Naxii

Package Leaflet: Information for the Patient

Naxii, 220 mg, Coated Tablets

Naproxen Sodium

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Naxii and what is it used for

Naxii contains the active substance naproxen sodium, which belongs to a group of non-steroidal anti-inflammatory drugs with analgesic, anti-inflammatory, and antipyretic effects.
Indications for useinclude treatment of moderate and mild pain, including:

• joint pain
• back pain
• muscle pain
• toothache
• headache
• menstrual cramps
• mild pain associated with colds and reduction of fever.

2. Important information before taking Naxii

When not to take Naxii:

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have had asthma, hives, or an allergic reaction after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• If you have had gastrointestinal bleeding or perforation after taking non-steroidal anti-inflammatory drugs.

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• If you have active or recently active peptic ulcer or gastrointestinal bleeding.
• If you have hemophilia.
• If you have severe heart failure, severe liver failure, and/or severe kidney failure.
• If you have had multiple episodes of gastrointestinal ulcers or bleeding.
• In the third trimester of pregnancy.

Warnings and precautions

Before taking Naxii, discuss it with your doctor or pharmacist.
Be cautious when taking Naxii:

• in elderly patients, as they are more likely to experience side effects, especially if they have had gastrointestinal bleeding or perforation in the past,
• in patients with gastrointestinal diseases, such as ulcerative colitis or Crohn's disease, as it may worsen symptoms,
• if you are taking medications that may increase the risk of ulcers or bleeding, such as corticosteroids, anticoagulants (e.g., warfarin), or certain antidepressants (selective serotonin reuptake inhibitors),
• if you experience skin rash, mucosal lesions, or other symptoms of hypersensitivity after taking Naxii, discontinue use,
• if you have angioedema, asthma, rhinitis, or other allergic diseases, as there is a risk of hypersensitivity reactions,
• if you have bleeding disorders,
• if you are taking steroid medications,
• if you are taking diuretics,
• if you are taking other pain medications,
• if you have severe kidney, liver, or heart dysfunction.

Naxii, like other non-steroidal anti-inflammatory drugs, may adversely affect fertility in women.
This effect is reversible and disappears after treatment is stopped.
Naxii, like other non-steroidal anti-inflammatory drugs with anti-inflammatory and antipyretic effects, may mask symptoms of other diseases, making diagnosis more difficult.
Concomitant use of naproxen sodium with other non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Patients who have experienced gastrointestinal side effects in the past, especially the elderly, should report any concerning abdominal symptoms (including gastrointestinal bleeding) to their doctor.
Taking medications like Naxii may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses.
Do not exceed the recommended dose and duration of treatment (up to 10 days).
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In case of heart problems, previous stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), discuss treatment with your doctor or pharmacist.
Severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of Naxii. Discontinue use and seek medical attention immediately if any symptoms of these severe skin reactions occur, as described in section 4.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age.

Naxii and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Be cautious when taking Naxii with:

• cyclosporin, as it may increase the risk of kidney damage,
• lithium, as it may cause nausea, increased thirst, polyuria, tremors, and disorientation,
• methotrexate at a dose of 15 mg/week or higher, as it may increase the risk of toxic effects,
• other non-steroidal anti-inflammatory drugs or corticosteroids, as it may increase the risk of gastrointestinal ulcers and bleeding,
• anticoagulants (e.g., warfarin), as it may increase the risk of bleeding,
• antiplatelet agents and certain antidepressants (selective serotonin reuptake inhibitors), as it may increase the risk of gastrointestinal bleeding,
• diuretics and blood pressure-lowering medications (including ACE inhibitors), as it may reduce their effectiveness,
• acetylsalicylic acid used for blood clot prevention.

Effect on laboratory tests:
Naproxen sodium has been shown to affect the measurement of 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5-HIAA) in urine.
Tell your doctor about all medications you have taken recently, including those available without a prescription.

Naxii with food and drink

Food may slightly delay the absorption of the active substance.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Naxii if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Naxii may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first 6 months of pregnancy, do not take Naxii unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Naxii, if taken for more than a few days, may cause kidney problems in the unborn baby (which may lead to low amniotic fluid levels) or narrowing of the ductus arteriosus in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
Avoid taking Naxii while breastfeeding, as naproxen passes into human milk.
Fertility effects – see "Warnings and precautions" section.

Driving and using machines

While taking Naxii, side effects such as drowsiness, dizziness, insomnia may occur, which may affect your ability to drive or operate machinery.
Therefore, patients taking Naxii should observe their reactions before driving or operating machinery.

Naxii contains lactose and sodium

Lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 tablet), which means it is essentially "sodium-free".

3. How to take Naxii

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
Oral use.
Method of administration:
Each dose should be taken with a glass of water – the medicine can be taken with or without food. Food may slightly delay the absorption of the medicine.
Dosage for adults and adolescents over 16 years:

• Take 1 tablet (220 mg) every 8 to 12 hours as needed for pain relief.
• For some patients, an initial dose of 2 tablets (440 mg) followed by 1 tablet (220 mg) after 12 hours may provide greater pain relief.
• Do not exceed the daily dose of 660 mg (3 tablets), unless your doctor decides otherwise.
• Do not take Naxii for more than 10 days for pain or more than 3 days for fever, unless under medical supervision. If symptoms persist or worsen, consult your doctor.

Use in children and adolescents under 16 years:

• Do not give to children and adolescents under 16 years, unless your doctor decides otherwise.

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Overdose of Naxii

Significant overdose is characterized by dizziness, drowsiness, abdominal pain, discomfort in the abdominal cavity, heartburn, nausea, vomiting, transient liver function disorders, increased risk of bleeding, kidney function disorders, metabolic acidosis, respiratory failure, or disorientation. In a few patients, seizures have occurred, but it is not known if this is related to naproxen use. There have also been reports of acute, reversible renal failure.

Missed dose of Naxii

Do not take a double dose to make up for a missed dose.

Stopping Naxii treatment

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Naxii can cause side effects, although not everybody gets them.
Side effects can be minimized by using the smallest effective dose for the shortest duration necessary for symptom relief.
Non-steroidal anti-inflammatory drugs have been associated with edema, hypertension, and heart failure.
Taking medications like Naxii may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If you experience any of the following side effects, stop taking Naxii and contact your doctor immediately:

• widespread rash, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2. (frequency not known)
• characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same location(s) upon re-administration of the drug and may take the form of round or oval red patches and skin swelling, blisters (hives), itching (frequency not known)

Common side effects:(may affect up to 1 in 10 people)

• dizziness, headache, feeling of emptiness in the head,
• nausea, vomiting, heartburn, abdominal pain.

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

• lethargy, insomnia, drowsiness,
• dizziness,
• diarrhea, constipation, vomiting,
• rash, itching, hives.

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

• gastrointestinal ulcers (sometimes with bleeding or perforation), gastrointestinal bleeding, bloody vomiting, black stools,
• angioedema,

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• kidney function disorders,
• swelling of hands and feet, especially in patients with hypertension or kidney failure, fever (including chills and febrile illnesses).

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

• hypersensitivity reactions, including anaphylactic shock leading to death,
• blood disorders: leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia,
• psychiatric disorders: depression, sleep disorders, inability to concentrate,
• aseptic meningitis, cognitive function disorders, seizures,
• vision disorders, corneal clouding, optic neuritis, papillitis, optic disc swelling,
• hearing impairment, tinnitus, hearing disorders,
• congestive heart failure, hypertension, pulmonary edema, palpitations,
• vasculitis,
• dyspnea, asthma, eosinophilic pneumonia,
• pancreatitis, colitis, aphthous stomatitis, oral mucositis, esophagitis, gastrointestinal ulcers,
• hepatitis (including fatal cases), jaundice,
• alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme, blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema nodosum, lupus erythematosus, hypersensitivity reactions to light, including porphyria cutanea tarda or pseudoporphyria, blistering skin separation, purpura, petechiae, excessive sweating,
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure, hematuria, nephrogenic diabetes insipidus,
• induction of labor,
• closure of the ductus arteriosus in the fetus,
• in women: fertility disorders,
• edema, increased thirst, malaise,
• increased creatinine levels, abnormal liver function tests, hyperkalemia.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C,
02-222 Warsaw, tel.: +48 (22) 492 13 01, fax: +48 (22) 492 13 09, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. How to store Naxii

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
The packaging is labeled with: EXP – expiry date, Lot – batch number.
Medicines should 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 package and other information

What Naxii contains

• The active substance is naproxen sodium.
• The other ingredients are: core: talc, povidone, lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide; coating: Opadry Light Blue YS-2-10657 (hydroxypropyl methylcellulose, propylene glycol, titanium dioxide (E 171), and aluminum lake of indigo carmine).

What Naxii looks like and contents of the pack

Oblong, coated tablet, biconvex, blue.
Available packs:2, 10, 20, or 30 coated tablets.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40,
50-507 Wrocław

• For more information, contact:
  USP Zdrowie Sp. z o.o.
  Poleczki 35,
  02-822 Warsaw, tel. +48 (22) 543 60 00

Date of last revision of the package leaflet:

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