Envarsus 0.75mg; 1mg; 4mg prolonged-release tablet

Package leaflet: Information for the patient

ENVARSUS® 0.75 mg

ENVARSUS® 1mg

ENVARSUS® 4mg

prolonged-release tablets

Tacrolimus

1. What Envarsus is and what it is used for

Envarsus contains the active substance tacrolimus. It is an immunosuppressant. Following your kidney or liver transplant, your body’s immune system will try to reject the new organ. Envarsus is used to control your body’s immune response, enabling your body to accept the transplanted organ.

You may also be given Envarsus for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.

Envarsus is used in adults.

2. What you need to know before you take Envarsus

3. How to take Envarsus

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

This medicine 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 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 once 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 daily doses just after transplantation will generally be in the range of:

0.11 - 0.17 mg per kg body weight per day depending on the transplanted organ. When treating rejection, the 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 this medicine, 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. Your doctor will usually reduce your Envarsus dose once your condition has stabilised.

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

Envarsus is taken orally once daily, generally on an empty stomach.

Take the tablets immediately following removal from the blister. The tablets should be swallowed whole with a glass of water. Do not swallow the desiccant contained in the foil wrapper.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tacrolimus 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 Envarsus.

Please contact your doctor immediately, should you experience severe effects.

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

Very common side effects (may affect more than 1 in 10 people):

• increased blood sugar, diabetes mellitus, increased potassium in the blood
• difficulty in sleeping
• trembling, headache
• increased blood pressure
• liver function tests abnormal
• diarrhoea, nausea
• kidney problems

Common side effects (may affect up to 1 in 10 people):

• reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests)
• 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 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, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms
• stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting, abdominal pain, indigestion, constipation, passing wind, bloating, loose stools
• bile duct disorders, 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

Uncommon side effects (may affect up to 1 in 100 people):

• changes in blood clotting, reduction in the number of all types of blood cells (seen in blood tests)
• dehydration, inability to urinate
• abnormal blood test results: reduced protein or sugar, increased phosphate, increase of the enzyme lactate dehydrogenase
• coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems
• clouding of the eye lens, 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 contents in your throat, delayed emptying of the stomach
• inflammation of the skin, burning sensation in the sunlight
• joint disorders
• painful menstruation and abnormal menstrual bleeding
• multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, weight loss

Rare side effects (may affect up to 1 in 1,000 people):

• Small bleedings 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 side effects (may affect up to 1 in 10,000 people):

• Muscular weakness
• Abnormal heart scan
• Liver failure
• Painful urination with blood in the urine
• Increase of fat tissue

Unknown frequencies side effects (may affect less than 1 in 10,000 people):

• Cases of pure red cell aplasia (a very severe reduction in red blood cell counts),
• agranulocytosis (a severely lowered number of white blood cells)
• haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown)
• Febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever)
• Abnormality of the optic nerve (optic neuropathy)

5. How to store Envarsus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and wrapper after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original aluminium foil wrapper in order to protect from light.

Use all the prolonged-release tablets within 45 days of opening the aluminium wrapping.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information