipromine.
• Antidepressants that inhibit serotonin reuptake: paroxetine, fluoxetine.
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial medication).
• Procarbazine (used to treat cancer).
• Selegiline (used for Parkinson's treatment).

Interference with diagnostic tests

If you are going to have any diagnostic tests (blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, as it can alter the results of these tests.

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

You should not drink alcoholic beverages during treatment with this medication, as it can cause serious side effects.

Do not take it with grapefruit or bitter orange juice. The rest of the food and beverages do not affect the efficacy of the medication.

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 medication.

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, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and using machines

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

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

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

This medication contains 1.8 mg of aspartame (E-951) per ml. Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It can have a mild laxative effect. Caloric value: 2.3 kcal/g maltitol.

This medication contains less than 1 mmol of sodium (23 mg) per ml; that is, it is essentially "sodium-free".

This medication contains 5.45 mg of propylene glycol (E-1520) per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

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

The small amount of alcohol in this medication does not produce any noticeable effect.

Athletes are informed that this medication contains a component that can result in a positive doping test.

3. How to take Pharmagrip cough and congestion

Follow the administration instructions of the medication 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 and adolescents over 12 years: 1 measure of 10 ml every 6-8 hours (3-4 times a day). Do not take more than 3 g of paracetamol every 24 hours (see section "Warnings and precautions").

Patients with liver or kidney disease: must consult their doctor before taking this medication. If your doctor prescribes this medication, you must wait at least 8 hours between each intake.

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

Use in children and adolescents

This medication is indicated only in adolescents from 12 years. Children under 12 years should not take it.

How to take:

This medication is taken orally.

Shake the bottle well before use.

Measure the amount of medication to take with the dosing cup that comes with the bottle. After use, wash the dosing cup.

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.

The administration of this medication is subject to the appearance of all symptoms. As they disappear, this medication should be suspended.

If it worsens, or if symptoms persist for more than 5 days (3 days for fever), or if others such as high fever, skin rashes, or persistent headache appear, you should consult your doctor.

If you take morePharmagrip cough and congestionthan youshould

If you have taken more Pharmagrip cough and congestion than you should, symptoms such as dizziness, vomiting, loss of appetite, jaundice (yellowing of the skin), and abdominal pain may appear. Convulsions, respiratory alterations, hallucinations, increased blood pressure, irregular heartbeats, 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, disorders of consciousness, rapid 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have ingested an overdose, go quickly to a medical center even if you have no symptoms, since they often do not manifest until 3 days after taking the overdose, even in cases of severe poisoning.

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

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

There have been cases of abuse with medications containing dextromethorphan, particularly in adolescents, which can lead to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary eye movement), fever, tachypnea (rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

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

Stop using Pharmagrip cough and congestion 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

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

• discomfort
• low blood pressure (hypotension)
• increased levels of transaminases in blood

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

• kidney disease, 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, hemolytic anemia) and hypoglycemia (low blood sugar)

Adverse effects of unknown frequency (cannot be estimated from available data):

• a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2)
• heart rate disorders (tachycardia, bradycardia, and arrhythmias), palpitations, difficulty breathing (dyspnea)
• symptoms of excitement, sleep disorders, restlessness, dizziness, vertigo, headache, convulsions, hallucinations, and mental confusion. In case of convulsions or hallucinations, stop taking this medication immediately
• involuntary closure of the eyelids (blepharospasm), fear of light, and tearing
• nausea, vomiting, gastrointestinal discomfort, inflammation of the intestine with frequent diarrhea (ulcerative colitis), and constipation
• inflammation of the colon due to insufficient blood irrigation (ischemic colitis)
• urinary retention in men, pain or difficulty urinating
• tremors, paleness, weakness, and increased sweating
• decreased blood flow to the optic nerve (ischemic optic neuropathy)

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

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 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 adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Pharmagrip cough and congestion

Keep this medication out of 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.

This medication does not require special storage conditions.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications 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 medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Pharmagrip cough and congestion

The active ingredients 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, methylparaben sodium (E-219), aspartame (E-951), ammonium glycyrrhizate, propylparaben sodium (E-217), orange flavor (contains propylene glycol (E-1520) and ethanol), orange juice flavor, masking flavor, and purified water.

Appearance of the product and package contents

Pharmagrip cough and congestion is a homogeneous suspension of ivory or camel color and orange flavor.

It is presented in topaz glass bottles with a content of 125 ml of oral suspension, provided with a metal cap with a Pilfer Proof closure. Each package is provided with a dosing cup with marks 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 last revision of thisprospectus:February 2025.

Other sources of information

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

You can access detailed information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). 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