Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Provera Tablets 200 mg
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Medroxyprogesterone acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
–
2.
This medicine contains medroxyprogesterone acetate, which is one of a group of medicines called 'Progestogens'. Progestogens act like progesterone, a natural sex hormone. Medroxyprogesterone acetate can slow down the growth of certain tumours which are sensitive to hormones. Provera tablets are used in the treatment of cancer in the breast, kidney (in men and women) and in the lining of the womb (endometrial cancer). It is also used to treat cancer which has spread to other parts of the body (metastatic cancer) in post-menopausal women (women who have stopped having their periods). It is not expected that Provera Tablets will be used in children for the above indications. If you are not certain why you are being given this medicine, ask your doctor. You must talk to a doctor if you do not feel better or if you feel worse.
What you need to know before you take it
e Provera Tablets
Do not take Provera Tablets:
- If you are hypersensitive (allergic) to medroxyprogesterone acetate or other similar hormone medicines or any of the other ingredients of this medicine (listed in section 6).
- If you have liver problems
- If you have a heart condition where you feel pain in your chest when you exert yourself (angina) or have had a heart attack or if you have been told that you are at risk of developing cardiovascular diseases
- If you have raised levels of calcium in the blood (hypercalcaemia) associated with metastasised bone cancer
- If you have suspected or recently diagnosed breast cancer for the first time
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If you have undiagnosed vaginal bleeding If you have past or recent blood clot disorders, including deep vein thrombosis (DVT), pulmonary embolism (clot(s) in the lung), thrombophlebitis (inflammation of the blood vessels) or if you have been told that you are at risk of developing these conditions If you have a history of a condition known as porphyria (a hereditary blood disorder) If you have a missed abortion (where the woman's body does not expel the dead foetus), miscarriage or pregnancy.
Warnings and precautions Talk to your doctor or pharmacist if you have or have ever had any of the following conditions to help him or her decide if Provera Tablets are suitable for you:
- fluid retention
- diseases that affect the heart and blood vessels (cardiovascular disease)
- epilepsy
- migraine headaches
- sudden vision disturbance
- asthma
- liver or kidney problems
- diabetes
- a meningioma (a usually benign tumour that forms in the layers of tissue that cover your brain and spinal cord)
- depression or a history of depression
- hyperlipidaemia (raised levels of fat in the blood)
- if you are taking or have recently taken any other medicines, even those not prescribed
- jaundice (a condition which causes the skin or whites of the eye to appear yellow)
- a significant increase in high blood pressure
- hormonal imbalance Treatment with Provera Tablets may cause you to have symptoms associated with Cushing's syndrome. Meningioma Use of medroxyprogesterone acetate has been linked to the development of a usually benign tumour of the tissue surrounding the brain and spinal cord (meningioma). The risk increases especially when you use it for longer duration (several years). If you are diagnosed with meningioma, your doctor will reconsider your treatment with Provera Tablets. If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straightaway. Risk of Venous Thromboembolism (VTE) All women have a small chance of having a blood clot in the veins of the leg, in the lung or other parts of the body. The chances of getting a clot are very slightly increased if you are taking a hormone medicine like Provera Tablets. You are more likely to get a clot whether or not you are taking Provera Tablets if you:
- are very overweight
- have relatives who have had blood clots
- have had a blood clot in the veins or lungs before
- are unable to move for long periods of time (for example after an operation)
- have a serious injury or have major surgery
- have a history of repeated miscarriage (See section 4 on 'Possible side effects' for more information on the warning signs of blood clots).
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Tell your doctor if you have just had an operation or if you are going to have an operation while taking Provera Tablets. Other medicines and Provera Tablets: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some drugs may affect the action of Provera Tablets in your body. Tell your doctor or pharmacist if you are taking:
- anticonvulsants like phenobarbital, phenytoin, carbamazepine for epilepsy (fits)
- anti-infective medicines like rifampicin, rifabutin, efavirenz or nevirapine for infections caused by bacteria and yeast
- ritonavir and nelfinavir, sometimes used to treat HIV and AIDS
- cytotoxic drugs (drugs that kill cancerous cells)
- ciclosporin for suppressing the immune system
- herbal preparations containing St. John's wort
- aminoglutethimide sometimes used in Cushing's syndrome
- anticoagulants like warfarin for thinning the blood
- pain killers like aspirin, ibuprofen or naproxen and vasodilators like hydralazine, minoxidil may affect the way Provera Tablets work. Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Avoid becoming pregnant while being treated with Provera Tablets. This medicine must not be taken if you are pregnant as hormonal medicines may affect the developing baby. Tell your doctor if you have had an abortion or missed a period during treatment. Your doctor may give you a pregnancy test before starting treatment. If you are sexually active, you are advised to use effective birth control to prevent pregnancy while taking Provera Tablets. Breast-feeding You should stop breast feeding before starting treatment with Provera Tablets as this medicine may be harmful to infants being breast-fed. You should wait at least 6 weeks after your baby has been born before you start using Provera Tablets as it is transferred to breastmilk. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding. Fertility After finishing treatment with Provera Tablets women may experience a delay before they are able to become pregnant. Driving and using machines There are no special precautions, and you can drive or operate machines as long as you feel well and able to do so. Laboratory Tests: Please inform your doctor if you need to have any blood tests or gynaecological assessment, as Provera Tablets may affect their results. Provera Tablets contain sodium benzoate and sodium This medicine contains 0.139 mg (100 mg tablet), 0.278 mg (200 mg tablet), 0.555 mg (400 mg tablet) sodium benzoate in each tablet. Sodium benzoate may increase jaundice
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(yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). However, this medicine is normally only used by adults, this warning is only included for completeness. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. 3.
How to take it
Provera Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You will be closely monitored and regularly assessed before and during your treatment with Provera Tablets, especially if you are prescribed large doses of the tablet. Cancer of the Endometrium (womb lining) and Kidney: The usual dose is 200 mg to 600 mg a day. Breast Cancer: The usual dose is 400 mg to 1500 mg a day. The chance of having a minor side effect, such as indigestion and weight gain, increases as the dose increases. Swallow each tablet whole. Take your tablets at the same time each day. Follow your doctors' instructions. These can be found in the label of your pack. If you are not sure ask your doctor. Treatment may be required for 8 to 10 weeks before any effect can be found. If you take more Provera Tablets than you should If you take too many Provera tablets, contact your doctor straight away. If you forget to take Provera Tablets If you forget to take your dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Provera Tablets Do not stop taking your medicine or alter the dose you are currently taking without seeing your doctor first. It is important to keep taking your medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause some side effects although not everybody gets them. Reasons for stopping Provera Tablets immediately If you experience any of the symptoms mentioned below, you should stop taking Provera tablets and seek emergency medical help immediately. Uncommon side-effects: may affect up to 1 in 100 people
- increased symptoms of diabetes mellitus (e.g feeling thirsty, passing urine more frequently)
- heart failure (e.g shortness of breath, swelling in legs)
- swelling in the veins due to blood clots
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• •
blood clots, including clots in the lung (e.g pain and swelling in legs, sudden shortness of breath, sudden, severe, sharp pain in your chest, coughing up blood, heart beating more rapidly, any part of your body feeling weak or numb or unable to move) raised blood calcium levels (hypercalcaemia)
Rare side-effects: may affect up to 1 in 1,000 people Your treatment will be discontinued if you have any of the following rare symptoms:
- yellowing of the skin or whites of the eyes or liver problems
- significant increase in blood pressure
- new onset of migraine-type headache
- allergic reaction (wheezing, difficulty breathing, feeling faint, swelling of the face or tongue, swelling of the hands and feet, intense itchy skin rash)
- heart attack (chest pain, tightness or pressure in the chest, shortness of breath)
- stroke (severe or long headache, sight is affected in any way, difficulty speaking, collapse, fainting)
- deep-vein thrombosis (DVT) (pain, tenderness or swelling in your calf, ankle or foot, purple discolouration of the skin of the leg or the skin becomes red and warm to touch) Not known: frequency cannot be estimated from the available data
- unusual vaginal bleeding
- loss of vision
- sudden onset of enlarged eyeball
- double vision
- migraine
- severe allergic reaction (anaphylactic reaction)
- nettle rash or hives
- meningioma (a usually benign tumour of the tissue surrounding the brain and spinal cord) (see section 2 "Warnings and precautions")
- palpitation If you get any other side effects reported with Provera tablets these should be discussed with your doctor. Side-effects may include the following: Common side-effects: may affect up to 1 in 10 people
- impotence
- difficulty sleeping
- tiredness
- dizziness
- tremors
- effects like fine hand tremors
- headache
- vomiting
- constipation
- feeling sick
- weight fluctuation
- change in appetite
- sweating
- fluid retention Uncommon side-effects: may affect up to 1 in 100 people
- breast pain and tenderness
- unexpected or unusual vaginal bleeding or spotting
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• • • • • • • • •
changes in libido (sex drive) euphoria (a state of extreme well-being and pleasure) depression muscular cramps diarrhoea dry mouth acne facial hair growth Cushingoid syndrome (e.g. puffiness, moon face, weight gain)
Rare side-effects: may affect up to 1 in 1,000 people
- nervousness
- drowsiness
- hair loss
- rash
- decreased sugar tolerance
- fever
- any part of your body feels weak or numb or cannot move Not known: frequency cannot be estimated from the available data
- stopping or extended break of your periods and vaginal discharge
- milky discharge from the breast when not pregnant or breastfeeding
- confusion
- loss of concentration
- vision disorders
- cloudy vision
- cramps in calves at night
- glucose present in urine
- raised white blood cells and platelets Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Provera Tablets
Keep this medicine out of the sight and reach of children. The unopened bottles should be stored in the original container until ready for use.
- Provera 100 mg Tablets: Store below 25 ̊C.
- Provera 200 mg Tablets: Store below 25 ̊C.
- Provera 400 mg Tablets: Store at room temperature (15 ̊C – 30 ̊C). Provera Tablets should not be used after the expiry date printed on the blister or bottle label and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6.
Contents of the pack and other information
What Provera Tablets contain Each Provera Tablet contains either 100 mg, 200 mg or 400 mg of the active ingredient medroxyprogesterone acetate. Provera Tablets also contain the following inactive ingredients: microcrystalline cellulose, maize starch, byco C, macrogol 400, sodium starch glycollate, docusate sodium, sodium benzoate (E 211) and magnesium stearate. See section 2 "Provera Tablets contain sodium benzoate and sodium". What Provera Tablets look like and contents of the pack Provera Tablets are available in the following pack sizes: Provera 100 mg Tablets: 30, 60 and 100 tablets in blister strips and 100 tablets in bottle. Provera 200 mg Tablets: 30 and 100 tablets in blister strips and 100 tablets in bottle. Provera 400 mg Tablets: 30 tablets in blister strips and 60 tablets in bottle. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ UK Manufacturer: Pfizer Italia S.r.l. Località Marino del Tronto 63100 Ascoli Piceno (AP) Italy Company Contact Address: For further information on this medicine, please contact Medical Information at Pfizer Limited in Walton Oaks, Tadworth, Surrey, UK. Tel.: 01304 616161 This leaflet was last revised in 10/2025. Ref: PV HD 12_2
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Frequently asked questions about Provera Tablets 200 mg
How do I take Provera Tablets 200 mg?
Provera Tablets 200 mg comes as tablet containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Provera Tablets 200 mg?
The active substance in Provera Tablets 200 mg is medroxyprogesterone acetate.
Are there equivalent medicines to Provera Tablets 200 mg?
Medicines with the same active substance, strength and form include: Medroxyprogesterone Acetate 200 mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Provera Tablets 200 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Provera Tablets 200 mg without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: medroxyprogesterone acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Progestogen indicated for the treatment of certain hormone dependant neoplasms, such as:
1. Endometrial carcinoma.
2. Renal cell carcinoma.
3. Carcinoma of breast in post menopausal women.
4.2. Posology and method of administration
Posology
Adults
Endometrial and renal cell carcinoma
200 - 600 mg daily
Breast carcinoma
400 - 1500 mg daily
The incidence of minor side-effects, such as indigestion and weight gain, increases with the increase in dose.
Response to hormonal therapy may not be evident until after at least 8-10 weeks of therapy.
Elderly patients: This product has been used primarily in the older age group for the treatment of malignancies. There is no evidence to suggest that the older age group is any less prepared to handle the drug metabolically than is the younger patient. Therefore, the same dosage, contra-indications, and precautions would apply to either age group.
Paediatric population: The product is not anticipated for paediatric use in the indications recommended.
Method of administration
For Oral use.
4.3. Contraindications
Medroxyprogesterone acetate is contraindicated in the following conditions:
• thrombophlebitis, thromboembolic disorders, and where there is a high risk of developing such manifestations [presence or history of atrial fibrillation, valvular disorders, endocarditis, heart failure, pulmonary embolism; thromboembolic ischaemic attack (TIA), cerebral infarction; atherosclerosis; immediate post surgery period]
• hypercalcaemia in patients with osseous metastases
• hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• impaired liver function or active liver disease
• missed abortion, metrorrhagia, known or suspected pregnancy
• undiagnosed vaginal bleeding
• previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism)
• active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
• suspected or early breast carcinoma
Progestogens are known to be porphyrogenic. Patients with a history of attacks or aged under 30 are at greatest risk of an acute attack while on progesterone treatment. A careful assessment of potential benefit should be made where this risk is present.
4.4. Special warnings and precautions for use
Warnings:
In the treatment of carcinoma of breast occasional cases of hypercalcaemia have been reported.
Unexpected vaginal bleeding during therapy with medroxyprogesterone acetate should be investigated.
Medication should not be readministered 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 not be readministered.
Medroxyprogesterone acetate may produce Cushingoid symptoms.
Some patients receiving medroxyprogesterone acetate may exhibit suppressed adrenal function. Medroxyprogesterone acetate may decrease ACTH and hydrocortisone blood levels.
Treatment with medroxyprogesterone acetate should be discontinued in the event of:
• jaundice or deterioration in liver function
• significant increase in blood pressure
• new onset of migraine-type headache
Meningioma
Cases of meningioma (single and multiple) have been reported in patients treated with
medroxyprogesterone acetate for a prolonged time (several years). If a patient is diagnosed with meningioma, the need for further treatment with medroxyprogesterone acetate should be carefully considered on a case-by-case basis taking into account individual benefits and risks. In some cases, shrinkage of meningioma was observed after treatment discontinuation of depot medroxyprogesterone acetate.
Caution is advised when recommending medroxyprogesterone acetate to patients with a history of meningioma.
Precautions:
Animal studies show that medroxyprogesterone acetate possesses adrenocorticoid activity. This has also been reported in man, therefore, patients receiving large doses continuously and for long periods should be observed closely for signs normally associated with adrenocorticoid therapy, such as hypertension, sodium retention, oedema, etc. Care is needed in treating patients with diabetes and/or arterial hypertension.
Before using medroxyprogesterone acetate, the general medical condition of the patient should be carefully evaluated.
This product should be used under the supervision of a specialist and the patient kept under regular surveillance.
Patients with the following conditions should be carefully monitored while taking progestogens:
• Conditions which may be influenced by potential fluid retention
o
Epilepsy
o
Migraine
o
Asthma
o
Cardiac dysfunction
o
Renal dysfunction
• History of mental depression
• Diabetes (a decrease in glucose tolerance has been observed in some patients).
• Hyperlipidaemia
The pathologist (laboratory) should be informed of the patient's use of medroxyprogesterone acetate if endometrial or endocervical tissue is submitted for examination.
The physician/laboratory should be informed that medroxyprogesterone acetate may decrease the levels of the following endocrine biomarkers:
• Plasma/urinary steroids (e.g. cortisol, oestrogen, pregnanediol, progesterone, testosterone)
• Plasma/urinary gonadotrophins (e.g. LH and FSH)
• Sex-hormone-binding-globulin
The use of medroxyprogesterone acetate in oncology indications may also cause partial adrenal insufficiency (decrease in pituitary-adrenal axis response) during Metyrapone testing. Thus, the ability of adrenal cortex to respond to ACTH should be demonstrated before metyrapone is administered.
Although medroxyprogesterone acetate has not been causally associated with the induction of thromboembolic disorders, any patient with a history or who develops this kind of event while undergoing therapy with medroxyprogesterone acetate should have her status and need for treatment carefully assessed before continuing therapy.
Risk of venous thromboembolism (VTE)
The risk of VTE has not been assessed for progesterone alone. However, VTE is a known risk factor of oestrogen-only and combined hormone replacement therapy. When prescribing medroxyprogesterone acetate for oncology indications the following precautions and risk factors should be considered in the light of the patient's condition, the dose of medroxyprogesterone acetate and the duration of therapy:
• Generally recognised risk factors for VTE include a personal or family history of VTE or known thromboembolic states, severe obesity (BMI > 30 kg/m2) and systemic lupus erythematosus
• The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery.
• If VTE develops after initiating therapy, medroxyprogesterone acetate should be discontinued. Patients should be told to contact their doctor immediately if they become aware of a symptom suggestive of potential thromboembolism (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Excipient Information
Each 200 mg tablet contains 0.278 mg sodium benzoate (see section 2). Benzoates may increase unconjugated bilirubin levels by displacing bilirubin from albumin, which may increase neonatal jaundice. Neonatal hyperbilirubinaemia may lead to kernicterus (non-conjugated bilirubin deposits in the brain tissue) and encephalopathy. However, this medicinal product is not indicated for use in children and this warning is only included for completeness.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
4.5. Interaction with other medicinal products and other forms of interaction
Interaction with other medicinal products
The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. These compounds include anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz,).
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of progestogens. Progestogen levels may therefore be reduced.
Aminoglutethimide has been reported to decrease plasma levels of some progestogens.
Concurrent administration of ciclosporin and MPA has been reported to lead to increased plasma ciclosporin levels and/or decreased plasma MPA levels.
Interactions with oral anti-coagulants have been reported rarely, but causality has not been established.
When used in combination with cytotoxic drugs, it is possible that progestogens may reduce the haematological toxicity of chemotherapy.
Special care should be taken when progestogens are administered with other drugs which also cause fluid retention, such as NSAIDs and vasodilators.
Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted and therefore, the clinical effects of CYP3A4 inducers or inhibitors are unknown.
Other forms of interaction
Progestogens can influence certain laboratory tests (e.g. tests for hepatic function, thyroid function and coagulation).
4.6. Fertility, pregnancy and lactation
Fertility
MPA at oral doses may inhibit ovulation.
Women may experience a delay in return to fertility (conception) following discontinuation of this medicine.
Pregnancy
Medroxyprogesterone acetate is contraindicated in women who are pregnant. Some reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female foetuses. If medroxyprogesterone acetate is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the foetus.
Infants from unintentional pregnancies that occur 1 to 2 months after injection of medroxyprogesterone acetate injectable suspension may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because pregnancies while on medroxyprogesterone acetate are uncommon.
Breast-feeding
Medroxyprogesterone acetate and/or its metabolites are secreted in breast milk.
In nursing mothers treated with medroxyprogesterone acetate injection 150 mg IM every 3 months, milk composition, quality, and amount are not adversely affected.
Neonates and infants exposed to MPA from breast milk have been studied for developmental and behavioural effects through puberty. No adverse effects have been noted.
However, due to limitations of the data regarding the effects of MPA in breastfed infants less than six weeks old, medroxyprogesterone acetate should be given no sooner than six weeks post-partum when the infant's enzyme system is more developed.
4.7. Effects on ability to drive and use machines
No adverse effect has been reported.
4.8. Undesirable effects
The table below provides a listing of adverse drug reactions with frequency based on all-causality data from 1337 patients who received MPA in 4 pivotal studies that evaluated efficacy and safety of MPA for oncology indications.
The following lists of adverse reactions are listed within the organ system classes, under headings of frequency (number of patients expected to experience the reaction), using the following categories:
Very common (≥1/10)
Common (≥1/100 to <1/10);
Uncommon (≥1/1000 to <1/100);
Rare (≥1/10,000 to <1/1000);
Very rare (<1/10,000);
Not known (cannot be estimated from the available data).
System Organ Class
Very Common
≥1/10
Common
≥ 1/100 to < 1/10
Uncommon
≥ 1/1000 to < 1/100
Rare
≥ 1/10,000 to < 1/1000
Very Rare
< 1/10,000
Frequency Not Known (cannot be estimated from available data)
Neoplasms benign, malignant and unspecified
Meningioma
Immune system disorders
Angioedema
Drug hypersensitivity
Anaphylactic reaction, Anaphylactoid reaction
Endocrine disorders
Corticoid-like effects
Prolonged anovulation
Metabolism and nutritional disorders
Weight fluctuation, Increased appetite
Diabetes mellitus exacerbated, Hypercalcaemia
Psychiatric disorders
Insomnia
Depression, Euphoria, Changes in libido
Nervousness
Confusion
Nervous system disorders
Headache, Dizziness, Tremors
Cerebral infarction, Somnolence
Loss of concentration, Adrenergic-like effects
Eye disorders
Retinal embolism and thrombosis, Cataract diabetic, Visual impairment
Cardiac disorders
Cardiac failure congestive
Myocardial infarction
Tachycardia, Palpitations
Vascular disorders
Thrombophlebitis
Embolism and thrombosis
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
Gastrointestinal disorders
Vomiting, Constipation, Nausea,
Diarrhoea, Dry mouth
Hepatobiliary disorders
Jaundice
Skin and subcutaneous tissue disorders
Hyperhidrosis
Acne, Hirsutism
Alopecia, Rash
Urticaria, Pruritus
Musculoskeletal and connective tissue disorders
Muscle spasms
Renal and urinary system disorders
Glycosuria
Reproductive system and breast disorders
Erectile dysfunction
Dysfunctional uterine bleeding (irregular, increase, decrease, spotting), Breast pain
Amenorrhoea, Uterine cervical erosions, Cervical discharge, Galactorrhoea
General disorders and administration site conditions
Oedema /fluid retention, Fatigue
Malaise, Pyrexia
Investigations
Glucose tolerance decreased, Blood pressure increased
Liver function test abnormal, White blood cell count increased, Platelet count increased
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No action required other than cessation of therapy.
💬 Ask about this leaflet
Ask anything about Provera Tablets 200 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Medroxyprogesterone acetate
- Depo-Provera 150mg/ml Injection Sterile suspension for injection
- Medroxyprogesterone Acetate 200 mg Tablets
- Medroxyprogesterone Acetate 10 mg Tablets
- Medroxyprogesterone Acetate 100 mg Tablets
- Medroxyprogesterone Acetate 2.5 mg Tablets
- Medroxyprogesterone Acetate 400 mg Tablets
- Medroxyprogesterone Acetate 5 mg Tablets
- Provera 100 mg Tablets
- Provera Tablets 10 mg
- Provera Tablets 2.5 mg
- Provera Tablets 400 mg
- Provera Tablets 5 mg
- SAYANA PRESS 104 mg/0.65 ml suspension for injection