Prograf. 1 mg. 30 capsules
Prograf. 1 mg. 30 capsules
Prograf WHAT IS AND WHAT IT IS USED FOR ?
Prograf belongs to a group of medicines called immunosuppressants . After organ transplant ( eg, liver , kidney , heart) immune system in your body will try to reject the new organ . Prograf is used to control the immune response of your body , allowing it to accept the transplanted organ . Prograf is often used in combination with other drugs that suppress the immune system too .
You may be given Prograf before rejecting your transplanted liver, kidney, heart or other organ or if any other previous treatment you have received has not been able to control this immune response after your transplantation.
2 . BEFORE YOU TAKE Prograf
Do not use Prograf :
- If you are allergic (hypersensitive) to tacrolimus or any of the ingredients of Prograf .
- If you are allergic (hypersensitive) to any of the antibiotics from the subgroup of macrolide antibiotics (eg, erythromycin , clarithromycin, josamycin ) .
Take special care with Prograf
Have to take Prograf every day until you need immunosuppression to prevent rejection of your transplanted organ . You should keep in regular contact with your doctor .
While taking Prograf , at different intervals , your doctor may want to do tests (including blood, urine , heart function, visual and neurological tests) . This is quite normal and will help your doctor choose the right dose of Prograf .
Please avoid taking herbal medicinal products, eg . St. John's wort (Hypericum perforatum) or other vegetable products , as it can affect the effectiveness and dose Prograf you need . If in doubt, please consult your doctor before taking any herbal products or remedies herbal .
If you have liver problems or have had a medical condition that may have affected your liver , please tell your doctor, as this could change your dose of Prograf receive.
If you have diarrhea for more than one day , please tell your doctor because you may need a dose adjustment Prograf taking. Limit your exposure to sunlight and UV rays while taking Prograf by wearing appropriate protective clothing and use sun protector with a high protection factor. This is due to the potential risk of malignant skin changes with immunosuppressive therapy. If you need to have any vaccinations , please inform your doctor. He will advise you how to do best.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taking other medicines , including medicines obtained without a prescription and herbal medicines .
Prograf should not be used together with cyclosporine .
Blood levels of Prograf may be affected by other medicines you are taking , and blood levels of other drugs can be affected by the use of Prograf , which may require an increase or decrease in the dose of Prograf . In particular, you should tell your doctor if you are taking or have recently taken medicines with active ingredients:
- Antifungal drugs 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. ritonavir
- Omeprazole or lansoprazole, used for treatment of gastric ulcer contraceptive pill or other hormonal treatment
- Nifedipine, nicardipine, diltiazem and verapamil , or other drugs used to treat high blood pressure or heart problems
- Drugs known as " statins " , used in the treatment of elevated cholesterol and triglycerides
- Phenytoin or phenobarbital, used for the treatment of epilepsy, prednisolone and methylprednisolone, nefazodone group of corticosteroids used for the treatment of depression wort (Hypericum perforatum)
Tell your doctor if you are taking or need to take ibuprofen , amphotericin B or antivirals (eg aciclovir ) . They can worsen kidney or nervous system if used with Prograf .
Your doctor should know if you are taking potassium supplements or potassium-sparing diuretics (eg, amiloride , triamterene or spironolactone) , certain pain killers ( so-called NSAIDs , eg . Ibuprofen) , anticoagulants , or oral antidiabetics while receiving Prograf .
If you need to make a vaccine , please first contact your doctor. Taking Prograf with food and drink
Prograf should be taken on an empty stomach or at least 1 hour before or 2-3 hours after a meal. When taking Prograf should avoid grapefruit and grapefruit juice.
Pregnancy and lactation
If you are planning to become pregnant or think you may be pregnant , ask your doctor or pharmacist before taking on any medicine. Prograf is excreted in breast milk. Therefore should not breastfeed while taking Prograf .
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 Prograf . These effects occurred more often if Prograf be used concomitantly with alcohol consumption.
Important information about some of the ingredients of Prograf
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine .
3 . HOW TO TAKE Prograf
Always take Prograf exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
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 medication should be taken twice daily - Consult as quickly 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 have taken the right drug .
Starting dose to prevent rejection of your transplantnran body will be determined by your doctor depending on your body weight. Initial doses immediately after transplantation are generally on the order of 0.075 mg - 0.30 mg / kg weight / day in dependence of the transplanted organ .
The dose depends on your condition and what you are taking other immunosuppressive agents . Will require regular blood tests to determine the correct dose and to adjust from time to time . Your doctor will usually reduce your dose of Prograf , once your condition has stabilized. It will tell you exactly how many capsules to take and how often to do this.
Prograf is taken orally twice a day usually in the morning and evening. Usually you have to take Prograf fasting or at least 1 hour before or 2 to 3 hours after a meal. The capsules should be swallowed whole with a glass of water. While taking Prograf avoid grapefruit or grapefruit juice. Do not swallow the desiccant contained in the foil wrapper .
If you take more than the dose of Prograf
If you accidentally take too much of Prograf , visit your doctor immediately or contact the casualty department at your nearest hospital ^ .
If you forget to take Prograf
Do not take a double dose to make up for forgotten individual doses .
If you forget to take Prograf capsules , wait until the time for the next dose and then continue the scheme.
If you stop taking Prograf
Discontinuation of Prograf may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor tells you to .
If you have further questions on the use of Prograf , contact your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Prograf can also cause side effects, although not everybody gets them.
Prograf reduces safeguards your body to prevent rejection of your transplanted organ . For this reason, your body can not fight as good as usual with infections. So if you are taking Prograf may get sick more often than usual infections of the skin; mouth , stomach and intestines , lungs and urinary tract.
May lead to serious reactions, including allergic and anaphylactic reactions. The occurrence of benign and malignant tumors following treatment with Prograf due to immunosuppression.
Possible side effects are listed according to the following categories:
- Very common side effects occurring in more than one in ten patients. Common side effects occur in less than one of ten patients, but more than one hundred patients.
- Uncommon adverse events occurred in less than one percent of the patients , but more than one thousand patients.
- Rare side effects are experienced in less than one in a thousand patients , but more than one of ten thousand patients.
- Very common side effects occur in less than one in ten thousand patients.
- Very common side effects:
Increased blood sugar, diabetes mellitus, increased blood potassium
Tremor , headache
Increased blood pressure
Diarrhea , nausea
- Common side effects:
Reduction in blood cells ( platelets, red or white blood cells) , increase in white blood cells , changes in the number of red blood cells ( proven by tests)
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 symptoms of anxiety , confusion and disorientation , depression, changes mood , nightmares , hallucinations, psychotic disorders Fits, disturbances of 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 Tinnitus
Reduced blood flow in the heart vessels, faster heartbeat Bleeding, partial or complete blockage of blood vessels, reduced blood pressure
Zadyhvane , changes in lung tissue , 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, stomach problems Abnormal liver enzymes and function , yellowing of the skin due to liver problems , liver tissue damage and inflammation of the liver
Itching, rash, hair loss , acne, increased sweating pain in the 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:
Changes in blood clotting , decrease the number of all blood cells ( proven by tests)
Dehydration, reduced protein or sugar in the blood , increased blood phosphate coma, cerebral hemorrhage , stroke , paralysis, brain disorders , abnormalities in speech and speech , memory problems opacity of the eye lens , impaired hearing
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 becomes impaired
Inability to urinate, painful menstruation and abnormal menstrual bleeding
Failure of some organs , influenza like illness , increased sensitivity to heat and cold , feeling of pressure in the chest, feeling of nervousness or discomfort, increase of the enzyme lactate dehydrogenase in the blood , weight loss
- Rare side effects:
Minor hemorrhages in the skin due to blood clots
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 : muscle weakness, abnormal heart image
Liver failure, narrowing of the bile ducts Painful urination with blood in the urine increase fat
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 ) .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE Prograf ?
Keep out of reach of children.
Take the capsules immediately after removal from the blister .
Prograf not use after the expiry date stated on the carton and blister after " EXP" . Expiry date refers to the last day of that month. Use all prolonged-release capsules within 1 year of opening the aluminum wrapper .
This medicinal product does not require any special temperature storage conditions. Store in the original package to protect from moisture.
6 . ADDITIONAL INFORMATION
What does Prograf ?
Prograf 0.5 mg hard capsules
The active substance is tacrolimus. Each capsule contains 0.5 mg of tacrolimus as tacrolimus monohydrate.
Capsule content : hiiromeloza . croscarmellose sodium, lactose monohydrate, magnesium stearate.
Capsule shell: titamov di oxide ( 1-1171 ) . yellow iron oxide (E172), gelatin. Printing ink on the capsule shell: shellac, lecithin ( soy) , hydroxypropylcellulose . simethicone . red iron oxide ( P172 ) .
Prograf 1 mg hard capsules :
The active substance is tacrolimus. Each capsule contains I mg tacrolimus , tacrolimus monohydrate. Auxiliary ingredients:
Capsules but content : hiiromeloza , croscarmellose sodium, lactose monohydrate, magnesium stearate.
Capsule shell: titanium dioxide ( E171 ) , gelatin . Printing ink on the capsule shell: shellac, lecithin ( soy) , hydroxypropyl cellulose , simethicone , iron oxide red ( E172) .
Prograf 5 mg hard capsules
The active ingredient tacrolimus . Each capsule contains 5 mg of tacrolimus as tacrolimus monohydrate. Auxiliary ingredients:
Capsule contents : hiiromeloza , croscarmellose sodium, lactose monohydrate. magnesium stearate.
Capsule shell: titanium dioxide (E 171) , iron oxide red ( E172 ) , gelatin . Printing ink on the capsule shell: shellac, lecithin ( soy) , simethicone , titanon dioxide ( N171 ) .
Prograf looks like and contents of the pack ?
Prograf 0.5 mg hard capsules
Pale yellow opaque capsules imprinted in red with "0.5 mg" and " ( 0607 " containing white powder.
Prog graph 0.5 mg hard capsules are supplied in blisters or blnsteri perforated single doses each containing 10 capsules and protective aluminum foil sushi wire protects the capsule from moisture. The desiccant should be swallowed . Pack of 30 hard capsules are supplied in blister packs . a box with 30 * 1 hard capsules are supplied in blister perforated unit dose .