Vincigrip Forte granules for oral solution orange-flavored

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vincigrip Forte granules for oral solution orange flavour

Paracetamol/Pseudoephedrine hydrochloride/Chlorpheniramine maleate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for use contained 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 more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, or if fever persists for more than 3 days or pain and other symptoms last for more than 5 days.

Contents of the leaflet

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

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

Vincigrip Forte is a combination of paracetamol, pseudoephedrine, and chlorphenamine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal discharge.

Pseudoephedrine is a sympathomimetic that reduces nasal congestion.

It is indicated for the symptomatic relief of catarrhal conditions and influenza-like illnesses, with or without fever, mild to moderate pain, nasal congestion, and nasal discharge in adults and adolescents aged 14 years and older.

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

2. What you need to know before taking Vincigrip Forte

Do not take Vincigrip Forte

• If you are allergic to the active substances 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 due to your medication.
• If you have hyperthyroidism.
• If you are being treated with monoamine oxidase inhibitors (MAOIs), such as certain antidepressants or medicines used to treat Parkinson's disease.
• If you are being treated with sympathomimetic drugs (medicines used to treat asthma, or medicines that increase heart rate).
• If you are being treated with beta-blockers (medicines used to treat high blood pressure or cardiovascular diseases).
• If you have glaucoma (increased intraocular pressure).
• If you have a serious heart or arterial disease (such as coronary artery disease, angina pectoris, or cerebral hemorrhage).
• If you have a serious 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 of age must not take this medicine.

Warnings and precautions

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

• Do not take more medicine than recommended in section 3. How to take Vincigrip Forte orange-flavored granules for oral solution.

• Avoid simultaneous use of this medicine with other products containing paracetamol, as high doses may cause liver damage. Do not use more than one product containing paracetamol without consulting your doctor.

• In chronic alcoholics, caution should be taken not to exceed 2 g/day of paracetamol (3 sachets of Vincigrip Forte). Do not take this medicine if you are also taking other products containing nasal decongestants.

• Treatment should be discontinued at least 24 hours before any surgical procedure.

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

• Sudden abdominal pain or rectal bleeding may occur when taking Vincigrip Forte, due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Vincigrip Forte and contact your doctor or seek immediate medical attention. See section 4.

• Vincigrip Forte orange-flavored granules for oral solution may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking Vincigrip Forte granules for oral solution immediately 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 following the use of medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Vincigrip Forte orange-flavored granules for oral solution immediately and seek immediate medical assistance if you experience symptoms that could be signs of RPES or RCVS (for symptoms, see section 4 "Possible side effects").

• There is a potential for abuse of one of the active ingredients in Vincigrip Forte orange-flavored granules for oral solution, pseudoephedrine. High doses of pseudoephedrine can be toxic. Continuous use may lead to tolerance and result in taking more Vincigrip Forte orange-flavored granules than the recommended dose to achieve the desired effect, increasing the risk of overdose. Do not exceed the maximum recommended dose or duration of treatment (see section 3).

During treatment with Vincigrip, inform your doctor immediately 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 have 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 with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

The following patients should consult their doctor before taking this medicine:

• 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 also be sensitive to other antihistamines (such as chlorphenamine).
• Diabetes mellitus (may increase blood glucose concentration).
• Cardiovascular diseases.
• Pheochromocytoma.
• Prostatic hypertrophy (may precipitate urinary retention).
• Bladder neck obstruction.
• Urinary retention.
• Chronic obstructive pulmonary disease (COPD) (the anticholinergic effects of chlorphenamine may cause thickening of bronchial secretions and airway obstruction).
• 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 diagnostic tests

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

This medicine may interfere with skin tests using allergens. It is recommended to discontinue taking this medicine at least 3 days before starting such tests and to inform your doctor.

Athletes

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Other medicines and Vincigrip Forte

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, a dose adjustment or discontinuation of treatment may be necessary:

• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medicines to treat tuberculosis: isoniazid, rifampicin.

• Medicines to treat seizures 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 potassium-wasting diuretics (diuretics used to treat hypertension or other conditions).

• Medicines to prevent nausea and vomiting: metoclopramide and domperidone.

• Medicines to treat gout: probenecid and sulfinpyrazone.

• Medicines to treat high blood pressure (hypertension) and arrhythmias (heart rhythm disorders): propranolol.

• Medicines to lower blood cholesterol levels: cholestyramine.

• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).

• Ototoxic medicines (those that may damage the ear as an adverse effect).

• Photosensitizing medicines (those that may cause light allergy as an adverse effect).

• Urinary acidifiers: ammonium chloride.

• Urinary alkalinizers: sodium bicarbonate, citrates.

• Inhalational anesthetics.

• Antidepressants (tricyclics and monoamine oxidase inhibitors). See section 2. Do not take Vincigrip Forte.

• Some medicines to lower blood pressure or increase urine elimination (such as beta-blockers, ACE inhibitors, Rauwolfia alkaloids such as reserpine).

• Central nervous system stimulants: amphetamines, xanthines. Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

• Digitalis glycosides (used for heart conditions).

• Thyroid hormones (used for thyroid diseases).

• Levodopa (used to treat Parkinson's disease).

• Nitrates (used to treat angina pectoris).

• Monoamine oxidase inhibitors (MAOIs), including furazolidone (antibacterial) and procarbazine (anticancer): concurrent use is not recommended, as they may 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 such as chlorphenamine may be enhanced. If gastrointestinal problems occur, patients should be advised to inform their doctor immediately, as paralytic ileus may develop. See section 2. Warnings and precautions.

• Monoamine oxidase inhibitors (MAOIs): concomitant administration of this medicine should be avoided, and even within 15 days after stopping MAOI treatment (antidepressants such as tranylcypromine, moclobemide; for Parkinson’s disease such as selegiline; anticancer such as procarbazine; or anti-infectives such as linezolid), because increased catecholamine release may prolong and intensify the vasopressor and cardiac stimulant effects of pseudoephedrine, potentially causing severe hypertension, hyperthermia, and headache.

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

Use of Vincigrip Forte with food, drinks, and alcohol

While being treated with this medicine, you must not consume alcoholic beverages, as they may enhance the adverse effects of this medicine.

Additionally, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Limit consumption of drinks 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 during the first trimester of pregnancy because it may cause intestinal and facial malformations in the newborn. It should also not be taken during the remainder 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 adverse effects in the infant.

Driving and using machines

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

Vincigrip Forte contains sodium, mannitol (E-421), and sunset yellow FCF (E-110)

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

It may cause a mild laxative effect due to the presence of mannitol.

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110).

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

3. How to take Vincigrip Forte

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 14 years of age: 1 sachet (650 mg paracetamol) every 6–8 hours (3 or 4 times daily) as needed.

Do not take more than 3 grams of paracetamol in any 24-hour period (see section “Warnings and precautions”).

How to take:

Vincigrip Forte is taken orally.

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

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

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

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 must not take this medicine without consulting their doctor.

They are usually more prone to the adverse effects of pseudoephedrine and chlorpheniramine.

If you take more Vincigrip Forte than you should

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

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or excessive drowsiness), clumsiness, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output. Metabolic acidosis (decrease in the blood's alkaline reserve). With prolonged use, depletion of plasma volume (decreased blood volume) may occur.

In more severe cases, the following may occur: decreased potassium levels in the blood (hypokalaemia), mental disorders with altered perception of reality (psychosis), seizures, coma, and hypertensive crises.

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

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

In case of overdose or accidental ingestion, seek immediate medical attention at the nearest hospital emergency department or contact the Toxicology Information Service (telephone: 91 562 04 20), stating the name of the medicine and the amount ingested.

4. Possible adverse effects

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

During the period of use of the combination of paracetamol, chlorpheniramine and pseudoephedrine, the following adverse effects have been reported, whose frequency could not be accurately determined.

The adverse effects that may occur more frequently are:

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

The adverse effects that may occur less frequently are:

Nervous excitement (generally with high doses and more frequently in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, anxiety, headache, lack of coordination, tremors and even convulsions.

Other possible adverse effects include: dilation of the pupils, cardiac disturbances (usually due to overdose), such as rapid heartbeat (tachycardia), irregular heartbeat (palpitations) and disturbances in heart rhythm (arrhythmias). Increase in blood pressure (hypertension), mainly in hypertensive patients, or drop in blood pressure (hypotension). Cases of intestinal disorders with blood in the stool have been reported within a few days of starting treatment.

Skin reactions such as hardened lesions (erythemas), itching and dermatitis.

Difficulty or pain during urination. Blood disorders (changes in blood count such as agranulocytosis, leucopenia, aplastic anaemia 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 eyes, face, tongue and breathing difficulties), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorpheniramine. Hearing disturbances, chest tightness, wheezing, oedema (swelling). Liver disorders that may present with stomach or abdominal pain and dark urine, sexual impotence and menstrual disturbances.

Adverse effects that may occur rarely:

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

Adverse effects that may occur very rarely:

Kidney disorders, cloudy urine, urticaria, jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), myocardial infarction and severe skin reactions.

Adverse effects whose frequency cannot be determined from the available data:

A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Hepatitis which may lead to acute liver failure, angioedema (generalized hives accompanied by swelling of feet, hands, throat, lips and airways), very 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 supply (ischaemic colitis). Decreased blood flow to the optic nerve (ischaemic optic neuropathy).

Serious conditions affecting the blood vessels in the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Vincigrip Forte 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

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vincigrip Forte

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

No special storage conditions are required.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are 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 Vincigrip Forte

The active substances 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 (potato starch, gluten-free), povidone K-90, sodium saccharin, orange flavour, and sunset yellow FCF (E-110).

Nature of the product and contents of the pack

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

Each pack 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 most recent review of this summary: January 2025

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