Package leaflet: Information for the user

Warning! Keep this leaflet. The 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 this leaflet carefully 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
a doctor or pharmacist.

Keep this leaflet so that 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 10 days of treatment for pain or 3 days for fever, or if your condition worsens, consult a doctor.

Table of contents

What Aleve is and what it is used for
What you need to know 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 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 asthma, urticaria, or allergic-type reactions occurred 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 gastrointestinal ulcers or bleeding from ulcers,
during the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Aleve, discuss it 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 possibility of reduced protective effect of acetylsalicylic acid,
if skin rash, mucosal lesions, or other signs of hypersensitivity appear after taking Aleve, especially at the beginning of treatment, discontinue the drug,
if the patient has a history of angioedema, bronchial asthma, nasal mucosal inflammation, nasal polyps, allergic conditions, or chronic respiratory diseases, due to the risk of hypersensitivity reactions,
if the drug is used in patients with blood clotting disorders,
in patients taking steroid medications,
in patients taking diuretics,
in patients taking other painkillers,
if the drug is used in patients with severe renal, hepatic, or cardiac impairment.

Patients who 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.
Like other NSAIDs, Aleve, 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 (no longer than 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 the treatment approach 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
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 it may increase the risk of kidney damage,
lithium, as nausea, excessive thirst, polyuria, tremor, and disorientation may occur,
methotrexate at a dose 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 to prevent blood clots,
anticoagulants such as warfarin, as the risk of bleeding may increase,
antiplatelet drugs 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-ketosteroids and 5-hydroxyindoleacetic acid (5-HIAA) in urine.
Tell 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 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 the mother and the child and may delay or prolong labor.
Do not use Aleve during the first six months of pregnancy 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 week 20 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 surrounding the baby (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 reversible and resolves after discontinuation of naproxen.

Driving and operating machinery
During treatment with 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 of sodium 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 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 may be taken regardless of meals. Food may slightly delay the 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 daily dose must not exceed 660 mg unless otherwise decided by a doctor.
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 symptoms change, consult a doctor.
Use in children
Aleve must not be used in children under 16 years of age, unless otherwise directed 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 function disorders, 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 kidney failure have also been reported.
In case of ingestion of a large amount of sodium naproxen, gastric lavage may be performed and standard supportive measures applied, 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.
Stopping Aleve
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, 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.
The use of medicines in the group of non-steroidal anti-inflammatory drugs 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):

somnolence, insomnia, drowsiness,
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, 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,
haematopoietic system 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, hearing disturbances,
congestive heart failure, hypertension, pulmonary oedema, palpitations,
vasculitis,
dyspnoea, bronchial asthma, eosinophilic pneumonia,
pancreatitis, inflammation of the gastrointestinal tract (colitis), aphthae, stomatitis, 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 nodosum, lichen planus, acneiform eruptions, skin rashes, systemic lupus erythematosus, photosensitivity reactions including late cutaneous porphyria (pseudoporphyria) or bullous epidermal detachment, petechiae, purpura, hyperhidrosis,
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 levels, abnormal liver function test results, increased blood potassium levels (hyperkalaemia).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, more information on the safety of the medicine can be collected.

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 stated month.
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 package and other information

What Aleve contains
The active substance is naproxen sodium. Each coated tablet contains 220 mg of naproxen sodium.
Other ingredients: povidone K 30, microcrystalline cellulose, talc, magnesium stearate;
Coating composition: Opadry Blue YS-1-4215: titanium dioxide, hypromellose, polyethylene glycol 8000, indigotine (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 authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, country of export:
Bayer Healthcare SAS
1, rue Claude Bernard
59000 Lille
France

Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chaussee 1
06803 Greppin
Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Number of marketing authorisation in France, country of export: 274 286-9
Parallel import authorisation number: 376/17