Nasivin Zatoki i Katar

Leaflet attached to the packaging: information for the user

Nasivin Sinus and Cold, 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 more information, you should talk to your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days in adolescents and 5 days in adults there is no improvement or the patient feels worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is Nasivin Sinus and Cold and what is it used for

Nasivin Sinus and Cold contains the active substance ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID), and pseudoephedrine, which has a decongestant effect on the nasal mucosa.

• Ibuprofen reduces pain, swelling, and lowers high body temperature.
• Pseudoephedrine acts on the blood vessels in the nose to reduce nasal congestion.

Nasivin Sinus and Cold is indicated for the relief of symptoms of nasal congestion with accompanying headache, fever, and/or pain in the course of a cold or flu. Nasivin Sinus and Cold is indicated for use in adults and adolescents over 15 years of age. The combination drug should only be used if the patient has a blocked nose in combination with pain or fever. Do not use the medicine if only one of these symptoms is present. If there is no improvement or worsening after 3 days in adolescents and 5 days of taking the medicine in adults, you should contact your doctor.

2. Important information before taking Nasivin Sinus and Cold

When NOT to take Nasivin Sinus and Cold:

• if you are allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6),
• in patients under 15 years of age,
• during pregnancy and breastfeeding,
• if you have ever had allergic reactions (such as: wheezing, bronchospasm, asthma exacerbation, nasal polyps, rhinitis with itching, facial swelling, urticaria, or rash)

after taking aspirin (acetylsalicylic acid) or other pain, antipyretic, or anti-inflammatory medications,

• if you have (or have recurring) stomach or duodenal ulcers (peptic ulcer) or bleeding (2 or more episodes of confirmed ulceration or bleeding),
• if you have had perforation or bleeding of the gastrointestinal tract due to NSAID use in the past,
• if you have other bleeding disorders,
• if you have severe liver failure,
• if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
• if you have severe heart failure,
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension,
• if you have severe heart or circulatory disorders (such as: coronary artery disease, heart disease, angina pectoris, rapid heartbeat), hyperthyroidism, diabetes, pheochromocytoma (adrenal gland tumor),
• if you have had a heart attack,
• if you have had a stroke or are at risk of stroke,
• if you have had seizures,
• if you have unexplained blood disorders,
• if you have glaucoma (high eye pressure),
• if you have difficulty urinating and/or prostate enlargement,
• if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease (MCTD), a disease that attacks the immune system, e.g., causing joint pain and skin changes,
• if you are taking:
• aspirin (acetylsalicylic acid) (more than 75 mg per day) or other nonsteroidal anti-inflammatory drugs (NSAIDs) or other pain or decongestant medications, e.g., phenylpropanolamine, phenylephrine, or ephedrine, methylphenidate, taken orally or nasally,
• non-selective monoamine oxidase inhibitors (known as MAOIs and used to treat Parkinson's disease or depression) or have taken them in the last 2 weeks (see "Nasivin Sinus and Cold and other medicines"),
• blood thinners (oral anticoagulants, heparins, antiplatelet agents),
• corticosteroids,
• lithium (used in bipolar disorder or depression),
• selective serotonin reuptake inhibitors (SSRIs) (antidepressants),
• methotrexate in high doses (over 20 mg per week) (an immunosuppressive drug).

Warnings and precautions

Before taking Nasivin Sinus and Cold, you should talk to your doctor or pharmacist:

• if you have asthma or an allergic disease; there is a risk of an asthma attack,
• if you have bleeding disorders,
• if you have mild to moderate, well-controlled high blood pressure, heart failure, and heart disease,
• if you have psychosis,
• if you have a history of gastrointestinal disorders (see "When NOT to take Nasivin Sinus and Cold"),
• if you have mild or moderate kidney or liver function disorders,
• if you are taking anti-migraine medications,
• if you have an infection - see below, the section entitled "Infections".

Taking anti-inflammatory and/or pain medications, such as Nasivin Sinus and Cold, may be associated with a small increased risk of heart attack or stroke, especially with high doses and long-term treatment. Any risk increases with higher doses and longer treatment. Do not exceed the recommended dose and duration of treatment.
You should stop taking Nasivin Sinus and Cold if you experience high blood pressure, rapid or irregular heartbeat, nausea, or any neurological symptoms, such as headache or worsening of headache.
After taking 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 can be associated with reduced blood flow to the brain. If symptoms occur that may be symptoms of PRES or RCVS, you should stop taking Nasivin Sinus and Cold immediately and seek medical help immediately (symptoms, see section 4 "Possible side effects").
Ibuprofen has been associated with allergic reactions to this drug, including respiratory disorders, facial swelling, and angioedema.
If you experience these symptoms, you should stop taking Nasivin Sinus and Cold immediately and see a doctor or go to the emergency room.
During treatment with Nasivin Sinus and Cold, a decrease in blood flow to the optic nerve may occur. If you experience sudden vision loss, you should stop taking Nasivin Sinus and Cold and seek medical help immediately. See section 4.
During treatment with Nasivin Sinus and Cold, sudden abdominal pain or rectal bleeding due to inflammatory bowel disease (ischemic colitis) may occur. If such gastrointestinal symptoms occur, you should stop taking Nasivin Sinus and Cold and seek medical help immediately. See section 4.

Infections

Nasivin Sinus and Cold may mask symptoms of infection, such as fever and pain. Therefore, Nasivin Sinus and Cold may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should consult your doctor immediately.
Before taking Nasivin Sinus and Cold, you should discuss treatment with your doctor or pharmacist if:

• you have heart disease, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass grafting (bypass), peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA") (see "When NOT to take Nasivin Sinus and Cold").
• you have high blood pressure, diabetes, or high cholesterol, heart disease, or stroke in your family history, or you are a smoker (see "When NOT to take Nasivin Sinus and Cold").

During treatment, you should avoid consuming alcohol.
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), and anaphylaxis. Serious skin reactions have been reported, 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) in association with Nasivin Sinus and Cold treatment. You should stop taking Nasivin Sinus and Cold and seek medical help immediately if you experience any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a serious skin reaction. See section 4.
There is a risk of renal impairment in adolescents who are dehydrated.
If symptoms persist or worsen, you should consult your doctor.

Children and adolescents

Nasivin Sinus and Cold should not be used in children and adolescents under 15 years of age.

Nasivin Sinus and Cold and other medicines

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

Do NOT take Nasivin Sinus and Cold with:

• aspirin,
• other nonsteroidal anti-inflammatory drugs (NSAIDs),
• other pain or antipyretic medications,
• monoamine oxidase inhibitors (MAOIs used to treat Parkinson's disease or depression) taken in the last 14 days,
• other decongestant medications used to relieve nasal congestion (e.g., phenylpropanolamine, phenylephrine, and ephedrine, methylphenidate, taken orally or nasally),
• blood thinners such as anticoagulants and antiplatelet agents (e.g., aspirin (acetylsalicylic acid), warfarin, ticlopidine),
• medicines that may increase the risk of stomach ulcers or bleeding, such as steroids, antidepressants (e.g., fluoxetine, paroxetine), or NSAIDs, including aspirin
• lithium,
• methotrexate in high doses (over 20 mg per week).

Other medicines may affect the action of Nasivin Sinus and Cold, or Nasivin Sinus and Cold may affect the action of other medicines. For example:

• blood thinners (such as anticoagulants and antiplatelet agents, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan, guanethidine, reserpine, and methyldopa),
• medicines that may increase the risk of stomach ulcers or bleeding, such as steroids, antidepressants (e.g., fluoxetine, paroxetine), or NSAIDs, including aspirin and selective cyclooxygenase (COX)-2 inhibitors,
• medicines for irregular heartbeat, angina, heart failure, or fluid retention (e.g., digitalis glycosides, quinidine), as Nasivin Sinus and Cold may reduce their effect or increase the risk of irregular heartbeat, high blood pressure, or impaired kidney function,
• cyclosporine (an immunosuppressive drug) due to the possible increased risk of kidney impairment,
• medicines used to treat depression (lithium, tricyclic antidepressants) may increase the risk of side effects,
• concomitant use of phenytoin (an antiepileptic drug) may result in increased serum levels of these drugs. Monitoring of phenytoin serum levels is not routinely required for proper use of the medicine (up to 5 days),
• other decongestant or appetite-suppressing medications, as they may increase the risk of side effects,
• reversible monoamine oxidase A inhibitors (RIMAs, used to treat depression), linezolid (an antibiotic), and ergot alkaloids (used to treat Parkinson's disease) may increase the risk of high blood pressure,
• probenecid or sulfinpyrazone may delay the excretion of ibuprofen,
• sulfonylurea derivatives (antidiabetic medications): although interactions with ibuprofen have not been reported, it is recommended to check blood sugar levels as a precaution when using them together,
• diuretics (medicines that increase urine production),
• methotrexate in high doses (over 20 mg per week), as it may increase the effect of methotrexate,
• quinolone antibiotics due to increased risk of seizures,
• takrolimus, trimetoprim, corticosteroids,
• anti-migraine medications,
• zydovudine (used to treat HIV infection), terpene derivatives, clobutinol, atropine-like substances, and local anesthetics that may increase the risk of seizures,
• heparin injections or (and) products containing Ginkgo biloba, due to increased risk of bleeding.

Some other medicines may also affect the action of Nasivin Sinus and Cold, and Nasivin Sinus and Cold may affect the action of other medicines. Therefore, you should always consult your doctor or pharmacist before taking Nasivin Sinus and Cold with other medicines, including those available without a prescription.
In the perioperative period, a severe hypertensive reaction may occur due to the use of pseudoephedrine. Therefore, you should stop taking Nasivin Sinus and Cold a few days before scheduled surgery and inform the anesthesiologist.

Nasivin Sinus and Cold with food and drink

Tablets should be swallowed with water, preferably after a meal.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Nasivin Sinus and Cold should not be used during pregnancy.
The active substances, ibuprofen and pseudoephedrine, may cause serious disorders in the unborn child.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause kidney and heart disorders in the unborn child. They may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor.
From the 20th week of pregnancy, nonsteroidal anti-inflammatory drugs (NSAIDs) may result in kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart.

Breastfeeding

The active substances, ibuprofen and pseudoephedrine, have been present in breastfed infants of mothers taking them.
Therefore, Nasivin Sinus and Cold should not be used during breastfeeding.

Fertility

Nasivin Sinus and Cold contains ibuprofen, which belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

No effect of Nasivin Sinus and Cold on the ability to drive and use machines has been observed. However, you should take into account the possibility of dizziness or drowsiness.

What Nasivin Sinus and Cold contains

• Sodium - this medicine contains 1.65 mg of sodium per tablet. This should be taken into consideration in patients on a controlled sodium diet.

The use of pseudoephedrine may result in positive doping test results.

3. How to take Nasivin Sinus and Cold

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should talk to your doctor or pharmacist.
Nasivin Sinus and Cold is intended for oral use only.

Recommended dose:

Adults and adolescents over 15 years: 1 tablet every 4-6 hours, as needed. In case of more severe symptoms, 2 tablets every 6-8 hours, as needed.
Do not exceed the maximum daily dose of 6 tablets.
Tablets should be swallowed with water, preferably after a meal. Tablets should not be broken or crushed.
Nasivin Sinus and Cold should only be used if you have a blocked nose or headache and (or) fever. If you only have one of these symptoms (blocked nose or headache and (or) fever), you should consult your doctor or pharmacist for an alternative treatment method.
In patients over 60 years of age, treatment should be started with the lowest possible dose due to the increased risk of gastrointestinal bleeding, ulceration, or perforation. Your doctor may recommend taking protective gastrointestinal medications with Nasivin Sinus and Cold if you belong to this age group.
You should consult your doctor if you have mild or moderate chronic kidney or liver disease, as dose adjustment may be necessary.
You should use the smallest effective dose for the shortest duration necessary to relieve symptoms.
If the symptoms of the infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2).

Use in children and adolescents

Do not use in children and adolescents under 15 years of age.

Duration of treatment

The medicine is intended for short-term use. You should use the smallest effective dose for the shortest duration necessary to relieve symptoms.
Do not exceed 5 days of treatment in adults.
Do not exceed 3 days of treatment in adolescents (15-18 years).
If symptoms persist or worsen, you should consult your doctor.

Overdose of Nasivin Sinus and Cold

In case of overdose of ibuprofen or pseudoephedrine, or accidental ingestion by a child, you should always consult your doctor or go to the nearest hospital for information on the risk and actions to be taken.
Symptoms of overdose may include nausea, abdominal pain, vomiting (including vomiting with visible blood streaks), headache, ringing in the ears, uncoordinated and involuntary eye movements.
After taking high doses, drowsiness, chest pain, rapid heartbeat, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.

Missed dose of Nasivin Sinus and Cold

You should not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, you should talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nasivin Sinus and Cold can cause side effects, although not everybody gets them.

You should STOP taking this medicine and seek medical help IMMEDIATELY:

• if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• changes in vision.
• in case of the following symptoms, which may indicate severe allergic reactions:
• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe itching of the skin with hives
• severe skin reactions, including blisters under the skin
• rapid heartbeat with low blood pressure
• in case of symptoms of gastrointestinal bleeding:
• bright red stools, feeling weak, black tarry stools, abdominal pain that does not go away, vomiting blood or dark particles that look like coffee grounds

Other side effects:

Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, difficulty sleeping, restlessness, irritability, or fatigue
• vision disorders
• dry mouth, thirst
• gastrointestinal discomfort, nausea, vomiting, diarrhea, loss of appetite, indigestion (heartburn)

Rare (may affect up to 1 in 1,000 people):

• ringing in the ears (tinnitus)
• nervousness, tremors, anxiety, restlessness, insomnia
• worsening of asthma, wheezing
• allergic reaction with bronchospasm (shortness of breath)
• abdominal pain, bloating, constipation
• edema, high blood pressure, rapid heartbeat, heart failure, irregular heartbeat, rapid pulse, chest pain, heart attack
• kidney damage, increased creatinine levels in the blood
• rash, hives, itching, redness, excessive sweating

Very rare (may affect up to 1 in 10,000 people):

• peptic ulcer disease (stomach/duodenal ulcer), sometimes with bleeding or perforation (blood in vomit or stool), gastritis, mouth ulcers, worsening of ulcerative colitis and Crohn's disease
• liver disorders, particularly with long-term treatment, liver failure, acute hepatitis
• infectious inflammatory conditions, symptoms of aseptic meningitis (headache, fever, stiff neck, nausea, vomiting, or disorientation), especially in patients with existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease), blood disorders (anemia, leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding or bruising
• severe allergic reactions (symptoms may include facial swelling, angioedema, wheezing, bronchospasm, rapid heartbeat, low blood pressure, anaphylactic shock)
• psychotic reactions, depression
• kidney failure or other kidney function disorders, increased creatinine levels in the blood
• esophagitis (heartburn), pancreatitis, intestinal stricture
• red scaly rash with thickening of the skin and blisters, usually on the trunk, often with fever at the start of treatment. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• hair loss, severe skin infections, complications related to soft tissues in chickenpox

Frequency not known (frequency cannot be estimated from the available data)

• serious conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
• decreased blood flow to the optic nerve, which can cause vision loss or problems with vision (ischemic optic neuropathy)
• dilated pupils
• increased blood sugar levels
• drug reaction with eosinophilia and systemic symptoms (DRESS): a severe skin reaction can occur, known as DRESS. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell). If such symptoms occur, you should stop taking this medicine and seek medical help immediately.
• ischemic colitis (inflammation of the colon due to reduced blood flow)
• stroke
• gastrointestinal disorders that can cause sudden abdominal pain or rectal bleeding
• seizures
• difficulty urinating in men with prostate enlargement
• hallucinations, abnormal behavior
• skin becomes sensitive to light (photosensitivity reactions)
• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome

Medicines like Nasivin Sinus and Cold may be associated with a small increased risk of heart attack or stroke.

Reporting side effects

If you experience any side effects, including those 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, 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can be reported to the marketing authorization holder.

5. How to store Nasivin Sinus and Cold

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

This medicine does not require special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP" or "Expiry date (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 pack and other information

What Nasivin Sinus and Cold contains

• Active substancesare ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to 24.6 mg of pseudoephedrine).
• Other ingredients are:microcrystalline cellulose, maize starch, povidone K-30, colloidal anhydrous silica, stearic acid 95, sodium croscarmellose, sodium lauryl sulfate; Opadry Yellow: hypromellose, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), polysorbate 80, red iron oxide (E 172), black iron oxide (E 172); Opadry fx Silver: polyvinyl alcohol, partially hydrolyzed, talc (E 553b), macrogol 3350, MICA-Based Pearlescent Pigment containing: potassium aluminum silicate (E 555), titanium dioxide (E 171); polysorbate 80.

(For further information on sodium, see the end of section 2).

What Nasivin Sinus and Cold looks like and contents of the pack

Nasivin Sinus and Cold is a yellow, oval, biconvex tablet (approximately 15.6 mm x 7.7 mm).
Tablets are available in blisters of 12, 20, and 24 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

P&G Health Germany GmbH
Sulzbacher Str.40
65824 Schwalbach am Taunus
Germany
To obtain more detailed information on 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:

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow
P&G Health Austria GmbH & Co. OG,
Hösslgasse 20,
9800 Spittal an der Drau,
Austria

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

Italy:
Vicks Flu Action 200 mg/30mg film-coated tablets
Austria:
WICK DayMed Duo 200mg/30mg film-coated tablets
Germany:
WICK DuoGrippal 200 mg/30 mg film-coated tablets
Spain: ilviSinus 200mg/30mg film-coated tablets
Hungary:
Ibuprofen/Pseudoephedrine Wick 200 mg/30 mg film-coated tablets
Poland
Nasivin Sinus and Cold
Romania:
Ibuprofen/Pseudoephedrine Wick 200 mg/30 mg film-coated tablets

Date of last revision of the leaflet: 11/2024