PIRFENIDONE SANDOZ 267 mg FILM-COATED TABLETS

2. What you need to know before you take Pirfenidone Sandoz

Do not takePirfenidone Sandoz

• if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6),
• if you have previously had angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue that may be associated with difficulty breathing or wheezing,
• if you are taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]),
• if you have severe or terminal liver disease,
• if you have severe or terminal kidney disease that requires dialysis.

If any of the above applies to you, do not take pirfenidone. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pirfenidone:

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (also UVA lamps) while taking pirfenidone. Use a daily sunscreen and cover your arms, legs, and head to reduce sun exposure (see section 4: Possible side effects).
• Do not take other medicines, such as tetracycline antibiotics (e.g. doxycycline), that may increase your sensitivity to sunlight.
• You must inform your doctor if you have kidney problems.
• You must inform your doctor if you have mild to moderate liver problems.
• You should avoid smoking before and during treatment with pirfenidone. Tobacco can reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidone may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidone treatment. Stop using pirfenidone and consult your doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Pirfenidone may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting to take pirfenidone, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver is working properly. It is important that you have these blood tests periodically throughout the time you are taking pirfenidone.

Children and adolescents

Do not give pirfenidone to children and adolescents under 18 years of age.

Other medicines and Pirfenidone Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important if you are taking the following medicines, as they may alter the effect of pirfenidone.

The following medicines may increase the side effects of pirfenidone:

• enoxacin (a type of antibiotic),
• ciprofloxacin (a type of antibiotic),
• amiodarone (used to treat certain types of heart conditions),
• propafenone (used to treat certain types of heart conditions),
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).

The following medicines may reduce the effectiveness of pirfenidone:

• omeprazole (used to treat disorders such as indigestion, gastroesophageal reflux disease),
• rifampicin (a type of antibiotic).

Taking Pirfenidone Sandoz with food and drink

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may make pirfenidone not work properly.

Pregnancy and breast-feeding

As a precautionary measure, it is preferable to avoid the use of pirfenidone if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are not known.

If you are breast-feeding or planning to breast-feed, consult your doctor or pharmacist before taking pirfenidone. Since it is not known whether pirfenidone is excreted in breast milk, your doctor will explain the risks and benefits of taking this medicine during breast-feeding if you decide to do so.

Driving and using machines

Do not drive or operate machinery if you feel dizzy or tired after taking pirfenidone.

Pirfenidone Sandoz contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is, essentially “sodium-free”.

3. How to take Pirfenidone Sandoz

Treatment with pirfenidone should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of IPF.

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Normally, you will be given this medicine by gradually increasing the dose as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet), 3 times a day with food (a total of 801 mg/day),
• between days 8 and 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (a total of 1,602 mg/day),
• from day 15 (maintenance), take a dose of 801 mg (3 yellow tablets or 1 dark pink tablet), 3 times a day with food (a total of 2,403 mg/day).

The recommended maintenance dose of pirfenidone is 801 mg (3 yellow tablets or 1 dark pink tablet) three times a day with food, a total of 2,403 mg/day.

Swallow the tablets whole with water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to side effects

Your doctor may decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UVA lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Sandoz than you should

Go to your doctor, pharmacist, or the emergency department of the nearest hospital immediately if you take more tablets than you should, and take your medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pirfenidone Sandoz

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses. Each dose should be separated by an interval of at least 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidone Sandoz

In certain situations, your doctor will advise you to stop taking pirfenidone. If for any reason you stop taking pirfenidone for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day and gradually increase it to 801 mg 3 times a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking pirfenidone and seek medical attention immediately if you notice any of the following symptoms or signs:

• Swelling of the face, lips or tongue, itching, hives, difficulty breathing or wheezing, or feeling of fainting, which are signs of angioedema, a severe allergic reaction or anaphylaxis.
• Yellowing of the eyes or skin, or dark urine, possibly accompanied by itching of the skin, pain in the upper right part of the abdomen (stomach), loss of appetite, bleeding or bruising more easily than normal, or feeling of tiredness. These may be signs of abnormal liver function and could indicate liver damage, a rare side effect of pirfenidone.
• Red patches not raised or circular on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes are often preceded by fever or flu-like symptoms. (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any type of side effect, consult your doctor.

Very common side effects(may affect more than 1 in 10 people):

• infections of the throat or respiratory tract that reach the lungs and/or sinusitis,
• feeling sick (nausea),
• stomach problems, such as acid reflux, vomiting, and constipation,
• diarrhea,
• indigestion or stomach heaviness,
• weight loss,
• decreased appetite,
• difficulty sleeping,
• fatigue,
• dizziness,
• headache,
• difficulty breathing,
• cough,
• joint pain.

Common side effects(may affect up to 1 in 10 people):

• bladder infections,
• drowsiness,
• altered taste,
• hot flashes,
• stomach problems, such as bloating, pain, and discomfort, heartburn, and gas,
• blood tests may indicate increased liver enzymes,
• skin reactions after sun exposure or use of UVA lamps,
• skin problems such as itching, irritation, or redness, dryness, rash,
• muscle pain,
• weakness or lack of energy,
• chest pain,
• sunburn.

Uncommon side effects(may affect up to 1 in 100 people):

• low sodium levels in the blood. This may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting,
• blood test results may show decreased white blood cell count.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the container, bottle, and blister after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Sandoz

Pirfenidone Sandoz 267 mg film-coated tablets

• The active substance is pirfenidone. Each tablet contains 267 mg of pirfenidone.
• The other ingredients are:

Core of the tablet: pregelatinized corn starch, sodium croscarmellose (E468), hydroxypropyl cellulose (E463), colloidal anhydrous silica (E551), magnesium stearate (E572).

Coating of the tablet (Opadry yellow 85F220100): partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553B), and yellow iron oxide (E172).

Pirfenidone Sandoz 801 mg film-coated tablets

• The active substance is pirfenidone. Each tablet contains 801 mg of pirfenidone.
• The other ingredients are:

Core of the tablet: pregelatinized corn starch, sodium croscarmellose (E468), hydroxypropyl cellulose (E463), colloidal anhydrous silica (E551), magnesium stearate (E572).

Coating of the tablet (Opadry dark pink 85F240048): partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553B), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance and packaging

Pirfenidone Sandoz 267 mg: are yellow, oval, film-coated tablets, approximately 1.2 x 0.7 cm, biconvex, engraved with “SD267” on one side.

Pirfenidone Sandoz 801 mg: are dark pink, oval, film-coated tablets, approximately 1.8 x 0.9 cm, biconvex, engraved with “SD801” on one side.

Pirfenidone Sandoz 267 mg is available in PVC/PE/PVDC-Alu blister packs.

• Blister pack with 63 or 252 tablets.
• Single-dose blister pack with 63x1 or 252x1 tablets.
• Start of treatment pack for 2 weeks:

• Multi-pack blister with 63 (1 pack of 21 and 1 pack of 42) tablets.

• Single-dose multi-pack blister with 63 (1 pack of 21x1 and 1 pack of 42x1) tablets.
• Continuation packs:

• Multi-pack blister with 252 (3 packs of 84) tablets or,
• single-dose multi-pack blister with 252 (3 packs of 84x1) tablets.

The blisters of the pack containing 63 tablets and the 2-week start of treatment pack are marked with the following symbols and abbreviated day names as a reminder to take the dose three times a day:

(dawn; morning dose) (sun; afternoon dose) and (moon; night dose).

Mon, Tue, Wed, Thu, Fri, Sat, Sun

Pirfenidone Sandoz 801 mg is available in PVC/PE/PVDC-Alu blister packs.

• Blister pack with 84 or 252 tablets.
• Single-dose blister pack with 84x1 or 252x1 tablets.
• Continuation packs:
• • Multi-pack blister with 252 (3 packs of 84) tablets or,
  • single-dose multi-pack blister with 252 (3 packs of 84x1) tablets

The blisters of Pirfenidone Sandoz 801 mg are marked with the following symbols and abbreviated day names as a reminder to take the dose three times a day:

(dawn; morning dose) (sun; afternoon dose) and (moon; night dose).

Mon, Tue, Wed, Thu, Fri, Sat, Sun

These symbols do not apply to single-dose blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2d,

9220 Lendava,

Slovenia

Date of last revision of this leaflet:May 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).