RYEQO 40/1/0.5 relugolix 40 mg/estradiol 1 mg/norethisterone acetate 0.5 mg film coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

relugolix, Quantity: 40 mg; estradiol, Quantity: 1 mg (Equivalent: estradiol hemihydrate, Qty 1.032 mg); norethisterone acetate, Quantity: 0.5 mg

Available from:

Gedeon Richter Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; sodium starch glycollate type A; magnesium stearate; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; triacetin; iron oxide yellow

Administration route:

Oral

Units in package:

28 tablets, 3 x 28 tablets (84 tablets total)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ryeqo is indicated in adult women of reproductive age for:,? treatment of moderate to severe symptoms of uterine fibroids,,?symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (see section 5.1 PHARMACODYNAMIC PROPERTIES).

Product summary:

Visual Identification: Round, light yellow to yellow, film-coated tablet, debossed on one side with "415".; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-09-06

Patient Information leaflet

RYEQO
1
RYEQO®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details. [Include if
applicable]
1.
WHY AM I USING RYEQO?
RYEQO contains the active ingredients relugolix, estradiol hemihydrate
and norethisterone acetate. RYEQO® is used to treat
moderate to severe symptoms of uterine fibroids (commonly known as
myomas).
For more information, see Section 1. Why am I using RYEQO? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RYEQO?
Do not use if you have ever had an allergic reaction to RYEQO or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
RYEQO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RYEQO and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE RYEQO?
•
Take one tablet each day.
•
The tablet must be taken orally every day, at about the same time,
with or without food with a little liquid.
More instructions can be found in Section 4. How do I use RYEQO? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RYEQO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
RYEQO.
•
Tell your doctor if you have any medical conditions, take any
medicines for any other condition, or are
planning on having surgery.
•
Tell your doctor if you become pregnant whilst using RYEQO.
THINGS YOU
SHOULD NOT DO
•
Do not stop using RYEQO before talking to your doctor first.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how RYEQO affects you.
•

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