Sandoz Pirfenidone Tablets: Uses, Side Effects and Dosage

What is Sandoz Pirfenidone used for?

Sandoz Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.

How does Sandoz Pirfenidone work?

How Sandoz Pirfenidone works is not yet fully understood. It may reduce inflammation and fibrosis in your lungs. It may slow down worsening of your IPF.

What are the ingredients in Sandoz Pirfenidone?

Medicinal ingredient: pirfenidone

Non-medicinal ingredients:

• Capsules: Croscarmellose sodium, hypromellose, magnesium stearate and pregelatinized starch; Capsule shell: gelatin and titanium dioxide; Capsule printing ink: ammonium hydroxide, black iron oxide, potassium hydroxide, propylene glycol, and shellac.

• Tablets:

  • Tablet of 267 mg: Croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, silicon dioxide, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol-partly hydrolyzed, talc, titanium dioxide.
  • Tablet of 801 mg: Croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, pregelatinised starch, silicon dioxide, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, polyethylene glycol 3350, polyvinyl alcohol-partly

Serious Warnings and Precautions

Sandoz Pirfenidone come in the following dosage forms:

• Capsules: 267 mg.
• Tablets: 267 mg and 801 mg.

Do not use Sandoz Pirfenidone if:

• you are allergic to pirfenidone or any of the other ingredients in this medicine.
• you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue which may be associated with difficulty breathing or wheezing.
• you have severe or end-stage liver disease.
• you have severe or end-stage kidney disease or you require dialysis.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Pirfenidone. Talk about any health conditions or problems you may have, including if you:

• Have liver or kidney problems or disease.

• Are pregnant or planning to become pregnant. It is not known whether taking Sandoz Pirfenidone may be harmful to an unborn baby.

• Are breastfeeding or planning to do so. It is not known if Sandoz Pirfenidone passes into breast milk.

Other warnings you should know about:

Driving and using machines: Before you perform tasks, which may require you to be alert and coordinated, wait until you know how you will respond to Sandoz Pirfenidone. Dizziness and tiredness can occur when you take Sandoz Pirfenidone. Taking Sandoz Pirfenidone with food may decrease dizziness.

Be careful when driving or using machines.

Increased sensitivity to sunlight: You may become more sensitive to sunlight when taking Sandoz Pirfenidone.

You should:

• Avoid other medicines which may make you more sensitive to sunlight. Ask your pharmacist if you are not sure.
• Avoid or minimize exposure to direct or indirect sunlight, including through windows and from sunlamps.
• Wear an effective sunblock daily (at least SPF 50, against UVA and UVB).
• Wear clothing that protects against sun exposure such as a wide-brimmed hat and long sleeves.
• Seek shade.

Sandoz Pirfenidone can cause weight loss. Your healthcare professional will monitor your weight while you are taking this medicine.

Do not drink grapefruit juice during the time that you are taking Sandoz Pirfenidone. Grapefruit juice may prevent Sandoz Pirfenidone from working properly.

Do not smoke before and during treatment with Sandoz Pirfenidone. Cigarette smoking may reduce the effect of Sandoz Pirfenidone.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may also interact with Sandoz Pirfenidone:

• medicines used to treat an abnormal heartbeat (e.g., amiodarone, mexiletine, quinidine)
• medicines used to treat depression and/or anxiety (e.g., bupropion, duloxetine, fluoxetine, moclobemide, paroxetine)
• medicines used to treat seizures (e.g., carbamazepine, phenytoin)
• medicines used to treat bacterial infections (e.g., ciprofloxacin, rifampin)
• medicines used to treat heartburn (e.g., esomeprazole, omeprazole)
• medicines used to treat fungal infections (e.g., fluconazole, miconazole, terbinafine, voriconazole)
• Cinacalcet, used to lower parathyroid hormone levels
• methoxsalen, used to treat skin conditions such as psoriasis
• oral contraceptives (i.e., “The Pill” for birth control)

How to take Sandoz Pirfenidone:

• Sandoz Pirfenidone should only be prescribed and monitored by healthcare professionals with the appropriate training and experience in the diagnosis and treatment of IPF.
• Always take Sandoz Pirfenidone exactly as your healthcare professional has told you. You should check with your healthcare professional or pharmacist if you are not sure.

• Swallow the capsules/tablets:

  • Whole
  • With a drink of water

• Severe Drug Interactions can occur if Sandoz Pirfenidone is taken in combination with some other medications. In particular, do not take Sandoz Pirfenidone with fluvoxamine.
• Talk to your healthcare professional if you are currently taking ciprofloxacin (antibiotic). A dose adjustment may be required.

• If you currently take fluvoxamine, a different medication should be prescribed for you before you begin taking Sandoz Pirfenidone.

  • With food or during or after a meal to reduce the risk of side effects such as persistent stomach problems and dizziness (see Serious Side Effects and What to Do About Them)

Usual dose:

Sandoz Pirfenidone is usually prescribed in increasing doses as follows:

• If taking capsules:

  • Days 1 to 7: Take 1 capsule three times a day with food (a total of 3 capsules a day or 801 mg a day)
  • Days 8 to 14: Take 2 capsules three times a day with food (a total of 6 capsules a day or 1602 mg a day)
  • Day 15 and onwards: Take 3 capsules three times a day with food (a total of 9 capsules a day or 2403 mg a day)

• If taking tablets:

  • 267 mg tablets are yellow in colour.
  • 801 mg tablets are pink in colour.
  • Days 1 to 7: Take 1 yellow tablet three times a day with food (a total of 3 tablets a day or 801 mg a day)
  • Days 8 to 14: Take 2 yellow tablets three times a day with food (a total of 6 tablets a day or 1602 mg a day)
  • Day 15 and onwards: Take 3 yellow tablets three times a day with food OR take 1 pink tablet three times a day with food (a total of 2403 mg a day).

Your healthcare professional may reduce your dose if you have:

• skin reactions to sunlight or sun lamps.
• significant changes to your liver enzymes.
• stomach problems.

If your stomach problems do not get better, your healthcare professional may stop treatment with Sandoz Pirfenidone.

If you have not taken Sandoz Pirfenidone for 14 days or more in a row:

• your healthcare professional will restart your treatment with the lowest dose.
• the dose will be gradually increased over 2 weeks to the usual dose.

Overdose:

Missed dose:

If a dose is missed, the next dose should be taken as originally planned. Double doses should not be taken to make up for forgotten doses.

What are possible side effects from using Sandoz Pirfenidone?

These are not all the possible side effects you may have when taking Sandoz Pirfenidone. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Skin problems such as rash, itchy skin, skin redness, dry skin
• Tiredness, feeling weak or feeling low in energy
• Indigestion, heartburn, acid reflux, decreased appetite, changes in taste, bloating, abdominal pain and discomfort
• Infections of the throat or the airways going into the lungs and/or sinusitis, influenza and/or common cold
• Difficulty sleeping, feeling sleepy
• Headache
• Muscle pain, aching joints/joint pains
• Weight loss

Sandoz Pirfenidone may cause liver problems and other abnormal blood test results. You will need blood tests to check your blood levels and to make sure that your liver is working properly. Blood tests should be done before you start taking Sandoz Pirfenidone, at monthly intervals for the first 6 months and then every three months while you are taking this medicine. Your healthcare professional will decide when to perform blood tests and will interpret the results.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Keep out of reach and sight of children.
• Store capsules/tablets at room temperature (15 – 30°C).

If you want more information about Sandoz Pirfenidone:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.

Last revised: JUN 10, 2024