Bayer Aleve 24 tablets

For mild to moderate pain.
With anti-inflammatory effect.

field of use

Naproxen sodium, the active ingredient in Aleve film-coated tablets, belongs to the group of non-steroidal (= “cortisone-free”) drugs (NSAIDs) that have analgesic, fever-reducing and anti-inflammatory effects.

• For the relief of mild to moderate pain such as
• headache
• toothache
• back pain
• menstrual cramps

Pain associated with colds Pain in the gastrointestinal tract must not be treated with naproxen. 

Contraindications

Aleve film-coated tablets must not be taken

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6). This hypersensitivity can manifest itself as an asthma attack, shortness of breath, with or without (possibly itchy) skin reddening (e.g. nettle rash) or by a cold-like reaction of the nasal mucosa (blocked or runny nose).
• if you are hypersensitive to medicines containing acetylsalicylic acid or substances similar to the active substance naproxen (so-called “NSAIDs” = non-steroidal anti-inflammatory drugs). This also applies if you have previously reacted hypersensitively to such substances!
• if you suffer from a blood disease (e.g. blood formation disorders, disorders of the formation of the red blood pigment, pathologically increased tendency to bleed)
• if you suffer from severe heart failure
• if you have an active ulcer or bleeding in the gastrointestinal tract
• if you suffer from recurring stomach and/or intestinal ulcers or bleeding (have already had two or more ulcers or bleeding)
• if you have or have had stomach or gut bleeding or perforation of the stomach or gut caused by taking NSAIDs such as Aleve
• if you have a brain haemorrhage
• if you are currently suffering from any other acute heavy bleeding
• if you suffer from severe liver dysfunction
• if you suffer from severe kidney problems
• from the 6th month of pregnancy and during breastfeeding (see "Pregnancy, breastfeeding and fertility")
• Children up to the age of 12 or people weighing less than 50 kg, as the active ingredient content of the film-coated tablet is too high for them. 

interactions

Ask your doctor for advice before taking Aleve film-coated tablets if you are already taking any of the following medicines:

Medicinal product Possible effect when combined with Aleve film-coated tablets

• Other anti-inflammatory, analgesic or antipyretic drugs (NSAIDs) including acetylsalicylic acid and so-called "COX-2 inhibitors" (such as celecoxib, rofecoxib, parecoxib) - Increase in side effects, especially increased bleeding tendency of the gastrointestinal tract (see 2. "What should you before using Aleve - film-coated tablets?")
• Low-dose acetylsalicylic acid Naproxen may reduce the anticoagulant effect of acetylsalicylic acid (see 2. “Warning and precautions”)
• Cardiac glycosides (“digitalis”) – medicines to increase cardiac output – increased side effects possible
• Corticosteroids (“cortisone”) - Increased risk of stomach ulcers and bleeding
• Anticoagulant drugs and drugs for "blood thinning" - increased effect possible and increased bleeding tendency in the gastrointestinal tract
• Lithium supplements (medicines for mental illness) - Increased side effects of lithium
• Quinolones (certain medicines used to treat infections) - convulsions may occur (very rare)
• Zidovudine (medicine used for HIV infection) - increase in the amount of zidovudine in the blood, which can lead to increased side effects
• Phenytoin (certain medicine for epilepsy) - possible increase in phenytoin side effects (monitoring of the amount of phenytoin in the blood and, if necessary, dose adjustment is recommended)
• Certain medicines used to treat gout (Probenecid) - Delay in the excretion of naproxen, which can lead to increased side effects
• Certain medicines for depression (“SSRIs”) - risk of gastrointestinal bleeding is increased
• Diuretic medicines ("diuretics") - reduction of the antihypertensive effect possible and increased risk of kidney damage (increased blood pressure checks recommended, sufficient fluid intake must be ensured)
• Drugs for high blood pressure - weakening of their blood pressure lowering effect (increased blood pressure checks recommended)
• "ACE inhibitors" (certain drugs against high blood pressure) - Increased risk of kidney damage and acute kidney failure, especially in elderly and dehydrated people (make sure you drink enough fluids)
• Methotrexate (medicine that reduces certain immune reactions and cell division) - increase in the side effects of methotrexate
• Ciclosporin (drug that reduces the immune response) - increased risk of gastrointestinal damage, kidney damage (avoid combination or reduce dose; monitoring of kidney function recommended)
• Tacrolimus (used to treat organ rejection after transplantation) - Increased risk of kidney damage
• Medicines for diabetes - blood sugar fluctuations are possible (increased blood sugar checks recommended)
• Alcohol - Increased risk of bleeding in the gastrointestinal tract (combination should be avoided)

Taking Aleve film-coated tablets with food and drink
Consuming alcoholic beverages during treatment with Aleve film-coated tablets increases the risk of bleeding in the gastrointestinal tract and should therefore be avoided.

The absorption of naproxen, the active ingredient in Aleve film-coated tablets, may be slightly delayed if taken with a meal.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first 6 months of pregnancy, the intake of Aleve film-coated tablets should be avoided as far as possible and should only be taken if expressly prescribed by a doctor.
Aleve film-coated tablets must not be taken during the last 3 months of pregnancy. There is a risk of malformations in the child's circulatory system and the risk of birth delays and increased bleeding during birth.

Breast- feeding
Since naproxen passes into breast milk, Aleve should not be taken while breast-feeding.

Desire to have children
Aleve film-coated tablets should not be taken by women who wish to become pregnant, since the active ingredient naproxen - like all NSAIDs - can impair fertility. 

application

To take.
Take Aleve film-coated tablets whole with meals and plenty of liquid. Aleve - film-coated tablets become more effective when taken on an empty stomach. For patients who have a sensitive stomach, it is advisable to take Aleve film-coated tablets with meals.

Aleve film-coated tablets (like all NSAIDs) should be dosed as little as is necessary to treat pain and should be taken for the shortest possible time. This precaution will help keep any side effects to a minimum.

Unless otherwise prescribed by the doctor, the usual dose is:

Adolescents from the age of 12 and weighing at least 50 kg and adults:
1 film-coated tablet every 8 - 12 hours.
The daily dose of 3 film-coated tablets must not be exceeded without medical advice.

Children up to 12 years of age and people weighing less than 50 kg
Due to the high active ingredient content, Aleve film-coated tablets are not suitable for use in these patient groups, since body weight cannot be used to dose them.

Special patient groups

Elderly patients (over 65 years of age)
Careful monitoring by your doctor is required. In elderly patients, it is particularly important to choose the lowest effective dose of Aleve film-coated tablets. (see section 2 “What you need to know before you take Aleve film-coated tablets”)

Patients with liver dysfunction
There is a risk of an overdose when using Aleve film-coated tablets in patients with liver dysfunction. Therefore, the lowest effective dose of Aleve film-coated tablets should be selected. Careful monitoring by your doctor is required.
If you suffer from severe liver dysfunction, you must not take Aleve film-coated tablets (see section 2 "What you need to know before you take Aleve film-coated tablets?").

Patients with kidney problems
If you suffer from kidney problems, your doctor may reduce the dose of Aleve film-coated tablets.
If you have severe kidney problems, you must not take Aleve film-coated tablets (see section 2 "What you need to know before you take Aleve film-coated tablets?").

Aleve - film-coated tablets should not be taken for more than 4 days without medical advice. If there is no improvement in the first 4 days, a doctor should also be consulted.

If you have the impression that the effect of Aleve is too strong or too weak, talk to your doctor or pharmacist.  

side effects

The list of the following undesirable effects includes all known side effects from treatment with naproxen, including those from high-dose long-term therapy in rheumatism patients.

In the case of the following adverse drug reactions, it must be taken into account that they are predominantly dose-dependent and vary from patient to patient.

The most frequently observed side effects involve the digestive tract. Stomach/duodenal ulcers (peptic ulcers), perforations (perforations) or bleeding, sometimes fatal, can occur, particularly in elderly patients (see section 2). Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, inflammation of the mouth lining with ulceration (stomatitis) and aggravation of inflammatory bowel disease (colitis and Crohn's disease) have been reported after use. Less frequently gastritis has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose range and the duration of use.

Fluid retention, high blood pressure and heart failure have been reported in association with NSAID treatment.

Using medicines like Aleve could be associated with a slightly increased risk of having a heart attack or stroke.

If you experience these possible signs of serious side effects, please stop using the medicine and seek medical advice immediately:

• shortness of breath
• Severe drop in blood pressure
• Impaired consciousness or severe or increasing impairment of general well-being
• swelling of the face or throat, difficulty swallowing
• (Itchy) skin rashes, reddening, blistering or bleeding of the skin
• Local painful, overheated redness and swelling, possibly with fever
• Severe headache or abdominal pain – especially if it occurs suddenly
• Vomiting blood or coffee grounds like vomiting
• Bloody or black stools
• heart problems (chest pain)
• Severe fatigue with loss of appetite, with or without yellowing of the skin and eyes
• Neck stiffness with headache
• visual disturbances or hearing disturbances
• Flu-like symptoms, mouth sores, sore throat and nosebleeds.

The following side effects may also occur:

Common: may affect up to 1 in 10 people

• Headache, dizziness, lightheadedness
• Indigestion, nausea, heartburn, stomach pain

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity reactions with skin rash, itching, skin bleeding, swelling
• Insomnia, agitation, irritability, fatigue, drowsiness
• visual disturbances
• Gastrointestinal ulcers (possibly with bleeding and perforation), vomiting blood, tarry stool (=blood stool) or bloody diarrhea; Constipation, diarrhea, feeling of fullness
• Rash, itching, hives
• muscle pain, muscle weakness

Rare: may affect up to 1 in 1,000 people

• vomiting, gastrointestinal bleeding
• Skin swelling, increased sensitivity to light
• Decrease in urination. Development of swelling (especially in patients with high blood pressure or kidney failure)
• fever and feeling cold

Very rare: may affect up to 1 in 10,000 people

• a worsening of infectious diseases has been described in temporal relation to the use of NSAIDs. This may be related to the mechanism of action of NSAIDs.
• Blood disorders (decrease in red blood cells or decrease or increase in certain white blood cells, decrease in platelets or decrease in all blood cells)
• Severe hypersensitivity reactions including hypotension and shock with fatal outcome, involvement of the respiratory tract with bronchoconstriction
• Psychiatric disorders, depression, nightmares, difficulty concentrating
• seizures
• Certain form of meningitis in patients with immune system disorders (SLE, mixed connective tissue disease); memory problems, convulsions
• Inflammation of the optic nerve
• ringing in the ears (tinnitus), hearing impairment, dizziness
• Heart failure, pulmonary congestion, palpitations
• high blood pressure, inflammation of the blood vessels
• Participation of the respiratory tract with narrowing of the bronchi, shortness of breath, certain forms of pneumonia
• Inflammation of the pancreas, colon, oral mucosa, esophagus; Inflammation with ulcers in the oral mucosa or gastrointestinal tract
• Liver damage especially after long-term therapy, liver inflammation (also with fatal outcome), jaundice
• severe, sometimes fatal, skin conditions with skin inflammation and/or blistering and bleeding; severe skin reactions with increased sensitivity to sunlight; ringworm, patchy rash, pustular rash, bleeding from the skin; hair loss (mostly reversible = temporary); reddening of the skin, sweating
• a worsening of infection-related inflammations (e.g. development of a tissue-destroying inflammation in the area of ​​the muscle connective tissue) has been described in temporal connection with the general use of NSAIDs.
• Kidney damage, especially with long-term therapy; increase in the level of uric acid in the blood; Kidney dysfunction, inflammation of the kidneys, acute kidney failure, blood or protein in the urine, swelling of the limbs
• Developmental disorder in the circulatory system of the unborn child (premature closure of the ductus arteriosus)
• Temporary female infertility
• Swelling, thirst, feeling sick

Not known: frequency cannot be estimated from the available data

• Lens and optic nerve swelling, corneal opacity
• Influencing laboratory findings 

composition

The active substance is: Naproxen
1 film-coated tablet contains 220 mg naproxen sodium (equivalent to 200 mg naproxen).
The other ingredients are:
Tablet core: microcrystalline cellulose magnesium stearate povidone K 30 talc
Tablet coating: colors (E132, E171).