Patient Information
Entoris
(budesonide) (bew DEH so nide) extended release tablets
What are Entoris extended release tablets?
Entoris is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis (UC) under control (induce remission).
It is not known if Entoris is safe and effective in children.
Who should not take Entoris extended release tablets?
Do not take Entoris extended release tablets if:
you are allergic to budesonide or any of the ingredients in Entoris extended release tablets. See the end of this leaflet for a complete list of ingredients in Entoris extended release tablets.
What should I tell my healthcare provider before taking Entoris extended release tablets?
Before you take Entoris extended release tablets tell your healthcare provider if you:
have liver problems
are planning to have surgery
have chickenpox or measles or have recently been near anyone with chickenpox or measles
have an infection
have or had a family history of diabetes, cataracts or glaucoma
have or had tuberculosis
have high blood pressure (hypertension)
have decreased bone mineral density (osteoporosis)
have stomach ulcers
have any other medical condition
are pregnant or plan to become pregnant. It is not known if Entoris extended release tablets will harm your unborn baby.
are breastfeeding or plan to breastfeed. Entoris extended release tablets can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Entoris extended release tablets or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter vitamins, and herbal supplements. Entoris extended release tablets and other medicines may affect each other causing side effects.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Entoris extended release tablets?
Take Entoris extended release tablets exactly as your healthcare provider tells you to take them.
Your healthcare provider will tell you how many Entoris extended release tablets to take.
Take Entoris extended release tablets in the morning.
Take Entoris extended release tablets whole with water. Do not chew, crush, or break Entoris extended release tablets before swallowing.
If you take too much of Entoris, call your healthcare provider right away or go to the nearest hospital emergency room.
What should I avoid while taking Entoris extended release tablets?
Do not eat grapefruit or drink grapefruit juice while taking Entoris extended release tablets. Eating grapefruit or drinking grapefruit juice can increase the level of Entoris extended release tablets in your blood.
What are the possible side effects of Entoris extended release tablets?
Entoris can cause some serious side effects, including:
Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of Entoris extended release tablets can cause you to have too much glucocorticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:
oacne
obruise easily
orounding of your face (moon face)
oankle swelling
othicker or more hair on your body and face
oa fatty pad or hump between your shoulders (buffalo hump)
opink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms
Adrenal suppression. When Entoris extended release tablets is taken for a long period of time (chronic use), the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with Entoris extended release tablets including:
otiredness
oweakness
onausea
ovomiting
olow blood pressure
Immune system effects and a higher chance of infections.
Entoris extended release tablets weaken your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles, while taking Entoris extended release tablets.
Tell your health care provider about any signs or symptoms of infection during treatment with Entoris extended release tablets, including:
ofever
opain
oaches
ochills
ofeeling tired
onausea and vomiting
Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to Entoris extended release tablets may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse while taking Entoris extended release tablets.
The most common side effects of Entoris extended release tablets include:
headache
nausea
decreased blood cortisol levels
stomach-area pain
tiredness
stomach or intestinal gas
bloating
acne
urinary tract infection
joint pain
constipation
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Entoris extended release tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Entoris extended release tablets?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep the bottle tightly closed to protect Entoris from light and moisture.
Keep out of reach of children
General Information about Entoris extended release tablets
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Entoris for a condition for which it was not prescribed. Do not give Entoris to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Entoris that is written for health professionals.
For more information go to www.Entoris.com or call 1-800-321-4576.
What are the ingredients in Entoris extended release tablets?
Active Ingredients: budesonide
Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Taj Pharma India