Dispersible tablet 0.1 m

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.Save 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 give it to others. It can harm them, even if they show signs of illness similar to yours.If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Certican is and what it is used for 
2. What you need to know before using Certican 
3. How to use Certican 
4. Possible side effects 
5. How to store Certican 
6. Package contents and other information

1. What Certican is and what it is used for

The active substance in Certican is called everolimus.

Everolimus belongs to a group of medicines called immunosuppressive medicines. It is used in adults to prevent the body’s immune system from rejecting a transplanted kidney, liver, or a transplanted heart. Certican is used with medicines containing ciclosporin in kidney or heart transplants, tacrolimus in liver transplants, and corticosteroids.

2. What you need to know before using Certican

Do not take Certican

  • if you are allergic (hypersensitive) to everolimus or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic (hypersensitive) to sirolimus.

If any of the above applies to you, tell your doctor and do not take Certican.

Warnings and cautions

Talk to a doctor before taking Certican:

  • Medicines that inhibit the immune system, such as Certican, can reduce the body’s ability to fight infection. You should therefore consult your doctor or transplant center if you get a fever, general malaise, cough, or severe burning when you urinate, which persists for several days. Talk to your doctor or transplant center immediately if you feel confused, have impaired speech, memory loss, headaches, visual disturbances, or seizures, as this may be a sign of a rare but very serious condition called progressive multifocal leukoencephalopathy (PML).
  • If you have recently undergone major surgery or if you still have unhealed surgical wounds, Certican may increase the risk of wound healing problems.
  • Drugs that inhibit the immune system, such as Certican, may increase the risk of developing cancer, especially in the skin and lymphoid system. Therefore, limit your exposure to sunlight and UV (ultraviolet) light by wearing protective clothing and frequently using sunscreen with a high sun protection factor.
  • Your doctor will closely monitor your kidney function, blood fat and blood sugar levels as well as the amount of protein in your urine.
  • If you have liver problems or have previously had a disease that may have affected the liver, tell your doctor, as it may be necessary to adjust the Certicand dose accordingly.
  • If you experience breathing symptoms (such as coughing, difficulty breathing, and wheezing), please tell your doctor. Your doctor may decide if and how you need to continue with Certican, and/or if you need to be treated with other medicines to improve this condition.
  • Certican can reduce sperm production and thus affect the ability of men to have children. This effect generally disappears after the end of treatment. Male patients who want to have children should discuss treatment with their doctor.

Elderly (65 years and older)

The experience of Certican in the elderly is limited.

Children and adolescents (under 18 years)

Certican should not be used in children and adolescents for kidney, heart, or liver transplantation.

Other medicines and Certican

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Some medicines may affect the effect of Certican. It is very important that you tell your doctor if you are taking any of the following medicines:

  • other immunosuppressive drugs, in addition to cyclosporine, tacrolimus, and corticosteroid s
  • antibiotics, eg rifampicin, rifabutin, clarithromycin, erythromycin, or telithromycin
  • HIV medicines, such as ritonavir, efavirenz, nevirapine, nelfinavir, indinavir, or amprenavir
  • medicines used to treat fungal infections, such as voriconazole, fluconazole, ketoconazole, or itraconazole
  • drugs used to treat epilepsy, such as phenytoin, phenobarbital, or carbamazepine
  • medicines used to treat high blood pressure or heart problems, such as verapamil, nicardipine, or diltiazem
  • dronedarone, a drug that regulates heart rhythm
  • drugs used to lower blood cholesterol levels, such as atorvastatin, pravastatin, or fibrates.
  • medicines used to treat acute seizures or as sedatives before or during surgery or other medical procedures, such as midazolam
  • octreotide, a drug used to treat acromegaly, a rare hormonal disorder most commonly found in middle-aged adults
  • imatinib, a drug that inhibits the growth of tumor cells
  • St. John’s wort ( Hypericum perforatum ), a natural remedy for the treatment of depression
  • If you need to be vaccinated, consult your doctor first.

Certican with food and drink

Food intake can affect how much of Certican is absorbed from the gut. To keep the same levels of Certican in your body, you should always take Certican in the same way. Therefore, take Certican either always with food or always on an empty stomach.

Do not take Certican with grapefruit juice or grapefruit. Grapefruit and grapefruit juice affect the effects of Certican in the body.

Pregnancy, breastfeeding, and fertility

If you are pregnant, do not take Certican, unless your doctor thinks it is absolutely necessary.

If you are a woman and you may become pregnant, you should use an effective contraceptive during treatment with Certican and 8 weeks after stopping treatment.

If you think you may be pregnant, ask your doctor or pharmacist for advice before taking Certican.

You should not breast-feed while taking Certican. It is not known if Certican is transferred to breast milk.

Certican can affect male fertility.

Driving and using machines

No studies on the effects of Certican on the ability to drive and use machines have been performed. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Certican contains lactose

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 use Certican

Your doctor will decide exactly what dose of Certican to take and when to take it.

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much to take

  • The usual starting dose is 1.5 mg per day for kidney and heart transplants and 2.0 mg per day for liver transplants.
  • The starting dose is usually divided into 2 doses, one in the morning and one in the evening.

How to take Certican

Certican may only be taken by mouth.

You should take the first dose of this medicine as early as possible after a kidney and heart transplant and approximately four weeks after a liver transplant.

You should take the tablets together with ciclosporin microemulsion for kidney and heart transplants and with tacrolimus for liver transplants.

Do not switch from Certican dispersible tablets to Certican tablets without talking to your doctor first.

  • Place Certican dispersible tablets in about 25 ml of water in a plastic cup.
  • The maximum amount of Certican that can be suspended (dispersed) in 25 ml of water is 1.5 mg.
  • Wait for about 2 minutes for the tablets to disintegrate and shake gently before drinking the liquid.
  • Afterward, immediately rinse the cup with another 25 ml of water and drink completely.

Checks during treatment with Certican

Your doctor may need to adjust your dose based on how much Certican is in your blood and depending on how you respond to treatment. Your doctor will take regular blood tests to measure the blood levels of everolimus and ciclosporin. Your doctor will also carefully monitor your kidney function, blood fat, and sugar levels as well as the amount of protein in your urine.

If you forget to take Certican

If you forget to take the Certicand dose, take it as soon as you remember and then continue taking the doses at the usual times. Ask your doctor for advice. Do not take a double dose to make up for forgotten tablets.

If you stop taking Certican

Do not stop taking this medicine unless your doctor tells you to. You will need to take this medicine for as long as you need immunosuppression to prevent rejection of the transplanted kidney, heart, or liver. If you stop taking Certican, you will have an increased risk of your body rejecting the transplanted organ.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Because Certican is taken with other medicines, it is not always certain that the side effects are due to Certican. They can also be caused by the other drugs.

The following side effects need immediate medical attention

  • infection is
  • inflammation of the lungs
  • allergic reactions
  • fever and bruising in the form of red spots on the skin, with or without unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine output (thrombotic microangiopathy, hemolytic uremic syndrome ).

If you develop any of the following symptoms, stop taking Certican and contact a doctor immediately:

  • persistent or worsening lung or respiratory symptoms such as cough, difficulty breathing, or wheezing
  • fever, malaise, chest or abdominal pain, chills, burning when you urinate
  • swelling of the face, lips, tongue, or throat
  • difficulty swallowing
  • bruising or bleeding for no apparent reason
  • hives
  • pain, abnormal heat, swelling or oozing from the surgical wound.

Other reported side effects are as follows:

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

  • infection (viral, bacterial, and fungal infections)
  • lower respiratory tract infections, such as lung infections such as pneumonia
  • upper respiratory tract infections, such as inflammation of the throat and common cold
  • urinary tract infections
  • anemia (decreased number of red blood cells )
  • low levels of white blood cells, which can lead to a higher risk of infection
  • decreased levels of platelets, which can lead to bleeding and bruising of the skin
  • high-fat content ( lipids, cholesterol, and triglycerides ) in the blood
  • the onset of diabetes (high blood sugar)
  • decreased potassium levels in the blood
  • anxiety
  • difficulty sleeping
  • headache
  • fluid accumulation in the sac around the heart, which in severe symptoms can reduce the heart’s ability to pump blood if it becomes severe
  • high blood pressure
  • venous thrombosis (blockage of the large vein due to blood clot)
  • fluid accumulation in the lungs and chest cavity, which in severe symptoms can make you short of breath
  • cough
  • shortness of breath
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • general pain
  • fever
  • fluid accumulation in tissue are
  • abnormal wound healing.

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

  • blood poisoning
  • wound infections
  • cancer and benign tumor er
  • skin cancer
  • renal damage with low platelet levels and low levels of red blood cells with or without redness ( thrombocytopenia purpura / hemolytic uremic syndrome)
  • degradation of red blood cells
  • low levels of red blood cells and platelets
  • fast heart rate
  • nosebleeds
  • decreased number of blood cells (symptoms of this may include weakness, bruising and frequent infections )
  • a blood clot in the kidney blood vessel which can lead to graft loss, usually within 30 days after the kidney transplant
  • bleeding condition
  • a cyst containing lymph fluid
  • pain in the mouth or throat
  • inflammation of the pancreas
  • cold sores
  • acne
  • hives ( urticaria ) and other allergic symptoms such as swelling of the face or throat ( angioedema )
  • rash
  • joint pain
  • muscle aches
  • protein in the urine
  • kidney effects
  • impotence
  • hernia at the surgical site
  • abnormal liver values
  • menstrual disorders (such as lack of or abundant menstruation).

Uncommon (may affect up to 1 in 100 people):

  • lymph tissue cancer (lymphoma / lymphoproliferative disease after transplantation)
  • low level of testosterone
  • inflammation of the lungs
  • inflammation of the liver
  • jaundice
  • ovarian cysts.

Other possible side effects are

Other side effects have been reported in a small number of people, but the exact frequency is unknown:

  • abnormal accumulation of protein in the lungs (symptoms of this may include persistent dry cough, fatigue, and difficulty breathing)
  • inflammation of the blood vessels
  • Swelling, the feeling of heaviness or tension, pain, limited mobility of body parts (this can occur anywhere in the body and is a possible sign of an abnormal accumulation of fluid in soft tissue due to a blockage in the lymphatic system, so-called lymphedema)
  • severe skin rash with swelling of the skin.
  • low level of iron in the blood.

If you have any questions about any of these side effects, talk to your doctor.

In addition, there may be side effects that you are not aware of, such as abnormal laboratory values ​​including tests on kidney function. During your treatment with Certican, your doctor may therefore take blood samples to monitor changes.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Certican

  • Keep out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP.
  • The expiration date is the last day of the specified month.
  • No special temperature instructions.
  • Store the blister cards in the original packaging. Sensitive to light. Moisture sensitive.
  • Do not use any Certican packaging that is damaged or shows signs of being broken
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is everolimus. Each dispersible tablet contains 0.1 mg and 0.25 mg of everolimus, respectively

Other excipients are:

Certican 0.1 mg dispersible tablets: butylhydroxytoluene (E 321), magnesium stearate, lactose monohydrate (1 mg), hypromellose, crospovidone, colloidal anhydrous silica, and anhydrous lactose (72 mg).

Certican 0.25 mg dispersible tablets: butylhydroxytoluene (E 321), magnesium stearate, lactose monohydrate (2 mg), hypromellose, crospovidone, colloidal anhydrous silica, and anhydrous lactose (179 mg).

What the medicine looks like and the contents of the pack

  • Certican 0.1 mg dispersible tablets are white to yellowish, marbled, round, flat with a ground edge and 7 mm in diameter, marked “I” on one side and “NVR” on the other.
  • Certican 0.25 mg dispersible tablets are white to yellowish, marbled, round, flat with a ground edge and 9 mm in diameter, marked “YES” on one side and “NVR” on the other.

Certican dispersible tablets are supplied in packs of 50, 60, 100, and 250 dispersible tablets.

Not all pack sizes may be marketed.

Certican is also available in the form of tablets.

Marketing Authorisation Holder:

Novartis Sverige AB

Box 1218

164 28 Kista

Manufacturer :

Novartis Pharmacéutica SA,

Ronda de Santa Maria, 158,

08210 Barberà del Vallès, Barcelona,

Spain

Muhammad Nadeem

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