Aleve Filmtablet 220 mg 12 pcs

What Aleve is and what it is used for

Aleve contains the active substance naproxen as naproxen sodium. It has pain-relieving, fever-reducing and anti-inflammatory properties.

The duration of action is 8-12 hours.

Aleve is suitable for short-term treatment, ie for a maximum of 3 days treatment of:

• back pain;
• pain in joints and ligaments;
• pain after injury;
• pain during menstrual bleeding;
• toothache;
• Headache;
• Fever in influenza illnesses.

When should Aleve not be used?

• If you are allergic to any of the ingredients or have had shortness of breath or allergic-like skin reactions after taking acetylsalicylic acid or other pain or rheumatism medicines, so-called non-steroidal anti-inflammatory drugs;
• if you are pregnant or breastfeeding (see also the chapter "Can Aleve be taken during pregnancy or while breastfeeding?");
• if you have an active stomach and/or duodenal ulcer or gastrointestinal bleeding;
• in chronic intestinal inflammation (Crohn's disease, ulcerative colitis);
• if you have severe impairment of liver or kidney function;
• with severe heart failure;
• for the treatment of pain after coronary bypass surgery on the heart (or use of a heart-lung machine);
• in children and adolescents under 16 years of age. Aleve film-coated tablets have not been tested for use in children and adolescents under 16 years of age.

When is caution needed when taking Aleve?

During treatment with Aleve film-coated tablets, ulcers in the mucous membranes of the upper gastrointestinal tract, rarely bleeding or, in isolated cases, perforation (perforation in the stomach or intestines) may occur. These complications can occur at any time during treatment, even without warning symptoms. To reduce this risk, the smallest effective dose should be used over the shortest possible duration of therapy. Contact your doctor if you have stomach pain and suspect it is related to taking the medicine.

Elderly patients may be more sensitive to the medicine than younger adults. It is particularly important that elderly patients report any side effects to their doctor immediately.

In the following situations, you may only take Aleve film-coated tablets if prescribed by a doctor and under medical supervision:

• if you are currently receiving medical treatment for a serious illness;
• if you have previously suffered from a stomach or duodenal ulcer;
• if you have already had a heart attack, stroke or vein thrombosis, or if you have risk factors (such as high blood pressure, diabetes (sugar diabetes), high blood fat levels, smoking); for certain painkillers with a similar effect, the so-called COX-2 inhibitors, an increased risk of heart attack and stroke has been found at high doses and/or long-term treatment. It is not known whether this increased risk also applies to Aleve film-coated tablets;
• if you have heart disease or kidney disease, if you are taking medicines for high blood pressure (e.g. diuretics, ACE inhibitors) or if you lose more fluids, e.g. through excessive sweating; taking Aleve film-coated tablets can affect the way your kidneys work, which can lead to an increase in blood pressure and/or fluid retention (oedema);
• if you have liver disease;
• if you are being treated with anticoagulants (blood thinners, anticoagulants) or have a blood clotting disorder;
• if you suffer from asthma;
• if you are taking anti-rheumatic medicines or other painkillers (e.g. acetylsalicylic acid, aspirin, ibuprofen);
• if you are taking medicines such as antiepileptics (phenytoin), medicines to treat diabetes (except insulin), water pills (eg furosemide), gout medicines (Probenecid), medicines containing sulphonamide to treat infections or medicines containing lithium or methotrexate.

Simultaneously taking Aleve and low-dose acetylsalicylic acid (such as Aspirin Cardio) should be avoided and only done after consulting your doctor.

During treatment with Aleve, exposure to the sun (UV radiation) on the skin should be avoided as far as possible (see also the section "What side effects can Aleve have?").

Serious skin reactions have been reported in association with treatment with non-steroidal anti-inflammatory drugs. The highest risk of such reactions appears to be at the beginning of therapy. If you develop a skin rash, including fever, mucosal lesions, blisters, or any other sign of allergy, you should stop using Aleve and seek medical attention immediately, as these may be the first signs of a very serious skin reaction (see section 'What Aleve can have side effects?» ).

This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie essentially 'sodium-free'.

Tell your doctor, pharmacist or druggist if you

• suffer from other diseases
• have allergies or
• use other medicines (including those you have bought yourself!).

Aleve can impair the ability to react, the ability to drive and the ability to use tools or machines!

Can Aleve be taken during pregnancy or breastfeeding?

Pregnancy

You should not take Aleve unless clearly necessary and directed by a doctor. If taken during the first 6 months of pregnancy, the dose should be kept as low and the duration of treatment as short as possible.

Taking nonsteroidal anti-inflammatory drugs (NSAIDs) from the 20th week of pregnancy can harm your unborn child. If you have to take NSAIDs for more than 2 days, your doctor may need to monitor the amount of amniotic fluid in the womb and the fetal heart.

If you are pregnant or planning to become pregnant, you should only take Aleve after consulting your doctor. Aleve should not be taken during the last trimester of pregnancy.

Lactation

Aleve should not be taken during breast-feeding unless your doctor has given you permission to do so.

How do you use Aleve?

Adults and young people aged 16 and over:

Take 1 film-coated tablet every 8 to 12 hours with plenty of liquid. In individual cases, 2 film-coated tablets can be taken at the same time as an initial dose, followed by 1 film-coated tablet if necessary, but only 12 hours later.

Maximum daily dose:

Do not take more than 3 film-coated tablets of Aleve in any 24-hour period, unless prescribed by a doctor.

65 years and over:

Unless otherwise prescribed by the doctor, a maximum of 2 film-coated tablets per day.

Duration of treatment:

Do not use Aleve for more than 3 days and only to treat the conditions listed above.

If symptoms worsen despite taking Aleve, or if the painful area becomes red or swollen, consult your doctor. A serious illness can be the cause.

Even if the symptoms do not improve within 3 days at the latest, you should consult your doctor so that the reason can be clarified.

Children and young people under the age of 16:

Aleve must not be used in children and adolescents under 16 years of age. The use and safety of Aleve in children and adolescents under 16 years of age have not been systematically tested.

Follow the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Aleve have?

The most common side effects are: headache, dizziness, lightheadedness, abdominal pain, nausea and burning.

More rarely, insomnia, drowsiness, diarrhea, nausea, vomiting, black stools, skin rashes, swelling of the face, feet or legs and fever have been observed.

Although photosensitivity reactions are very rare, they can be serious under certain circumstances (see also the section “When should you be careful when taking Aleve?”).

The following side effects may occur when taking Aleve, which may require medical attention:

Please tell your doctor straight away if you get any of the following symptoms and stop taking Aleve:

• Diarrhea, flatulence, upset stomach, heartburn or upper abdominal pain, vomiting, nausea
• Vomiting blood, blackening of the stool
• Unusual tiredness, dizziness, severe headache, confusional state
• Skin symptoms such as rash, itching
• Swelling of the face, feet or legs
• Wheezing breathing and shortness of breath
• Chest pains and cough
• blood in the urine

Frequency not known: A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include a rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).

If you notice any side effects that are not described here, you should inform your doctor, pharmacist or druggist.

What should also be noted?

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

Durability

Store in the original packaging at 15 - 30 °C.

Storage Notice

Keep Aleve out of the reach of children!

The medicinal product may only be used up to the date marked “EXP” on the container.

What's in Aleve?

Active ingredients

1 oval film-coated tablet contains naproxen sodium as the active ingredient, equivalent to 200 mg naproxen and 20 mg sodium

Excipients

Microcrystalline Cellulose (E460), Povidone K30 (E1202), Talc (E553b), Magnesium Stearate (E470B), Purified Water, Opadry Blue YS-1-4215, Hydroxypropyl Methylcellulose (E464), Titanium Dioxide (E171), Macrogol 8000, E132

Registration Number

53810 (Swissmedic).

Where can you get Aleve? What packs are available?

In pharmacies and drugstores, without medical prescription.

Packs of 12 film-coated tablets.

Marketing Authorization Holder

Bayer (Switzerland) AG, 8045 Zurich.