ESBRIET 801 MG FILM COATED TABLET

Product Description:

• Esbriet contains the active substance pirfenidone and is used to treat mild to moderate idiopathic pulmonary fibrosis (ilf) in adults.


• Ilf is a condition where the lung tissue becomes swollen and scarred over time, making it difficult to breathe deeply. 


• This makes it difficult for the lungs to function as they should. 


• Esbriet helps to reduce scarring and swelling in the lungs, and makes it easier to breathe better.

Warnings And Precautions:

Do not use Esbriet:

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients in this medicine.


• If you have previously had angioedema associated with the use of pirfenidone, including symptoms such as swelling of the face, lips and/or tongue, which may be associated with breathing problems or wheezing


• If you are using a medicine called fluvoxamine (used to treat depression and obsessive -compulsive disorder )


• If you have severe or terminal liver disease.


• If you have severe or terminal kidney disease requiring dialysis.


• Do not take Esbriet if any of the above applies to you. Consult your doctor or pharmacist if you are unsure.


• Talk to your doctor or pharmacist before using Esbriet.


• You may become more sensitive to sunlight (photosensitivity reaction) while taking Esbriet. Avoid the sun (including solarium) while taking Esbriet. Use sunscreen daily and cover your arms, legs and head to reduce exposure to sunlight .


• You should not take other medicines, such as tetracycline antibiotics (such as doxycycline), which can make you more sensitive to sunlight.


• Inform the doctor if you have kidney problems.


• Tell your doctor if you have mild to moderate liver problems.


• You should stop smoking before and during treatment with Esbriet.


• Cigarette smoking can reduce the effectiveness of Esbriet.


• Esbriet can cause dizziness and chronic fatigue. 


• Be careful if you are going to participate in activities where you have to be alert and have good coordination.


• Esbriet can cause weight loss. Your doctor will check your weight while you are taking this medicine.


• Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in connection with treatment with Esbriet.


• Stop using Esbriet and contact your doctor immediately if you notice any of the symptoms associated with these serious skin reactions.


• Esbriet can cause serious liver damage which in some cases has been fatal. You must have a blood test before you start Esbriet, every month for the first 6 months and then every 3 months while you are taking this medicine, to check if your liver is working properly. It is important that you have these regular blood tests as long as you are taking Esbriet.

Children and youth:

• Esbriet must not be given to children and adolescents under the age of 18.

Taking esbriet with food and drink:

• Do not drink grapefruit juice while taking this medicine. Grapefruit can prevent esbriet from working properly.

Pregnancy And Breastfeeding:

• As a precaution, it is best to avoid using esbriet if you are pregnant, planning to become pregnant or think you may be pregnant. 


• The risk to the unborn child is unknown.


• Consult your doctor or pharmacist before taking esbriet if you are breast-feeding or plan to breast-feed.


• It is unknown whether esbriet passes into breast milk.


• If you wish to breast-feed, your doctor will discuss with you the risks and benefits of taking this medicine while you are breast-feeding.

Driving and using machines:

• Do not drive or use machines if you are dizzy or tired after taking esbriet.

How To Use:

• Treatment with Esbriet should be started and monitored by a specialist with experience in the diagnosis and treatment of idiopathic pulmonary fibrosis .


• Always use this medicine exactly as your doctor or pharmacist has told you. Contact a doctor or pharmacist if you are unsure.


• You will usually receive the medicine in increasing doses as follows:


• For the first 7 days, take one dose of 267 mg (1 yellow tablet) 3 times a day with food (total 801 mg/day)


• From day 8 to 14, take one dose of 534 mg (2 yellow tablets or 1 orange tablet) 3 times a day with food (total 1602 mg/day)


• From day 15 onwards (maintenance) take one dose of 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food (total 2403 mg/day).


• The recommended daily maintenance dose of Esbriet is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, a total of 2403 mg/day.


• Swallow the tablets whole with water, during or after a meal to reduce the risk of side effects such as nausea and dizziness. See a doctor if symptoms persist.


• Dose reduction in case of side effects
  The doctor can reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or solarium or significant liver enzyme changes.

If you take too much Esbriet:

• Contact a doctor, pharmacy or emergency room immediately if you have taken too many tablets, and take the medicine with you.

If you have forgotten to take Esbriet:

• If you have forgotten a dose, take it as soon as you remember. 


• You must not take a double dose to make up for a missed dose.


• At least 3 hours should pass between each dose. 


• You must not take more tablets per day than your doctor has prescribed.

If you stop treatment with Esbriet:

• In some situations, your doctor may recommend that you discontinue treatment with Esbriet. 


• If for any reason you have to stop taking Esbriet for more than 14 consecutive days, your doctor will restart treatment with one dose of 267 mg 3 times a day and gradually increase to one dose of 801 mg 3 times a day.


• Ask your doctor or pharmacist if you have any questions about the use of this medicine.

Ingredient:

• 801 mg tablet
  The active substance is pirfenidone. 


• Each film-coated tablet contains 801 mg of pirfenidone.

What Esbriet looks like and the contents of the pack

801 mg tablet:

• Esbriet 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets, marked “PFD”.
  The box pack contains one box of 90 tablets.
  

Product Details: