RELUEASE Tablet 10's

Introduction About RELUEASE TABLET

Reluease contains the active substances relugolix, estradiol and norethisterone acetate. Reluease used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb).

Relugolix works by reducing the production of ovarian hormones that stimulate fibroid activity, while estradiol and norethisterone acetate help maintain estrogen levels within an appropriate range to support bone health and reduce the likelihood of low-estrogen-related symptoms during therapy. This combination offers a balanced hormonal approach for women who require medical management of fibroid-related symptoms under specialist supervision.

RELUEASE Tablet is generally recommended for premenopausal adult women who have been diagnosed with uterine fibroids and whose symptoms affect their daily activities or quality of life. The tablet should be swallowed whole with water once daily, with or without food, preferably at the same time each day. Do not crush, chew, or split the tablet. Continue taking the medicine for the duration advised by your gynecologist, even if symptoms improve. Regular follow-up visits may be recommended to evaluate symptom control, monitor bone health, and assess the ongoing need for therapy.

Before starting RELUEASE Tablet, inform your healthcare professional if you have a history of blood clots, stroke, heart disease, liver disease, hormone-sensitive cancers, osteoporosis, unexplained vaginal bleeding, high blood pressure, migraine with aura, or smoking, particularly if you are over 35 years of age. The medicine should be used only under medical supervision, and regular monitoring may be advised during treatment.

 Common side effects include hot flushes, headache, excessive sweating, irregular or reduced menstrual bleeding, hair thinning, mood changes, decreased sexual desire, and joint pain. Many of these effects are mild and improve as the body adjusts to treatment.

RELUEASE Tablet is not recommended during pregnancy or breastfeeding. Pregnancy should be excluded before starting therapy, and patients should use effective non-hormonal contraception during treatment and for the period recommended by their healthcare professional after stopping the medicine. If pregnancy is suspected, discontinue the medicine only after consulting your healthcare professional.

Seek prompt medical attention if you experience severe chest pain, sudden shortness of breath, swelling or pain in one leg, vision changes, severe headache, jaundice, or signs of an allergic reaction.

Uses Of RELUEASE TABLET

• Reluease is indicated for the management of heavy menstrual bleeding associated with uterine Leiomyomas (Fibroids) in premenopausal women.

Benefits of RELUEASE TABLET

Helps Reduce Heavy Menstrual Bleeding

• Helps significantly reduce menstrual blood loss associated with uterine fibroids.
• May improve daily functioning by reducing excessive menstrual bleeding.
• Supports better quality of life in women experiencing fibroid-related symptoms.

Helps Improve Fibroid-Related Symptoms

• Helps reduce symptoms such as pelvic discomfort, pelvic pressure, and menstrual pain associated with uterine fibroids.
• May improve comfort during routine daily activities.

Supports Maintenance of Bone Health

• The estradiol component helps maintain estrogen levels during treatment.
• Helps reduce the likelihood of bone mineral density loss that may occur with relugolix alone.
• Norethisterone acetate complements estradiol as part of hormone add-back therapy.

Provides Long-Term Medical Management

• Offers a non-surgical treatment option for women whose healthcare professional considers medical management appropriate.
• May reduce the need for repeated interventions in selected patients under specialist supervision.

Convenient Once-Daily Therapy

• Taken as a single oral tablet once daily.
• Provides consistent hormone suppression and hormone replacement with regular daily use.

How RELUEASE TABLET Works

• This medicine contains Relugolix, which blocks certain receptors in the brain and this reduces the production of hormones that in turn stimulate the ovaries to produce estradiol and progesterone.
• When blocked, the levels of estrogen and progesterone circulating in the body are reduced.
• This medicine also contains two types of female hormones, estradiol which belongs to a group of medicines called estrogens and norethisterone which belongs to a group of medicines called progestogens.
• The inclusion of these hormones in Reluease maintains a hormonal state similar to the beginning of your menstrual cycle and thus relieves your symptoms while helping to protect the strength of your bones.

How to use RELUEASE TABLET

How to Take

• It is recommended that you start taking Reluease within the first 7 days after the start of bleeding due to your period.
• If you start at another time of your menstrual cycle, you may initially experience irregular or heavier bleeding.
• Take one tablet once daily, exactly as prescribed.
• Swallow the tablet whole with a glass of water.
• Do not crush, chew, or break the tablet.
• It may be taken with or without food.
• Take it at approximately the same time every day to maintain consistent medicine levels.

During Treatment

• Continue treatment for the full duration recommended by your healthcare professional.
• Do not stop the medicine without medical advice, even if symptoms improve.
• Attend scheduled follow-up appointments to monitor symptom improvement and bone health.
• Your healthcare professional may periodically assess blood pressure and, if needed, bone mineral density.

What if I forgot to take RELUEASE TABLET

• If you miss one tablet, take it as soon as you remember and then resume taking your tablet the next day as usual. Do not take a double dose to make up for a forgotten tablet.
• If you miss two or more tablets in a row, consult with your doctor and use a nonhormonal contraceptive (e.g. condoms) for the next 7 days of treatment.

Overdose

• There have been no reports of serious harmful effects from taking several doses of this medicine at once.
• Large doses of estrogen may cause nausea and vomiting, and vaginal bleeding.
• If you have taken too many Reluease tablets ask your doctor or pharmacist for advice.

Side Effects Of RELUEASE TABLET

Common

• hot flush
• hyperhidrosis or night sweats
• uterine bleeding
• alopecia
• decreased libido.

Warning & Precautions

Other Warnings for RELUEASE TABLET

Before Taking inform your doctor if you have:

• history of blood clots, stroke
• osteoporosis
• hormone-sensitive cancers
• migraine with aura
• diabetes

Who should not take RELUEASE TABLET

• osteoporosis.
• if you suffer from headaches with focal neurological symptoms such as paralysis or loss of muscle control, or migraines with visual disturbance.
• any type of cancer which might be made worse by exposure to female sex hormones, such as cancer of the breast or the genital organs.
• if you have any genital bleeding of unknown origin.
• if you are taking hormonal contraception (for example birth control pills) and unwilling to discontinue its use.

Safety Advice

• Maintain adequate calcium and vitamin D intake if recommended by your healthcare professional.
• Follow a balanced diet and regular physical activity to support bone health.
• Report any unusual vaginal bleeding, severe headache, chest pain, shortness of breath, or leg swelling immediately.
• Keep all follow-up appointments during therapy.

Drug - Drug interaction

1. P-glycoprotein (P-gp) Inhibitors

These medicines can increase relugolix levels in the body.

Examples:

• Clarithromycin
• Erythromycin
• Verapamil
• Amiodarone

Possible Effect:

• Increased exposure to relugolix.
• Higher likelihood of treatment-related adverse effects.

2. P-glycoprotein (P-gp) Inducers

These medicines may reduce relugolix concentrations.

Examples:

• Rifampicin (Rifampin)
• Carbamazepine
• Phenytoin
• Phenobarbital
• St. John's Wort

Possible Effect:

• Reduced effectiveness of RELUEASE Tablet.
• Decreased suppression of ovarian hormone production.

3. Hormonal Contraceptives

Examples:

• Combined oral contraceptive pills
• Hormonal patches
• Hormonal vaginal rings

Possible Effect:

• May interfere with treatment.
• Additional hormone exposure may alter the intended therapeutic effect.

4. Estrogen or Progestin Medicines

Examples:

• Estradiol tablets
• Conjugated estrogens
• Norethisterone
• Medroxyprogesterone

Possible Effect:

• May increase hormone exposure.
• May alter the benefit-risk profile of treatment.

5. Strong CYP3A Enzyme Inducers

Examples:

• Rifampicin
• Carbamazepine
• Phenytoin

Possible Effect:

• May reduce circulating concentrations of estradiol and norethisterone.
• Could reduce overall treatment effectiveness.

6. Medicines That Increase Blood Clot Risk

Examples:

• Tamoxifen
• Selective estrogen receptor modulators (SERMs)

Possible Effect:

• Combined use may increase the risk of thromboembolic events.

7. Anticoagulants

Examples:

• Warfarin
• Apixaban
• Rivaroxaban

Possible Effect:

• Hormonal therapy may influence bleeding patterns.
• Additional clinical monitoring may be required.

8. Herbal Products

Examples:

• St. John's Wort

Possible Effect:

• May reduce relugolix exposure and decrease treatment effectiveness.

Synopsis

Drug	Relugolix, Estradiol, and Norethisterone Acetate
Pharmacological Category	Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist with Estrogen and Progestin (Hormone Add-Back Therapy)
Therapeutic Indication	Used for the management of moderate to severe symptoms associated with uterine fibroids in premenopausal women, including heavy menstrual bleeding.
Dosage Forms	Tablet

More Information

1. What Is Hormone Add-Back Therapy in RELUEASE Tablet?

Hormone Add-Back Therapy Explained

RELUEASE Tablet combines Relugolix with Estradiol and Norethisterone acetate as hormone add-back therapy. While relugolix lowers ovarian hormone production to help control fibroid-related symptoms, the added estradiol and norethisterone acetate help maintain hormone levels within a therapeutic range. This approach helps reduce the likelihood of low-estrogen symptoms and supports bone mineral density during treatment.

Regular Monitoring Supports Safe Use

Your healthcare professional may recommend periodic assessments during treatment, including:

• Blood pressure monitoring.
• Evaluation of menstrual bleeding patterns.
• Assessment of symptom improvement.
• Bone health monitoring if treatment is continued for an extended period.
• Review of any new medicines that may interact with therapy.

Lifestyle Measures That Complement Treatment

Healthy lifestyle habits can help support overall gynecological health while taking RELUEASE Tablet:

• Eat a balanced diet rich in calcium, vitamin D, iron, and protein.
• Include regular weight-bearing exercise, such as walking or light strength training, to support bone health.
• Stay well hydrated, especially during heavy menstrual bleeding.
• Maintain a healthy body weight and avoid smoking, as smoking may increase the risk of cardiovascular complications associated with hormone-containing medicines.

Importance of Adherence

RELUEASE Tablet works best when taken once daily at the same time each day. Missing doses may reduce hormone suppression and affect symptom control. If you frequently miss doses, speak with your healthcare professional for strategies to improve adherence.

Menstrual Changes During Treatment

Changes in menstrual bleeding are expected during therapy. Some women may notice lighter periods, irregular bleeding, or temporary absence of menstrual periods. These changes are usually related to the medicine's hormonal effects. Inform your healthcare professional if bleeding becomes unusually heavy, persistent, or occurs after a period of no bleeding.

Fertility Considerations

RELUEASE Tablet is intended to manage symptoms associated with uterine fibroids and is not a contraceptive. Ovulation may return after treatment is discontinued. Women who wish to avoid pregnancy should use effective non-hormonal contraception during treatment and for the period recommended by their healthcare professional after the last dose.

FAQs About RELUEASE TABLET

References

1. ORGOVYX. relugolix tablet. Sumitomo Pharma America, Inc. [Revised in August 2023]. [Accessed on 30th July 2026]  

2. Orgovyx 120 mg film-coated tablet. EMA. Europa.eu. Summary of Product Characteristics. [Revised in April 2022]. [Accessed on 30th July 2026]  

3. Relugolix: a novel androgen deprivation therapy for management of patients with advanced prostate cancer. NIH. National Library of Medicine. National Center for Biotechnology Information. March 2021. [Accessed on 30th July 2026]  

4. Estradiol. NIH National Library of Medicine. National centre for biotechnology information. PubChem. July 2022. [Accessed on 30th July 2026] 

5. TTK Healthcare Limited. Primiwal Tablet. [Revised in February 2021] [Accessed on 30th July 2026] 

6. Norethisterone. Leeford Health Care Ltd. Accessed on 30th July 2026]