Vicks Antigrip Complex

Leaflet attached to the packaging: information for the user

Vicks AntiGrip Complex 500 mg + 200 mg + 10 mg, powder for oral solution
preparation
Paracetamol + Guaifenesin + Phenylephrine hydrochloride

Read the leaflet carefully before taking 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.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

• 1. What is Vicks AntiGrip Complex and what is it used for
• 2. Important information before taking Vicks AntiGrip Complex
• 3. How to take Vicks AntiGrip Complex
• 4. Possible side effects
• 5. How to store Vicks AntiGrip Complex
• 6. Contents of the packaging and other information

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

Vicks AntiGrip Complex contains three active substances:

• Paracetamol is a well-known pain reliever. It is effective in pain, including headache and sore throat, and reduces fever (antipyretic action).
• Guaifenesin (an expectorant) thins out thick mucus, making it easier to cough up in wet cough.
• Phenylephrine hydrochloride (a nasal decongestant) reduces the swelling of the nasal mucosa, allowing it to be cleared.

Vicks AntiGrip Complex is intended for short-term use to relieve symptoms of colds, chills, and flu (mild to moderate pain, fever, nasal congestion, wet cough) in adults and adolescents aged 12 and over.
Vicks AntiGrip Complex should only be taken when the patient has a combination of cold and flu symptoms, such as pain and/or fever, nasal congestion, and wet cough.
If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Vicks AntiGrip Complex

When not to take Vicks AntiGrip Complex:

• if the patient is allergic (hypersensitive) to paracetamol, guaifenesin, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
• 6)
• if the patient has heart disease
• if the patient has high blood pressure (hypertension)
• if the patient has liver or severe kidney function disorders
• if the patient has hyperthyroidism
• if the patient is currently taking other sympathomimetic medicines (such as pseudoephedrine, oxymetazoline, clonidine, salbutamol, and others)
• if the patient has diabetes
• if the patient has glaucoma (increased eye pressure) with a narrow angle of filtration
• if the patient has porphyria, a congenital disorder characterized by excessive pigmentation of urine
• if the patient is taking tricyclic antidepressants
• if the patient is taking beta-adrenergic blockers
• if the patient is taking monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease or has taken them in the last 14 days

Warnings and precautions

Important: contains paracetamol. Do not take with other medicines containing paracetamol.
In case of overdose, despite the patient's good condition, a doctor should be consulted immediately due to the risk of delayed, severe liver damage. Do not take this medicine with other flu, cold, and cough medicines.
Before taking Vicks AntiGrip Complex, discuss it with a doctor or pharmacist

• if the patient has alcoholic liver disease or regularly consumes alcohol. Regular alcohol consumption impairs liver function, and paracetamol-containing medicines may increase the risk of toxic effects on the liver.
• if the patient is a man and has an enlarged prostate, which may cause difficulty urinating
• if the patient has circulation problems (including Raynaud's syndrome)
• if the patient has a persistent cough lasting longer than a week, a cough producing a large amount of mucus (phlegm), or a persistent cough such as in smokers, asthma, chronic bronchitis, or emphysema
• if the patient has severe hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, chronic nutritional disorders, or is dehydrated.

While taking Vicks AntiGrip Complex, the doctor should be informed immediately if:
The patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic).
There have been reports of a severe disease called metabolic acidosis (a blood and body fluid disorder) in patients who take paracetamol in regular doses for a longer period or take 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 Complex is not indicated for use in children under 12 years of age.

Vicks AntiGrip Complex and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Before starting Vicks AntiGrip Complex, discuss it with your doctor if you are taking:

• medicines containing paracetamol or other nasal decongestantsused during colds and flu. If you are taking these medicines, do not take Vicks AntiGrip Complex. Do not take Vicks AntiGrip Complex if you are taking:
• monoamine oxidase inhibitors(MAOIs) used to treat depressionor Parkinson's disease. Do not takeVicks AntiGrip Complex if you have taken MAOIs in the last 14 days.
• tricyclic antidepressantsused to treat depression, such as amitriptyline or imipramine.
• medicines used to treat high blood pressure(antihypertensive medicines), including beta-adrenergic blockers, or medicines that improve heart function or correct irregular heart rhythm (digoxin, lanoxin, digitoxin). Atropine sulfate, commonly used for eye exams, to treat low heart rate, and as an antidote for flucloxacillin (an antibiotic), due to the serious risk of a blood and body fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).
• 2).
• medicines against nausea and vomiting(e.g., metoclopramide or domperidone).
• blood-thinning medicines(anticoagulants), such as warfarin or other coumarin derivatives.
• cholesterol-lowering medicines(e.g., cholestyramine).
• sedatives (barbiturates).
• medicines used to treat epilepsy, such as lamotrigine and barbiturates
• acetylsalicylic acid and other salicylates used to reduce pain, fever, and blood clots.
• alpha-adrenergic receptor agonists, such as medicines used to treat attention deficit hyperactivity disorder (clonidine, guanfacine), medicines for spasticity (tizanidine)
• Medicines used for migraine headaches (ergotamine, dihydroergotamine)
• probenecid or AZT (zidovudine).
• isoniazid or rifampicin (used to prevent and treat tuberculosis).

Taking Vicks AntiGrip Complex with food, drink, and alcohol

Do not take the medicine with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult a doctor or pharmacist before taking this medicine. If necessary and only if recommended by a doctor or pharmacist, Vicks AntiGrip Complex may be taken during pregnancy. This medicine may be taken during breastfeeding only under medical supervision. You should then take the smallest possible dose that reduces pain and/or fever, for the shortest possible time. Consult a doctor or midwife if pain and/or fever do not decrease or if you need to take the medicine more frequently.

Driving and using machines

The medicine may cause dizziness and disorientation. If these symptoms occur, do not drive or operate machinery.

Vicks AntiGrip Complex contains aspartame, sucrose, and sodium

• Aspartame (E951): this medicine contains 6 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic metabolic disorder in which phenylalanine accumulates because it cannot be properly removed by the body.
• Sucrose (content in one sachet - 2000 mg): if you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.
• Sodium: this medicine contains 157 mg of sodium (a main ingredient used in cooking/table salt) in each sachet. This corresponds to 7.85% of the maximum recommended daily intake of sodium for adults. Inform your doctor or pharmacist if you need to take 3 or more sachets per day for a longer period, especially if you are on a low-sodium diet.

3. How to take Vicks AntiGrip Complex

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 12 and over:
The recommended dose is one sachet.
The dose (one sachet) may be taken up to four times a day, at intervals of at least 4 hours between doses. Do not take more than 4 sachets in 24 hours.
Do not take a higher dose than recommended.

Use in children and adolescents

This medicine is not indicated for use in children under 12 years of age.

Method of administration

The medicine is in the form of a powder for dissolving in water to drink as a hot beverage.
Pour one sachet of powder into a cup and add hot, but not boiling, water (about 250 ml).
Let it cool and reach a temperature suitable for drinking, then drink the opalescent, yellow solution with a citrus-menthol flavor and aroma.

Duration of treatment

If symptoms persist for more than 3 days or worsen, consult a doctor.

Taking a higher dose of Vicks AntiGrip Complex than recommended:

Consult a doctor immediately, despite the patient's good condition

of an adult or child, due to the risk of delayed, severe liver damagein case of taking a higher dose than recommended or if the medicine has been accidentally ingested by a child.

Missing a dose

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking the medicine, consult a pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking the medicine immediately and seek medical help:

• Rarely (may affect up to 1 in 1000 people) may occur severe allergic reactions (anaphylaxis), such as skin rash, itching, swelling of the lips, tongue, throat, face, wheezing, or difficulty breathing.
• Very rarely (may affect up to 1 in 10,000 people) have been reported cases of severe skin reactions. If a skin reaction occurs, stop taking the medicine and seek medical help immediately. Stevens-Johnson syndrome and (or) toxic epidermal necrolysis may initially appear as red spots resembling targets or round spots, often with blisters in the center of the torso. They may also cause ulcers in the mouth, throat, nose, genitals, and eyes (redness and swelling of the eyes). These serious skin rashes are often preceded by fever and/or flu-like symptoms. Rashes may develop into widespread skin peeling and life-threatening complications or end in death.
• Very rarely (may affect up to 1 in 10,000 people) during paracetamol treatment, some blood cell disorders may occur, such as an increased number of nosebleeds or easy bruising.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
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, you can help provide more information on the safety of this medicine.

5. How to store Vicks AntiGrip Complex

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the sachet or carton after "EXP". The expiry date refers to the last day of the month.
The shelf life of the solution after dissolving the contents of the sachet in water: the solution is stable for 90 minutes.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Vicks AntiGrip Complex contains

• -The active substances of the medicine are: paracetamol, guaifenesin, phenylephrine hydrochloride. Each sachet of the medicine is one dose of the medicine containing active substances: paracetamol 500 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 10 mg.
• -Other ingredientsare: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate, aspartame (E951), acesulfame potassium (E950), menthol powder, lemon flavor, lemon juice flavor, quinoline yellow (E104). See section 2.

What Vicks AntiGrip Complex looks like and what the pack contains

Vicks AntiGrip Complex is a white powder, packaged in laminated sachets in a cardboard box. The box contains 5 or 10 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder:

WICK Pharma, a branch of Procter & Gamble GmbH

Sulzbacher Str. 40-50,

D-65824 Schwalbach am Taunus

Germany

For more detailed information on this medicine, 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:

Procter & Gamble Manufacturing GmbH
Procter & Gamble Strasse 1
64521 Gross-Gerau, Hessen
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Bulgaria:
Vicks AntiGrip Complex 200 mg/500 mg/10 mg powder for oral solution
Estonia:
TriFlunex 500 mg/200 mg/10 mg suukaudse lahuse pulber
Germany: WICK DayMed Kombi Erkältungsgetränk Paracetamol 500 mg/ Phenylephrin HCl 10 mg/Guaifenesin 200 mg Pulver zur Herstellung einer Lösung zum Einnehmen
Ireland:
Paracetamol 500 mg Guaifenesin 200 mg Phenylephrine 10 mg Hydrochloride
Italy:
Vicks Flu-Tripla Azione
Latvia:
TriFlunex 500 mg/200 mg/10 mg Pulveris iekšīgi lietojama Šķīduma Pagatavošanai
Lithuania:
TriFlunex 500 mg/ 200 mg/ 10 mg milteliai geriamajam tirpalui
Romania: Vicks AntiGrip Complex 500mg/200mg/10mg pulbere pentru soluţie orală
Spain: IlviGrip Expertorante polvo para solución oral
Czech Republic:
Vicks SymptoMed Complete citrón
Hungary:
Grippo Med Wick Citrom izü por belsöleges oldathoz
United Kingdom: Vicks Cold and Flu Care Daymed Complete Hot Drink

Date of last revision of the leaflet: January 2025