Vicks antigrip day and night

Patient Information Leaflet

Vicks AntiGrip Day and Night
500 mg + 60 mg, coated tablets
Paracetamolum + Pseudoephedrini hydrochloridum
500 mg + 25 mg, coated tablets
Paracetamolum + Diphenhydramini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Vicks AntiGrip Day and Night is and what it is used for
2. What you need to know 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 pack and other information

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

Vicks AntiGrip Day and Night contains paracetamol, an analgesic and antipyretic medicine, pseudoephedrine
which reduces nasal mucosal congestion, and diphenhydramine,
an antihistamine which causes drowsiness.

• Paracetamol relieves body aches, headache, and fever.
• Pseudoephedrine acts on blood vessels in the nose, reducing nasal mucosal congestion.
• Diphenhydramine relieves cold symptoms such as runny nose, sneezing, clears nasal discharge, and is suitable for use at night.

Vicks AntiGrip Day and Night is indicated for short-term symptomatic treatment of nasal and sinus mucosal congestion associated with symptoms of cold and flu such as aches, headache and/or fever, only when pain occurs during sleep time and prevents falling asleep.
Vicks AntiGrip Day and Night is indicated for use in adults and adolescents over 15 years of age.
The pack contains two types of tablets, of different colours, to be taken at different times of the day.
Please read the patient leaflet carefully to ensure that you take the correct tablets at the appropriate time
of day.

• "Day tablets": yellow tablets containing paracetamol and pseudoephedrine – to be taken during the day.
• "Night tablets": blue tablets containing paracetamol and diphenhydramine – to be taken at night.

2. Important information before using Vicks AntiGrip Day and Night

When not to use Vicks AntiGrip Day and Night:

• if the patient is hypersensitive to paracetamol, pseudoephedrine, diphenhydramine or any of the excipients of the medicine (listed in section 6);
• if the patient has very high blood pressure (severe hypertension) or untreated hypertension;
• if the patient has suffered a stroke caused by bleeding in part of the brain;
• if the patient has heart disease or tachycardia (rapid heartbeat);
• if the patient is taking beta-blockers;
• if the patient is taking monoamine oxidase inhibitors (MAOIs, used in the treatment of Parkinson's disease or depression) or has taken them within the last 14 days;
• if the patient is taking other sympathomimetic drugs reducing congestion (including those reducing nasal mucosal congestion);
• if the patient has diabetes;
• if the patient has a pheochromocytoma (a rare tumour affecting heart rate or blood pressure);
• if the patient has glaucoma (increased pressure in the eyeball);
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or renal failure;
• if the patient has severe liver disease;
• if the patient has difficulty urinating and/or benign prostatic hyperplasia;
• if the patient has hyperthyroidism;
• if the patient is pregnant or breastfeeding.

DO NOT use Vicks AntiGrip Day and Night in children under 15 years of age.
Warnings and precautions
Diphenhydramine may cause drowsiness. DO NOT take the blue tablets during the day.
To avoid overdose, DO NOT take other medicines containing paracetamol, vasoconstrictors, or antihistamines, including those with local action, or other medicines used for cough and cold.
Avoid drinking alcoholic beverages while taking this medicine.
During treatment with Vicks AntiGrip Day and Night, sudden abdominal pain or rectal bleeding may occur due to inflammation of the large intestine (ischaemic colitis). If such gastrointestinal symptoms occur, stop taking Vicks AntiGrip Day and Night and contact a doctor immediately or seek urgent medical help. See section 4.
After taking Vicks AntiGrip Day and Night, reduced blood flow to the optic nerve may occur. If sudden vision loss occurs, discontinue taking Vicks AntiGrip Day and Night and contact a doctor immediately or seek urgent medical help. See section 4.
Before starting treatment with Vicks AntiGrip Day and Night, consult your doctor or pharmacist if:

• the patient is taking antidepressants (sedatives, opioid analgesics, antipsychotics, or tranquilizers);
• the patient has kidney or liver disease (e.g. Gilbert's syndrome);
• the patient is taking drugs that impair liver function;
• the patient has glucose-6-phosphate dehydrogenase deficiency (favism);
• the patient has glutathione deficiency (antioxidant);
• the patient has anaemia;
• the patient is dehydrated;
• the patient is chronically undernourished;
• the patient weighs less than 50 kg;
• the patient is elderly;
• the patient has hypertension;
• the patient has asthma, chronic cough, emphysema (lung disease), or bronchospasm (airway muscle spasm);
• the patient suffers from alcoholism, as regular alcohol consumption adversely affects liver function and may increase the risk of hepatotoxicity from paracetamol-containing medicines;
• the patient has psychosis;
• the patient has arterial or venous occlusion (vascular occlusive disease);
• the patient has gastric outlet obstruction or urinary symptoms such as reduced flow, incomplete emptying, increased frequency, pain, or discomfort.

During treatment with Vicks AntiGrip Day and Night, inform the doctor immediately if the patient develops severe conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an imbalance in blood and body fluids) when taking paracetamol regularly over a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
If the patient develops fever with generalised skin redness and blistering rash, stop taking Vicks AntiGrip Day and Night and contact a doctor immediately or seek urgent medical help. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.
If symptoms suggestive of PRES or RCVS occur, immediately stop taking Vicks AntiGrip Day and Night and seek immediate medical assistance (symptoms, see section 4 "Possible side effects").
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
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.
It is especially important to inform the doctor or pharmacist if the patient is taking any of the following medicines, as their effects may be altered:

• antidepressants (e.g. MAOIs such as moclobemide and brofaromine, tricyclic antidepressants such as amitriptyline);
• medicines used to treat hypertension, including guanethidine, debrisoquine, methyldopa, reserpine, alpha- and beta-adrenergic receptor blockers;
• other sympathomimetic drugs, such as nasal decongestants, appetite suppressants, and amphetamine-type stimulants;
• an antidepressant known as a monoamine oxidase inhibitor (MAOI). Do not take this medicine if the patient has stopped taking an MAOI within the last 14 days. If in doubt, consult a doctor or pharmacist (see section "Other medicines" below);
• medicines causing liver damage, such as anticonvulsants used in epilepsy treatment (phenytoin, carbamazepine, phenobarbital, lamotrigine);
• medicines used to treat tuberculosis (isoniazid, rifampicin);
• medicines used to treat HIV (zidovudine, ritonavir);
• antibiotics such as chloramphenicol, linezolid;
• medicines used to treat gout, e.g. probenecid;
• metoclopramide or domperidone (used to treat nausea and vomiting), antacids (used to treat heartburn);
• kaolin (short-term symptomatic treatment of various conditions, including diarrhoea, dry skin) or activated charcoal;
• cholestyramine (a cholesterol-lowering medicine);
• anticoagulants (blood thinners) such as warfarin;
• alcohol or medicines causing drowsiness, such as central nervous system depressants (e.g. tranquilizers, hypnotics, opioid analgesics, and anxiolytics);
• anticholinergic drugs (affecting the nervous system), such as atropine;
• ergot alkaloids, such as medicines used to treat migraine, e.g. ergotamine and methysergide;
• cardiac glycosides (e.g. digoxin) used to treat heart disease;
• halogenated anaesthetics such as cyclopropane, halothane, enflurane, isoflurane;
• salicylates/acetylsalicylic acid (aspirin);
• inhibitors of the CYP2D6 isoenzyme of cytochrome P450, such as metoprolol and venlafaxine;
• antiarrhythmic, precalcary, or drugs that may cause hypokalaemia (e.g. certain diuretics);
• flucloxacillin (an antibiotic), due to the serious risk of disturbances in blood and body fluids (called metabolic acidosis), which require urgent treatment (see section 2).

Effect of Vicks AntiGrip Day and Night on laboratory test results
Medicines containing paracetamol may affect blood uric acid and glucose test results.
Medicines containing pseudoephedrine may affect doping test results in athletes.
Medicines containing pseudoephedrine may affect skin test results. This medicine should not be taken at least 3 days before starting a skin test.
Pregnancy, breastfeeding and effects on fertility
Pregnancy and breastfeeding
Do not take Vicks AntiGrip Day and Night during pregnancy or breastfeeding.
If the patient suspects she may be pregnant or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Fertility
The effect of this medicine on fertility has not been fully studied.
Driving and operating machinery
Night tablet:
The night tablet contains diphenhydramine, which may cause drowsiness or drowsiness. It may also cause dizziness, blurred vision, and disturbances in cognitive and psychomotor function. These effects may significantly impair the patient's ability to drive or operate machinery. If any of these symptoms occur, DO NOT drive or operate machinery.
Day tablet:
The day tablet contains pseudoephedrine. In rare cases, dizziness or hallucinations may occur; therefore, anyone intending to drive should take this into account.
Vicks AntiGrip Day and Night contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Vicks AntiGrip Day and Night

Vicks AntiGrip Day and Night should always be taken as recommended by a doctor. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 15 years and over:
Four tablets per day should be taken according to the instructions below.

Take only one tablet at a time, only during the time of day indicated on the packaging.
DO NOT take more than 3 yellow tablets per day (during the day).
DO NOT take the blue tablet (intended for night use) during the day. Do not take
more than 1 blue tablet per day.
Use in children and adolescents
This medicine must NOT be given to children under 15 years of age.
Route and method of administration
For oral use only.
Swallow the tablets whole (without chewing) with an adequate amount of liquid.
Duration of treatment
This medicine is intended for short-term use only. Do not take the medicine
for longer than 4 days.
Use of a higher than recommended dose of Vicks AntiGrip Day and Night
If the patient or another person has accidentally taken a higher than recommended dose of Vicks AntiGrip Day
and Night, seek medical advice immediately.
Contact a doctor immediately, even if the patient feels well, because an excessive
dose of paracetamol may cause delayed, serious liver damage.
Missed dose of Vicks AntiGrip Day and Night
This medicine should be taken exactly as described in the dosing instructions above. DO NOT
take a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency unknown (frequency cannot be estimated from the available data):

• Serious disorders affecting blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

You must immediately STOP taking Vicks AntiGrip Day and Night and seek immediate medical help
if you experience any symptoms indicating posterior reversible encephalopathy syndrome (PRES) or
reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• changes in vision.

You must immediately STOP taking Vicks AntiGrip Day and Night and seek medical help
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), itching, urticaria, facial swelling, redness, swelling of the lips, tongue or throat,
difficulty breathing, increased frequency of nosebleeds or noticing that bruises or bleeding occur more easily,
stroke, fainting with low blood pressure, heart attack or reduced blood flow to the heart. Severe skin reactions
have been reported very rarely.

* Cases of bronchospasm after paracetamol intake have been reported, but occurrence is more likely in
aspirin-sensitive or NSAID-sensitive asthmatics.

You must STOP taking Vicks AntiGrip Day and Night and consult a doctor immediately
if you experience any of the following:

• hallucinations have been observed in a small number of people, although this is rare;
• restlessness or sleep disturbances;
• rare cases of blood disorders have been reported, although they were not necessarily related to paracetamol use;
• liver function disorders, which may cause yellowing of the eyes or skin (jaundice) and darkening of the urine;
• effects on heart function, e.g. irregular or rapid heartbeat (tachycardia);
• increased blood pressure;
• in a small number of men, particularly those with prostate problems, difficulty in passing urine may occur;
• sudden fever, skin redness or numerous small pustules (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. Pseudoephedrine should be discontinued if these symptoms occur and you should contact a doctor or seek immediate medical help.

Other possible side effects may include:

• difficulty falling asleep;
• drowsiness (alcohol, sedatives and hypnotics may intensify this effect), dizziness, blurred vision, dilated pupils, dry eyes, dry mouth, nose and throat;
• thirst;
• stomach pain, diarrhoea, nausea, vomiting, abdominal pain, constipation, loss of appetite;
• feeling tired;
• confusion, particularly in elderly people, restlessness, nervousness, reduced concentration, unsteadiness, anxiety;
• seizures, tingling or numbness (pins and needles sensation), dyskinesias (involuntary, uncontrolled movements of the face, hands or feet), tremors;
• muscle twitching, stimulation, irresistible urge to move legs and other limbs (restless legs syndrome);
• colitis due to reduced blood flow (ischaemic colitis);
• reduced blood flow to the optic nerve (ischaemic optic neuropathy), which may lead to vision loss or problems with visual acuity – frequency unknown;
• thicker bronchial mucus, palpitations, stimulation of the central nervous system, which may lead to restlessness or psychotic symptoms;
• significant reduction in blood cell counts, increasing the risk of infection;
• increased blood glucose levels;
• increased liver enzyme levels (transaminases), detected in blood tests;
• a serious condition which may cause increased blood acidity (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2) – frequency unknown.

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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, e-mail: website:
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Vicks Antigrip Day and Night

Keep this medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What the medicine Vicks AntiGrip Day and Night contains:

• The active substances in the daytime tablet are paracetamol (500 mg per tablet) and pseudoephedrine hydrochloride (60 mg per tablet).
• The active substances in the nighttime tablet are paracetamol (500 mg per tablet) and diphenhydramine hydrochloride (25 mg per tablet).
• Other components: microcrystalline cellulose, sodium croscarmellose, copovidone, anhydrous colloidal silicon dioxide, magnesium stearate.
  Coating of the daytime tablet: SheffCoat Brilliant Yellow coating mixture containing: hypromellose, talc (E553b), glyceryl triacetate (E1518), pearl pigment based on mica (aluminosilicate potassium (E 555)-(mica) and titanium dioxide (E 171)), yellow iron oxide (E172).
  Coating of the nighttime tablet: SheffCoat Brilliant Blue coating mixture containing: hypromellose, talc (E553b), glyceryl triacetate (E1518), pearl pigment based on mica (aluminosilicate potassium (E 555)-(mica) and titanium dioxide (E 171)), indigo carmine, aluminium lake (E132).

What Vicks AntiGrip Day and Night looks like and contents of the pack
Daytime tablets: yellow, oval, biconvex coated tablets (approximate dimensions 9 mm x 18 mm).
Nighttime tablets: blue, round, biconvex coated tablets with bevelled edges (approximate diameter 12 mm).
Pack size: 16 coated tablets (12 daytime coated tablets and 4 nighttime coated tablets) packed in PVC/PCTFE/Aluminium child-resistant blister packs, in a cardboard box.

Marketing Authorisation Holder
WICK-Pharma-Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Strasse 40
65824 Schwalbach am Taunus
Germany

For further information regarding this medicine, please contact the local representative of the Marketing Authorisation Holder:
Procter & Gamble Health Poland Sp. z o.o.
ul. Zabraniecka 20, 03-872 Warszawa
tel. 801 25 88 25

Manufacturer
P&G Health Austria GmbH & Co. OG
Hösslgasse 20
9800 Spittal an der Drau
Austria

This medicine is authorised for sale 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 plėvele dengtos tabletės
Latvia: Wipar 500 mg/60mg + 500 mg/25 mg apvalkotās