Envarsus 1mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tacrolimus monohydrate

Available from:

Chiesi Ltd

ATC code:

L04AD02

INN (International Name):

Tacrolimus monohydrate

Dosage:

1mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020200; GTIN: 5028613002940

Patient Information leaflet

ENVARSUS
®
0.75 MG
ENVARSUS
®
1MG
ENVARSUS
® 4MG
PROLONGED-RELEASE TABLETS
TACROLIMUS
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EXAMPLE AF TER FOLDING
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160
ITEM CHIESI
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BAR - CODE
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37,5
37,5
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. 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 pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Envarsus is and what it is used for
2. What you need to know before you take
Envarsus
3. How to take Envarsus
4. Possible side effects
5. How to store Envarsus
6. Contents of the pack and other information
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
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 to any
macrolide-antibiotic (e.g. erythromycin,
clarithromycin, josamycin).
WARNINGS AND PRECAUTIONS
Envarsus contains the active substance
tacrolimus presented in a prolonged release
formulation. Envarsus is taken once daily a

Summary of Product characteristics

OBJECT 1
ENVARSUS 0.75MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 20-Apr-2016 | Chiesi
Limited
1. Name of the medicinal product
Envarsus 0.75 mg prolonged-release tablets
Envarsus 1 mg prolonged-release tablets
Envarsus 4 mg prolonged-release tablets
2. Qualitative and quantitative composition
Envarsus 0.75 mg prolonged-release tablets
Each prolonged-release tablet contains 0.75 mg tacrolimus (as
monohydrate).
Excipient with known effect:
Each tablet contains 41.7 mg lactose (as monohydrate).
Envarsus 1 mg prolonged-release tablets
Each prolonged-release tablet contains 1 mg tacrolimus (as
monohydrate).
Excipient with known effect:
Each tablet contains 41.7 mg lactose (as monohydrate).
Envarsus 4 mg prolonged-release tablets
Each prolonged-release tablet contains 4 mg tacrolimus (as
monohydrate).
Excipient with known effect:
Each tablet contains 104 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
0.75 mg:
Oval, white to off-white uncoated tablet, debossed with “0.75“ on
one side and “TCS“ on the other
side.
1 mg:
Oval, white to off-white uncoated tablet, debossed with “1“ on one
side and “TCS“ on the other side.
4 mg:
Oval, white to off-white uncoated tablet, debossed with “4“ on one
side and “TCS“ on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of transplant rejection in adult kidney or liver allograft
recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal products
in adult patients.
4.2 Posology and method of administration
Envarsus is a once-a-day oral formulation of tacrolimus. Envarsus
therapy requires careful monitoring by
adequately qualified and equipped personnel. This medicinal product
should only be prescribed, and
changes in immunosuppressive therapy be initiated, by physicians
experienced in immunosuppressive
therapy and the management of transplant patients.
Inadvertent, unintentional, or unsuper