Pirfenidone Teva 267 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Pirfenidone Teva 267 mg film-coated tablets EFG
Pirfenidone Teva 801 mg film-coated tablets EFG
Read the entire 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, 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, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Pirfenidone Teva is and what it is used for
- What you need to know before taking Pirfenidone Teva
- How to take Pirfenidone Teva
- Possible adverse effects
- How to store Pirfenidone Teva
- Contents of the pack and other information
1. What Pirfenidone Teva is and what it is used for
Pirfenidone Teva 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 breathe deeply. In these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps reduce scarring and inflammation in the lungs, helping you breathe better.
2. What you need to know before taking Pirfenidona Teva
Do not take Pirfenidona Teva
- 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 Teva. If you have any doubts, consult your doctor or pharmacist.
Warnings and precautions
Consult your doctor or pharmacist before starting pirfenidone
- You may become more sensitive to sunlight (photosensitivity reaction) while taking pirfenidone. Avoid sunlight (including UVA lamps) while taking pirfenidona. Use sunscreen daily 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 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.
- Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and 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 can cause serious liver problems, which in some cases have been fatal. You will need to have a blood test before starting pirfenidona, once a month for the first 6 months, and then every 3 months thereafter 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
Do not give this medicine to children and adolescents under 18 years of age.
Other medicines and Pirfenidona Teva
Inform 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 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 cause pirfenidona to not work properly.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable 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 planning to breastfeed, talk to your doctor or pharmacist before taking this medicine. Since 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 using machines
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., essentially "sodium-free".
3. How to take Pirfenidone Teva
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.
This medicine is usually administered 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 (total of 801 mg/day)
- from days 8 to 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (total of 1,602 mg/day)
- from day 15 onwards (maintenance), take a dose of 801 mg (3 yellow tablets or 1 purple tablet), 3 times a day with food (total of 2,403 mg/day).
The recommended maintenance daily dose of pirfenidone is 801 mg (3 yellow tablets or 1 purple tablet) three times a day 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 the 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 Teva than you should
Go immediately to your doctor, pharmacist, or the nearest hospital emergency department if you take more tablets than you should, and take your medication with you.
If you forget to take Pirfenidone 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 forgotten doses. Each dose should be separated by at least 3 hours. Do not take more tablets per day than your prescribed daily dose.
If you stop taking Pirfenidone Teva
In certain situations, your doctor may 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 three times a day and gradually increase it to 801 mg 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 experiences them.
Stop taking pirfenidone and seek immediate medical attention if you notice any of the following symptoms or signs:
- Swelling of the face, lips and/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 part of the stomach (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 or circular patches on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes are often preceded by fever or flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
- Widespread rash, elevated body temperature, and swollen 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 heaviness
- Weight loss
- Loss of appetite
- Difficulty sleeping
- Fatigue
- Dizziness
- Headache
- Breathing difficulty
- Cough
- Muscle pain/joint pain
Common adverse effects (may affect up to 1 in 10 people):
- Bladder infections
- Drowsiness
- Taste disturbance
- Hot flushes
- Stomach problems, such as bloating sensation, 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 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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Pirfenidone Teva
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Pack contents and other information
Composition of Pirfenidone Teva
Tablets of 267 mg
The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
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 801 mg
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
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).
Description of the product and contents of the pack
Pirfenidone Teva 267 mg: yellow, oval-shaped film-coated tablets, approximately 12.9 x 5.9 mm in size, engraved with "3610" on one side and "T" on the other.
Bottle presentations contain either one bottle with 63 tablets or three bottles with 84 tablets each (252 tablets in total).
Blister packs contain 63 or 252 film-coated tablets.
Unit-dose perforated blister packs contain 63x1 or 252x1 film-coated tablets.
Each 267 mg blister strip is marked with symbols and day abbreviations as a reminder to take one dose three times daily.
Pirfenidone Teva 801 mg: yellow, oval-shaped film-coated tablets, approximately 20.1 x 59.3 mm in size, engraved with "3611" on one side and "T" on the other.
Bottle presentations contain one bottle with 84 tablets or three bottles with 84 tablets each (252 tablets in total).
Blister packs contain 84 film-coated tablets, and multiple packs contain 252 (3x84) film-coated tablets.
Unit-dose perforated blister packs contain 84x1, and multiple packs contain 252 (3x84x1) film-coated tablets.
Each 801 mg blister strip is marked with symbols and day abbreviations as a reminder to take one dose three times daily:
Sunrise symbol (sunrise; morning dose), sun symbol (sun; afternoon dose), and moon symbol (moon; evening dose).
Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid, Spain
Manufacturer
Actavis Ltd., BLB
016 Bulebel Industrial Estate
Zejun ZTN 3000
Malta
Date of latest revision of this leaflet: April 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es