Vicks Antigrip Max

Leaflet attached to the packaging: patient information

Vicks AntiGrip Max

(1000 mg + 16 mg + 4 mg)/sachet, granules for oral solution preparation
Paracetamol + Phenylephrine hydrogen tartrate + Chlorphenamine maleate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Vicks AntiGrip Max and what is it used for
• 2. Important information before taking Vicks AntiGrip Max
• 3. How to take Vicks AntiGrip Max
• 4. Possible side effects
• 5. How to store Vicks AntiGrip Max
• 6. Package contents and other information

1. What is Vicks AntiGrip Max and what is it used for

Vicks AntiGrip Max is indicated for the symptomatic treatment of colds and flu, accompanied by fever, mild or moderate pain (e.g., headache, throat, muscle, and sinus pain), swelling of the nasal mucosa and sinuses with discharge production. Vicks AntiGrip Max is a combination of three active substances:

• Paracetamol - an antipyretic and analgesic substance
• Phenylephrine - a substance that reduces swelling of the nasal mucosa and sinuses
• Chlorphenamine - an antihistamine substance that reduces nasal discharge

If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Vicks AntiGrip Max

When not to take Vicks AntiGrip Max

• If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• If the patient has hypertension;
• If the patient has hyperthyroidism;
• If the patient has any severe heart or vascular disease (such as coronary artery disease);
• If the patient has tachycardia (rapid heart rate);
• If the patient has severe renal impairment;
• If the patient has glaucoma (increased eye pressure);
• If the patient has severe liver disease;
• If the patient is taking monoamine oxidase inhibitor (MAOI) drugs (such as certain antidepressants or drugs used to treat Parkinson's disease) and for 15 days after their discontinuation;
• The medicine is contraindicated in children and adolescents due to the high dose of paracetamol.

Warnings and precautions

• Other paracetamol-containing medicines should not be taken, as this may lead to overdose. Paracetamol overdose can occur both after taking too high a single dose and after exceeding the recommended dose within a day. (See section 3 "Taking a higher dose of Vicks AntiGrip Max than recommended").
• Sympathomimetics (such as decongestants, appetite suppressants, or psychostimulants with amphetamine-like action) and other antihistamine medicines (including those applied to the skin) and medicines used to treat colds and flu should not be taken at the same time.
• Caution should be exercised in patients with alcoholism and patients who regularly drink alcohol, and no more than 2 sachets of Vicks AntiGrip Max (2 g of paracetamol) should be taken per day. During treatment, alcohol should not be consumed due to the increased risk of toxic liver damage.
• In patients with anemia, heart disease, lung disease, and liver function disorders, only occasional use is allowed, and medical advice should be sought before taking this medicine.
• There have been reports of toxic effects on the liver in cases where paracetamol was administered at a daily dose not exceeding 4 g.
• Patients with asthma who are allergic to acetylsalicylic acid should consult their doctor before taking this medicine. Patients allergic to antihistamines should consult their doctor before starting this medicine, as they may also be allergic to other medicines.
• Patients sensitive to the action of sedative drugs and patients with epilepsy should consult their doctor before starting this medicine, as they may experience worsening of symptoms and interactions with drugs used to treat these conditions.
• The concomitant use of chlorphenamine and other serotonergic drugs, including SSRIs and SNRIs, may increase the risk of serotonin syndrome.

Before taking Vicks AntiGrip Max, the patient should discuss the following with their doctor or pharmacist:

• if the patient has kidney or lung disease
• if the patient has a problem with urination and/or prostate enlargement
• if the patient has diabetes
• if the patient has asthma
• if the patient has very slow heart rate, hypotension (low blood pressure), atherosclerosis of cerebral vessels
• if the patient has pancreatitis, stomach ulcers, narrowing of the pylorus and duodenum
• if the patient has thyroid disease
• if the patient has anemia
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (may lead to methemoglobinemia and hemolytic anemia) and methemoglobin reductase.

If patients taking tricyclic antidepressants or other drugs with similar action experience gastrointestinal symptoms, they should consult their doctor as soon as possible. These symptoms may be due to the development of paralytic ileus (cessation of intestinal motility, which can lead to bowel obstruction).

• Patients taking carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other liver enzyme-inducing drugs;
• Patients who may have a glutathione deficiency, such as those with eating disorders, HIV infection, dehydration, starvation, or malnutrition;
• Patients who regularly drink alcohol;
• Patients with liver disease (including Gilbert's syndrome).

During treatment with Vicks AntiGrip Max, the patient should immediately inform their doctor if:

they have severe diseases, including severe kidney or liver disorders, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder) when taking paracetamol at regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Children and adolescents

Vicks AntiGrip Max is contraindicated in children and adolescents due to the high dose of paracetamol.

Use of Vicks AntiGrip Max in the elderly

Vicks AntiGrip Max should not be used in the elderly without consulting a doctor. There is a likelihood that a lower dose will be required in these patients. Due to the presence of phenylephrine and chlorphenamine, elderly patients may experience side effects such as bradycardia (slow heart rate) or decreased cardiac minute volume. Blood pressure should be monitored, especially in patients with heart disease. In older patients, it is more likely to experience symptoms such as dizziness, sedation, confusion, low blood pressure, excitement, dry mouth, and urinary retention.

Use of Vicks AntiGrip Max by athletes

Taking Vicks AntiGrip Max may result in a positive doping test.

Vicks AntiGrip Max and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Taking Vicks AntiGrip Max with other medicines may lead to interactions. Due to the presence of paracetamol:

• Oral anticoagulants (acenocoumarol, warfarin, and other coumarins);
• Antiepileptic drugs (lamotrigine, phenytoin, phenobarbital, methylphenobarbital, primidone);
• Antitubercular drugs (isoniazid, rifampicin);
• Certain diuretics (loop diuretics, e.g., furosemide);
• Drugs used to treat gout (probenecid);
• Drugs used to treat nausea and vomiting (metoclopramide and domperidone);
• Propranolol used to treat high blood pressure and heart rhythm disorders;
• Cholestyramine (used to reduce cholesterol in the blood);
• Activated charcoal;
• Prolonged use of carbamazepine;
• St. John's wort or other liver enzyme-inducing drugs;
• Acetylsalicylic acid;
• Zidovudine; The patient should inform their doctor or pharmacist if they are taking:
• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Due to the presence of phenylephrine:

• Monoamine oxidase inhibitors (drugs used to treat, among other things, depression, such as phenelzine, isocarboxazid, nialamide, tranylcypromine, moclobemide, or drugs used to treat Parkinson's disease, such as selegiline). The administration of Vicks AntiGrip Max should be delayed by at least 15 days from the end of treatment with these drugs;
• Alpha-adrenergic receptor blockers (drugs used to treat migraine, such as dihydroergotamine, ergotamine, phenylephrine, or drugs that induce labor, such as oxytocin);
• Beta-adrenergic receptor blockers (drugs used to treat hypertension or mild prostate enlargement);
• Tricyclic antidepressants, such as amitriptyline, amoxapine, clomipramine, desipramine, and doxepin, or tetracyclic ones like maprotiline;
• Inhalation anesthetics, such as cyclopropane and halothane;
• Antihypertensive drugs that act through the sympathetic nervous system, such as methyldopa, guanethidine;
• Drugs that cause potassium loss (such as diuretics, e.g., furosemide and others);
• Drugs that affect heart conduction (cardiac glycosides, such as digoxin, antiarrhythmic drugs);
• Thyroid hormones;
• Atropine sulfate (used, among other things, in heart and digestive system diseases);
• Drugs that block alpha and beta adrenergic receptors used in heart and vascular diseases (such as labetalol, carvedilol).

Due to the presence of chlorphenamine:

• Concomitant use of the following drugs may enhance the occurrence of side effects:
• Drugs acting on the central nervous system (used to treat depression, insomnia, anxiety);
• Monoamine oxidase inhibitors (including furazolidone, pargyline, and procarbazine);
• Tricyclic or tetracyclic antidepressants, such as maprotiline;
• Ototoxic drugs (which may cause hearing loss as a side effect);
• Drugs that sensitize to light.
• Concomitant use of chlorphenamine and other serotonergic drugs, including SSRIs and SNRIs, may increase the risk of serotonin syndrome.

Effect on laboratory test results

If the patient is to undergo diagnostic tests (blood tests, urine tests, skin tests using allergens), they should inform their doctor that they are taking Vicks AntiGrip Max, as this medicine may affect laboratory test results.

Vicks AntiGrip Max with food, drink, and alcohol

During treatment with Vicks AntiGrip Max, the patient should not drink alcohol, as it may cause overdose symptoms, such as enhanced sedative effect. Taking Vicks AntiGrip Max in patients who regularly drink alcohol (three or more alcoholic beverages per day) may lead to liver damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

There are insufficient data on the use of the active substances of this medicinal product in pregnant women. Vicks AntiGrip Max should not be used during pregnancy unless absolutely necessary. The decision to take the medicine will be made by the doctor. The medicine should only be used if the potential benefits to the mother outweigh the risk to the fetus. The smallest effective dose should be used for the shortest possible time and as infrequently as possible.

Breastfeeding

Paracetamol and chlorphenamine pass into breast milk, so breastfeeding women should not take this medicine.

Driving and using machines

Vicks AntiGrip Max may cause dizziness or blurred vision, drowsiness, and sedation, which may affect the ability and speed of reaction, so the patient should not drive vehicles or operate machines while taking this medicine.

Warnings about excipients

Vicks AntiGrip Max contains mannitol (E 421).

The medicine contains 3 g of mannitol (E 421) in one sachet, which may have a mild laxative effect. The medicine contains less than 1 mmol (23 mg) of sodium in one sachet, which means the medicine is considered "sodium-free". The medicine contains trace amounts of sulfites from the flavor composition (aroma component), which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Vicks AntiGrip Max

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The medicine is for oral use. If fever persists for more than 3 days of treatment, pain or other symptoms persist for more than 5 days, symptoms worsen, or new symptoms appear, the patient should consult their doctor. Vicks AntiGrip Max should be taken when pain and fever symptoms occur. If these symptoms resolve, the patient should stop taking the medicine. The recommended dose is: Adults: one sachet every 6-8 hours. Do not take more than 4 sachets in 24 hours. Elderly: do not take more than 3 sachets in 24 hours. In adult patients with a body weight below 50 kg, patients with Gilbert's syndrome (familial non-hemolytic jaundice), dehydrated patients, chronically malnourished patients, or patients with chronic alcoholism, the dose should be reduced by half and the following dosing regimen should be used: one sachet 2-3 times a day at 6-8 hour intervals. Do not exceed 3 sachets per day. Patients with mild to moderate liver impairment: 1 sachet at least every 8 hours. Do not take more than 2 sachets per day (2 g of paracetamol). Patients with renal impairment: Due to the paracetamol content, this medicine is not recommended for use in this patient group. Method of preparation: The contents of one sachet should be dissolved in a small amount of hot, but not boiling, water (preferably in half a glass of water). Let it cool and reach a temperature suitable for drinking.

Taking a higher dose of Vicks AntiGrip Max than recommended

WARNING! Other paracetamol-containing medicines should not be taken with Vicks AntiGrip Max, as this may lead to overdose. If an overdose has occurred, the patient should immediately contact their doctor or go to the nearest Emergency Department, even if no symptoms have occurred, as this may lead to life-threatening liver damage. This also applies to cases of severe overdose. Symptoms of overdose related to paracetamol: nausea, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, diarrhea, excessive sweating, overdose may also lead to: coagulation disorders (blood clotting and bleeding). Acute liver failure and liver necrosis may occur, which can lead to death. Symptoms related to phenylephrine: excessive nervous system stimulation with symptoms such as anxiety, fear, excitement, headaches, seizures, insomnia, confusion, irritability, loss of appetite, nausea, vomiting, psychosis with hallucinations (more common in children), hypertension, cerebral hemorrhage, pulmonary edema, cardiac arrhythmias, palpitations, vasoconstriction with possible reduced blood flow to vital organs, decreased urine production, and metabolic acidosis. Symptoms related to chlorphenamine: increased drowsiness, dryness of the mouth, nose, and throat, shortness of breath, cardiac arrhythmias, nervous system stimulation (hallucinations, seizures, insomnia), hypotension. Treatment of paracetamol overdose is more effective if started within 4 hours of taking the overdose. In all cases, vomiting should be induced and gastric lavage performed. Hospital treatment involves intravenous or oral administration of an antidote - N-acetylcysteine. In cases of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment is used.

Missing a dose of Vicks AntiGrip Max

If a dose is missed, it should be taken as soon as possible. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Vicks AntiGrip Max

Administration of the medicinal product depends on the presence of symptoms (pain, fever). If these symptoms resolve, the medicinal product should be discontinued. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vicks AntiGrip Max can cause side effects, although not everybody gets them. If the following serious, life-threatening side effects occur, the patient should stop taking the medicine immediately and contact their doctor or Emergency Department:

Kaszel, trudności z połykaniem, trudności z oddychaniem, szybkie bicie serca, świąd, opuchnięcie powiek lub okolicy oczu, twarzy i/lub języka lub gardła, wysypki skórne, pokrzywka, duszność (anafilaksja), zatrzymanie moczu, żółte zabarwienie skóry i/lub gałek ocznych, zawał mięśnia sercowego, arytmia komorowa, obrzęk płuc i krwawienie domózgowe, zwiększenie liczby krwawień z nosa lub zauważenie, że łatwiej powstają siniaki lub krwawienia. Paracetamol may cause severe skin reactions characterized by acute generalized pustular rash or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain or large blisters and widespread skin erosion, fever, and lymphadenopathy. Some patients taking Vicks AntiGrip Max may experience the following side effects:

Common (more than 1 in 100 people, but less than 1 in 10 people):

Somnolence, nausea, and muscle weakness (which may resolve after 2-3 days of treatment), involuntary facial movements, coordination disorders, tingling, numbness, or changes in skin temperature, tremors, dry mouth, loss of appetite, changes in taste and smell, gastrointestinal disorders that may decrease when the medicine is taken with food (e.g., nausea, vomiting, indigestion, diarrhea, constipation, abdominal pain), dryness of the nasal and throat mucosa, drying of mucous membranes, increased sweating, blurred or double vision, headaches, and dizziness. In some patients, especially those with enlarged prostate, urinary retention, and difficulty urinating may occur.

Uncommon (more than 1 in 1000 people, but less than 1 in 100 people) or rare (more than 1 in 10,000 people, but less than 1 in 1000 people):

Nervous system stimulation (anxiety, insomnia, tremors, hallucinations, seizures, and more), or fatigue, chest pressure, cardiac arrhythmias, rapid heart rate (usually with overdose), decreased or increased blood pressure, dizziness, cholestasis, liver inflammation, or other liver function disorders (including abdominal pain, dark urine), severe allergic reactions (cough, difficulty swallowing, itching, swelling of the eyelids or eye area, face, and/or tongue, shortness of breath, fatigue, etc.), hypersensitivity to light, fatigue, may experience disorientation or fainting due to hypotension or hypertension, cross-allergy to chlorphenamine-like drugs, changes in blood morphology, sore throat, edema (swelling), tinnitus, acute labyrinthitis (part of the ear), impotence, intermenstrual bleeding.

Rare (more than 1 in 10,000 people, but less than 1 in 1000 people):

Increased liver enzyme activity, myocardial infarction, ventricular arrhythmia, pulmonary edema, and cerebral hemorrhage (usually with high doses).

Very rare (less than 1 in 10,000 people):

Blood disorders such as thrombocytopenia (decreased platelet count), agranulocytosis (significant decrease in granulocyte count, which can increase the frequency of infections), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), hemolytic anemia, hypoglycemia (significant decrease in blood sugar levels), kidney disorders, cloudy urine, allergic skin inflammation, skin rash, hives, severe skin reactions, hypersensitivity reactions (blisters, anaphylactic shock, bronchospasm), jaundice. Paracetamol may cause liver damage in cases of high doses or prolonged treatment.

Frequency not known (cannot be estimated from available data):

Anxiety, apprehension, confusion, weakness, irritability, dizziness, nausea, tremors, insomnia, chest pain or discomfort, severe bradycardia (very slow heart rate), vasoconstriction, increased cardiac workload (especially in elderly patients or patients with cerebral or coronary circulation disorders), cold hands and feet, flushing, difficulty breathing, shortness of breath, worsening renal perfusion, decreased urine production, and urinary retention, pale skin, hair loss, hyperglycemia (elevated blood sugar levels), hypokalemia (low potassium levels in serum), severe disease that can cause acidosis (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2). When taking high doses, the following may occur: seizures, psychotic states with hallucinations, vomiting. It is possible to induce or exacerbate heart disease, palpitations. With prolonged use, hypovolemia (reduced blood volume) may develop, and excessive sweating may occur.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Vicks AntiGrip Max

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vicks AntiGrip Max contains

The active substances of the medicine are paracetamol, phenylephrine hydrogen tartrate, and chlorphenamine maleate. Each sachet contains: 1000 mg of paracetamol; 15.58 mg of phenylephrine hydrogen tartrate, which corresponds to 8.21 mg of phenylephrine; 4 mg of chlorphenamine maleate, which corresponds to 2.8 mg of chlorphenamine. The excipients are: mannitol (E 421), sodium saccharin, anhydrous colloidal silica, povidence K30, orange flavor PHS 132958 (contains butylhydroxyanisole (E 320), sulfites, citral, citronellol, D-limonene, geraniol, linalool).

What Vicks AntiGrip Max looks like and what the package contains

Vicks AntiGrip Max is a granule (white to yellowish-white) for oral solution preparation, with an orange flavor. One package contains 10 or 14 sachets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Wick-Pharma, a branch of Procter & Gamble GmbH, Sulzbacher Straße 40, 65824 Schwalbach am Taunus, Germany. For more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder: Procter & Gamble Health Poland Sp. z o.o., ul. Zabraniecka 20, 03-872 Warsaw, tel. 801 25 88 25

Manufacturer

Laboratorios Alcalá Farma, S.L., Avenida de Madrid, 82, 28802 Alcalá de Henares, Madrid, Spain

Date of last revision of the leaflet: