Vicks antigrip sinuses and catarrh

Package leaflet: Information for the patient

Vicks AntiGrip Sinuses and Cold
(650 mg + 16 mg + 4 mg)/sachet, granules for oral solution
Paracetamolum + Phenylephrini hydrogenotartras + Chlorphenamini maleas
Please read this leaflet carefully before using the 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 doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, consult your doctor.

Leaflet contents:

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

1. What Vicks AntiGrip Sinuses and Cold is and what it is used for

Vicks AntiGrip Sinuses and Cold is indicated for the symptomatic treatment of cold and flu associated with fever, mild to moderate pain (e.g. headache, sore throat, muscle pain, sinus pain), nasal and sinus mucosal swelling with nasal discharge.
Vicks AntiGrip Sinuses and Cold is a combination of three active substances:

• paracetamol – an antipyretic and analgesic agent
• phenylephrine – a substance that reduces swelling of the nasal and sinus mucosa
• chlorphenamine – an antihistamine that reduces nasal secretions.

If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before taking Vicks AntiGrip Sinuses and Cold

When not to take Vicks AntiGrip Sinuses and Cold

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• If you have hypertension (high blood pressure);
• If you have hyperthyroidism;
• If you have any severe heart or arterial disease (such as coronary heart disease);
• If you have tachycardia (rapid heartbeat);
• If you have severe renal impairment;
• If you have glaucoma (increased intraocular pressure);
• If you have severe liver disease;
• If you are being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressants or drugs used in Parkinson’s disease), or within 15 days after discontinuation of such treatment;
• This medicine is contraindicated in children and adolescents due to the high dose of paracetamol.

Warnings and precautions

• Do not take more than one medicine containing paracetamol, as this may lead to poisoning. Paracetamol poisoning may occur after a single excessive dose or by exceeding the recommended daily dose. (See section 3 “Taking more Vicks AntiGrip Sinuses and Cold than recommended”).
• Do not take sympathomimetics (such as nasal decongestants, appetite suppressants, or psychostimulants with amphetamine-like effects), other antihistamines (e.g. antiallergic drugs), including those applied to the skin, or other cold and flu remedies at the same time.
• Exercise caution in patients with alcohol-related disease or those who regularly consume alcohol. Do not exceed 3 sachets of Vicks AntiGrip Sinuses and Cold (2 g paracetamol) per day. Avoid alcohol during treatment due to increased risk of hepatotoxic liver damage.
• In patients with anaemia, heart or lung disease, or impaired liver function, occasional use may be permitted, but medical advice should be sought before taking this medicine.
• Cases of hepatotoxic effects have been reported with paracetamol administered at daily doses not exceeding 4 g.
• Patients with asthma who are allergic to acetylsalicylic acid should consult a doctor before taking this medicine.
• Patients allergic to antihistamines should consult a doctor before starting this medicine, as cross-allergy to other antihistamines may occur.
• Patients sensitive to sedative drugs or those with epilepsy should consult a doctor before starting this medicine, as symptoms of the disease may worsen and interactions with antiepileptic drugs may occur.
• Concomitant use of chlorphenamine and other serotonergic drugs, including SSRIs and SNRIs, may increase the risk of serotonin syndrome.

Before starting Vicks AntiGrip Sinuses and Cold, discuss with your doctor or pharmacist if you have:

• Kidney or lung disease
• Difficulty urinating and/or benign prostatic hyperplasia
• Diabetes
• Bronchial asthma
• Very slow heart rate, hypotension (low blood pressure), or cerebral arteriosclerosis
• Pancreatitis, peptic ulcer, pyloric or duodenal stenosis
• Thyroid disorders
• Anaemia
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may lead to methaemoglobinaemia and haemolytic anaemia) or methaemoglobin reductase deficiency

If patients treated with tricyclic antidepressants or other drugs with similar effects develop gastrointestinal symptoms, they should consult a doctor immediately. These symptoms may indicate paralytic ileus (cessation of intestinal peristalsis and movement of intestinal contents).

• Increased risk of liver damage during paracetamol use exists in patients:
  • Receiving long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John’s wort, or other drugs inducing liver enzymes;
  • At risk of glutathione deficiency (e.g. due to eating disorders, HIV infection, dehydration, fasting, or malnutrition);
  • Who regularly consume alcohol;
  • With liver disease (including Gilbert’s syndrome).

During treatment with Vicks AntiGrip Sinuses and Cold, inform your doctor immediately if: You have severe diseases, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).
In these situations, patients have been reported to develop a serious condition called metabolic acidosis (a disturbance in blood and body fluid balance) when taking paracetamol regularly over a long 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.

Children and adolescents

Vicks AntiGrip Sinuses and Cold is contraindicated in children and adolescents due to the high dose of paracetamol.

Use of Vicks AntiGrip Sinuses and Cold in elderly patients

Do not use Vicks AntiGrip Sinuses and Cold in elderly patients without consulting a doctor. A lower dose may be required in these patients. Due to the presence of phenylephrine and chlorphenamine, adverse effects such as bradycardia (slow heart rate) or reduced cardiac output may occur in elderly patients.
Blood pressure should be monitored, especially in patients with heart disease. In elderly patients, symptoms such as dizziness, sedation, confusion, low blood pressure, agitation, dry mouth, and urinary retention are more likely.

Use of Vicks AntiGrip Sinuses and Cold by athletes

Use of Vicks AntiGrip Sinuses and Cold may result in a positive doping control test.

Vicks AntiGrip Sinuses and Cold and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Taking Vicks AntiGrip Sinuses and Cold with other medicines may lead to interactions.

Due to the presence of paracetamol:
If you are taking any of the following medicines, dosage adjustment or discontinuation of treatment may be necessary:

• Oral anticoagulants (acenocoumarol, warfarin, and other coumarins);
• Antiepileptic drugs (lamotrigine, phenytoin, phenobarbital, methylphenobarbital, primidone);
• Antituberculosis drugs (isoniazid, rifampicin);
• Certain diuretics used to increase urine output (loop diuretics such as furosemide);
• Drugs used in the treatment of gout (probenecid);
• Drugs used for nausea and vomiting (metoclopramide and domperidone);
• Propranolol used in the treatment of high blood pressure and cardiac arrhythmias;
• Colestyramine (used to lower blood cholesterol);
• Activated charcoal;
• Long-term use of carbamazepine;
• St John’s wort or other drugs inducing liver enzymes;
• Acetylsalicylic acid;
• Zidovudine.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Due to the presence of phenylephrine:
If you are taking any of the following medicines, treatment may need to be discontinued or administration of Vicks AntiGrip Sinuses and Cold delayed:

• Monoamine oxidase inhibitors (drugs used in the treatment of depression, such as phenelzine, isocarboxazid, nialamide, tranylcypromine, moclobemide, or drugs used in Parkinson’s disease, such as selegiline). Administration of Vicks AntiGrip Sinuses and Cold should be postponed for at least 15 days after stopping these drugs;
• Alpha-adrenergic receptor blockers (drugs used in migraine treatment such as dihydroergotamine, ergotamine, phenylephrine, or drugs inducing labour, e.g. oxytocin);
• Beta-adrenergic receptor blockers (drugs used in the treatment of hypertension or mild benign prostatic hyperplasia);
• Tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, and doxepine, or tetracyclic antidepressants such as maprotiline;
• Inhalational anaesthetics such as cyclopropane and halothane;
• Antihypertensive drugs acting on the sympathetic nervous system such as methyldopa, guanethidine;
• Drugs causing potassium loss (such as diuretics, e.g. furosemid and others);
• Drugs affecting cardiac conduction (cardiac glycosides such as digoxin, antiarrhythmics);
• Thyroid hormones;
• Atropine sulphate (used, among others, in heart and gastrointestinal diseases);
• Drugs blocking both alpha and beta adrenergic receptors used in heart and arterial diseases (such as labetalol, carvedilol).

Due to the presence of chlorphenamine:
Concomitant use of the following drugs may increase the occurrence of adverse effects:

• Drugs acting on the central nervous system (used in the treatment of depression, insomnia, anxiety);

• Monoamine oxidase inhibitors (including furazolidone, pargyline, and procarbazine);

• Tricyclic or tetracyclic antidepressants, e.g. maprotiline;

• Ototoxic drugs (which may cause hearing damage as an adverse effect);

• Drugs causing photosensitivity.

• Concomitant use of chlorphenamine and other serotonergic drugs, including SSRIs and SNRIs, may increase the risk of serotonin syndrome.

Effect on laboratory test results

If you are undergoing diagnostic tests (blood or urine tests, skin tests with allergens), inform your doctor that you are taking Vicks AntiGrip Sinuses and Cold, as this medicine may alter laboratory test results.

Vicks AntiGrip Sinuses and Cold with food, drink, and alcohol

During treatment with Vicks AntiGrip Sinuses and Cold, alcohol should not be consumed, as it may cause symptoms of overdose, such as increased sedative effects. Use of Vicks AntiGrip Sinuses and Cold in patients who regularly consume alcohol (three or more alcoholic drinks per day) may lead to liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
There are insufficient data on the use of the active substances of this medicinal product in pregnant women. Vicks AntiGrip Sinuses and Cold should not be used during pregnancy unless absolutely necessary. The decision to use the medicine will be made by the doctor. The medicine may be used only if the potential benefit to the mother outweighs the risk to the fetus. In such cases, the lowest effective dose should be used for the shortest possible duration and as infrequently as possible.

Breastfeeding
Paracetamol and chlorphenamine pass into human milk; therefore, breastfeeding women should not use this medicine.

Driving and operating machinery

Vicks AntiGrip Sinuses and Cold may cause dizziness or blurred vision, drowsiness, and sedation, thereby affecting reaction ability and speed. Therefore, do not drive or operate machinery while taking this medicine.

Warnings regarding excipients

Vicks AntiGrip Sinuses and Cold contains mannitol (E 421).
The medicine contains 3 g of mannitol (E 421) per sachet and may therefore cause a mild laxative effect.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning it is considered "sodium-free".
The medicine contains trace amounts of sulphites derived from the flavouring composition (aroma component), which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Vicks AntiGrip Sinuses and Cold

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
If fever persists for longer than 3 days of treatment, or pain or other symptoms last more than 5 days, worsen, or new symptoms appear, consult a doctor.
Vicks AntiGrip Sinuses and Cold should be used when experiencing pain and fever symptoms. Once symptoms subside, treatment should be discontinued.

Recommended dosage:
Adults: one sachet every 4–6 hours (four to six times daily). Do not exceed 6 sachets in 24 hours.
Elderly patients: do not exceed 3 sachets in 24 hours.

For adult patients weighing less than 50 kg, patients with Gilbert’s syndrome (non-haemolytic familial jaundice), dehydrated patients, chronically undernourished patients, or patients with chronic alcohol-related disease, the dose should be halved. The following dosing schedule should be applied: one sachet 2–3 times daily, at intervals of 6–8 hours. Do not exceed 3 sachets per day.

Patients with mild to moderate hepatic impairment:
One sachet every at least 8 hours. Do not exceed 3 sachets per day (maximum 2 g paracetamol per day).

Patients with renal impairment:
Due to the paracetamol content, this medicine is not recommended for use in this patient group.

Preparation instructions:
Dissolve the contents of one sachet in a small amount of hot, but not boiling water (preferably half a glass of water). Allow to cool to a drinkable temperature.

Use of a higher than recommended dose of Vicks AntiGrip Sinuses and Cold
WARNING! Do not take other medicines containing paracetamol together with Vicks AntiGrip Sinuses and Cold, as this may lead to poisoning.
If a dose exceeding the recommended amount has been taken, contact a doctor immediately or go to the nearest hospital emergency department, even if no symptoms are present, as life-threatening liver damage may occur. This also applies in cases of severe poisoning.

Symptoms of overdose
Related to paracetamol: nausea, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, diarrhoea, excessive sweating. Overdose may also lead to coagulation disorders (blood clotting problems and bleeding). Acute liver failure and liver necrosis may occur, which can result in death.

Related to phenylephrine: excessive stimulation of the nervous system with symptoms such as restlessness, anxiety, excitation, headache, seizures, insomnia, confusion, irritability, loss of appetite, nausea, vomiting, psychosis with hallucinations (more common in children), hypertension, cerebral haemorrhage, pulmonary oedema, cardiac arrhythmias, palpitations, vasoconstriction with possible reduction in blood flow to vital organs, reduced urine output, metabolic acidosis, and increased cardiac workload.

Related to chlorphenamine: pronounced drowsiness, dryness of the mouth, nose and throat, shortness of breath, cardiac arrhythmias, nervous system stimulation (hallucinations, seizures, insomnia), hypotension.

Treatment of paracetamol overdose is most effective if initiated within 4 hours of ingestion of an excessive dose.
In all cases, vomiting should be induced and gastric lavage performed. Hospital treatment involves intravenous or oral administration of the antidote – N-acetylcysteine.
In cases of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment should be administered.

Missed dose of Vicks AntiGrip Sinuses and Cold
If a dose is missed, take it as soon as possible.
Do not take a double dose to make up for a missed dose.

Discontinuation of Vicks AntiGrip Sinuses and Cold
Administration of the medicinal product depends on the presence of symptoms (pain, fever).
Once these symptoms have subsided, treatment should be discontinued.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following severe, life-threatening adverse effects occur, stop taking the medicine immediately and contact a doctor or go to the hospital emergency department without delay: cough, difficulty swallowing, difficulty breathing, rapid heartbeat, itching, swelling of the eyelids or around the eyes, face and/or tongue or throat, rash, hives, shortness of breath (anaphylaxis), urinary retention, yellowing of the skin and/or the whites of the eyes, heart attack, ventricular arrhythmia, pulmonary oedema and intracranial haemorrhage, increased frequency of nosebleeds or noticing that bruises or bleeding occur more easily.

Paracetamol may cause severe skin reactions characterised by acute generalised blistering rash or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or by rupturing large blisters, extensive erosions on the skin, peeling of large sheets of epidermis, and fever.

The following adverse effects may occur in some patients taking Vicks AntiGrip Zatoki i Katar:

Common (affects more than 1 in 100 people but less than 1 in 10 people):
Drowsiness, nausea and muscle weakness (which may resolve after 2–3 days of treatment), involuntary movements of facial muscles, coordination disturbances, tingling and numbness or changes in skin temperature, tremors, dry mouth, loss of appetite, disturbances in taste and smell, gastrointestinal complaints which may be reduced when taking the medicine with food (e.g. nausea, vomiting, indigestion, diarrhoea, constipation, epigastric pain), dryness of the nasal and throat mucosa, drying of mucous membranes, excessive sweating, blurred or double vision, headache and dizziness. In some patients, particularly those with enlarged prostate, urinary retention and difficulty urinating may occur.

Uncommon (affects more than 1 in 1,000 people but less than 1 in 100 people) or rare (affects more than 1 in 10,000 people but less than 1 in 1,000 people):
Nervous excitation (manifesting as anxiety, insomnia, tremor, hallucinations, palpitations and even seizures) or fatigue, chest tightness, cardiac rhythm disturbances, increased heart rate (usually with overdose), low or high blood pressure, dizziness, cholestasis, hepatitis or other liver function disorders (including abdominal pain, dark urine), severe allergic reactions (cough, difficulty swallowing, itching, swelling of eyelids or around the eyes, face and/or tongue, shortness of breath, fatigue, etc.), photosensitivity, fatigue, disorientation or feeling faint due to hypotension or hypertension, cross-allergy to drugs similar to chlorpheniramine, blood morphology changes, sore throat, oedema (swelling), tinnitus, acute labyrinthitis (part of the ear), impotence, intermenstrual bleeding.

Rare (affects more than 1 in 10,000 people but less than 1 in 1,000 people):
Increased liver enzyme activity, myocardial infarction, ventricular arrhythmia, pulmonary oedema and intracranial haemorrhage (usually with high-dose use).

Very rare (affects less than 1 in 10,000 people):
Blood disorders such as: thrombocytopenia (reduced number of platelets), agranulocytosis (marked reduction in granulocytes – one type of white blood cell, which may increase the frequency of infections), leukopenia (reduced number of leukocytes), neutropenia (reduced number of neutrophil granulocytes), haemolytic anaemia, hypoglycaemia (marked reduction in blood glucose concentration), kidney disorders, cloudy urine, allergic dermatitis, skin rash, urticaria, severe skin reactions, hypersensitivity reactions (skin blisters, anaphylactic shock, bronchospasm), jaundice.

Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.

Frequency not known (cannot be estimated from available data):
Anxiety, restlessness, confusion, weakness, irritability, dizziness, nausea, tremors, insomnia, chest pain or discomfort, severe bradycardia (very slow heartbeat), vasoconstriction, increased cardiac workload (particularly affecting elderly patients or patients with cerebral or coronary circulation disorders), cold hands and feet, flushing, difficulty breathing, shortness of breath, worsening renal perfusion, reduced urine output and urinary retention, pale skin, piloerection, hyperglycaemia (increased blood glucose concentration), hypokalaemia (low serum potassium concentration), serious condition that may cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2). With high-dose use, seizures, psychotic states with hallucinations and vomiting may occur. Induction or worsening of heart disease and palpitations are possible. With prolonged use, hypovolaemia and excessive sweating may develop.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vicks AntiGrip Sinus and Cold

Keep the medicine out of sight and reach of children.
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. Such practices help protect the environment.

6. Contents of the pack and other information

What Vicks AntiGrip Sinuses and Catarrh contains
The active substances are: paracetamol, phenylephrine hydrochloride and chlorphenamine maleate.
Each sachet contains: 650 mg paracetamol; 15.58 mg phenylephrine hydrochloride, equivalent to
8.21 mg phenylephrine; 4 mg chlorphenamine maleate, equivalent to 2.8 mg chlorphenamine.
The excipients are: mannitol (E 421), sodium saccharin, colloidal anhydrous silica,
povidone K30, orange flavour PHS 132958 (containing butylated hydroxyanisole (E 320), sulphites,
citral, citronellol, D-limonene, geraniol, linalool).

What Vicks AntiGrip Sinuses and Catarrh looks like and contents of the pack
Vicks AntiGrip Sinuses and Catarrh is a granulate (white to yellowish-white) for oral solution with an orange flavour.
One pack contains 10 or 14 sachets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wick - Pharma - Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Straße 40
65824 Schwalbach am Taunus
Germany

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

Manufacturer
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares
Madrid
Spain