Pirfenidone Zentiva 801 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Pirfenidone Zentiva 267 mg film-coated tablets EFG

Pirfenidone Zentiva 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Pirfenidona Zentiva 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 taking Pirfenidona Zentiva

Do not take Pirfenidona Zentiva

• 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 pirfenidona. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting pirfenidona.

• You may experience increased sensitivity to sunlight (photosensitivity reaction) while taking pirfenidona. Avoid sunlight (including UV lamps) while taking this medicine. 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), 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 effect of this medicine.
• Pirfenidona may cause dizziness and fatigue. Be cautious if you need to perform activities requiring attention and coordination.
• Pirfenidona may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• 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 this medicine and seek immediate medical attention if you notice any symptoms related to serious skin reactions described in section 4.

Pirfenidona can cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting this medicine, once a month for the first 6 months, and then every 3 months while taking this medicine, to check that your liver is functioning properly. It is important that you have these blood tests performed regularly throughout the time you are taking pirfenidona.

Children and adolescents

Pirfenidona is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Pirfenidona Zentiva

Tell 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 pirfenidona.

The following medicines may increase the side effects of pirfenidona:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat certain heart conditions)
• propafenone (used to treat certain heart conditions)
• 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, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidona Zentiva with food and drink

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

Pregnancy and breastfeeding

As a precautionary measure, it is advisable to avoid using this medicine 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 this medicine. 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 pirfenidona.

Pirfenidona Zentiva contains lactose and sodium

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

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

3. How to take Pirfenidone Zentiva

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 as 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:

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

The recommended maintenance daily dose of pirfenidone is 801 mg (3 yellow tablets or 1 brown tablet) three times daily with meals, 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 Zentiva than you should

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

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pirfenidone Zentiva

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 a 3-hour interval. Do not take more tablets per day than prescribed in your daily dose.

If you stop taking Pirfenidone Zentiva

In certain situations, your doctor may advise you to stop taking pirfenidone. If, for any reason, you stop taking this medicine for more than 14 consecutive days, your doctor will restart your treatment at a dose of 267 mg three times daily, and gradually increase it to 801 mg three times daily.

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 itching of the skin, pain in the upper right side 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 this medicine.
• Non-elevated or circular red spots 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, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse effects are

If you experience any 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
• Fatigue
• Dizziness
• Headache
• Breathing difficulty
• Cough
• Joint pain

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

• Bladder infections
• Drowsiness
• Changes in taste
• Hot flushes
• Stomach problems such as bloating, 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 a decrease in white blood cells.

Reporting of adverse effects

If you experience any 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Zentiva

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

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

This medicine does not require any special storage conditions.

Medicines must 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, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Zentiva

Tablets of 267 mg

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

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

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Tablets of 801 mg

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

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

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

267 mg tablets

Pirfenidone Zentiva 267 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets, printed with "267".

Blister packs contain 63 film-coated tablets (pack of 63 film-coated tablets or multiple pack composed of 1 pack containing 21 film-coated tablets and 1 pack containing 42 film-coated tablets) or 252 film-coated tablets (pack of 252 film-coated tablets or multiple pack consisting of 3 packs, each containing 84 film-coated tablets).

801 mg tablets

Pirfenidone Zentiva 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets, printed with "801".

Blister packs contain 84 film-coated tablets or 252 film-coated tablets (pack of 252 film-coated tablets or multiple pack of 3 packs, each containing 84 film-coated tablets).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.

U kabelovny 130,

Dolni Mecholupy, 102 37

Prague 10,

Czech Republic

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area,

Larisa, 41004, Greece

or

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.
Avenida de Europa, 19, Edificio 3, Planta 1.
28224 Pozuelo de Alarcón, Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: August 2023

Detailed information about this medication is available on the website of the Spanish Agency of Medicaments and Medical Devices (AEMPS) at http://www.aemps.gob.es/