Tevligraf Capsules

TEVLIGRAF is an immunosuppressant. Following your kidney liver or heart transplant, your body’s immune system will try to reject the new organ. TEVLIGRAF is used to control your body’s immune response, enabling your body to accept the transplanted organ. You may also be given TEVLIGRAF for an ongoing rejection of your transplanted organ when the previous treatment you were taking was unable to control this immune response after your transplantation. TEVLIGRAF is used in adults.

Do not take TEVLIGRAF:

• If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of TEVLIGRAF (listed in section 6).
• If you are allergic to any macrolide antibiotic (e.g. clarithromycin, erythromycin, josamycin).
• If you are pregnant or breastfeeding (see section 4.6).
• If you are taking the oral contraceptive pill, TEVLIGRAF may change how it works. Other forms of contraception should be used e.g. condoms (see Other medicines and TEVLIGRAF).
• With live attenuated vaccines.

Warnings and precautions:

Take special care with TEVLIGRAF: TEVLIGRAF contains the active substance tacrolimus presented in a prolonged-release formulation (delivers the dose over an extended period). TEVLIGRAF is taken once daily and is not interchangeable with other existing medicines containing tacrolimus (immediate release formulations). Tell your doctor if any of the following apply to you:

• If you are taking any medicines mentioned below under Other medicines and TEVLIGRAF.
• If you need to be vaccinated.
• If you feel strong abdominal pain accompanied or not with other symptoms, such as chills, fever, nausea or vomiting.
• If you have diarrhoea for more than one day.
• If you have an alteration of the electrical activity of your heart called QT-prolongation.
• If you experience symptoms like headache, change in behaviour, seizures (body shakes rapidly and uncontrollably) and blurred or disturbed vision.
• If you have or have had liver problems.

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 TEVLIGRAF that you need to receive. If in doubt please consult your doctor prior to taking any herbal products or remedies. Your doctor may need to adjust your dose of TEVLIGRAF.

You should limit your exposure to the sun and UV (ultraviolet) light whilst taking TEVLIGRAF. This is because immunosuppressants could increase the risk of skin cancer. Wear protective clothing and use a sunscreen with a high sun protection factor. You should keep in regular contact with your doctor. From time to time, your doctor may need to do blood, urine, heart, or eye tests, to set the right dose of TEVLIGRAF.

Precaution for handling:

Direct contact with any part of your body like your skin or eyes, or breathing in of the powder contained in the capsules should be avoided. If such contact occurs, wash the skin and eyes.

Children and adolescents:

The use of TEVLIGRAF is not recommended in children and adolescents under 18 years.

Do not share medicines prescribed for you with any other person. Always take TEVLIGRAF exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. TEVLIGRAF should only be prescribed for you by a doctor with experience in the treatment of transplant patients.

Make sure that you receive the same tacrolimus (TEVLIGRAF) medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine. If the appearance of the 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 daily doses just after transplantation will generally be in the range of 0,10 to 0,30 mg per kg body weight per day depending on the transplanted organ. When treating rejection, these same doses may be used. Your dose depends on your general condition and on which other immunosuppressive medicines you are taking. Following the initiation of your treatment with TEVLIGRAF, frequent blood tests will be taken by your doctor to define the correct dose. Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.

TEVLIGRAF is taken orally once daily in the morning. Take TEVLIGRAF 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 following 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.

You will need to take TEVLIGRAF every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor.

If you take more TEVLIGRAF than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take TEVLIGRAF: If you have forgotten to take your TEVLIGRAF capsules in the morning, take them as soon as possible on the same day. Do not take double dose to make up for forgotten individual doses.

If you stop taking TEVLIGRAF: Stopping your treatment with TEVLIGRAF may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor tells you to do so.

TEVLIGRAF can have side effects. Not all side effects reported for TEVLIGRAF are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TEVLIGRAF, please consult your healthcare provider for advice. TEVLIGRAF reduces your body’s defence mechanism (immune system), which will not be as good at fighting infections. Therefore, you may be more prone to infections while you are taking TEVLIGRAF. Some infections could be serious or fatal and may include infections caused by bacteria, viruses, fungi, parasites, or other infections.

Tell your doctor immediately if you get signs of an infection including:

• Fever, cough, sore throat, feeling weak or generally unwell.
• Memory loss, trouble thinking, difficulty walking or loss of vision - these may be due to a less frequent, serious brain infection, which can be fatal (Progressive Multifocal Leukoencephalopathy or PML).

Severe effects may occur, including allergic and anaphylactic reactions. Benign and malignant tumours have been reported following TEVLIGRAF treatment.

If any of the following happens, stop taking TEVLIGRAF and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to TEVLIGRAF. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you have or suspect you may have any of the following serious side effects:

Serious frequent side effects:

• Gastrointestinal perforation: strong abdominal pain accompanied or not with other symptoms, such as chills, fever, nausea or vomiting.
• Insufficient function of your transplanted organ.
• Blurred vision.

Serious less frequent side effects:

• Haemolytic uraemic syndrome, a condition with the following symptoms: low or no urine output (acute renal failure), extreme tiredness, yellowing of the skin or eyes (jaundice) and abnormal bruising or bleeding and signs of infection.
• Thrombotic Thrombocytopenic Purpura (or TTP) a condition characterised by fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute renal failure (low or no urine output).
• Toxic epidermal necrolysis: erosion and blistering of skin or mucous membranes, red swollen skin that can detach in large parts of the body.
• Blindness.
• Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, serious illness with blistering of skin, mouth, eyes and genitals, hives, tongue swelling, red or purple skin rash that spreads, skin shedding.
• Torsades de Pointes: change in the heart frequency that can be accompanied or not of symptoms, such as chest pain (angina), faint, vertigo or nausea, palpitations (feeling the heartbeat) and difficulty breathing.

Serious side effects - frequency is unknown:

• Opportunistic infections (bacterial, fungal, viral and protozoal): prolonged diarrhoea, fever and sore throat.
• Benign and malignant tumours have been reported following treatment as a result of immunosuppression.
• Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown accompanied with tiredness) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported. It is not known exactly how often these side effects occur. You may have no symptoms or depending on the severity of the condition, you may feel: fatigue, apathy, abnormal paleness of the skin (pallor), shortness of breath, dizziness, headache, chest pain and coldness in hands and feet.
• Cases of agranulocytosis (a severely lowered number of white blood cells accompanied with ulcers in the mouth, fever and infections). You may have no symptoms or you may feel sudden fever, rigors and sore throat.
• Posterior Reversible Encephalopathy Syndrome (PRES): headache, confusion, mood changes, fits, and disturbances of your vision. These could be signs of a disorder known as posterior reversible encephalopathy syndrome, which has been reported in some patients treated with TEVLIGRAF.
• Optic neuropathy (abnormality of the optic nerve): problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or restriction of your field of vision. These are all serious side effects. You may need urgent medical attention.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Store in the original package to protect from light and moisture. Do not use after the expiry date stated on the blisters. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).