LoginEsbriet
Generic Name: pirfenidone
Product Name: Esbriet
Indication: What Esbriet is used for
Esbriet contains the active ingredient pirfenidone.
Esbriet is used to treat Idiopathic Pulmonary Fibrosis (IPF).
IPF is a condition that causes ongoing scarring of the lungs, making it hard for them to work properly, and becomes worse over time.
Esbriet helps to slow down the rate of scarring in your lungs, and may slow down the worsening of your IPF.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
It is available only with a doctor’s prescription.
There is not enough information to recommend the use of this medicine for children.
Action: How Esbriet works
The mechanism of action of pirfenidone has not been fully established. Idiopathic pulmonary fibrosis (IPF) is a chronic fibrotic and inflammatory pulmonary disease affected by the synthesis and release of pro-inflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and interleukin-1-beta (IL-1β). Existing data indicate that pirfenidone exerts both anti-fibrotic and anti-inflammatory properties in animal models of inflammation and pulmonary fibrosis.
Esbriet contains 267 mg of pirfenidone as the active ingredient. Other ingredients include microcrystalline cellulose (460), croscarmellose sodium, povidone, magnesium stearate. The capsule shell contains gelatin and titanium dioxide (171) while the capsule brown printing ink contains shellac (904), iron oxide black (172), iron oxide red (172), iron oxide yellow (172), propylene glycol (1520), and ammonium hydroxide.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Dose advice: How to use Esbriet
Before you take Esbriet
When you must not take it
- Do not take Esbriet if you have an allergy to:
- Any medicine containing pirfenidone;
- Any of the ingredients listed in the ingredients of this medication.
- Some of the symptoms of an allergic reaction may include:
- Shortness of breath;
- Wheezing or difficulty breathing;
- Swelling of the face, lips, tongue or other parts of the body;
- Rash, itching or hives on the skin.
- Do not take this medicine if you are pregnant.
- It may affect your developing baby if you take it during pregnancy.
- Do not breast-feed if you are taking this medicine.
- It is not known if pirfenidone passes into breast milk. Talk to your doctor or pharmacist before taking Esbriet, your doctor will discuss the risks and benefits of taking this medicine while breast feeding.
- Do not give this medicine to a child or adolescents under the age of 18 years.
- Safety and effectiveness in children and adolescents younger than 18 years have not been established.
- Do not take Esbriet if you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD).
- Do not take Esbriet if you have experienced angioedema when previously taking Esbriet.
- Some of the symptoms of an allergic reaction may include:
- Shortness of breath;
- Wheezing or difficulty breathing;
- Swelling of the face, lips, tongue or other parts of the body;
- Rash, itching or hives on the skin.
- Some of the symptoms of an allergic reaction may include:
- Do not take Esbriet if you have or have had any of the following:
- Severe liver problems;
- Severe kidney problems including dialysis.
- Do not take Esbriet after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
- If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any of the following medical conditions:
- Kidney problems;
- Liver problems;
- Are a smoker.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
You may become more sensitive to sunlight while taking Esbriet.
Avoid the sun, including sunlamps or tanning beds, while taking Esbriet. Wear sunblock daily and cover your arms legs and head to reduce exposure to sunlight.
You should stop smoking before and during treatment with Esbriet.
Cigarette smoking can reduce the effect of Esbriet.
Esbriet may cause dizziness and tiredness.
Be careful if you have to take part in activities where you have to be alert and coordinated.
Esbriet can cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
If you have not told your doctor about any of the above, tell him/ her before you start taking Esbriet.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Esbriet may interfere with each other. These include:
- Fluvoxamine a medicine used to treat depression and OCD;
- Tetracyclines (such as doxycycline) medicines used to treat infections and which may make you more sensitive to sunlight;
- Ciprofloxacin and enoxacin, medicines used to treat infections;
- Omeprazole, a medicine used in the treatment of indigestion, and stomach ulcers;
- Rifampicin a type of antibiotic;
- Amiodarone, a medicine used to treat some types of heart disease;
- Propafenone, a medicine used to treat some types of heart disease.
These medicines may be affected by Esbriet or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take Esbriet
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained here.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.
How much to take
The recommended dose of Esbriet is:
Days 1 to 7: one capsule, three times a day with food;
Days 8 to 14: two capsules, three times a day with food;
Day 15 onward: three capsules, three times a day with food.
How to take it
Swallow the capsules whole with a full glass of water.
Take Esbriet with or immediately after food.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
Take Esbriet with or immediately after food.
This will reduce the risks of side effects such as nausea (feeling sick) and dizziness.
Do not drink grapefruit juice while taking Esbriet. Grapefruit may prevent Esbriet from working properly.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take it
If you forget to take a dose take it as soon as you remember, but separate each dose by 3 hours. Do not take more than 3 doses a day.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Esbriet. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using Esbriet
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Esbriet.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to prevent unwanted side effects.
Things you must not do
Do not take Esbriet to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen.
If for any reason you have to stop taking Esbriet for more than 14 consecutive days, your doctor will restart your treatment with 1 capsule 3 times a day, gradually increasing this to 3 capsules 3 times a day.
Things to be careful of
Be careful driving or operating machinery until you know how Esbriet affects you.
This medicine may cause dizziness, and tiredness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
After using Esbriet
Storage
Keep your capsules in the bottle until it is time to take them.
If you take the capsules out of the bottle they may not keep well.
Keep your capsules in a cool dry place where the temperature stays below 30°C.
Do not store Esbriet or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-anda-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Schedule of Esbriet
Esbriet is a Schedule 4 – Prescription Only Medicine.
Side effects of Esbriet
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Esbriet.
This medicine helps most people with IPF, but it may have unwanted side effects in a few people. All medicines can have side effects.
Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- Skin reactions after going out in the sun or using sunlamps or tanning beds;
- Rash or itching;
- Feeling sick (nausea);
- Tiredness;
- Diarrhoea;
- Indigestion or stomach upset;
- Loss of appetite;
- Headache;
- Muscle aches or pain;
- Dizziness.
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
- Infection of the throat or of the airways going into the lungs or/or sinusitis;
- Weight loss;
- Difficulty in sleeping;
- Dizziness;
- Feeling sleepy;
- Changes in taste;
- Stomach problems such as acid reflux, vomiting, feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind.
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- Yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal;
- Swelling of face, lips and/or tongue, difficulty in breathing or wheezing.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
For further information talk to your doctor.
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