40 mg / 1 mg / 0.5 mg film-coated tablets
Regalix / estradiol/norethisterone acetate
What Ryeqo Is And What It Is Used For
Ryeqo contains the active substances relugolix, estradiol, and norethisterone acetate. It is used to treat moderate to severe symptoms of uterine fibroids, which is a benign tumor of the uterus. Ryeqo is used in adult women (over 18 years of age) who have not entered menopause.
In some women, uterine fibroids can cause heavy menstrual bleeding and pelvic pain (pain below the navel). The drug is used to treat fibroids to stop or reduce bleeding and to reduce pain and discomfort in the pelvis associated with fibroids.
This drug contains relugolix, a substance that blocks certain receptors in the brain which leads to reduced production of a hormone that normally stimulates the ovaries to produce estradiol and progesterone. When the receptors are blocked, the levels of estrogen and progesterone that circulate in the body decrease.
This drug also contains two types of female hormones: estradiol which belongs to a group of drugs called estrogen er, and norethisterone which belongs to a group of drugs called progestin er. Taking these hormones has been included in Ryeqo maintains a hormonal state similar to that at the beginning of the menstrual cycle. In this way, the symptoms are relieved at the same time as the drug helps to keep the skeleton strong.
What You Need To Know Before Using Ryeqo
Do Not Use Ryeqo
Do not use Ryeqo if you have any of the conditions listed below.
If you have any of these conditions, tell your doctor:
- If you are allergic to relugolix, estradiol, norethisterone acetate, or any of the other ingredients of this medicine (listed in section 6)
- If you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs ( pulmonary embolism ), heart (heart attack), brain ( stroke ), or other parts of your body
- If you have or have ever had a disease caused by blood clots in the arteries, such as
- Heart attack, stroke, or angina
- If you have a coagulation disorder such as
- Protein C deficiency
- Protein S deficiency
- Antithrombin-III deficiency
- Factor V Leiden mutation
- If you have osteoporosis
- If you suffer from headaches with focal neurological symptoms, such as paralysis or impaired muscle control, or migraines with visual disturbances
- If you have any type of cancer that may be aggravated by exposure to female sex hormones, such as breast or genital cancer
- If you have or have ever had a tumor in your liver
- If you have or have ever had a liver disease and your liver function values have not returned to normal
- If you are pregnant or if you think you may be pregnant or breast-feeding
- If you have genital bleeding of unknown origin
- If you are taking a hormonal contraceptive, such as the contraceptive pill, and do not want to stop using it
If any of the above conditions occur for the first time when you take Ryeqo, stop taking the medicine immediately and contact your doctor.
If you are not sure about any of the above, talk to your doctor before taking Ryeqo.
Warnings And Cautions
Talk to your doctor or pharmacist before taking Ryeqo.
You should know that most women have less or no menstrual bleeding at all during treatment and for a few weeks afterward.
Your doctor will talk to you about your medical history and family history. Your doctor will also need to check your blood pressure and check if you are pregnant. You may also need to undergo a physical examination and additional checks that are specific to your medical needs and/or problems, such as a breast examination and an examination to measure how strong your legs are.
Stop taking Ryeqo and contact a doctor immediately if you:
- Experience any of the conditions mentioned in the section “Do not use Ryeqo”
- Gets signs of liver disease :
- Yellowed skin or yellow whites of the eyes (jaundice)
- Nausea or vomiting
- Fever
- Severe fatigue
- Dark urine
- Itching
- Pain in the upper abdomen
- Gets severely elevated blood pressure. Symptoms may include
- Headache
- Fatigue
- Dizziness
- Get migraines for the first time or unusually severe headaches that occur more often than before
- Note any signs of a blood clot that could mean that you have a blood clot in a bone (ie deep vein thrombosis ) or the lungs (ie pulmonary embolism ), or that you have had a heart attack or stroke. Under “Ryeqo and the risk of blood clots” you will find a description of the symptoms of these serious conditions.
- Getting pregnant.
Tell your doctor if any of the following apply to you:
- You have one or more of the risk factors for developing a blood clot listed below.
- You have high blood pressure.
- You have osteoporosis.
- You suffer from migraines.
- You think you may be pregnant. Ryeqo treatment usually results in a significant reduction or even absence of menstrual bleeding, which makes it difficult to detect a possible pregnancy.
- If you have or have had depression before.
- If you have kidney disease.
Ryeqo and risk of blood clots
The use of other drugs that contain estrogen and progestogens increases the risk of blood clots. The risk of blood clots with Ryeqo has not been established. Ryeqo reduces estrogen levels to a level similar to that at the beginning of your normal menstrual cycle.
Factors that may increase the risk of blood clots in veins and/or arteries:
- Rising age (especially if you are over 35 years old).
- If you are overweight (body mass index or BMI over 30 kg / m 2 ).
- If you need to have an operation or stay in bed for a long period due to injury or illness (eg with a plastered leg)
- If you have given birth recently
- If someone in your family has had a blood clot in their bones, lungs, or another organ, or has had a heart attack or stroke at a young age (eg before the age of 50)
- If you smoke.
- If you have heart problems ( valve disease, a heart rhythm disorder called atrial fibrillation ).
- If you have diabetes.
- If you have certain diseases such as systemic lupus erythematosus ( SLE – a disease that affects the natural defense system), sickle cell disease (a hereditary disease of the red blood cells ), Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease), or cancer.
The more conditions you have, the greater the risk of developing a blood clot.
The symptoms of a blood clot depend on where the blood clot is located.
Symptoms of a blood clot in the leg ( deep vein thrombosis, DVT )
The symptoms of a blood clot in a bone, so-called deep vein thrombosis (DVT), can include:
- Swelling of the legs and/or feet or along a vein in the leg
- Pain or tenderness in the leg that is only felt when standing or walking
- Increasing heat in the affected bone with red discoloration or discoloration of the bone
Symptoms of blood clots in the lungs ( pulmonary embolism )
Symptoms of a blood clot in the lungs, called pulmonary embolism (PE), may include:
- Sudden onset of unexplained shortness of breath or rapid breathing
- Sudden cough that may be associated with severe chest pain
- Bloody vomiting
- Severe instability or dizziness
- Fast or irregular heartbeat
Symptoms of heart attack
Symptoms of myocardial infarction may be temporary and may include:
- Pain
- Discomfort
- Pressure
- Heaviness
- Pressure, or fullness in the chest, arm, or below the sternum
- Discomfort that radiates to the back, jaw, neck, arm, abdomen
- Feeling full, indigestion or suffocation
- Sweating
- Nausea
- Vomiting, or dizziness
- Extreme weakness
- Anxiety, or shortness of breath
- Fast or irregular heartbeat
Symptoms of stroke
Symptoms of a stroke may include:
- Sudden numbness or weakness in the face, arms, or legs, especially on one side of the body
- Sudden difficulty walking
- Dizziness
- Loss of balance or coordination
- Sudden confusion
- Difficulty speaking or understanding
- Sudden vision problems in one or both eyes
- Sudden, severe, or prolonged headache without a known cause
- Unconsciousness or fainting with or without seizures
Operation
If you are going to have surgery, you must tell the surgeon that you are taking Ryeqo.
Liver tumors or liver disease
In rare cases, liver tumors or liver disease have been reported in women taking estrogen and progestogens. If you get any symptoms of jaundice, contact your doctor for further medical advice.
Impaired renal function
If you experience that urine production decreases or you notice possible fluid retention (accumulation of fluid in the body) that causes swelling in the legs, ankles, or feet, you should contact a doctor for further medical advice.
Altered bleeding pattern during menstruation
Treatment with Ryeqo usually results in a significant reduction or even absence of menstrual bleeding (your period) during the first 30 days of treatment. However, if you continue to have heavy bleeding, tell your doctor.
Depression
If you feel that your mood has changed or you are experiencing symptoms of depression, you should contact your doctor for further medical advice.
High blood pressure
In rare cases, treatment with Ryeqo may lead to a slight increase in blood pressure. If you get symptoms of high blood pressure, contact your doctor for further medical advice.
Prolapse or expulsion of fibroids
Myoma can develop anywhere in the uterine wall, including the submucosa, a thin layer of tissue in the uterus. In some women, fibroids can protrude or slide through the cervix and into the vagina, leading to significantly more severe uterine bleeding or pain. If you recover from severe bleeding after your symptoms have improved with treatment with Ryeqo, you should contact your doctor for medical advice.
Diseases of the gallbladder
Some women taking estrogen and progestogen hormones, including Ryeqo, have reported gallbladder problems ( gallstones or gallbladder inflammation ). If you experience unusually severe pain under the chest or in the upper abdomen, consult a doctor for medical advice.
Children And Young People
Ryeqo should not be taken by children under 18 years of age as the safety and efficacy of Ryeqo have not been established in this age group.
Other Medicines And Ryeqo
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Talk to your doctor if you are taking any of the following medicines. These medicines can affect Ryeqo or be affected by Ryeqo:
- Some medicines are used to treat epilepsy eg
- Carbamazepine
- Topiramate
- Phenytoin
- Phenobarbital
- Primidone
- Oxcarbazepine
- Felbamate
- Some medicines are used to treat HIV / AIDS (human immunodeficiency virus / acquired immunodeficiency syndrome) eg
- Ritonavir
- Efavirenz
- Some medicines used to treat hepatitis C virus ( HCV ) eg
- Boceprevir
- Sofosbuvir
- Velpatasvir
- Voxilaprevir
- Telaprevir
- Glekaprevir
- Some medicines used to treat fungal infections eg
- Ketoconazole
- Itraconazole
- Fluconazole
- Griseofulvin
- Some medicines are used to treat bacterial infections eg
- Rifampicin
- Rifabutin
- Clarithromycin
- Erythromycin
- Gentamicin
- Tetracycline
- Griseofulvin
- Some medicines are used to treat high blood pressure in the arteries of the lungs (eg bosentan ).
- Some medicines are used to treat high blood pressure eg
- Diltiazem
- Carvedilol
- Verapamil
- Some medicines are used to treat irregular heartbeats eg
- Amiodarone
- Dronedarone
- Propafenone
- Quinidine
- Verapamil
- Some medicines are used to treat angina eg
- Ranolazine
- Carvedilol
- Verapamil
- Some medicines prevent organ rejection after transplantation (eg cyclosporine).
- Herbal medicines contain St. John’s wort ( Hypericum perforatum ).
Pregnancy And Breastfeeding
Do not take Ryeqo if you are pregnant or breastfeeding. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you become pregnant, stop taking Ryeqo and consult a doctor.
Ryeqo stops ovulation and it is therefore unlikely that you will become pregnant while using Ryeqo if you use the medicine according to the instructions. Ovulation and menstrual bleeding return quickly after stopping treatment with Ryeqo and alternative contraceptive methods are recommended immediately after stopping Ryeqo.
Depending on when in your cycle you start taking Ryeqo, it may take time to achieve completely inhibited ovulation with Ryeqo. Therefore, you should use non-hormonal contraceptives (eg condoms) for the first month after you start taking Ryeqo.
If you miss your dose for two consecutive days or more, use non-hormonal contraceptives (eg condoms) for the next 7 days of treatment.
Laboratory samples
If you need to take a blood or urine sample, tell your doctor or laboratory staff that you are taking Ryeqo as this medicine may affect
Driving And Using Machines
Ryeqo has no known effect on the ability to drive and use machines
Ryeqo Contains Lactose
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 Ryeqo
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is one tablet per day.
- The tablet must be taken by mouth every day at about the same time, with or without food with a little liquid.
It is recommended that you start taking Ryeqo one of the first five days after the start of your period. If you start at another time in the menstrual cycle, you may initially experience bleeding that is irregular or heavier.
If You Take More Ryeqo Than You Should
No serious adverse effects have been reported from multiple doses of this medicine. Large doses of estrogen can cause nausea and vomiting and bleeding from the vagina. If you have taken too many Ryeqo tablets, talk to your doctor or pharmacist.
If You Forget To Take Ryeqo Tablets
If you have missed a dose, take it as soon as you remember, and then continue to take your tablet the next day as usual. Do not take a double dose to make up for a forgotten tablet.
If You Stop Taking Ryeqo
Talk to your doctor first if you want to stop taking Ryeqo tablets. Your doctor will explain the effects of stopping treatment and discuss other options with you.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Ryeqo Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects of Ryeqo have been reported and are listed below according to how common they are.
Common Ryeqo side effects (may affect up to 1 in 10 people):
- Hot flashes
- Very abundant, irregular, or prolonged bleeding from the uterus
- Hair loss
- Decreased sex drive
- Irritability
- Increased sweating
- A lump in the breast tissue (breast cyst)
- Indigestion
- Night sweats
Uncommon Ryeqo side effects (may affect up to 1 in 100 people):
- Rejection of myoma et ( myoma et completely or partially penetrates through the vagina, usually with increased bleeding from the vagina).
How To Store Ryeqo
- 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 outer carton and can after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. The hormonal active substances in the tablet can have harmful effects if they reach the aquatic environment. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Content Declaration
- The active substances are relugolix, estradiol, and norethisterone acetate. One film-coated tablet contains 40 mg relugolix, 1 mg estradiol (in the form of hemihydrate), and 0.5 mg norethisterone acetate.
- The other ingredients are lactose M
- Monohydrate
- Mannitol (E421)
- Sodium starch glycolate
- Hydroxypropylcellulose (E463), magnesium stearate (E572)
- Hypromellose type 2910 (E464)
- Titanium dioxide (E171)
- Triacetin (E1518)
- Yellow iron oxide (E152)
What The Medicine Looks Like And The Contents Of The Pack
- Ryeqo is a light yellow to yellow, film-coated 8 mm round tablet, with “415” on one side and smooth on the other side.
- Ryeqo tablets are available in jars containing 28 film-coated tablets. Each jar also contains a desiccant and is equipped with an induction-sealed childproof lid.
- Pack sizes:
- One can (28 tablets)
- Three cans (84 tablets)
- Not all pack sizes may be marketed
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői out 19-21.
1103 Budapest
Hungary
Manufacturer (plants releasing batch)
Gedeon Richter Plc.
Gyömrői out 19-21.
1103 Budapest
Hungary