Package Leaflet: Information for the User

Pirfenidona Sandoz 267 mg Film-Coated Tablets

Pirfenidona Sandoz 801 mg Film-Coated Tablets

pirfenidona

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Pirfenidona Sandoz contains the active ingredient pirfenidona and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the lung tissues become swollen and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. Pirfenidona helps to reduce lung scarring and swelling, and helps you breathe better.

Do not takePirfenidona Sandoz

• if you are allergic to pirfenidona or any of the other ingredients of this medicine (listed in section 6),
• if you have previously had angioedema with pirfenidona, 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 pirfenidona. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pirfenidona:

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

Pirfenidona may cause severe liver problems. Some cases have been fatal. You will need to have a blood test before starting to take pirfenidona, once a month for the first 6 months, and then every 3 months while taking this medicine, to check the proper functioning of your liver. It is essential that you have these blood tests periodically throughout the time you are taking pirfenidona.

Children and adolescents

Do not administer pirfenidona to children and adolescents under 18 years old.

Other medicines and Pirfenidona Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

The following medicines may increase the side effects of pirfenidona:

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

The following medicines may reduce the effectiveness of pirfenidona:

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

Taking Pirfenidona Sandoz with food and drinksandbeverages

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

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid the use of pirfenidona if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are unknown.

If you are breastfeeding or plan to breastfeed, talk to your doctor or pharmacist before taking pirfenidona. As it is not known whether pirfenidona is excreted in breast milk, your doctor will explain the risks and benefits of taking this medicine during breastfeeding if you decide to do so.

Driving and operating machinery

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

Pirfenidona Sandoz contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

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

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

Normally, you will be administered this medication by gradually increasing the dose in the following way:

• During 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 daily 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 of discomfort) 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 UV-A lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Sandoz than you should

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

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

If you forgot 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 compensate for the missed doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets per day than correspond to your prescribed daily dose.

If you interrupt treatment with 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, the 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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 a feeling of fainting, which are signs of angioedema, a severe allergic reaction, or anaphylaxis.
• Yellowing of the eyes or skin, dark urine, possibly accompanied by itching of the skin, abdominal pain in the upper right side of the abdomen, loss of appetite, bleeding, or the formation of bruises more easily than normal, or a feeling of fatigue. These may be signs of abnormal liver function and could indicate liver damage, a rare side effect of pirfenidone.
• Flat, circular patches on the trunk, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions are often preceded by fever or flu-like symptoms. (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Generalized rash, elevated body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects are

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

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

• Throat or respiratory tract infections that reach the lungs and/or sinusitis,
• Unpleasant feeling (nausea),
• Stomach problems, such as acid reflux, vomiting, and constipation,
• Dysentery,
• Indigestion or stomach heaviness,
• Weight loss,
• Loss of appetite,
• Difficulty sleeping,
• Fatigue,
• Dizziness,
• Headache,
• Difficulty breathing,
• Cough,
• Joint pain.

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

• Urinary tract infections,
• Drowsiness,
• Alteration of taste,
• Headaches,
• Stomach problems, such as feeling heavy, pain, and abdominal discomfort, heartburn, and flatulence,
• Blood tests may indicate elevated liver enzymes,
• Skin reactions after exposure to the sun or use of UVA lamps,
• Cutaneous problems such as itching, irritation, or redness, dryness, rash,
• Muscle pain,
• Weakness or lack of energy,
• Chest pain,
• Sunburn.

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

• Low sodium levels in the blood. This can cause headaches, dizziness, confusion, muscle cramps, nausea, and vomiting,
• Lab test results may show a decrease in white blood cells.

Reporting side effects

If you experience any type of side effect, consult your doctoror,pharmacist,even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label of the container, bottle, and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines that you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Pirfenidona Sandoz Composition

Pirfenidona Sandoz 267 mg film-coated tablets

• The active ingredient is pirfenidone. Each tablet contains 267 mg of pirfenidone.
• The other components are:

Tablet core: pregelatinized maize starch, sodium croscarmellose (E468), hydroxypropyl cellulose (E463), anhydrous colloidal silica (E551), magnesium stearate (E572).

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

Pirfenidona Sandoz 801 mg film-coated tablets

• The active ingredient is pirfenidone. Each tablet contains 801 mg of pirfenidone.
• The other components are:

Tablet core: pregelatinized maize starch, sodium croscarmellose (E468), hydroxypropyl cellulose (E463), anhydrous colloidal silica (E551), magnesium stearate (E572).

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

Appearance of the product and contents of the package

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

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

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

• Blister pack with 63 or 252 tablets.
• Single-dose blister pack of 63x1 or 252x1 tablets.
• Starting treatment pack of 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 starting treatment pack are marked with the following symbols and abbreviated day names as a reminder to take the dose three times a day:

(sunrise; morning dose)(sun; afternoon dose) and(moon; evening dose).

Su, Mo, We, Th, Fr, Sa, Do

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

• Blister pack with 84 or 252 tablets.
• Single-dose blister pack of 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 Pirfenidona Sandoz 801 mg are marked with the following symbols and abbreviated day names as a reminder to take the dose three times a day:

(sunrise; morning dose)(sun; afternoon dose) and(moon; evening dose).

Su, Mo, We, Th, Fr, Sa, Do

These symbols do not apply to single-dose blister packs.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2d,

9220 Lendava,

Slovenia

Last review date of this leaflet:May2024.

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