Pirfenidone medical valley
Poland
Table of Contents
Package leaflet: Information for the patient
Pirfenidon Medical Valley, 267 mg, film-coated tablets
Pirfenidon Medical Valley, 534 mg, film-coated tablets
Pirfenidon Medical Valley, 801 mg, film-coated tablets
Pirfenidonum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms appear identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately.
See section 4.
Table of contents:
- What Pirfenidon Medical Valley is and what it is used for
- Important information before taking Pirfenidon Medical Valley
- How to take Pirfenidon Medical Valley
- Possible side effects
- How to store Pirfenidon Medical Valley
- Contents of the pack and other information
1. What Pirfenidon Medical Valley is and what it is used for
Pirfenidon Medical Valley contains the active substance pirfenidone and is used to treat
idiopathic pulmonary fibrosis (IPF) in adults.
Idiopathic pulmonary fibrosis is a disease in which lung tissue becomes inflamed and, over time, develops scarring (fibrosis), making deep breathing difficult. This impairs proper lung function. Pirfenidon Medical Valley helps reduce lung scarring and inflammation and helps improve breathing.
2. Important information before taking Pirfenidon Medical Valley
When not to take Pirfenidon Medical Valley
if the patient is allergic to pirfenidone or any of the other ingredients of this medicine
(listed in section 6)
if the patient previously experienced angioedema during treatment with pirfenidone,
with symptoms such as swelling of the face, lips and (or) tongue, which may have been associated
with breathing difficulties or wheezing
if the patient is taking a medicine called fluvoxamine (used in the treatment of depression and obsessive-compulsive
disorder)
in cases of severe or end-stage liver failure
in cases of severe or end-stage renal failure requiring dialysis therapy.
If any of the above conditions apply, Pirfenidon Medical Valley must not be used. In case of doubt, please consult your doctor or pharmacist.
Warnings and precautions
Before starting treatment with Pirfenidon Medical Valley, discuss it with your doctor or
pharmacist.
During treatment with Pirfenidon Medical Valley, increased sensitivity to sunlight (photosensitivity reaction) may develop. While taking Pirfenidon Medical Valley, exposure to sunlight (including solarium use) should be avoided. Sunscreen should be used and arms, legs and head covered to minimize exposure to sunlight (see section 4: Possible side effects).
Do not take other medicines such as tetracycline antibiotics (e.g. doxycycline), which may increase sensitivity to sunlight.
Inform your doctor if you have kidney function disorders.
Inform your doctor if you have mild or moderate liver function disorders.
Before starting and during treatment with Pirfenidon Medical Valley, smoking must be discontinued. Smoking may reduce the effectiveness of Pirfenidon Medical Valley.
Pirfenidon Medical Valley may cause dizziness and fatigue. Exercise caution when performing activities requiring alertness and coordination.
Pirfenidon Medical Valley may cause weight loss. Your doctor will monitor your body weight during treatment with this medicine.
Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) have been reported with treatment using Pirfenidon Medical Valley. If any symptoms associated with these serious skin reactions (described in section 4) occur, stop taking Pirfenidon Medical Valley immediately and contact your doctor without delay.
Pirfenidon Medical Valley may cause severe liver function disorders, some of which have been fatal. Before starting treatment with Pirfenidon Medical Valley, blood tests should be performed and repeated monthly for the first 6 months of treatment, then every 3 months throughout the treatment period to monitor liver function. It is essential to undergo regular blood tests for the entire duration of treatment with Pirfenidon Medical Valley.
Children and adolescents
Pirfenidon Medical Valley must not be given to children and adolescents under 18 years of age.
Pirfenidon Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
This is particularly important when taking any of the following medicines, as they may alter the effects of Pirfenidon Medical Valley.
Medicines that may increase side effects of Pirfenidon Medical Valley:
enoxacin (a type of antibiotic)
ciprofloxacin (a type of antibiotic)
amiodarone (a medicine used to treat certain heart conditions)
propafenone (a medicine used to treat certain heart conditions)
fluvoxamine (a medicine used to treat depression and obsessive-compulsive disorder (OCD)).
Medicines that may reduce the effectiveness of Pirfenidon Medical Valley:
omeprazole (a medicine used to treat conditions such as indigestion, gastroesophageal reflux disease)
rifampicin (a type of antibiotic).
Taking Pirfenidon Medical Valley with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Pirfenidon Medical Valley.
Pregnancy and breastfeeding
As a precautionary measure, it is better to avoid using Pirfenidon Medical Valley if you are pregnant, planning pregnancy, or suspect you might be pregnant, as the potential risk to the unborn child is unknown.
If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking Pirfenidon Medical Valley. It is not known whether Pirfenidon Medical Valley passes into human milk; therefore, your doctor will discuss the risks and benefits of using this medicine during breastfeeding if you decide to breastfeed while on treatment.
Driving and operating machinery
Do not drive or operate any machinery if you experience dizziness or fatigue after taking Pirfenidon Medical Valley.
Pirfenidon Medical Valley contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. considered "sodium-free".
3. How to take Pirfenidon Medical Valley
Treatment with Pirfenidon Medical Valley should be initiated and supervised by a specialist doctor experienced in the diagnosis and treatment of idiopathic pulmonary fibrosis.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The medicine is usually administered in increasing doses as follows:
Days 1–7: 267 mg (1 yellow tablet) three times daily with food (total 801 mg/day)
Days 8–14: 534 mg (2 yellow tablets or 1 orange tablet) three times daily with food (total 1602 mg/day)
Day 15 onwards (maintenance treatment): 801 mg (3 yellow tablets or 1 brown tablet) three times daily with food (total 2403 mg/day).
The recommended maintenance daily dose of Pirfenidon Medical Valley is 801 mg (3 yellow tablets or 1 brown tablet) taken three times daily with food, giving a total of 2403 mg/day.
Tablets should be swallowed whole with water, during or after meals to reduce the risk of side effects such as nausea and dizziness. If symptoms persist, consult your doctor.
Dose reduction due to side effects
Your doctor may reduce the dose if you experience side effects such as gastrointestinal problems, any skin reactions to sunlight or solarium exposure, or significant changes in liver enzyme activity.
Taking more Pirfenidon Medical Valley than recommended
If you take more tablets than prescribed, contact your doctor, pharmacist, or the emergency department of your nearest hospital immediately and bring the medicine with you.
Missing a dose of Pirfenidon Medical Valley
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a missed dose. Maintain at least a 3-hour interval between doses. Do not take more tablets in one day than the recommended daily dose.
Stopping Pirfenidon Medical Valley
In certain situations, your treating doctor may advise stopping treatment with Pirfenidon Medical Valley. If treatment with Pirfenidon Medical Valley is interrupted for more than 14 consecutive days for any reason, your doctor will restart treatment at a dose of 267 mg three times daily, gradually increasing the dose to 801 mg three times daily.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Pirfenidon Medical Valley must be stopped immediately and medical help sought
if the patient notices any of the following objective or subjective symptoms:
Swelling of the face, lips and (or) tongue, itching, urticaria, difficulty breathing or
wheezing, or feeling faint. These are symptoms of a severe allergic reaction known as
angioedema or anaphylaxis.
Yellowing of the eyes or skin, or dark urine, which may be accompanied by itching of the skin,
pain in the upper right part of the abdomen, loss of appetite, bleeding or bruising more easily than usual,
or feeling tired. These may be symptoms of liver dysfunction and could indicate liver damage,
which is an uncommon adverse reaction of Pirfenidon Medical Valley.
Red, flat or circular spots on the trunk, often with centrally located blisters, peeling skin,
ulceration of the mouth, throat, nose, genital organs 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 fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other adverse reactions that may occur
Talk to your doctor if you experience any adverse reactions.
Very common adverse reactions (may affect more than 1 in 10 people):
infections of the throat or respiratory tract leading to lungs and (or) sinusitis
nausea
stomach problems such as regurgitation of stomach contents into the oesophagus, vomiting, constipation
diarrhoea
indigestion or upset stomach
weight loss
decreased appetite
sleep disturbances
fatigue
dizziness
headache
dyspnoea
cough
joint pain
Common adverse reactions (may affect up to 1 in 10 people):
urinary bladder infections
drowsiness
taste disturbances
hot flushes
stomach problems such as bloating, abdominal pain and discomfort, heartburn, and flatulence
blood tests may indicate increased liver enzyme activity
skin reactions after exposure to sunlight or solarium
skin problems such as itching, redness, dryness of the skin, skin rash
muscle pain
feeling weak or lack of energy
chest pain
sunburn
Uncommon adverse reactions (may affect up to 1 in 100 people):
low sodium levels in the blood. This may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
blood tests may show reduced white blood cell count.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Pirfenidon Medical Valley
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What Pirfenidon Medical Valley contains
- The active substance is pirfenidone.
Pirfenidon Medical Valley 267 mg: Each coated tablet contains 267 mg of pirfenidone.
Pirfenidon Medical Valley 534 mg: Each coated tablet contains 534 mg of pirfenidone.
Pirfenidon Medical Valley 801 mg: Each coated tablet contains 801 mg of pirfenidone. - Other ingredients are:
Tablet core: Microcrystalline cellulose, povidone K29-32, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.
Tablet coating: Polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, and yellow iron oxide (E 172) (Pirfenidon Medical Valley 267 mg and 534 mg), red iron oxide (E 172) (Pirfenidon Medical Valley 534 mg and 801 mg), black iron oxide (E 172) (Pirfenidon Medical Valley 801 mg).
What Pirfenidon Medical Valley looks like and contents of the pack
Pirfenidon Medical Valley 267 mg: Yellow, oval, biconvex coated tablets approximately 13.2 x 6.2 mm in size, smooth on both sides.
Pirfenidon Medical Valley 534 mg: Orange, oval, biconvex coated tablets approximately 16.3 x 8.5 mm in size, smooth on both sides.
Pirfenidon Medical Valley 801 mg: Brown, oval, biconvex coated tablets approximately 20.2 x 9.5 mm in size, smooth on both sides.
Packaged in PVC/PCTFE/Aluminum foil blisters in cardboard boxes.
Pack sizes:
Pirfenidon Medical Valley 267 mg is packaged in blisters in cardboard boxes containing 21, 63, or 252 coated tablets.
Pirfenidon Medical Valley 534 mg is packaged in blisters in cardboard boxes containing 21 coated tablets.
Pirfenidon Medical Valley 801 mg is packaged in blisters in cardboard boxes containing 84 or 252 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Email: [email protected]
Manufacturer/Importer
Laboratorios Liconsa S.A
Avenida De Miralcampo 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Pirfenidon Medical Valley
Netherlands: Pirfenidon Xiromed 267 mg filmomhulde tabletten
Pirfenidon Xiromed 534 mg filmomhulde tabletten
Pirfenidon Xiromed 801 mg filmomhulde tabletten
Iceland: Pirfenidon Medical Valley 267 mg filmuhúðaðar töflur
Pirfenidon Medical Valley 534 mg filmuhúðaðar töflur
Pirfenidon Medical Valley 801 mg filmuhúðaðar töflur
Germany: Pirfenidon AXiromed 267 mg Filmtabletten
Pirfenidon AXiromed 534 mg Filmtabletten
Pirfenidon AXiromed 801 mg Filmtabletten
Norway: Pirfenidon Medical Valley
Poland: Pirfenidon Medical Valley
Sweden: Pirfenidon Medical Valley 267 mg filmdragerade tabletter
Pirfenidon Medical Valley 534 mg filmdragerade tabletter
Pirfenidon Medical Valley 801 mg filmdragerade tabletter