Naproxen sweatshirt film tablets, 30 pcs

Instructions for use for Naproxen sweatshirt film tablets, 30 pcs

Important notes (compulsory information):

Naproxen sweatshirt 220 mg film-coated tablets. Active substance: Naproxen sodium. Applications: For light to moderately strong pain, such as headaches, toothache, control pain and fever.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.



LEAFLET: INFORMATION FOR THE USER

Naproxen Schwörer 220 mg film-coated tablets
Active ingredient: naproxen sodium

Read the entire leaflet carefully because it contains important information for you. This medicine is also available without prescription. However, to achieve the best possible treatment success, naproxen sweaters must be used properly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms aggravate or get no improvement after 4 days, you must consult a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is naproxen sweaters and what is it used for?
2. What do you need to consider before taking Naproxen sweatshirt?
3. How is Naproxen swearing to take?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is Naproxen to store sworn?
6. ADDITIONAL INFORMATION

1. What is naproxen sweater and what is it applied for?

Naproxen sweaters is an analgesic, fever-lowering and anti-inflammatory medicine (non-steroidal anti-phlogistikum / analgesic). Naproxen sweaters is applied to light up to moderately strong pain, such as headaches, toothache, regulating pain and fever.

2. What do you need to consider before taking Naproxen sweatshirt?

Naproxen sweaters must not be taken:

• if they are hypersensitive (allergic) to naproxen or any other ingredients of naproxen sweaters
• if you have reacted in the past with asthma attacks, nasal mucosal swellings or skin reactions to take acetylsalicylic acid or other non-steroidal anti-stimulus
• with unclear blood formation disorders
• for existing or past stomach / duodenal ulcer (peptic ulcer) or bleeding (at least 2 different episodes of proven ulcers or bleeding)
• in gastrointestinal bleeding or breakthrough (perforation) in the prehistory associated with a previous therapy with non-steroidal antirheumatics (NSAR)
• for brain bleeding (cerebrovascular bleeding) or other active bleeding
• if you suffer from heavy liver or renal impairment
• for heavy heart failure (heart failure)
• in the last three months of pregnancy
• children under 12 years, as this dose thickness is usually not suitable due to the active ingredient content.

Safety in the gastrointestinal tract:
A simultaneous application of naproxen sweaters with other NSAR, including so-called COX 2 inhibitors (Cycloxigenase-2 inhibitors) should be avoided. Side effects can be reduced by applying the lowest effective dose to the shortest time required for symptom control.

Elderly patients:
In the case of elderly patients, adverse effects after the application of NSAR, in particular bleeding and breakthroughs in the stomach and intestinal sector, which may may be life-threatening. Therefore, in older patients, a particularly careful medical monitoring is required.

Bleeding of the Magen bowel tract, ulcers and breakthroughs (Perforations):
Bleeding of the gastrointestinal tract, ulcers and perforations, even with fatal output, were reported during treatment with all NSAs. They occurred with or without prior warning symptoms or Serious events in the gastrointestinal tract in the prehistory at any time of therapy. The risk for the occurrence of gastrointestinal bleeding, ulcers and breakages is higher with increasing NSAR dose, in patients with ulcations in the history, in particular with the complications of bleeding or breakthrough (see Section 2: "Naproxen Schwörer must not be taken become "), and in older patients. These patients should start treatment with the lowest available dose. For these patients as well as patients receiving accompanying therapy with low-metered acetylsalicylic acid (ASS) or other medicines that may increase the risk of gastrointestinal diseases require combination therapy with gastric mucosal protective medicines (e.g., misoprostol or proton pump inhibitor) are considered. If you, especially at a higher age, have a history of side effects on the gastrointestinal tract, you should report any unusual symptoms in the abdomen (especially gastrointestinal bleeding), especially at the beginning of the therapy. Caution is advised if you at the same time receive medicines that can increase the risk of ulcers or bleeding, such as: As oral corticosteroids, blood cluttering drugs such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, for the treatment of depressive moods, or thrombocyte aggregation inhibitors such as ass (s. Section 2: "When taking / application of naproxen sweaters with other medicines"). If).
it comes to gastrointestinal bleeding or ulcers during treatment with naproxen sweaters, the treatment must be deducted. NSAR should be in patients with a gastrointestinal disease in the prehistory (Colitis ulcerosa, Crohn's disease) to be used with caution, as your condition can deteriorate (see Section 4:

Effects at the cardiovascular system.
Pharmaceuticals such as naproxen sweaters may be associated with a slightly increased risk of cardiac attacks ("heart attack") or strokes. Any risk is more likely with high doses and longer lasting treatment. Do not exceed the recommended dose or treatment time (maximum 4 days)! If you have heart problems or a preceding stroke or think that you could have a risk to these diseases (e.g., if you have high blood pressure, diabetes or high cholesterol levels or smokers), you should discuss your treatment with your doctor or pharmacist:

Skin reactions.
NSAR therapy has been very rarely reported on serious skin reactions with redness and blistering, some fatal output (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis / Lyell syndrome; s. Section 4). The highest risk of such reactions seems to be at the beginning of therapy, as these reactions occurred in the majority of cases in the first treatment month. At the first sign of rashes, mucosal defects or other signs of a hypersensitivity reaction, naproxen skew should be discontinued and the doctor should be consulted immediately:

Other notes:
Naproxen sweaters should only be applied under strict balance of benefit risk ratio)

• for certain congenital blood formation disorders (eg. B. acute intermittent porphyria).
• For certain autoimmune diseases (systemic lupus erythematosodes and mixing collagenosis:

A particularly careful medical monitoring is required

• with impaired renal or liver function
• immediately after larger surgical procedures.
• In allergies (e.g., skin reactions on other medicines, asthma, hay fever), chronic nasal mucosal thriplets or chronic respiratory respiratory respiratory diseases

Severe acuteHypersensitivity reactions (for example, anaphylactic shock) are very rarely observed. For the first signs of a heavy hypersensitivity reaction after taking / administration of naproxen sweaters, the therapy must be aborted. The symptoms corresponding, medically necessary measures must be initiated by expert persons. Naproxen, the active ingredient of naproxen sweaters, can temporarily the platelet function (Thrombocyte aggregation) inhibit. Patients with blood clotting disorders should therefore be carefully monitored. With longer permanent administration of naproxen sweaters, a regular control of liver values, renal function and blood image is required. When taking naproxen sweaters before operational interventions, the doctor or dentist should be consulted or to inform. For prolonged use of painkillers, headaches can not be treated by increased doses of the medicine. Ask your doctor about advice if you often suffer from headaches despite taking naproxen sweatshops! Generally, the habitual intake of painkillers, especially when combining multiple analgesic agents, can lead to permanent kidney damage with the risk of renal failure (analgesics nephropathy). Naproxen sweaters belongs to a group of medicines (NSAR), which can affect the fertility of women. This effect is reversible after discontinuation of the medicine (reversible).

Children:
Please note the instructions under Section 2: "Naproxen sweaters must not be taken".

When taking / application of naproxen sweaters with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines. The simultaneous use of naproxen sweaters and digoxin (means for strengthening heart force), phenytoin (agent for the treatment of convulsive accidents) or lithium (agents for the treatment of spiritual-mental disorders) can increase the concentration of these medicines in the blood. A control of serum lithium mirrors, the serum digoxin and serum phenytoin mirror is when used as intended (Maximum over 4 days) usually not required. Naproxen sweaters can weaken the effect of dewatering and blood pressure-lowering medicines (diuretics and antihypertensives). Naproxen sweaters can weaken the effect of ACE inhibitors (means for the treatment of heart failure and hypertension). With simultaneous use, the risk for the occurrence of a kidney function malfunction may continue to increase. The simultaneous administration of naproxen sweaters and potassium-efficient drainage means (certain diuretics) can lead to an increase in the potassium mirror in the blood. Simultaneous administration of naproxen sweaters with other inflammatory and pain-resources from the group of NSA and glucocorticoids increases the risk of gastrointestinal ulcers or bleeding. Thrombocyte aggregation inhibitors such as acetylsalicylic acid and certain antidepressants (selective serotonin recording inhibitors / SSRI) Can increase the risk of gastrointestinal bleeding. The administration of naproxen sweaters within 24 hours before or after administration of methotrexate can lead to an increased blood concentration of methotrexate and an increase in undesirable effects. Certain NSAR, such as naproxen, can strengthen the kidney-damaging effect of Ciclosporin (agent which is used to prevent transplant compounds, but also in rheumatic treatment). NSAR can enhance the effect of blood clotting inhibiting medicines such as warfarin.

When taking Naproxen sweaters together with food and beverages:
During the use of naproxen sweaters, you should not drink alcohol as possible.

Pregnancy:
If a pregnancy is detected during the use of naproxen sweaters, the doctor is notified. You may use naproxen sweaters in the first and second pregnancy a third party only after consulting your doctor. In the last third of pregnancy naproxen sweaters may not be used because of an increased risk of complications for mother and child.

Latving:
The active ingredient naproxen and its degradation products go over in small amounts into the breast milk. An application of naproxen sweaters during breastfeeding should be avoided as a precaution.

Driveion and use of machines:
Since in the use of naproxen sweaters in higher dosing central nervous side effects such as fatigue and dizziness can occur, the reaction assets can be changed in individual cases and the ability to actively participate in road traffic and servicing machines can be affected. This applies even more in combination with alcohol. You can then no longer respond to unexpected and sudden events quickly and specifically enough. Do not drive in this case car or other vehicles! Do not operate any tools or machines! Do not work without a safe grip!

3. How is Naproxen swearing to take?

Unless otherwise prescribed by the doctor, the following dosing guidelines apply: Always take Naproxen Schwörer exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure. Take naproxen sweaters without medical or dental advice no longer than 3 days for fever or 4 days in pain. Unless otherwise prescribed by the doctor, the usual dose is:

Age: First Dose: Further single dose: At a distance of 8 - 12 hours to take maximum daily dose:
Adults and adolescents from 12 years1 - 2 film-coated tablets (corresponding to 220 mg to 440 mg naproxen sodium) 1 film tablet (corresponding to 220 mg of naproxen sodium) to 3 film-coated tablets (corresponding to up to 660 mg naproxen sodium)

Patients with impaired liver or renal function should not take more than 2 film-coated tablets per day, distributed to 2 single doses. Please take the film-coated tablets so far with plenty of fluid (eg. As a glass of water) as possible before eating. This promotes the effect entry. For patients who have a sensitive stomach, it is recommended to take naproxen sweaters during meals. Please talk to your doctor or pharmacist if you have the impression that the effect of naproxen sweaters is too strong or too weak.

If you take more Naproxen sweaters than you should:
As symptoms of overdose can cause abdominal pain, nausea and vomiting. Furthermore, it can also lead to a headache, dizziness, dizziness, visual disturbances and frightening, ears, as well as rarely to blood pressure drops and unconsciousness. If there is suspected overdose with naproxen sweatshop, please notify your doctor. If you feel, do not feel sufficient pain relief, then do not independently increase the dosage, but talk to your doctor.

If you forget to take Naproxen sweaters:
If you have forgotten taking once, take more than the usual recommended amount at the next gift.

4. Which side effects are possible?

Like all medicines, naproxen sweatshirt can also have side effects. If you are watching the following side effects, please discuss this with your doctor who determines how to proceed. The assessment of side effects is based on the following frequency information:

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Possible side effects:
The enumeration of the following undesirable effects includes all Bekannext effects under treatment with naproxen, including those under high-dose long-term therapy for rheumatist. The frequency information that goes beyond very rare messages relate to the short-term application up to daily doses of a maximum of 750 mg naproxen for oral dosage forms (3 film-coated tablets correspond to 660 mg of naproxen sodium). The following undesirable pharmaceutical effects must be taken into account that they are predominantly dose-dependent and patient to patient. The most frequently observed side effects involve the digestive tract. Stomach / duodenal ulcers (Peptic ulcer), perforations (breakthroughs) or bleeding, sometimes fatal, can occur, especially in older patients (see Section 2). Nausea, vomiting, diarrhea, bloating, constipation, digestive complaints, abdominal pain, teery chair, blebering, ulcerative stomatitis and aggravation of colitis and crohn's disease (see Section 2) have been reported according to application. Less frequently gastritis has been observed. In particular, the risk of the occurrence of gastrointestinal bleeding depends on the dose range and the application time. Edema, hypertension and heart failure were reported in connection with NSAR treatment. Pharmaceuticals such as naproxen sweaters may be with a slightly increased risk of cardiac cases ("Heart attack") or strokes connected.

Heart diseases:
- Very rare: heart muscle weakness (heart failure).

Diseases of the blood and the lymphatic system:
- Very rare: disorders of blood formation: Leukopenia (reducing white blood cells), thrombocytopenia (reducing platelets), tank tops (reducing blood cells of all systems), agranulocytosis (reduction of granulocytes). First symptoms can be: fever, sore throat, superficial wounds in the mouth, flu-like discomfort, strong shock, nosebleed and skin bleeding. During long-term therapy, the blood count should be regularly controlled.

Diseases of the nervous system:
- Often: headache, dizziness.

Eye diseases:
- Occasionally: visual disturbances.

Diseases of the ear and the labyrinth:
- Very rare: hearing disturbances, ear noises (tinnitus).

Diseases of the gastrointestinal tract:
- Often: gastrointestinal complaints such as nausea, heartburn, stomach ache.
- Occasionally: bloating, constipation (constipation), diarrhea (Diarrhea); Ulcers of the gastrointestinal tract (gastrointestinal ulcer), under certain circumstances with bleeding, vomiting of blood (Hematemesis), bloody chair (melana) and breakthrough.
- Rare: vomiting. If stronger pain in the upper abdomen, bruising, blood in the chair and / or a black staining of the chair occur, so you have to settle naproxen sweaters and immediately inform the doctor.

Diseases of kidneys and urinary tract:
- Occasionally: Reduction of urinary excretion. Water collection in the body (training of Ödemen, e.g. peripheral edema), especially in patients with hypertension or renal insufficiency.
- very rare: kidney taste damage (papilla nephosis), especially for long-term therapy; Increased urinary acid concentration in the blood (hyperuricemia); Acute kidney failure, nephrotic syndrome (water collection in the body and strong protein excretion in urine), interstitial nephritis (inflammatory kidney disease). Reduction of urinary excretion, accumulation of water in the body (Edema) and general malaise may be an expression of kidney disease to renal failure. If the symptoms mentioned appear or worse, you must settle naproxen sweaters and contact your doctor immediately. Kidney function should be regularly controlled for prolonged application.

Diseases of the skin and subcutaneous tissue:
- Rare: increased photosensitivity.
- Very rare: alopecia (hair loss, mostly reversible). Pseudoporphyrie (reinforced vulnerability of the skin with bubbles after injury). Heavy (bulleas) skin reactions like rash with redness and blistering (Stevens-Johnson syndrome and toxic epidermal necrolysis / Lyell syndrome).

Infections and parasitic diseases:
- very rare under the use of naproxen the symptoms of a brain inflammation (aseptic Meningitis) How strong headaches, nausea, vomiting, fever, neck stiffness or consciousness true is observed. An increased risk seems to be for patients who already suffer from certain autoimmune diseases (systemic lupus erythematoses, mixing collagenosis.
- Very rare is in the temporal connection with the application of certain anti-inflammatory medicinal products (NSAR, including naproxen sweaters), a deterioration of infectious inflammation (e.g., developing a necrotizing fasciitis) has been described. If during the use of naproxen sweatshops of an infection (e.g., Redness, swelling, overheating, pain, fever) occur or worsen, therefore, should the doctor be consulted immediately.

Vascular diseases:
- Very rare: hypertension (hypertension).

Diseases of the immune system:
- Occasionally: Hypersensitivity reactions with rashes, skinchilds and skin bleeding. In this case, the doctor is to be informed immediately, and Naproxen sweaters can no longer be taken.
- very rare: asthma attacks (possibly with blood pressure drop); Bronchospasms (spasm of bronchial muscles); Eosinophilic pneumonia (certain form of pneumonia); Heavy general hypersensitivity reactions. Signs can be: Facial, tongue and larynet edema, shortness of breath, tachycardia, blood pressure down to life-threatening shock. If these appearances occur, which can occur even with initial applications, immediate medical assistance is required.

Liver and bile diseases:
- Very rare: liver damage, especially for long-term therapy.

Psychiatric diseases:
- Occasionally: insomnia, excitement, irritability, fatigue.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How is Naproxen to store sworn?

Store drug out of reach of children! Store in the original packaging to protect the content from light. You must not use the medicinal product after the expiration date specified on the carton / blister strip no longer.

6. Further information

What contains naproxen sweaters?
The active ingredient is: naproxen as a sodium salt. 1 film tablet contains 220 mg of naproxen sodium, corresponding to 200 mg of naproxen. The other ingredients are: microcrystalline cellulose, talcum, povidone (25), hypromellosis, magnesium stearate (ph.eur.), Macrogol (4000), titanium dioxide.

Like naproxen sweaters looks and content of the pack:
Naproxen swear is a white round film tablet. Available in packs of 10, 20 and 30 film-coated tablets.

Pharmaceutical entrepreneur and manufacturer:
Pharma Schwörer GmbH
Goethestraße 29
D-69257 Wiesenbach
Telephone: 06223 4347
Fax: 06223 47438
E-mail: [email protected]

This information information was last revised in April 2016.

Source: Information of the leaflet
Status: 12/2016