Vicks antigrip complex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Vicks AntiGrip Complex (TriFlunex)
500 mg + 200 mg + 10 mg, effervescent powder for oral solution
Paracetamolum + Guaifenesinum + Phenylephrini hydrochloridum
Vicks AntiGrip Complex and TriFlunex are different trade names for the same medicinal product.
Please read the entire leaflet carefully 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Leaflet contents:

1. What Vicks AntiGrip Complex is and what it is used for
2. What you need to know 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 Vicks AntiGrip Complex is and what it is used for

Vicks AntiGrip Complex is intended to relieve symptoms of cold and flu.
The medicine contains three active substances:

• Paracetamol is a well-known analgesic. It is effective against pain, including headache and sore throat, and reduces fever (antipyretic effect).
• Guaifenesin (an expectorant) thins viscous mucus, facilitating expectoration in productive cough.
• Phenylephrine hydrochloride (a nasal decongestant) reduces nasal mucosal congestion and thus helps clear nasal passages.

Vicks AntiGrip Complex should be taken only when the patient has pain and/or fever, nasal congestion, and productive cough.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before using Vicks AntiGrip Complex

When not to use 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)
• 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 of 5
• if the patient has hyperthyroidism
• if the patient has diabetes
• if the patient has glaucoma (increased eye pressure) with narrow drainage angle
• if the patient has porphyria, a congenital disorder characterized by excessive urine pigmentation
• if the patient is taking tricyclic antidepressants
• if the patient is taking beta-adrenolytics (beta-blockers)
• if the patient is taking monoamine oxidase inhibitors (MAOIs) – used to treat depression or Parkinson’s disease, or has taken them within the last 14 days
• if the patient is taking medicines to lower blood pressure or for angina pectoris.

Warnings and precautions
Important: contains paracetamol. Do not take with other medicines containing paracetamol.
In case of overdose, even if the patient feels well, contact a doctor immediately due to the risk of delayed, severe liver damage. Do not take this medicine with other flu, cold or cough medicines.
Before taking Vicks AntiGrip Complex, discuss it with your doctor or pharmacist if:

• the patient has liver function problems
• the patient is male and has an enlarged prostate, which may cause difficulty in passing urine
• the patient has circulatory problems (including Raynaud’s syndrome)
• the patient has a persistent or chronic cough, such as in tobacco smokers, asthma, chronic bronchitis or emphysema
• the patient has severe haemolytic anaemia, glucose-6-phosphate dehydrogenase deficiency, chronic malnutrition, or is dehydrated.

Children and adolescents
Do not use Vicks AntiGrip Complex in children under 12 years of age.
Vicks AntiGrip Complex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Before starting Vicks AntiGrip Complex, discuss with your doctor if the patient is taking:

• medicines containing paracetamol or other medicines reducing nasal mucosal congestion used for colds and flu. Do not take Vicks AntiGrip Complex if these medicines are being used.
• monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease. Do not take Vicks AntiGrip Complex if the patient has taken MAOIs within the last 14 days.
• tricyclic antidepressants used to treat depression, such as amitriptyline or imipramine.
• medicines used to treat high blood pressure (antihypertensives), including beta-adrenolytics, or medicines improving heart function or correcting abnormal heart rhythm (digoxin, lanoxin, digitoxin).
• phenothiazines (used as antipsychotics to treat conditions such as schizophrenia or paranoia, or as anti-nausea and anti-vomiting medicines).
• anti-nausea and antiemetic medicines (e.g. metoclopramide or domperidone).
• medicines that reduce blood clotting (anticoagulants), e.g. warfarin or other coumarin derivatives.
• medicines to lower high cholesterol levels (e.g. cholestyramine).
• sedatives (barbiturates).
• probenecid or AZT (zidovudine).
• isoniazid (used for prevention and treatment of tuberculosis).

Taking Vicks AntiGrip Complex with food, drink and alcohol
Do not take this medicine with alcohol.
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Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine. If necessary and only when recommended by a doctor or pharmacist, Vicks AntiGrip Complex may be used during pregnancy. In such cases, the lowest possible dose that reduces pain and/or fever should be used for the shortest possible time. Consult your doctor if pain and/or fever do not improve or if the patient needs to take the medicine more frequently.

Driving and operating machinery
This medicine may cause centrally-mediated 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 eliminated from the body.
• Sucrose: if the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• Sodium: this medicine contains 157 mg of sodium (main cooking ingredient/table salt) in each sachet. This corresponds to 7.85% of the maximum recommended daily sodium intake for adults. Inform your doctor or pharmacist if you need to take 3 or more sachets per day for a prolonged period, especially if on a low-salt (low-sodium) diet.

3. How to use Vicks AntiGrip Complex

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents over 12 years of age:
1 sachet every 4–6 hours as needed. Do not use more than 4 sachets in 24 hours.
Do not exceed the recommended dose.
Do not take the medicine with alcoholic drinks.
Use in children and adolescents
Do not give to children under 12 years of age.
Method of administration
The medicine is a powder for dissolution in water for oral intake, intended to be taken as a hot drink.
Empty the contents of one sachet into a cup and add hot, but not boiling water (approximately 250 ml).
Allow the solution to cool to a drinkable temperature, then drink the opalescent, yellow solution with a citrus-menthol aroma and taste.
Duration of treatment
Prolonged use of the medicine is not recommended.
If symptoms worsen or do not improve after 3 days, consult a doctor.
Overdose of Vicks AntiGrip Complex:
Seek immediate medical advice in case of taking more than the recommended dose or if a child has taken more than the recommended dose, even if the adult or child feels well, due to the risk of delayed, severe liver damage.
If you have any further doubts regarding the use of this medicine, consult a pharmacist.
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Missed dose
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any of the following serious adverse reactions occur, stop taking the medicine immediately and seek urgent medical help:

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

Other adverse reactions

Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products
at 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Vicks AntiGrip Complex

Keep this 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 packaging. The expiry date refers to the last day of the stated month.
The shelf-life of the solution after dissolving the sachet contents in water: the solution is stable for 90 minutes.
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Medicines must 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 package and other information

What Vicks AntiGrip Complex contains

• The active substances are: paracetamol, guaifenesin, phenylephrine hydrochloride. Each sachet of the medicine constitutes one dose containing the following active substances: paracetamol 500 mg, guaifenesin 200 mg and phenylephrine hydrochloride 10 mg.
• Other ingredients are: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate, aspartame (E 951), potassium acesulfame (E 950), menthol, powder; lemon flavour, lemon juice flavour, quinoline yellow (E 104). See section 2.

What Vicks AntiGrip Complex looks like and contents of the pack
Vicks AntiGrip Complex is a white to off-white powder, packed in sachets within a cardboard
box. The medicine is available in cardboard boxes containing 5 or 10 sachets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Latvia, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Latvia, country of export: 14-0198
Parallel import authorisation number: 372/22
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