Vicks Antigrip Dzieni i Noc

Leaflet attached to the packaging: information for the user

Vicks AntiGrip Day and Night

500 mg + 60 mg, coated tablets

Paracetamol+ Pseudoephedrine hydrochloride

500 mg + 25 mg, coated tablets

Paracetamol+ Diphenhydramine hydrochloride

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Vicks AntiGrip Day and Night and what is it used for

Vicks AntiGrip Day and Night contains paracetamol, a pain-relieving and antipyretic medicine, pseudoephedrine, which reduces nasal congestion, and diphenhydramine, an antihistamine that causes drowsiness.

• Paracetamol relieves body aches, headaches, and fever.
• Pseudoephedrine acts on the blood vessels in the nose, relieving nasal congestion.
• Diphenhydramine relieves symptoms of a cold, sneezing, and runny nose, and is suitable for nighttime use.

Vicks AntiGrip Day and Night is indicated for the short-term symptomatic treatment of nasal congestion and sinusitis associated with cold and flu symptoms, such as pain, headache, and/or fever, exclusively in cases where pain occurs during sleep that prevents falling asleep.

Vicks AntiGrip Day and Night is indicated for use in adults and adolescents over 15 years of age.

The packaging contains two types of tablets, in different colors, for use at different times of the day.

You should carefully read the patient leaflet to take the correct tablets at the correct time of day.

• "Day tablets": yellow tablets containing paracetamol and pseudoephedrine - for use during the day.
• "Night tablets": blue tablets containing paracetamol and diphenhydramine - for use at night.

2. Important information before taking Vicks AntiGrip Day and Night

When not to take Vicks AntiGrip Day and Night:

DO NOT take Vicks AntiGrip Day and Night in children under 15 years of age.

Warnings and precautions

Diphenhydramine may cause drowsiness. DO NOT take blue tablets during the day!

To avoid overdose, DO NOT take other medicines that contain paracetamol, decongestants, or antihistamines, including those for local use and other medicines for cough and cold.

During treatment with Vicks AntiGrip Day and Night, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, you should stop taking Vicks AntiGrip Day and Night and contact a doctor or seek medical help immediately. See section 4.

If the patient experiences a fever with generalized redness of the skin and a pustular rash, they should stop taking Vicks AntiGrip Day and Night and contact a doctor or seek medical help immediately. See section 4.

Children and adolescents

Vicks AntiGrip Day and Night MUST NOT be used in children under 15 years of age.

Vicks AntiGrip Day and Night and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

This is especially important to inform your doctor or pharmacist if you are taking any of the following medicines, as their effect may be altered:

• antidepressants (e.g., MAOIs, including moclobemide and brofaromine, tricyclic antidepressants, including amitriptyline)
• medicines used to treat high blood pressure, including guanethidine, debryzochine, methyldopa, reserpine, alpha- and beta-adrenergic receptor blockers
• medicines that can cause liver damage, such as antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, lamotrigine), medicines used to treat tuberculosis (isoniazid, rifampicin), medicines used to treat HIV (zidovudine, ritonavir), or antibiotics such as chloramphenicol, linezolid
• medicines used to treat gout, such as probenecid
• metoclopramide or domperidone (used to treat nausea and vomiting)
• cholestyramine (a cholesterol-lowering medicine)
• anticoagulant medicines (blood thinners) such as warfarin
• alcohol and other medicines that depress the central nervous system (e.g., sedatives, hypnotics, opioid analgesics, and anxiolytics)
• anticholinergic medicines (affecting the nervous system) such as atropine
• medicines used to treat migraine, such as ergotamine and methysergide
• cardiac glycosides (e.g., digoxin) used to treat heart conditions
• halogenated anesthetics, such as cyclopropane, halothane, enflurane, isoflurane
• salicylates/ acetylsalicylic acid (aspirin)
• CYP2D6 cytochrome P450 isoenzyme inhibitors, such as metoprolol and venlafaxine
• antiarrhythmic, antianginal, or medicines that may cause hypokalemia (e.g., certain diuretics).
• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe kidney impairment, sepsis, malnutrition, chronic alcoholism, and those taking maximum daily doses of paracetamol.

Effect of Vicks AntiGrip Day and Night on laboratory tests

The medicine may affect the results of uric acid and glucose tests in the blood.

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If necessary and only if prescribed by a doctor, Vicks AntiGrip Day and Night may be used during pregnancy. You should use the lowest possible dose that reduces pain and/or fever, for the shortest possible time. You should consult a doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.

Fertility

The effect of this medicine on fertility has not been thoroughly investigated.

Driving and using machines

Night tablet:

The night tablet contains diphenhydramine, which may cause drowsiness or dizziness. It may also cause blurred vision, impaired cognitive and psychomotor functions.

Such effects may significantly impair the patient's ability to drive vehicles and operate machinery. If these symptoms occur, DO NOT drive vehicles or operate machinery.

Day tablet:

The day tablet does not have an effect that affects the ability to drive vehicles and operate machinery. However, due to the possibility of rare occurrences of dizziness or vertigo, this possibility should be considered in the context of driving vehicles.

Vicks AntiGrip Day and Night contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Vicks AntiGrip Day and Night

Vicks AntiGrip Day and Night should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.

Recommended dose:

Adults and adolescents over 15 years of age:

You should take four tablets per day according to the following instructions.

You may only take one tablet at a time, only during the day as indicated on the packaging.

DO NOT take more than 3 yellow tablets per day (during the day).

DURING THE DAY, DO NOT take blue tablets (intended for nighttime use).

Use in children and adolescents

DO NOT give this medicine to children under 15 years of age.

Route and method of administration

For oral use only.

Swallow the tablets whole (without chewing) with a sufficient amount of liquid.

Duration of treatment

This product is intended for short-term use only. You should not take the medicine for more than 4 days.

Taking a higher dose of Vicks AntiGrip Day and Night than recommended

If you or someone else has taken a higher dose of Vicks AntiGrip Day and Night than recommended, you should contact a doctor immediately.

You should contact a doctor immediately, even if you feel well, because an overdose of paracetamol may cause delayed, serious liver damage.

Missing a dose of Vicks AntiGrip Day and Night

This medicinal product should be taken exactly as described in the above dosage instructions.

DO NOT take a double dose to make up for a missed dose.

In case of any further doubts about taking 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.

STOP taking Vicks AntiGrip Day and Night and seek medical helpimmediately if you experience any of the following symptoms:

allergic reactions, including anaphylactic reactions, angioedema, Stevens-Johnson syndrome, and bronchospasm*, skin rashes (which may be severe and include blistering and peeling of the skin) and itching. Very rare cases of severe skin reactions have been reported.

* Bronchospasm has been reported after taking paracetamol, but it is more likely to occur in asthmatic patients sensitive to aspirin or other NSAIDs.

STOP taking Vicks AntiGrip Day and Night and consult a doctorif you experience any of the following symptoms:

• in a small number of people, hallucinations have been reported, although this is rare
• restlessness or sleep disturbances
• rare cases of blood disorders have been reported, although they are not necessarily related to paracetamol
• liver function disorders
• effects on heart function, such as rapid heart rate (tachycardia)
• increased blood pressure
• in a small number of men, particularly those with prostate problems, difficulty urinating may occur
• sudden fever, skin redness, or numerous small blisters (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Vicks AntiGrip Day and Night. See section 2.

Other side effects may include:

• difficulty falling asleep
• drowsiness, dizziness, blurred vision, headache
• dryness of the mouth, nose, and throat
• stomach pain, diarrhea, nausea, and vomiting
• feeling tired
• confusion, especially in the elderly, restlessness, nervousness
• seizures, paresthesia, dyskinesia
• muscle tremors
• ischemic colitis (inflammation of the colon due to insufficient blood flow).
• -reduced blood flow to the optic nerve (ischemic optic neuropathy) (frequency not known)

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of 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, e-mail: 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 Day and Night

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

There are no special precautions for storing the medicine.

DO 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. Contents of the packaging and other information

What Vicks AntiGrip Day and Night contains

• The active substances in the day tablet are paracetamol (500 mg per tablet) and pseudoephedrine hydrochloride (60 mg per tablet).
• The active substances in the night tablet are paracetamol (500 mg per tablet) and diphenhydramine hydrochloride (25 mg per tablet).
• Other ingredients are: microcrystalline cellulose, sodium croscarmellose, copovidone, anhydrous colloidal silica, magnesium stearate, Day tablet coating:SheffCoat Brilliant Yellow mixture with the composition: hypromellose, talc (E553b), glycerol trioctanoate (E1518), pearl pigment based on mica (aluminum-potassium silicate (E 555) - mica and titanium dioxide (E 171)), yellow iron oxide (E172) Night tablet coating:SheffCoat Brilliant Blue mixture with the composition: hypromellose, talc (E553b), glycerol trioctanoate (E1518), pearl pigment based on mica (aluminum-potassium silicate (E 555) - mica and titanium dioxide (E 171)), indigo carmine, aluminum lake (E132).

What Vicks AntiGrip Day and Night looks like and what the packaging contains

Day tablets: yellow, oval, biconvex, coated tablets (approximate dimensions 9 mm x 18 mm).

Night tablets: blue, round, biconvex, coated tablets with beveled edges (approximate diameter 12 mm).

Pack size: 16 coated tablets (12 day tablets and 4 night tablets) packaged in a child-resistant PVC/PCTFE/Aluminum blister pack, in a cardboard box.

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

tel. 801 25 88 25

Manufacturer

P&G Health Austria GmbH & Co. OG

Hösslgasse 20

9800 Spittal an der Drau

Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland

Vicks AntiGrip Day and Night

Germany

WICK DayNait Filmtabletten

Estonia

Wipar

Italy

Vicks Flu Giorno Notte

Lithuania

Wipar 500mg/60mg+500mg/25mg film-coated tablets

Latvia

Wipar 500 mg/60mg + 500 mg/25 mg coated tablets

Date of last revision of the leaflet: