Vicks Antigrip Complex

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Vicks AntiGrip Complex (TriFlunex)

500 mg + 200 mg + 10 mg, powder for oral solution

Paracetamol + Guaifenesin + Phenylephrine hydrochloride
Vicks AntiGrip Complex and TriFlunex are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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.

• 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 tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their 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 pack and other information

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

Vicks AntiGrip Complex is intended to relieve the symptoms of colds and flu.
The medicine 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 the thick mucus, making it easier to cough up in a wet cough.
• Phenylephrine hydrochloride (a decongestant) reduces the swelling of the nasal mucosa and thus allows it to be cleared.

Vicks AntiGrip Complex should only be taken when the patient has pain and/or fever, nasal congestion, and a wet cough.
If there is no improvement after 3 days or if 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 disease or severe kidney disease Page 1 5
• if the patient has hyperthyroidism
• if the patient has diabetes
• if the patient has glaucoma (increased eye pressure) with a narrow angle of filtration
• if the patient has porphyria, which is a congenital disorder characterized by excessive pigmentation of the 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
• if the patient is taking blood pressure-lowering drugs or anti-angina pectoris drugs.

Warnings and precautions

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

• if the patient has liver function problems
• 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 persistent or chronic cough, such as in smokers, with asthma, with chronic bronchitis, or with emphysema
• if the patient has severe hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, chronic nutritional disorders, or is dehydrated.

Children and adolescents

Vicks AntiGrip Complex should not be taken by children under 12 years of age.

Vicks AntiGrip Complex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking now or have taken recently, as well as any medicines they plan to take.
Before starting to take Vicks AntiGrip Complex, the patient should discuss it with their doctor if they are taking:

• medicines containing paracetamol or other decongestant medicinesused during colds and flu. If the patient is taking these medicines, they should not take Vicks AntiGrip Complex.
• monoamine oxidase inhibitors (MAOIs)used to treat depressionor Parkinson's disease. Do not takeVicks AntiGrip Complex if the patient has 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 drugs), including beta-adrenergic blockers, or to improve heart function or correct abnormal heart rhythm (digoxin, lanoxin, digitoxin).
• phenothiazines (used as antipsychotic drugs to treat conditions such as schizophrenia or paranoia, or as anti-emetic drugs).
• medicines against nausea and vomiting(e.g., metoclopramide or domperidone).
• blood-thinning medicines(anticoagulants), e.g., warfarin or other coumarin derivatives.
• cholesterol-lowering medicines(e.g., cholestyramine).
• sedatives (barbiturates).
• probenecid or AZT (zidovudine).
• isoniazid (used to prevent and treat tuberculosis).

Taking Vicks AntiGrip Complex with food, drink, and alcohol

Do not take the medicine with alcohol.
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Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine. If necessary and only if advised by a doctor or pharmacist, Vicks AntiGrip Complex may be taken during pregnancy. The patient should take the smallest possible dose that reduces pain and/or fever, for the shortest possible time. The patient should consult their doctor if pain and/or fever do not decrease or if they need to take the medicine more frequently.

Driving and using machines

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

Vicks AntiGrip Complex contains aspartame, sucrose, and sodium

• Aspartame (E951): this medicine contains 6 mg of aspartame per 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: if the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
• Sodium: this medicine contains 157 mg of sodium (a major ingredient used in cooking/table salt) per sachet. This corresponds to 7.85% of the maximum recommended daily intake of sodium for adults. The patient should inform their doctor or pharmacist if they need to take 3 or more sachets per day for a longer period, especially if they 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, the patient should consult their doctor or pharmacist.

Recommended dose:

Adults and adolescents over 12 years of age:
1 sachet every 4-6 hours as needed. Do not take more than 4 sachets in 24 hours.
Do not exceed the recommended dose.
Do not take the medicine with alcoholic beverages.

Use in children and adolescents

Do not give to children under 12 years of age.

Method of administration

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

Duration of treatment

Prolonged use of the medicine is not recommended.
If symptoms worsen or do not improve after 3 days, the patient should consult their doctor.

Taking a higher dose of Vicks AntiGrip Complex:

The patient should contact their doctor immediatelyif they take a higher dose than recommended or give a higher dose than recommended to a child, despite the patient's good health
adult or child, due to the risk of delayed, severe liver damage.
If the patient has any further doubts about taking the medicine, they should consult their pharmacist.
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Missing a dose

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Vicks AntiGrip Complex can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, the patient should stop taking the medicine and seek medical help immediately:

• Very rare cases of severe skin reactions have been reported. Rarely, severe allergic reactions (anaphylaxis), wheezing, or breathing difficulties have occurred. (Rare: affects less than 1 in 1000 people, but more than 1 in 10,000 people; Very rare: affects less than 1 in 10,000 people).
• Very rarely, when taking paracetamol, some blood cell and pancreas disorders (pancreatitis) may occur (affects less than 1 in 10,000 people).

Other side effects

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine

5. How to store Vicks AntiGrip Complex

The medicine should be stored out of sight and reach of children.

Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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.
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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. Contents of the pack 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 the active substances: paracetamol 500 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 10 mg.
• The other ingredients are: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate, aspartame (E 951), acesulfame potassium (E 950), menthol, powder; citrus flavor, lemon juice flavor, quinoline yellow (E 104). See section 2.

What Vicks AntiGrip Complex looks like and what the pack contains

Vicks AntiGrip Complex is a white powder, packaged in sachets in a cardboard box. The medicine is available in cardboard boxes of 5 and 10 sachets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

WICK Pharma, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany

Manufacturer:

Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom
Procter & Gamble Manufacturing GmbH, Procter & Gamble Strasse 1, 64521 Gross-Gerau, Hessen, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Licence number in Latvia, the country of export: 14-0198

Parallel import licence number: 372/22 Date of approval of the leaflet: 10.10.2022

[Information about the trademark]
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