PIRFENIDONE STADA 801 mg FILM-COATED TABLETS

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 all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Pirfenidone Stada contains the active substance pirfenidone and is used to treat Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the lung tissue becomes thickened and scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps to reduce scarring and swelling of the lungs, and helps you breathe better.

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

Do not take Pirfenidone Stada:

• 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 unsure, 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 liver problems, mild to moderate.
• 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 and toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with pirfenidone treatment. Stop taking pirfenidone and seek medical attention immediately if you notice any of the 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 function. It is essential 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 Stada

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 Stada with food and drinks

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

Pregnancy and breastfeeding

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 breastfeeding or plan 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 Stada contains sodium and lactose

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

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

3. How to take Pirfenidone Stada

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 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 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 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

It is possible that 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.

Method of administration

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 Pirfenidone Stada 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget 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 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 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 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 further questions about 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 side of the abdomen (stomach), loss of appetite, bleeding or bruising more easily than usual, or feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of pirfenidone.
• Red patches without elevation, or circular patches on the trunk, often with central blisters, skin peeling, 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 swelling of the lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any side effects, talk to 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 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 side effects(may affect up to 1 in 10 people):

• bladder infections
• drowsiness
• altered taste
• hot flashes
• stomach problems, such as heaviness, pain, and discomfort, stomach burning, and flatulence
• 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 can 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, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, 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 that appears on the blister and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Contents of the pack and other information

Pirfenidone Stada 267 mg film-coated tablets:

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

The other ingredients are: lactose monohydrate, croscarmellose sodium, hypromellose, colloidal anhydrous 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 substance is pirfenidone. Each tablet contains 534 mg of pirfenidone.

The other ingredients are: lactose monohydrate, croscarmellose sodium, hypromellose, colloidal anhydrous 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 substance is pirfenidone. Each tablet contains 801 mg of pirfenidone.

The other ingredients are: lactose monohydrate, croscarmellose sodium, hypromellose, colloidal anhydrous 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 pack contents

Film-coated tablets

Pirfenidone Stada 267 mg: yellow, oval, biconvex tablets, with the inscription “L814” on one side 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 side 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 side and smooth on the other, approximately 20.0 mm long and 9.2 mm wide.

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

Not all pack sizes may be marketed.

Marketing authorisation 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 last revision of this leaflet:April 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/