Drug Ingredient Information
TACROLIMUS-0.5MG
TACROLIMUS
| Information for
patients
|
| Drug Information |
Tacrolimus belongs to a group of medicines called immunosuppressants. Following your organ transplant (e.g. liver, kidney, heart), your body’s immune system will try to reject the new organ. Tacrolimus is used to control your body’s immune response enabling your body to accept the transplanted organ.Tacrolimus is often used in combination with other medicines that also suppress the immune system. You may also be given Tacrolimus for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation |
| Drug Alert |
| Alert |
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Tacrolimus®.
- If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics
(e.g. erythromycin, clarithromycin, josamycin). |
| Before Consuming
the Medicine
|
| Avoid Drug |
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Tacrolimus®.
- If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics
(e.g. erythromycin, clarithromycin, josamycin). |
| Drug Special Care |
You will need to take Tacrolimus® every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor.
-Whilst you are taking Tacrolimus® your doctor may want to carry out a number of tests (including blood, urine, heart function, visual and neurological tests) from time to time. This is quite normal and will help your doctor to decide on the most appropriate dose of Tacrolimus® for you.
-Please avoid taking any herbal remedies, e.g. St. John’s wort (Hypericum perforatum) or any other herbal products as this may affect the effectiveness and the dose of Tacrolimus® that you need to receive. If in doubt please consult your doctor prior to taking any herbal products or remedies.
-If you have liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Tacrolimus® that you receive.
-If you have diarrhoea for more than one day, please tell your doctor, because it might be necessary to adapt the dose of Tacrolimus® that you receive.
-Limit your exposure to sunlight and UV light whilst taking Tacrolimus® by wearing appropriate protective clothing and using a sunscreen with a high sun protection factor. This is because of the potential risk of malignant skin changes with immunosuppressive therapy.
-If you need to have any vaccinations, please inform your doctor beforehand. Your doctor will advise you on the best course of action. |
| Drug Drug Interactions |
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 remedies. Tacrolimus must not be taken with ciclosporin. Tacrolimus blood levels can be affected by other medicines you take, and blood
levels of other medicines can be affected by taking Tacrolimus which may require an increase or decrease in Tacrolimus® dose. In particular, you should tell your doctor if you are taking or have recently taken medicines with active substances like:
-antifungal medicines and antibiotics (particularly so-called macrolide antibiotics) used to treat infections e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin, and rifampicin
-HIV protease inhibitors e.g ritonavir
-omeprazole or lansoprazole, used for treating stomach ulcers
-hormone treatments with ethinylestradiol (e.g the oral contraceptive pill) or danazol
-medicines for high blood pressure or heart problems such as nifedipine, nicardipine, diltiazem and verapamil
-medicines known as “statins” used to treat elevated cholesterol and triglycerides
-the anti-epileptic medicines phenytoin or phenobarbital
-the corticosteroids prednisolone and methylprednisolone
-the anti-depressant nefazodone
-St. John’s Wort (hypericum perforatum)
Tell your doctor if you are taking or need to take ibuprofen, amphotericin B, or antivirals (e.g. aciclovir). These may worsen kidney or nervous system problems when taken together with Tacrolimus. Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone), certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you take Tacrolimus. If you need to have any vaccinations, please inform your doctor beforehand. |
| Drug Pregnancy Interaction |
If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine. Tacrolimus is excreted into breast milk. Therefore you should not breast-feed whilst receiving Tacrolimus. |
| Drug Breast feeding Interaction |
If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine. Tacrolimus is excreted into breast milk. Therefore you should not breast-feed whilst receiving Tacrolimus. |
| Drug Machinery Interaction |
Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Tacrolimus. These effects are more frequently observed if Tacrolimus® is taken in conjunction with alcohol use. |
| Drug More Information |
You should generally take Tacrolimus® on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal.Grapefruit and grapefruit juice should be avoided while taking Tacrolimus. |
| How to take the
Medicine
|
| Consumption Info |
no data available |
| Drug quanitty |
Always take Tacrolimus® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine. This medicine should be taken twice a day. If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight. Initial doses just after transplantation will generally be in the range of 0.075 – 0.30 mg per kg body weight per day depending on the transplanted organs. Your dose depends on your general condition and on which other immunosuppressive medication you are taking. Regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time. Your doctor will usually reduce your Tacrolimus dose once your condition has stabilised. Your
doctor will tell you exactly how many capsules to take and how often.Tacrolimus is taken orally twice daily, usually in the morning and evening. You should generally take Tacrolimus on an empty stomach or at least 1 hour before or 2 to 3 hours after the meal. The capsules should be swallowed whole with a glass of water. Take the capsules immediately following removal from the blister. Avoid grapefruit and grapefruit juice while taking Tacrolimus. Do not swallow the desiccant contained in the foil wrapper. |
| Drug Dose |
no data available |
| Excess Drug Consumption |
If you have accidentally taken too much Tacrolimus see your doctor or contact your nearest hospital emergency department immediately. |
| Forgot Drug Consumption |
Do not take a double dose to make up for forgotten individual doses. If you have forgotten to take your Tacrolimus capsules, wait until it is time for the next dose, and then continue as before. |
| Stop Drug Consumption |
Stopping your treatment with Tacrolimus® may increase the risk of rejection of your transplanted organ. Do not
stop your treatment unless your doctor tells you to do so. |
| Possible Side
Effects
|
| General Information |
-Increased blood sugar, diabetes mellitus, increased potassium in the blood
-Difficulty in sleeping
-Trembling, headache
-Increased blood pressure
-Diarrhoea, nausea
-Kidney problems |
| Common Drug Side Effects |
-Reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts
-Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts
-Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare, hallucination, mental disorders
-Fits, 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 your ears
-Reduced blood flow in the heart vessels, faster heartbeat
-Bleeding, partial or complete blocking of blood vessels, reduced blood pressure
-Shortness in breath, changes in the lung tissue, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms
-Inflammations or ulcers causing abdominal pain or diarrhoea, bleeds in the stomach, inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation,flatulence, bloating, loose stools, stomach problems
-Changes in 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 joints, limbs or back, muscle cramps
-Insufficient function of the kidneys, reduced production of urine, impaired or painful urination
-General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed
-Insufficient function of your transplanted organ |
| Rare Drug Side Effects |
-Small bleeds in your skin due to blood clots
-Increased muscle stiffness
- Blindness
-deafness
-collection of fluid around the heart
-Acute breathlessness
-Cyst formation in your pancreas
-Problems with blood flow in the liver
-Serious illness with blistering of skin, mouth, eyes and genitals, increased hairiness
-Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer |
| Very Rare Drug Side Effects |
-Muscular weakness
-Echocardiogram abnormal
-Liver failure, narrowing of the bile vessel
-Painful urination with blood in the urine
-Increase of fat tissue |
| Drug Side Effects Symptoms |
-Changes in blood clotting, reduction in all blood cell counts
-Dehydration, reduced protein or sugar in the blood, increased phosphate in the blood
-Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems
-Blurring of the vision due to abnormality in the lens of the eye
-Impaired hearing
-Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal
-Blood clot in a vein of a limb, shock
-Difficulties in breathing, respiratory tract disorders, asthma
-Obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach
-Dermatitis, burning sensation in the sunlight
-Joint disorders
-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 on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood, weight loss |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children.Take the hard capsules immediately following removal from the blister.Do not use Tacrolimus® after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Use all the capsules within 1 year of opening the aluminium wrapping. =This medicinal product does not require any special temperature storage conditions.Store in the original package in order to protect from moisture. |
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