Blamonehel

Patient Information Leaflet

Gunacresa 267 mg film-coated tablets
Gunacresa 801 mg film-coated tablets
Pirfenidone
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  Contents of this leaflet:

1. What Gunacresa is and what it is used for
2. What you need to know before taking Gunacresa
3. How to take Gunacresa
4. Possible side effects
5. How to store Gunacresa
6. Contents of the pack and other information

1. What Gunacresa is and what it is used for

Gunacresa contains the active substance pirfenidone and is used to treat mild to moderate idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adults.
IPF is a disease in which lung tissues become inflamed and damaged over time, leading to difficulty in breathing deeply. This impairs proper lung function.
Gunacresa helps reduce lung damage and inflammation, and helps improve breathing.

2. What you need to know before taking Gunacresa

Do not take Gunacresa

• if you are allergic to pirfenidone or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced 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 conditions apply to you, do not take Gunacresa. If in doubt, consult your doctor or
pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Gunacresa.

• You may become more sensitive to sunlight (photosensitivity reaction) while taking Gunacresa. Avoid sun exposure (including tanning lamps) during treatment with Gunacresa. Apply sunscreen daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects).
• Do not take other medicines such as tetracycline antibiotics (e.g. doxycycline) that may increase your sensitivity to sunlight.
• If you have kidney problems, inform your doctor.
• If you have mild to moderate liver problems, inform your doctor.
• Stop smoking before and during treatment with Gunacresa. Cigarette smoking may reduce the effect of Gunacresa.
• Gunacresa may cause dizziness and fatigue. Be cautious if you need to perform activities requiring mental alertness and coordination.
• Gunacresa may cause weight loss. Your doctor will monitor your weight during treatment with this medicine.
• Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with Gunacresa treatment. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop treatment with Gunacresa and seek immediate medical advice.

Gunacresa may cause severe liver problems, which in some cases have been fatal. You will need to have a blood test before starting Gunacresa, monthly for the first 6 months, and then every 3 months during treatment to monitor proper liver function. It is important that you attend these regular blood tests while taking Gunacresa.
Children and adolescents
Do not give Gunacresa to children and adolescents under 18 years of age.
Other medicines and Gunacresa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This section is particularly important if you are taking the following medicines, as they may alter the effect of Gunacresa.
Medicines that may increase the side effects of Gunacresa:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat certain heart conditions)
• propafenone (used to treat certain heart conditions)
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).

Medicines that may reduce the effectiveness of Gunacresa:

• omeprazole (used to treat conditions such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Gunacresa with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Gunacresa.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Gunacresa during pregnancy, or if you suspect you might be pregnant or are planning a pregnancy, because the potential risks to the fetus are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Gunacresa. Since it is not known whether Gunacresa passes into breast milk, your doctor will evaluate the risks and benefits of taking this medicine during breastfeeding if you decide to breastfeed.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or fatigue after taking Gunacresa.
Gunacresa contains sodium
Gunacresa contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Gunacresa

Treatment with Gunacresa must be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of IPF.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The medicine will usually be administered in increasing doses as follows:

• for the first 7 days, take one 267 mg dose (1 yellow tablet) three times a day with food (for a total of 801 mg/day)
• from day 8 to day 14, take one 534 mg dose (2 yellow tablets) three times a day with food (for a total of 1,602 mg/day)
• from day 15 onwards (maintenance phase), take one 801 mg dose (3 yellow tablets or 1 purple tablet) three times a day with food (for a total of 2,403 mg/day).

The recommended daily maintenance dose of Gunacresa is 801 mg (3 yellow tablets or 1 purple tablet) three times a day with food, for a total of 2,403 mg/day.
Swallow the tablet whole with water during or after meals to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to adverse effects
Your doctor may reduce your dose if you experience adverse effects such as stomach problems, skin reactions to sunlight or tanning lamps, or significant changes in liver enzymes.

If you take more Gunacresa than you should
If you have taken more tablets than prescribed, contact your doctor, pharmacist, or nearest emergency department immediately, and bring the medicine with you.

If you forget to take Gunacresa
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose. There must be at least three hours between doses. Do not take more tablets in one day than prescribed according to the recommended daily dose.

If you stop taking Gunacresa
In certain specific cases, your doctor may advise you to stop taking Gunacresa. If, for any reason, you need to interrupt treatment with Gunacresa for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg three times a day, gradually increasing this dose up to 801 mg three times a day.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Gunacresa and contact your doctor immediately if:

• You experience swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or wheezing, or a feeling of fainting, which are symptoms of angioedema, a serious allergic reaction or anaphylaxis.
• You develop yellowing of the whites of the eyes or skin, dark urine, possibly accompanied by itching of the skin, pain in the upper right part of the abdomen, loss of appetite, increased tendency to bleeding or bruising, or feeling tired. These may be signs of impaired liver function and could indicate liver damage, which is an uncommon adverse reaction to Gunacresa.
• You develop flat or circular reddish skin lesions on the trunk, often with central blisters,

skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms. These signs and symptoms may indicate the onset of Stevens-Johnson syndrome or toxic epidermal necrolysis.
Other possible side effects include
Talk to your doctor if you notice any side effect.
Very common side effects (may affect more than 1 in 10 people):

• Throat or airway infections reaching the lungs and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems such as acid reflux, vomiting, and constipation
• Diarrhoea
• Indigestion or stomach discomfort
• Weight loss
• Decreased appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Shortness of breath
• Cough
• Joint pain/pain in joints Common side effects (may affect up to 1 in 10 people):
• Bladder infections
• Drowsiness
• Altered taste
• Hot flushes
• Stomach problems such as bloating, pain and abdominal discomfort, heartburn, and passing gas
• Blood tests may show increased liver enzyme levels
• Skin reactions after exposure to sunlight or use of sunlamps
• Skin problems such as itching, redness, dry skin, rash
• Muscle pain
• Feeling weak or lacking energy
• Chest pain
• Sunburn. Uncommon side effects (may affect up to 1 in 100 people):
• Low levels of sodium in the blood. These can cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• Blood tests may show a reduction in white blood cells.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gunacresa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack label and on the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gunacresa contains
267 mg tablet
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 consists of: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172).

801 mg tablet
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 consists of: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).

Description of the appearance of Gunacresa and contents of the pack
The 267 mg film-coated tablets of Gunacresa are yellow, oval-shaped, approximately 12.9 x 5.9 mm in size, with "3610" engraved on one side and "T" on the other. The blister pack contains 63 film-coated tablets or 252 film-coated tablets. Each 267 mg blister is marked with symbols and abbreviated day names to remind patients to take a dose three times daily:

(sunrise; morning dose) (sun; midday dose) and (moon; evening dose).

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

The 801 mg film-coated tablets of Gunacresa are purple, oval-shaped, approximately 20.1 x 9.3 mm in size, with "3611" engraved on one side and "T" on the other. The blister pack contains 84 film-coated tablets. Each 801 mg blister is marked with symbols and abbreviated day names to remind patients to take a dose three times daily:

(sunrise; morning dose) (sun; midday dose) and (moon; evening dose).

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

Not all pack sizes may be marketed.

Marketing Authorization Holder
Day Zero ehf.
Reykjavíkurvegi 62
Hafnarfjördur - 220
Iceland

Manufacturer
Actavis Ltd.
BLB 015 - 016 Bulebel Industrial Estate
Zejtun – ZTN 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Italy: Gunacresa