Aleve

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging 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 more information, you should ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 10 days for pain or 3 days for fever, there is no improvement or you feel 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 packaging 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, exert 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

• during the third trimester of pregnancy.

Warnings and precautions

You should discuss with your doctor or pharmacist before starting to take Aleve.

• 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,
• in patients taking steroid medications,
• in patients taking diuretics,
• in patients taking other pain medications,

Patient with a history of gastrointestinal side effects, especially elderly patients, should report any disturbing abdominal symptoms (including gastrointestinal bleeding) to their doctor.
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 or have recently taken, as well as any medicines you 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 determination 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 baby, you should ask your doctor or pharmacist for advice 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 baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in you and your baby 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 prescribed 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 baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
Do not take this medicine during 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 stopping naproxen.

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 with or without food. Food may slightly slow down the absorption of the medicine.
Recommended dose

Use in adults

220 mg every 8 to 12 hours as needed. In some patients, an initial dose of 440 mg followed by 220 mg after 12 hours may provide greater pain relief.
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, especially if they have had gastrointestinal bleeding or perforation in the past. In these patients, a lower dose should be considered.
Aleve should not be used for more than 10 days for pain or more than 3 days for fever unless under the supervision of a doctor. If symptoms persist or worsen, you should consult your doctor.

Use in children

Children under 16 years of age should not take Aleve unless directed 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 if this symptom was related to the use of naproxen.
There have also been a few cases of acute, reversible renal failure.
If a patient has taken a large amount of naproxen sodium, the stomach should be emptied and standard supportive measures should be taken, 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 questions about the use of 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 using the lowest effective dose for the shortest possible time.
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, stomach 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 anaphylaxis with fatal outcome,
• hematological disorders: leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia,
• psychiatric disorders, depression, sleep disorders, inability to concentrate,
• aseptic meningitis, cognitive function disorders, seizures,
• visual disturbances, corneal clouding, optic neuritis, papillitis, disc edema,
• hearing impairment, tinnitus, hearing disorders,
• congestive heart failure, hypertension, pulmonary edema, palpitations,
• vasculitis,
• dyspnea, asthma, eosinophilic pneumonia,
• pancreatitis, colitis, aphthous stomatitis, oral mucositis, esophagitis, gastrointestinal ulcers,
• hepatitis (including fatal cases), jaundice,
• alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme, blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, psoriasis, acne, skin rash, lupus erythematosus, photosensitivity reactions, including porphyria cutanea tarda (pseudoporphyria) or blistering skin detachment, purpura, petechiae, excessive sweating,
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure, kidney disease, hematuria, proteinuria,
• closure of the arterial duct in the fetus,
• in women: fertility disorders,
• edema, increased thirst, malaise,
• increased creatinine levels, abnormal liver function tests, hyperkalemia.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides, 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 side effects, you can help provide 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 packaging 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: povidone K 30, microcrystalline cellulose, talc, magnesium stearate;
Coating: Opadry Blue YS-1-4215: titanium dioxide, hypromellose, macrogol 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, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in France, the country of export: 274 286-9
3400927428692

Parallel import authorization number: 376/17

Date of leaflet approval: 06.08.2024

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