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BRIEF PRODUCT INFORMATION

1. HUMAN MEDICAL PRODUCT NAME

APROWELL 275 mg TABLET

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

3. PHARMACEUTICAL FORM

Film tablet.

APROWELL is, with a notch on the face (the tablet with notch can be split into equal halves, canby dividing

available in blister10 and 20 tablets in white and light convex roundbe used)

packs of.

4. CLINICAL FEATURES

4.1. Therapeutic indications

Treatment of symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis is indicated for the treatment of acute gouty

arthritis, acute musculoskeletal pain, postoperative pain and dysmenorrhea.

4.2. Posology and mode of administration

Posology / administration frequency and duration In the

treatment of pain, primary dysmenorrhea, acute musculoskeletal pain: The recommended initial dose is

550 mg, followed by 550 mg every 12 hours or 275 mg every 6-8 hours.

The initial daily dose should not exceed 1375 mg and then 1100 mg.

In Acute Gut: The recommended initial dose is 3 tablets (825 mg) and then1at 8-hour intervals

continued intablet (275 mg).

During long-term treatment, the dose canto increase or decrease according to the clinical response from the patient

be adjusted.

Inlowto provide a higher level of anti-inflammatory / analgesic activity as needed, the

patients who toleratedosesdaily dose up to 6 months can be increased up to 1500 mg. At such

high doses, physiciansincreased clinical benefits are greater than potentially increased risk

should observe that the.

Method:

of administrationSwallow the mouth with sufficient water. Should be taken after meals.

Additional information on special populations:

Kidney / Liver failure:

Should not be used if renal function tests are impaired.

Caution should be used when using in patients with hepatic dysfunction.

One or more liver function tests havenonsteroidal antiinflammatory drugs

been reported to increase with.

Pediatric population:

APROWELL shouldunder 16 years of age as safety and efficacy studies have not been completed

not be used in children. However, only juvenile rheumatoid arthritis shouldolder than 5 years

be used at a dose of 10 mg / kg / day in childrenwith an interval of 12 hours.

Geriatric population: As

the elimination of the drug may decrease in the elderly, caution should be exercised at the dose and the lowest effective dose should be

used.

In terms of risk of gastrointestinal bleeding patients during treatment with NSAIDs closely

II.shouldbeMonitoring

4.3. Contraindications

APROWELL is contraindicated in patients known to be hypersensitive to naproxen sodium.

Itasthma, urticaria or allergic reactions as a result of ingestion of aspirin or other NSAIDs

should not be used in patients with. Severe, rarelyNSAIDs have been reported in such patients

fatal, anaphylaxis-like reactions in. (See section 4.4 Special

-Warnings and measures)

aprowell, coronary artery bypass graft (CABG) surgery, peri-operative pain therapy

is contraindicated. (see section 4.4 Special warnings and precautions for use)

APROWELL,with previous or ongoing activeassociated with previous NSAID drug therapy

in patients with active or previous recurrentgastrointestinal bleeding or perforation

peptic ulcer / haemorrhage, in patients(two or more times, separately). separately proven ulcers

or bleeding) is contraindicated.

It should not be used in patients with severe renal, hepatic failure or severe heart failure.

It is contraindicated in the last trimester of pregnancy.

4.4. Special warnings and precautions for use

Cardiovascular (CV) risk

- NSAIDs can cause fatal CV thrombotic events, myocardial infarction, andrisk of stroke

an increased. This risk may increase depending on the duration of use. Theor

risk may be higher in patients with CVdisease risk factors. APROWELL

is contraindicated in the treatment of pain before coronary artery bypass surgery.Gastrointestinal (GI) risks

NSAIDsseverethat may be fatal, such as bleeding, ulceration, stomach or intestinal perforation

causeGI adverse effects. These adverse events may occur at any time,a prior warning

with or without.

Older patients have a higher risk of severe GI effects.Warnings

Careful use of those at risk for Alzheimer's disease

Cardiovascular effects

Cardiovascular Thrombotic Eventsstudies of

VariousCOX-2 selective and non-selective NSAIDs lasting up to three years,

severe cardiovascular (CV) thrombotic event, myocardial infarction and strokewhich can be fatal

have shown an increased risk of. COX-2 selective or non-selective NSAIDssimilar risks

may have. Patients with known KV disease or CV risk factors are at greater risk

. To minimize the potential CV risk in patients treated with NSAIDs,

the lowest effective dose should be used for the shortest possible time. Physicians and patientsalready have

should be prepared for such symptoms, even if they do notCV symptoms. Patientssevere CV

beaboutsymptoms and / or findings and what to do if they occur

shouldinformed.

use of aspirinrisk of a severe CV thrombotic event associated with NSAID use

There is no consistent evidence that thereduces the. The combined use of aspirin and NSAIDssevere

increases the risk of developinggastrointestinal (GI) events. (see section 4.4 Special

Warningsand Precautions)

COX-2 after selective NSAIDs CABG surgery of treatment of pain in the first 10-14 days, two

large, controlled clinical studyto increase myocardial infarction and stroke

was foundincidence.(see section 4.3. Contraindications ) hypertension

aprowell of NSAIDs includingexisting or new development of hypertension

leads to a deterioration ofand hypertension each of these conditionsincreasedrisk of CV

may contribute to an events.Inthiazide or loop diuretics when using NSAIDs,

patients usingthe response to these therapeutics may be impaired.including APROWELL

NSAIDsshould be used with caution in patients with hypertension.initiation of NSAID

Blood pressure (BP) should be closely monitored duringand during treatment.

Congestive heart failure and edema In

some patients receiving NSAIDs, fluid retention and edema were observed. APROWELLfluid

should be used with caution in patients withretention or heart failure.

heart failure, cardiac dysfunction, liver dysfunction, and hypertension

patients with sodium restriction, including

Caution should be exercised in. These risks increase after 10 days of use.

Gastrointestinal Effects - Ulceration, Bleeding and Perforation Risk:

NSAIDs including APROWELL mayfatal inflammation, bleeding, ulceration,

cause severe gastrointestinal (GI) adverse events such asstomach, thin and large bowel perforation

. These serious adverse eventsin patients treated with NSAIDs, with

can develop at any timeor without any stimulatory symptoms.

Only one of the five patients who developed severe adverse events in the upper GI tract during the treatment of NSAIDs was

symptomatic. Upper GI canal ulcers caused by NSAIDs, intensive bleeding and

perforation occur in approximately 1% of patients treated for 3 to 6 months and inoftreated for 1 year

2-4%patients. This trend continues in long-term use

and increases the likelihood of serious GI event development at any time of treatment.

However, short-term treatment is not without risk.

NSAIDs should becaution in patients with a history of ulcerative or gastrointestinal bleeding

prescribed with.prior history of peptic ulcer and / or gastrointestinal bleeding andNSAIDs

Patients withusing. The risk of GI bleeding increased 10-fold compared to those without these risk factors.

Patients treated with NSAIDs. Other factors that increase the risk of GI bleeding include the use of oral

corticosteroids or anti-coagulants, prolonged use of NSAIDs, smoking,

alcohol use, advanced age, and general impairment.of the spontaneousFatal GI events belong to

Mostreports ofpatients with poor health or general health, sothesepatients

care should be taken to treatgroups of.

The lowestto minimize the potential risk of GI in patients treated with NSAIDs

effective dose should be used as soon as possible. Doctors and patientsuse of NSAIDs

prepared for signs and symptoms of GI bleeding and ulceration during the

should be, and additional evaluation andimmediately if they suspect a serious GI adverse event

treatment should be initiated. This approachuntil the disappearance of the severe GI adverse event

should be the discontinuation of NSAIDs. Alternativewithout NSAIDsfor high-risk patients

treatmentshould be considered.