ALEVE - Film tablets

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

Application

1. What are Aleve film-coated tablets and what are they used for?

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

For the relief of mild to moderate pain such as

- headache
- toothache
- backache
- Menstrual cramps
- Pain from colds

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

How is it applied?

What are Aleve - Film-Coated Tablets and what are they used for?

Naproxen sodium, the active substance in Aleve - Film-Coated Tablets, belongs to the group of non-steroidal (= "cortisone-free") medicines (NSAIDs) that have an analgesic, antipyretic and anti-inflammatory effect.

For the relief of mild to moderate pain such as

- headache
- toothache
- backache
- Menstrual cramps
- Pain from colds

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

What should you pay attention to before taking it?

What should you be aware of before taking Aleve - Film-Coated Tablets?

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 may manifest itself as an asthma attack, shortness of breath, with or without (possibly itchy) reddening of the skin (e.g. hives) or by a cold-like reaction of the nasal mucous membranes (blocked or runny nose)
- if you are hypersensitive to medicines containing acetylsalicylic acid or substances similar to the active substance naproxen (so-called "NSAIDs" = N-. "NSAIDs" = Nnon-Steroidal Anti-Rheumatics). This also applies if you have had a hypersensitive reaction to such substances in the past!
- if you suffer from a blood disorder (e.g. blood formation disorders, disorders in the formation of red blood pigment, abnormally increased bleeding tendency)
- if you suffer from severe heart muscle weakness
- if you have an active ulcer or bleeding in the gastrointestinal tract
- if you have recurrent stomach and/or intestinal ulcers or bleeding.br>- if you suffer from recurrent stomach and/or intestinal ulcers or bleeding (have already suffered from an ulcer or bleeding two or more times)- if you suffer or have suffered from stomach or intestinal bleeding or a stomach or intestinal rupture caused by taking NSAIDs -like Aleve
- if you suffer from a brain haemorrhage
.- if you are currently suffering from any other acute major bleeding
- if you have severe liver dysfunction
- if you have severe kidney dysfunction
- from 6 months of pregnancy and during pregnancy. from the 6th month of pregnancy and during breast-feeding (see "Pregnancy, breast-feeding and fertility")
- by children up to the age of 12, or persons under 50 kg body weight, as the active substance content of the film-coated tablet is too high for them.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Aleve - Film-Coated Tablets.

Special care is needed when taking ALEVE - Film-Coated Tablets,

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• If you are taking medicines that increase the risk of gastrointestinal ulcers or bleeding in combination with Aleve - Film-Coated Tablets. In this case, you should only take Aleve - Film-Coated Tablets under medical supervision (see section 2 "Taking Aleve - Film-Coated Tablets with other medicines").
• in older people (over 65 years): The possible side effects - especially on the part of the digestive tract (which can also be fatal) - are more frequent and run a more dangerous course in elderly persons - which is why, if you are already elderly, you should start treatment with the lowest dose that is still effective (see section 3 "How to take Aleve - film-coated tablets?" and section 4 "What are the possible side effects?").
• for cardiovascular diseases: If you suffer or have suffered from high blood pressure and/or heart failure. Taking Aleve film-coated tablets can lead to an increase in fluid in the body (fluid retention, oedema) - an increase in blood pressure and increased cardiac stress are possible consequences.
  The use of medicines such as Aleve - film-coated tablets could be associated with a slightly increased risk of having a heart attack or stroke. Any risk increases with the level of dosage and duration of use. Therefore, do not increase the dosage and/or duration of therapy recommended to you.
  Naproxen may weaken the anticoagulant effect of acetylsalicylic acid. Please talk to your doctor if you are being treated with acetylsalicylic acid and intend to take naproxen.
  If you have heart problems, have already had a stroke or think you may be at increased risk of these conditions (such as: High blood pressure, diabetes, high cholesterol or if you are a smoker), talk to your doctor or pharmacist about this treatment.
• In respiratory diseases: If you have or have had asthma or allergies (e.g. hay fever, chronic swelling of the nasal mucous membranes, other swelling of the skin and mucous membranes, hives) or chronic constrictive diseases of the respiratory tract, an asthma attack (shortness of breath) may be triggered. Tell your doctor if you have already observed such reactions when taking other NSAIDs.
• In gastrointestinal tract disorders: Bleeding, ulcers and perforations in the digestive tract - which can also be fatal - are observed during treatment with non-steroidal anti-inflammatory drugs (NSAIDs) such as Aleve - film-coated tablets. These side effects can occur suddenly with or without warning symptoms. If you have already suffered from a corresponding illness, e.g. a stomach ulcer, please pay special attention to pain in the abdomen or blackening of the stool, interrupt the intake immediately if you suspect a new ulcer and contact your doctor.
• In chronic diseases of the intestinal tract:
  If you suffer from chronic inflammatory diseases such as Crohn's disease or ulcerative colitis, Aleve - film-coated tablets may trigger an exacerbation - which is why you should not start taking them without first seeking medical advice.
• If you have kidney disease: If you have reduced kidney function, your doctor will decide whether you should take Aleve - Film-Coated Tablets and may order certain laboratory tests.
• If you have liver disease: if you have impaired liver function, your doctor will decide whether you should take Aleve - Film-Coated Tablets and will order certain laboratory tests if necessary.
• during operations: Immediately after major operations, careful monitoring (of mineral and water balance or kidney function) is also recommended.
• In skin disorders: Very rarely, severe, sometimes fatal skin disorders with inflammatory skin changes and/or blistering and bleeding have been caused by NSAIDs (non-steroidal anti-rheumatic drugs) such as Aleve - film-coated tablets (see section 4 "What side effects are possible?"). If you notice any skin reactions such as unusual redness, patches or blisters, stop taking Aleve - Film-Coated Tablets and contact your doctor.
• After childbirth: In the puerperium, the use of medicines containing the active substance naproxen is not recommended because it may delay the involution of the uterus.
• In heavy menstrual bleeding: In the case of abnormally increased and prolonged menstrual bleeding, Aleve - Film-Coated Tablets should only be used with caution because of possible impairment of blood clotting.
• In immune system disorders: In certain disorders of the immune system ("autoimmune diseases") such as lupus erythematosus, taking NSAIDs may cause meningitis or kidney dysfunction. If you suffer from an autoimmune disease, you should therefore only take Aleve - Film-Coated Tablets after discussing it with your doctor and watch out for symptoms such as headaches, stiffness in the neck or reduced urination.
• In metabolic diseases: In the case of a disorder of the biosynthesis of the red blood pigment (porphyria), Aleve - Film-Coated Tablets may only be taken under medical supervision
.

General information

Hypersensitivity reactions
At the first signs of hypersensitivity reactions such as facial swelling, swelling in the respiratory tract (e.g. swelling of the larynx), shortness of breath, asthma, palpitations, skin reactions (e.g. itching, redness, rash, hives) and/or drop in blood pressure, stop taking the medicine and contact a doctor immediately. (e.g. itching, redness, rash, hives) and/or drop in blood pressure, discontinue use of the medicinal product suspected of causing the reaction and contact a doctor immediately.

At	Patients
the	Nasal mucosa
chronic	Respiratory tract infections
more frequently observed than in other persons - however, they are also without corresponding
Prehistory possible.

Pain management and concomitant diseases
If your general condition does not improve during treatment with naproxen, or if you continue to suffer from pain, fever, fatigue or other signs of illness, please ask your doctor for advice. The use/taking of painkillers may mask any warning signs of disease due to pain relief and inhibition of inflammatory signs. You may need additional therapy besides pain management.

Headache due to painkillers:
Prolonged, high-dose use of painkillers may cause headaches, which must not be treated by increased use of painkillers.

Kidney damage from painkillers:
The habitual use of certain painkillers over a long period of time can lead to permanent kidney damage with the risk of kidney failure.

If any of the above applies to you or has applied to you in the past. you, please discuss this with your doctor.

Laboratory findings
If the doctor orders checks of the blood count, blood coagulation, liver and kidney function, ophthalmological checks and any other check-ups (e.g. determination of the blood level of certain medicines), these must be strictly adhered to. This is especially true for patients with liver dysfunction, heart failure, high blood pressure or kidney damage.

If you are to have an examination of adrenal function, you must have
the intake of Aleve - film-coated tablets must be (temporarily) interrupted at least 3 days beforehand, otherwise the result of the tests may be influenced. Other laboratory values for determining e.g. the liver, kidney or blood can also be influenced.

If you have diabetes mellitus and are taking blood sugar-lowering medicines (e.g. sulphonylurea derivatives), your blood sugar must be monitored particularly carefully so that a possible increased blood sugar drop is not overlooked.

If gastrointestinal bleeding or visual and hearing disorders occur, Aleve
- Film-coated tablets should be discontinued immediately.

Taking Aleve - film-coated tablets with other medicines.

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Be sure to ask your doctor for advice before taking Aleve - Film-Coated Tablets if
You are already taking one of the following medicines:

Possible effect in combination with Medicines
Aleve film-coated tablets.
Other anti-inflammatory,
Increase in side effects, especially analgesic or antipyretic side effects.
Increased gastrointestinal drug (NSAID) bleeding tendency included.
-
tract (see 2. "What should you do before taking acetylsalicylic acid and so-called "COX-2-.
Application of Aleve - film-coated tablet inhibitors" (such as celecoxib, rofecoxib,
observe?")
Parecoxib)
Naproxen may weaken the anticoagulant effect of acetylsalicylic acid (see 2. "Warnings and low-dose acetylsalicylic acid
Cautions")


Heart glycosides ("digitalis") - Medicinal products for the
- Increased side effects possible
Strengthening cardiac output
Increased risk of stomach ulcers andcorticosteroids ("cortisone") -
-bleeding
Anticoagulant medicines and
- Effect intensification possible and increased medicines for "blood thinning".
Inclination to bleed in the gastrointestinal tractLithium preparations (medicines against
Enhanced side effects
psychological illnesses) -
from Lithium
Chinolone (certain medicines against
- Occurrence of cramps possible (very rare)infections).
Zidovudine (medicine used to treat HIV)
- Increase the amount of zidovudine in the blood, thereby infection is used).
Increased side effects possible

Increase in phenytoin side effects possible Phenytoin (certain medicinal product against
-
(Control of the amount of phenytoin in the blood and epilepsy).
If necessary, dose adjustment is recommended).

Determined medicinal product for gout
- Delay of naproxen excretion, (probenecid).
thereby increased side effects possible

Certain medicines for
- Risk of gastrointestinal bleeding is increasedDepression ("SSRI")

Possible reduction in blood pressure-lowering effect and increased risk of diuretic drugs
-
Kidney damage (increased blood pressure controls ("dehydrating agents")
recommended, make sure to drink enough fluids)

Attenuation of their antihypertensive medicines for high blood pressure -.
Effect (increased blood pressure controls recommended)

Increased risk of kidney damage as well as "ACE - inhibitors" (certain medicines
acute renal failure, especially in the elderly and -
against high blood pressure)
dehydrated persons (ensure sufficient fluid intake).

Methotrexate (medicinal product which
determined immune reactions and the
- Enhancement of the side effects of methotrexatecell division reduced).

Ciclosporin (medicinal product that stimulates the
Reinforcement of the risk of gastrointestinal immune reaction reduced) -
Damage, kidney damage (avoid combination or reduce dose, control of kidney function recommended).
Tacrolimus (medicinal product against
Organ rejection after transplantation) - Increased risk of kidney damage Medicines for diabetes
Blood sugar fluctuations are possible-.
(increased blood glucose checks recommended)

Alcohol - Increased risk of bleeding in the gastrointestinal tract (combination to be avoided).

Take Aleve - Film-Coated Tablets with food and drink.

Drinking 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, when taken can lead to
a meal may be slightly delayed.
Pregnancy, lactation and reproductive capacity.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first 6 months of pregnancy, the use of Aleve film-coated tablets should be avoided as far as possible and should only be taken on the express instructions of a doctor.
Aleve film-coated tablets must not be taken during the last 3 months of pregnancy. There is a risk of maldevelopment of the circulatory system in the child and a risk of birth delays and increased bleeding at birth.

breastfeeding
As naproxen passes into breast milk, Aleve - Film-Coated Tablets must not be taken when breast-feeding.

Wanting a child
Aleve film-coated tablets should not be taken by women who want to become pregnant, as the active ingredient naproxen - like all NSAIDs - can affect fertility.

Driving ability and ability to operate machinery.

Caution: This medicinal product may impair the ability to react and drive.
!

The active substance naproxen has a slight to moderate effect on the ability to drive and use machines.

If, however, you experience side effects such as visual disturbances, dizziness or tiredness, you must refrain from activities that require increased attention (e.g. driving, operating machines or dangerous tools). If you experience side effects such as visual disturbances, dizziness or drowsiness, you must refrain from activities that require increased attention (e.g. driving, operating machines or dangerous tools), as in this case you will no longer be able to react quickly and purposefully enough to unexpected and sudden events.

Aleve - film-coated tablets contain sodium, but less than 1 mmol (23 mg) of sodium per tablet, which means it is almost "sodium-free".

How should the medicine be taken?

How to take Aleve - Film-Coated Tablets?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

To take.
Take Aleve - Film-Coated Tablets whole with meals with plenty of liquid. Aleve - film-coated tablets work more quickly if taken on an empty stomach. For patients with a sensitive stomach, it is recommended that Aleve film-coated tablets are taken during meals.
Aleve film-coated tablets (like all NSAIDs) should be taken in as small a dose as is necessary to treat the pain and for the shortest possible time. This precaution helps to minimise any side effects.

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

Adolescents over the age of 12 and weighing at least 50 kg Body weight and adults:
1 film-coated tablet every 8 hours. age and weighing at least 50 kg Body weight and adults:
1 film-coated tablet every 8 - 12 hours.
The daily dose of 3 film-coated tablets must not be exceeded without a doctor's instructions.

Children up to 12 years of age and persons under 50 kg body weight
Due to the high active substance content, Aleve - Film-Coated Tablets are not suitable for use in these patient groups, as it is not possible to dose according to body weight.

Special patient groups

Older patients (overover 65 years)
Careful monitoring by your doctor is required. In elderly patients, it is especially important to choose the lowest dose of Aleve - film-coated tablets that is still effective. (See section 2 "What should you be aware of before taking Aleve - Film-Coated Tablets?")

Patients with liver dysfunction
Patients with liver dysfunction are at risk of overdose when using Aleve - Film-Coated Tablets. Therefore, the lowest still effective dose of Aleve - Film-Coated Tablets should be chosen. Careful monitoring by your doctor is required.
If you have severe liver dysfunction, do not take Aleve - Film-Coated Tablets (see section 2 "What you should know before taking Aleve - Film-Coated Tablets").").

Patients with kidney dysfunction
If you have kidney dysfunction, your doctor may reduce the dose of Aleve - Film-Coated Tablets.
If you have severe kidney impairment, you must not take Aleve - Film-Coated Tablets (see section 2 "What should you be aware of before taking Aleve - Film-Coated Tablets?").

Aleve - Film-Coated Tablets must not be taken for more than 4 days without medical advice. If there is no improvement within the first 4 days, a doctor should also be consulted.

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

If you have taken a larger amount of Aleve - Film-Coated Tablets than you should
.If you feel that you are not getting enough pain relief, do not increase the dosage on your own but talk to your doctor.

The signs of taking too high a dose of naproxen may include: Fatigue, heartburn, indigestion, nausea, vomiting, diarrhoea, cramps. The amount of the dose that is life-threatening is not known.

If you suspect an overdose with Aleve, please notify a doctor immediately.

For doctors: Information on the treatment of poisoning with naproxen can be found at the end of this leaflet !
If you forget to take Aleve - Film-Coated Tablets:
Do not take twice the amount if you have forgotten to take it before.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Aleve - film-coated tablets?

Store in the original packaging to protect the contents from light. Do not store above 30°C.
Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister after "Use by". The expiry date refers to the last day of the month indicated.

Care	You
Pharmacist,	how
thereby contribute to the protection of the environment.

Special instructions for storage

5. How should Aleve - Film-Coated Tablets be stored?

Store in the original packaging to protect the contents from light. Do not store above30°C.
Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Aleve - Film-Coated Tablets contain

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:
Dyes (E 132, E 171).

What Aleve - Film-Coated Tablets look like and contents of the pack
The film-coated tablet is oval, domed on both sides and light blue, with an imprint on one side: BAYER
Pack sizes: 12 or 24 film-coated tablets
Not all pack sizes may be marketed.

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