Label: Information for the Patient

Vincigrip Forte Granulated Orange Flavored Oral Solution

Paracetamol/Pseudoephedrine Hydrochloride/Chlorphenamine Maleate

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

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

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve, or if fever persists for more than 3 days or pain or other symptoms persist for more than 5 days.

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 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 14 years and older.

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

No take Vincigrip Forte

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension by your medication.
• If you have hyperthyroidism.
• If you are taking a monoamine oxidase inhibitor (MAOI) medication, such as some antidepressants or medications for Parkinson's disease.
• If you are taking sympathomimetic medications (medications used to treat asthma or medications to increase heart rate).
• If you are taking beta-blocker medications (medications for high blood pressure or cardiovascular diseases).
• If you have glaucoma (elevated 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, acute (sudden), or chronic (long-term) kidney disease or kidney failure.
• If you are in the first trimester of pregnancy.
• Children or adolescents under 14 years old cannot take this medication.

Warnings and precautions

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

• Do not take more medication than recommended in section 3. How to take Vincigrip Forte granulated for oral solution orange flavor.
• Avoid taking this medication with other medications that contain paracetamol, as high doses can cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.
• In chronic alcoholics, be careful not to take more than 2 g/day of paracetamol (3 packets of Vincigrip Forte). If you take other products that contain nasal decongestants, do not take this medication.
• Suspend treatment at least 24 hours before surgery.
• The simultaneous use of cocaine with pseudoephedrine may increase cardiovascular effects and the risk of adverse effects.
• Abdominal pain or rectal bleeding may occur with the use of Vincigrip Forte due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Vincigrip Forte and contact your doctor or seek medical attention immediately. See section 4.

• Vincigrip Forte granulated for oral solution orange flavor may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking Vincigrip Forte granulated for oral solution orange flavor and contact your doctor or seek medical attention immediately. See section 4.
• Reversible posterior 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 granulated for oral solution orange flavor immediately and seek medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible adverse effects").
• There is a possibility of abuse of one of the active ingredients in Vincigrip Forte granulated for oral solution orange flavor, pseudoephedrine. High doses of pseudoephedrine can be toxic. Continuous use may lead to tolerance and require taking more Vincigrip Forte granulated orange flavor than the recommended dose to achieve the desired effect, which may increase the risk of overdose. Do not exceed the maximum recommended dose or treatment duration (see section 3).

Inform your doctor immediately if you experience:

Severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and body fluids) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, somnolence, feeling unwell (nausea) and vomiting.

You should consult your doctor before taking this medication:

• Patients with kidney, heart, or lung diseases and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients 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.
• Phaeochromocytoma.
• Prostatic hypertrophy (may precipitate urinary retention).
• Urethral obstruction.
• Urinary retention.
• Chronic obstructive pulmonary disease (the anticholinergic effects of chlorphenamine may produce thickening of bronchial secretions and obstruct airways).
• Pyloric or duodenal obstruction or peptic ulcer stenosis (may worsen).
• Epileptic patients.

Children and adolescents

This medication is contraindicated in children and adolescents under 14 years old.

Interference with analytical tests

Inform your doctor if you are taking this medication, as it may alter test results.

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

Athletes

Inform athletes that this medication contains a component that may establish a positive analytical result for doping control.

Other medications and Vincigrip Forte

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

Particularly, if you are using any of the following medications, as it may be necessary to change the dose or discontinue treatment:

• Medications for epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for tuberculosis: isoniazid, rifampicin.
• Medications for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications to increase urine elimination: loop diuretics (furosemide) and other diuretics that produce potassium loss (diuretics for hypertension or other).
• Medications to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications for gout: probenecid and sulfinpyrazone.
• Medications for hypertension (high blood pressure) and arrhythmias (heart rhythm disorders): propranolol.
• Medications to lower cholesterol levels in the blood: cholestyramine.
• Medications that produce depression on the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (that may damage the ear).
• Phototoxic medications (that may cause light allergy).
• Urinary acidifiers: ammonium chloride.
• Urinary alkalinizers: sodium bicarbonate, citrates.
• Inhalation anesthetics.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant) or other medications with anticholinergic action: may potentiate the anticholinergic effects of these medications or antihistamines like chlorphenamine. If gastrointestinal problems occur, inform patients to report them as soon as possible to their doctor, as it may cause paralytic ileus. See section 2. Warnings and precautions.
• MAOIs: avoid concurrent administration of this medication and even in the 15 days after completion of treatment with MAOIs (antidepressants like tranilcipromina, moclobemida, for Parkinson's disease like selegilina, anticancer drugs like procarbazina, or anti-infectious drugs like linezolida) as it may increase the risk of hypertensive crisis, hyperpyrexia, and headache due to the increased release of catecholamines.

Do not use with other medications indicated for nasal decongestion relief.

Use of Vincigrip Forte with food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as it may increase the risk of adverse effects.

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

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

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

The consumption of this medication with food does not affect its efficacy.

Pregnancy and lactation

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

This medication is contraindicated in the first trimester of pregnancy, as it may cause intestinal and facial malformations in the newborn. Additionally, it should not be taken during the rest of pregnancy unless your doctor considers it strictly necessary.

Women in lactation should not take this medication, as it passes into breast milk and may cause adverse effects in the baby.

Driving and operating machinery

This medication may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.

Vincigrip Forte contains sodium, mannitol (E-421), and yellow-orange S (E-110)

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

It may cause a mild laxative effect due to mannitol.

It may cause allergic reactions due to yellow-orange S (E-110).

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 old: 1 tablet (650 mg of paracetamol) every 6-8 hours (3 or 4 times a day) as needed.

Do not take more than 3 grams of paracetamol per 24 hours (see section “Warnings and precautions”).

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

How to take:

Vincigrip Forte is taken orally.

Empty the contents of the tablet into a half glass of water, stirring until it dissolves completely.

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

The medication should be taken as long as symptoms appear. As symptoms disappear, this medication should be discontinued.

Use in children and adolescents

This medication is contraindicated in children and adolescents under 14 years old.

Use in patients over 65 years old

These patients cannot take this medication without consulting their doctor.

They are often more prone to the adverse 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 do not have symptoms, as symptoms 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, yellowish discoloration 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 (this last 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 alkalinity reserve). In prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

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

The treatment of overdose is more effective if it is initiated within 4 hours after ingestion of the overdose of the medication.

Patients undergoing barbiturate treatment 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 Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the period of use of the paracetamol, chlorphenamine, and pseudoephedrine association, the following side effects have been reported, whose frequency could not be established with precision.

The side 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 moving the face, clumsiness, tremors, alterations in sensations, and paresthesia; blurred vision or double vision, dryness of the nose and throat, thickening of mucosities, dryness of the mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is taken with food) such as nausea, vomiting, diarrhea, constipation, and stomach pain, urinary retention, and increased sweating.

The side 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 side effects that may appear are: dilated pupils, cardiac alterations (usually due to overdose) such as rapid heartbeats (tachycardia), irregular heartbeats (palpitations), and alterations in heart rhythm (arrhythmias). Increased blood pressure (hypertension) mainly in hypertensive patients or decreased blood pressure (hypotension). Cases of intestinal diseases with presence of blood in stools have been presented a few days after starting treatment.

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

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

The side effects that may appear in rare occasions:

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

The side effects that may appear in very rare occasions:

Renal diseases, cloudy urine, urticaria, jaundice (yellowish discoloration of the skin), blood disorders (neutropenia, hemolytic anemia), hypoglycemia (low blood sugar), myocardial infarction, and severe skin reactions.

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

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

:

Heptatitis that may lead to acute liver failure, angioedema (generalized urticaria accompanied by inflammation of feet, hands, throat, lips, and respiratory pathways), severe skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized pustular psoriasis) and ischemic colitis due to insufficient blood irrigation. Decreased blood flow to the optic nerve (ischemic optic neuropathy).

Severe diseases affecting the cerebral blood vessels known as reversible posterior encephalopathy syndrome (REPS) and reversible cerebral vasoconstriction syndrome (RCVS)

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

• intense headache of sudden onset
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://www.notificaram.es.

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

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Vincigrip Forte

The active principles 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, carboxymethylcellulose sodium (gluten-free potato starch), povidone K-90, sodium saccharin, orange and yellow S (E-110) flavor.

Appearance of the product and content of the packaging

Vincigrip Forte is presented in sachets containing orange-flavored oral granules for solution.

Each package contains 10 sachets.

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/ Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

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

Last review date of this leaflet:January 2025

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