Patient leaflet - Pirfenidone Lupin 801 mg film-coated tablets
1. What Pirfenidone Lupin film-coated tablets are and what they are used for
Pirfenidone Lupin film-coated tablets contain the active substance pirfenidone and it is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.
IPF is a condition in which the tissues in your lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply. This makes it hard for your lungs to work properly. Pirfenidone Lupin film-coated tablets helps to reduce scarring and swelling in the lungs, and helps you breathe better.
2. What you need to know before you take Pirfenidone Lupin film-coated tablets
Do not take Pirfenidone Lupin film-coated tablets
if you are allergic to pirfenidone or 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 affects you, do not take Pirfenidone Lupin film-coated tablets. If you are unsure ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Lupin film-coated tablets
You may become more sensitive to sunlight
(photosensitivity reaction) when taking Pirfenidone Lupin film-coated tablets. Avoid the sun (including sunlamps) whilst taking Pirfenidone Lupin 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 tell your doctor if you suffer from kidney
problems.
You should tell your doctor if you suffer from mild to
moderate liver problems.
You should stop smoking before and during treatment with
Pirfenidone Lupin film-coated tablets. Cigarette smoking can reduce the effect of Pirfenidone Lupin film-coated tablets.
Pirfenidone Lupin 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 Lupin film-coated tablets can cause weight
loss. Your doctor will monitor your weight whilst you are taking this medicine.
Stevens-Johnson syndrome, toxic epidermal necrolysis
and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with pirfenidone treatment. Stop using Pirfenidone Lupin 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.
Pirfenidone Lupin 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 Lupin 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 Lupin film-coated tablets.
Children and adolescents
Do not give Pirfenidone Lupin film-coated tablets to children and adolescents under the age of 18.
Other medicines and Pirfenidone Lupin film-coated tablets
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 Lupin film-coated tablets.
Medicines that may increase side effects of Pirfenidone Lupin 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)).
Medicines that may reduce how well Pirfenidone Lupin film-coated tablets works:
omeprazole (used in the treatment of conditions such as
indigestion, gastroesophageal reflux disease)
- rifampicin (a type of antibiotic)
Pirfenidone Lupin film-coated tablets with food and drink
Do not drink grapefruit juice whilst taking this medicine. Grapefruit may prevent Pirfenidone Lupin film-coated tablets from working properly.
Pregnancy and breast-feeding
As a precautionary measure, it is preferable to avoid the use of Pirfenidone Lupin 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 Lupin 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.
Driving and using machines
Do not drive or use machines if you feel dizzy or tired after taking Pirfenidone Lupin film-coated tablets.
Pirfenidone Lupin film-coated tablets contain sodium:
Pirfenidone Lupin contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
3. How to take Pirfenidone Lupin film-coated tablets
Treatment with Pirfenidone Lupin film-coated tablets should be started and overseen by a specialist doctor experienced in the diagnosis and treatment of IPF.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your medicine will usually be given to you 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), 3 times a day with food (a total of 1,602 mg/day)
from day 15 onwards (maintenance), take a dose of 801 mg
(3 yellow tablets or 1 brown tablet), 3 times a day with food (a total of 2,403 mg/day).
The recommended maintenance daily dose of pirfenidone is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, for a total of 2403 mg/day.
Swallow the tablets whole with a drink of water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If symptoms continue, see your doctor.
Dose reduction due to side effects
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.
If you take more Pirfenidone Lupin film-coated tablets than you should
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 to take Pirfenidone Lupin film-coated tablets
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.
If you stop taking Pirfenidone Lupin film-coated tablets
In some situations, your doctor may advise you to stop taking Pirfenidone Lupin film-coated tablets. If for any reason you have to stop taking Pirfenidone Lupin film-coated tablets for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day, gradually increasing this to a dose of 801 mg 3 times a day. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Pirfenidone Lupin film-coated tablets and seek medical attention immediately if you notice any of the following Pirfenidone Lupin 267 mg film-coated tablets Pirfenidone Lupin 801 mg film-coated tablets
276044
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Swelling of the face, lips and/or tongue, itching, hives,
difficulty breathing or wheezing, or feeling faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
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 Lupin film-coated tablets.
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 (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Widespread rash, high body temperature and enlarged
lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other side effects may include
Talk to your doctor if you get any side effects.
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
- dizzines
- 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 feeling bloated, abdominal pain
and discomfort, heart burn, 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 nausea and vomiting.
- blood tests may show decrease in white blood cells.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google play or Apple App store. By reporting
side effects, you can help provide more information on the safety of this medicine.
5. How to store Pirfenidone Lupin film-coated tablets
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 and carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Pirfenidone Lupin film-coated tablets contain
267 mg film-coated tablets:
The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
The other ingredients are pregelatinized starch, croscarmellose sodium, magnesium stearate & purified water. The tablets are coated with polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol/PEG, talc, iron oxide yellow and purified water.
801 mg film-coated tablets:
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
The other ingredients are pregelatinized starch, croscarmellose sodium, magnesium stearate & purified water. The tablets are coated with polyvinyl alcohol-part hydrolyzed, titanium dioxide macrogol/PEG, talc, iron oxide red, ferrosoferric oxide/black iron oxide and purified water.
What Pirfenidone Lupin film-coated tablets look like and contents of the pack
267 mg film-coated tablets:
Yellow coloured, oval shaped, biconvex film coated tablets debossed with 'P1' on one side and plain on the other side The packs contain 21, 42, 63, 84 or 168 film-coated tablets and the multipack contain 252 (continuation pack 3x84) film-coated tablets.
The 267 mg blisters strips are each marked with the following symbols as a reminder to take a dose three times a day:
801 mg film-coated tablets:
Brown coloured, oval shaped, biconvex film coated tablets debossed with 'P2' on one side and plain on the other side The pack contains 84 film-coated tablets and the multipack contains 252 (continuation pack 3x84) film-coated tablets. The 801 mg blisters strips are each marked with the following symbols as a reminder to take a dose three times a day:
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin Healthcare (UK) Limited
The Urban Building
2nd floor, 3-9 Albert Street
Slough, Berkshire
SL1 2BE
United Kingdom
This leaflet was last revised in 02/2024.
Code No. MP/DRUGS/25/8/2010 ID#: 276044
(sunrise; morning dose) (sun; daytime dose) and (moon; evening dose).
(sunrise; morning dose) (sun; daytime dose) and (moon; evening dose).