Nurofen sinus

Patient Information Leaflet

Nurofen Zatoki, 200 mg + 30 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read the entire leaflet carefully before using 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 you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if symptoms worsen, consult your doctor.

Table of Contents

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

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

Nurofen Zatoki is a coated tablet containing 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
The medicine has analgesic, anti-inflammatory, and antipyretic properties. It helps clear nasal passages and paranasal sinuses.
It is intended for short-term use to relieve nasal and paranasal sinus congestion accompanied by headache, sinus-related pain, and fever associated with influenza or the common cold.

2. Important information before using Nurofen Zatoki

When not to use Nurofen Zatoki:

• in patients under 12 years of age;
• in patients with a pheochromocytoma;
• if the patient is allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if allergic reactions (e.g. urticaria, angioedema, rhinitis, or bronchial asthma) have ever occurred after taking ibuprofen, acetylsalicylic acid, or other NSAIDs;
• in patients with active or past history of gastric or duodenal ulcer, perforation, or gastrointestinal bleeding, including events occurring after use of NSAIDs;
• if the patient has severe liver failure, severe renal failure, or severe heart failure;
• in patients with narrow-angle glaucoma;
• in patients with urinary retention;
• in patients with hyperthyroidism;
• in patients with bleeding disorders;
• in patients with a history of haemorrhagic stroke;
• in patients with risk factors that may increase the likelihood of haemorrhagic stroke, such as those taking vasoconstrictive drugs or other drugs reducing blood flow, administered orally or intranasally;
• in women during pregnancy and breastfeeding;
• in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days after stopping such treatment;
• if the patient has very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication;
• if the patient has severe acute or chronic kidney disease or renal failure.

Warnings and precautions
When to exercise particular caution when using Nurofen Zatoki

• in systemic lupus erythematosus or mixed connective tissue disease;
• in gastrointestinal disorders (ulcerative colitis, Crohn's disease);
• if cardiac arrhythmias, hypertension, myocardial infarction, or heart failure have been diagnosed;
• if neurological symptoms are present;
• if renal function disorders have been diagnosed;
• if hepatic function disorders have been diagnosed;
• if bronchial asthma or allergic disease has been diagnosed (the medicine may cause bronchospasm);
• if diabetes has been diagnosed;
• if bladder neck obstruction is present;
• if pyloric stenosis is present;
• if benign prostatic hyperplasia is present;
• if increased intraocular pressure has been diagnosed.

During treatment with Nurofen Zatoki, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue the medicine immediately and contact a doctor or seek medical help without delay. See section 4.
During treatment with Nurofen Zatoki, sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischaemic colitis) may occur. If such gastrointestinal symptoms occur, discontinue Nurofen Zatoki immediately and seek medical advice or help without delay. See section 4.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients who have previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with gastrointestinal disorders, even if occurring in the past, particularly elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of treatment.
Prolonged, concurrent use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
If symptoms persist, worsen, or do not resolve after 3 days, or if new symptoms appear, consult a doctor.
Before using Nurofen Zatoki, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker.
• the patient has an infection – see below under the heading “Infections”.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms are observed, discontinue Nurofen Zatoki immediately and contact a doctor or emergency medical services without delay.
Infections
Nurofen Zatoki may mask symptoms of infection such as fever and pain. Therefore, Nurofen Zatoki may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, medical advice should be sought immediately.
Skin reactions
Severe skin reactions have occurred with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If any of the symptoms related to these severe skin reactions described in section 4 occur, discontinue Nurofen Zatoki immediately and seek medical help.
Nurofen Zatoki belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
As with other centrally acting stimulant medicines, there is a risk of abuse when using pseudoephedrine. Toxic effects may eventually occur with increased doses. Continuous use may lead to diminished effect with increased risk of overdose. Depression may occur after abrupt discontinuation.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.
If symptoms that could indicate PRES or RCVS occur, discontinue Nurofen Zatoki immediately and seek immediate medical help (symptoms, see section 4 “Possible side effects”).
Note for athletes: After using pseudoephedrine, a positive result in doping tests may occur.
Adolescents
In dehydrated patients – adolescents aged 12–18 years – there is a risk of impaired kidney function.
Use in elderly patients
Elderly patients are more susceptible to adverse effects than younger individuals. To minimise the risk of adverse effects, this medicine should be taken for the shortest period necessary to relieve symptoms.
Nurofen Zatoki and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for use.
Avoid using this product with the following medicines:

• monoamine oxidase inhibitors (MAOIs) and within 14 days after stopping such treatment. Concurrent use of MAO inhibitors and sympathomimetic agents (stimulating the sympathetic nervous system) may cause hypertensive crises;
• acetylsalicylic acid, unless the doctor has specifically recommended low-dose acetylsalicylic acid (not more than 75 mg per day), due to possible increased risk of adverse effects;
• other NSAIDs, including selective cyclooxygenase-2 inhibitors. Avoid concurrent use of two or more NSAIDs due to possible increased risk of adverse effects.

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

• anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Exercise caution when using this product with the following medicines:

• diuretics: may increase the risk of NSAID 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 GFR, and increase serum glycoside concentrations. Sympathomimetic agents such as pseudoephedrine may increase the risk of cardiac arrhythmias;

• lithium: evidence suggests potential increased serum lithium concentrations during concomitant ibuprofen use;

• methotrexate: risk of increased methotrexate serum concentration when used concomitantly with ibuprofen;

• cyclosporine: increased risk of nephrotoxicity;

• mifepristone: do not use NSAIDs within 8–12 days after mifepristone administration, as they may reduce mifepristone's effectiveness;

• tacrolimus: concomitant use of NSAIDs with tacrolimus may increase the risk of nephrotoxic effects;

• zidovudine: evidence suggests increased risk of joint haemorrhages and bruising in haemophilia patients and HIV-positive patients taking zidovudine and ibuprofen concurrently;

• quinolone antibiotics: animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotic use. Patients taking NSAIDs and quinolones may be at increased risk of seizures;

• ergot alkaloids (ergotamine, dihydroergotamine, methysergide, bromocriptine, cabergoline, lisuride, pergolide), dopamine receptor agonists: increased risk of ergot alkaloid poisoning;

• other sympathomimetic agents (phenylephrine, ephedrine, phenylpropanolamine, including appetite suppressants and amphetamine-like psychostimulants): risk of hypertension;

• oxytocin: risk of hypertension;

• anticholinergic medicines (including tricyclic antidepressants): increased drug effect, thus increasing the risk of hypertension and arrhythmias;

• medicines that neutralise gastric juice: increase the absorption rate of pseudoephedrine, whereas kaolin reduces this rate;

• halogenated hydrocarbons: during use of volatile halogenated anaesthetic gases used in general anaesthesia, in combination with pseudoephedrine, an acute hypertensive reaction may occur in the perioperative period; this is also possible when these medicines are used concurrently with other indirect sympathomimetics.
  Therefore, pseudoephedrine treatment should be discontinued 24 hours before planned general anaesthesia.

• linezolid (a medicine used to treat bacterial infections), as pseudoephedrine may cause elevated blood pressure in patients taking this medicine.

Other medicines may also interact with or be affected by Nurofen Zatoki treatment. Therefore, always consult a doctor or pharmacist before using Nurofen Zatoki with other medicines.
Pregnancy, breastfeeding, and effects on fertility
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Nurofen Zatoki must not be used in women during pregnancy or breastfeeding.
Fertility
See section “Warnings and precautions”.
Driving and operating machinery
Exercise caution when driving or operating machinery during treatment with this medicine.
Nurofen Zatoki contains quinoline yellow (E 104) and sunset yellow (E 110)
This medicine may cause allergic reactions.
Nurofen Zatoki 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 Nurofen Zatoki
This medicine should always be taken exactly as described in this patient leaflet or as advised by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally.
For short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not use the medicine for longer than 3 days without medical advice.
Taking the medicine at the lowest effective dose for the shortest necessary period to relieve symptoms reduces the risk of adverse effects.
Dosage
Adults and adolescents over 12 years of age: Initial dose is 2 tablets. Then, if needed, one to two tablets every 4 to 6 hours. Do not exceed six tablets (1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) in 24 hours. Consult a doctor if treatment is required for longer than 3 days or if symptoms worsen.
Mild to moderate liver function disorders: Monitoring of liver function may be indicated. The medicine is contraindicated in patients with severe liver failure.
Mild to moderate kidney function disorders: Monitoring of kidney function may be indicated. The medicine is contraindicated in patients with severe renal failure.
Children: Do not give this medicine to children under 12 years of age.
Elderly patients: No special dosage adjustment is necessary unless kidney or liver function is impaired, in which case dosage should be individually determined.
Overdose of Nurofen Zatoki
If a patient has taken more than the recommended dose of Nurofen Zatoki or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Stimulation, drowsiness, confusion, or coma may also occur. Seizures may occur occasionally. After a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, cold sensation, and breathing difficulties may occur. Prolongation of prothrombin time/INR may also occur, likely due to effects on circulating coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, asthma symptoms may worsen. Additionally, low blood pressure and slowed breathing may occur.
The doctor will provide symptomatic and supportive treatment. Within the first hour after ingestion, activated charcoal may be administered (adults: 50 g; children: 1 g/kg body weight).
In all symptomatic overdose cases, the doctor will check electrolyte levels and perform an electrocardiogram.
Missed dose of Nurofen Zatoki
Do not take a double dose to make up for a missed tablet.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed below have been observed during use of the medicine at over-the-counter doses, taken as needed. Other side effects may occur during long-term use of the medicine.

Uncommon: may affect up to 1 in 100 patients

• hypersensitivity with urticaria and itching;
• headache, tremor;
• abdominal pain, nausea and dyspepsia;
• skin rash.

Rare: may affect up to 1 in 1,000 patients

• insomnia, restlessness, depression;
• dizziness;
• diarrhoea, flatulence, constipation and vomiting, inflammation of the gastric mucosa;
• irritability, fatigue.

Very rare: may affect up to 1 in 10,000 patients

• blood morphology disorders;
• severe hypersensitivity reactions including: facial, tongue and throat swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock);
• aseptic meningitis;
• heart failure and oedema, tachycardia, arrhythmia, palpitations;
• hypertension;
• gastrointestinal ulcers, perforation or bleeding from the gastrointestinal tract, tarry stools, vomiting blood, oral ulceration;
• exacerbation of colitis and Crohn's disease;
• liver disorders;
• severe skin reactions (SCAR) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• acute kidney failure, dysuria (discomfort during urination), reduced urine output, hypernatraemia (increased sodium concentration in blood);
• decreased haemoglobin concentration.

Frequency unknown: frequency cannot be estimated from the available data

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

Immediately stop taking Nurofen Sinus and seek immediate medical help if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• sudden, severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.
  • increased thirst;
  • psychogenic anorexia, hallucinations, anxiety, restlessness, disorientation;
  • tinnitus, muscle weakness, tremor;
  • respiratory tract reactivity, including asthma, bronchospasm, dyspnoea;
  • chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
  • dry mouth;
  • excessive sweating;
  • urinary retention, urinary incontinence;
  • colitis caused by insufficient blood supply (ischaemic colitis);
  • reduced blood flow in the optic nerve (ischaemic optic neuropathy);
  • red, non-elevated, target-like or round skin lesions on the trunk, often with blisters in the centre, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
  • widespread rash, high fever and swollen lymph nodes (DRESS syndrome);
  • red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, stop taking Nurofen Sinus immediately and seek medical help without delay. See also section 2.
  • skin becomes sensitive to light.

Other side effects may occur in some individuals during treatment with this medicine. If any of the above symptoms, or other symptoms not listed in this leaflet, are observed, discontinue the medicine and consult a doctor.

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

5. How to store Nurofen Sinus
Store below 25°C. Keep in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after: 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. This will help protect the environment.

6. Contents of the pack and other information

What Nurofen Zatoki contains

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

What Nurofen Zatoki looks like and contents of the pack
The medicine is contained in a cardboard box containing:
12 coated tablets in 1 blister made of Aluminium/PVC/PVDC or
24 coated tablets in 2 blisters made of Aluminium/PVC/PVDC

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Tel.: (22) 211 26 92