Diclofenac Sodium Enteric Coated Tablets 50mg

• Customization: Available
• Application: Internal Medicine
• Usage Mode: For oral administration
• Model NO.: Diclofenac 50mg
• Suitable for: Elderly, Children, Adult
• State: Solid
• Shape: Tablet
• Type: Organic Chemicals
• Pharmaceutical Technology: Chemical Synthesis
• Package: 10 Tablets* 2 Blisters/Box
• Carton Package: 100 Boxes
• Gross Weight: 8.5kg
• Net Weight: 7.2kg
• Quality Standard: Bp
• Transport Package: Carton
• Specification: 50mg
• Origin: China
• Production Capacity: 10000000 Boxes/Month

Product Description

What is Diclofenac Sodium Tablets used for?

Diclofenac Sodium Tablet is commonly used to treat pain that does not last for long periods, as well as redness, swelling, and inflammation caused by several conditions including arthritis and menstrual cramps.
Diclofenac Sodium Tablet is also used to treat migraines.
Diclofenac tablet may also be used for other conditions as determined by your healthcare provider.

How does diclofenac work (mechanism of action)?

Diclofenac works by blocking certain substances in the body (prostaglandins) that cause pain and inflammation.

How is diclofenac supplied (dosage forms)?

Dosage forms and strengths

• 50mg/single-dose packet for oral solution
• 25/50/100mg oral capsules
• 50 / 100mg oral tablets

How should I store diclofenac Sodium Tablets?

Diclofenac Sodium Tablets should be stored at room temperature, between 20 ºC to 25 ºC. It can be exposed to temperatures between 15 ºC to 30 ºC for shorter periods of time, such as when transporting it. Store in a cool, dry place, away from moisture.

Side Effects

What are the most common side effects of diclofenac?

The most common side effects of diclofenac are listed below.

• Stomach pain or upset stomach
• Constipation or diarrhea
• Nausea or vomiting
• Dizziness
• Drowsiness
• Sweating

There may be other side effects of diclofenac that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine.

What are the serious side effects of diclofenac?

While less common, the most serious side effects of diclofenac are described below, along with what to do if they happen.
Severe Allergic Reactions. Diclofenac can cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain
• Dark colored urine
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Heart Attack and Stroke. Diclofenac can increase your risk of a heart attack or stroke that can lead to death. This risk is increased in people with existing heart disease and with longer use of diclofenac and higher doses. Do not take diclofenac if you have had a recent heart attack without talking to your healthcare provider. This could increase your risk of having another heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.

• Chest pain or pressure
• Fast or abnormal heartbeat
• Trouble breathing
• Pain in your back, jaw, throat, or arm
• Sweating, upset stomach, vomiting, or dizziness
• Sudden weakness on one side of your body
• Sudden and severe headache
• Slurred speech or trouble understanding speech

Stomach Bleeding. Diclofenac can increase your risk of bleeding, ulcers, and tears (perforation) in your gut. The risk is higher if you have a history of stomach ulcers, bleeding problems, take higher doses of diclofenac or take it for longer than directed, have poor health, are of older age, have liver disease, smoke, drink alcohol, or take certain other medicines. Stop taking diclofenac and get emergency help if you have any of the following symptoms.

• Vomit blood
• Black or tarry poop
• Stomach pain that does not go away
• Upset stomach
• Feel faint

Bleeding. Diclofenac can increase your risk of bleeding, especially if you have a bleeding disorder or take other medicines that increase your risk of bleeding. Tell your healthcare provider right away if you notice signs of bleeding including easy bruising or bleeding.
Anemia. Diclofenac may cause anemia, which is when you have low levels of red blood cells. Tell your healthcare provider if you have any of the following symptoms of anemia.

• Unusual weakness or tiredness
• Cold hands and feet
• Fast or abnormal heartbeat
• Pale or yellowish skin
• Dizziness, lightheadedness, or feeling like you are about to pass out
• Shortness of breath

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking diclofenac. Stop taking diclofenac and call your healthcare provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting
• Stomach or belly pain
• Fever
• Weakness or unusual tiredness
• Itching
• Loss of appetite
• Light-colored poop
• Dark-colored urine (pee)
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure (Hypertension). Diclofenac may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while taking this medicine.
If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your healthcare provider right away if you have any of the following symptoms of severely high blood pressure.

• Sudden severe headache
• Chest pain
• Dizziness or confusion
• Trouble breathing
• Nausea or vomiting
• Blurry or other changes to vision
• Anxiety
• Buzzing in the ears
• Nosebleed
• Feeling of skipped heartbeats

Fluid Retention (Edema) and Heart Failure. Diclofenac can cause fluid retention, also called edema, which can lead to heart failure. Fluid retention can also cause serious issues in people with heart failure. Stop taking diclofenac and call your healthcare provider right away if you have any of the following symptoms. 

• Shortness of breath
• Stretched or shiny skin
• Swollen body parts, such as the belly or ankles
• Unusually fast weight gain
• Unusual tiredness

Kidney Damage. Kidney damage can happen when taking diclofenac. Call your healthcare provider right away if you have any of the following symptoms of kidney damage.

• Reduced need to pee
• Swelling in your feet, ankles, or legs
• Weakness or unusual tiredness
• Difficulty catching your breath or chest pain/pressure
• Confusion
• Nausea
• Seizures

High Potassium Levels (Hyperkalemia). Diclofenac can cause a high potassium level (hyperkalemia), which can be serious and may lead to death. Your healthcare provider may check your potassium levels, especially if you take certain other medicines. Call your healthcare provider right away if you have any of the following symptoms of a high potassium level.

• Muscle weakness or unusual tiredness
• Slow heartbeat or feeling of skipped heartbeats
• Nausea or vomiting
• Trouble breathing
• Abnormal heart rhythm

Severe Skin Reactions. Diclofenac can cause severe skin reactions, called Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop diclofenac and call your healthcare provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

• Painful red or purple skin that looks burned and peels off
• Flat red rash or blisters on your skin, mouth, nose, and genitals
• Red, painful, watery eyes

Warnings & Precautions

Who should not use diclofenac?

Allergies to Ingredients. People who are allergic to any of the following should not take diclofenac.

• Diclofenac
• Zipsor
• Cambia
• Bovine protein, which is commonly found in gelatin (capsules)
• Aspirin or any other medicine known as a non-steroidal anti-inflammatory drug (NSAID)
• Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific diclofenac products they stock.
Heart Surgery. Do not take diclofenac right before or after a heart surgery called coronary artery bypass graft (CABG). Taking diclofenac during this time can increase your risk of heart attack or stroke.

What should I know about diclofenac Sodium Tablet before using it?

Do not take diclofenac unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share diclofenac with other people, even if they have the same condition as you. It may harm them.
Keep diclofenac out of the reach of children.
You should take diclofenac at the lowest effective dose and for the shortest amount of time to treat your condition in order to minimize side effects. See the Side Effects section for more details.
People who are 65 and older can be at greater risk for some side effects from diclofenac. Talk to your healthcare provider about your risks if you are in this age group.
Diclofenac can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin. If you get a sunburn, stop taking diclofenac and call your healthcare provider right away.
If you are able to get pregnant, diclofenac may make this more difficult. These effects on fertility seem to be reversible. Talk to your healthcare provider if you have concerns about this.

What should I tell my healthcare provider before using Diclofenac Sodium Tablets?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if diclofenac is right for you.
Other Medicines and Supplements. Diclofenac may interact with other medicines and supplements. Before taking diclofenac, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Do not take diclofenac at 20 weeks or later in pregnancy without talking to your healthcare provider. Taking diclofenac during this time may cause harm to an unborn baby and complications during delivery. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take diclofenac while you are pregnant or trying to get pregnant.
Breastfeeding. Diclofenac passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take diclofenac while breastfeeding.

Interactions

Does diclofenac interact with foods or drinks?

There are no known interactions between diclofenac capsules and tablets (including delayed-release and extended-release tablets) and foods or drinks. However, taking the diclofenac liquid (made from the powder) with food may reduce how well it works. Diclofenac liquid should be taken on an empty stomach.
It is unknown if drinking alcohol will affect diclofenac, but both diclofenac and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does diclofenac interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking diclofenac.

• A blood thinner, such as warfarin, which is a medicine used to treat or prevent blood clots
• An antiplatelet medicine, such as clopidogrel (Plavix), ticagrelor (Brilinta), aspirin/dipyridamole, or cilostazol, which is a medicine used to prevent blood clots
• A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and OTC products for pain, swelling, and fever
• A corticosteroid, which is a medicine for certain inflammatory conditions
• Aspirin, which is in many prescription and OTC products, including those for pain, swelling, and fever
• A salicylate, such as diflunisal or salsalate, which is a medicine used for osteoarthritis or rheumatoid arthritis
• A selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), which is a medicine commonly used for anxiety and depression
• An angiotensin-converting enzyme (ACE) inhibitor, such as enalapril or lisinopril, which is a medicine for high blood pressure, heart failure, and certain kidney problems
• An angiotensin II receptor blocker (ARB), such as losartan or valsartan, which is a medicine for high blood pressure, heart failure, and other heart conditions
• A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
• Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
• Lithium, which is a medicine for certain mental health conditions
• Methotrexate (Trexall and others), which is a medicine commonly used for rheumatoid arthritis or certain types of cancer
• Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
• Pemetrexed (Alimta, Pemfexy), which is a medicine to treat certain cancers
• Voriconazole (Vfend), which is a medicine used for fungal infections
• Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis

This may not be a complete list of medicines that can interact with diclofenac. Always check with your healthcare provider.