Biofenac Tablet

Generic Name(s): Diclofenac

Why it's used

Biofenac Tablet is used to relieve pain and inflammatory conditions of joints. It is a prescription medicine. This medicine works by restricting the functions of natural enzymes (Cyclooxygenase -1 and Cyclooxygenase-2) in the body which prevents the release of inflammatory agents. Biofenac is also used to relieve pain and inflammatory conditions caused by injuries and diseases affecting body movements. It is also used to relieve pain and inflammation associated with other painful conditions such as fracture, trauma, low back pain, dislocations, dental and other minor operation, tearing or stretching of tissue that connects bones and joints, or pulled muscle.
Biofenac Tablet may also be taken in combination with other medicines to treat certain conditions as recommended by the doctor. Biofenac Tablet is used together with opioid Analgesics for the management of mild to severe pain.
When not to use
Biofenac Tablet cannot be used to treat pain that occurs after or before heart bypass surgery.
Nonsteroidal Anti-inflammatory Drugs
Biofenac belongs to a class of medicines called Nonsteroidal Anti-inflammatory Drugs. Nonsteroidal anti-inflammatory drugs, also called as NSAIDs, help reduce fever, decrease pain, and prevent clotting of blood. NSAIDs also reduce inflammation in the body when used in higher doses.

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How to use

Follow directions on the product label, information guide, and provided by your doctor before using Biofenac. Use this medicine as per your doctor's instructions.
Biofenac Tablet is used to relieve pain. Pain medicines usually work the best if used at the first sign of pain and may not work well if delayed until the symptoms have worsened.
Biofenac is used with or after food when taken by mouth.

Typical Dosage

The typical adult dose of Biofenac is 100-200 mg in one day. There are no known habit-forming tendencies with this medicine.
This medicine should be used on an as-needed basis.
If using the delayed-release form of this medicine, do not crush or chew the medicine, unless indicated on the package. Crushing or chewing of the medicine can result in unpleasant taste resulting in patients not following the medicine schedule. Crushing or chewing can also release all of the medicine at once, resulting in a decrease of effectiveness and a possible increase in side-effects.
To decrease the possibility of side-effects, you might be recommended to use the extended-release form of this medicine by your doctor. The extended-release medicine helps in maintaining a steady level of the medicine in your body for a longer period of time. Do not crush or chew the medicine, unless indicated on the package or by your doctor.
Biofenac injection is intended to use in the veins only. Inject over 15 seconds every 6 hours as desired.

Talk to Your Doctor

Tell your doctor if you develop new symptoms.
To see the impact of Biofenac Tablet on the body, your doctor may recommend a lower initial dose. Please follow your doctor's instructions carefully. A lower dose of Biofenac Tablet may be recommended to reduce the risk of side-effects.

Use in Children

The safety and effectiveness of using this medicine in children has not been established.

Avoid Alcohol

Avoid drinking alcohol with Biofenac.

Avoid Contact

Wash your hands thoroughly after touching or coming in contact with Biofenac.

Storage

Store Biofenac Tablet at 20-25°C (68 to 77°F) for injection and at 15-30°C (59-86°F) for the tablet, away from moisture, and away from light. Keep this medicine away from children and pets.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Biofenac Tablet for symptoms for which it was not prescribed. Do not give Biofenac Tablet to others who may have similar symptoms as you. Self-medication can cause harm.

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How to take Biofenac

The dose and frequency of using Biofenac will depend on the following factors:
  • age of the patient
  • the weight of the patient
  • patient's health
  • response to the medicine

Biofenac Dosage

Dosage for painful and stiff joints (osteoarthritis)

Adult
  • Recommended: 100-150 mg/day in divided doses (50 mg twice or thrice a day or 75 mg twice a day)

Dosage for swollen and painful joints (rheumatoid arthritis)

Adult
  • Recommended: 150-200 mg/day in divided doses (50 mg three or four times a day or 75 mg twice a day)

Dosage for inflammation of the spinal joints

Adult
  • Recommended: 100-125 mg/day, taken as 25 mg four times a day, with an extra dose of 25-mg at bedtime if necessary

Minimum Age

18 years

Forms

Tablet
Strength: 25 mg, 50 mg, 75 mg
Injection
Strength: 37.5 mg/mL

Special Instructions

Acute pain
A dose of 37.5 mg is given through an injection in the veins over 15 seconds after every 6 hours as needed. Do not exceed the dose more than 150 mg/day.

Overdose

What to do if you overdose on Biofenac?
If you have taken more than the recommended dose of Biofenac, an activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) may be given. Passing the contents of the bowels out of the body (osmotic cathartic) within 4 hours of ingestion with large overdose (5 to 10 times the usual dose) should be recommended.
Symptoms of an overdose of Biofenac
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Biofenac Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Biofenac

Before you use Biofenac, tell your doctor of your medical and health history including the following:
Patients with asthma, hives, allergic-type reactions and ulcer disease may experience severe and rarely fatal allergic reactions. Patients with stomach and intestinal bleeding may experience severe stomach bleeding on using this medicine. Patients with a history of heart disease are at an increased risk of thrombotic heart disease, heart attack, and stroke.
Before you use Biofenac Tablet, discuss with your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Tell your doctor if you are allergic any of the following substances: aspirin, or other NSAIDs.
Before having surgery during the use of Biofenac, discuss with your doctor and dentist about the medicinal products you use including prescription/non-prescription/herbal medicines.
The use of this medicine may change bleeding time. Patients with bleeding disorders or taking anticoagulants may experience increased bleeding time when using Biofenac. Such patients should be monitored for platelet function.
The use of this medicine may change hemoglobin. Blood deficiency (also known as anaemia) can occur in patients using this medicine. Check hemoglobin levels of patients who show any signs and symptoms of anemia.
The use of Biofenac Tablet may change blood pressure. Using Biofenac may lead to occurrence or worsening of high blood pressure. Blood pressure monitoring is required in the starting and during the course of therapy.
The use of this medicine may change transaminases (alanine transaminase and aspartate transaminase). Biofenac increases transaminases levels in the liver which may lead to severe liver reactions. Monitor transaminases within 4 to 8 weeks after taking Biofenac.
The use of Biofenac Tablet may change Complete blood count. Bleeding can occur in patients taking Biofenac and monitor signs and symptoms of bleeding. Check complete blood count in patients on long-term treatment with Biofenac.

Seizures

Biofenac Tablet can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Biofenac Tablet can worsen the sleepiness. Biofenac Tablet may cause rarely seizures in some people. If you perform any activities where a loss of consciousness may cause harm to you (or others), you should discuss with your doctor.

Use in Pregnancy

The use of Biofenac is known to be not safe for use in pregnant women. If you are planning to become pregnant or are currently pregnant, you should discuss with your doctor the potential impact of this medicine on the baby before you start to using it. This medicine may cause harm to an unborn baby such as heart dysfunction (also known as premature closure of the ductus arteriosus). Biofenac belongs to the NSAID class of medicines. NSAIDs should not be taken after 29 weeks of pregnancy as these medicines may cause serious harm to the unborn baby.

Use while Breastfeeding

The use of Biofenac Tablet Biofenac Tablet while breastfeeding should only be when required. It is not known whether this medicine passes into breast milk. This medicine should be used during breastfeeding only after considering the importance of the drug to the mother.

Use while Conceiving

Biofenac may impact fertility in women. If you are trying to conceive, discuss with your doctor on the use of this medicine. Use of Biofenac may decrease the conceiving abilities in women planning to become pregnant. Therefore, Biofenac should be discontinued in women having difficulties in conceiving or who are receiving infertility treatment.

Alcohol

Limit drinking alcohol with Biofenac. Drinking alcohol may cause increased risk of stomach and intestinal bleeding.

Increased Risks

This medicine may cause bleeding in the stomach. Regular use of tobacco or alcohol while using this medicine can increase your risk. Discuss with your doctor if you smoke and drink alcohol regularly. This medicine may increase your sensitivity to sunlight. If this happens, use a sunscreen and cover your skin when you are outdoors. Limit your time in the sun.

Long-term Use

Long-term use of this medicine may lead to kidney disorder (Renal Papillary Necrosis), kidney damage, heart attack, stroke, ulcers, and stomach and intestinal bleeding.

What precautions should be taken during Pregnancy and Nursing, and administering Biofenac to Children or the Older Adults?

Pregnant Women

Contraindicated or Not Recommended
Warning: This medicine may cause harm to an unborn baby such as heart dysfunction (also known as premature closure of the ductus arteriosus).

Breastfeeding

Only When Necessary
Warning: This medicine may pass into breast milk which may cause serious side effects to the fetus. #Name# should be used in breastfeeding mothers only if the potential benefit of the drug justifies its potential risk.

Younger Adults Population

No Known Risk
Warning: Safety and effectiveness of this medicine in children have not been confirmed.

Older Adults Population

Precaution
Warning: Elderly patients have decreased functioning of the kidney, precautions should take when using Biofenac. Also, kidney parameters should be monitored in such patients.

Biofenac Side-effects

The following side-effects may commonly occur when using Biofenac Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Biofenac Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
  • kidney insufficiency
Rarely, the use of Biofenac Tablet may cause the following side-effects:
The following severe side-effects may also occur when using Biofenac Tablet:
  • heart disorder such as stroke and heart attack (possibly fatal)
    The patient should get medical advice when experiencing such signs and symptoms.
  • serious skin adverse disorders such as redness and peeling of the skin (exfoliative dermatitis) and severe skin reaction (possibly fatal)
    Symptoms: skin rash, blisters, fever, itching, skin discoloration hives
    Discontinue the use of the drug at the first appearance of skin rash or any other signs of allergy.
  • gastrointestinal disorders (possibly fatal)
    Symptoms: stomach and intestinal bleeding, ulceration, and ruptured lining of the small intestine, stomach, or large intestine, diarrhea, dry mouth, indigestion, inflammation of the gastrointestinal tract (gastroenteritis), decreased appetite, nausea, rectal hemorrhage swelling and sores inside the mouth
    The medicine should be discontinued. Monitor the patients for signs or symptoms of gastrointestinal bleeding
  • severe liver reactions, including the decrease in liver size (fulminant hepatitis) with and without jaundice, jaundice and liver failure ((possibly) fatal and liver transplantation)
    Symptoms: increased number of eosinophiles (eosinophilia), rash, abdominal pain, diarrhea dark urine
    If the symptoms persist or worsen, the medicine should be discontinued.
  • metabolic and nutritional disorders
    Symptoms: creatinine increased
  • nervous system disorders
    Symptoms: depression, dizziness, drowsiness, lethargy burning sensation in the parts of the body
  • respiratory system disorder (possibly fatal and leads to bronchospasm)
    Symptoms: asthma, shortness of breath (dyspnea), sudden contraction of the larynx (laryngismus), inflammation of the larynx (laryngitis) inflammation of the pharynx (pharyngitis)
  • musculoskeletal disorders
    Symptoms: leg cramps muscle pain
  • sensory organ disorders
    Symptoms: abnormal vision, blurred vision, cataract, ear pain, eye disorder, eye pain, changes in taste loss of hearing
Your doctor has prescribed this medicine because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious cases of side-effects. This page does not contain a complete list of all possible side-effects.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Biofenac by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:
  • kidney insufficiency

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:
The medicine should be discontinued.

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
The medicine should be discontinued.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Exposure to Sun

Patients with sun exposure are at an increased risk when using this medicine. These patients are at an increased risk of ultraviolet light-induced skin cancer. Such patients should avoid exposure to sunlight.

Undergoing Treatment with Corticosteroids

Patients taking corticosteroid therapy are at an increased risk when using this medicine. These patients are at an increased risk of corticosteroid-induced illness after sudden discontinuation or substitution of corticosteroids with Biofenac. Patients should discontinue corticosteroids slowly.

Blood Coagulation Disorders

Patients with coagulation disorders are at an increased risk when using this medicine. These patients may experience prolonged bleeding when using Biofenac. Careful monitoring should be done of the patients who are affected by the change in the platelet function.

Non-Infectious and Painful Conditions

Patients with non-infectious and painful conditions are at an increased risk when using this medicine. Using Biofenac in these patients may reduce the use of diagnostic signs such as fever and inflammation.

Topical Use of Biofenac

Patients using Biofenac topically are at an increased risk when using this medicine. These patients are at an increased risk of irritation in the eyes. Such patients should wash their eyes and consult the doctor if irritation persists for more than one hour.

Kidney Injury and Damaging of Kidney Cells

Patients taking diuretics and ACE-inhibitors therapy are at an increased risk when using this medicine. Long-term use of Biofenac may result in damaged kidney cells and other kidney injuries. Patients should be cautious while taking this medicine.

Life-Threatening Allergic Reactions

Patients with aspirin-sensitive asthma or patients without prior exposure to Biofenac are at an increased risk when using this medicine. Severe or life-threatening allergic reaction (anaphylactoid reactions) may occur. Use this medicine with caution in patients with existing asthma.

Biofenac Use in Pregnancy or Breastfeeding

Pregnant women is at an increased risk when using this medicine. This medicine should not be used by pregnant women.

Severe Skin Disorders (exfoliative dermatitis)

Such patients are at an increased risk when using this medicine. This may affect absorption and tolerability of the Biofenac. It can cause serious skin adverse events such as severe skin reaction, and redness or peeling of the skin (exfoliative dermatitis). Patients should discontinue the medicine at the first appearance of skin rash.

History of Stomach Ulcers

Patients with the history of stomach ulcer or stomach and intestine disease are at an increased risk when using this medicine. These patients are at higher risk for developing bleeding in the stomach or intestine when using this medicine. Patients should start with the lowest dose for the shortest duration to decrease the risk of bleeding.

Heart Disorders

Patients with heart diseases such as thrombotic heart events, heart attack, and stroke may be at an increased risk. It may cause an increased risk of serious thrombotic heart events, heart attack, and stroke, which can be fatal. Patients should know about the signs or symptoms of serious heart disease and measures to take if they occur. Treatment should be started with the lowest effective dose for the shortest duration to minimize the risk of serious heart disease.

Stomach and Intestinal Adverse Events

Elderly patients, combined use of oral corticosteroids or anticoagulants and Biofenac, patients who are on longer duration of NSAID therapy, alcohol use, smoking, have poor general health status, and older age are at an increased risk for serious stomach and intestinal events such as bleeding, ulceration and perforation. Patients should use the lowest effective dose for the shortest duration to reduce the risk of stomach or intestinal bleeding.

Prolonged treatment with Biofenac

Patients taking Biofenac are at an increased risk when using this medicine. Elevation of transaminases, high blood pressure, heart disease and bleeding may occur. Long-term use of Biofenac can result in damaged kidney cells and other kidney injuries. The medicine should be discontinued immediately if increased transaminases or blood pressure persist or worsen.

Elderly Patients

Elderly patients are at an increased risk when using this medicine. Long-term use of Biofenac may result in damaged kidney cells and other kidney injuries. Patients should be cautious while taking this medicine.

Abnormal Functioning of Kidneys, Heart and Liver

Patients with abnormal functioning of kidneys, heart failure and liver dysfunction are at an increased risk when using this medicine. Long-term use of Biofenac may result in damaged kidney cells and other kidney injuries. Patients should be cautious while taking this medicine.

Interactions with Biofenac

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Biofenac Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Non-Steroidal-Anti-Inflammatory-Drugs

Biofenac Tablet may interact with aspirin, which is used to treat pain, fever, or inflammation. When Biofenac is used with aspirin, it potentially increases the undesired harmful effects. Patients should not take both medicines together.

Anticoagulants

There may be an interaction of Biofenac with anticoagulants (warfarin, NSAIDs and antiplatelets), which are used to prevent blood clot formation. When Biofenac is used with anticoagulants and antiplatelets, it increases the risk of stomach and intestinal bleeding. Patients should be cautious when taking both medicines together. Closely monitor such patients if required.

Antihypertensive Agents

Biofenac Tablet interacts with antihypertensive agents (beta-blockers, angiotensin converting enzyme (ACE) inhibitors), which are used to treat high blood pressure and heart failure. Biofenac decreases the blood pressure lowering effect of antihypertensive drugs. Precaution should be taken in patients using Biofenac with antihypertensives. The blood pressure should be regularly monitored in elderly patients. Patients who are at an increased risk of kidney failure should be monitored for the functioning of kidneys and should be properly hydrated.

Diuretics

Special instructions need to be followed while taking this medicine along with diuretics (furosemide and thiazides), which are used to treat heart failure and high blood pressure. Biofenac may reduce the sodium excretion (natriuretic) effect of furosemide and thiazides in the urine. When Biofenac is used with diuretics, patients should be observed for the signs of kidney failure to assure the ability for the production of urine.

Antidepressants

Your doctor's guidelines may need to be followed while taking this medicine along with lithium, which is used to treat mental disorders. Biofenac increases the level of lithium in the blood. Patients should be observed for the signs of harmful effects due to the increased amount of lithium in the body.

Anticancer Drugs

Biofenac Tablet may interact with methotrexate, which is used to treat breast and neck cancer. Biofenac restricts the accumulation of methotrexate in kidneys, which may lead to harmful effects of methotrexate. Patients should be cautious when using both medicines together.

Immunosuppressant

There may be an interaction of Biofenac with cyclosporine, which is used to prevent organ rejection of the heart, kidney, and liver. When Biofenac is used with cyclosporine, it may increase the cyclosporin induced kidney damage. Patients should take necessary precautions while taking cyclosporin in combination with Biofenac. Also, a lower dose of cyclosporin is recommended in such case.

Topical Treatments

Biofenac Tablet interacts with topicals sunscreen, insect repellant, lotion, moisturizer and cosmetics). Before any topical treatment to the same surface treated with Biofenac, patients should wait until the treated area gets completely dry.

Cardiac Glycosides

Special instructions need to be followed while taking this medicine along with digoxin, which is used to treat heart failure. Biofenac increases the level of digoxin in the blood. When Biofenac is used with digoxin, it is recommended to monitor digoxin levels in the blood.

Antifungal Drugs

Your doctor's guidelines may need to be followed while taking this medicine along with voriconazole, which is used to treat fungal infections. When Biofenac is used with voriconazole, it may lead to undesirable effects of Biofenac. The patient should be cautious when using Biofenac with voriconazole. Also, the dose adjustment is recommended in such patients.

Antibacterial Drugs

Biofenac Tablet may interact with rifampin, which is used to treat bacterial infections. When Biofenac is used with rifampin, it may lead to decreased effectiveness of Biofenac. The patient should be cautious when using Biofenac with rifampin. Also, the dose adjustment is recommended in such patients.

Antidiabetics

There may be an interaction of Biofenac with antidiabetics, which are used to treat high blood glucose levels. When Biofenac is used with antidiabetics, it can either increase or decrease the blood glucose levels. Monitoring of the blood glucose level is recommended in patients taking both medicines together.

Quinolone Antibiotics

Biofenac Tablet interacts with quinolones, which are used to treat bacterial infections. When Biofenac is used with quinolones, it may cause seizures. Patients should be cautious when using both medicines together.

Bile Acid Sequestrant

Special instructions need to be followed while taking this medicine along with colestipol and cholestyramine, which are used to lower blood cholesterol levels. These medicines can decrease the absorption of Biofenac. Take Biofenac at least one hour before or 4 to 6 hours after taking colestipol/cholestyramine.

Antiprogestogen

Your doctor's guidelines may need to be followed while taking this medicine along with mifepristone, which is used to cause an abortion during the early part of a pregnancy. Biofenac decreases the absorption of mifepristone. Biofenac should not be used for 8-12 days after taking mifepristone.

Interactions of Biofenac by Severity

Severe

The following medicines are usually not to be taken together without consulting with your doctor or pharmacist.

Serious

The following medicines may interact when taken together and can cause harmful effects in the body. Please consult with your doctor or pharmacist before taking these medicines together.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Biofenac be not used?

Pain due to Heart Surgery

This medicine should not be given in patients for pain right before or after heart bypass surgery such as coronary artery bypass graft (CABG) surgery. These patients are at an increased risk of heart failure and stroke.

Allergic to Biofenac, aspirin or other NSAIDs

This medicine should not be used in patients allergic to Biofenac, aspirin or other NSAIDs. These patients may experience serious skin events such as redness and removal of the upper layer of the skin (exfoliative dermatitis), life-threatening drug-induced skin reaction and life-threatening skin reaction (Stevens-Johnson Syndrome), which may result in hospitalization. These patients may have the following symptoms if they use this medicine:
  • skin rash
  • injury in the mucous membrane (mucosal lesions)

History of asthma and hives

This medicine should not be given to patients with a history of asthma and hives. These patients may experience severe and fatal allergic reactions.

Kidney Failure

This medicine should not be given to patients with kidney failure.

Liver Failure

This medicine should not be given to patients with liver failure.

Stomach Ulcer

This medicine should not be given to patients with stomach ulcer.

Heart and Brain Disease

This medicine should not be given to patients with brain disease and heart disease such as heart failure and in reduced blood flow to limbs (peripheral arterial disease).

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Biofenac is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Biofenac Tablet .
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