Talomune 0,5 mg Capsules

TALOMUNE contains a medicine called tacrolimus. Which belongs to the class of medicines called immunosuppressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

TALOMUNE is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant.

You should not take TALOMUNE:

• If you are hypersensitive (allergic) to tacrolimus or any of the other ingredients of TALOMUNE (listed in section 6).
• If you are pregnant or breastfeeding your baby.
• If you are taking oral contraceptives (birth control). You should take other forms of birth control.
• If you received a live vaccine.
• If you are receiving ciclosporin (used in organ transplants).
• If you are drinking grapefruit juice.

Warnings and precautions

Take special care with TALOMUNE:

• If you are younger than 18 years old since there is limited date on safety and/or efficacy.
• If you are taking St. John’s Wort (Hypericum peforatum) or other herbal medicines (see Other medicines and TALOMUNE).
• If you have a disease called tuberculosis (usually affecting the lungs). Before you receive TALOMUNE you should be tested for tuberculosis.

TALOMUNE can cause serious side effects, including:

• Increased risk of cancer: People who take TALOMUNE have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
• Increased risk of infection: TALOMUNE is a medicine that affects your immune system. TALOMUNE can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving TALOMUNE that can cause death. Call your doctor right away if you have symptoms of an infection including fever, muscle aches, warm, red, or painful areas on your skin, fever, sweats or chills, cough or flu-like symptoms.

Before you take TALOMUNE, tell your healthcare provider about all of your medical conditions, including if you:

• plan to receive any live vaccines. People taking TALOMUNE should not receive live vaccines.
• have or have had liver problems.
• have or have had kidney problems.
• have or have had heart problems.

Do not share medicines prescribed for you with any other person.

Always take TALOMUNE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many TALOMUNE capsules to take and when to take them. Your doctor may change your TALOMUNE dose if needed.

The capsules should be swallowed with fluid, preferably water. TALOMUNE capsules should be taken on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal to achieve maximal absorption. Take TALOMUNE capsules at the same time each day. Taking TALOMUNE capsules at the same time each day helps to keep the amount of medicine in your body at a steady level.

The capsules should be taken out of the blister only immediately before intake. Do not open or crush TALOMUNE capsules. Do not eat grapefruit or drink grapefruit juice while taking TALOMUNE capsules.

What should I avoid while taking TALOMUNE capsules?

While you take TALOMUNE capsules you should not receive any live vaccines. Limit the amount of time you spend in sunlight and avoid exposure to ultraviolet (UV) light, such as tanning machines. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF).

If you take more TALOMUNE than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of acute overdose may include trembling, abnormal kidney function, hypertension, and swelling of the lower legs or ankles.

If you forget to take TALOMUNE

Do not take a double dose to make up for forgotten individual doses.

If you stop taking TALOMUNE

Do not stop taking or change your dose of TALOMUNE capsules without talking to your healthcare provider. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

TALOMUNE can have side effects. Not all side effects reported for TALOMUNE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TALOMUNE, please consult your health care provider for advice.

If any of the following happens, stop taking TALOMUNE and tell your doctor or nurse 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.

If you have them, you may have had an allergic reaction to TALOMUNE. Your doctor or nurse will stop the treatment and assist you with the adverse effects.

Tell your doctor immediately if you notice any of the following:

Frequent:

• problems from medicine errors. People who take tacrolimus have sometimes been given the wrong type of tacrolimus medicine. Check your TALOMUNE when you get a new prescription and before you take it to make sure you have received the correct TALOMUNE capsule. Check with the pharmacist and call your healthcare provider if you think you were given the wrong medicine.
• high blood sugar (diabetes). Your healthcare provider may do blood tests to check for diabetes while you take TALOMUNE. Call your healthcare provider right away if you have any symptoms of high blood sugar, including: frequent urination, increased thirst or hunger, blurred vision, confusion, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, or stomach pain.
• kidney problems. Your healthcare provider may do blood tests to check your kidney function while you take TALOMUNE.
• nervous system problems. Call your healthcare provider right away if you get any of these symptoms while taking TALOMUNE. These could be signs of a serious nervous system problem: headache, confusion, seizures, change in your vision, changes in behaviour, coma, tremors, numbness and tingling.
• high levels of potassium in your blood. Your healthcare provider may do blood tests to check your potassium level while you take TALOMUNE.
• high blood pressure. Your healthcare provider will monitor your blood pressure while you take TALOMUNE and may prescribe blood pressure medicine for you, if needed. Your healthcare provider may instruct you to check your blood pressure at home.
• severe low red blood cell count (anaemia).

Frequency unknown:

• changes in the electrical activity of your heart (QT prolongation).
• heart problems (myocardial hypertrophy). Tell your healthcare provider right away if you get any of these symptoms of heart problems while taking TALOMUNE: shortness of breath, chest pain, feel lightheaded, feel faint.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent

• infections in general, including cytomegalovirus (CMV) infection,
• tremors (shaking of the body),
• constipation,
• diarrhoea,
• headache,
• stomach pain,
• trouble sleeping,
• nausea,
• high blood sugar (diabetes),
• low levels of magnesium in your blood,
• low levels of phosphate in your blood,
• swelling of the hands, legs, ankles, or feet,
• weakness,
• pain,
• high levels of fat in your blood,
• high levels of potassium in your blood,
• low red blood cell count (anemia),
• low white blood cell count,
• fever,
• numbness or tingling in your hands and feet,
• inflammation of your airway (bronchitis),
• fluid around your heart.

Less frequent

• 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,
• 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,
• increased hairiness,
• thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer,
• muscular weakness,
• echocardiogram abnormal, liver failure, narrowing of the bile vessel,
• painful urination with blood in the urine,
• increase of fat tissue.

Not known (frequency cannot be estimated from the available data):

• weight decrease,
• fainting,
• respiratory distress,
• mouth ulcers,
• fatty liver,
• hot flushes,
• multi-organ failure,
• transplant rejection.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of TALOMUNE.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Store in the original package until required for use.
• HDPE Bottles: Keep the bottle tightly closed.
• Blisters: Do not remove blisters from carton until required for use.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).