Vicks antigrip max

Package leaflet: Information for the patient

Vicks AntiGrip Max
(1000 mg + 16 mg + 4 mg)/sachet, granules for oral solution
Paracetamolum + Phenylephrini hydrogenotartras + Chlorphenamini maleas
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult a doctor.

Table of contents:

1. What Vicks AntiGrip Max is and what it is 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. Contents of the pack and other information

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

Vicks AntiGrip Max is indicated for the symptomatic treatment of cold and flu associated with
fever, mild to moderate pain (e.g. headache, sore throat, muscle pain, sinus pain),
nasal and paranasal sinus mucosa swelling with nasal discharge.
Vicks AntiGrip Max is a combination of three active substances:

• paracetamol – an antipyretic and analgesic agent
• phenylephrine – a substance that reduces swelling of the nasal and paranasal sinus mucosa
• chlorphenamine – an antihistamine agent that reduces nasal discharge.

If there is no improvement after 3 days, or if you feel worse, consult a doctor.

2. Important information before using Vicks AntiGrip Max

When not to use Vicks AntiGrip Max

• If the patient is allergic to the active substances or to 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 arterial disease (such as coronary heart disease);
• If the patient has tachycardia (abnormally fast heartbeat);
• If the patient has severe renal failure;
• If the patient has glaucoma (increased intraocular pressure);
• If the patient has severe liver disease;
• If the patient is being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressants or drugs used in the treatment of Parkinson's disease), and within 15 days after discontinuation of such treatment;
• The medicine is contraindicated in children and adolescents due to the high dose of paracetamol.

Warnings and precautions

• Do not take other medicines containing paracetamol, as this may lead to poisoning. Paracetamol poisoning may occur after taking an excessive single dose or exceeding the recommended daily dose. (See section 3 “Use of a higher than recommended dose of Vicks AntiGrip Max”).
• Do not simultaneously use sympathomimetics (such as nasal decongestants, appetite suppressants, or psychostimulants with amphetamine-like effects), other antihistamines (e.g. antiallergic agents), including those applied to the skin, or medicines used to treat cold and flu.
• Exercise caution in patients with alcohol-related disease or those who regularly consume alcohol; do not administer more than 2 sachets of Vicks AntiGrip Max (2 g of paracetamol) per day. During treatment, alcohol consumption should be avoided due to increased risk of hepatotoxicity.
• In patients with anaemia, heart or lung diseases, or impaired liver function, occasional use may be permitted, but medical advice should be sought before taking this medicine.
• Cases of hepatotoxic effects have been reported with paracetamol administered at daily doses not exceeding 4 g.
• Asthmatic patients who are allergic to acetylsalicylic acid should consult a doctor before taking this medicine. Patients allergic to antihistamines should consult a doctor before starting treatment with this medicine, as they may also be allergic to other drugs.
• Patients sensitive to sedative effects and patients with epilepsy should consult a doctor before starting treatment with this medicine, as symptoms of the disease may worsen and interactions with medicines used to treat these conditions may occur.
• Concomitant use of chlorpheniramine and other serotonergic drugs, including SSRIs and SNRIs, may increase the risk of serotonin syndrome.

Before starting treatment with Vicks AntiGrip Max, discuss with your doctor or pharmacist if:

• the patient has kidney or lung diseases;
• the patient has difficulty urinating and/or benign prostatic hyperplasia;
• the patient has diabetes;
• the patient has bronchial asthma;
• the patient has very slow heart rate, hypotension (low blood pressure), or cerebral arteriosclerosis;
• the patient has pancreatitis, peptic ulcer disease, or pyloroduodenal stenosis;
• the patient has thyroid disorders;
• the patient has anaemia;
• the patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may lead to methaemoglobinaemia and haemolytic anaemia) or methaemoglobin reductase deficiency.

If gastrointestinal symptoms occur in patients treated with tricyclic antidepressants or other drugs with similar effects, consult a doctor immediately. These symptoms may be due to paralytic ileus (cessation of intestinal peristalsis moving food content).

There is an increased risk of liver damage with paracetamol use in patients:

• taking long-term carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's wort, or other drugs inducing liver enzymes;
• who may have glutathione deficiency, e.g. due to eating disorders, HIV infection, dehydration, starvation, or cachexia;
• who regularly consume alcohol;
• with liver diseases (including Gilbert's syndrome).

During treatment with Vicks AntiGrip Max, inform your doctor immediately if: The patient has severe conditions, including severe renal dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (abnormality in blood and body fluids) when taking paracetamol regularly over a long period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, 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 elderly patients
Do not use Vicks AntiGrip Max in elderly patients without consulting a doctor. It is likely that lower doses may be required in these patients.
Due to the presence of phenylephrine and chlorpheniramine, adverse effects such as bradycardia (slow heartbeat) or reduced cardiac output may occur in elderly patients.
Blood pressure should be monitored, especially in patients with heart disease. In elderly patients, symptoms such as dizziness, sedation, confusion, low blood pressure, excitation, dry mouth, and urinary retention are more likely to occur.

Use of Vicks AntiGrip Max by athletes
Use of Vicks AntiGrip Max may result in a positive doping control test.

Vicks AntiGrip Max with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Concomitant use of Vicks AntiGrip Max with other medicines may lead to interactions.

Due to the presence of paracetamol:
If the patient is taking any of the following medicines, dosage adjustment or discontinuation of treatment may be necessary:

• Oral anticoagulants (acenocoumarol, warfarin, and other coumarins);
• Antiepileptic drugs (lamotrigine, phenytoin, phenobarbital, methylphenobarbital, primidone);
• Antituberculosis drugs (isoniazid, rifampicin);
• Certain diuretics used to increase urine excretion (loop diuretics, e.g. furosemide);
• Drugs used in the treatment of gout (probenecid);
• Drugs used for nausea and vomiting (metoclopramide and domperidone);
• Propranolol (used in the treatment of high blood pressure and cardiac arrhythmias);
• Cholestyramine (used to reduce blood cholesterol);
• Activated charcoal;
• Long-term use of carbamazepine;
• St John's wort or other drugs inducing liver enzymes;
• Acetylsalicylic acid;
• Zidovudine.
  Inform your doctor or pharmacist if the patient is taking:
• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Due to the presence of phenylephrine:
If the patient is taking any of the following medicines, treatment may need to be discontinued or administration of Vicks AntiGrip Max delayed:

• Monoamine oxidase inhibitors (MAOIs) (drugs used in the treatment of, among others, depression, such as phenelzine, isocarboxazid, nialamide, tranylcypromine, moclobemide, or drugs used in the treatment of Parkinson's disease, such as selegiline). Administration of Vicks AntiGrip Max should be postponed by at least 15 days after discontinuation of these drugs;
• Alpha-adrenergic receptor blockers (drugs used in the treatment of migraine, such as dihydroergotamine, ergotamine, phenylephrine, or drugs inducing labour, e.g. oxytocin);
• Beta-adrenergic receptor blockers (drugs used in the treatment of hypertension or mild benign prostatic hyperplasia);
• Tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, and doxepine, or tetracyclic antidepressants such as maprotiline;
• Inhalational anaesthetics such as cyclopropane and halothane;
• Antihypertensive drugs acting via the sympathetic nervous system, such as methyldopa, guanethidine;
• Drugs causing potassium loss (such as diuretics, e.g. furosemide and others);
• Drugs affecting cardiac conduction (cardiac glycosides such as digoxin, antiarrhythmics);
• Thyroid hormones;
• Atropine sulphate (used, among others, in heart and gastrointestinal diseases);
• Drugs blocking both alpha and beta adrenergic receptors used in heart and vascular diseases (such as labetalol, carvedilol).

Due to the presence of chlorpheniramine:
Concomitant use of the following drugs may intensify adverse effects:

• Central nervous system-acting drugs (used in the treatment of depression, insomnia, anxiety);
• Monoamine oxidase inhibitors (including furazolidone, pargyline, and procarbazine);
• Tricyclic or tetracyclic antidepressants, e.g. maprotiline;
• Ototoxic drugs (which may cause hearing damage as adverse effects);
• Photosensitising drugs.
• Concomitant use of chlorpheniramine and other serotonergic drugs, including SSRIs and SNRIs, may increase the risk of serotonin syndrome.

Effect on laboratory test results
If the patient is undergoing diagnostic tests (blood, urine, skin tests using allergens), inform the doctor that Vicks AntiGrip Max is being taken, as this medicine may alter laboratory test results.

Vicks AntiGrip Max with food, drink, and alcohol
Do not consume alcohol during treatment with Vicks AntiGrip Max, as it may cause overdose symptoms such as enhanced sedative effects. Use of Vicks AntiGrip Max in patients who regularly consume alcohol (three or more alcoholic drinks per day) may lead to liver damage.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using 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 use the medicine will be made by the doctor. The medicine may be used only if the potential benefits to the mother outweigh the risks to the fetus. In such cases, the lowest effective dose should be used for the shortest possible duration and as infrequently as possible.

Breastfeeding
Paracetamol and chlorpheniramine pass into human milk; therefore, breastfeeding women should not use this medicine.

Driving and operating machinery
Vicks AntiGrip Max may cause dizziness, blurred vision, drowsiness, and sedation, thereby affecting reaction ability and speed. Therefore, do not drive or operate machinery while taking this medicine.

Warnings concerning excipients
Vicks AntiGrip Max contains mannitol (E 421).
The medicine contains 3 g of mannitol (E 421) per sachet, which may cause a mild laxative effect.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".
The medicine contains trace amounts of sulphites originating from the flavouring composition (aroma component), and therefore may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Vicks AntiGrip Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
If fever persists for more than 3 days of treatment, or pain or other symptoms last longer than 5 days, or if symptoms worsen or new symptoms appear, consult a doctor.
Vicks AntiGrip Max should be used when experiencing pain and fever. Treatment should be discontinued once symptoms have resolved.

Recommended dosage:
Adults: one sachet every 6–8 hours. Do not exceed 4 sachets in 24 hours.
Elderly patients: do not exceed 3 sachets in 24 hours.

For adult patients weighing less than 50 kg, patients with Gilbert's syndrome (hereditary non-hemolytic jaundice), dehydrated patients, chronically malnourished patients, or patients with chronic alcohol-related disease, the dose should be reduced by half. The following dosing schedule should be applied: one sachet 2–3 times daily at intervals of 6–8 hours. Do not exceed 3 sachets per day.

Patients with mild to moderate hepatic impairment:
One sachet every at least 8 hours. Do not exceed 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.

Preparation instructions:
Dissolve the contents of one sachet in a small amount of hot, but not boiling water (preferably half a glass of water). Allow to cool to a drinkable temperature.

Use of a higher than recommended dose of Vicks AntiGrip Max
WARNING! Do not take other medicines containing paracetamol together with Vicks AntiGrip Max, as this may lead to poisoning. If a dose exceeding the recommended amount has been taken, contact a doctor immediately or go to the nearest hospital emergency department, even if no symptoms are present, as this may result in life-threatening liver damage. This also applies in cases of severe poisoning.

Symptoms of overdose:
Related to paracetamol: nausea, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, diarrhoea, 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.

Related to phenylephrine: excessive stimulation of the nervous system with symptoms such as restlessness, anxiety, agitation, headache, seizures, insomnia, confusion, irritability, loss of appetite, nausea, vomiting, psychosis with hallucinations (more common in children), hypertension, cerebral haemorrhage, pulmonary oedema, cardiac arrhythmias, palpitations, vasoconstriction with possible reduction in blood flow to vital organs, reduced urine output, metabolic acidosis, and increased cardiac workload.

Related to chlorphenamine: pronounced drowsiness, dryness of the mouth, nose and throat, dyspnoea, cardiac arrhythmias, nervous system stimulation (hallucinations, seizures, insomnia), hypotension.

Treatment of paracetamol overdose is most effective if initiated within 4 hours of ingestion of an excessive dose.
In all cases, vomiting should be induced and gastric lavage performed. Hospital treatment consists of intravenous or oral administration of the antidote, N-acetylcysteine.
In cases of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment should be administered.

Missed dose of Vicks AntiGrip Max
If a dose is missed, take it as soon as possible.
Do not take a double dose to make up for a missed dose.

Discontinuation of Vicks AntiGrip Max
Administration of the medicinal product depends on the presence of symptoms (pain, fever).
Once these symptoms have resolved, administration of the medicinal product should be discontinued.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following severe, life-threatening adverse reactions occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay: cough, difficulty swallowing, breathing difficulties, rapid heartbeat, itching, swelling of the eyelids or around the eyes, face and/or tongue or throat, skin rash, hives, shortness of breath (anaphylaxis), urinary retention, yellowing of the skin and/or eyes, heart attack, ventricular arrhythmia, pulmonary oedema and intracranial haemorrhage, increased frequency of nosebleeds or noticing that bruises or bleeding occur more easily.

Paracetamol may cause severe skin reactions characterised by acute generalised blistering rash or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or by rupturing large blisters, extensive skin erosions, peeling of large sheets of the epidermis, and fever.

The following adverse reactions may occur in some patients taking Vicks Antigrip Max:

Common (affects more than 1 in 100 people but less than 1 in 10 people):
Drowsiness, nausea and muscle weakness (which may resolve after 2–3 days of treatment), involuntary facial muscle movements, coordination disturbances, tingling and numbness or altered sensation of skin temperature, tremors, dry mouth, loss of appetite, disturbances in taste and smell perception, gastrointestinal disorders which may improve when the medicine is taken with food (e.g. nausea, vomiting, dyspepsia, diarrhoea, constipation, epigastric pain), dryness of nasal and throat mucosa, drying of mucous membranes, increased sweating, blurred or double vision, headache and dizziness. In some patients, particularly those with enlarged prostate, urinary retention and difficulty urinating may occur.

Uncommon (affects more than 1 in 1,000 people but less than 1 in 100 people) or rare (affects more than 1 in 10,000 people but less than 1 in 1,000 people):
Nervous excitation (manifested by anxiety, insomnia, tremor, hallucinations, palpitations, and even seizures) or fatigue, chest tightness, heart rhythm disturbances, increased heart rate (usually with overdose), low or high blood pressure, dizziness, cholestasis, hepatitis or other liver function disorders (including abdominal pain, dark-coloured urine), severe allergic reactions (cough, difficulty swallowing, itching, swelling of the eyelids or around the eyes, face and/or tongue, shortness of breath, fatigue, etc.), photosensitivity, fatigue, disorientation or feeling faint due to hypotension or hypertension, cross-allergy to drugs similar to chlorpheniramine, blood morphology changes, sore throat, oedema (swelling), tinnitus, acute labyrinthitis (part of the ear), impotence, intermenstrual bleeding.

Rare (affects more than 1 in 10,000 people but less than 1 in 1,000 people):
Increased liver enzyme activity, myocardial infarction, ventricular arrhythmia, pulmonary oedema and intracranial haemorrhage (usually with high-dose use).

Very rare (affects less than 1 in 10,000 people):
Blood disorders such as: thrombocytopenia (reduced number of platelets), agranulocytosis (marked reduction in granulocytes – a type of white blood cell, which may increase the frequency of infections), leukopenia (reduced number of leukocytes), neutropenia (reduced number of neutrophil granulocytes), haemolytic anaemia, hypoglycaemia (marked decrease in blood glucose concentration), kidney disorders, cloudy urine, allergic dermatitis, skin rash, urticaria, severe skin reactions, hypersensitivity reactions (skin blisters, anaphylactic shock, bronchospasm), jaundice.

Paracetamol may cause liver damage when taken in large doses or during prolonged treatment.

Frequency unknown (cannot be estimated from available data):
Anxiety, restlessness, confusion, weakness, irritability, dizziness, nausea, tremors, insomnia, chest pain or discomfort, severe bradycardia (very slow heartbeat), vasoconstriction, increased workload of the heart muscle (particularly affecting elderly patients or patients with cerebral or coronary circulation disorders), cold hands and feet, flushing, breathing difficulties, shortness of breath, worsening of renal perfusion, reduced urine output and urinary retention, pale skin, piloerection, hyperglycaemia (increased blood glucose concentration), hypokalaemia (low potassium concentration in serum), serious condition leading to blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2). When large doses are used, seizures, psychotic states with hallucinations and vomiting may occur. There may be induction or worsening of heart disease, palpitations. With prolonged use, hypovolaemia and excessive sweating may develop.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vicks Antigrip Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "EXP". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Vicks AntiGrip Max contains
The active substances in the medicine are: paracetamol, phenylephrine hydrochloride and chlorpheniramine maleate.
Each sachet contains: 1000 mg paracetamol; 15.58 mg phenylephrine hydrochloride, equivalent to 8.21 mg phenylephrine; 4 mg chlorpheniramine maleate, equivalent to 2.8 mg chlorphenamine.
Excipients: mannitol (E 421), sodium saccharin, colloidal anhydrous silica, povidone K30, orange flavour PHS 132958 (containing butylated hydroxyanisole (E 320), sulphites, citral, citronellol, D-limonene, geraniol, linalool).

What Vicks AntiGrip Max looks like and contents of the pack
Vicks AntiGrip Max is a granulate (white to yellowish-white) for the preparation of an oral solution with an orange flavour.
One pack contains 10 or 14 sachets in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Wick - Pharma - Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Straße 40
65824 Schwalbach am Taunus
Germany

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Procter & Gamble Health Poland Sp. z o.o.
ul. Zabraniecka 20, 03-872 Warszawa
tel. 801 25 88 25

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