Tacrolimus 0.5 mg. 30 capsules
Tacrolimus belongs to a group of medicines called immunosuppressants. After organ transplantation (eg. Liver, kidney, heart) immune system in your body will try to reject the new organ. Tacrolimus is used to prevent rejection of the new transplant.
Tacrolimus may also be prescribed for the treatment of transplant rejection. If you are taking medicines to prevent rejection and were not efficient enough, then your doctor will change your treatment as you appoint Tacrolimus.
Tacrolimus is often used in combination with other drugs that suppress the immune system too.
2. BEFORE YOU TAKE tacrolimus ACCORD
Do not take Tacrolimus Accord:
If you are allergic (hypersensitive) to tacrolimus or any of the ingredients of Tacrolimus Accord;
If you are allergic (hypersensitive) to the subgroup of macrolide antibiotics, for example. erythromycin, clarithromycin, josamycin.
Take special care with Tacrolimus Accord:
Have to take tacrolimus every day until you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor;
During the period of treatment with Tacrolimus Accord, your doctor may want to do tests at different intervals (including blood, urine, heart function, visual and neurological tests). These tests are normal and will help your doctor to choose the most appropriate dose Tacrolimus for you;
Do not take herbal medicines, for example. St. John's wort (Nurericum perforatum) or other vegetable products, as it can affect the effectiveness of tacrolimus dose and hence the dose you should be taking. If in doubt, consult your doctor before taking any medicine;
If you have liver disorders or have had a disease that could have affected your liver, please tell your doctor, as it could to change the dose Tacrolimus Accord you get;
If you have diarrhea for more than one day, please tell your doctor because you may need a dose adjustment Accord you get;
Limit your exposure to sunlight and UV rays, while using Tacrolimus Accord by wearing protective clothing that covers you completely and use a sun protector with a high protection factor. This is necessary 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.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and medicinal plant-based products. Tacrolimus should not be taken with ciclosporin.
Tacrolimus blood levels can be affected by other medicines you take, and blood levels of other products to change the use of tacrolimus. Subsequently, this may require an increase or decrease in the dose of tacrolimus. In particular, you should tell your doctor if you are taking or have recently taken drugs with the following active ingredients:
antifungal drugs and antibiotics (in particular the 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, which is used to treat ulcers;
hormonal therapy with ethinyl estradiol (eg. oral contraceptive pill) or danazol;
medicines for high blood pressure such as nifedipine, nicardipine, diltiazem and verapamil;
medicines known as "statins" used to treat elevated cholesterol and triglycerides;
antiepileptic drugs phenobarbital and phenytoin;
corticosteroids prednisolone and methylprednisolone;
St. John's Wort (Hypericum perforatum).
Tell your doctor if you should take (or are currently taking) ibuprofen, amphotericin B or antivirals (such as acyclovir). These drugs can worsen problems with kidney or nervous system when taken together with Tacrolimus Accord.
While receiving Tacrolimus Accord, your doctor should know if you are taking potassium supplements or potassium-containing diuretics (certain tablets as amiloride, spironolactone or triamterene), certain pain killers (so-called NSAIDs, eg. Ibuprofen), anticoagulants, or oral antidiabetics.
Taking Tacrolimus Accord with food and drink:
Tacrolimus Accord should be taken on an empty stomach or at least 1 hour before or 2-3 hours after a meal. When using Tacrolimus Accord 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 any medicine.
Tacrolimus is excreted in human milk. Therefore you should not breast-feed while taking tacrolimus.
Driving and using machines:
Do not drive or use any tools or machines if you feel dizzy or drowsy or can not see clearly after the adoption of Tacrolimus Accord. These adverse reactions occurred more frequently when Tacrolimus Accord be taken with alcohol.
Important information about some of the ingredients of Tacrolimus Accord
Tacrolimus Accord 0.5 / 1 mg contain 0,050 / 0,048 g of lactose. When taken according to the recommended doses, each dose provides respectively 0,050 / 0,048 g of lactose. If your doctor has told you that you have an intolerance to some sugars, contact before taking this medicine. Patients with rare hereditary problems of galactose intolerance, hereditary lactase deficiency (Lapp lactase) or impaired glucose-galactose absorption should not use this medicine.
3. HOW TO TAKE tacrolimus ACCORD
Always take Tacrolimus Accord exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The initial dose of tacrolimus Accord used to prevent rejection of your transplanted organ will be determined by your doctor depending on your body weight. Initial doses just after transplantation are generally on the order of 0,075 and 0,30 mg / kg weight / day depending on the transplanted organ.
The dose depends on your general condition and what you are taking other immunosuppressive agents. Your doctor will perform regular blood tests to determine the correct dose and to adjust from time to time. Your doctor will usually reduce your dose Tacrolimus Accord, once your condition has stabilized. It will tell you how much Tacrolimus Accord to take and how often to do this.
Tacrolimus Accord is taken orally twice a day, usually in the morning and evening. Tacrolimus Accord should be taken on an empty stomach or at least 1 hour before or 2-3 hours after a meal. The capsules should be swallowed whole with a glass of water. The capsules should be taken immediately after removal from the blister. Avoid grapefruit juice when taking tacrolimus.
If you take more dose Tacrolimus Accord
If you accidentally take too many capsules, see your doctor immediately or contact the casualty department at your nearest hospital.
If you forget to take Tacrolimus Accord
Do not take a double dose to make up for a missed dose.
If you forget to take your Tacrolimus Accord, wait until the next scheduled dose and then continue with the scheme.
If you stop taking Tacrolimus Accord
Discontinuation of Tacrolimus Accord 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 questions about using this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tacrolimus Accord can cause side effects, although not everybody gets them.
Possible side effects are listed according to the following categories:
very common: affects more than 1 in 10 patients;
common: affects 1 to 10 patients in 100;
uncommon: affects 1 to 10 patients in 1000;
rare: affects 1 to 10 patients in 10,000;
very rare: affects less than 1 in 10,000 patients;
not known: frequency can not be estimated from the available data.
increased blood sugar;
increased content of potassium in the blood;
reduction in the number of blood cells (platelets, red and white blood cells), an increase in the number of white blood cells, changes in the number of red blood cells;
reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid retention, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood thereof;
symptoms of anxiety, confusion and disorientation, depression, mood swings, nightmares, hallucinations, psychotic disorders;
fainting, disturbances of consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing, nervous system disorders;
blurred vision, increased sensitivity to light;
ringing noise in the ears;
reduced blood flow in the heart vessels, heart rate;
bleeding, partial or complete obstruction of blood vessels, reduction in blood pressure;
shortness of breath, changes in lung tissue, collection of fluid around the lung, inflammation of the pharynx, cough, flu-like symptoms;
sores or ulcers, causing abdominal pain or diarrhea, stomach bleeding, inflammation or ulcers in the mouth, collection of fluid in the abdomen, vomiting, abdominal pain, disturbed digestion, constipation, flatulence, bloating, loose stools, stomach problems;
changes in liver function and liver enzymes, 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, embarrassed 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, impaired perception of temperature;
inadequate function of the transplanted organ.
changes in blood clotting, decrease the number of all blood cells;
dehydration, reduced protein or sugar in the blood, increased phosphate in the blood;
coma, cerebral hemorrhage, stroke, paralysis, brain disorders, abnormalities in speech and speech, memory problems;
darkening of the lens;
irregular heartbeat, stopping of the pulse, weakened heart, disorders of the heart muscle, increasing heart muscle, palpitations, abnormal ECG, abnormal heart rate and pulse;
blood clot in the vein of a limb, shock;
shortness of breath, respiratory tract disorders, asthma;
obstruction of the intestine, increase of the enzyme amylase in the blood return of stomach contents into the throat, delayed gastric emptying;
dermatitis, burning sensation when exposed to sunlight;
inability to urinate, painful menstruation and abnormal menstrual bleeding;
failure of some organs, influenza like illness, increased sensitivity to heat and cold, feeling of chest pressure, nervousness, increase of the enzyme lactate dehydrogenase in blood, loss of weight.
small hemorrhages in the skin due to blood clots;
increased muscle stiffness;
collection of fluid around the heart;
acute shortness of breath;
formation of cysts in the pancreas;
problems with blood flow to the liver;
increased hair growth;
serious illness with blistering of the skin, mouth, eyes and genitals;
tightness in the chest;
sense of reduced mobility;
narrowing of the bile ducts;
painful urination with blood in the urine;
an increase in adipose tissue.
Immunosuppressants, including tacrolimus, reduce the protective mechanisms of your body that prevent rejection of your transplanted organ. As a result, your blood will not be as good as normal at fighting infections. So if you are taking tacrolimus may be more susceptible to infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE tacrolimus ACCORD
Keep out of the reach and sight of children.
Do not use Tacrolimus Accord after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store below 25 ° C. Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. PopitayteVashiya pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Tacrolimus Accord:
The active ingredient is tacrolimus.
Each capsule contains 0,5 mg tacrolimus.
The other ingredients of Tacrolimus 0,5 mg Accord are: lactose monohydrate, croscarmellose sodium (E468), hypromellose (E464), magnesium stearate (E572).
Capsule shell of Accord Tacrolimus 0,5 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), sodium lauryl sulphate.
Ink printed on the capsule shell: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Tacrolimus Accord looks like and contents of the pack:
Accord Tacrolimus 0,5mg: Pale yellow hard gelatin capsules size "5" imprinted "TCR" on the cap and "0.5" on the body, containing white to off-white granular powder.
Tacrolimus Accord is available in Alu-Alu blister x 10 capsules.
Packs 20, 30, 50, 60 and 100 hard capsules.
Not all pack sizes may be marketed.