Sirolimus Tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Rapamune. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Rapamune against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Rapamune is used for
Rapamune belongs to a group of medicines called immunosuppressants. It helps to control your body's immune system after you have received an organ transplant. It is used to prevent your body from rejecting the transplanted kidney.
Rapamune is not recommended for patients who have received liver or lung transplants.
Your doctor may have prescribed Rapamune for another reason. Ask your doctor if you have any questions about why Rapamune has been prescribed for you.
Rapamune is not recommended for use in children, as there is limited information available on its effects in children.
This medicine is available only with a doctor's prescription.
Rapamune is not habit-forming.
Before you take Rapamune
When you must not take Rapamune
Do not take Rapamune if you have an allergy to sirolimus or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include wheezing, shortness of breath, difficulty breathing, or a tight feeling in your chest, swelling of the face, lips, tongue or other parts of the body, rash, itching, hives or flushed red skin, dizziness or light-headedness.
If you are not sure whether this applies to you, check with your doctor.
Do not take Rapamune if the packaging is torn or shows signs of tampering.
Do not take Rapamune after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure whether you should start taking Rapamune, contact your doctor.
Before you start to take Rapamune
Tell your doctor if:
1.You have any allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You are pregnant or intend to become pregnant.
Like most immunosuppressive medicines, Rapamune is not recommended for use during pregnancy.
If you are a woman, before starting Rapamune you must be using effective contraception methods and you must continue contraception for 12 weeks after treatment has stopped. If you are unsure, or think you may have become pregnant, talk to your doctor or pharmacist. Discuss contraceptive options with your doctor.
3.You are breast-feeding or plan to breast-feed.
Like most immunosuppressive medicines, Rapamune is not recommended while you are breast-feeding. It is not known whether Rapamune passes into breast milk. Ask your doctor or pharmacist for advice before breast-feeding your baby.
4.You have or have had any medical conditions, especially the following:
liver problems or a disease which may have affected your liver
high fat levels in the blood
a condition called rhabdomyolysis, which may cause a variety of symptoms including muscle weakness and tenderness and temporary paralysis.
If you have not told your doctor about any of the above, tell them before you start taking Rapamune.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Rapamune may interfere with each other. These include:
cyclosporin used to prevent transplant rejection
antibiotics such as rifampicin, clarithromycin, erythromycin and rifabutin
antifungal medicines such as ketoconazole, clotrimazole, fluconazole, voriconazole and itraconazole
medicines for high blood pressure or heart problems such as diltiazem, and verapamil
epilepsy medicines such as carbamazepine, phenobarbitone and phenytoin
medicines for stomach ulcer or reflux such as cimetidine and cisapride
medicines to prevent nausea and vomiting such as metoclopramide
danazol which is used to treat endometriosis
bromocriptine which is used to treat Parkinson's disease
protease inhibitors such as ritonavir, boceprevir, telaprevir and indinavir, which are used to treat HIV/AIDS
ACE inhibitors such as perindopril and ramipril which are used to treat high blood pressure
St. John's wort.
These medicines may be affected by Rapamune, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Rapamune.
How to take Rapamune
Rapamune is for oral use only.
Always take the medicine exactly as your doctor tells you.
How much to take
Your doctor will decide exactly what dose of Rapamune you must take and how often to take it.
Follow your doctor's instructions exactly and never change the dose yourself. Do not stop taking your medicine unless your doctor tells you to.
The usual starting dose is 6 mg after transplantation and then 2 mg once daily. You will also need to take medicines such as cyclosporin and corticosteroids.
After 2 to 4 months, your doctor will start reducing the dose of cyclosporin you take and increasing your dose of Rapamune. Eventually your cyclosporin will be completely stopped. Your doctor will determine how much Rapamune you need to take.
Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
How to take Rapamune
Swallow Rapamune tablets with a glass of water or orange juice. Do not take Rapamune tablets with grapefruit juice.
Rapamune tablets must be taken whole.
If you crush, split or chew the tablets you may not get the correct dose.
If you have problems with swallowing the tablets whole discuss with your doctor whether Rapamune Oral solution would be better for you.
Take Rapamune consistently, either with or without food.
When to take Rapamune
Take Rapamune once a day at about the same time each day.
Taking Rapamune at the same time each day will have the best effect. It will also help you remember when to take it.
If you are also taking cyclosporin, then you must take Rapamune 4 hours after your cyclosporin dose.
How long to take Rapamune
You will need to take Rapamune for the rest of your life, or until your doctor decides to change your immunosuppressive medication.
If you forget to take Rapamune
If it is almost time for your next dose (within 4 hours), skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed and always take Rapamune and cyclosporin approximately 4 hours apart.
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 go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Rapamune. Do this even if there are no signs of discomfort or poisoning. Take the labelled medicine pack with you, even if it is empty.
You may need urgent medical attention. If you take too much Rapamune, your heart may start beating abnormally.
While you are using Rapamune
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are taking Rapamune.
Attend all doctor's appointments to monitor your condition.
Your doctor needs to closely monitor the level of Rapamune found in your blood to make sure the dose you are taking is best for your condition.
Take any antibiotic medication for as long as your doctor prescribes them.
Taking antibiotics helps prevent getting an infection.
Things you must not do
Do not give Rapamune to anyone else even if they have the same condition as you.
Do not use Rapamune to treat any other complaints unless your doctor tells you to.
Do not stop taking Rapamune, or change the dosage, without checking with your doctor.
Kidney transplant patients need to remain on immunosuppressive medication indefinitely.
Things to be careful of
Limit your exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor.
Immunosuppressive medicines such as Rapamune may increase the risk of developing cancer of the lymph glands and skin.
If you develop new lumps, spots or moles anywhere on your body, , or you notice changes in existing lumps, spots or moles, tell your doctor.
This may be a sign of cancer. Immunosuppressant medicines, including Rapamune, may increase the risk of developing certain cancers, including skin cancer and lymphoma (cancer of the lymphatic system).
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Rapamune. Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
Side Effects
Check with your doctor as soon as possible if you have any problems while taking Rapamune, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
If you get any side effects, do not stop taking Rapamune without first talking to your doctor.
Rapamune helps most people with kidney transplants but it may have unwanted side effects. However, since Rapamune is often taken in combination with other medicines, Rapamune may not have necessarily caused the side effects.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following. These may be very serious side effects. You may need urgent medical attention or hospitalisation:
signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body shortness of breath, wheezing or troubled breathing
signs of excessive fluid on the lungs such as coughing, difficulty breathing and wheezing
swelling of hands, feet, limbs or abdomen or puffiness or swelling around the eyes due to fluid retention
constant "flu-like" symptoms such as fever, chills, sore throat, aching joints, swollen glands, cough, or any other signs of infection such as infection of a cut or scratch. Immuno-suppressive drugs may also increase the risk of getting an infection
new lumps, spots or moles, or changes to existing lumps, spots or moles, anywhere on your body. It is important to have these checked by a doctor as soon as possible
signs of a blood disorder such as tiredness, headaches, being short of breath when exercising, dizziness, paleness, nose bleeds, unusual bleeding or bruising
signs that blood clots may have formed, such as sudden severe headache, sudden loss of coordination, blurred vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the calves or thighs, chest pain, difficulty breathing, coughing blood
signs of a disorder which may cause headache, confusion, seizures and visual loss or disturbances.
Tell your doctor if you notice any of the following side effects:
burning sensation on urination or increased urgency to urinate
increased thirst and hunger
fluid filled swelling on the skin
abnormal wound healing
fast heart beat
pain
diarrhoea
mouth ulcers and cold sores
nose bleed
pneumonia
acne
rash
fever
headache
constipation
nausea
symptoms of ovarian cyst, such as discomfort around the pelvis or abdomen or pain or pressure upon urination or bowel movements
changes in menstrual bleeding patterns.
These are common side effects of Rapamune.
Tell your doctor you are taking Rapamune if you also want to be vaccinated.
Rapamune may affect your response to vaccination.
Unwanted side effects that you may not be aware of whilst taking Rapamune include an increase in blood pressure and changes in the levels of red or white blood cells or substances carried in your blood (e.g. fat, cholesterol, protein, potassium or liver enzymes). During treatment your doctor may do blood tests to measure these changes.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using Rapamune
Storage
Keep Rapamune tablets in their blister pack until it is time to take them.
If you take the tablets out of their blister pack they may not last as well.
Keep Rapamune tablets in a cool, dry place where the temperature stays below 25°C.
Do not store Rapamune tablets or any other medicine in the bathroom or near a sink. Do not leave Rapamune in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep Rapamune where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking Rapamune or the tablets have passed their expiry date, ask your pharmacist what to do with the left over tablets.
Product description
What it looks like
Rapamune 0.5 mg tablets are tan, triangular-shaped, sugar-coated tablets branded with red ink.
Rapamune 0.5 mg tablets are supplied in cartons of 100 tablets (10 blisters x 10 tablets each).
Rapamune 1 mg tablets are white, triangular-shaped, sugar-coated tablets branded with red ink.
Rapamune 1 mg tablets are supplied in cartons of 100 tablets (10 blisters x 10 tablets each).
Rapamune 2 mg tablets are yellow, triangular-shaped, sugar-coated tablets branded with red ink.
Rapamune 2 mg tablets are supplied in cartons of 100 tablets (10 blisters x 10 tablets each).
Ingredients
Each Rapamune tablet contains the active ingredient, sirolimus.
The other inactive ingredients are:
Lactose
Macrogol 8000
Magnesium stearate
Purified Talc
Macrogol 20000
Glyceryl mono-oleate
Shellac
Calcium sulfate
Cellulose-microcrystalline
Sucrose
Titanium dioxide
alpha-Tocopherol
Poloxamer
Povidone
Carnauba wax
Opacode ink red
Rapamune 0.5 mg and Rapamune 2 mg tablets also contain the colouring agents iron oxide yellow CI 77492, iron oxide black CI 77499 and iron oxide red CI 77491.
Rapamune does not contain gluten, tartrazine or any other azo dyes.
