5mg and 10 mg tablets
Medroxyprogesterone acetate
What Provera is and what it is used for
Provera contains medroxyprogesterone acetate. Medroxyprogesterone acetate is a synthetic hormone similar to the naturally occurring hormone progesterone that is formed in the ovary during the second half of the normal menstrual cycle.
Low dose Provera is used to treat menstrual disorders and also to treat menopausal symptoms.
Medroxyprogesterone acetate contained in Provera may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Provera
Do not use Provera
- if you are allergic to medroxyprogesterone acetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Provera if:
- you suffer from porphyria.
If bleeding occurs at a time other than the intended time, consult your treating physician, even if you experience severe headache or visual disturbance.
Other medicines and Provera
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Provera should not be used during pregnancy.
Provera passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if you use Provera more than temporarily during breastfeeding.
Driving and using machines
Provera has no or negligible influence on the ability to drive or perform precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
The sample contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Provera
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor who adjusts it individually for you.
If you use more Provera than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, always contact a doctor or hospital for risk assessment and advice.
If you forget to use Provera
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects more than 1 patient in 100): Weight gain, depression, headache, chest tightness, nausea, irregular bleeding, painful menstruation, accumulation of fluid in the body.
Uncommon (affects less than 1 patient in 100) :
Decreased sexual desire, acne, hair loss, and effects on liver function.
How to store Provera
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. day. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is medroxyprogesterone acetate. One tablet contains 5 mg and 10 mg medroxyprogesterone acetate, respectively.
– The other ingredients are lactose monohydrate 84.2 mg resp. 110 mg, corn starch, talc, sucrose 1.47 mg resp. 2 mg, liquid paraffin, calcium stearate.
5 mg tablets only: indigo carmine (dye E132).
What the medicine looks like and the contents of the pack
Appearance
5 mg tablets (round, blue, scored, 6.4 mm in diameter, marked U on one side and 286 on both sides with a scoreline on the other side).
10 mg tablets (round, white, scored, 7.1 mm in diameter, labeled UPJOHN 50).
Pack sizes
Pressure packaging, 5 mg tablets 40 pcs, 100 pcs
Pressure packaging, 10 mg tablets 10 pcs, 40 pcs, 100 pcs
Not all pack sizes and strengths may be marketed.
Marketing Authorisation Holder
PFIZER AB
191 90 Sollentuna
Phone: 08-550 520 00
Email: eumedinfo@pfizer.com