Aleve

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

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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 10 days for pain or 3 days for fever, there is no improvement or you feel worse, consult 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 pack 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,
• 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 they are more prone to adverse reactions, especially if they have a history of gastrointestinal bleeding or perforation,
• 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),
• if you are taking low-dose acetylsalicylic acid for cardiovascular protection, as it may reduce its protective effect,
• if you experience skin rash, mucosal lesions, or other signs of hypersensitivity after taking Aleve, stop taking the medicine,
• if you have angioedema, asthma, nasal polyps, or chronic respiratory 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 impairment.

Patient with a history of gastrointestinal adverse reactions, especially the elderly, should report any disturbing abdominal symptoms (including gastrointestinal bleeding) to their doctor.
This medicine belongs to a group of drugs (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is reversible and disappears after the end of treatment.
Aleve, like other NSAIDs, due to its anti-inflammatory and antipyretic effects, may mask symptoms of other diseases, making 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. Do not exceed the recommended dose and duration of treatment (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), consult your doctor or pharmacist.
Avoid concomitant use of naproxen sodium with other NSAIDs, including selective cyclooxygenase-2 inhibitors.

Aleve and Other Medicines

Tell your doctor or pharmacist about all medicines you are 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:

• cyclosporin, as it may increase the risk of kidney damage,
• lithium, as it may cause nausea, increased thirst, polyuria, tremors, or disorientation,
• 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 for blood clot prevention,
• anticoagulant medications, such as warfarin, as it may increase the risk of bleeding,
• antiplatelet agents 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 urinary 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5-HIAA).
Tell your doctor about all medications you have taken recently, 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 or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do 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, do not use this medicine unless absolutely necessary and under medical supervision. 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 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 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.
Avoid taking Aleve while breastfeeding, as naproxen passes into breast milk.
Naproxen may affect fertility. This effect is reversible and disappears after discontinuation of naproxen.

Driving and Operating Machines

During treatment with Aleve, side effects such as drowsiness, dizziness, insomnia may occur, 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, equivalent 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, consult 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

Adult Use

Single dose: 220 mg, every 8 to 12 hours until symptoms subside. In some patients, an initial dose of 440 mg, followed by 220 mg after 12 hours, may increase the analgesic effect.
Do not exceed the daily dose of 660 mg, unless your doctor decides otherwise.
Elderly Patients
Elderly patients are more susceptible to adverse reactions; therefore, smaller doses should be considered for these patients.
Aleve should not be used for more than 10 days for pain or more than 3 days for fever, unless under medical supervision. If symptoms persist or worsen, consult your doctor.

Pediatric Use

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

Overdose of Aleve

Significant overdose is characterized by dizziness, drowsiness, abdominal pain, discomfort in the abdominal cavity, heartburn, nausea, vomiting, transient liver function disorders, increased bleeding tendency, 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 also been a few cases of acute, reversible renal failure.
In case of ingestion of a large amount of naproxen sodium, gastric lavage can be performed, and supportive measures, such as administration of activated charcoal, can be taken. There is no specific antidote.

Missed Dose of Aleve

Do not take a double dose to make up for a missed dose.

Stopping Aleve Treatment

In case of further doubts about the use of this medicine, consult 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 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 illnesses).

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

• hypersensitivity reactions, including anaphylactic shock,
• hematological 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, excessive sweating,
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Aleve

Keep the 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 month.
Medicines should 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 Pack and Other Information

What Aleve Contains

The active substance is naproxen sodium. One coated tablet contains 220 mg of naproxen sodium.
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, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization 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:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorization Number in France, Country of Export:3400927428692
274 286-9
Parallel Import Authorization Number:192/17

Date of Leaflet Approval: 07.08.2024

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