Medroxyprogesterone Mylan 150 mg Suspension

MEDROXYPROGESTERONE MYLAN contains the active substance medroxyprogesterone acetate. Medroxyprogesterone acetate acts by preventing an egg from fully developing and being released from the ovaries during your menstrual cycle. If an egg is not released it cannot become fertilised by sperm and result in pregnancy. Medroxyprogesterone acetate also causes changes in the lining of your womb that makes it less likely for pregnancy to occur. It also thickens the mucus at the entrance of the womb, making it more difficult for sperm to enter. The anti-cancer activity of medroxyprogesterone acetate at high doses is not fully understood.

MEDROXYPROGESTERONE MYLAN is used for:

1. Endometriosis (a condition resulting from the appearance of endometrial tissue outside the uterus and causing pelvic pain, especially associated with menstruation).
2. Contraception (ovulation suppression): long-term female contraception every 3 months.
3. Endometrial Cancer: as add-on and/or to improve treatment.
4. Kidney Cancer: as add-on and/or to improve treatment.

MEDROXYPROGESTERONE MYLAN should not be administered to you:

• if you are hypersensitive (allergic) to medroxyprogesterone acetate or any of the other ingredients of MEDROXYPROGESTERONE MYLAN (listed in section 6).
• if you are or think you may be pregnant.
• if you have known or suspected breast cancer.
• if you have unexplained vaginal bleeding.
• if you have unexplained blood in your urine.
• if you have unexplained abnormalities with your breast(s).
• if you have liver problems.
• if you have or previously had inflammation of the veins (thrombophlebitis).
• if you have depression which is not well controlled with treatment.
• if you have had depression with previous use of hormonal contraception.

Warnings and precautions

Your doctor will ask about you and your family’s medical problems, check your blood pressure and exclude the likelihood of you being pregnant. You may also need other checks, such as a breast examination, but only if these examinations are necessary for you, or if you have any special concerns.

Tell your doctor or other health care provider before being given MEDROXYPROGESTERONE MYLAN:

• if you have risk factors for osteoporosis including bone disease, excessive alcohol and/or tobacco use, a low body mass index (BMI) or eating disorder (e.g., anorexia or bulimia), strong family history of osteoporosis or chronic use of medicines that can reduce bone mass density such as anti-epileptics (used for seizures) or steroids.
• if you have diabetes or a family history of diabetes.
• if you have severe pain or swelling in the calf (indicating a possible clot in the leg, which may be called phlebitis).
• if you have blood clotting disorders such as deep vein thrombosis (blood clot in the legs), pulmonary embolus (blood clot in the lung) or a stroke you should not receive further injections of MEDROXYPROGESTERONE MYLAN.
• if you have problems with your eyesight while using MEDROXYPROGESTERONE MYLAN, for example a sudden partial or complete loss of vision or double vision.
• if you have a history of abnormal or unexpected vaginal bleeding as you may need additional examination or testing before using MEDROXYPROGESTERONE MYLAN.
• if you have a past history of or current depression.
• if you have had depression with previous use of hormonal contraceptives.
• if you have problems with your liver or liver disease.
• if you have problems with your kidneys or kidney disease.
• if you have a history of heart disease or cholesterol problems including any family history.
• if you have a condition that may be affected by weight gain or fluid retention as MEDROXYPROGESTERONE MYLAN may cause these conditions to worsen (e.g., epilepsy, migraine, asthma or problems with your heart or kidneys).
• if you are using certain medicines such as high dose glucocorticoids (steroids), anti-epileptics, and thyroid hormones. Tell the person who provides your contraception if you are taking these or any other medicines - they may recommend a more suitable method of contraception.

Psychiatric disorders

Some women using hormonal contraceptives including MEDROXYPROGESTERONE MYLAN have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

MEDROXYPROGESTERONE MYLAN is an intramuscular injection (injected into the muscle) and will be administered by your doctor, nurse or other health care provider. MEDROXYPROGESTERONE MYLAN should be shaken well immediately before use.

Endometriosis:

The usual dose of MEDROXYPROGESTERONE MYLAN in this condition is 50 mg weekly or 100 mg every 2 weeks intramuscularly for at least 6 months.

Contraception:

MEDROXYPROGESTERONE MYLAN will be given to you every 12 weeks as a single intramuscular injection of 1 ml (150 mg medroxyprogesterone acetate) into the buttock or upper arm. The injection is given during the first 5 days after the beginning of a normal menstrual period. Following childbirth, the first MEDROXYPROGESTERONE MYLAN injection can be given within 5 days after childbirth if you are not breastfeeding, or, if exclusively breastfeeding, at or after the sixth week after giving birth to reduce risk that you are pregnant. MEDROXYPROGESTERONE MYLAN works as a contraceptive for 12 weeks in your body. There is no way of reversing the injection once it is given. For effective contraceptive cover, MEDROXYPROGESTERONE MYLAN must be given every 12 weeks. Make sure that you or your doctor makes your next appointment for 12 weeks’ time. If the time period since your last injection is more than 14 weeks, your health care provider will need to confirm that you are not pregnant before you are given another injection. Consult with your health care provider when switching from other methods of birth control (e.g., oral contraceptive pill) to ensure correct timing of the first MEDROXYPROGESTERONE MYLAN injection to provide continuous birth control coverage.

Endometrial and renal carcinoma:

Doses of 400 mg to 1000 mg of MEDROXYPROGESTERONE MYLAN intramuscularly per week are recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilised, it may be possible to maintain improvement with as little as 400 mg per month.

Use in children:

MEDROXYPROGESTERONE MYLAN is not indicated if you have not yet started your periods.

If you receive more MEDROXYPROGESTERONE MYLAN than you should Since a health care provider will administer MEDROXYPROGESTERONE MYLAN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget an injection of MEDROXYPROGESTERONE MYLAN If you forget your injection or are late getting your next injection (i.e. wait longer than 12 weeks between injections), there is a greater risk that you could become pregnant. Ask your doctor or healthcare professional to find out when you should receive your next injection of MEDROXYPROGESTERONE MYLAN and which type of contraception should be used in the meantime.

MEDROXYPROGESTERONE MYLAN can have side effects. Not all side effects reported for MEDROXYPROGESTERONE MYLAN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving MEDROXYPROGESTERONE MYLAN, please consult your health care provider for advice.

If any of the following happens, stop receiving MEDROXYPROGESTERONE MYLAN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• sudden skin rash or itching (especially affecting the whole body), swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious reaction to MEDROXYPROGESTERONE MYLAN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• a blood clot in the lungs (symptoms include shortness of breath, breath-related chest pains, coughing up blood);
• a blood clot in the leg (you may have pain, tenderness or swelling in your calf, ankle or foot or you may have painful or inflamed veins in your leg; you may find it difficult to put full weight on the affected leg or you have purple discolouration of the skin of the leg or the skin becomes red and warm to touch);
• jaundice (yellowing of the skin or the whites of the eyes). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

When used for contraception:

• nervousness,
• headache,
• dizziness,
• stomach pain or discomfort,
• weight increase or decrease,
• depression,
• libido decreased (reduced sex drive),
• feeling sick,
• feeling bloated,
• hair loss,
• acne,
• back pain,
• vaginal discharge,
• breast tenderness,
• difficult or painful period,
• urinary tract infection,
• oedema/fluid retention,
• weakness.

Less frequent

• appetite increased or decreased,
• difficulty sleeping,
• convulsions (fits),
• drowsiness,
• tingling,
• hot flush,
• liver disorder,
• facial hair growth,
• nettle rash or hives,
• itchy skin,
• temporary brown patches,
• difficult or painful period,
• unexpected or unusual vaginal bleeding or spotting,
• milky discharge from the breast when not pregnant or breastfeeding,
• pelvic pain,
• painful intercourse,
• prevention of lactation,
• breast cancer,
• reduction in red blood cell,
• blood disorder,
• difficulty reaching orgasm,
• behavior change,
• mood change,
• irritability,
• anxiety,
• migraine,
• paralysis,
• fainting,
• feeling of dizziness or spinning,
• heart beats more rapidly,
• high blood pressure,
• varicose veins,
• diarrhoea,
• rectal bleeding,
• digestive disorder,
• liver enzyme disorder,
• accumulation of fat (at injection site),
• inflammation of the skin,
• scar tissue formation,
• stretch marks,
• pain in a joint,
• muscular cramps,
• bone density decreased,
• osteoporosis (decrease in bone strength) including osteoporotic fractures,
• vaginal pain or inflammation,
• stopping or extended break of your periods,
• breast pain,
• uterine bleeding or excessive bleeding,
• periods with abnormally heavy or prolonged bleeding,
• vaginal dryness,
• change in breast size,
• ovarian or vaginal cyst,
• premenstrual syndrome,
• excessive thickening of the lining of the womb,
• breast lump,
• nipple bleeding,
• delayed egg release with longer menstrual cycles (periods),
• feel pregnant,
• abnormal smear,
• fever,
• tiredness,
• injection site pain or tenderness,
• injection site lump or dimple,
• feeling thirsty,
• hoarseness,
• facial nerve paralysis,
• decreased sugar tolerance.

Frequency not known

• severe depression with a higher risk of suicidal thoughts/behaviour and suicide.

When used for cancer:

Frequent side effects

• increased weight,
• tremors,
• increased sweating,
• swelling of feet and ankles,
• fluid retention.

Less frequent side effects

• rounded appearance of the face (‘moon-face’),
• inflammation of the veins,
• irregular and/or increased/decreased menstrual bleeding or spotting,
• fever.

Frequency not known

• osteoporosis (decrease in bone strength) including osteoporotic fractures,
• abnormal liver function test,
• severe depression with a higher risk of suicidal thoughts/behaviour and suicide,
• loss of fat tissue,
• injection site reactions including pain or tenderness at site of injection, persistent indentation or dimpling,
• lump or nodule at site of injection.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of MEDROXYPROGESTERONE MYLAN.

Store all medicines out of reach of children.

• Store at or below 30 °C.
• Do not freeze.
• Do not use after the expiry date stated on the carton or label.