Aleve

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Aleve(ALEVETABS)

220 mg, coated tablets

Naproxen sodium
Aleve and ALEVETABS are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 10 days for pain or 3 days for fever, there is no improvement or
• the patient feels worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is Aleve and what is it used for

Aleve belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) that, by reversibly inhibiting prostaglandin synthesis, have analgesic, antipyretic, and anti-inflammatory effects. Aleve reduces the severity of pain, lowers fever, and inhibits inflammatory reactions. Aleve has a rapid and long-lasting effect.

Indications for use

Treatment of mild to moderate pain, such as:

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

2. Important information before taking Aleve

When not to take Aleve

• 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 allergic reactions after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• if you have had gastrointestinal bleeding or perforation after taking nonsteroidal anti-inflammatory drugs,
• if you have active peptic ulcer,
• if you have bleeding disorders,
• if you have severe heart failure,
• if you have severe renal or hepatic impairment,
• if you have had recurrent gastrointestinal ulcers or bleeding in the past,
• in the third trimester of pregnancy.

Warnings and precautions

Before starting to take Aleve, you should discuss it with your doctor or pharmacist.

• 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), acetylsalicylic acid,
• if you are taking acetylsalicylic acid in low doses for cardiovascular disease prevention, as it may reduce the protective effect of acetylsalicylic acid,
• if you experience skin rash, mucosal lesions, or other signs of hypersensitivity after taking Aleve, you should stop taking the medicine,
• if you have angioedema, asthma, nasal polyps, or allergic diseases, as it may increase the risk of hypersensitivity reactions,
• if you are taking medications that may affect blood clotting,
• 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 problems.

Patient who have had gastrointestinal side effects in the past, especially if they are elderly, should inform their doctor about any worrying abdominal symptoms (including gastrointestinal bleeding).
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and disappears after the end of therapy.
Aleve, like other NSAIDs, due to its anti-inflammatory and antipyretic effects, may mask the symptoms of another disease, making its diagnosis more difficult.
Taking such medications 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 of the medicine. You should not take higher doses or use the medicine for longer than recommended (up to 10 days).
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), you should discuss the treatment with your doctor or pharmacist.
You should avoid taking naproxen sodium with other NSAIDs, including selective cyclooxygenase-2 inhibitors.

Aleve and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. You should inform your doctor or pharmacist if you are taking any of the following medicines:

• cyclosporin, as it may increase the risk of kidney damage,
• lithium, as it may cause nausea, increased thirst, polyuria, tremors, or confusion,
• 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 it may increase the risk of ulcers and gastrointestinal bleeding,
• acetylsalicylic acid used to prevent blood clots,
• anticoagulant medications, such as warfarin, as it may increase the risk of bleeding,
• antiplatelet medications and certain antidepressants (selective serotonin reuptake inhibitors), as it may increase the risk of gastrointestinal bleeding,
• diuretics and blood pressure-lowering medications (including angiotensin-converting enzyme inhibitors), as it may reduce their effectiveness.

Effect on laboratory tests
It has been found that naproxen sodium affects the measurement of 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5-HIAA) in urine.
You should tell your doctor about all the medicines you have taken recently, including those that are 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 or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should not take Aleve if you are in the last 3 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 risk of bleeding in you and your child and cause prolongation or delay of labor. During the first 6 months of pregnancy, you should not take the medicine unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period or when trying to conceive, you should use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Aleve may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
Do not take this medicine in the last trimester of pregnancy.
You should avoid taking Aleve while breastfeeding, as naproxen passes into breast milk.
Naproxen may affect fertility. This effect is reversible and disappears after the end of therapy.

Driving and using machines

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

Aleve contains sodium

One tablet contains 20 mg of sodium, which corresponds to the sodium 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.

3. How to take Aleve

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should ask your doctor or pharmacist.
Method of administration
Each dose should be taken with a glass of water – the medicine can be taken independently of meals. Food may slightly slow down the absorption of the medicine.
Recommended dose

Use in adults

Single dose: 220 mg, every 8 to 12 hours until symptoms disappear. In some patients, taking an initial dose of 440 mg, followed by 220 mg after 12 hours, may increase the analgesic effect.
You should not exceed the daily dose of 660 mg, unless your doctor decides otherwise.
Elderly patients
Elderly patients are more susceptible to side effects, and their dose should be adjusted accordingly.
Aleve should not be taken for more than 10 days for pain or more than 3 days for fever, unless under medical supervision. If symptoms persist or worsen, you should consult your doctor.

Use in children

Children under 16 years of age should not take Aleve, unless recommended by a doctor.

Taking a higher dose of Aleve than recommended

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, shortness of breath, or disorientation. In a few patients, seizures have occurred, but it is not known whether this symptom was related to the use of naproxen.
There have been a few cases of acute, reversible renal failure.
In case of suspected overdose, you should empty the stomach and take standard supportive measures, such as administering activated charcoal. There is no specific antidote.

Missing a dose of Aleve

You should not take a double dose to make up for a missed dose.

Stopping Aleve

If you have any further doubts about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aleve can cause side effects, although not everybody gets them.
Side effects can be minimized by taking the smallest effective dose for the shortest possible time necessary to relieve symptoms.
Nonsteroidal anti-inflammatory drugs have been associated with edema, hypertension, and heart failure.
Taking medications like Aleve may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
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, vomiting blood, black stools
• angioedema
• kidney function disorders
• edema of hands and feet, especially in patients with hypertension or kidney failure, fever (including chills and febrile diseases)

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

• hypersensitivity reactions, including anaphylactic shock,
• 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,
• hearing impairment, tinnitus, hearing disorders,
• congestive heart failure, hypertension, pulmonary edema, palpitations,
• vasculitis,
• dyspnea, asthma, eosinophilic pneumonia,
• pancreatitis, colitis, aphthous stomatitis, esophagitis, gastrointestinal ulcers,
• hepatitis (including fatal cases), jaundice,
• alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, skin rash, urticaria, lupus erythematosus, photosensitivity reactions, including porphyria cutanea tarda (pseudoporphyria) or blistering skin peeling, purpura, petechiae, excessive sweating,
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, kidney failure, kidney disease, hematuria,
• closure of the arterial duct in the fetus,
• in women: fertility disorders,
• edema, increased thirst, malaise,
• increased creatinine levels, abnormal liver function test results, hyperkalemia.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Aleve

The medicine should be stored 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.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Aleve contains

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

What Aleve looks like and contents of the package

The package contains 12 or 24 coated tablets.
For more detailed information, you should 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in France, the country of export: 34009 274 286 9 2
274 286-9
Parallel import authorization number: 98/19

Date of leaflet approval: 05.03.2024

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