Naxii

Package leaflet: Information for the patient

Naxii, 220 mg, coated tablets
Naproxenum natricum
Please read the following 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, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 10 days, or if the patient feels worse, consult a doctor.

Table of contents

1. What Naxii is and what it is 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 pack and other information

1. What Naxii is and what it is used for

Naxii contains the active substance naproxen sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, anti-inflammatory and antipyretic properties.
Naxii is indicated for the treatment of mild to moderate pain of various origins, including:

• joint pain
• back pain
• muscle pain
• toothache
• headache
• painful menstruation
• mild pain associated with colds and fever reduction.

2. Important information before using Naxii

When not to use Naxii:

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If bronchial asthma, urticaria, or an allergic-type reaction occurred after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the past.
• If gastrointestinal bleeding or perforation of the gastrointestinal tract occurred after using nonsteroidal anti-inflammatory drugs.

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• If the patient has active or recently healed peptic ulcer disease of the stomach or duodenum.
• If the patient has a bleeding tendency (haemorrhagic diathesis).
• If the patient has severe heart failure, severe liver failure, and/or severe kidney failure.
• If gastrointestinal ulceration or bleeding from ulcers has been diagnosed repeatedly in the patient's history.
• During the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Naxii, discuss it with your doctor or pharmacist.
When should special caution be exercised when using Naxii:

• In elderly patients, as adverse effects occur more frequently, especially if gastrointestinal bleeding or perforation due to ulceration occurred previously,
• In patients with gastrointestinal disorders such as ulcerative colitis or Crohn's disease, as symptoms may worsen,
• If the patient is taking medicines that may increase the risk of ulcers or bleeding, for example corticosteroids, anticoagulants such as warfarin, certain antidepressants (selective serotonin reuptake inhibitors), or acetylsalicylic acid,
• If, after taking Naxii, especially at the beginning of treatment, skin rash, mucosal changes, or other signs of hypersensitivity appear, discontinue use of the medicine,
• In patients with a history of angioedema, bronchial asthma, rhinitis, nasal polyps, allergic conditions, or chronic respiratory diseases, due to the risk of hypersensitivity reactions,
• If the medicine is used in patients with blood clotting disorders,
• In patients taking steroid medicines,
• In patients taking diuretics,
• In patients taking other painkillers,
• If the medicine is used in patients with severe kidney, liver, or heart dysfunction.

This medicine belongs to a group of medicines (NSAIDs) which may adversely affect fertility in women.
This effect is reversible and disappears after stopping treatment.
Like other NSAIDs, Naxii, due to its anti-inflammatory and antipyretic effects, may mask symptoms of another illness, making diagnosis more difficult.
Avoid concomitant use of naproxen sodium with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Patients who previously experienced gastrointestinal adverse effects, particularly if elderly, should report any concerning abdominal symptoms (including gastrointestinal bleeding) to their doctor.
Taking medicines such as 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 use higher doses or longer treatment duration than recommended (maximum 10 days).
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If you have heart problems, a history of stroke, or suspect you may be at risk of such conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment approach with your doctor or pharmacist.
Serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of Naxii. Discontinue use of Naxii and seek immediate medical advice if any of the symptoms associated with these serious skin reactions, described in section 4, occur.

Children and adolescents
This medicine should not be given to children and adolescents under 16 years of age.

Naxii with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
Exercise caution if Naxii is used concomitantly with:

• Cyclosporine, as it may increase the risk of kidney damage,
• Lithium, as nausea, excessive thirst, polyuria, tremor, and disorientation may occur,
• Methotrexate at doses of 15 mg per week or higher, as the risk of toxic effects of this substance may increase,
• Other nonsteroidal anti-inflammatory drugs or corticosteroids, as the risk of gastrointestinal ulcers and bleeding increases,
• Anticoagulants (e.g. warfarin), as the risk of bleeding may increase,
• Antiplatelet agents and certain antidepressants (selective serotonin reuptake inhibitors), as the risk of gastrointestinal bleeding increases,
• Diuretics and antihypertensive medicines (including angiotensin-converting enzyme inhibitors), as their effectiveness may decrease,
• Acetylsalicylic acid used for prevention of blood clots.

Effect on laboratory test results:
It has been shown that sodium naproxen affects the measurement of 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5-HIAA) in urine.
Inform your doctor about all medicines taken recently, including those available without prescription.

Naxii with food and drink
Food may slightly delay the absorption of the active substance.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take Naxii if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Naxii may cause kidney and heart problems in the unborn child. It may also increase the tendency to bleeding in both mother and child and may delay or prolong labour. Do not use Naxii during the first 6 months of pregnancy unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, prolonged use of Naxii (beyond a few days) may lead to kidney dysfunction in the unborn child (which may result in low levels of amniotic fluid surrounding the baby (oligohydramnios)) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment beyond a few days is required, your doctor may recommend additional monitoring.

Avoid using Naxii in breastfeeding women, as naproxen passes into human milk.

Effect on fertility – see section "Warnings and precautions".

Driving and using machines
When using Naxii, adverse effects such as drowsiness, dizziness, and insomnia may occur, which could affect the ability to drive or operate machinery. Therefore, patients taking Naxii should observe their individual response before driving or operating machinery.

Naxii contains lactose and sodium

Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 tablet), meaning the medicine is considered "sodium-free".

3. How to use Naxii

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral use.
Administration method:
Each dose should be taken with a glass of water – the medicine can be taken regardless of
meals. Food may slightly delay the absorption of the medicine.
Dosage for adults and adolescents above 16 years of age:
Single dose: 1 tablet (220 mg) every 8 to 12 hours, as long as symptoms persist.
In some individuals, an initial dose of 2 tablets (440 mg), followed by 1 tablet (220 mg) after 12 hours,
may enhance the analgesic effect.
Do not exceed the daily dose of 660 mg (3 tablets), unless otherwise decided by a doctor.
Naxii must not be used for longer than 10 days for pain or longer than 3 days for fever, unless under
medical supervision. If pain or fever persists, or if there are changes in observed symptoms, consult
your doctor.
Use in children and adolescents under 16 years of age:
Do not use in children and adolescents under 16 years of age, unless otherwise advised by a doctor.
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Taking a higher than recommended dose of Naxii
Significant overdose may cause dizziness, drowsiness, upper abdominal pain, abdominal discomfort,
heartburn, indigestion, nausea and vomiting, transient disturbances in liver function, increased
tendency to bleeding, disturbances in kidney function, metabolic acidosis, respiratory depression, or
disorientation. Seizures have been reported in a few patients, although it is not known whether this
was related to naproxen administration.
Several cases of acute, reversible renal failure have also been reported.
Missing a dose of Naxii
Do not take a double dose to make up for a missed dose.
Stopping treatment with Naxii
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.
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
The use of medicines from the group of non-steroidal anti-inflammatory drugs has been associated with oedema, arterial hypertension, and heart failure.
Taking medicines such as Naxii may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the following adverse effects occur, treatment with Naxii should be discontinued and medical advice should be sought immediately:

• extensive rash, high body temperature, elevated liver enzymes, blood disorders (eosinophilia), lymph node enlargement and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2. (frequency not known)
• characteristic skin allergic reaction called fixed drug eruption, which usually recurs in the same location(s) upon re-exposure to the drug and may present as round or oval red patches and swelling of the skin, blisters (urticaria), itching (frequency not known)

Common adverse effects: (may affect less than 1 in 10 people)

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

Uncommon adverse effects: (may affect less than 1 in 100 people)

• lethargy, insomnia, drowsiness,
• dizziness,
• diarrhoea, constipation, vomiting,
• rash, itching, urticaria.

Rare adverse effects: (may affect less than 1 in 1,000 people)

• gastrointestinal ulcers (sometimes with bleeding or perforation of the gastrointestinal tract), gastrointestinal bleeding, vomiting of blood, tarry stools,
• angioedema,

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• renal function disorders,
• swelling of hands and feet, particularly in patients with hypertension or renal impairment, fever (including chills and febrile illnesses).

Very rare adverse effects: (may affect less than 1 in 10,000 people)

• hypersensitivity reactions, including fatal anaphylactic shock,
• blood disorders: low red blood cell count (leukopenia), thrombocytopenia, deficiency of white blood cells called granulocytes (agranulocytosis), anaemia (aplastic anaemia), elevated levels of white blood cells called eosinophils (eosinophilia), anaemia (haemolytic anaemia),
• psychiatric disorders: depression, sleep disturbances, difficulty concentrating,
• aseptic meningitis, cognitive dysfunction, convulsions,
• visual disturbances, corneal opacity, intraocular optic neuritis, retrobulbar optic neuritis, optic disc oedema,
• hearing impairment, tinnitus, hearing disturbances,
• congestive heart failure, arterial hypertension, pulmonary oedema, palpitations,
• vasculitis,
• dyspnoea, bronchial asthma, eosinophilic pneumonia,
• pancreatitis, inflammation of a segment of the gastrointestinal tract (colon), aphthae, oral mucositis, oesophagitis, intestinal ulcers,
• hepatitis (including fatal cases), jaundice,
• alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme exudativum, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, nodular erythema, erythema chronicum, lichen planus, pustular reactions, skin rashes, systemic lupus erythematosus, photosensitivity reactions, including late cutaneous porphyria (pseudoporphyria) or bullous epidermal detachment, petechiae, purpura, excessive sweating,
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure, haematuria, nephrogenic proteinuria,
• induction of labour,
• closure of the fetal ductus arteriosus,
• in women: fertility disorders,
• oedema, increased thirst, malaise,
• increased creatinine levels, abnormal liver function tests, increased blood potassium levels (hyperkalaemia).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02 - 222 Warsaw
tel.: +48 (22) 492 13 01
fax: +48 (22) 492 13 09
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.
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5. How to store Naxii

Keep this medicine out of sight and reach of children.
Store the medicine at 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 stated month.
Blister labelling: EXP – expiry date, Lot – batch number.
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 Naxii contains

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

What Naxii looks like and contents of the pack
Blue, oblong, film-coated tablet, biconvex on both sides.
Available pack sizes: 2, 10, 20 or 30 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50 - 507 Wrocław
For further information, contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02 - 822 Warszawa
tel. +48 (22) 543 60 00
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