Leaflet: information for the patient

Pirfenidona Teva 267 mg film-coated tablets

Pirfenidona Teva 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 doubts, 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.

1. What isPirfenidona Tevaand what it is used for

2. What you need to know before starting to takePirfenidona Teva

3. How to takePirfenidona Teva

4. Possible side effects

5. Storage ofPirfenidona Teva

6. Contents of the pack and additional information

Pirfenidona Teva 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 lung tissues 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 lung scarring and inflammation, and helps you breathe better.

Do not takePirfenidona Teva

• if you are allergic to pirfenidona or any of the other ingredients of this medicine (listed in section6)
• if you have 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 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 takePirfenidona Teva. If you are unsure, 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 sun protection cream and cover your arms, legs, and head to reduce exposure to sunlight (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 should inform your doctor if you have kidney problems.
• You should inform your doctor if you have mild to moderate liver problems.
• You should avoid smoking before and during treatment with pirfenidona. Smoking may reduce the effect of this medicine.
• 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 medicine.
• Severe skin reactions such as Stevens-Johnson syndrome, 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 and in some cases have been fatal. You will need to have blood tests before starting to take pirfenidona and once a month for the first 6 months, and then every 3 months while you are taking this medicine, 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 this medicine to children and adolescents under 18 years old.

Other medicines and Pirfenidona Teva

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

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:

• 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 medicines 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 Teva with food and drinks

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

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid the use of 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 do so, talk to your doctor or pharmacist before taking this medicine. As it is not known whether pirfenidona 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 pirfenidona.

Pirfenidona Teva contains sodium

Pirfenidona Teva contains less than 1 mmol of sodium (23 mg) per tablet, i.e. is essentially "sodium-free".

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.

This medication is usually administered by gradually increasing the dose as follows:

• During the first 7 days, take a dose of 267mg (1 yellow tablet), 3 times a day with food (a total of 801mg/day)
• Between days 8 and 14, take a dose of 534mg (2 yellow tablets), 3 times a day with food (a total of 1.602mg/day)
• From day 15 (maintenance), take a dose of 801mg (3 yellow tablets or 1 purple tablet), 3 times a day with food (a total of 2.403mg/day).

The recommended daily maintenance dose of pirfenidone is 801mg (3 yellow tablets or 1 purple tablet) three times a day with food, a total of 2.403mg/day.

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.

Reduction of the dose 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.

If you take morePirfenidone Tevathan you should

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

If you forgot to takePirfenidone Teva

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up 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 withPirfenidone Teva

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 267mg 3 times a day and gradually increase it to 801mg 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, and/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 the appearance of bruises 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 patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions are often preceded by fever or flu-like symptoms (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
• Uncomfortable 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
• Muscle pain/joint pain.

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

• Urinary tract infections
• Drowsiness
• Alteration of taste
• Headaches
• Stomach problems, such as bloating, pain, and abdominal discomfort, stomach burning, and flatulence
• Blood tests may indicate elevated liver enzymes

• Sunburn or skin reactions after exposure to the sun 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.

Rare side effects(may affect up to 1 in 100 people):

• Low sodium levels in the blood. This can cause headaches, dizziness, confusion, muscle cramps, nausea, and vomiting
• Lab test results may show a decrease in white blood cells.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicationdoes not require special conservation conditions.

Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Pirfenidona Teva Composition

Tablets of 267mg

The active ingredient is pirfenidona. Each film-coated tablet contains 267mg of pirfenidona.

The other components are anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, povidone, and magnesium stearate.

The film coating contains: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), and black iron oxide (E172).

Tablets of 801mg

The active ingredient is pirfenidona. Each film-coated tablet contains 801mg of pirfenidona.

The other components are: anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, povidone, and magnesium stearate.

The film coating contains: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the package

Pirfenidona Teva 267mg:film-coated, oval-shaped, yellow tablets, approximately 12.9 x 5.9 mm, engraved with 3610 on one side and T on the other side.

The presentations in bottles contain a bottle with 63 tablets or three bottles with 84 tablets each (252 tablets in total).

The blister packs contain 63 or 252 film-coated tablets.

The perforated single-dose blister packs contain 63x1 or 252x1 film-coated tablets.

Each of the 267 mg blister strips is marked with symbols and abbreviations of the day as a reminder to take a dose three times a day.

Pirfenidona Teva 801mg:film-coated, oval-shaped, yellow tablets, approximately 20.1 x 59.3 mm, engraved with 3611 on one side and T on the other side.

The presentations in bottles contain a bottle with 84 tablets, three bottles with 84 tablets each (252 tablets in total).

The blister packs contain 84 film-coated tablets and the multiple packs contain 252 (3x84) film-coated tablets.

The perforated single-dose blister packs contain 84x1 and the multiple packs contain 252 (3x84x1) film-coated tablets.

Each of the 801 mg blister strips is marked with symbols and abbreviations of the day as a reminder to take a dose three times a day:

Sunrise symbol(sunrise; morning dose), sun symbol(sun; afternoon dose) andmoon symbol (moon; night dose).

Sun., Mon., Tue., Wed., Thu., Fri., Sat.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid, Spain.

Responsible manufacturer

Actavis Ltd., BLB

016 Bulebel Industrial Estate

Zejun ZTN 3000

Malta

Last review date of this leaflet:April 2024

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