ALEVE 220 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.
   1. You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Aleve and what is it used for
   1. Indications for use
4. Important information before using Aleve
   1. When not to use Aleve
   2. Warnings and precautions
   3. Aleve and other drugs
   4. Using Aleve with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to use Aleve
   1. Recommended dose
   2. Use in adults
   3. Use in children
   4. Using a higher than recommended dose of Aleve
   5. Missing a dose of Aleve
   6. Stopping the use of Aleve
6. Possible side effects
   1. Reporting side effects
7. How to store Aleve
8. Contents of the packaging and other information
   1. What Aleve contains
   2. What Aleve looks like and what the packaging contains
   3. Marketing authorization holder in France, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Marketing authorization number in France, the country of export:

Leaflet attached to the packaging: 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 ALEVETABSare different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

This drug should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet so that you can read it again if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 10 days in the case of pain or 3 days in the case of fever, there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Aleve and what is it used for
• 2. Important information before using Aleve
• 3. How to use 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, 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,
• painful menstruation,
• mild pain associated with a 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 drug (listed in section 6),
• if in the past, after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, the patient experienced bronchial asthma, hives, or allergic reactions,
• if after using nonsteroidal anti-inflammatory drugs, gastrointestinal bleeding or perforation occurred,
• 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 impairment,
• if the patient has had multiple episodes of gastrointestinal ulceration or bleeding in the past,
• in the third trimester of pregnancy.

Warnings and precautions

Before starting to use Aleve, the patient should discuss it with their 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 they may experience worsening of symptoms,
• if the patient is taking drugs that may increase the risk of ulcers or bleeding, such as corticosteroids, anticoagulants (e.g., warfarin), or certain antidepressants (selective serotonin reuptake inhibitors),
• if the patient is taking acetylsalicylic acid in small doses for cardiovascular disease prevention, as it may reduce the protective effect of acetylsalicylic acid,
• if after using Aleve, especially at the beginning of treatment, a skin rash, mucosal lesions, or other symptoms of hypersensitivity occur, the patient should stop taking the drug,
• if the patient has angioedema, bronchial asthma, nasal mucosal inflammation, nasal polyps, or allergic diseases, as they may experience hypersensitivity reactions,
• if the drug is used in patients with bleeding disorders,
• in patients taking steroid drugs,
• 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 have experienced gastrointestinal side effects in the past, especially if they are elderly, should report any disturbing abdominal symptoms (including gastrointestinal bleeding) to their doctor.
This drug belongs to a group of drugs (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is transient 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 drugs 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 drug. The patient should not use higher doses or longer treatment 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), the patient should discuss the treatment with their doctor or pharmacist.
The patient should avoid concomitant use of naproxen sodium with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
One tablet contains 20 mg of sodium, which corresponds to the amount of salt in one slice of bread.
The amount of sodium in a low-sodium diet is limited to ≤1.2 g (50 mmol) per day.

Aleve and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
The patient should inform their doctor or pharmacist if they are taking any of the following drugs:

• cyclosporine, 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 they may increase the risk of ulcers and gastrointestinal bleeding,
• acetylsalicylic acid used to prevent blood clots,
• anticoagulant drugs, such as warfarin, as they may increase the risk of bleeding,
• antiplatelet drugs and certain antidepressants (selective serotonin reuptake inhibitors), as they may increase the risk of gastrointestinal bleeding,
• diuretics and blood pressure-lowering drugs (including angiotensin-converting enzyme inhibitors), as they may reduce their effectiveness.

Effect on laboratory test results
It has been found that naproxen sodium affects the determination of 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5-HIAA) in urine.
The patient should tell their doctor about all the drugs they have taken recently, including those that are 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
Aleve should not be used during pregnancy, except in cases recommended and supervised by a doctor, as it, like other drugs of this type, affects the cardiovascular system of the human fetus. The use of Aleve during pregnancy requires careful consideration of the potential benefits and risks to the mother and fetus, especially in the first and second trimesters of pregnancy.
Aleve should be avoided in breastfeeding women, as naproxen passes into breast milk.
Naproxen may affect fertility. This effect is transient and disappears after the end of therapy.

Driving and using machines

During the use of Aleve, side effects such as drowsiness, dizziness, insomnia may occur, which may affect the ability to drive vehicles and operate machines.
Therefore, patients taking Aleve should observe their reactions before driving a vehicle or operating machines.

3. How to use Aleve

This drug should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Method of administration
Each dose should be taken with a glass of water - the drug can be taken regardless of meals. Food may slightly slow down the absorption of the drug.

Recommended dose

Use in adults

Single dose: 220 mg, every 8 to 12 hours until symptoms subside. In some patients, the use of an initial dose of 440 mg, followed by 220 mg after 12 hours, may increase the analgesic effect.
The daily dose should not exceed 660 mg, unless the doctor decides otherwise.
Patients in old age
Elderly patients are more susceptible to side effects, and at these patients, the use of lower doses should be considered.
Aleve should not be used for more than 10 days in the case of pain or more than 3 days in the case of fever, unless under medical supervision. If the pain or fever persists, or if changes in the observed symptoms are noted, the patient should consult their doctor.

Use in children

Children under 16 years of age should not use Aleve, unless a doctor recommends otherwise.

Using a higher than recommended dose of Aleve

Significant overdose is manifested by dizziness, drowsiness, abdominal pain, discomfort in the abdominal cavity, heartburn, nausea, vomiting, transient liver function disorders, increased tendency to 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. Several cases of acute, reversible renal failure have also been reported.
In case of suspected overdose, the stomach can be emptied, and standard supportive measures can be taken, such as administration of activated charcoal. There is no specific antidote.

Missing a dose of Aleve

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

Stopping the use of Aleve

In case of further doubts about the use of this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, Aleve can cause side effects, although not everybody gets them.
Side effects can be minimized by using the smallest effective dose for the shortest time necessary to relieve symptoms.
Nonsteroidal anti-inflammatory drugs have been associated with edema, hypertension, and heart failure.
Taking such drugs as Aleve may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Common side effects(may affect 1 in 10 to 1 in 100 patients):

• dizziness, headache, feeling of emptiness in the head
• nausea, vomiting, heartburn, abdominal pain

Uncommon side effects(may affect 1 in 100 to 1 in 1000 patients):

• drowsiness, insomnia, dizziness
• diarrhea, constipation, vomiting
• rash, itching, hives

Rare side effects(may affect 1 in 1000 to 1 in 10,000 patients):

• 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 patients):

• 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, bronchial asthma, eosinophilic pneumonia,
• pancreatitis, colitis, aphthous stomatitis, esophagitis, gastrointestinal ulcers, hepatitis (including liver failure),
• alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, lichen planus, skin reactions, lupus erythematosus, photosensitivity reactions, including porphyria cutanea tarda or epidermal necrolysis, purpura, petechiae, excessive sweating,
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure, kidney disease, hematuria,
• fetal ductal closure,
• in women: fertility disorders,
• edema, increased thirst, malaise,
• increased creatinine levels, abnormal liver function test results, hyperkalemia.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, 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
Reporting side effects will help to gather more information on the safety of the drug.

5. How to store Aleve

The drug should be stored out of sight and reach of children.
Store in the outer packaging to protect from light.
Do not use this drug after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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.
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 what the packaging contains

The packaging contains 12 or 24 coated tablets.
For more detailed information, the patient 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:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SA, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów

Marketing authorization number in France, the country of export:

274 544-8
34009 274 544 8 6
274 286-9
34009 274 286 9 2
Parallel import authorization number:382/17
Date of leaflet approval: 16.11.2022
[Information about the trademark]