Leaflet: information for the user

Pirfenidona Stada 267 mg film-coated tablets

Pirfenidona Stada 534 mg film-coated tablets

Pirfenidona Stada 801 mg film-coated tablets

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

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

Contents of the leaflet

1. What Pirfenidona Stada is and what it is used for
2. What you need to know before you start taking Pirfenidona Stada
3. How to take Pirfenidona Stada
4. Possible side effects
5. Storage of Pirfenidona Stada
6. Contents of the pack and additional information

Pirfenidona Stada 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 tissues of the lungs become inflamed 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 the scars and inflammation of the lungs, and helps you breathe better.

Do not take Pirfenidona Stada:

• if you are allergic to pirfenidona or any of the other ingredients of this medication (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 medication called fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD])
• if you have a severe or terminal liver disease
• if you have a severe or terminal kidney disease that requires dialysis

If any of the above applies to you, do not take pirfenidona. If you have any doubts, 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 daily sunscreen and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• Do not take other medications, 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 abstain from 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 medication.
• Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with pirfenidona treatment. Stop taking pirfenidona and seek medical attention immediately if you notice 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 blood tests before starting to take pirfenidona, once a month for the first 6 months, and then every 3 months while taking this medication, to check the proper functioning of your liver. It is essential that you have these blood tests regularly throughout the time you are taking pirfenidona.

Children and adolescents

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

Other medications and Pirfenidona Stada

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

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

The following medications 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 medications 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 Stada with food and drinks

Do not drink grapefruit juice while taking this medication. Grapefruit juice may make pirfenidona not work correctly.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using 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 medication 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 Stada contains sodium and lactose

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

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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 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)
• Between days 8 and 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet), 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 brown 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 brown tablet) three times a day with food, a total of 2403 mg/day.

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.

Administration form

This medication is for oral use.

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.

If you take more Pirfenidone Stada 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 Stada

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 the treatment with Pirfenidone Stada

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 (1 yellow tablet) 3 times a day and gradually increase it to 801 mg (3 yellow tablets or 1 brown tablet) 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, rashes, 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, or dark urine, possibly accompanied by itching of the skin, stomach pain on the upper right side, loss of appetite, bleeding, or bruising more easily than normal, or feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of pirfenidone.
• Flat red spots, or circular spots on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (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
• Diarrhea
• Indigestion or stomach heaviness
• Weight loss
• Loss of appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Difficulty breathing
• Cough
• Joint pain

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

• Urinary tract infections
• Drowsiness
• Altered taste
• Headaches
• Stomach problems, such as feeling heavy, pain, and abdominal discomfort, stomach burning, 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 headache, dizziness, confusion, muscle cramps, nausea, and vomiting.
• Lab test results may show decreased white blood cell counts.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance of Medicines for Human Use: https://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 blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need.By doing so, you will help protect the environment.

Pirfenidone Stada 267 mg film-coated tablets:

The active ingredient is pirfenidone. Each tablet contains 267 mg of pirfenidone.

The other components are: lactose monohydrate, croscarmellose sodium, hypromellose, anhydrous colloidal silica and magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc and yellow iron oxide (E172).

Pirfenidone Stada 534 mg film-coated tablets:

The active ingredient is pirfenidone. Each tablet contains 534 mg of pirfenidone.

The other components are: lactose monohydrate, croscarmellose sodium, hypromellose, anhydrous colloidal silica and magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) and red iron oxide (E172).

Pirfenidone Stada 801 mg film-coated tablets:

The active ingredient is pirfenidone. Each tablet contains 801 mg of pirfenidone.

The other components are: lactose monohydrate, croscarmellose sodium, hypromellose, anhydrous colloidal silica and magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the package:

Film-coated tablets

Pirfenidone Stada 267 mg: yellow, oval, biconvex tablets with the inscription “L814” on one face and smooth on the other, approximately 13.3 mm long and 6.5 mm wide.

Pirfenidone Stada 534 mg: orange, oval, biconvex tablets with the inscription “L813” on one face and smooth on the other, approximately 16.0 mm long and 8.0 mm wide.

Pirfenidone Stada 801 mg: brown, oval, biconvex tablets with the inscription “L812” on one face and smooth on the other, approximately 20.0 mm long and 9.2 mm wide.

Pirfenidone Stada 267 mg is presented in blisters packaged in cardboard boxes containing 21, 63, 84, 90, 168, 180, 252 or 270 tablets or single-dose blisters packaged in cardboard boxes containing 21 x 1, 63 x 1, 84 x 1, 90 x 1, 168 x 1, 180 x 1, 252 x 1 or 270 x 1 tablets.

Or in bottles containing 21, 90 or 180 tablets.

Pirfenidone Stada 534 mg is presented in blisters packaged in cardboard boxes containing 21 or 84 tablets or single-dose blisters packaged in cardboard boxes containing 21 x 1 or 84 x 1 tablets.

Or in bottles containing 21 or 90 tablets.

Pirfenidone Stada 801 mg is presented in blisters packaged in cardboard boxes containing 21, 63, 84, 90, 168, 180, 252 or 270 tablets or single-dose blisters packaged in cardboard boxes containing 21 x 1, 63 x 1, 84 x 1, 90 x 1, 168 x 1, 180 x 1, 252 x 1 or 270 x 1 tablets.

Or in bottles containing 90 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Laboratorio STADA, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern, Barcelona

Spain

info@stada.es

Responsible for manufacturing:

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Limited

3 Waterford Road, E91

D768 Clonmel, Co. Tipperary,

Ireland

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

4814NE Breda,

Netherlands

Last review date of this leaflet:April 2024

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