Vicks Antigrip Zatoki i Katar

Leaflet attached to the packaging: patient information

Vicks AntiGrip Sinus and Cold

(650 mg + 16 mg + 4 mg)/sachet, granules for oral solution
Paracetamol + Phenylephrine hydrochloride + Chlorphenamine maleate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell 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 Sinus and Cold and what is it used for
• 2. Important information before taking Vicks AntiGrip Sinus and Cold
• 3. How to take Vicks AntiGrip Sinus and Cold
• 4. Possible side effects
• 5. How to store Vicks AntiGrip Sinus and Cold
• 6. Package contents and other information

1. What is Vicks AntiGrip Sinus and Cold and what is it used for

Vicks AntiGrip Sinus and Cold is indicated for the symptomatic treatment of colds and flu, accompanied by fever, mild or moderate pain (e.g. headache, throat, muscle, sinus pain), swelling of the nasal mucosa and sinuses with discharge.
Vicks AntiGrip Sinus and Coldis 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 Sinus and Cold

When not to take Vicks AntiGrip Sinus and Cold

• 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 high blood pressure;
• If the patient has hyperthyroidism;
• If the patient has any severe heart or blood vessel disease (such as coronary artery disease);
• If the patient has tachycardia (rapid heart rate);
• If the patient has severe kidney failure;
• 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

• You should not take more than one medicine containing paracetamol, 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 24 hours. (See section 3 "Taking a higher dose of Vicks AntiGrip Sinus and Cold than recommended").
• You should not take sympathomimetics (such as decongestants, appetite suppressants, or psychostimulants with an effect similar to amphetamines), other antihistamines (including those applied to the skin), or medicines used to treat colds and flu.
• In patients with alcoholism and patients who regularly drink alcohol, caution should be exercised and no more than 3 sachets of Vicks AntiGrip Sinus and Cold (2 g of paracetamol) should be taken per day. During treatment, you should not drink alcohol due to the increased risk of toxic liver damage.
• In patients with anemia, heart disease, lung disease, and liver function disorders, occasional use is allowed, but you should consult a doctor before taking this medicine.
• There have been reports of toxic effects on the liver in cases where paracetamol was administered in a daily dose not exceeding 4 g;
• Patients with asthma 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 medicines.
• Patients sensitive to the sedative effect of medicines and patients with epilepsy should consult a doctor before starting treatment with this medicine, as they may experience worsening of symptoms and interactions with medicines used to treat these diseases.
• Concomitant use of chlorphenamine and other serotonergic drugs, including SSRIs and SNRIs, may increase the risk of serotonin syndrome.

Before taking Vicks AntiGrip Sinus and Cold, you should discuss it with your 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 diseases
• 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 effects experience gastrointestinal disorders, they should consult a doctor as soon as possible. These disorders may be the result of paralytic ileus (cessation of intestinal peristalsis, which moves food through the digestive system).

• When taking paracetamol, there is a greater risk of liver damage in patients taking carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other liver enzyme-inducing drugs;
• in whom there is a possibility of glutathione deficiency, e.g. with eating disorders, HIV infection, dehydration, starvation, or emaciation;
• who regularly drink alcohol;
• with liver disease (including Gilbert's syndrome).

During treatment with Vicks AntiGrip Sinus and Cold, you should immediately inform your doctor if:

If the patient has severe diseases, including severe kidney or liver function disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have reported the occurrence of a severe disease called metabolic acidosis (abnormality of blood and body fluids) when they took paracetamol in regular doses for a longer period or when they took 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 Sinus and Cold is contraindicated in children and adolescents due to the high dose of paracetamol.

Use of Vicks AntiGrip Sinus and Cold in the elderly

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

Use of Vicks AntiGrip Sinus and Cold by athletes

Using Vicks AntiGrip Sinus and Cold may result in a positive doping test.

Vicks AntiGrip Sinus and Cold and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking Vicks AntiGrip Sinus and Cold with other medicines may lead to interactions.
Due to the content of paracetamol:
If the patient is taking any of the following medicines, it may be necessary to change the dosage or discontinue treatment:

• 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; You should inform your doctor or pharmacist if you 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 content of phenylephrine:
If the patient is taking any of the following medicines, it may be necessary to discontinue treatment or delay the administration of Vicks AntiGrip Sinus and Cold:

• 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). You should delay the administration of Vicks AntiGrip Sinus and Cold by at least 15 days from the end of treatment with these drugs;
• Drugs blocking alpha-adrenergic receptors (drugs used to treat migraines, such as dihydroergotamine, ergotamine, phenylephrine, or drugs that induce labor, such as oxytocin);
• Drugs blocking beta-adrenergic receptors (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 acting through the sympathetic nervous system, such as methyldopa, guanethidine;
• Drugs that cause potassium loss (such as diuretics, e.g. furosemide);
• 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 blocking alpha and beta adrenergic receptors used in heart and blood vessel diseases (such as labetalol, carvedilol).

Due to the content of chlorphenamine:
Concomitant use of the following drugs may increase the risk 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 Sinus and Cold, as this medicine may affect laboratory test results.

Vicks AntiGrip Sinus and Cold with food, drink, and alcohol

During treatment with Vicks AntiGrip Sinus and Cold, you should not drink alcohol, as it may cause symptoms of overdose, such as increased sedative effect. Using Vicks AntiGrip Sinus and Cold 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. During pregnancy, Vicks AntiGrip Sinus and Cold should not be used 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 as short a time as possible 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 Sinus and Cold may cause dizziness or blurred vision, drowsiness, and sedation, thereby affecting reaction time and speed, so you should not drive vehicles or operate machines while taking this medicine.
Warnings about excipients

Vicks AntiGrip Sinus and Cold 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), so it may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Vicks AntiGrip Sinus and Cold

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a 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, you should consult a doctor.
Vicks AntiGrip Sinus and Cold should be used when pain and fever symptoms occur. If these symptoms subside, you should stop taking the medicine.
The recommended dose is:

Adults: one sachet every 4-6 hours (four to six times a day). Do not take more than 6 sachets in 24 hours.
Elderly: do not take more than 3 sachets in 24 hours.
In adult patients weighing less than 50 kg, patients with Gilbert's syndrome (familial non-hemolytic jaundice), patients who are dehydrated, chronically malnourished, or patients with chronic alcoholism, the dose should be reduced by half and the following dosing schedule 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 failure:
One sachet at least every 8 hours. Do not take more than 3 sachets per day (maximum 2 g of paracetamol per day).
Patients with kidney failure:
Due to the paracetamol content, this medicine is not indicated 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 Sinus and Cold than recommended

WARNING! You should not take other medicines containing paracetamol with Vicks AntiGrip Sinus and Cold, as this may lead to overdose.
If an overdose has occurred, you should immediately contact a 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.
Overdose symptoms

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.
Related to phenylephrine: excessive nervous system stimulation with symptoms such as anxiety, fear, agitation, headaches, seizures, insomnia, confusion, irritability, loss of appetite, nausea, vomiting, psychosis with hallucinations (more common in children), hypertension, cerebral hemorrhage, pulmonary edema, heart rhythm disorders, palpitations, vasoconstriction with possible reduced blood flow to vital organs, decreased urine production, and metabolic acidosis, increased heart effort.
Related to chlorphenamine: increased drowsiness, dryness of the mouth, nose, and throat, shortness of breath, heart rhythm disorders, 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, you should induce vomiting and perform gastric lavage. Hospital treatment involves intravenous or oral administration of an antidote - N-acetylcysteine.
In the case of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment is used.

Missing a dose of Vicks AntiGrip Sinus and Cold

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

Stopping treatment with Vicks AntiGrip Sinus and Cold

The administration of the medicinal product depends on the presence of symptoms (pain, fever).
If these symptoms subside, you should stop taking the medicinal product.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of the following serious, life-threatening side effects, you should stop taking the medicine immediately and contact a doctor or Emergency Department:

cough, difficulty swallowing, breathing difficulties, rapid heart rate, itching, swelling of the eyelids or eye area, face and/or tongue or throat, rash, hives, shortness of breath (anaphylaxis), urinary retention, yellowing of the skin and/or eyes, heart attack, arrhythmia, pulmonary edema, and cerebral hemorrhage, increased bleeding, or bruising.
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 joint pain.
Some patients taking Vicks AntiGrip Sinus and Cold may experience the following side effects:

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

Drowsiness, nausea, and muscle weakness (which may subside 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 taking the medicine 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 vision, and double vision. 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 stimulation (anxiety, insomnia, tremors, hallucinations, seizures), or fatigue, chest tightness, heart rhythm disorders, rapid heart rate (usually with overdose), decreased or increased blood pressure, dizziness, cholestasis, liver dysfunction (including abdominal pain, dark urine), severe allergic reactions (cough, difficulty swallowing, itching, swelling of the eyelids or eye area, face and/or tongue or throat, shortness of breath, etc.), hypersensitivity to light, fatigue, disorientation, or fainting due to hypotension or hypertension, cross-allergy to chlorphenamine, changes in blood morphology, sore throat, swelling (edema), 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, heart attack, arrhythmia, pulmonary edema, and cerebral hemorrhage (usually with high doses).

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

Blood disorders, such as thrombocytopenia (reduced platelet count), agranulocytosis (significant reduction in granulocyte count - one of the types of white blood cells, which can increase the frequency of infections), leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count), hemolytic anemia, hypoglycemia (significantly reduced blood sugar levels), kidney disorders, cloudy urine, allergic skin inflammation, skin rash, hives, severe skin reactions, hypersensitivity reactions (skin blisters, anaphylactic shock, bronchospasm), jaundice.
Paracetamol may cause liver damage when taken in high doses or with 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 effort (especially in elderly patients or patients with cerebral or coronary circulation disorders), cold hands and feet, flushing, breathing difficulties, shortness of breath, worsening kidney function, decreased urine production, and urinary retention, pallor, 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). With 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, fluid volume deficiency may develop, and excessive sweating may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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, you can help gather more information on the safety of this medicine.

5. How to store Vicks AntiGrip Sinus and Cold

The medicine should be stored out of sight and reach of children.
You should 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. You should ask your 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 Sinus and Cold contains

The active substances of the medicine are: paracetamol, phenylephrine hydrochloride, and chlorphenamine maleate.
Each sachet contains: 650 mg of paracetamol; 15.58 mg of phenylephrine hydrochloride, 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, linalol).

What Vicks AntiGrip Sinus and Cold looks like and contents of the pack

Vicks AntiGrip Sinus and Cold is a granule (white to yellowish-white) for oral solution, 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 - Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Straße 40
65824 Schwalbach am Taunus
Germany
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Procter & Gamble Health Poland Sp. z o.o.
ul. Zabraniecka 20, 03-872 Warsaw
phone: 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: