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Package leaflet: Information for the user
Rapamune 1 mg/mL oral solution sirolimus
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.What Rapamune is and what it is used for
2.What you need to know before you take Rapamune
3.How to take Rapamune
4.Possible side effects
5.How to store Rapamune
6.Contents of the pack and other information
1.What Rapamune is and what it is used for
Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants. It helps to control your body’s immune system after you have received a kidney transplant.
Rapamune is used in adults to prevent your body from rejecting transplanted kidneys and is normally used with other immunosuppressant medicines called corticosteroids and initially (the first 2 to
3 months) with ciclosporin.
2. What you need to know before you take Rapamune
Do not take Rapamune:
if you are allergic to sirolimus or any of the other ingredients of this medicine (listed in section 6).
if you are allergic to peanut or soya.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rapamune
If you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive and may result in your having additional blood tests.
Rapamune, like other immunosuppressive medicines, may decrease your body’s ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.
If you have a body mass index (BMI) greater than 30 kg/m2, you may be at increased risk of abnormal wound healing.
If you are considered to be at high risk for rejection, such as if you had a previous transplant that was lost to rejection.
Your doctor will perform tests to monitor the levels of Rapamune in your blood. Your doctor will also perform tests to monitor your kidney function, your blood fat (cholesterol and/or triglycerides) levels and possibly your liver function, during treatment with Rapamune.
Exposure to sunlight and UV light should be limited by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.
Children and adolescents
There is limited experience on the use of Rapamune in children and adolescents less than 18 years of age. The use of Rapamune is not recommended in this population.
Other medicines and Rapamune
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can interfere with the action of Rapamune and, therefore, dose adjustment of Rapamune may be required. In particular, you should inform your doctor or pharmacist if you are taking any of the following:
any other immunosuppressant medicines.
antibiotics or antifungal medicines used to treat infection e.g. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole. It is not recommended that Rapamune be taken with rifampicin, ketoconazole or voriconazole.
any high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem.
medicines used to treat ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide.
bromocriptine (used in the treatment of Parkinson’s disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (e.g. for HIV and hepatitis C such as ritonavir, indinavir, boceprevir, and telaprevir).
St. John’s Wort (Hypericum perforatum).
The use of live vaccines should be avoided with the use of Rapamune. Before vaccinations, please inform your doctor or pharmacist that you are receiving Rapamune.
The use of Rapamune may lead to increased levels of cholesterol and triglycerides (blood fats) in your blood that may require treatment. Medicines known as “statins” and “fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis). Please inform your doctor if you are taking medicines to lower your blood fats.
The combined use of Rapamune with
Rapamune with food and drink
Rapamune should be taken consistently, either with or without food. If you prefer to take Rapamune with food, then you should always take it with food. If you prefer to take Rapamune without food, then you should always take it without food. Food can affect the amount of medicine that gets into
your bloodstream, and taking your medicine in a consistent way means that the blood levels of Rapamune remain more stable.
Rapamune should not be taken with grapefruit juice.
Pregnancy,
Rapamune should not be used during pregnancy unless clearly necessary. You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped. If you are pregnant or
It is not known whether Rapamune passes into breast milk. Patients taking Rapamune should discontinue
Decreased sperm count has been associated with the use of Rapamune and usually returns to normal once treatment is stopped.
Driving and using machines
Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
Rapamune contains ethanol (alcohol)
Rapamune contains up to 2.5 vol % ethanol (alcohol). An initial dose of 6 mg contains up to 150 mg of alcohol which isequivalent to 3 mL beer or 1.25 mL wine. This amount of alcohol may be harmful for those suffering from alcoholism as well as for pregnant or
Maintenance doses of 4 mg or less contain small amounts of ethanol (100 mg or less) that are likely to be too low to be harmful.
3.How to take Rapamune
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
Your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation. Then you will need to take 2 mg of Rapamune each day, until otherwise directed by your doctor. Your dose will be adjusted depending on the level of Rapamune in your blood. Your doctor will need to perform blood tests to measure Rapamune concentrations.
If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.
It is recommended that Rapamune be used first in combination with ciclosporin and corticosteroids. After 3 months, your doctor may discontinue either Rapamune or ciclosporin, as it is not recommended that these medicines be taken together beyond this period.
Rapamune is for oral use only. Inform your doctor if you have difficulty taking the oral solution.
Rapamune should be taken consistently, either with or without food.
Instructions on how to dilute Rapamune
1.Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting. Insert the syringe adapter into the bottle until it is flush with the top of the bottle. Do not attempt to remove the syringe adapter from the bottle once inserted.
2.With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.
3.Withdraw the exact amount of Rapamune oral solution as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the bottom of the black line of the plunger is level with the appropriate mark on the dosing syringe. The bottle should remain in an upright position when withdrawing the solution. If bubbles form in the dosing syringe during withdrawal, empty the Rapamune solution back into the bottle and repeat the withdrawal procedure.
4.You may have been instructed to take your Rapamune oral solution at a particular time of day. If it is necessary to carry your medication with you, fill the dosing syringe to the appropriate mark and place a cap securely on it – the cap should snap into place. Then place the capped dosing syringe in the carrying case provided. Once in the syringe the medication may be kept at room temperature (not exceeding 25 C) or refrigerated and should be used within 24 hours.
5.Empty the contents of the dosing syringe into only a glass or plastic container holding at least
60 mL of water or orange juice. Stir well for one minute and drink immediately at once. Refill the glass with at least 120 mL of water or orange juice, stir well, and drink immediately. No other liquids, including grapefruit juice, should be used for dilution. The dosing syringe and cap are to be used once and then discarded.
When refrigerated the solution in the bottle may develop a slight haze. If this occurs, simply bring your Rapamune oral solution to room temperature and shake gently. The presence of this haze does not affect the quality of Rapamune.
If you take more Rapamune than you should
If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department straight away. Always take the labelled medicine bottle with you, even if it is empty.
If you forget to take Rapamune
If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin. After that, continue to take your medicines as usual. Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart. If you miss a dose of Rapamune completely, you should inform your doctor.
If you stop taking Rapamune
Do not stop taking Rapamune unless your doctor tells you to, as you risk losing your transplant.
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.
Allergic reactions
You should see your doctor immediately if you experience symptoms, such as swollen face, tongue and/or back of the mouth (pharynx) and/or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis). These may be symptoms of a serious allergic reaction.
Kidney damage with low blood cell counts (thrombocytopaenic purpura/haemolytic uraemic syndrome)
When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts, with or without rash (thrombocytopaenic purpura/haemolytic uraemic syndrome). If you experience symptoms, such as bruising or rash, changes in your urine, or changes in behaviour, or any others that are serious, unusual or prolonged, contact your doctor.
Infections
Rapamune reduces your body’s own defence mechanisms to stop you rejecting your transplanted organ. Consequently your body will not be as good as normal at fighting infections. So if you are taking Rapamune, you may therefore catch more infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract (see list below). You should contact your doctor if you experience symptoms that are serious, unusual, or prolonged.
Side effect frequencies
Very common: may affect more than 1 in 10 people
Fluid collection around the kidney
Swelling of the body including hands and feet
Pain
Fever
Headache
Increased blood pressure
Stomach pain, diarrhoea, constipation, nausea
Low red blood cells, low blood platelets
Increased fat in the blood (cholesterol and/or triglycerides), increased blood sugar, low blood potassium, low blood phosphorus, increased lactate dehydrogenase in the blood, increased creatinine in the blood
Joint pain
Acne
Urinary tract infection
Pneumonia and other bacterial, viral, and fungal infections
A reduced number of
Diabetes
Abnormal tests of liver function, elevated AST and/or ALT liver enzymes
Rash
Elevated protein in the urine
Menstrual disorders (including absent, infrequent or heavy periods)
Slow healing (this may include separation of the layers of a surgical wound or stitch line)
Rapid heart rate
There is a general tendency for fluid to collect in various tissues.
- Torisel - temsirolimus
Prescription drugs listed. Substance: "Sirolimus"
Common: may affect up to 1 in 10 people
Infections (including
Blood clots in the legs
Blood clots in the lung
Mouth sores
Fluid collection in the abdomen
Kidney damage with low blood platelets and low red blood cell counts, with or without rash (haemolytic uraemic syndrome)
Low levels of a type of white blood cells called neutrophils
Deterioration of bone
Inflammation that may lead to lung damage, fluid around the lung
Nose bleeds
Skin cancer
Kidney infection
Ovarian cysts
Fluid collection in the sac around the heart, that in some cases may decrease the heart's ability to pump blood
Inflammation of the pancreas
Allergic reactions
Shingles
Cytomegalovirus infection
Uncommon: may affect up to 1 in 100 people
Cancer of the lymph tissue
Bleeding from the lung
Protein in the urine, occasionally severe and associated with side effects, such as swelling
Scarring in the kidney that may reduce kidney function
Too much fluid collecting in the tissues due to irregular lymph function
Low blood platelets, with or without rash (thrombocytopaenic purpura)
Serious allergic reactions that can cause peeling of the skin
Tuberculosis
Infectious diarrhoea with Clostridium difficile
Serious liver damage
Rare: may affect up to 1 in 1,000 people
Protein
Serious allergic reactions that can affect blood vessels (see above paragraph on allergic reactions)
Not known: frequency cannot be estimated from the available data
Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss. Should any of these occur together, please contact your physician.
Reporting of side effects
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5.How to store Rapamune
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 carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 C - 8 C).
Keep Rapamune oral solution in its original bottle in order to protect from light.
Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days. If
necessary, you may store the bottle at room temperature up to 25 C for a short period of time, but no longer than 24 hours.
Once the dosing syringe has been filled with Rapamune oral solution, it should be kept at room temperature, but not above 25 C, for maximum 24 hours.
Once the contents of the dosing syringe have been diluted with water or orange juice, the preparation should be drunk immediately.
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 Rapamune contains
The active substance is sirolimus. Each mL of Rapamune oral solution contains 1 mg of sirolimus.
The other ingredients are:
Polysorbate 80 (E433) and phosal 50 PG (phosphatidylcholine, propylene glycol,
What Rapamune looks like and contents of the pack
Rapamune oral solution is a pale yellow to yellow solution supplied in a 60 mL bottle.
Each pack contains: one bottle (amber glass) containing 60 mL of Rapamune solution, one syringe adapter, 30 dosing syringes (amber plastic) and one syringe carry case.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: | Manufacturer: | ||
Pfizer Limited | Wyeth Pharmaceuticals | ||
Ramsgate Road | New Lane Havant | ||
Sandwich | Hants PO9 2NG | ||
Kent, CT13 9NJ | United Kingdom | ||
United Kingdom |
|
|
|
| Pfizer Service Company bvba |
| |
| Hoge Wei 10, | ||
| Belgium |
| |
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien | Lietuva |
Luxembourg/Luxemburg | Pfizer Luxembourg SARL filialas Lietuvoje |
Pfizer S.A. / N.V. | Tel. +3705 2514000 |
Tél/Tel: +32 (0)2 554 62 11 |
|
България | Magyarország |
Пфайзер Люксембург САРЛ, Клон | Pfizer Kft. |
България | Tel: +36 1 488 3700 |
Teл: +359 2 970 4333 |
|
Česká Republika | Malta |
Pfizer PFE, spol. s r.o. | Vivian Corporation Ltd. |
Tel: +420 283 004 111 | Tel: +35621 344610 |
Danmark | Nederland |
Pfizer ApS | Pfizer bv |
Tlf: +45 44 201 100 | Tel: +31 (0)10 406 43 01 |
Deutschland | Norge |
Pfizer Pharma GmbH | Pfizer Norge AS |
Tel: +49 (0)30 | Tlf: +47 67 52 61 00 |
Eesti | Österreich |
Pfizer Luxembourg SARL Eesti filiaal | Pfizer Corporation Austria Ges.m.b.H. |
Tel: +372 666 7500 | |
Ελλάδα | Polska |
PFIZER ΕΛΛΑΣ A.E. | Pfizer Polska Sp. z o.o., |
Τηλ.: +30 210 6785 800 | Tel.: +48 22 335 61 00 |
España | Portugal |
Pfizer, S.L. | Pfizer Biofarmacêutica, Sociedade Unipessoal Lda |
Télf:+34914909900 | Tel: +351 21 423 5500 |
France | România |
Pfizer | Pfizer Romania S.R.L |
Tél +33 (0)1 58 07 34 40 | Tel: +40 (0) 21 207 28 00 |
Hrvatska | Slovenija |
Pfizer Croatia d.o.o. | Pfizer Luxembourg SARL, Pfizer, podružnica za |
Tel: + 385 1 3908 777 | svetovanje s področja farmacevtske dejavnosti, |
| Ljubljana |
| Tel: +386 (0)1 52 11 400 |
Ireland | Slovenská Republika |
Pfizer Healthcare Ireland | Pfizer Luxembourg SARL, organizačná zložka |
Tel: +1800 633 363 (toll free) | Tel: + 421 2 3355 5500 |
Tel: +44 (0)1304 616161 |
|
Ísland | Suomi/Finland |
Icepharma hf | Pfizer Oy |
Tel: +354 540 8000 | Puh/Tel: +358 (0)9 430 040 |
Italia | Sverige |
Pfizer S.r.l. | Pfizer Innovations AB |
Tel: +39 06 33 18 21 | Tel: +46 (0)8 550 520 00 |
Kύπρος | United Kingdom |
PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch) | Pfizer Limited |
T : +357 22 817690 | Tel: +44 (0)1304 616161 |
Latvija |
|
Pfizer Luxembourg SARL filiāle Latvijā |
|
Tel. +371 67035775 |
|
|
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Package leaflet: Information for the user
Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets sirolimus
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet
1.What Rapamune is and what it is used for
2.What you need to know before you take Rapamune
3.How to take Rapamune
4.Possible side effects
5.How to store Rapamune
6.Contents of the pack and other information
1.What Rapamune is and what it is used for
Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants. It helps to control your body’s immune system after you have received a kidney transplant.
Rapamune is used in adults to prevent your body from rejecting transplanted kidneys and is normally used with other immunosuppressant medicines called corticosteroids and initially (the first 2 to
3 months) with ciclosporin.
2. What you need to know before you take Rapamune
Do not take Rapamune:
if you are allergic to sirolimus or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Rapamune
If you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive and may result in your having additional blood tests.
Rapamune, like other immunosuppressive medicines, may decrease your body’s ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.
If you have a body mass index (BMI) greater than 30 kg/m2, you may be at increased risk of abnormal wound healing.
If you are considered to be at high risk for rejection, such as if you had a previous transplant that was lost to rejection.
Your doctor will perform tests to monitor the levels of Rapamune in your blood. Your doctor will also perform tests to monitor your kidney function, your blood fat (cholesterol and/or triglycerides) levels and possibly your liver function, during treatment with Rapamune.
Exposure to sunlight and UV light should be limited by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.
Children and adolescents
There is limited experience on the use of Rapamune in children and adolescents less than 18 years of age. The use of Rapamune is not recommended in this population.
Other medicines and Rapamune
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can interfere with the action of Rapamune and, therefore, dose adjustment of Rapamune may be required. In particular, you should inform your doctor or pharmacist if you are taking any of the following:
any other immunosuppressant medicines.
antibiotics or antifungal medicines used to treat infection e.g. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole. It is not recommended that Rapamune be taken with rifampicin, ketoconazole or voriconazole.
any high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem.
medicines used to treat ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide.
bromocriptine (used in the treatment of Parkinson’s disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (e.g., for HIV and hepatitis C such as ritonavir, indinavir, boceprevir, and telaprevir).
St. John’s Wort (Hypericum perforatum).
The use of live vaccines should be avoided with the use of Rapamune. Before vaccinations, please inform your doctor or pharmacist that you are receiving Rapamune.
The use of Rapamune may lead to increased levels of cholesterol and triglycerides (blood fats) in your blood that may require treatment. Medicines known as “statins” and “fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis). Please inform your doctor if you are taking medicines to lower your blood fats.
The combined use of Rapamune with
Rapamune with food and drink
Rapamune should be taken consistently, either with or without food. If you prefer to take Rapamune with food, then you should always take it with food. If you prefer to take Rapamune without food, then you should always take it without food. Food can affect the amount of medicine that gets into
your bloodstream, and taking your medicine in a consistent way means that the blood levels of Rapamune remain more stable.
Rapamune should not be taken with grapefruit juice.
Pregnancy,
Rapamune should not be used during pregnancy unless clearly necessary. You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped.If you are pregnant or
It is not known whether Rapamune passes into breast milk. Patients taking Rapamune should discontinue
Decreased sperm count has been associated with the use of Rapamune and usually returns to normal once treatment is stopped.
Driving and using machines
Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
- Prevenar - Pfizer Limited
- Ibrance - Pfizer Limited
- Ecalta - Pfizer Limited
- Lifmior - Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
- Pregabalin pfizer - Pfizer Limited
Prescription drugs listed. Manufacturer: "Pfizer Limited"
Rapamune contains lactose and sucrose
Rapamune contains 86.4 mg of lactose and up to 215.8 mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3.How to take Rapamune
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
Your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation. Then you will need to take 2 mg of Rapamune each day, until otherwise directed by your doctor. Your dose will be adjusted depending on the level of Rapamune in your blood. Your doctor will need to perform blood tests to measure Rapamune concentrations.
If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.
It is recommended that Rapamune be used first in combination with ciclosporin and corticosteroids. After 3 months, your doctor may discontinue either Rapamune or ciclosporin, as it is not recommended that these medicines be taken together beyond this period.
Rapamune is for oral use only. Do not crush, chew, or split the tablets. Inform your doctor if you have difficulty taking the tablet.
Multiples of 0.5 mg tablets should not be used as a substitute for 1 mg and 2 mg tablets, as the different strengths are not directly interchangeable.
Rapamune should be taken consistently, either with or without food.
If you take more Rapamune than you should
If you have taken more medicine than you were told to, contact a doctor or go to the nearest hospital emergency department as soon as possible. Always take the labelled blister with you, even if it is empty.
If you forget to take Rapamune
If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin. After that, continue to take your medicines as usual. Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart. If you miss a dose of Rapamune completely, you should inform your doctor.
If you stop taking Rapamune
Do not stop taking Rapamune unless your doctor tells you to, as you risk losing your transplant.
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.
Allergic reactions
You should see your doctor immediately if you experience symptoms, such as swollen face, tongue and/or back of the mouth (pharynx) and/or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis). These may be symptoms of a serious allergic reaction.
Kidney damage with low blood cell counts (thrombocytopaenic purpura/haemolytic uraemic syndrome)
When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts, with or without rash (thrombocytopaenic purpura/haemolytic uraemic syndrome). If you experience symptoms such as bruising or rash, changes in your urine, or changes in behaviour or any others that are serious, unusual or prolonged, contact your doctor.
Infections
Rapamune reduces your body’s own defence mechanisms to stop rejecting your transplanted organ. Consequently your body will not be as good as normal at fighting infections. So if you are taking Rapamune, you may therefore catch more infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract (see list below). You should contact your doctor if you experience symptoms that are serious, unusual, or prolonged.
Side effect frequencies
Very common: may affect more than 1 in 10 people
Fluid collection around the kidney
Swelling of the body including hands and feet
Pain
Fever
Headache
Increased blood pressure
Stomach pain, diarrhoea, constipation, nausea
Low red blood cells, low blood platelets
Increased fat in the blood (cholesterol and/or triglycerides), increased blood sugar, low blood potassium, low blood phosphorus, increased lactate dehydrogenase in the blood, increased creatinine in the blood
Joint pain
Acne
Urinary tract infection
Pneumonia and other bacterial, viral, and fungal infections
A reduced number of
Diabetes
Abnormal tests of liver function, elevated AST and/or ALT liver enzymes
Rash
Elevated protein in the urine
Menstrual disorders (including absent, infrequent or heavy periods)
Slow healing (this may include separation of the layers of a surgical wound or stitch line)
Rapid heart rate
There is a general tendency for fluid to collect in various tissues.
Common: may affect up to 1 in 10 people
Infections (including
Blood clots in the legs
Blood clots in the lung
Mouth sores
Fluid collection in the abdomen
Kidney damage with low blood platelets and low red blood cell counts, with or without rash (haemolytic uraemic syndrome)
Low levels of a type of white blood cells called neutrophils
Deterioration of bone
Inflammation that may lead to lung damage, fluid around the lung
Nose bleeds
Skin cancer
Kidney infection
Ovarian cysts
Fluid collection in the sac around the heart, that in some cases may decrease the heart's ability to pump blood
Inflammation of the pancreas
Allergic reactions
Shingles
Cytomegalovirus infection
Uncommon: may affect up to 1 in 100 people
Cancer of the lymph tissue
Bleeding from the lung
Protein in the urine, occasionally severe and associated with side effects, such as swelling
Scarring in the kidney that may reduce kidney function
Too much fluid collecting in the tissues due to irregular lymph function
Low blood platelets, with or without rash (thrombocytopaenic purpura)
Serious allergic reactions that can cause peeling of the skin
Tuberculosis
Infectious diarrhoea with Clostridium difficile
Serious liver damage
Rare: may affect up to 1 in 1,000 people
Protein
Serious allergic reactions that can affect blood vessels (see above paragraph on allergic reactions)
Not known: frequency cannot be estimated from the available data
Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss. Should any of these occur together, please contact your physician.
Reporting of side effects
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 national reporting
system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
5.How to store Rapamune
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.
Do not store above 25˚C.
Keep the blister in the outer carton in order to protect from light.
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 Rapamune contains
The active substance is sirolimus.
Each Rapamune 0.5 mg coated tablet contains 0.5 mg of sirolimus.
Each Rapamune 1 mg coated tablet contains 1 mg of sirolimus.
Each Rapamune 2 mg coated tablet contains 2 mg of sirolimus.
The other ingredients are:
Tablet core: lactose monohydrate, macrogol, magnesium stearate, talc
Tablet coating: macrogol, glycerol monooleate, pharmaceutical glaze, calcium sulfate, microcrystalline cellulose, sucrose, titanium dioxide, poloxamer 188,
What Rapamune looks like and contents of the pack
Rapamune 0.5 mg is supplied to you as
Rapamune 1 mg is supplied to you as
Rapamune 2 mg is supplied to you as yellow to
The tablets are supplied in blister packs of 30 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: | Manufacturer: | |||||
Pfizer Limited | Pfizer Ireland Pharmaceuticals |
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Ramsgate Road | Little Connell |
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Sandwich | Newbridge |
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Kent, CT13 9NJ | Co. Kildare |
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United Kingdom | Ireland |
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| Pfizer Manufacturing Deutschland GmbH | |||||
| Betriebsstätte Freiburg | |||||
| Mooswaldallee 1 | |||||
| 79090 Freiburg | |||||
| Germany | |||||
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien | Lietuva |
Luxembourg/Luxemburg | Pfizer Luxembourg SARL filialas Lietuvoje |
Pfizer S.A. / N.V. | Tel. +3705 2514000 |
Tél/Tel: +32 (0)2 554 62 11 |
|
България | Magyarország |
Пфайзер Люксембург САРЛ, Клон | Pfizer Kft. |
България | Tel: +36 1 488 3700 |
Teл: +359 2 970 4333 |
|
Česká Republika | Malta |
Pfizer PFE, spol. s r.o. | Vivian Corporation Ltd. |
Tel: +420 283 004 111 | Tel: +35621 344610 |
Danmark | Nederland |
Pfizer ApS | Pfizer bvTel: +31(0)10 406 43 01 |
Tlf: +45 44 201 100 |
|
Deutschland | Norge |
Pfizer Pharma GmbH | Pfizer Norge AS |
Tel: +49 (0)30 | Tlf: +47 67 52 61 00 |
Eesti | Österreich |
Pfizer Luxembourg SARL Eesti filiaal | Pfizer Corporation Austria Ges.m.b.H. |
Tel: +372 666 7500 | |
Ελλάδα | Polska |
PFIZER ΕΛΛΑΣ A.E. | Pfizer Polska Sp. z o.o., |
Τηλ.: +30 210 6785 800 | Tel.: +48 22 335 61 00 |
España | Portugal |
Pfizer, S.L. | Pfizer Biofarmacêutica, Sociedade Unipessoal Lda |
Télf:+34914909900 | Tel: +351 21 423 5500 |
France | România |
Pfizer | Pfizer Romania S.R.L |
Tél +33 (0)1 58 07 34 40 | Tel: +40 (0) 21 207 28 00 |
Hrvatska | Slovenija |
Pfizer Croatia d.o.o. | Pfizer Luxembourg SARL, Pfizer, podružnica za |
Tel: + 385 1 3908 777 | svetovanje s področja farmacevtske dejavnosti, |
| Ljubljana |
| Tel: +386 (0)1 52 11 400 |
Ireland | Slovenská Republika |
Pfizer Healthcare Ireland | Pfizer Luxembourg SARL, organizačná zložka |
Tel: +1800 633 363 (toll free) | Tel: + 421 2 3355 5500 |
Tel: +44 (0)1304 616161 |
|
Ísland | Suomi/Finland |
Icepharma hf | Pfizer Oy |
Tel: +354 540 8000 | Puh/Tel: +358 (0)9 430 040 |
Italia | Sverige |
Pfizer S.r.l. | Pfizer Innovations AB |
Tel: +39 06 33 18 21 | Tel: +46 (0)8 550 520 00 |
Kύπρος | United Kingdom |
PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch) | Pfizer Limited |
T : +357 22 817690 | Tel: +44 (0)1304 616161 |
Latvija |
|
Pfizer Luxembourg SARL filiāle Latvijā |
|
Tel. +371 67035775 |
|
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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