Diflam tablets

Diflam

  • Active Ingredient: Diclofenac
  • 100 mg
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What is Diflam?

The active ingredient of Diflam brand is diclofenac. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. The inactive ingredients in Diclofenac sodium delayed-release tablets include: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Used for

Diflam is used to treat diseases such as: Ankylosing Spondylitis, Aseptic Necrosis, Back Pain, Frozen Shoulder, Migraine, Muscle Pain, Osteoarthritis, Pain, Period Pain, Rheumatoid Arthritis, Sciatica, Spondyloarthritis.

Side Effect

Possible side effects of Diflam include: vomiting of blood or material that looks like coffee grounds; belching; hearing loss; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; slow or fast heartbeat; pale skin.

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Rated Diflam for Osteoarthritis Report

The best NSAID I have found for my arthritis pain. Took ibuprofen, Aleve, meloxicam, none of which worked.

On this page

  1. About Diflam
  2. Key facts
  3. Who can take and can't take Diflam
  4. How and when to use them
  5. Taking Diflam with other painkillers
  6. Side effects
  7. How to cope with side effects
  8. Pregnancy and breastfeeding
  9. Cautions with other medicines
  10. Common questions

Serious allergic reaction

In rare cases, it's possible to have a serious allergic reaction to Diflam.

Q: What are the side effects of Diflam?

A: Diflam is a medication in the NSAID family of drugs that is used to treat pain caused by inflammation. Diflam is used to treat a variety of conditions including arthritis, migraines, and joint pain. The prescribing information on Diflam lists the following as the most common side effects of the medication: stomach pain constipation or diarrhea heartburn gas nausea/vomiting dizziness swelling ringing of the ears. Some side effects that you should report to your physician include: slurred speech confusion weakness shortness of breath high blood pressure dark, tarry stools dark urine yellowing of the skin or eyes rapid weight gain or unusual swelling of the hands, feet or ankles. Lori Poulin, PharmD

Special Populations

Pediatric: The pharmacokinetics of VOLTAREN has not been investigated in pediatric patients.

Race: Pharmacokinetic differences due to race have not been identified.

Hepatic Impairment: Hepatic metabolism accounts for almost 100% of VOLTAREN elimination, so patients with hepatic disease may require reduced doses of VOLTAREN compared to patients with normal hepatic function.

Renal Impairment: Diflam pharmacokinetics has been investigated in subjects with renal insufficiency. No differences in the pharmacokinetics of Diflam have been detected in studies of patients with renal impairment. In patients with renal impairment (inulin clearance 60-90, 30-60, and

Hepatotoxicity

Elevated serum aminotransferase levels have been reported in up to 15% of patients taking oral Diflam chronically, but are greater than 3 times the upper limit of normal in only 2% to 4% (Cases 1 and 2). Clinically apparent and symptomatic liver disease with jaundice due to Diflam is rare (1 to 5 cases per 100,000 prescriptions, occurring in 1 to 5 persons per 10,000 exposed). Nevertheless, more than a hundred instances of clinically apparent liver injury due to Diflam have been reported in the literature and, in most case series, Diflam ranks in the top 10 causes of drug induced liver injury. The time to onset of liver injury varies from within a week to over a year after starting. The majority of cases present within 2 to 6 months (Cases 3 and 4), and the more severe cases tend to present earlier. The pattern of injury is almost exclusively hepatocellular, although cases presenting with mixed patterns have been reported. The clinical picture is that of jaundice preceded by anorexia, nausea, vomiting and malaise. Fever and rash occur in 25% of cases and some cases have immunoallergic features, while others resemble chronic hepatitis and have autoimmune features. In most cases, liver histology reveals an acute lobular hepatitis. However, a cases with prolonged latency Diflam hepatotoxicity can have clinical and histologic features of chronic hepatitis (Case 2). There seems to be greater susceptibility for Diflam liver injury among women than men. The injury can be severe, and several cases of acute liver failure have been attributed to Diflam.

Likelihood score: A (well known cause of clinically apparent liver injury).

Topical forms of Diflam (solutions, gels, creams, patches) have been associated with only a low rate of serum enzyme elevations (generally less than 1%) that may be no greater than occurs with placebo or vehicle application. However, product labels for topical Diflam mention the possibility of liver injury and at least one case of clinically apparent liver injury attributed to topical Diflam has been reported in the literature. Nevertheless, clinically apparent liver injury due to topical forms of Diflam must be exceedingly rare.

Labor Or Delivery

There are no studies on the effects of VOLTAREN during labor or delivery. In animal studies, NSAIDS, including Diflam, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

INDICATIONS

Carefully consider the potential benefits and risks of VOLTAREN ® (Diflam sodium enteric-coated tablets) and other treatment options before deciding to use VOLTAREN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).

VOLTAREN is indicated:

  • For relief of the signs and symptoms of osteoarthritis
  • For relief of the signs and symptoms of rheumatoid arthritis
  • For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

FDA warning: Nonstero >
  • This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
  • Diflam is a nonsteroidal anti-inflammatory drug (NSAID). All NSAIDs can increase your risk of heart attack, heart failure, or stroke. This risk can go up the longer you use NSAIDs, and if you use high doses. Your risk may be higher if you have risk factors for heart disease, such as high blood pressure. If you have heart disease, talk to your doctor before using Diflam. You shouldn’t use Diflam before you have surgery, especially heart bypass surgery. Talk to your doctor if you use Diflam and will have surgery soon. NSAIDs such as Diflam can increase your risk of serious side effects, including stomach bleeding or ulcers.

2. Key facts

  • Take Diflam tablets or capsules with a meal or snack, or just after eating.
  • It's best to take the lowest dose of Diflam for the shortest time to control your symptoms.
  • The most common side effects are headaches, dizziness, stomach pain, feeling or being sick, diarrhoea and rashes.
  • Diflam tablets come as either Diflam potassium or Diflam sodium. They work as well as each other.
  • Diflam is also called by the brand names Voltarol, Dicloflex, Econac and Fenactol.

Rare Side Effects

In severe cases, Diflam may cause a deadly liver condition known as fatal fulminant hepatitis.

Get medical help if you have any yellowing or graying of the skin or eyes, if your lower extremities or abdomen is swelling, if you are extra sleepy, or become confused.

How Diflam works

Diflam is given to treat painful conditions such as arthritis, sprains and strains, gout, migraine, dental pain, and pain after surgical operations. It eases pain and reduces inflammation. Diflam is available on prescription.

Diflam works by blocking the effect of chemicals in your body, called cyclo-oxygenase (COX) enzymes. These enzymes help to make other chemicals in the body, called prostaglandins. Prostaglandins are produced at sites of injury or damage, and cause pain and inflammation. By blocking the effect of COX enzymes, fewer prostaglandins are produced, which means pain and inflammation are eased.

There are two forms of Diflam - Diflam sodium and Diflam potassium. The main difference between the two is that Diflam potassium is absorbed into the body more quickly than Diflam sodium. A quick action is useful where immediate pain relief is required, and a prolonged action is more useful in reducing inflammation. Some brands of Diflam also contain a medicine called misoprostol. The brands are called Arthrotec® and Misofen®, and are prescribed for arthritis. Misoprostol helps to protect the stomach against irritation which can be caused by taking Diflam over a period of time.

Diflam is not a suitable medicine for people who have heart disease (such as heart failure), or who have circulatory problems, or who have had a heart attack or a stroke. This is because it has been found that there is a small increased risk of heart attack and stroke in this group of people. Other anti-inflammatory medicines are more suitable for people with these conditions - ask your doctor or pharmacist for advice about an alternative medicine.

Diflam is also formulated as skin gels, patches and as eye drops. There is more information about these formulations in the separate medicine leaflets called Diflam gel/patch for pain and inflammation, Diflam gel for sun damage and Diflam eye drops.

Other warnings

  • High blood pressure warning: This drug can cause high blood pressure, or worsen high blood pressure if you already have it. Your doctor will likely monitor your blood pressure while you use this drug.
  • Water retention warning: This drug can cause your body to retain water, leading to edema (swelling or puffiness).
  • Liver function warning: Using Diflam may affect some of your liver function tests. Your doctor should monitor your liver function while you use Diflam.
  • Allergic reaction warning: If you have an allergy to aspirin or other nonstero >

Diflam is a prescription drug. It comes as a topical gel, oral capsule, oral tablet, eye drops, transdermal patch, topical solution, and powder packets for oral solution.

Diflam topical gel is available as the brand-name drugs Solaraze and Voltaren. It’s also available as a generic drug. Generic drugs usually cost less than brand-name versions. In some cases, they may not be available in every strength or form as a brand-name drug.

Warnings for other groups

For pregnant women: Before 30 weeks of pregnancy, this drug is a pregnancy category C drug. After 30 weeks of pregnancy, it’s a pregnancy category D drug.

A category C drug means that means that studies have shown that the drug can be a risk to the offspring of lab animals. However, not enough studies have been done to show risk in humans.

Category D means two things:

  1. Studies show a risk of adverse effects to the fetus when the mother uses the drug.
  2. The benefits of using Diflam during pregnancy may outweigh the potential risks in certain cases.

Do not use Diflam if you’re pregnant, unless your doctor advises you to. Be especially sure to avoid using Diflam at 30 weeks of pregnancy and later.

For women who are breastfeeding: This drug may pass into the breast milk, which means it may pass to a child who is breastfed. This may lead to dangerous effects for the child.

Talk to your doctor regarding whether breastfeeding is a good choice for you.

For seniors: Seniors are at higher risk for stomach problems, bleeding, water retention, and other side effects from Diflam. Seniors may also have kidneys that aren’t working at peak levels, so the drug can build up and cause more side effects.


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