Pirfenidone Stada 801 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pirfenidone Stada 267 mg film-coated tablets EFG

Pirfenidone Stada 534 mg film-coated tablets EFG

Pirfenidone Stada 801 mg film-coated tablets EFG

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

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

Package leaflet contents

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

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

Pirfenidona Stada 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 scarred over time, making it difficult to breathe deeply. Under these conditions, the lungs have difficulty functioning properly. Pirfenidone helps reduce lung scarring and inflammation, improving your ability to breathe.

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

Do not take Pirfenidona Stada:

• 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

Consult your doctor or pharmacist before starting treatment with pirfenidone.

• You may experience increased sensitivity to sunlight (photosensitivity reaction) while taking pirfenidone. Avoid exposure to sunlight (including UVA lamps) while taking pirfenidone. Daily use of sunscreen cream and covering your arms, legs, and head are recommended to reduce exposure to sunlight (see section 4: Possible side effects).
• You should 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 must refrain from smoking before and during treatment with pirfenidona. Tobacco may reduce the effectiveness of pirfenidona.
• Pirfenidona may cause dizziness and fatigue. Be cautious when performing activities requiring attention and coordination.
• Pirfenidona may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis, as well as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with pirfenidone treatment. Stop taking pirfenidona and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Pirfenidona may cause serious liver problems. Some cases have been fatal. A blood test will be required before starting pirfenidona, once a month for the first 6 months, and then every 3 months thereafter while taking this medicine, to monitor proper liver function. It is important that you receive these blood tests regularly throughout the entire duration of treatment with pirfenidona.

Children and adolescents

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

Other medicines and Pirfenidona Stada

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

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 and gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidone Stada with food and drinks

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

Pregnancy and lactation

As a precautionary measure, it is preferable to avoid the use of pirfenidone if you are pregnant, planning to become pregnant, or think you might be pregnant, as the potential risks to the fetus are unknown.

If you are breastfeeding or planning to breastfeed, speak with 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 operating machinery

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

Pirfenidone Stada contains sodium and lactose

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

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pirfenidona Stada

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

Follow exactly the instructions for use of this medicine provided 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:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet), 3 times daily with food (total 801 mg/day)
• from days 8 to 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet), 3 times daily with food (total 1,602 mg/day)
• from day 15 onwards (maintenance), take a dose of 801 mg (3 yellow tablets or 1 brown tablet), 3 times daily with food (total 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 meals, for a total of 2,403 mg/day.

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.

Administration method

This medicine 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 unwell) and dizziness. If symptoms persist, consult your doctor.

If you take more Pirfenidona Stada than you should

Contact your doctor, pharmacist, or go immediately to 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, indicating the medication and the amount ingested.

If you forget to take Pirfenidona Stada

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 must be separated by a minimum interval of 3 hours. Do not take more tablets per day than the number corresponding to your prescribed daily dose.

If you interrupt 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, your doctor will restart your treatment at a dose of 267 mg (1 yellow tablet) three times a day and will gradually increase it to 801 mg (3 yellow tablets or 1 brown tablet) 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 will experience 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 skin itching, 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 could be signs of abnormal liver function and may indicate liver damage, which is an uncommon adverse effect of pirfenidone.
• Red, non-elevated spots, or circular rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and 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 type 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 discomfort
• weight loss
• decreased appetite
• difficulty sleeping
• tiredness
• 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, abdominal pain and discomfort, heartburn, 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 reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Stada

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

Do not use this medicine after the expiry date stated on the blister pack and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Pirfenidone Stada 267 mg film-coated tablets EFG:

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

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

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

Pirfenidone Stada 534 mg film-coated tablets EFG:

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

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

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

Pirfenidone Stada 801 mg film-coated tablets EFG:

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

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

Coating: partially hydrolysed 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 Container

Film-coated tablets

Pirfenidone Stada 267 mg: yellow, oval, biconvex tablets, with the imprint “L814” on one side and smooth on the other, approximately 13.3 mm in length and 6.5 mm in width.

Pirfenidone Stada 534 mg: orange, oval, biconvex tablets, with the imprint “L813” on one side and smooth on the other, approximately 16.0 mm in length and 8.0 mm in width.

Pirfenidone Stada 801 mg: brown, oval, biconvex tablets, with the imprint “L812” on one side and smooth on the other, approximately 20.0 mm in length and 9.2 mm in width.

Pirfenidone Stada 267 mg is available in blisters packed in cardboard cartons containing 21, 63, 84, 90, 168, 180, 252, or 270 tablets, or in single-dose perforated blister strips packed in cardboard cartons 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.

Alternatively, in bottles containing 21, 90, or 180 tablets.

Pirfenidone Stada 534 mg is available in blisters packed in cardboard cartons containing 21 or 84 tablets, or in single-dose perforated blister strips packed in cardboard cartons containing 21 x 1 or 84 x 1 tablets.

Alternatively, in bottles containing 21 or 90 tablets.

Pirfenidone Stada 801 mg is available in blisters packed in cardboard cartons containing 21, 63, 84, 90, 168, 180, 252, or 270 tablets, or in single-dose perforated blister strips packed in cardboard cartons 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.

Alternatively, in bottles containing 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern, Barcelona

Spain

[email protected]

Manufacturer

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

Date of the most recent review of this leaflet: April 2024

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