Tacrolimus-Teva

Tacrolimus.

Tacrolimus-Teva 0.5 mg capsules: The active substance is tacrolimus. Each capsule contains 0.5 mg of tacrolimus.
Tacrolimus-Teva 1 mg capsules: The active substance is tacrolimus. Each capsule contains 1 mg of tacrolimus.
Tacrolimus-Teva 5 mg capsules: The active substance is tacrolimus. Each capsule contains 5 mg of tacrolimus.
Excipients/Inactive Ingredients: For 0.5 mg: The other ingredients are: Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous, Magnesium stearate.
Capsule shell: Titanium dioxide (E-171), Yellow Iron Oxide (E-172), Gelatin.
For 1 mg: The other ingredients are: Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous, Magnesium stearate.
Capsule shell: Titanium dioxide (E-171), Gelatin.
For 5 mg: The other ingredients are: Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous, Magnesium stearate.
Capsule shell: Titanium dioxide (E-171 ), Red Iron Oxide (E-172), Gelatin.

Tacrolimus-Teva is an immunosuppressant. Following organ transplant (e.g. liver, kidney, heart), the body's immune system will try to reject the new organ.
Tacrolimus-Teva is used to control the body's immune response enabling the body to accept the transplanted organ.
Tacrolimus-Teva is often used in combination with other medicines that also suppress the immune system. Tacrolimus-Teva may also be given for an ongoing rejection of transplanted liver, kidney, heart or other organ when any previous treatment taken was unable to control the immune response after transplantation.

Always take Tacrolimus-Teva exactly as advised by the doctor. Check with the doctor or pharmacist if not sure.
Make sure to receive the same tacrolimus medicine every time the prescription is collected, unless the 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 the doctor or pharmacist as soon as possible to make sure that it is the right medicine.
The starting dose to prevent the rejection of the transplanted organ will be determined by the doctor calculated according to the 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 organ.
The dose depends on the general condition and on which other immunosuppressive medication being taken. Regular blood tests by the doctor will be required to define the correct dose and to adjust the dose from time to time. The doctor will usually reduce the tacrolimus capsules dose once the condition has stabilised. The doctor will advise exactly how many capsules to take and how often.
Tacrolimus-Teva is taken orally twice daily, usually in the morning and evening. Take Tacrolimus capsules on an empty stomach or at least 1 hour before or 2 to 3 hours after the meal. The capsules should he swallowed whole with a glass of water. Avoid grapefruit and grapefruit juice while taking Tacrolimus capsules. Do not swallow the desiccant contained in the foil wrapper.

If the patient accidentally taken too much, see the doctor or contact the nearest hospital emergency department immediately.

Do not take Tacrolimus-Teva: If allergic (hypersensitive) to tacrolimus or any of the other ingredients of Tacrolimus-Teva (see Description).
If allergic (hypersensitive) to sirolimus or to any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).

Tell the doctor if any of the following applies: If any medicines mentioned under Interactions are taken.
If the patient has or have had liver problems.
If the patient has diarrhoea for more than one day.
If the patient needs to receive any vaccinations.
The doctor may need to adjust the dose of Tacrolimus-Teva.
Keep regular contact with the doctor from time to time, the doctor may need to do blood, urine, heart, eye tests, to set the right dose of Tacrolimus-Teva.
Limit exposure to the sun and UV (ultraviolet) light whilst taking Tacrolimus-Teva. This is because immunosuppressants could increase the risk of skin cancer. Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Important information about some of the ingredients of Tacrolimus-Teva: Tacrolimus-Teva contains lactose. If the patient has an intolerance to some sugars, contact the doctor before taking this medicine.
If the patient forgets to take Tacrolimus-Teva: Do not take a double dose to make up for forgotten individual doses.
If the patient forgets to take the capsules, wait until it is time for the next dose, and then continue as before.
If the patient stops taking Tacrolimus-Teva: Stopping the treatment may increase the risk of rejection of the transplanted organ. Do not stop the treatment unless the doctor advised.
Driving and using machines: Do not drive or use any tools or machines if feeling dizzy or sleepy, or have problems seeing clearly after taking this medicine. These effects are more frequently observed if the patient also drinks alcohol.

If the patient plans to become pregnant or thinks may be pregnant, ask the doctor or pharmacist for advice before taking any medicine.
Tacrolimus passes into breast milk. Therefore, the patient should not breast-feed whilst using Tacrolimus-Teva.

Like all medicines, Tacrolimus-Teva can cause side effects, although not everybody gets them.
Tacrolimus-Teva reduces the body's own defense mechanism to stop rejecting the transplanted organ. Consequently, the body will not be as good as usual at fighting infections. So if the patient is taking Tacrolimus-Teva, the patient may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
Severe effects may occur, including allergic and anaphylactic reactions. Benign and malignant tumours have been reported following treatment as result of immunosuppression.
Possible side effects are listed according to the following categories: Very common side effects are experienced in more than one in ten patients.
Common side effects are experienced in less than one in ten patients but in more than one per one hundred patients.
Uncommon side effects are experienced in less than one in one hundred patients but more than one per one thousand patients.
Rare side effects are experienced in less than one per one thousand patients but more than one per ten thousand patients.
Very rare side effects are experienced in less than one per ten thousand patients.
Very common side effects: affects more than 1 user in 10: Increased blood sugar, diabetes mellitus, increased potassium in the blood; difficulty in sleeping; trembling, headache; increased blood pressure; diarrhoea, nausea; kidney problems.
Common side effects: affects 1 to 10 users in 100: 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 (seen in blood tests); 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 the 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 throat, cough, flu-like symptoms; inflammations or ulcers causing abdominal pain or diarrhoea, bleedings in the stomach, inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, passing wind, 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 the body, pain and discomfort, increase of the enzyme alkaline phosphatase in the blood, weight gain, feeling feverish; insufficient function of the transplanted organ.
Uncommon side effects: affects 1 to 10 users in 1,000: Changes in blood clotting, reduction in the number of all types of blood cells; 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; clouding of the eyes; impaired hearing; irregular heartbeat, skipped heartbeat, reduced performance of 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 the throat, delayed emptying of the stomach; dermatitis, burning sensation in the sunlight; joint disorders; inability to urinate, painful menstruation and abnormal menstrual bleedings; failure of some organs, influenza like illness, increased sensitivity to heat and cold, feeling of pressure on the chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in the blood, weight loss.
Rare side effects: affects 1 to 10 users in 10,000: Small bleedings in the skin due to blood clots; increased muscle stiffness; blindness; deafness; collection of fluid around the heart; acute breathlessness; cyst formation in the 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 the chest, decreased mobility, ulcer.
Very rare side effects: affects less than 1 user in 10,000: Muscular weakness; abnormal heart scan; liver failure, narrowing of the bile vessel; painful urination with blood in the urine; increase of fat tissue.
If any of the side effects gets serious, or if any side effects not listed in the monograph are noticed, tell the doctor or pharmacist.

Tell the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal preparations.
Tacrolimus-Teva must not be taken with cyclosporine.
Tacrolimus-Teva blood levels can be affected by other medicines taken, and blood levels of other medicines can be affected by taking Tacrolimus-Teva which may require an increase or decrease in dose. In particular, tell the doctor if the patient is taking or have recently taken medicines like: Antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat infections, such as ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin and rifampicin.
HIV medicines (e.g. ritonavir), used to treat HIV infection.
Medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine).
The contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments with danazol.
Medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem and verapamil).
Medicines known as "statins" used to treat elevated cholesterol and triglycerides.
Phenytoin or phenobarbital, used to treat epilepsy.
The corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids used to treat inflammations or suppress the immune system (e.g. in transplant rejection).
Nefazodone, used to treat depression.
Herbal preparations containing St. John's Wort (Hypericum perforatum).
Tell the doctor if the patient is taking or needs to take ibuprofen, amphotericin B or antivirals (e.g. aciclovir). These may worsen kidney or nervous system problems when taken together with Tacrolimus-Teva.
The doctor also needs to know if the patient is taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease, (e.g. amiloride, triamterene or spironolactone), non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while taking Tacrolimus-Teva.
If the patient needs vaccinations, tell the doctor in advance that this medicine is being taken.
Taking Tacrolimus-Teva with food and drink: Take Tacrolimus-Teva on an empty stomach or 2 to 3 hours after a meal. Wait at least 1 hour until the next meal. Avoid grapefruit (also as juice) while on treatment with Tacrolimus-Teva since it can affect its levels.

Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Store below 25°C.
Store in the originai package (within the foil pouch) in order to protect from moisture & light.
Once the foil pouch is opened, the product should be used within 1 year.

Immunosuppressants

L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.

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