PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Aleve (ALEVETABS)
220 mg, coated tablets
Naproxenum natricum
Aleve and ALEVETABS are different trade names for the same medicine.
Please read this leaflet carefully before taking 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.

Keep this leaflet, so you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 10 days for pain or 3 days for fever, or
if you feel worse, you should contact your doctor.

Leaflet contents

What Aleve is and what it is used for
Important information before taking Aleve
How to take Aleve
Possible side effects
How to store Aleve
Contents of the pack and other information

1. What Aleve is and what it is used for

Aleve belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which exert analgesic, antipyretic and anti-inflammatory effects by reversibly inhibiting prostaglandin synthesis. Aleve reduces the intensity of pain, lowers fever and suppresses inflammatory reactions. Aleve has a rapid and prolonged effect.
Indications
Treatment of mild to moderate pain, such as:

headache,
toothache,
muscle pain,
joint pain,
back pain,
painful menstruation,
mild pain associated with the common cold.
Reduction of fever.

2. Important information before using Aleve

When not to use Aleve

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 allergic-type reactions occurred in the past after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
if gastrointestinal bleeding or perforation of the gastrointestinal tract occurred after using nonsteroidal anti-inflammatory drugs,
if the patient has active peptic ulcer disease,
if the patient has a bleeding disorder,
if the patient has severe heart failure,
if the patient has severe renal or hepatic insufficiency,
if the patient has a history of recurrent peptic ulceration or bleeding,
during the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Aleve, consult your doctor or pharmacist.

in elderly patients, as they are more likely to experience adverse effects, especially if gastrointestinal bleeding or perforation due to peptic ulceration occurred in the past,
in patients with gastrointestinal disorders such as ulcerative colitis or Crohn's disease, as symptoms may worsen,
if the patient is taking medications that may increase the risk of ulcers or bleeding, such as corticosteroids, anticoagulants (e.g. warfarin), certain antidepressants (selective serotonin reuptake inhibitors), or acetylsalicylic acid,
if the patient is taking low-dose acetylsalicylic acid for cardiovascular disease prevention, due to the potential for reduced protective effect of acetylsalicylic acid,
if, after taking Aleve—especially at the beginning of treatment—skin rash, mucosal lesions, or other signs of hypersensitivity occur, discontinue the medication immediately,
if the patient has a history of angioedema, bronchial asthma, rhinitis, nasal polyps, allergic conditions, or chronic respiratory diseases, due to the risk of hypersensitivity reactions,
if Aleve is used in patients with coagulation disorders,
in patients taking steroid medications,
in patients taking diuretics,
in patients taking other analgesic medications,
if Aleve is used in patients with severe renal, hepatic, or cardiac dysfunction.

Patients who have previously experienced gastrointestinal adverse effects, particularly if elderly, should report any concerning abdominal symptoms (including gastrointestinal bleeding) to their doctor.
This medicine belongs to a group of drugs (nonsteroidal anti-inflammatory drugs, NSAIDs) that may temporarily impair fertility in women. This effect is reversible and resolves after discontinuation of therapy.
Aleve, like other NSAIDs, due to its anti-inflammatory and antipyretic effects, may mask symptoms of another illness, making diagnosis more difficult.
Use of medications such as Aleve 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).
If you have heart problems, a history of stroke, or suspect you are at risk for these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss treatment options with your doctor or pharmacist.
Avoid concomitant use of naproxen sodium with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors.

Aleve and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take. Inform your doctor or pharmacist if you are taking any of the following medicines:

cyclosporine, as it may increase the risk of kidney damage,
lithium, as nausea, increased thirst, polyuria, tremor, and disorientation may occur,
methotrexate at doses of 15 mg/week or higher, as it may increase the risk of toxic effects of this substance,
other nonsteroidal anti-inflammatory drugs or corticosteroids, as the risk of gastrointestinal ulcers and bleeding increases,
acetylsalicylic acid used for prevention of blood clots,
anticoagulants such as 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 drugs (including angiotensin-converting enzyme inhibitors), as their effectiveness may be reduced.

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

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not take Aleve if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor. During the first six months of pregnancy, do not use this medicine unless absolutely necessary and prescribed by a doctor. 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, Aleve may cause kidney function disturbances in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.
Do not take this medicine during the third trimester of pregnancy.
Avoid using Aleve in breastfeeding women, as naproxen passes into breast milk.
Naproxen may impair fertility. This effect is temporary and reverses after discontinuation of naproxen.

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

Aleve contains sodium
One tablet contains 20 mg of sodium, equivalent to the salt content in one slice of bread. The recommended daily intake in a low-sodium diet is limited to ≤1.2 g (50 mmol) per day.

3. How to use Aleve

This medicine should always be taken exactly as described in the patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Method of administration
Each dose should be taken with a glass of water – this medicine may be taken regardless of meals. Food may slightly delay absorption of the medicine.
Recommended dose
Use in adults
Single dose of 220 mg every 8 to 12 hours as needed, until symptoms subside. In some individuals, an initial dose of 440 mg followed by 220 mg after 12 hours may enhance analgesic effect.
The maximum daily dose of 660 mg must not be exceeded unless otherwise directed by a physician.
Elderly patients
Elderly individuals may be more susceptible to adverse effects; therefore, lower doses should be considered in these patients.
Aleve must not be used for longer than 10 days for pain or for more 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
Aleve should not be used in children under 16 years of age, unless otherwise directed by a physician.
Overdose of Aleve
Significant overdose may cause dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea and vomiting, transient liver function disturbances, increased tendency to bleeding, kidney function disorders, metabolic acidosis, respiratory depression, or disorientation. Seizures have been reported in a few patients, although it is not known whether these were related to naproxen administration.
There have also been reports of several cases of acute, reversible renal failure.
In case of ingestion of a large amount of sodium naproxen, gastric lavage may be performed and standard supportive measures initiated, such as administration of activated charcoal. There is no specific antidote.
Missed dose of Aleve
Do not take a double dose to make up for a missed dose.
Discontinuation of Aleve
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
The use of non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with oedema, hypertension, and heart failure.
Taking medicines such as Aleve may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Common adverse effects (may occur in 1 in 10 to 1 in 100 patients):

dizziness, headache, feeling of emptiness in the head
dyspepsia, nausea, heartburn, abdominal pain

Uncommon adverse effects (may occur in 1 in 100 to 1 in 1000 patients):

drowsiness, insomnia, somnolence
dizziness
diarrhoea, constipation, vomiting
rash, itching, urticaria

Rare adverse effects (may occur in 1 in 1000 to 1 in 10,000 patients):

gastrointestinal ulcers (sometimes with bleeding or perforation), gastrointestinal bleeding, haematemesis, melaena
angioedema
renal function disorders
oedema of hands and feet, particularly in patients with hypertension or renal insufficiency, fever (including chills and febrile illnesses)

Very rare adverse effects (may occur in less than 1 in 10,000 patients):

hypersensitivity reactions, including fatal anaphylactic shock,
blood disorders: low white blood cell count (leukopenia), thrombocytopenia, deficiency of white blood cells called granulocytes (agranulocytosis), anaemia (aplastic anaemia), increased number 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, 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, chronic erythema, lichen planus, pustular reactions, skin rashes, systemic lupus erythematosus, photosensitivity reactions including cutaneous porphyria (pseudoporphyria) or bullous epidermolysis, petechiae, purpura, hyperhidrosis,
interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal diseases, renal haematuria, proteinuria,
closure of the fetal ductus arteriosus,
in women: fertility disorders,
oedema, increased thirst, malaise,
increased creatinine levels, abnormal liver function test results, 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Aleve

Keep this medicine out of the sight and reach of children. Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Aleve contains
The active substance is naproxen sodium. One coated tablet contains 220 mg of naproxen sodium.
The other ingredients are: microcrystalline cellulose, povidone K 30, talc, magnesium stearate.
Film-coat composition: Opadry Blue YS-1-4215: hypromellose, titanium dioxide, polyethylene glycol 8000, indigo carmine (E 132).

What Aleve looks like and contents of the pack
The pack contains 12 or 24 coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:
Bayer Healthcare SAS
220 Avenue de la Recherche
59120 Loos
France

Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chaussee 1
06803 Greppin
Germany

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorization number in France, the country of export: 34009 274 286 9 2
274 286-9

Parallel import authorization number: 98/19