VINCIGRIP FORTE ORAL SOLUTION GRANULES, ORANGE FLAVOR

Introduction

Package Leaflet: Information for the Patient

Vincigrip Forte Granules for Oral Solution Orange Flavor

Paracetamol/Pseudoephedrine Hydrochloride/Chlorphenamine Maleate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Vincigrip Forte and what is it used for
2. What you need to know before taking Vincigrip Forte
3. How to take Vincigrip Forte
4. Possible side effects
5. Storage of Vincigrip Forte
6. Package Contents and Additional Information

1. What is Vincigrip Forte and what is it used for

It is an association of paracetamol, pseudoephedrine, and chlorphenamine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Pseudoephedrine is a sympathomimetic that reduces nasal congestion.

It is indicated for the symptomatic relief of catarrhal and flu-like processes that occur with or without fever, mild to moderate pain, congestion, and nasal secretion in adults and adolescents from 14 years of age.

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

2. What you need to know before taking Vincigrip Forte

Do not take Vincigrip Forte

• If you are allergic to the active ingredients or to 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 hyperthyroidism.
• If you are being treated with a monoamine oxidase inhibitor (MAOI) such as some antidepressant or anti-Parkinson's disease medications.
• If you are being treated with sympathomimetic medications (medications used to treat asthma or medications to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the treatment of hypertension or cardiovascular diseases).
• If you have glaucoma (increased eye pressure).
• If you have a severe heart or artery disease (such as coronary artery disease or angina pectoris or cerebral hemorrhage).
• If you have liver disease.
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• If you are in the first trimester of pregnancy.
• Children and adolescents under 14 years of age cannot take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Vincigrip Forte.

• Do not take more than the recommended dose of the medicine. See section 3. How to take Vincigrip Forte granules for oral solution orange flavor.
• Avoid simultaneous use of this medicine with others that contain paracetamol, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• In chronic alcoholics, caution should be exercised not to take more than 2 g/day of paracetamol (3 sachets of Vincigrip Forte). If you are taking other products that contain nasal decongestants, do not take this medicine.
• 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.
• Sudden abdominal pain or rectal bleeding may occur with the use of Vincigrip Forte due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Vincigrip Forte and contact your doctor or seek immediate medical attention. See section 4.

• With Vincigrip Forte granules for oral solution orange flavor, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Vincigrip Forte granules for oral solution orange flavor 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 may involve reduced blood flow to the brain. Stop using Vincigrip Forte granules for oral solution orange flavor immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to learn about the symptoms, see section 4 "Possible side effects").
• There is a possibility of abuse of one of the active ingredients contained in Vincigrip Forte granules for oral solution orange flavor, pseudoephedrine. High doses of pseudoephedrine can be toxic. Continuous use can lead to tolerance and taking more Vincigrip Forte granules orange flavor 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).

During treatment with Vincigrip, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) 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 unwell (nausea) and vomiting.

Patients with kidney, heart, or lung disease and patients with anemia should consult their doctor before taking this medicine.

• Patient with asthma sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Diabetes mellitus (may increase blood glucose levels).
• Cardiovascular diseases.
• Pheochromocytoma.
• Prostatic hypertrophy (may precipitate urinary retention).
• Obstruction of the vesical neck.
• Urinary retention.
• Chronic obstructive pulmonary disease (the anticholinergic effects of chlorphenamine could produce thickening of bronchial secretions and obstruct the airways).
• Pyloroduodenal obstruction or stenosing peptic ulcer (may worsen).
• Epileptic patients.

Children and Adolescents

This medicine is contraindicated in children and adolescents under 14 years of age.

Interference with Analytical Tests

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

This medicine may interfere with skin tests that use allergens. It is recommended to suspend the use of this medicine at least 3 days before starting the tests and inform the doctor.

Athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Other Medicines and Vincigrip Forte

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

In particular, if you are using any of the following medications, it may be necessary to change the dose or interrupt treatment:

• Medicines for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis: isoniazid, rifampicin.
• Medicines for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to increase urine elimination: loop diuretics (furosemide) and other diuretics that cause potassium loss (diuretics for treating hypertension or other conditions).
• Medicines to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines for treating gout: probenecid and sulfinpyrazone.
• Medicines for treating hypertension (high blood pressure) and arrhythmias (heart rhythm disorders): propranolol.
• Medicines to lower cholesterol levels in the blood: cholestyramine.
• Medicines that depress the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which have the adverse effect of producing allergy to light).
• Urinary acidifiers: ammonium chloride.
• Urinary alkalizers: sodium bicarbonate, citrates.
• Inhaled anesthetics.
• Antidepressants (tricyclic and monoamine oxidase inhibitors). See section 2. Do not take Vincigrip Forte.
• Certain medicines for lowering blood pressure or promoting urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine).
• Stimulants of the nervous system: amphetamines, xanthines. Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that must be treated urgently (see section 2).
• Digitalis glycosides (used for the heart).
• Thyroid hormones (used for thyroid diseases).
• Levodopa (used for Parkinson's disease treatment).
• Nitrates (used for angina pectoris treatment).

• Monoamine oxidase inhibitors (MAOIs), including furazolidone (antibacterial) and procarbazine (anticancer): their simultaneous use is not recommended because they can prolong and intensify the anticholinergic and central nervous system depressant effects of antihistamines.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant) or other medicines with anticholinergic action: the anticholinergic effects of these medicines or antihistamines like chlorphenamine may be potentiated. If gastrointestinal problems appear, patients should be warned to inform their doctor as soon as possible, as paralytic ileus may occur. See section 2. Warnings and Precautions.
• Monoamine oxidase inhibitors (MAOIs): it is recommended to avoid the concomitant administration of this medicine and even in the 15 days following the end of treatment with MAOI (antidepressants such as tranylcypromine, moclobemide, for Parkinson's disease such as selegiline, anticancer such as procarbazine, or anti-infectives such as linezolid) since, due to the increased release of catecholamines, they can prolong and intensify the vasopressor and cardiac stimulant effects of pseudoephedrine, potentially causing severe hypertension, hyperpyrexia, and headache.

Do not use with other medicines indicated for the relief of nasal congestion.

Use of Vincigrip Forte with Food, Drinks, and Alcohol

While being treated with this medicine, you cannot take alcoholic beverages, as it may potentiate the appearance of the side effects of this medicine.

Additionally, the use of medicines containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) may cause liver damage.

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

Do not take with bitter orange juice, as it may cause a hypertensive crisis.

Taking this medicine with food does not affect its efficacy.

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.

This medicine is contraindicated in the first trimester of pregnancy because it may cause malformations in the intestine and face of the newborn. Additionally, it should not be taken during the rest of pregnancy unless your doctor considers it strictly necessary.

Women who are breastfeeding should not take this medicine, as it passes into breast milk and may cause side effects in the baby.

Driving and Using Machines

This medicine may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Vincigrip Forte Contains Sodium, Mannitol (E-421), and Orange Yellow S (E-110)

This medicine contains 36.34 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to approximately 1.82% of the maximum recommended daily sodium intake for an adult.

It may produce a mild laxative effect because it contains mannitol.

This medicine may cause allergic reactions because it contains Orange Yellow S (E-110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to Take Vincigrip Forte

Follow the administration instructions for the medicine contained in this package leaflet 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 14 years of age: 1 sachet (650 mg of paracetamol) every 6-8 hours (3 or 4 times a day) if necessary.

Do not take more than 3 grams of paracetamol every 24 hours (see "Warnings and Precautions" section).

Patient with liver, kidney, or heart disease:should consult their doctor. (See section 2)

How to take:

Vincigrip Forte is taken orally.

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

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

Taking the medicine is subject to the appearance of symptoms. As they disappear, this medication should be suspended.

Use in Children and Adolescents

This medicine is contraindicated in children and adolescents under 14 years of age.

Use in Patients Over 65 Years of Age

These patients cannot take this medicine without consulting their doctor.

They are usually more prone to the side effects of pseudoephedrine and chlorphenamine.

If You Take More Vincigrip Forte Than You Should

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

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). In prolonged use, it may cause depletion of plasma volume (decrease in blood volume).

In more severe cases, it may cause: decrease in potassium levels in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crises.

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to the doctor or the Emergency Service of the nearest hospital or consult the Toxicology Information Service (telephone: 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible Adverse Effects

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

During the period of use of the paracetamol, chlorphenamine, and pseudoephedrine combination, the following adverse effects have been reported, whose frequency cannot be established with precision.

The adverse effects that may appear more frequently are:

Mild drowsiness, dizziness, and muscle weakness, which in some patients disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations, and tingling; blurred vision or double vision, dryness of the nose and throat, thickening of mucus, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is administered with food) such as nausea, vomiting, diarrhea, constipation, and stomach pain, urinary retention, and increased sweating.

The adverse effects that may appear less frequently are:

Nervous excitement (usually with high doses and more frequently in the elderly and children) that may include symptoms such as: restlessness, insomnia, nervousness, anxiety, headache, discoordination, tremors, and even convulsions.

Other adverse effects that may appear are: dilation of the pupils, cardiac alterations (usually due to overdose) such as rapid heartbeats (tachycardia), irregular heartbeats (palpitations), and alterations in heart rhythm (arrhythmias). Increase in blood pressure (hypertension) mainly in hypertensive patients or decrease in blood pressure (hypotension). Cases of intestinal diseases with blood in the stool have been reported a few days after starting treatment.

Alterations in the skin such as hardened lesions (erythema), itching, and dermatitis.

Difficulty or pain when urinating. Blood alterations (changes in blood formula such as agranulocytosis, leucopenia, aplastic anemia, or thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; severe hypersensitivity reactions, anaphylactic reaction (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, and difficulty breathing), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Auditory alterations, chest tension, breathing sounds (wheezing), edema (swelling). Liver disorders that may present with stomach or abdominal pain and dark urine, impotence, and alterations in menstruation.

The adverse effects that may appear in rare cases:

Discomfort, increased levels of transaminases in the blood, hallucinations (more frequent with high doses), nightmares, screaming, and confusion in children, slow heartbeats or bradycardia (frequent with high doses).

The adverse effects that may appear in very rare cases:

Kidney diseases, cloudy urine, urticaria, jaundice (yellowish skin color), blood alterations (neutropenia, hemolytic anemia), hypoglycemia (low blood sugar), myocardial infarction, and severe skin reactions.

The adverse effects whose frequency of appearance is unknown (cannot be estimated from the available data:

A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

:

Hepatitis that can lead to acute liver failure, angioedema (generalized urticaria accompanied by inflammation of the feet, hands, throat, lips, and respiratory tract), severe blistering skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis), and inflammation of the colon due to insufficient blood irrigation (ischemic colitis). Decrease in blood flow to the optic nerve (ischemic optic neuropathy).

Serious diseases that affect the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

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

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

Reporting 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 http://www.notificaram.es.

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

5. Storage of Vincigrip Forte

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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.

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 your 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 Vincigrip Forte

The active ingredients are: paracetamol, pseudoephedrine hydrochloride, and chlorphenamine maleate. Each sachet contains 650 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, and 4 mg of chlorphenamine maleate.

The other components (excipients) are: mannitol (E-421), sodium cyclamate, sodium carboxymethyl starch (gluten-free potato starch), povidone K-90, sodium saccharin, orange flavor, and yellow-orange S (E-110).

Appearance of the Product and Package Contents

Vincigrip Forte is presented in sachets containing granules for oral solution with an orange flavor.

Each package contains 10 sachets.

Marketing Authorization Holder

Laboratorios Salvat, S.A.

C/ Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

or

PHARMALOOP, S.L.

C/Bolivia, 15 – Polig Industrial Azque

28006 Alcalá de Henares, Madrid

Spain

Date of the Last Revision of this Prospectus:January 2025

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