Nurofen Zatoki

Leaflet accompanying the packaging: information for the user

Nurofen Sinus, 200 mg + 30 mg, coated tablets

Ibuprofen + Pseudoephedrine hydrochloride

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• 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.
• 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 Nurofen Sinus and what is it used for
• 2. Important information before taking Nurofen Sinus
• 3. How to take Nurofen Sinus
• 4. Possible side effects
• 5. How to store Nurofen Sinus
• 6. Contents of the pack and other information

1. What is Nurofen Sinus and what is it used for

Nurofen Sinus is a coated tablet containing 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride. The medicine has analgesic, anti-inflammatory, and antipyretic effects. It decongests the nose and paranasal sinuses. It is intended for short-term use to relieve symptoms of nasal and paranasal sinus congestion with accompanying headache, sinus-related pain, and fever in the course of flu or cold.

2. Important information before taking Nurofen Sinus

When not to take Nurofen Sinus:

• in patients under 12 years of age;
• in patients with a pheochromocytoma;
• if the patient is hypersensitive to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs;
• if the patient has ever had allergic reactions after taking ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (e.g., urticaria, angioedema, bronchial asthma);
• in patients with active or history of peptic ulcer or perforation or bleeding, also those that occurred after taking non-steroidal anti-inflammatory drugs;
• if the patient has severe liver or kidney or heart failure;
• in patients with narrow-angle glaucoma;
• in patients with urinary retention;
• in patients with hyperthyroidism;
• in patients with hemophilia;
• in patients with a history of hemorrhagic stroke;
• in patients with risk factors that may increase the likelihood of a hemorrhagic stroke, such as those taking vasoconstrictor medications or other medications that reduce congestion, taken orally or intranasally;
• in pregnant or breastfeeding women;
• in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with them;
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure.

Warnings and precautions

When to be particularly careful when taking Nurofen Sinus

• in the presence of systemic lupus erythematosus and mixed connective tissue disease;
• in gastrointestinal diseases (ulcerative colitis, Crohn's disease);
• if there are rhythm disturbances, hypertension, myocardial infarction, or heart failure;
• if there are symptoms of neurological disorders;
• if there are kidney function disorders;
• if there are liver function disorders;
• if there is bronchial asthma or allergic disease (the medicine may cause bronchospasm);
• if there is diabetes;
• if there is urethral stricture;
• if there is pyloric stenosis;
• if there is benign prostatic hyperplasia;
• if there is increased intraocular pressure.

During the use of Nurofen Sinus, the following may occur: decreased blood flow in the optic nerve. In case of sudden vision loss, the use of the medicine should be discontinued and medical help should be sought immediately. See section 4. During the use of Nurofen Sinus, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, the use of Nurofen Sinus should be discontinued and medical help should be sought immediately. See section 4. There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. Patients with gastrointestinal diseases, even if they occurred in the past, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). Taking anti-inflammatory and analgesic medications, such as ibuprofen, may be associated with a small increased risk of myocardial infarction or stroke, especially when used in high doses. The recommended dose and treatment duration should not be exceeded. If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms occur, the patient should consult a doctor. Before taking Nurofen Sinus, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.
• the patient has an infection - see below, section entitled "Infections".

During the use of ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, facial and neck edema (angioedema), chest pain. If any of these symptoms are observed, the use of Nurofen Sinus should be discontinued immediately and medical help should be sought. Infections Nurofen Sinus may mask the symptoms of an infection, such as fever and pain. Therefore, Nurofen Sinus may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately. Skin reactions Severe skin reactions have occurred with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should discontinue the use of Nurofen Sinus and seek medical help. Nurofen Sinus belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is reversible and disappears after the end of treatment. As with other centrally acting stimulants, there is a risk of pseudoephedrine abuse. Taking increased doses may eventually lead to toxic effects. Continuous use may lead to a decrease in the medicine's effect, increasing the risk of overdose. After sudden discontinuation of the medicine, depression may occur. After the use of pseudoephedrine-containing medications, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain. If symptoms occur that may be symptoms of PRES or RCVS, the use of Nurofen Sinus should be discontinued immediately and medical help should be sought immediately (symptoms, see section 4 "Possible side effects"). Warning for athletes: after taking pseudoephedrine, a positive result of doping tests may occur.

Adolescents

In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney function disorder.

Use in elderly patients

Elderly patients are more prone to side effects than younger patients. To minimize the risk of side effects, this medicine should be taken for the shortest period necessary to relieve symptoms.

Nurofen Sinus and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Concomitant use with the following medicines should be avoided:

• monoamine oxidase inhibitors and within 14 days of stopping treatment with them. During concomitant use of monoamine oxidase inhibitors and sympathomimetic medicines (stimulating the sympathetic nervous system), hypertensive crises may occur;
• acetylsalicylic acid, unless the doctor recommends taking low doses of acetylsalicylic acid (no more than 75 mg per day), due to the possible increased risk of side effects;
• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors. Concomitant use of two or more NSAIDs should be avoided due to the possible increased risk of side effects.

Nurofen Sinus may affect the action of other medicines or other medicines may affect the action of Nurofen Sinus. For example:

• anticoagulant medicines (e.g., acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Caution should be exercised when using the product with the following medicines:

• diuretics: may increase the risk of NSAID-induced neurotoxicity;
• corticosteroids: increased risk of gastrointestinal ulceration or bleeding;
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding;
• cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase serum glycoside levels. Sympathomimetic agents such as pseudoephedrine may increase the risk of arrhythmias;
• lithium: there is evidence of a potential increase in lithium levels in the blood during concomitant use with ibuprofen;
• methotrexate: there is a risk of increased methotrexate levels in the blood during concomitant use with ibuprofen;
• cyclosporin: increased risk of nephrotoxicity;
• mifepristone: NSAIDs should not be used within 8-12 days after mifepristone administration, as they may reduce the effect of mifepristone;
• tacrolimus: concomitant use of NSAIDs with tacrolimus may increase the risk of nephrotoxicity;
• zydovudine: there is evidence of an increased risk of bleeding into the joints and hematomas in patients with hemophilia, HIV-positive, taking zidovudine and ibuprofen concomitantly;
• quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may be at increased risk of seizures;
• ergot alkaloids (ergotamine, dihydroergotamine, methysergide, and bromocriptine, cabergoline, lisuride, pergolide), dopamine receptor agonists: increased risk of ergotism;
• other sympathomimetic agents (phenylephrine, ephedrine, phenylpropanolamine, including appetite suppressants and amphetamine-like psychostimulants): risk of hypertension;
• oxytocin: risk of hypertension;
• anticholinergic agents (including tricyclic antidepressants): increased effect of the medicine, resulting in an increased risk of hypertension and arrhythmias;
• antacids: increase the rate of pseudoephedrine absorption, while kaolin decreases this rate;
• halogenated hydrocarbon derivatives: during the use of gaseous halogen derivatives - volatile anesthetics used in general anesthesia, in combination with pseudoephedrine, an acute hypertensive reaction may occur during the perioperative period; this is also possible when these medicines are used concomitantly with other indirect sympathomimetics. Therefore, pseudoephedrine treatment should be discontinued 24 hours before scheduled general anesthesia.

Also, some other medicines may be affected by or have an effect on the treatment with Nurofen Sinus. Therefore, before taking Nurofen Sinus with other medicines, the patient should always consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Nurofen Sinus should not be used in pregnant or breastfeeding women.

Fertility

See section "Warnings and precautions".

Driving and using machines

During the use of the medicine, caution should be exercised when driving vehicles and operating machines.

Nurofen Sinus contains yellow quinoline (E 104) and orange yellow (E 110)

The medicine may cause allergic reactions.

Nurofen Sinus contains sodium

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

3. How to take Nurofen Sinus

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The medicine should be taken orally. Only for short-term use. The smallest effective dose should be used for the shortest period necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2). The medicine should not be used for more than 3 days without the doctor's recommendation. Taking the medicine in the smallest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects.

Dosage

Adults and adolescents over 12 years of age: the initial dose is 2 tablets. Then, if necessary, 1-2 tablets every 4-6 hours. Do not take more than 6 tablets (1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride) in 24 hours. The patient should consult their doctor if it is necessary to take the medicine for more than 3 days or if the symptoms worsen. Mild to moderate liver function disorders:monitoring of liver function may be necessary. The medicine is contraindicated in patients with severe liver failure. Mild to moderate kidney function disorders:monitoring of kidney function may be necessary. The medicine is contraindicated in patients with severe kidney failure. Children:the medicine should not be given to children under 12 years of age. Elderly patients: no special dose adjustment is necessary unless kidney or liver function is impaired, in which case the dose should be determined individually.

Overdose of Nurofen Sinus

If the patient has taken a larger dose of Nurofen Sinus than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. They may also include agitation, drowsiness, disorientation, or coma. Seizures may occur occasionally. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred. Additionally, there may be an increase in prothrombin time/INR, probably due to the effect on circulating clotting factors. Acute kidney failure and liver damage may occur. In people with asthma, asthma symptoms may worsen. Additionally, there may be low blood pressure and slow breathing. The doctor will provide symptomatic and supportive treatment. Within the first hour of taking the medicine, activated charcoal (adults: 50 g; children: 1 g/kg body weight) may be given. In all cases of overdose with symptoms, the doctor will check electrolyte levels and perform an electrocardiogram.

Missed dose of Nurofen Sinus

A double dose should not be taken to make up for a missed tablet. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed during the use of the medicine in doses available without a prescription, for short-term use. During long-term use, other side effects may also occur. Uncommon: may affect up to 1 in 100 people

• hypersensitivity with urticaria and itching;
• headache, tremor;
• stomach pain, nausea, and indigestion;
• skin rash.

• insomnia, agitation, depression;
• dizziness;
• diarrhea, bloating, constipation, and vomiting, gastritis;
• irritability, fatigue.

• blood morphology disorders;
• severe hypersensitivity reactions including: facial, tongue, and throat edema, dyspnea, tachycardia, blood pressure drop (anaphylaxis, angioedema, or severe shock);
• aseptic meningitis;
• heart failure and edema, tachycardia, arrhythmia, palpitations;
• hypertension;
• peptic ulcers, perforation, or gastrointestinal bleeding, melena, hematemesis, ulceration of the oral cavity;
• worsening of ulcerative colitis and Crohn's disease;
• liver function disorders;
• severe skin reactions (SCAR) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS));
• acute kidney failure, dysuria (discomfort during urination), decreased urine output, hypernatremia (increased sodium levels in the blood);
• decreased hemoglobin levels.

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

The patient should stop taking Nurofen Sinus and seek medical help immediately if they experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• visual disturbances.
• increased thirst;
• psychogenic anorexia, hallucinations, anxiety, restlessness, disorientation;
• tinnitus, muscle weakness, tremor;
• respiratory tract reactivity, including asthma, bronchospasm, dyspnea;
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.
• dry mouth;
• excessive sweating;
• urinary retention, incontinence;
• ischemic colitis (inflammation of the colon due to insufficient blood flow).
• decreased blood flow in the optic nerve (ischemic optic neuropathy).

Some people may experience other side effects during the use of the medicine. If the patient observes the above symptoms or any other symptoms not listed in this leaflet, they should stop taking the medicine and consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nurofen Sinus

Store in a temperature below 25°C. Store in the original packaging to protect from moisture. The medicine should be kept out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. 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 Nurofen Sinus contains

• The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride - 1 coated tablet contains: ibuprofen 200 mg, pseudoephedrine hydrochloride 30 mg
• The other ingredients are: tablet core: calcium phosphate, microcrystalline cellulose, povidone, sodium croscarmellose, magnesium stearate; coating ingredients: hypromellose, talc, Opaspray Yellow M-IF-6168 (hypromellose, titanium dioxide (E 171), quinoline yellow (E 104), orange yellow (E 110)) or Mastercote Yellow FA 0156 (hypromellose, titanium dioxide (E 171), quinoline yellow (E 104), orange yellow (E 110)); printing ink: Opacode S-1-277001 (shellac, iron oxide black (E 172), propylene glycol).

What Nurofen Sinus looks like and contents of the pack

The medicine is in a cardboard box containing: 12 coated tablets in 1 blister pack of Aluminum/PVC/PVDC or 24 coated tablets in 2 blister packs of Aluminum/PVC/PVDC

Marketing authorization holder and importer

Marketing authorization holder

Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwór Mazowiecki

Importer

RB NL Brands B.V. WTC Schiphol Airport, Schiphol Boulevard 207, 1118 BH Schiphol, Netherlands For more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder: Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwór Mazowiecki Tel.: (22) 211 26 92

Date of last revision of the leaflet: