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 2.5 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
- Provera contains the active substance medroxyprogesterone acetate, which is one of a group of medicines called 'progestogens'. Progestogens are similar to the natural female hormone, progesterone.
- Provera has several uses. You can take Provera to treat or manage: o Heavy periods o Painful periods o Irregular periods or periods that are more frequent than normal o Absence of periods o Mild to moderate endometriosis (where tissue from your womb is found outside your womb) 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 Provera may not be suitable for all women. Please read the following list carefully to see if any of these apply to you. Consult your doctor if you are not sure. Do not take Provera if you: o are allergic to medroxyprogesterone acetate or other similar hormone medicines, or to any of the other ingredients of this medicine (listed in section 6) o are pregnant, or think you might be pregnant. Your doctor may give you a pregnancy test before starting treatment or if you miss a period during treatment. o have now or have had in the past breast cancer o have now or have had in the past blood clots forming in your veins (venous thrombosis) o have now or have had in the past blood clots forming in your arteries (arterial thrombosis) o have liver problems o have porphyria where your body lacks the ability to correctly produce certain enzymes and it manifests with either neurological complications or with skin problems (or occasionally both) Warnings and precautions
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Talk to your doctor or pharmacist before taking Provera Tablets if you have or have ever had any of the following conditions to help them decide if Provera is suitable for you:
- Epilepsy
- Migraine headaches
- Asthma
- Heart problems
- 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
- High blood pressure
- Liver problems
- Gallstones
- Systemic lupus erythematosus (SLE) = an allergic condition which causes joint pain, skin rashes and fever
- Hearing problems Provera, especially in high doses, may cause weight gain and fluid retention. 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 part of the body. The chances of getting a clot are very slightly higher if you are taking a hormone medicine like Provera. You are more likely to get a clot whether or not you are taking Provera if you:
- are very overweight
- have had a blood clot in the veins or lungs before
- have relatives who have had blood clots
- 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 Tell your doctor if you have just had an operation or if you are going to have an operation while taking Provera. Section 4 of this leaflet 'Possible side effects', also has more information on the warning signs of blood clots. Other medicines and Provera Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. The effect of Provera may be altered when taken at the same time as any of the following medicines:
- Aminoglutethimide, sometimes used in Cushing's syndrome
- Medicines for thinning the blood (e.g. warfarin)
- Medicines for treating convulsions (e.g. phenobarbital, phenytoin and carbamazepine)
- Ritonavir and nelfinavir, sometimes used to treat HIV and AIDS
- Medicines for treating infections (e.g. rifampicin, rifabutin, nevirapine, efavirenz)
- St John's wort, a herbal treatment for depression Pregnancy, breast-feeding and fertility 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. Page 2 of 6
Provera must not be taken if you are pregnant as hormonal medicines can affect the developing baby. It is important you use another method of contraception (e.g. a condom) while taking Provera, as it is not a contraceptive. Breast-feeding 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. If you are breast-feeding, speak to your doctor who will advise whether you should use an alternative method of feeding your baby. Fertility After finishing treatment with Provera Tablets women may experience a delay before they are able to become pregnant. Driving and using machines No effect on the ability to drive or use machines has been seen with Provera. Provera contain lactose monohydrate, sucrose and sunset yellow (E110) Lactose monohydrate and sucrose are types of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Provera 2.5 mg Tablets also contain sunset yellow (E110) which may cause allergic reactions.
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. The number of tablets will depend on the condition you are being treated for. This information can also be found on the label on the box the tablets come in. The following information will help you see what the usual dose is for a particular problem. Taking Provera for heavy or irregular bleeding and other period problems You will usually take 2.5mg-10mg for 5-10 days beginning 16 days to 21 days after your last period began. Treatment should be given for 2 consecutive cycles. In some cases, your doctor may also prescribe oestrogen to be taken at the same time as Provera at doses of 5-10mg for 10 days. A few days after you stop taking the tablets you may have bleeding like a period (breakthrough bleeding). Taking Provera when you have amenorrhoea (when you are not having periods) You will usually take 2.5mg-10mg for 5-10 days beginning on a day which has been calculated or assumed to represent Day 16 to Day 21 of your menstrual cycle. Repeat the treatment for 3 consecutive cycles. In some cases, your doctor may also prescribe oestrogen to be taken at the same time as Provera for 10 days. A few days after you stop taking the tablets, you may have bleeding like a period (breakthrough bleeding). Taking Provera for endometriosis (where tissue from your womb is found outside your womb) You will usually take 10mg 3 times a day (30mg) for 3 months (90 days) starting on the first day of your period. If you have any irregular spotting or bleeding during treatment this is normal and nothing to worry about. If you do not have a period after you finish a course of Provera, check with your doctor in case you are pregnant. If you forget to take Provera Page 3 of 6
Take the tablet as soon as you remember, and carry on taking the tablets at the normal times. Do not take a double dose to make up for a forgotten dose. If you take more Provera than you should If you take too many tablets, contact your doctor straight away. If you stop taking Provera 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 side effects, although not everyone gets them. Reasons for stopping Provera treatment immediately Rarely, Provera may cause a severe allergic reaction which can be life-threatening in some cases. You can get some or all of the following symptoms: wheezing, difficulty breathing, feeling faint, swelling of the face or tongue, hands and feet, intense itchy skin rash. If you think you are reacting badly to the medicine, get emergency medical help immediately. If you get any of the following symptoms, you should stop taking the tablets and see your doctor immediately. These are symptoms of a blood clot in the lungs which may all occur together:
- Sudden, severe, sharp pain in your chest
- Coughing up blood
- You suddenly become short of breath
- Your heart beats more rapidly These can be symptoms of a blood clot in the brain ('a stroke'):
- You have an unusually severe or long headache
- Your sight is affected in any way
- You find it difficult to speak
- You collapse or faint
- Any part of your body feels weak or numb These are symptoms of a deep-vein thrombosis (DVT):
- You have severe pain, tenderness or swelling in your calf, ankle or foot
- You have purple discolouration of the skin of the leg or the skin becomes red and warm to touch Tell your doctor if you get any other side effects reported with Provera which may include the following: Very common: may affect more than 1 in 10 people
- headache
- feeling sick
- unexpected or unusual vaginal bleeding or spotting Common: may affect up to 1 in 10 people
- severe allergic reaction to the drug (e.g. wheezing, difficulty breathing)
- depression
- difficulty sleeping Page 4 of 6
• • • • • • • • • • • •
nervousness dizziness hair loss acne nettle rash or hives itchy skin vaginal discharge breast pain breast tenderness fever tiredness weight increase
Uncommon: may affect up to 1 in 100 people
- Facial hair growth
- milky discharge from the breast when not pregnant or breastfeeding
- oedema/fluid retention Not known: frequency cannot be estimated from the available data
- severe allergic reaction (anaphylactic reaction)
- swelling in face/throat which may cause difficulty breathing
- delayed egg release with longer menstrual cycle (periods)
- drowsiness
- swelling in the veins due to blood clots
- tenderness or swelling in your calf, ankle or foot
- rash
- stopping or extended break of your periods
- abnormality of cervix
- decreased sugar tolerance
- weight decrease 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.
How to store it
Provera Tablets Keep this medicine out of the sight and reach of children. Provera tablets should not be used after the expiry date which is stated on the carton, blister strip or bottle label after EXP. The expiry date refers to the last day of that month. For the blister and carton presentation, do not store your tablets above 25°C. 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.
Contents of the pack and other information
What Provera looks like and contents of the pack Provera 2.5mg tablets are orange and are available in blisters containing 10, 30, 50, or 100 tablets or in bottles containing 100 tablets. Page 5 of 6
Provera 5mg tablets are blue and are available in packs of 10, 20 or 100 tablets or in bottles containing 100 tablets. Provera 10mg tablets are white and are available in packs of 10, 20, 30, 50, 90 or 100 tablets or in bottles containing 50 tablets. Not all pack sizes may be marketed. What Provera Tablets contains The active substance is medroxyprogesterone acetate. Each tablet contains either 2.5mg, 5mg or 10mg medroxyprogesterone acetate. The other ingredients are: 2.5 mg: Lactose monohydrate, sucrose, maize starch, liquid paraffin, talc, calcium stearate, sunset yellow (E110), purified water. 5 mg:
Lactose monohydrate, starch, sucrose, liquid paraffin, calcium stearate, talc, the colour FD & C Blue No. 2 Aluminium Lake, purified water.
10 mg:
Lactose monohydrate, sucrose, maize starch, liquid paraffin, talc, calcium stearate, purified water. Provera contain lactose monohydrate, sucrose and sunset yellow (E110). Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom. Manufacturer: Pfizer Italia S.r.l., Località Marino del Tronto, 63100 Ascoli Piceno (AP), Italy. Company Contact Address: For further information on your medicine, please contact Medical Information, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Telephone: 01304 616161. This leaflet was last revised in 02/2024. Ref: PV LD 11_0
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Frequently asked questions about Provera Tablets 2.5 mg
How do I take Provera Tablets 2.5 mg?
Provera Tablets 2.5 mg comes as tablet containing 2.5mg. 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 2.5 mg?
The active substance in Provera Tablets 2.5 mg is medroxyprogesterone acetate.
Are there equivalent medicines to Provera Tablets 2.5 mg?
Medicines with the same active substance, strength and form include: Medroxyprogesterone Acetate 2.5 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 2.5 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 2.5 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 dysfunctional (anovulatory) uterine bleeding, secondary amenorrhoea and for mild to moderate endometriosis.
4.2. Posology and method of administration
Posology
Adults:
Dysfunctional (anovulatory) uterine bleeding: 2.5 - 10 mg daily for 5 - 10 days commencing on the assumed or calculated 16th - 21st day of the cycle. Treatment should be given for two consecutive cycles. When bleeding occurs from a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate in doses of 5 - 10 mg for 10 days.
Secondary amenorrhoea: 2.5 - 10 mg daily for 5 - 10 days beginning on the assumed or calculated 16th to 21st day of the cycle. Repeat the treatment for three consecutive cycles. In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate in doses of 5 - 10 mg for 10 days.
Mild to moderate endometriosis: Beginning on the first day of the menstrual cycle, 10 mg three times a day for 90 consecutive days.
Elderly: Not applicable
Paediatric population: Not applicable
Method of administration
For oral use.
4.3. Contraindications
Known or suspected pregnancy;
Known, past or suspected breast cancer;
Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);
Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal;
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Porphyria
4.4. Special warnings and precautions for use
Medical Examination/Follow-Up
Before initiating or reinstituting therapy, a complete personal and family medical history should be taken. Physical (including pelvic) examination should be guided by this and by the contraindications (section 4.3) and warnings (section 4.4) for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman, but may include, if judged appropriate by the clinician, abdominal and pelvic examination. Women should be encouraged to participate in the national breast cancer screening programme (mammography) and the national cervical screening programme (cervical cytology) as appropriate for their age.
The possibility of genital tract pathology should be considered before commencing treatment in women with abnormal uterine bleeding, especially in women over 45, who may require gynaecological investigation.
A negative pregnancy test should be demonstrated before starting therapy (see section 4.6).
Doses of up to 30 mg a day may not suppress ovulation and patients should be advised to take adequate contraceptive measures, where appropriate.
Conditions which need Supervision
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with medroxyprogesterone acetate, in particular:
- A history of, or risk factors for, thromboembolic disorders (see below)
- Risk factors for oestrogen dependent tumours, e.g. 1 degree heredity for breast cancer
- Hypertension
- Liver disorders (e.g. liver adenoma)
- Diabetes mellitus with or without vascular involvement
- Cholelithiasis
- Migraine or (severe) headache
- Systemic lupus erythematosus.
- Epilepsy
- Asthma
- Otosclerosis
Meningiomas have been reported following long term administration of progestogens, including medroxyprogesterone acetate. This medicine should be discontinued if a meningioma is diagnosed. Caution is advised when recommending medroxyprogesterone acetate to patients with a history of meningioma.
Rare cases of thrombo-embolism have been reported with use of medroxyprogesterone acetate, especially at higher doses. Causality has not been established.
History or emergence of the following conditions require careful consideration and appropriate investigation: signs of a blood clot; migraine or unusually severe headaches or acute visual disturbances of any kind.
Medroxyprogesterone acetate, especially in high doses, may cause weight gain and fluid retention. With this in mind, caution should be exercised in treating any patient with a pre-existing medical condition, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, that might be adversely affected by weight gain or fluid retention.
Some patients receiving medroxyprogesterone acetate may exhibit a decreased glucose tolerance. The mechanism for this is not known. This fact should be borne in mind when treating all patients and especially known diabetics.
This product contains lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains the colour E110 which may cause allergic reactions.
Patients with a history of treatment for mental depression should be carefully monitored while receiving medroxyprogesterone acetate therapy. Some patients may complain of premenstrual like depression while on medroxyprogesterone acetate therapy.
Reasons for Immediate Withdrawal of Therapy:
Therapy should be discontinued in case a contraindication is discovered and in the following situations:
- Jaundice or deterioration in liver function
- Significant increase in blood pressure
- New onset of migraine-type headache
4.5. Interaction with other medicinal products and other forms of interaction
Aminoglutethimide administered concurrently with medroxyprogesterone acetate may significantly depress the bioavailability of medroxyprogesterone acetate.
Interactions with other medicinal treatments (including oral anti-coagulants) have rarely been reported, but causality has not been determined. The possibility of interaction should be borne in mind in patients receiving concurrent treatment with other drugs.
The metabolism of progestogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
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.
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.
Clinically, an increased metabolism of progestogens may lead to decreased effect.
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 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 Phase 3 clinical studies that evaluated efficacy and safety of DMPA in gynaecology. Those most frequently (>5%) reported adverse drug reactions were dysfunctional uterine bleeding (19%), headache (12%) and nausea (10%).
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)
Immune system disorders
Drug hypersensitivity
Anaphylactic reaction, Anaphylactoid reaction, Angioedema
Endocrine disorders
Anovulation
Psychiatric disorders
Depression, Insomnia, Nervousness
Nervous system disorders
Headache
Dizziness
Somnolence
Vascular disorders
Embolism and thrombosis
Gastrointestinal disorders
Nausea
Skin and subcutaneous tissue disorders
Alopecia, Acne, Urticaria Pruritus
Hirsutism
Rash
Reproductive system and breast disorders
Dysfunctional uterine bleeding (irregular, increase, decrease, spotting)
Cervical discharge, Breast pain, Breast tenderness
Galactorrhoea
Amenorrhoea, Uterine cervical erosion
General disorders and administration site conditions
Temperature elevation, Fatigue
Oedema, Fluid retention
Investigations
Weight increased
Glucose tolerance decreased, Weight decreased
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
In animals medroxyprogesterone acetate has been shown to be capable of exerting an adreno-corticoid effect, but this has not been reported in the human, following usual dosages. The oral administration of medroxyprogesterone acetate at a rate of 100 mg per day has been shown to have no effect on adrenal function.
💬 Ask about this leaflet
Ask anything about Provera Tablets 2.5 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 200 mg
- Provera Tablets 400 mg
- Provera Tablets 5 mg
- SAYANA PRESS 104 mg/0.65 ml suspension for injection