0.75 mg prolonged-release tablet is, 1 mg prolonged-release tablet is, 4 mg prolonged-release tablet is 
tacrolimus

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Envarsus is and what it is used for 
2. What you need to know before taking Envarsus 
3. How to take Envarsus 
4. Possible side effects 
5. How to store Envarsus 
6. Contents of the packaging and other information 

1. What Envarsus is and what it is used for

Envarsus contains the active substance tacrolimus. It is an immunosuppressive agent. After the kidney or liver transplant, the body’s immune system tries to repel the new organ.

Envarsus is used to control the body’s immune response so that the body can accept the transplanted organ.

You can also receive Envarsus for an ongoing rejection reaction of your transplanted liver, kidney, heart, or another organ when the previous treatment you have received has not been able to control the immune response after your transplant.

Envarsus is used in adults.

2. What you need to know before taking Envarsus

Do not take Envarsus:

  • if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to sirolimus or any macrolide antibiotic (eg erythromycin, clarithromycin, josamycin).

Warnings and cautions

Envarsus contains the active substance tacrolimus which is added in a prolonged-release formulation. Envarsus is taken once daily and can not be replaced with other existing medicines containing tacrolimus (immediate release or prolonged-release formulation) on the same dose.

Talk to a doctor before taking Envarsus:

  • if you have or have had liver problems.
  • if you have diarrhea for more than one day.
  • if you are taking any of the medicines mentioned under “Other medicines and Envarsus”.
  • if you have a change in the electrical activity of the heart, so-called QTprolongation.

Contact your doctor immediately if you suffer from:

  • problems with your vision such as blurred vision, changes in color vision, difficulty seeing details, or if your field of vision becomes limited.
  • severe abdominal pain with or without other symptoms, such as chills, fever, nausea, or vomiting.
  • an infection that leads to kidney problems or symptoms of the nervous system.
  • headache, altered mental status, seizures, and visual disturbances.
  • weakness, change of skin or eye color, prone to bruising, infection, cough, anemia ( anemia ).

Your doctor may need to adjust the dose of Envarsus or decide to stop taking tacrolimus.

You should keep in regular contact with your doctor. Sometimes your doctor may need to perform tests on blood, urine, heart, or eyes to set the correct dose of Envarsus.

Avoid exposing yourself to the sun and UV (ultraviolet) light whilst taking Envarsus. This is because immunosuppressive agents may increase the risk of skin cancer. Wear protective clothing and use sunscreen with a high protection factor.

Children and young people

The use of Envarsus is not recommended for children and adolescents under 18 years of age.

Other medicines and Envarsus

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal remedies.

It is not recommended to take Envarsus with ciclosporin (another medicine used to prevent transplant rejection).

Tell your doctor if you have hepatitis C. Your liver function may change when you treat hepatitis C and this may affect the amount of tacrolimus in your blood. Your doctor may need to closely monitor the level of tacrolimus in your blood and adjust the dose after you start treatment for hepatitis C.

The amount of Envarsus in your blood may be affected by other medicines you are taking, and the number of other medicines in your blood may be affected by you taking Envarsus, which may require you to stop treatment or increase or decrease the dose of Envarsus. In particular, you should tell your doctor if you are taking or have recently taken medicines such as:

  • antifungal drugs and antibiotics, in particular, so-called macrolide antibiotics, used to treat infections (eg ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole and isavuconazole, erythromycin, clarithromycin, josamycin, isoniazid, and rifampicin)
  • letermovir, which is used to prevent diseases caused by CMV ( cytomegalovirus in humans)
  • HIV – protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir), and booster medicine cobicistat combination tablets used to treat HIV – infection
  • HCV – protease inhibitors (eg telaprevir, boceprevir, and the combination of ombitasvir / paritaprevir/ritonavir with or without dasabuvir) used to treat hepatitis C
  • nilotinib and imatinib (used to treat certain cancers)
  • mycophenolic acid, which is used to suppress the immune system to prevent rejection of the transplanted organ
  • medicines for stomach ulcers and reflux of stomach acid (eg omeprazole, lansoprazole, or cimetidine)
  • antiemetics used to treat nausea and vomiting (eg metoclopramide)
  • cisapride or the antacid magnesium- aluminum hydroxide used to treat heartburn
  • birth control pills or other hormone treatments with Ethinyl estradiol, hormone treatments with danazol
  • medicines used to treat high blood pressure or heart problems (eg nifedipine, nicardipine, diltiazem, and verapamil)
  • antiarrhythmic substances (eg amiodarone ) used to control arrhythmia (irregular heartbeat)
  • medicines called statins used to treat elevated cholesterol and triglyceride s
  • phenytoin or phenobarbital used to treat epilepsy
  • prednisolone and methylprednisolone, which belong to the class of corticosteroids and are used to treat inflammation or suppress the immune system (eg in transplant rejection)
  • carbamazepine used to prevent and control seizures
  • metamizole used to treat pain and high fever
  • nefazodone used to treat depression
  • herbal preparations containing St. John’s wort ( Hypericum perforatum )

Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation, and pain), amphotericin B (used to treat fungal infections), antibiotics(used to treat bacterial infections, eg aminoglycosides, vancomycin, or clotrimazole), or antiviral agents (used to treat viral infections such as aciclovir). These can aggravate problems with the kidneys or nervous system if taken with Envarsus.

While taking Envarsus, your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, high blood pressure, and kidney disease (eg amiloride, triamterene, or spironolactone ), non-steroidal anti-inflammatory drugs ( NSAIDs ), for example. ibuprofen ) is used for fever, inflammation, and pain, anticoagulants (blood thinners), or drugs for diabetes taken by mouth.

If you need to be vaccinated, tell your doctor before receiving the vaccine.

Envarsus with food and drink

Avoid grapefruit (also as a juice) while you are being treated with Envarsus, as it may affect your blood levels.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Tacrolimus is excreted in human milk. Therefore, you should not breast-feed while taking Envarsus.

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or sleepy, or have difficulty seeing clearly after taking Envarsus. These effects are more common if you also drink alcohol.

Envarsus contains lactose

Envarsus contains lactose (milk sugar).

  • Envarsus 0.75 mg tablets: 41.7 mg
  • Envarsus 1 mg tablets: 41.7 mg
  • Envarsus 4 mg tablets: 104 mg

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Envarsus

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

This medicine should only be prescribed to you by a doctor who has experience in treating patients who have had a transplant.

Important information

Make sure you get the same tacrolimus medicine every time you pick up your prescription unless your transplant specialist has agreed with you to change to another tacrolimus medicine.

This medicine should be taken once daily. If the medicine does not look like it is normal, or if the dose instructions have been changed, talk to your doctor or pharmacist as soon as possible to make sure you are getting the right medicine.

How much Envarsus should I take?

The starting dose to prevent rejection of your transplanted organ is determined by your doctor based on your body weight.

The initial daily dose just after the transplant is usually in the range: 0.11–0.17 mg per kg body weight per day, depending on the transplanted organ. When treating rejection, the same dose can be used.

Dose one depends on your general condition and what other immunosuppressive drugs you are taking. After starting your treatment with this medicine, your doctor will perform frequent blood tests to determine the correct dose. Thereafter, the doctor needs to do regular blood tests to determine the correct dose and adjust the dose occasionally. The doctor will usually reduce your Envarsus- dose once your condition has stabilized.

How should I take the Envarsus tablets?

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

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

How long should I take the Envarsus tablets?

You must take Envarsus every day for 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 Envarsus then you should

If you have taken too much Envarsus, contact your doctor or nearest emergency department immediately.

If you forget to take Envarsus

Do not take a double dose to make up for a forgotten tablet. Take the tablet as soon as possible on the same day.

If you stop taking Envarsus

Termination of treatment with Envarsus may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor has told you to.

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

4. Possible side effects

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

Tacrolimus weakens the body’s defense mechanism (immune system), which will not be as good at fighting infections. Therefore, it may be easier for you to get an infection while you are taking Envarsus.

Contact your doctor immediately if you get serious side effects.

Serious side effects may occur, including allergic and anaphylactic reactions. Benign and malignant tumors have been reported after treatment with Envarsus.

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

  • Elevated blood sugar, diabetes mellitus, elevated potassium in the blood
  • Sleeping problems
  • Shaking, headache
  • High blood pressure
  • Abnormal liver function tests
  • Diarrhea, nausea
  • Kidney problems

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

  • Decreased number of blood cells ( platelets, red or white blood cells), increased number of white blood cells, altered number of red blood cells (seen in blood tests)
  • Decreased amount of magnesium, phosphate, potassium, calcium, or sodium in the blood, fluid overload, increased amount of uric acid or lipids in the blood, decreased appetite, loss of appetite, increased acidity in the blood, other changes in blood salts (seen in blood tests)
  • Anxiety symptoms, confusion, and disorientation, depression, mood swings, nightmares, hallucinations, mental disorders
  • Seizures, disturbances of consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, disorders of the nervous system
  • Blurred vision, increased photosensitivity, eye problems
  • Ringing sound in the ears
  • Reduced blood flow in the heart vessels, faster heartbeat
  • Bleeding, partial or complete blockage of blood vessels decreased blood pressure
  • Shortness of breath, diseases of the lung tissues, accumulation of fluid around the lungs, inflammation of the throat, cough, flu-like symptoms
  • Stomach problems such as inflammation or sores that cause abdominal pain or diarrhea, bleeding in the stomach, inflammation or sores in the mouth, accumulation of fluid in the abdomen, vomiting, abdominal pain, indigestion, constipation, gas, bloated stomach, loose stools
  • Disorders of the bile duct, yellowish skin due to liver problems, damage to liver tissue, and inflammation of the liver
  • Itching, rash, hair loss, acne, increased sweating
  • Pain in joints, limbs, or back, muscle cramps
  • Insufficient renal function, decreased urine output, impaired or painful urination
  • General weakness, fever, accumulation of fluid in the body, pain, and discomfort, increased amount of enzyme and alkaline phosphatase in the blood, weight gain, disturbed perception of body temperature
  • The insufficient function of the transplanted organ

Less common side effects are (may affect up to 1 in 100 people):

  • Changes in blood coagulation decreased the number of all types of blood cells (seen in blood tests)
  • Dehydration, inability to urinate
  • Psychotic behaviors, such as delusions, hallucinations, and confusion
  • Abnormal blood test results: decrease in protein or sugar, increase in phosphate, increase in enzyme and lactate dehydrogenase
  • Coma, bleeding in the brain, stroke, paralysis, disturbance in the brain, abnormal speech and language, memory problems
  • The blurring of the lens of the eye, partial or total inability to hear
  • Irregular heartbeat, heart failure, impaired heart function, heart muscle disease, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, abnormal heart rate, and heart rate
  • A blood clot in a friend in arm or leg, shock
  • Breathing difficulties, respiratory diseases, asthma
  • Acute or chronic inflammation of the pancreas, inflammation of the mucous membrane on the inside of the abdominal wall, blockage in the intestine, increased amount of enzyme and amylase in the blood, reflux of stomach contents up into the pharynx, slower emptying of the stomach
  • Inflammation of the skin, burning sensation in sunlight
  • Diseases of the joints
  • Painful menstruation and abnormal menstrual bleeding
  • Multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure in the chest, nervousness or abnormal feeling, weight loss

Rare side effects are (may affect up to 1 in 1000 people):

  • Minor bleeding in the skin due to blood clot
  • Increased stiffness in the muscles
  • Blindness, deafness
  • Accumulation of fluid around the heart
  • Acute shortness of breath
  • Cyst formation in the pancreas, a precursor to intestinal obstruction
  • Problems with blood flow in the liver
  • Severe disease with blisters on the skin, mouth, eyes, and genitals
  • Increased hair
  • Thirst falls, feeling of tightness in the chest, reduced mobility, sores

Very rare side effects are (may affect up to 1 in 10,000 people):

  • Muscle weakness
  • Impaired hearing
  • Abnormal results on ultrasound examination of the heart
  • Liver failure
  • Painful urination with blood in the urine
  • Increase in adipose tissue

Has been reported (occurs in an unknown number of people):

  • Cases of pure erythrocyte plasma (a very severe decrease in red blood cell count)
  • Agranulocytosis (a sharp decrease in white blood cell count)
  • Hemolytic anemia (decreased number of red blood cells due to abnormal degradation)
  • Febrile neutropenia (a decrease in the white blood cells that fight infection, along with fever)
  • Visual nerve damage ( 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 EXP: EXP: / EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Store in the original cover in aluminum foil. Sensitive to light.

Use all prolonged-release tablets within 45 days of opening the aluminum cover.

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

6. Contents of the packaging and other information

Content declaration

  • The active substance is tacrolimus.

    Envarsus 0.75 mg prolonged-release tablet isOne prolonged-release tablet contains 0.75 mg tacrolimus (as monohydrate).
    Envarsus 1 mg prolonged-release tablet is one prolonged-release tablet contains 1 mg tacrolimus (as monohydrate).
    Envarsus 4 mg prolonged-release tablet is one prolonged-release tablet contains 4 mg tacrolimus (as monohydrate).
  • The other ingredients are hypromellose, lactose monohydrate, macrogol 6000, poloxamer 188, magnesium stearate, tartaric acid (E334), butylhydroxytoluene (E321), dimethicone 350.

What the medicine looks like and the contents of the pack

Envarsus 0.75 mg prolonged-release tablets are oval, white to off-white uncoated tablets, debossed with “0.75” on one side and “TCS” on the other.

Envarsus 1 mg prolonged-release tablets are oval, white to off-white uncoated tablets, debossed with “1” on one side and “TCS” on the other.

Envarsus 4 mg prolonged-release tablets are oval, white to off-white uncoated tablets, debossed with “4” on one side and “TCS” on the other.

Envarsus is supplied in PVC / aluminum blisters containing 10 tablets. 3 blisters are packed together in a protective cover of aluminum foil, including a desiccant. Packs of 30, 60, and 90 prolonged-release tablets are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chiesi Farmaceutici SpA

Via Palermo, 26 / A

43122 Parma

Italy

Manufacturer

Rottendorf Pharma GmbH

Ostenfelder Straβe 51 – 61

59320 Ennigerloh

Germany

or

Chiesi Farmaceutici SpA

Via San Leonardo 96

43122 Parma

Italy

or

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Vienna

Austria

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienChiesi sa / nvTel: + 32 (0) 2 788 42 00 LithuaniaChiesi Pharmaceuticals GmbHTel: +43 1 4073919
BulgariaChiesi Bulgaria EOODTel: + 359 29201205 Luxembourg / LuxemburgChiesi sa / nvTel: + 32 (0) 2 788 42 00
Czech RepublicChiesi CZ sroTel: +420 261221745 HungaryChiesi Hungary Kft.Tel .: + 36-1-429 1060
DenmarkChiesi Pharma ABTel: +46 8 753 35 20 MaltaChiesi Farmaceutici SpATel: + 39 0521 2791
GermanyChiesi GmbHTel: + 49 40 89724-0 The NetherlandsChiesi Pharmaceuticals BVTel: + 31 0 88 5016400
EestiChiesi Pharmaceuticals GmbHTel: +43 1 4073919 NorwayChiesi Pharma ABTel: +46 8 753 35 20
GreeceChiesi Hellas AEBE:Ηλ: + 30 210 6179763 AustriaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919
SpainChiesi España, SAUTel: + 34 93 494 8000 PolandChiesi Poland Sp. ZooTel .: + 48 22 620 1421
FranceChiesi SASTel: + 33 1 47688899 PortugalChiesi Farmaceutici SpATel: + 39 0521 2791
CroatiaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 RomaniaChiesi Romania SRLTel: + 40 212023642
IrelandChiesi Farmaceutici SpATel: + 39 0521 2791 SloveniaChiesi Slovenija dooTel: + 386-1-43 00 901
IcelandChiesi Pharma ABTel: +46 8 753 35 20 Slovak RepublicChiesi Slovakia sroTel: + 421 259300060
ItalyChiesi Farmaceutici SpATel: + 39 0521 2791 Finland / FinlandChiesi Pharma ABTel: +46 8 753 35 20
LatviaChiesi Pharmaceuticals GmbHTel: + + 43 1 4073919 United KingdomChiesi LtdTel: + 44 0161 4885555

Muhammad Nadeem

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