Consumer medicine information

Medroxyprogesterone Sandoz Tablets

Medroxyprogesterone acetate


Brand name

Medroxyprogesterone Sandoz Tablets

Active ingredient

Medroxyprogesterone acetate




Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Medroxyprogesterone Sandoz Tablets.

What is in this leaflet

This leaflet answers some common questions about Medroxyprogesterone Sandoz.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Medroxyprogesterone Sandoz is used for

This medicine is used to treat:

  • endometriosis, a condition in which material similar to the lining of the uterus (womb) grows outside the uterus, causing pain or bleeding.
  • secondary amenorrhoea (a lack of menstrual bleeding not due to pregnancy). Medroxyprogesterone Sandoz, with or without an oestrogen, helps to re-establish a regular menstrual cycle.
  • abnormal uterine bleeding, changed or irregular bleeding pattern. Medroxyprogesterone Sandoz helps to re-establish a regular menstrual cycle.
  • symptoms of menopause in women with an intact uterus. Medroxyprogesterone Sandoz tablets are used in combination with oestrogen therapy to protect the lining of the uterus while the oestrogen relieves the symptoms.

It contains the active ingredient medroxyprogesterone acetate. Medroxyprogesterone acetate is a chemical similar to the natural hormone progesterone.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

There is no evidence that Medroxyprogesterone Sandoz is addictive.

Before you take Medroxyprogesterone Sandoz

When you must not take it

Do not take this medicine if you have an allergy to:

  • medroxyprogesterone acetate, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product description
  • any other similar medicines.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take this medicine if you have or have had any of the following medical conditions:

  • blood clots
  • pulmonary embolism
  • swelling and redness along a vein which is extremely tender when touched
  • stroke
  • severe liver disease
  • breast cancer or breast lumps not diagnosed by your doctor
  • bleeding or discharge from your nipples
  • uncontrolled high blood pressure
  • unusual or irregular vaginal bleeding or blood in your urine that has not been diagnosed by your doctor.

Do not take this medicine if you have had your uterus removed.

Do not take this medicine if you are pregnant.

It may affect your developing baby if you take it during pregnancy.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • heart or kidney problems
  • migraine
  • unusual or irregular vaginal bleeding
  • asthma
  • epilepsy (convulsions or seizures)
  • diabetes or a family history of diabetes
  • depression or a family history of depression
  • osteoporosis
  • genital or breast cancer.

If you have not told your doctor about any of the above, tell him/her before you start taking Medroxyprogesterone Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Medroxyprogesterone Sandoz may interfere with each other. These include:

  • aminoglutethimide (Cytadren®), a medicine used to treat certain types of breast cancer.

This medicine may be affected by Medroxyprogesterone Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Medroxyprogesterone Sandoz.

How to take Medroxyprogesterone Sandoz

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

The dose of Medroxyprogesterone Sandoz will vary depending on the condition for which you are being treated. Medroxyprogesterone Sandoz should be used at the lowest effective dose to treat your condition.

Your doctor may tell you to take this medicine every day or in repeating cycles with a break in between.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Medroxyprogesterone Sandoz may not work as well and your problem may not improve.

How to take it

Swallow the tablets whole with a full glass of water.

Medroxyprogesterone Sandoz tablets should not be broken or crushed.

When to take Medroxyprogesterone Sandoz

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take Medroxyprogesterone Sandoz

Continue taking your medicine for as long as your doctor tells you.

Your doctor will prescribe this medicine for the shortest duration necessary to effectively treat your condition.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Medroxyprogesterone Sandoz. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking Medroxyprogesterone Sandoz

Things you must do

Always follow your doctor's instructions carefully.

If you become pregnant while taking this medicine, tell your doctor immediately. Medroxyprogesterone Sandoz should not be used during pregnancy.

Tell your doctor immediately if you have sudden partial or complete loss of vision or sudden onset of double vision or migraine.

You will need to be examined and may need to stop taking your medicine.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Medroxyprogesterone Sandoz.

If you are about to have any laboratory tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked.

Regularly check your breasts for any lumps and have regular professional breast examinations and mammograms, as recommended by your doctor.

Tell your doctor if, for any reason, you have not taken this medicine exactly as prescribed.

Tell your doctor if you feel that your medicine is not helping your condition.

Always discuss with your doctor any problems or difficulties during or after taking Medroxyprogesterone Sandoz.

Things you must not do

Do not take Medroxyprogesterone Sandoz to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not change your dose or stop taking Medroxyprogesterone Sandoz without your doctor's permission.

Things to be careful of

Be careful driving or operating machinery until you know how Medroxyprogesterone Sandoz affects you.

This medicine may cause dizziness, drowsiness and fatigue in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Medroxyprogesterone Sandoz.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

The use of oestrogen at the same time as Medroxyprogesterone Sandoz may also increase the risk of side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • nervousness, difficulty concentrating
  • problems sleeping, drowsiness, fatigue
  • shaking
  • dizziness, headache, nausea or vomiting
  • dry mouth
  • depression or excitation
  • tremor
  • skin conditions, such as hives, itching, rash or acne
  • unusual hair loss or thinning or increased hairiness
  • constipation or diarrhoea
  • changes in sexual drive
  • fever
  • leg cramps
  • sweating
  • irregular vaginal bleeding or spotting, unusual changes in vaginal secretions or lack of menstrual periods
  • tenderness of the breast or unusual secretions of breast milk
  • changes in your weight
  • yellowing of the skin or eyes (jaundice)
  • fluid retention - if you suffer from epilepsy (convulsions or seizures) or breathlessness, this increase in fluid retention may make symptoms worse.

These are the more common side effects of the medicine. Mostly, these are mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

  • confusion or memory loss
  • changes in your breasts, for example lumps.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
  • chest pain or shortness of breath
  • painful swelling in a leg
  • severe headaches or changes in speech or vision.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are not common.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After taking Medroxyprogesterone Sandoz


Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Medroxyprogesterone Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.


If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Medroxyprogesterone Sandoz 10mg - white, round tablets, with a score notch on one side.

Available in blister packs of 30 tablets.


Active ingredients:

  • Medroxyprogesterone Sandoz 10mg - 10mg medroxyprogesterone acetate

Inactive ingredients:

  • maize starch
  • sodium starch glycollate
  • lactose
  • microcrystalline cellulose
  • colloidal anhydrous silica
  • magnesium stearate.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.


Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500

Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Auckland 0754
New Zealand
Tel: 0800 354 335

This leaflet was revised in June 2011.

Australian Register Number
10mg tablets: AUST R 79252


Brand name

Medroxyprogesterone Sandoz Tablets

Active ingredient

Medroxyprogesterone acetate




Name of the medicine

Medroxyprogesterone acetate.


Maize starch, sodium starch glycollate, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.


Chemical name: 6α-methyl-3,20- dioxopregn-4- en-17-yl acetate. Molecular formula: C24H34O4. MW: 386.5. CAS: 71-58-9. A white or almost white, crystalline powder, practically insoluble in water, soluble in acetone, sparingly soluble in alcohol and in methanol, slightly soluble in ether.



Medroxyprogesterone acetate induces responses in laboratory animals comparable to those caused by progesterone. It is more potent than progesterone. Medroxyprogesterone acetate induces glandular maturation in the endometrium, maintains pregnancy, delays parturition, inhibits ovulation and suppresses oestrous cycles. It is devoid of androgenic and oestrogenic activity. In selected animal tests it has some adrenal corticoid-like activity and in dogs increases serum growth hormone levels.


Medroxyprogesterone acetate is a progestational agent. When administered in recommended doses to women with adequate endogenous oestrogen, it transforms proliferative into secretory endometrium. Medroxyprogesterone acetate may inhibit gonadotrophin production, which in turn prevents follicular maturation and ovulation. Like progesterone, medroxyprogesterone acetate is thermogenic. At the very high dosage levels used in the treatment of certain cancers (500 mg daily or more), corticoid-like activity may be manifest.


Medroxyprogesterone acetate is an orally active progestational steroid having an apparent half-life of about 30 hours.
Medroxyprogesterone acetate is rapidly absorbed after oral administration. There is high interindividual variability in serum levels after standard doses given by either route of administration.
Medroxyprogesterone acetate is metabolised and conjugated in the liver. Metabolic products are predominantly excreted in the urine as both conjugated and free forms.


Animal toxicology.

Acute toxicity.

The oral LD50 of medroxyprogesterone acetate was found to be greater than 10,000 mg/kg in the mouse. The intraperitoneal LD50 in the mouse was 6,985 mg/kg.

Subacute and chronic toxicity.

Medroxyprogesterone acetate administered orally to rats and mice (334 mg/kg/day) and dogs (167 mg/kg/day) for 30 days was found to be nontoxic. Medroxyprogesterone acetate was administered orally to dogs and rats at 3, 10 and 30 mg/kg/day for six months. The drug was considered to be nontoxic at these levels but with anticipated hormonal effects at the higher dose.

Reproduction studies.

Medroxyprogesterone acetate given orally at 1, 10 and 50 mg/kg/day in pregnant beagle bitches produced clitoral hypertrophy in the female pups of the high dose animals. No abnormalities were noted in any of the male pups. Subsequent evaluation of the reproductive potential of the bitches from the litters of treated females revealed no reduction in fertility potential.

Carcinogenesis and mutagenesis.

Long-term toxicology studies in the monkey, dog and rat with parenteral medroxyprogesterone acetate have disclosed the following. Beagle dogs receiving 75 mg/kg and 3 mg/kg every 90 days for seven years developed mammary nodules, as did some of the control animals. The nodules appearing in the control animals were intermittent in nature, whereas the nodules in the drug treated animals were larger, more numerous, persistent, and there were two high dose animals that developed breast malignancies.
Two monkeys receiving 150 mg/kg every 90 days for ten years developed undifferentiated carcinoma of the uterus. No uterine malignancies were found in monkeys receiving 30 mg/kg, 3 mg/kg, or placebo every 90 days for ten years. Transient mammary nodules were found during the study in the control, 3 mg/kg and 30 mg/kg groups, but not in the 150 mg/kg group. At sacrifice (after ten years), the only nodules extant were in three of the monkeys in the 30 mg/kg group. Upon histopathological examination these nodules were determined to be hyperplastic. No uterine or breast abnormalities were revealed in the rat after two years. The relevance of any of these findings with respect to humans has not been established.

Clinical Trials

Bone mineral density changes.

There are no studies on the bone mineral density (BMD) effects of medroxyprogesterone acetate.
However, a clinical study of adult women of childbearing potential given medroxyprogesterone acetate (MPA) 150 mg by intramuscular (IM) injection every three months, for contraception, demonstrated an average decrease of 5.4% in lumbar spine BMD over five years, with at least partial recovery of this bone loss during the first two years after treatment was discontinued. A similar clinical study of MPA 150 mg IM injection every three months in adolescent females, for contraception, demonstrated similar decreases in BMD, which were also more pronounced during the first two years of treatment and which again were at least partially reversible when treatment was discontinued. Decreases in serum oestrogen due to medroxyprogesterone acetate may result in a decrease in BMD in a premenopausal woman and may increase her risk for developing osteoporosis later in life (see Warnings).


Endometriosis. For use in the treatment of visually proven (laparoscopy) endometriosis where the required endpoint of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful.
Secondary amenorrhoea proven not due to pregnancy. In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate.
Abnormal uterine bleeding in the absence of organic pathology.
Adjunct to oestrogen therapy in women with an intact uterus.


Thrombophlebitis, thrombotic or thromboembolic disorders, cerebral apoplexy or patients with a past history of these conditions; markedly impaired liver function; undiagnosed vaginal bleeding; undiagnosed urinary tract bleeding; undiagnosed breast pathology; missed abortion; known sensitivity to medroxyprogesterone acetate or to any excipients; known or suspected pregnancy (see Precautions); severe uncontrolled hypertension; known or suspected malignancy of the breast (excluding use in oncology indications).


The doctor should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism and retinal thrombosis). Should any of these occur, the drug should be discontinued immediately.
Discontinue medication pending examination if there is sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilloedema or retinal vascular lesions, medication should be withdrawn.
Clinical suppression of adrenocorticoid function has not been observed at low dose levels, however, at the high doses used in the treatment of cancer, corticoid-like activity has been reported. Medroxyprogesterone acetate may decrease adrenocorticotrophic hormone and hydrocortisone blood levels. Animal studies show that medroxyprogesterone possesses adrenocorticoid activity.
Several randomised, prospective trials on the long-term effects of a combined oestrogen/ progestin regimen in postmenopausal women have reported an increased risk of several disorders including cardiovascular diseases (e.g. coronary heart disease and stroke), breast cancer and venous thromboembolism. Mortality can be increased in those who are diagnosed with incident breast cancers. The possible effect of hormone replacement therapy (HRT) on mammographic density and on the sensitivity and specificity of breast cancer screening should also be considered. Combination HRT should not be used in hysterectomised women because it is not needed to prevent endometrial changes in these women and it may increase the risk of breast cancer.
Current use of oestrogen only or oestrogen plus progestin products in postmenopausal women for five or more years has been associated with an increased risk of ovarian cancer.
The benefits and risks of HRT must always be carefully weighed, including consideration of the emergence of risks as therapy continues. Use of combined oestrogen/ progestin therapy in postmenopausal women should be prescribed at the lowest effective doses and limited to the shortest duration consistent with treatment goals and risks for the individual women, and should be periodically evaluated. HRT in postmenopausal women is not generally appropriate for long-term use and should not be prescribed for longer than six months without re-examining the patient.

Effects on laboratory tests.

The following laboratory tests may be affected by the use of medroxyprogesterone acetate: gonadotrophin levels; plasma progesterone levels; urinary pregnanediol levels; plasma testosterone levels (in the male); plasma oestrogen levels (in the female); sex hormone binding globulin; plasma cortisol levels; glucose tolerance test; metyrapone test: the use of MPA in oncology indications may cause partial adrenal insufficiency (decrease in pituitary-adrenal axis response) during metyrapone testing. Thus the ability of the adrenal cortex to respond to adrenocorticotrophic hormone should be demonstrated before metyrapone is administered.

Decrease in bone mineral density.

There are no studies on the bone mineral density (BMD) effects of medroxyprogesterone acetate.
However, two clinical studies of adult women of childbearing potential and of adolescent females given medroxyprogesterone acetate 150 mg IM (intramuscularly) every three months, for contraception, demonstrated significant decreases in BMD (see Clinical Trials). Decreases in serum oestrogen due to medroxyprogesterone acetate may result in a decrease in BMD in a premenopausal woman and may increase her risk for developing osteoporosis later in life.
An evaluation of BMD may be appropriate in some patients who use medroxyprogesterone acetate long-term. It is recommended that all patients have adequate calcium and vitamin D intake.

Use in the elderly.

A higher incidence of probable dementia in women aged 65 years and older has been reported during treatment with an HRT regimen of conjugated oestrogens and medroxyprogesterone acetate. 85% of cases of probable dementia occurred in the subgroup of women (54%) that were older than 70 years of age. Use of hormone therapy to prevent dementia or mild cognitive impairment in women 65 years or older is not recommended.
The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. This evaluation should exclude the presence of genital or breast neoplasia unless the patient is to be treated with medroxyprogesterone acetate for recurrent endometrial, breast or renal cancer.
Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma or cardiac or renal dysfunction, require careful observation.
Breakthrough bleeding is likely to occur in patients being treated for endometriosis. No other hormonal intervention is recommended for managing this bleeding. Nonfunctional causes should also be borne in mind, and in cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated.
A decrease in glucose tolerance has been observed in some patients on progestogens. The mechanism of this decrease is obscure. This fact should be borne in mind when treating all patients and for this reason, diabetic patients should be carefully observed while receiving progestogen therapy.
Patients who have a history of mental depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
The age of the patient constitutes no absolute limiting factor although treatment with progestogens may mask the onset of the climacteric.
The pathologist should be advised of progestogen therapy when relevant specimens are submitted.
Weight gain may be associated with the use of medroxyprogesterone acetate. Caution should therefore be exercised in treating any patient with a pre-existing condition that may be adversely affected by weight gain.
The high doses of medroxyprogesterone acetate used in the treatment of cancer patients may, in some cases, produce Cushingoid symptoms, e.g. moon facies, fluid retention, glucose tolerance and blood pressure elevation.
With the exception of anamnestic endometriosis, use of gestagen is not recommended in women without intact uterus.

Use in pregnancy.

(Category D)
Medroxyprogesterone acetate tablets are not to be used as a test for pregnancy or where pregnancy is suspected. If medroxyprogesterone acetate is used during pregnancy, or if the patient becomes pregnant while using medroxyprogesterone acetate, the patient should be apprised of the potential risk to the fetus. (see Contraindications).
Animal studies have shown that high doses of progestogens can cause masculinisation of the female foetus. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias may be approximately doubled with exposure to progesterones.


In perimenopausal patients where the endometrium is still proliferative, persistence of the endometrial proliferation may occur during administration of hormone replacement therapy (HRT). An endometrial biopsy may be performed at the discretion of the attending doctor.


In a study of women 65 years of age and older (a randomised controlled substudy of the Women's Health Initiative, the Women's Health Initiative Memory Study; n = 4,532, 54% older than 70), those treated with conjugated oestrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg were reported to have a twofold increase in the risk of developing probable dementia. After an average follow-up of four years, the absolute risk of probable dementia was 45 per 10,000 woman years in the placebo group. It is unknown whether these findings apply to younger postmenopausal women. Therefore, in the older women, the use of Medroxyprogesterone Sandoz for the prevention of osteoporosis should only be considered for those who have failed on, or were intolerant of, nonoestrogen medication.
Hormone therapy for the prophylaxis of dementia or mild cognitive impairment is not recommended.

Ovarian carcinoma.

The conjugated equine estrogens/ medroxyprogesterone acetate substudy revealed that estrogen plus gestagen increased the risk of ovarian carcinoma, but the increase was not statistically significant.


Aminoglutethimide administered concomitantly with medroxyprogesterone acetate may significantly depress the bioavailability of medroxyprogesterone acetate. Users of high dose medroxyprogesterone acetate should be warned about the possibility of decreased efficacy with the use of aminoglutethimide.
The need for insulin or oral antidiabetics can be changed due to an influence on glucose tolerance.
MPA is metabolised in vitro primarily by hydroxylation via the CYP3A4. While specific drug-drug interaction studies evaluating the clinical effect of CYP3A4 inhibitors or inducers of CYP3A4 on MPA have not been conducted or reported in the literature, physicians should consider that interactions could occur which may result in compromised efficacy. Coadministration with CYP3A4 inducers may result in decreased systemic levels of MPA whilst coadministration with CYP3A4 inhibitors may result in increased MPA levels.
Combination hormone replacement therapy should only be used in nonhysterectomised women (see Precautions).

Adverse Effects

The following events, listed in order of seriousness rather than frequency of occurrence, have been associated with the use of progestogens including medroxyprogesterone.


Anaphylaxis and anaphylactoid-like reactions, angioedema.


Cerebral and myocardial infarction, congestive heart failure, increased blood pressure, palpitations, retinal thrombosis, tachycardia, thromboembolic disease, thrombophlebitis, pulmonary embolism.

Central nervous system.

Confusion, loss of concentration, euphoria, vision disorders, dementia, nervousness, insomnia, somnolence, fatigue, depression, dizziness and headache and tremor. Some patients may complain of premenstrual-like depression while on medroxyprogesterone acetate.


Urticaria, pruritus, rash, acne, hirsutism, alopecia and sweating.


Irregular uterine bleeding (increase, decrease), spotting and amenorrhoea, prolonged anovulation.

Gastrointestinal/ hepatobiliary.

Nausea, vomiting, constipation, diarrhoea, cholestatic icterus, dry mouth, disturbed liver function, jaundice.

Metabolic and nutritional.

Adrenergic-like effects (e.g. fine hand tremors, cramps in calves at night), corticoid-like effects (e.g. Cushingoid syndrome), decreased glucose tolerance, diabetic cataract, exacerbation of diabetes mellitus, glycosuria.


Tenderness and galactorrhoea, mastodynia. The use of oestrogens and progestogens by postmenopausal women has been associated with an increased risk of breast cancer (see Warnings).


Cervical erosions, changes in excretions and secretions.


Changes in appetite, changes in libido, oedema/ fluid retention, hyperpyrexia, weight change, malaise, hypercalcaemia.
Moderate elevation of blood pressure, transient elevation of alkaline phosphatase and/or serum transaminase activities, elevations of serum calcium and potassium levels, and increases in white cell and platelet counts.

Postmarketing experience.

There have been postmarketing reports of erectile dysfunction in association with use of MPA in oncology treatments.

Dosage and Administration


Beginning on the first day of the menstrual cycle, Medroxyprogesterone Sandoz 10 mg three times daily for 90 consecutive days.

Secondary amenorrhoea not due to pregnancy.

In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with Medroxyprogesterone Sandoz 10 mg daily for ten days; 10 mg daily for five to ten days beginning on the assumed or calculated 16th to 21st day of the cycle. Treatment should be repeated for three consecutive cycles.

Abnormal uterine bleeding in the absence of organic pathology.

10 mg daily for five to ten days beginning on the assumed or calculated 16th to 21st day of the cycle. Treatment should be repeated for three consecutive cycles.

Adjunct to oestrogen therapy.

10 to 20 mg daily for at least ten days of each cycle. Use of combined oestrogen/ progestogen therapy in postmenopausal women should be prescribed at the lowest effective doses and limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically evaluated. HRT in postmenopausal women is not generally appropriate for long-term use and should not be prescribed for longer than six months without re-examining the patient.


Medroxyprogesterone Sandoz 10 mg tablets should not be broken or crushed.


Contact the Poisons Information Centre on 131 126 for advice on management of overdose.
Oral doses up to 3 g/day have been well tolerated. Patients receiving pharmacological doses of medroxyprogesterone acetate for treatments of neoplasms (400 mg/day or greater) may occasionally exhibit effects resembling those of glucocorticoid excess.
As with the management of any overdosage, the doctor should carefully observe the patient for the potential side effects.


Overdose treatment is symptomatic and supportive.


Tablets, 10 mg (round, scored on one side): 30's, 100's* (PVC/PVDC blister pack).
*Not currently marketed in Australia.


Store below 25°C. Protect from light.

Poison Schedule