Pirfenidone Sandoz 267 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pirfenidone Sandoz 267 mg film-coated tablets EFG

Pirfenidone Sandoz 801 mg film-coated tablets EFG

pirfenidone

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

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pirfenidone Sandoz is and what it is used for
2. What you need to know before taking Pirfenidone Sandoz
3. How to take Pirfenidone Sandoz
4. Possible side effects
5. How to store Pirfenidone Sandoz
6. Contents of the pack and other information

1. What Pirfenidona Sandoz is and what it is used for

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

IPF is a disease in which lung tissues become inflamed and progressively scarred over time, making it difficult to take deep breaths. Under these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps reduce lung scarring and inflammation, thereby helping you breathe better.

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

Do not take Pirfenidone Sandoz

• if you are allergic to pirfenidone or to 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, which 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 end-stage liver disease,
• if you have severe or end-stage kidney disease requiring dialysis.

If any of the above apply to you, do not take pirfenidone. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take pirfenidone:

• You may become more sensitive to sunlight (photosensitivity reaction) while taking pirfenidone. Avoid sunlight (including UVA lamps) while taking pirfenidone. Use sunscreen daily and cover your arms, legs, and head to reduce sun exposure (see section 4: Possible side effects).
• You should not take other medicines, such as tetracycline antibiotics (e.g. doxycycline), which 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 must refrain from smoking before and during treatment with pirfenidone. Tobacco may reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be cautious when performing activities requiring attention and coordination.
• Pirfenidone may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Cases of 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 contact your doctor immediately if you notice any symptoms related to these serious 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 pirfenidone, once a month for the first 6 months, and then every 3 months thereafter while taking this medicine, to check that your liver is functioning properly. It is important that you have these blood tests performed regularly for as long as 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 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 pirfenidone:

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

Taking Pirfenidone Sandoz with food and drinks

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

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid using pirfenidone 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 planning to breastfeed, talk to 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 breastfeeding 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 physicians experienced in the diagnosis and treatment of IPF.

Always follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You will normally be given this medicine with a gradually increasing dose as follows:

• 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),
• from days 8 to 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 onwards (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, for 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 unwell) and dizziness. If symptoms persist, contact your doctor.

Dose reduction due to side effects

Your doctor may decide to reduce your 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 immediately to your doctor, pharmacist, or the nearest hospital emergency department if you take more tablets than you should, and take your medication with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating 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 at least 3 hours. Do not take more tablets per day than prescribed in your daily dose.

If you stop taking Pirfenidone Sandoz

In certain situations, your doctor may 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 at a dose of 267 mg three times a day, and gradually increase it to 801 mg three times a day.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking pirfenidone and seek immediate medical attention 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 faint, which are signs of angioedema, a serious 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 stomach area (abdomen), loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These may be signs of abnormal liver function and could indicate liver damage, an uncommon adverse effect of pirfenidone.
• Non-elevated or circular red patches on the trunk, often with central blisters, peeling skin, or sores in the mouth, throat, nose, genitals, and eyes. These serious 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 syndrome or drug hypersensitivity syndrome).

Other possible adverse effects are

If you experience any kind of adverse effect, consult your doctor.

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

• Throat or respiratory tract infections reaching the lungs and/or sinusitis,
• Feeling unwell (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 adverse effects (may affect up to 1 in 10 people):

• Bladder infections,
• Drowsiness,
• Altered taste,
• Hot flushes,
• Stomach problems, such as feeling of fullness, pain and abdominal discomfort, stomach burning, and flatulence,
• Blood tests may show increased liver enzymes,
• Skin reactions after exposure to sunlight 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 adverse effects (may affect up to 1 in 100 people):

• Low levels of sodium in the blood. This may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting,
• Blood test results may show decreased white blood cells.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse 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 stated on the container, bottle, and blister pack label 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are:

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

Tablet coating (Opadry Yellow 85F220100): partially hydrolysed 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 components are:

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

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

Nature of the product and contents of the container

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

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

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

• Blister pack containing 63 or 252 tablets.

• Unit-dose blister packs of 63x1 or 252x1 tablets.

• Starter pack for 2-week treatment initiation:

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

  • Unit-dose multi-pack blister containing 63 tablets (1 pack of 21x1 and 1 pack of 42x1).

• Maintenance packs:

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

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

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

Lu, Ma, Mi, Ju, Vi, Sa, Do

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

• Blister pack containing 84 or 252 tablets.
• Unit-dose blister packs of 84x1 or 252x1 tablets.
• Maintenance packs:
  • Multi-pack blister containing 252 tablets (3 packs of 84), or
  • Unit-dose multi-pack blister containing 252 tablets (3 packs of 84x1)

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 daily:

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

Lu, Ma, Mi, Ju, Vi, Sa, Do

These symbols do not apply to unit-dose blisters.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 the most recent 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/).