Pirfenidone 801 mg Film-coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Pirfenidone Film-coated Tablets are and what they are used for
2. What you need to know before you take Pirfenidone Film-coated Tablets
3. How to take Pirfenidone Film-coated Tablets
4. Possible side effects
5. How to store Pirfenidone Film-coated Tablets
6. Contents of the pack and other information

• if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced an allergic reaction to 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 affects you, do not take Pirfenidone Film-coated Tablets. If you are unsure, ask your doctor or pharmacist.

Talk to your doctor or pharmacist before taking Pirfenidone Film-coated Tablets

• if you suffer from kidney problems
• if you suffer from mild to moderate liver problems.
• Pirfenidone Film-coated Tablets may cause serious liver problems and some cases have been fatal. You will need a blood test before you start taking Pirfenidone Film-coated Tablets and at monthly intervals for the first 6 months and then every 3 months thereafter whilst you are taking this medicine to check whether your liver is working properly. It is important that you have these regular blood tests for as long as you are taking Pirfenidone Film-coated Tablets.
• You may become more sensitive to sunlight (photosensitivity reaction) when taking Pirfenidone Film-coated Tablets. Avoid the sun (including sunlamps) whilst taking Pirfenidone Film-coated Tablets. Wear sunblock 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 (such as doxycycline), which may make you more sensitive to sunlight.
• You should stop smoking before and during treatment with Pirfenidone Film-coated Tablets. Cigarette smoking can reduce the effect of Pirfenidone Film-coated Tablets.
• Pirfenidone Film-coated Tablets may cause dizziness and tiredness. Be careful if you have to take part in activities where you have to be alert and co-ordinated.
• Pirfenidone Film-coated Tablets can cause weight loss. Your doctor will monitor your weight whilst you are taking this medicine.
• Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pirfenidone treatment. Stop using Pirfenidone Film-coated Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Do not give Pirfenidone Film-coated Tablets to children and adolescents under the age of 18.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you are taking the following medicines, as they may change the effect of Pirfenidone Film-coated Tablets.

Medicines that may increase side effects of Pirfenidone Film-coated Tablets:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat some types of heart disease)
• propafenone (used to treat some types of heart disease)
• fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD)). Do not take Pirfenidone Film-coated Tablets if you are taking fluvoxamine.
• doxycycline (or other tetracycline antibiotic)

Medicines that may reduce how well Pirfenidone Film-coated Tablets work:

• omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Do not drink grapefruit juice whilst taking this medicine. Grapefruit may stop Pirfenidone Film-coated Tablets from working properly.

As a precaution, it is preferable to avoid the use of Pirfenidone Film-coated Tablets if you are pregnant, planning to become pregnant, or think you might be pregnant, as the potential risks to the unborn child are unknown.

If you are breast-feeding or plan to breast-feed, speak to your doctor or pharmacist before taking Pirfenidone Film-coated Tablets. As it is unknown whether pirfenidone passes into breast milk, your doctor will discuss the risks and benefits of taking this medicine while breast-feeding if you decide to do so.

Do not drive or use machines if you feel dizzy or tired after taking Pirfenidone Film-coated Tablets.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.

Your doctor may reduce your dose if you suffer from side effects such as, stomach problems, any skin reactions to sunlight or sun lamps, or significant changes to your liver enzymes.

Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more tablets than you should, and take your medicine with you.

If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. Each dose should be separated by at least 3 hours. Do not take more tablets each day than your prescribed daily dose.

In some situations, your doctor may advise you to stop taking Pirfenidone Film-coated Tablets. If for any reason you have to stop taking Pirfenidone Film-coated Tablets for more than 14 days in a row, your doctor will restart your treatment with a dose of 267 mg three times a day, gradually increasing this to a dose of 801 mg three times a day.

• if you experience swelling of the face, lips and/or tongue, itching, hives (red, itchy, and swollen areas (welts) on the skin), difficulty breathing or wheezing, or feeling faint, which are signs of, a serious allergic reaction.
• if you experience yellowing of the eyes or skin, or dark urine, potentially accompanied by itching of the skin, pain on the upper right side of your stomach area (abdomen), loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These may be signs of abnormal liver function and could indicate liver injury, which is an uncommon side effect of Pirfenidone Film-coated Tablets.
• If you experience reddish non-elevated, or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Very common side effects (may affect more than 1 in 10 people):

• infections of the throat or the airways going into the lungs and/or sinusitis
• feeling sick (nausea)
• stomach problems such as acid reflux, vomiting and feeling constipated
• diarrhoea
• indigestion or stomach upset
• weight loss
• decreased appetite
• difficulty sleeping
• tiredness
• dizziness
• headache
• shortness of breath
• cough
• aching joints/joint pains

Common side effects (may affect up to 1 in 10 people):

• bladder infections
• feeling sleepy
• changes in taste
• hot flushes
• stomach problems such as acid reflux, being sick (vomiting), feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind
• blood tests may show increased levels of liver enzymes
• skin reactions after going out in the sun or using sunlamps
• skin problems such as itchy skin, skin redness or red skin, dry skin, skin rash
• muscle pain
• feeling weak or feeling low in energy
• chest pain
• sunburn.

Uncommon side 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 feeling sick (nausea) and being sick (vomiting).
• blood tests may show decrease in white blood cells

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.

Pirfenidone 267 mg Film-coated Tablets:

• The active substance is pirfenidone.
• Each film-coated tablet contains 267 mg of pirfenidone
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide and sodium stearyl fumarate.
• The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc and iron oxide yellow (E172).

Pirfenidone 801 mg Film-coated Tablets:

• The active substance is pirfenidone.
• Each film-coated tablet contains 801 mg of pirfenidone
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide and sodium stearyl fumarate.
• The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc. iron oxide black (E172), and iron oxide red (E172).

Pirfenidone 267 mg Film-coated Tablets are light yellow to yellow coloured, oval shaped tablets, debossed with “A106” on one side and plain on the other side.

The blister packs contain 21, 42, 84 or 168 film-coated tablets. The 2-week treatment initiation pack contains 63 (3 blisters of 21) film-coated tablets and the continuation pack contains 252 (12 blisters of 21) film-coated tablets.

The 267 mg blisters strips are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:

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

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

Pirfenidone 801 mg Film-coated Tablets are light brown to brown coloured, oval shaped tablets, debossed with “A108” on one side and plain on the other side.

The blister packs contain 21, 63 or 84 film-coated tablets. The continuation pack contains 252 (12 blisters of 21) film-coated tablets.

The 801 mg blisters strips are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:

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

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

Not all pack sizes may be marketed.