Pirfenidona cipla 801 mg comprimidos recubiertos con pelicula efg
Introduction
Leaflet: information for the user
Pirfenidona Cipla 267 mg film-coated tablets
Pirfenidona Cipla 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 questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you must 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 is Pirfenidona Cipla and what is it used for
Pirfenidona Cipla 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 swollen and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. This medication helps to reduce lung scarring and swelling, and helps you breathe better.
2. What you need to know before starting Pirfenidona Cipla
- If you are allergic to pirfenidona or any of the other components of this medication (listed in section 6).
- If you have previously 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 medication 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 this medication. If you have any doubts, consult your doctor or pharmacist.
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medication.
- You may be more sensitive to sunlight (photosensitivity reaction) when taking pirfenidona. Avoid the sun (also UVA lamps) while taking pirfenidona. Use daily sunscreen and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
- Do 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 should avoid smoking before and during treatment with pirfenidona. Smoking may reduce the effect of pirfenidona.
- 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 medication.
- 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. Some cases have been fatal. You will need to have blood tests before starting to take pirfenidona, once a month for the first 6 months, and then every 3 months while taking this medication, to check the proper functioning of your liver. It is essential that you have these blood tests periodically throughout the time you are taking pirfenidona.
Children and adolescents
Do not administer pirfenidona to children and adolescents under 18 years old.
Other medications and Pirfenidona Cipla
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
This is especially important if you are taking the following medications, as they may alter the effect of pirfenidona.
The following medications may increase the side effects of pirfenidona:
- enoxacina (a type of antibiotic).
- ciprofloxacin (a type of antibiotic).
- amiodarone (used to treat some types of cardiomyopathies).
- propafenone (used to treat some types of cardiomyopathies).
- fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).
The following medications may reduce the effectiveness of pirfenidona:
- omeprazole (used to treat conditions such as indigestion, gastroesophageal reflux disease).
- rifampicin (a type of antibiotic).
Taking Pirfenidona Cipla with food and drinks
Do not drink grapefruit juice while taking this medication. Grapefruit juice may make pirfenidona not work correctly.
Pregnancy and breastfeeding
As a precaution, it is recommended 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 plan to do so, talk to your doctor or pharmacist before taking this medication. Since it is not known if pirfenidona is excreted in breast milk, your doctor will explain the risks and benefits of taking this medication 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 Cipla contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".
3. How to Take Pirfenidone Cipla
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.
Normally, you will be administered this medication 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 (a total of 801 mg/day).
- Between days 8 and 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (a total of 1.602 mg/day). A dose of 534 mg will be obtained through the administration of 2 yellow tablets (267 mg).
- From day 15 (maintenance), take a dose of 801 mg (3 yellow tablets or 1 pink tablet), 3 times a day with food (a total of 2.403 mg/day).
The recommended daily maintenance dose of pirfenidone is 801 mg (3 yellow tablets or 1 pink tablet) three times a day with food, 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 of discomfort) and dizziness. If symptoms persist, consult 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 UV-A lamps, or significant changes in liver enzymes.
If you take more Pirfenidone Cipla than you should
Go to your doctor, pharmacist, or the nearest hospital emergency department immediately if you take more tablets than you should, and bring your medication with you.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Pirfenidone Cipla
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to compensate 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 treatment with Pirfenidone Cipla
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 267 mg 3 times a day and gradually increase it to 801 mg 3 times a day.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
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 experience 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.
- You have yellow eyes or skin, dark urine, and possibly accompanied by itching of the skin, stomach pain on the upper right side (abdomen), loss of appetite, bleeding, or the appearance of bruises more easily than normal, or you feel tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of pirfenidone.
- Flat red spots, or circular spots on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome or toxic epidermal necrolysis).
- Generalized skin rash, elevated body temperature, and enlarged 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.
- Feeling unwell (nausea).
- Stomach problems, such as acid reflux, vomiting, and constipation.
- Diarrea.
- Indigestion or stomach heaviness.
- Weight loss.
- Loss of appetite.
- Difficulty sleeping.
- Tiredness.
- Dizziness.
- Headache.
- Difficulty breathing.
- Cough.
- 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 feeling heavy, pain, and abdominal discomfort, stomach burning, and flatulence.
- Blood tests may indicate an increase in liver enzymes.
- Skin reactions after exposure to the sun or the use of UVA lamps.
- Cutaneous 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 the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Pirfenidona Cipla
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the blister or box after “CAD”. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
- The active ingredient is pirfenidona.
- 267 mg tablets:Each film-coated tablet contains 267 mg of pirfenidona.
- 801 mg tablets:Each film-coated tablet contains 801 mg of pirfenidona.
- The other components are:
- Tablet core:anhydrous colloidal silica (E551), hypromellose (E464), mannitol (E421), sodium carboxymethylcellulose (Type A), and sodium stearate fumarate.
- Coating material:macrogol (E1521), poly(vinyl alcohol) (E1203), talc (E553b), and titanium dioxide (E171).
267 mg film-coated tablets also contain yellow iron oxide (E172).
801 mg film-coated tablets also contain red iron oxide (E172).
Appearance of the product and contents of the package
267 mg tablets
Pirfenidona Cipla 267 mg film-coated tablets EFG are yellowish to yellow, biconvex, beveled-edge tablets, oval-shaped, and smooth on both sides. The tablet size is approximately 14 mm × 7 mm.
Initial treatment pack for 2 weeks: the multiple pack contains 63 film-coated tablets (1 pack of 21 and 1 pack of 42).
84 film-coated tablets.
Continuation pack: the multiple pack contains 252 film-coated tablets (3 packs of 84).
801 mg tablets
Pirfenidona Cipla 801 mg film-coated tablets EFG are pale pink to pink, biconvex, capsule-shaped, film-coated, and smooth on both sides. The tablet size is approximately 20 mm × 9 mm.
84 film-coated tablets.
Continuation pack: the multiple pack contains 252 film-coated tablets (3 packs of 84).
Each blister strip is marked with the following symbols and abbreviations, serving as a reminder to take a dose three times a day:
(sunrise; morning dose)(sun; afternoon dose) and(moon; night dose).
Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Only some package sizes may be marketed.
Marketing authorization holder and manufacturer
Cipla Europe NV
De Keyserlei 58-60, Box 19
2018, Antwerp
Belgium
Local representative
Cipla Europe NV subsidiary in Spain
C/Guzmán el Bueno 133, Edificio Britannia
28003, Madrid
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Sweden:Pirfenidon Cipla
Belgium:Pirfenidon Cipla
Germany:Pirfenidon Cipla
Spain:Pirfenidona Cipla 267 mg film-coated tablets EFG
Pirfenidona Cipla 801 mg film-coated tablets EFG
Norway:Pirfenidon Cipla
France:Pirfenidone Cipla
Italy:Pirfenidone Cipla
Poland:Pirfenidon Cipla
Ireland:Pirfenidone Cipla
Finland:Pirfenidon Cipla
Last revision date of this leaflet: March 2024
For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).
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