Aleve

Package Leaflet: Information for the User

Aleve, 220 mg, Coated Tablets

Naproxen Sodium

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 10 days for pain or 3 days for fever, no improvement occurs or you feel worse, consult a doctor.

Table of Contents of the Package 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 work by reversibly inhibiting prostaglandin synthesis, exerting analgesic, antipyretic, and anti-inflammatory effects. Aleve reduces the severity of pain, lowers fever, and inhibits inflammatory reactions.

Indications

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 had recurrent peptic ulcer or gastrointestinal bleeding in the past,

in the past,

• if you have a bleeding disorder,
• if you have severe heart failure,
• if you have severe renal or hepatic impairment,
• in the third trimester of pregnancy.

Warnings and precautions

Before taking Aleve, 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),
• 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, especially at the beginning of treatment, you should stop taking the medicine,
• if you have angioedema, asthma, nasal polyps, or chronic respiratory diseases, as you may be at 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 disorders.

Patient with a history of gastrointestinal side effects, especially the elderly, 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 female fertility. This effect is reversible and disappears after stopping 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 cardiovascular disorders, previous stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), consult your doctor or pharmacist. During naproxen treatment, allergic reactions to this medicine have been reported, including difficulty breathing, face and neck swelling (angioedema), chest pain. You should stop taking Aleve and contact your doctor immediately if you experience any of these symptoms. 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, and about any medicines you plan to take. Inform your doctor or pharmacist if you are taking any of the following medicines:

• cyclosporin, as the risk of kidney damage may increase,
• lithium, as nausea, increased thirst, polyuria, tremors, and disorientation may occur,
• methotrexate at a dose of 15 mg per week or higher, as the risk of toxic effects of this medicine may increase,
• other nonsteroidal anti-inflammatory drugs or corticosteroids, as the risk of ulcers and gastrointestinal 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 blood pressure-lowering medications (including angiotensin-converting enzyme inhibitors), as their effectiveness may decrease.

Effect on laboratory tests Naproxen sodium has been shown to affect the measurement of urinary 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5-HIAA). Tell your doctor about all medicines you have taken recently, including those available without a prescription.

Using 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 prolong labor. During the first 6 months of pregnancy, do not take 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, leading to reduced amniotic fluid or constriction of the fetal ductus arteriosus. If longer treatment is necessary, your doctor may recommend additional monitoring. Do not take this medicine in 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 stopping treatment.

Driving and using machines

While taking 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 of 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 this package leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. 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.

Dosage

Adults

Single dose: 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 better pain relief. Do not exceed the daily dose of 660 mg, unless directed by a doctor. Elderly patientsElderly patients are more susceptible to side effects; therefore, a lower dose should be considered. 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, consult a doctor.

Children

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

Overdose

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 if this symptom was related to naproxen use. Several cases of acute, reversible renal failure have been reported. If a large amount of naproxen sodium has been taken, the stomach should be emptied and supportive measures initiated, such as administration of activated charcoal. There is no specific antidote.

Missed dose

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

Stopping treatment

In case of further doubts about taking this medicine, consult a 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. Nonsteroidal anti-inflammatory drugs have been associated with edema, hypertension, and heart failure. Taking such medications as 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 empty-headed;
• 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 feverish conditions).

Very rare side effects (may affect up to 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, difficulty concentrating;
• 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, rash, skin eruptions;
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure, kidney disease, hematuria;
• fetal ductus arteriosus closure;
• female fertility disorders;
• edema, increased thirst, malaise;
• increased creatinine levels, abnormal liver function tests, hyperkalemia.

Frequency not known (frequency cannot be estimated from the available data):

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you experience any of the following side effects, stop taking Aleve and contact your doctor immediately:

Frequency not known (frequency cannot be estimated from the available data):

• characteristic skin allergic reaction, called fixed drug eruption, which usually recurs in the same place (places) after re-exposure to the medicine and may take the form of round or oval red patches and skin swelling, blisters (hives), itching.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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. By reporting side effects, you can help provide 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 original 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 tablet contains 220 mg of naproxen sodium, equivalent to 200 mg of naproxen. 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 3, 7, 12, or 24 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bayer Sp. z o.o. Al. Jerozolimskie 158 02-326 Warsaw Tel. 22 572 35 00

Manufacturer:

Bayer Bitterfeld GmbH Salegaster Chaussee 1 Ortsteil Greppin 06803 Bitterfeld-Wolfen Germany

Date of last revision of the package leaflet:

• 04.2025