DICLOFENAC POTASSIUM

Main information

  • Trade name:
  • DICLOFENAC POTASSIUM- diclofenac potassium tablet, film coated
  • Composition:
  • DICLOFENAC POTASSIUM 50 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DICLOFENAC POTASSIUM- diclofenac potassium tablet, film coated
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are indicated: - For treatment of primary dysmenorrhea - For relief of mild to moderate pain - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis Diclofenac is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS ; Anaphylactic Reactions, Serious Skin Reactions ). - History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in s
  • Product summary:
  • Product: 50090-0646 NDC: 50090-0646-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-0646-1 21 TABLET, FILM COATED in a BOTTLE NDC: 50090-0646-3 45 TABLET, FILM COATED in a BOTTLE NDC: 50090-0646-4 90 TABLET, FILM COATED in a BOTTLE

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 50090-0646-0, 50090-0646-1, 50090-0646-3, 50090-0646-4
  • Last update:
  • 28-05-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

A-S Medication Solutions

----------

Medication Guide for Nonsteroidal Anti-

Inflammatory Drugs (NSAIDs)

What is the most

important information I

should know about

medicines called

Nonsteroidal Anti-

inflammatory Drugs

(NSAIDs)?

NSAIDs can cause serious

side effects, including:

Increased risk of a

heart attack or

stroke that can lead

to death. This risk

may happen early

in treatment and

may increase:

with

increasing

doses of

NSAIDs

with longer

use of

NSAIDs

Do not take NSAIDs right

before or after a heart

surgery called a “coronary

artery bypass graft

(CABG).”

Avoid taking NSAIDs

after a recent heart attack,

unless your healthcare

provider tells you to. You

may have an increased

risk of another heart attack

if you take NSAIDs after a

recent heart attack.

Increased risk of

bleeding, ulcers,

and tears

(perforation) of the

esophagus (tube

leading from the

mouth to the

stomach), stomach

and intestines:

anytime

during use

without

warning

symptoms

that may

cause death

The risk of getting an

ulcer or bleeding increases

with:

past history of

stomach ulcers, or

stomach or

intestinal bleeding

with use of

NSAIDs

taking medicines

called

“corticosteroids”,

“anticoagulants”,

“SSRIs”, or

“SNRIs”

increasing doses of

NSAIDs

longer use of

NSAIDs

smoking

drinking alcohol

older age

poor health

advanced liver

disease

bleeding problems

NSAIDs should only be

used:

exactly as

prescribed

at the lowest dose

possible for your

treatment

for the shortest

time needed

What are NSAIDs?

NSAIDs are used to treat

pain and redness,

swelling, and heat

(inflammation) from

medical conditions such as

different types of arthritis,

menstrual cramps, and

other types of short-term

pain.

Who should not take

NSAIDs?

Do not take NSAIDs:

if you have had an

asthma attack,

hives, or other

allergic reaction

with aspirin or any

other NSAIDs.

right before or

after heart bypass

surgery.

Before taking NSAIDs,

tell your healthcare

provider about all of your

medical conditions,

including if you:

have liver or

kidney problems

have high blood

pressure

have asthma

are pregnant or

plan to become

pregnant. Talk to

your healthcare

provider if you are

considering taking

NSAIDs during

pregnancy. You

should not take

NSAIDs after 29

weeks of

pregnancy.

are breastfeeding

or plan to breast

feed.

Tell your healthcare

provider about all of the

medicines you take,

including prescription or

over-the-counter

medicines, vitamins or

herbal supplements.

NSAIDs and some other

medicines can interact

with each other and cause

serious side effects. Do

not start taking any new

medicine without talking

to your healthcare

provider first.

What are the possible side

effects of NSAIDs?

NSAIDs can cause serious

side effects, including:

See “What is the most

important information I

should know about

medicines called

Nonsteroidal Anti-

inflammatory Drugs

(NSAIDs)?

new or worse high

blood pressure

heart failure

liver problems

including liver

failure

kidney problems

including kidney

failure

low red blood cells

(anemia)

life-threatening

skin reactions

life-threatening

allergic reactions

Other side effects

of NSAIDs

include: stomach

pain, constipation,

diarrhea, gas,

heartburn, nausea,

vomiting, and

dizziness.

Get emergency help right

away if you get any of the

following symptoms:

shortness of breath

or trouble

breathing

chest pain

weakness in one

part or side of your

body

slurred speech

swelling of the

face or throat

Stop taking your NSAID

and call your healthcare

provider right away if you

get any of the following

symptoms:

nausea

more tired or

weaker than usual

diarrhea

itching

your skin or eyes

look yellow

indigestion or

stomach pain

flu-like symptoms

vomit blood

there is blood in

your bowel

movement or it is

black and sticky

like tar

unusual weight

gain

skin rash or blisters

with fever

swelling of the

arms, legs, hands

and feet

If you take too much of

your NSAID, call your

healthcare provider or get

medical help right away.

These are not all the

possible side effects of

NSAIDs. For more

information, ask your

healthcare provider or

pharmacist about

NSAIDs.

Call your doctor for

medical advice about side

effects. You may report

side effects to FDA at 1-

800-FDA-1088.

Other information about

NSAIDs

Aspirin is an

NSAID but it does

not increase the

chance of a heart

attack. Aspirin can

cause bleeding in

the brain, stomach,

and intestines.

Aspirin can also

cause ulcers in the

stomach and

intestines.

Some NSAIDs are

sold in lower doses

without a

prescription (over-

the-counter). Talk

to your healthcare

provider before

using over-the-

counter NSAIDs

for more than 10

days.

General information about

the safe and effective use

of NSAIDs

Medicines are sometimes

prescribed for purposes

other than those listed in a

Medication Guide. Do not

use NSAIDs for a

condition for which it was

not prescribed. Do not

give NSAIDs to other

people, even if they have

the same symptoms that

you have. It may harm

them.

If you would like more

information about

NSAIDs, talk with your

healthcare provider. You

can ask your pharmacist or

healthcare provider for

information about

NSAIDs that is written for

health professionals.

This Medication Guide

has been approved by the

U.S. Food and Drug

Administration.

Revised May 2016

Revised: 1/2019

Document Id: 38eb1211-3f0e-4925-9341-4b9feb450633

34391-3

Set id: 29235691-2395-4ea1-892a-379c59e7d3c4

Version: 7

Effective Time: 20190124

A-S Medication Solutions