Pirfenidon Medical Vallei

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

Pirfenidone

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist.
See section 4.

Package Leaflet Contents:

• 1. What is Pirfenidon Medical Valley and what is it used for
• 2. Important information before taking Pirfenidon Medical Valley
• 3. How to take Pirfenidon Medical Valley
• 4. Possible side effects
• 5. How to store Pirfenidon Medical Valley
• 6. Package contents and other information

1. What is Pirfenidon Medical Valley and what is it 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 the lung tissue becomes inflamed and scarred over time, leading to difficulty breathing deeply. This impairs the proper functioning of the lungs. Pirfenidon Medical Valley helps reduce scarring and inflammation of the lungs 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 medication (listed in section 6)
if the patient has previously experienced angioedema while taking pirfenidone, with symptoms such as facial, lip, and/or tongue swelling, and which may have been associated with difficulty breathing or wheezing
if the patient is taking a medication called fluvoxamine (used to treat depression and obsessive-compulsive disorder)
in case of severe or end-stage liver failure
in case of severe or end-stage kidney failure requiring dialysis.
If any of these conditions occur, do not take Pirfenidon Medical Valley. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Pirfenidon Medical Valley, discuss it with a doctor or pharmacist
During treatment with Pirfenidon Medical Valley, increased sensitivity to sunlight may develop (photosensitivity reaction). While taking Pirfenidon Medical Valley, avoid exposure to sunlight (including sunbeds). Use sunscreens and cover arms, legs, and head to minimize exposure to sunlight (see section 4: Possible side effects).
Do not take other medications, such as tetracycline antibiotics (e.g., doxycycline), which may increase sensitivity to sunlight.
Tell your doctor about any kidney function disorders.
Tell your doctor about any mild or moderate liver function disorders.
Before starting treatment with Pirfenidon Medical Valley and during treatment, stop smoking. Smoking may reduce the effectiveness of Pirfenidon Medical Valley.
Pirfenidon Medical Valley may cause dizziness and fatigue. Be careful when performing tasks that require attention and coordination.
Pirfenidon Medical Valley may cause weight loss. The doctor will monitor the patient's weight.
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients treated with Pirfenidon Medical Valley. Stop taking Pirfenidon Medical Valley and seek medical attention immediately if any symptoms of these severe skin reactions occur, as described in section 4.
Pirfenidon Medical Valley may cause severe liver function disorders, and some cases have been fatal. Before starting treatment with Pirfenidon Medical Valley, perform blood tests, which will be repeated once a month for the first 6 months of treatment, and then every 3 months throughout the treatment period to monitor liver function. It is essential to perform regular blood tests throughout the treatment period with Pirfenidon Medical Valley.

Children and adolescents

Pirfenidon Medical Valley should not be given to children and adolescents under 18 years of age.

Pirfenidon Medical Valley and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
This is especially important when taking the following medications, as they may affect the action of Pirfenidon Medical Valley.
Medications that may increase the side effects of Pirfenidon Medical Valley:
enoxacin (a type of antibiotic)
ciprofloxacin (a type of antibiotic)
amiodarone (a medication used to treat certain heart conditions)
propafenone (a medication used to treat certain heart conditions)
fluvoxamine (a medication used to treat depression and obsessive-compulsive disorder (OCD)).
Medications that may reduce the effectiveness of Pirfenidon Medical Valley:
omeprazole (a medication used to treat conditions such as heartburn, gastroesophageal reflux disease)
rifampicin (a type of antibiotic).

Taking Pirfenidon Medical Valley with food and drink

Do not drink grapefruit juice while taking this medication. Grapefruit may interfere with the proper functioning of Pirfenidon Medical Valley.

Pregnancy and breastfeeding

As a precautionary measure, it is recommended to avoid taking Pirfenidon Medical Valley if the patient is pregnant, plans to become pregnant, or suspects she may be pregnant, as the potential risk to the unborn child is unknown.
If the patient is breastfeeding or plans to breastfeed, she should consult a doctor or pharmacist before taking Pirfenidon Medical Valley. It is not known whether Pirfenidon Medical Valley passes into breast milk, so the doctor will discuss the risks and benefits of taking this medication during breastfeeding, if the patient decides to breastfeed during treatment.

Driving and operating machinery

Do not drive or operate machinery if dizziness or fatigue occurs after taking Pirfenidon Medical Valley.

Pirfenidon Medical Valley contains sodium

The medication contains less than 1 mmol of sodium (23 mg) per capsule, which means the medication is considered "sodium-free".

3. How to take Pirfenidon Medical Valley

Treatment with Pirfenidon Medical Valley should be initiated and supervised by a specialist doctor with experience in the diagnosis and treatment of idiopathic pulmonary fibrosis.
Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The medication is usually taken in increasing doses as follows:
for 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);
from day 8 to 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet) 3 times a day with food (a total of 1602 mg/day);
from day 15 (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food (a total of 2403 mg/day).
The recommended daily maintenance dose of Pirfenidon Medical Valley is 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day, taken with food, for a total of 2403 mg/day.
Swallow the tablets whole with water, during or after a meal, to reduce the risk of side effects such as nausea (vomiting) and dizziness. If symptoms persist, consult a doctor.
Dose reduction due to side effects
The doctor may reduce the dose of the medication if the patient experiences side effects, such as stomach problems, any skin reactions to sunlight or sunbeds, or significant changes in liver enzyme activity.

Taking a higher dose of Pirfenidon Medical Valley than recommended

In case of taking a higher dose than recommended, contact a doctor, pharmacist, or the emergency department of the nearest hospital immediately and take the medication with you.

Missing a dose of Pirfenidon Medical Valley

If a dose is missed, take it as soon as possible. Do not take a double dose to make up for the missed dose. Maintain at least a 3-hour interval between doses. Do not take more tablets in a day than the recommended daily dose.

Stopping treatment with Pirfenidon Medical Valley

In certain situations, the treating doctor may advise stopping treatment with Pirfenidon Medical Valley. If treatment with Pirfenidon Medical Valley is interrupted for more than 14 consecutive days, the doctor will restart treatment with a dose of 267 mg 3 times a day, gradually increasing the dose to 801 mg 3 times a day.
In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Pirfenidon Medical Valley can cause side effects, although not everybody gets them.
Stop taking Pirfenidon Medical Valley and seek medical attention immediately if the patient notices any of the following symptoms:
Facial, lip, and/or tongue swelling, itching, hives, difficulty breathing or wheezing, or a feeling of fainting. 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 abdomen, loss of appetite, bleeding or bruising more easily than usual, or a feeling of fatigue. These may be symptoms of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidon Medical Valley.
Red, non-raised, or circular spots on the torso, often with centrally located blisters, peeling skin, 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, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other side effects that may occur

Talk to a doctor if the patient experiences any side effects.
Very common side effects(may affect more than 1 in 10 people):
infections of the throat or respiratory tract leading to the lungs and/or sinusitis
nausea
stomach problems, such as gastroesophageal reflux, vomiting, constipation
diarrhea
indigestion or stomach upset
weight loss
decreased appetite
sleep disorders
fatigue
dizziness
headache
shortness of breath
cough
joint pain.
Common side effects(may affect up to 1 in 10 people):
urinary tract infections
drowsiness
taste disorders
hot flashes
stomach problems, such as bloating, abdominal pain, and discomfort in the abdominal cavity, heartburn, and gas
blood tests may indicate increased liver enzyme activity
skin reactions to sunlight or sunbeds
skin problems, such as itching, redness, dryness, skin rash
muscle pain
feeling of weakness or lack of energy
chest pain
sunburn.
Uncommon side effects(may affect up to 1 in 100 people):
low sodium levels in the blood. This may cause headache, dizziness, disorientation, weakness, muscle cramps, or nausea and vomiting.
Blood tests may show a decrease in white blood cell count.

Reporting side effects

If side effects occur, including any side effects not listed in this package leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to store Pirfenidon Medical Valley

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the blister and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
There are no special precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Pirfenidon Medical Valley contains

• The active substance is pirfenidone. Pirfenidon Medical Valley, 267 mg: Each film-coated tablet contains 267 mg of pirfenidone. Pirfenidon Medical Valley, 534 mg: Each film-coated tablet contains 534 mg of pirfenidone. Pirfenidon Medical Valley, 801 mg: Each film-coated tablet contains 801 mg of pirfenidone.
• Other ingredients are: Tablet core: Microcrystalline cellulose, povidone K29-32, sodium croscarmellose, colloidal silicon dioxide, 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), and 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 film-coated tablets, approximately 13.2 x 6.2 mm in size, smooth on both sides.
Pirfenidon Medical Valley, 534 mg: orange, oval, biconvex film-coated tablets, approximately 16.3 x 8.5 mm in size, smooth on both sides.
Pirfenidon Medical Valley, 801 mg: brown, oval, biconvex film-coated tablets, approximately 20.2 x 9.5 mm in size, smooth on both sides.
Blisters of PVC/PCTFE/Aluminum in a cardboard box.
Package sizes:
Pirfenidon Medical Valley, 267 mg is packaged in blisters, in cardboard boxes containing 21, 63, or 252 film-coated tablets.
Pirfenidon Medical Valley, 534 mg is packaged in blisters, in cardboard boxes containing 21 film-coated tablets.
Pirfenidon Medical Valley, 801 mg is packaged in blisters, in cardboard boxes containing 84 or 252 film-coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Email: safety@medicalvalley.se

Manufacturer/Importer

Laboratorios Liconsa S.A
Avenida De Miralcampo 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Pirfenidon Medical Valley
Netherlands:
Pirfenidon Xiromed 267 mg film-coated tablets
Pirfenidon Xiromed 534 mg film-coated tablets
Pirfenidon Xiromed 801 mg film-coated tablets
Iceland:
Pirfenidon Medical Valley 267 mg film-coated tablets
Pirfenidon Medical Valley 534 mg film-coated tablets
Pirfenidon Medical Valley 801 mg film-coated tablets
Germany:
Pirfenidon AXiromed 267 mg film-coated tablets
Pirfenidon AXiromed 534 mg film-coated tablets
Pirfenidon AXiromed 801 mg film-coated tablets
Norway: Pirfenidon Medical Valley
Poland:
Pirfenidon Medical Valley
Sweden:
Pirfenidon Medical Valley 267 mg film-coated tablets
Pirfenidon Medical Valley 534 mg film-coated tablets
Pirfenidon Medical Valley 801 mg film-coated tablets
Date of last revision of the package leaflet:04/2024