ADVAGRAF 0.5 mg. 30 capsules
ADVAGRAF 0.5 mg. 30 capsules
What Advagraf is and what it is used
Advagraf contains the active substance tacrolimus. It is an immunosuppressant. After organ transplant (liver, kidney) immune system, your body will try to reject the new organ. Advagraf is used to control the immune response of your body, allowing it to accept the transplanted organ.
Advagraf you may be an ongoing rejection of your transplanted liver, kidney, heart or other authority, if any other previous treatment you were taking was unable to control this immune response after your transplantation.
Advagraf is used in adults.
2. What you should know before taking Advagraf
Do not use Advagraf:
if you are allergic (hypersensitive) to tacrolimus or any other ingredients of Advagraf (listed in section 6);
if you are allergic to sirolimus or any macrolide antibiotic (eg, erythromycin, clarithromycin, josamycin).
Warnings and Precautions
As Prograf, and contain the active substance Advagraf tacrolimus. Advagraf however be taken once a day until Prograf is taken twice daily. This is because capsules Advagraf
providing a sustained release (slow release over a longer period of time) of tacrolimus. Advagraf and Prograf are not interchangeable.
Tell your doctor if any of the following concerns you:
if you are taking any of the medicines mentioned below in "Other medicines and Advagraf";
if you have or have had liver problems;
if you have diarrhea for more than one day;
if you feel severe abdominal pain accompanied with or without other symptoms, such as chills, fever, nausea or vomiting;
if you have a disorder of the electrical activity of the heart, called "QT-prolongation."
You may need your doctor to adjust your dose Advagraf.
You should keep in regular contact with your doctor. At various times, your doctor may want to perform blood tests, urine, heart, eyes to appoint the most appropriate dose for you Advagraf.
You should limit your exposure to sunlight and UV (ultraviolet) light while taking Advagraf. This is because immunosuppressants may increase the risk of skin cancer. Wear suitable protective clothing and use sunscreen with a high SPF.
Children and adolescents
Not recommended for use Advagraf in children and adolescents under 18 years.
Other medicines and Advagraf
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal products.
Not recommended for use with cyclosporine Advagraf (another medicine used to prevent organ transplant rejection).
Advagraf blood levels can be affected by other medicines you are taking, and blood levels of other drugs can be affected by use of Advagraf, which may require interruption, increase or decrease the dose Advagraf.
In particular, you should tell your doctor if you are taking or have recently taken drugs such as:
antifungals and antibiotics, in particular so-called macrolide antibiotics used to treat infections of, e. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin, and rifampicin;
HIV-protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir) used to treat HIV infection;
HIV-protease inhibitors (e.g., telaprevir, boceprevir) used for the treatment of hepatitis C infection;
drugs for the treatment of gastric ulcers and acids (e.g., omeprazole, lansoprazole or cimetidine);
antiemetics, used to treat nausea and vomiting (e.g., metoclopramide);
cisapride or antacid magnesium aluminum hydroxide used to treat heartburn;
contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments with danazol;
drugs used to treat high blood pressure or heart problems (e.g., nifedipine, nicardipine, diltiazem and verapamil);
antiarrhythmics (amiodarone) used to control arrhythmia (irregular heart beat);
drugs known as "statins", used in the treatment of elevated cholesterol and triglycerides;
phenytoin or phenobarbital, used in the treatment of epilepsy;
Drug prednisolone and methylprednisolone from the group of corticosteroids used for the treatment of inflammation or suppression of the immune system (e.g., in transplant rejection);
nefazodone, used to treat depression;
herbal preparations containing St. John's wort (Hypericum perforatum).
Tell your doctor if you are taking or need to take ibuprofen (used in fever, inflammation and pain), amphotericin B (used to treat bacterial infections) or antiviral agents (used to treat viral infections, eg. Acyclovir). They can worsen kidney or nervous system when taken together with Advagraf.
Your doctor should know if you are taking potassium supplements or certain diuretics used to treat heart failure, hypertension or renal disease (eg, amiloride, triamterene or spironolactone), nonsteroidal anti-inflammatory drugs (NSAIDs, eg. Ibuprofen) used for the treatment of fever, inflammation and pain, anticoagulants (blood thinners) or oral agents for diabetes while receiving Advagraf.
If you need to be vaccinated, please tell your doctor in advance.
Advagraf with food and drink
Avoid grapefruit (and juice) during treatment with Advagraf, because it can affect its levels in the blood.
Pregnancy and lactation
If you are pregnant, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking Advagraf.
Advagraf passes into breast milk. Therefore should not breastfeed while using Advagraf.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Advagraf. These effects are more common if you are taking Advagraf together with alcohol.
Advagraf contains lactose and lecithin (soy)
Advagraf contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Printing ink used on Advagraf capsules contains soya lecithin. Tell your doctor if you are allergic to peanut or soya, to decide whether you should use this medication.
3. How to take Advagraf
Always take Advagraf exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist. This medicine should you only be prescribed by a physician experienced in the treatment of transplant patients.
Whenever obtaining the recipe make sure you are prescribed the same medicine containing tacrolimus, except when your transplant specialist has agreed to replace him with another medicine containing tacrolimus. This medicine should be taken once daily. Consult soon as possible with your doctor or pharmacist if you are the type of medicine is not the same as before, or if there is a change in the prescribed dose to make sure you take the right medicine.
Starting dose to prevent rejection of your transplanted organ will be determined by your doctor calculated according to your body weight. Initial daily doses immediately after transplantation are generally on the order of 0,10 mg-0, 30 mg / kg body weight / day in dependence of the transplanted organ. When treating rejection may be used in the same dosages.
The dose depends on your condition and on which other immunosuppressive drugs taking.
After the start of your treatment with Advagraf will make frequent blood tests by your doctor to determine the correct dose. Subsequently, your doctor will require regular blood tests to determine the correct dose and to adjust the dose from time to time. Your doctor will usually reduce your dose Advagraf, once your condition has stabilized. It will tell you exactly how many capsules to take and how often to do this.
You should take Advagraf every day until you need immunosuppression to prevent rejection of your transplanted organ. You must have regular contact with your doctor.
Advagraf is taken orally once daily in the morning. Take Advagraf on an empty stomach or 2 to 3 hours after a meal. Wait at least 1 hour until the next meal. Take the capsules immediately after removal from the blister. The capsules should be swallowed whole with a glass of water. Do not swallow the desiccant contained in the foil wrapper.
If you take more Advagraf than
If you accidentally take too much Advagraf, immediately contact your doctor or the emergency room of the nearest hospital.
If you forget to take Advagraf
If you forget to take capsules Advagraf morning, take them as soon as possible on the same day. Do not take a double dose the next morning.
If you stop taking Advagraf
Discontinuation of Advagraf may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Advagraf can cause side effects, although not everybody gets them.
Advagraf reduces defense mechanisms (immune system) to your body, therefore your body can not fight as good as usual with infections. Therefore, while taking Advagraf, you may be more susceptible to infections.
May lead to serious reactions, including allergic and anaphylactic reactions. The occurrence of benign and malignant tumors occurs with Advagraf.
Cases of pure red cell aplasia (a very significant reduction in the number of red blood cells), agranulocytosis (very large reduction in the number of white blood cells) and hemolytic anemia (low red blood cells due to abnormal destruction).
Very common side effects (may affect more than 1 in 10 people):
Increased blood sugar, diabetes, increased levels of potassium in the blood;
High blood pressure;
Abnormal tests of liver function;
Common side effects (may affect up to 1 in 10 people):
Reduction in blood cells (platelets, red or white blood cells), increase in white blood cells, changes in the number of red blood cells (reported in studies of blood);
Reduced magnesium, phosphate, potassium, calcium and sodium in the blood, fluid retention, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes of salts in the blood (seen in blood tests);
Anxiety symptoms, confusion and disorientation, depression, mood swings, nightmares, hallucinations, psychotic disorders;
Seizures, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders;
Blurred vision, increased sensitivity to light, eye disorders;
Ringing sound in the ears;
Reduced blood flow in the heart vessels, faster heartbeat;
Bleeding, partial or complete blockage of blood vessels, decreased blood pressure;
Breathlessness, disorders of the respiratory tissues of the lung, the collection of fluid around the lung, inflammation of the pharynx, cough, flu-like symptoms;
Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhea, bleeding, inflammation or ulcers in the mouth, collection of fluid in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, loose stools;
Disorders of the bile duct, yellowing of the skin due to liver problems, damage of the liver tissue and inflammation of the liver;
Itching, rash, hair loss, acne, increased sweating;
Pain in joints, limbs or back, muscle cramps;
Insufficient kidney function, decreased urine production, impaired or painful urination;
General weakness, fever, fluid retention in the body, pain and discomfort, increase of the enzyme alkaline phosphatase in the blood, weight gain, feeling of temperature disturbed;
Insufficient function of the transplanted organ.
Uncommon side effects (may affect up to 1 in 100 people):
Changes in blood clotting, decrease the number of all blood cells (seen in blood tests);
Dehydration, inability to urinate;
Abnormal blood tests: reduced protein or sugar, elevated phosphate, elevated lactate dehydrogenase enzyme;
Coma, cerebral hemorrhage, stroke, paralysis, brain disorders, abnormalities in speech and speech, memory problems;
Clouding of the lens of the eye, hearing-impaired;
Irregular heartbeat, stopping of the heartbeat, reduced heart rate, cardiac muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse;
Blood clot in a vein of a limb, shock;
Difficulty breathing, respiratory tract disorders, asthma;
Obstruction of the intestine, increase of the enzyme amylase in the blood reflux of stomach contents into the throat, delayed gastric emptying;
Skin irritation, burning sensation when exposed to sunlight;
Painful menstruation and abnormal menstrual bleeding;
Multiorgan failure, influenza like illness, increased sensitivity to heat and cold, feeling of pressure in the chest, feeling of nervousness or discomfort, weight loss.
Rare side effects (may affect up to 1 in 1000 people):
Minor hemorrhages in the skin, due to a blood clot;
Increased muscle stiffness;
Collection of fluid around the heart;
Acute shortness of breath;
Cyst formation in the pancreas;
Problems with blood supply to the liver;
Serious illness with blistering of the skin, mouth, eyes and genitals, increased hair growth;
Thirst, fainting, chest tightness, feeling of reduced mobility ulcer.
Very rare side effects (may affect up to 1 in 10,000 people):
Changes in imaging of the heart;
Painful urination with blood in the urine;
An increase in body fat.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet. You can also report side effects directly through the national system of communication. As reported side effects, you can do your bit to get more information on the safety of this medicine.
5. How to store Advagraf
Keep out of reach of children.
Advagraf not use after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month. Use all prolonged-release capsules within 1 year of opening the aluminum wrapper.
Store in the original package to protect from moisture.
Do not dispose of medications in 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 pack and other information
What does Advagraf
The active ingredient is tacrolimus.
Each capsule contains Advagraf 0.5 mg 0,5 mg tacrolimus (as monohydrate).
Each capsule of Advagraf 1 mg contains 1 mg of tacrolimus (as monohydrate).
Each capsule Advagraf 3 mg contains 3 mg tacrolimus (as monohydrate).
Each capsule contains 5 mg of Advagraf 5 mg of tacrolimus (as monohydrate).
Other ingredients are:
Capsule: hypromellose, ethylcellulose, lactose, magnesium stearate.
Capsule: Titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), sodium lauryl sulfate, gelatin.
Printing ink: shellac, lecithin (soy), simethicone, iron oxide red (E172), hydroxypropyl cellulose.
Advagraf looks like and contents of the pack
Advagraf 0,5 mg hard capsules prolonged-release hard gelatin capsules imprinted in red with "0.5 mg" on the light yellow capsule cap and "647" on the orange capsule body, containing white powder.
Advagraf 0,5 mg is supplied in blisters or blisters with perforated unit dose containing 10 capsules within a protective foil wrapper, including a desiccant. Packs of 30, 50 and 100 capsules extended release are available in blister packs with a 30x1, 50x1 and 100x1 hard prolonged-release capsules are available in blister packs with perforated unit dose.