Patient Information Leaflet

WARNING: Keep this leaflet, information on the immediate packaging is 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 the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
a doctor 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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 10 days of treatment for pain or 3 days for fever, or if you feel worse, consult your doctor.

Table of 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 non-steroidal anti-inflammatory drugs (NSAIDs) which, by reversibly inhibiting prostaglandin synthesis, exert analgesic, antipyretic and anti-inflammatory effects. Aleve reduces pain intensity, 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 colds.

Reduction of fever.

2. Important information before using Aleve

When not to use Aleve

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
if asthma, urticaria or allergic-type reactions occurred after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
if gastrointestinal bleeding or perforation occurred after taking 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 gastrointestinal ulceration or bleeding,
during the third trimester of pregnancy.

Warnings and precautions
Before starting to use Aleve, discuss this with your doctor or pharmacist.

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 medications 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 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 changes or other hypersensitivity symptoms appear, the medicine should be discontinued,
if the patient has a history of angioedema, bronchial asthma, nasal mucosa inflammation, nasal polyps, allergic diseases or chronic respiratory disorders, due to the possibility of hypersensitivity reactions,
if Aleve is used in patients with blood clotting disorders,
in patients taking steroid medications,
in patients taking diuretics,
in patients taking other painkillers,
if Aleve is used in patients with severe kidney, liver or heart 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) which may adversely affect 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.
Taking medicines 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 (up to 10 days).
If you have heart problems, have had a stroke, or suspect you may be at risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss treatment options with your doctor or pharmacist.
Avoid concomitant use of naproxen sodium with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
One tablet contains 20 mg of sodium, equivalent to the salt content in one slice of bread.
The amount of sodium in a low-sodium diet is limited to ≤1.2 g (50 mmol) per day.
Aleve and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Inform your doctor or pharmacist if you are taking any of the following medicines:

cyclosporine, as the risk of kidney damage may increase,
lithium, as nausea, increased thirst, polyuria, tremor, and disorientation may occur,
methotrexate at doses of 15 mg/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,
acetylsalicylic acid used to prevent 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 medicines (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 measurement of 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5-HIAA) in urine.
Inform your doctor about all medicines 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, you should consult your doctor or pharmacist before using this medicine.
Aleve should not be used during pregnancy except in cases recommended and supervised by a doctor, as, like other drugs of this type, Aleve affects the cardiovascular system of the human fetus. The use of Aleve during pregnancy requires careful consideration of potential benefits and risks to both mother and fetus, especially during the first and second trimesters of pregnancy.
Avoid using Aleve in breastfeeding women, as naproxen passes into breast milk.
Naproxen may impair fertility. This effect is reversible and resolves after discontinuation of naproxen.
Driving and operating machinery
During treatment with Aleve, adverse effects such as drowsiness, dizziness, and 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.

3. How to use Aleve

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Method of administration
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.
Recommended dose
Use in adults
Single dose: 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 are more susceptible to adverse effects; therefore, lower doses should be considered in this population.
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 any change in symptoms occurs, consult a doctor.
Use in children
Aleve should not be used in children under 16 years of age, unless otherwise advised by a doctor.
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 dysfunction, metabolic acidosis, respiratory depression, or disorientation. Seizures have been reported in a few patients, although it is unclear whether this was related to naproxen administration. Several cases of acute, reversible renal failure have also been reported.
In case of ingestion of a large amount of sodium naproxen, gastric lavage and standard supportive measures such as administration of activated charcoal may be considered. 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 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 minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
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
indigestion, 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 of the gastrointestinal tract), gastrointestinal bleeding, haematemesis (vomiting blood), melaena (black tarry stools)
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 granulocytes (agranulocytosis), anaemia (aplastic anaemia), increased number of 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, auditory 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, mucositis, oesophagitis, intestinal ulcers, hepatitis (including
alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme exudativum, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, nodular erythema, persistent erythema, 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, kidney diseases, renal haematuria, proteinuria,
closure of the fetal ductus arteriosus,
in women: fertility disorders,
oedema, increased thirst, malaise,
increased creatinine concentration, abnormal liver function test results, increased blood potassium concentration (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 for Monitoring Adverse Drug Reactions of the 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aleve

Keep this medicine out of 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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: povidone K 30, microcrystalline cellulose, talc, magnesium stearate.
Film-coating composition: Opadry Blue YS-1-4215: titanium dioxide, hypromellose, polyethylene glycol 8000, indigo carmine (E 132).

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

Marketing authorisation 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:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical and Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów

Marketing authorisation numbers in France, the country of export:
274 544-8
34009 274 544 8 6
274 286-9
34009 274 286 9 2

Parallel import authorisation number: 382/17