PROVERA TABLETS 10MG

Active substance: MEDROXYPROGESTERONE ACETATE MICRONISED

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Provera

1. What Provera Tablets are and
what they are used for


®

2.5mg, 5mg, 10mg Tablets

FRONTE

Medroxyprogesterone acetate
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please
ask your doctor or pharmacist.
• This medicine has been prescribed for you
personally and you should not pass it on
to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet
1. What Provera Tablets are
and what they are used for
2. Before you take Provera Tablets
3. How to take Provera Tablets
4. Possible side effects
5. Storing Provera Tablets
6. Further information








Provera Tablets are one of a group
of medicines called ‘progestogens’.
Progestogens are similar to the natural female
hormone progesterone. Provera contains the
progestogen called medroxyprogesterone
acetate as the active ingredient.
Provera has several uses. You can take
Provera to treat or manage:
Heavy periods
Painful periods
Irregular periods or periods that are more
frequent than normal
Absence of periods
Mild to moderate endometriosis (where tissue
from your womb is found outside your womb)

2. Before you take 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:


are allergic to medroxyprogesterone acetate
or other similar hormone medicines, or to any
of the other ingredients of Provera tablets
(see Section 6 ‘Further information’ for more
details)

Taking Provera when you are not
having periods

4. Possible side effects

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 of
your menstrual cycle. A few days after you stop
taking the tablets you will usually have bleeding
like a period.

Reasons for stopping Provera treatment
immediately

RETRO

Your treatment will be repeated for three 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.

Taking Provera for endometriosis
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.

What do I do if I forget to take a tablet?
Take the tablet as soon as you remember, and
carry on taking the tablets at the normal times.

What if I take too many tablets at once?
If you take too many tablets, contact your doctor
straight away. Make sure that nobody else takes
your tablets.

Like all medicines Provera can cause side
effects, although not everyone gets them.

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 could all be warning
signs of thrombosis (a blood clot) which will
need urgent treatment.
• Sudden, severe, sharp pain in your chest
• Coughing up blood
• You suddenly become short of breath
• Your heart beats more rapidly
These are symptoms of a blood clot in the lungs
• 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 can be symptoms of a blood clot in the
brain (‘a stroke’)









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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
have now or have had in the past
breast cancer
have now or have had in the past blood clots
forming in your veins (venous thrombosis)
have now or have had in the past blood clots
forming in your arteries (arterial thrombosis)
have liver problems
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)

Take special care with Provera
Tell your doctor if you have any of the following
conditions to help him or her decide if Provera is
suitable for you:
• Epilepsy
• Migraine headaches
• Asthma
• Heart problems
• Kidney problems
• Diabetes
• Depression or a history of depression
• High blood pressure
• Liver problems
• Gallstones
• Systemic lupus erythematosus (SLE) = an allergic



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
These are symptoms of a deep-vein thrombosis
(DVT).

Other side effects
You can also get the following side effects with
medicines like Provera:
Effects on the reproductive system and
breasts: breast pain and tenderness, a milky
discharge from the breast when not pregnant or
breast-feeding (galactorrhoea).
Effects on the nervous system: headache,
depression, dizziness, fatigue, difficulty sleeping,
feeling sleepy, nervousness.
Effects on the stomach and intestines:
feeling sick.
Effects on your heart and circulation: blood
clots, including clots in the lung, and swelling in
the veins due to blood clots, stroke, heart attacks.
Effects on your skin, nose, throat or hair:
generalised itching, rash, hives, acne, excessive
hair growth on the face or body, hair loss.
Miscellaneous: fluid retention and swelling of
hands and ankles, weight changes, decreased
tolerance to sugars like glucose.

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condition which causes joint pain, skin rashes
and fever
• Hearing problems

this medicinal product.
Provera 2.5 mg tablets also contain sunset yellow
(E110) which may cause allergic reactions.

Risk of Venous Thromboembolism (VTE)

Taking other medicines

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.

Important information on some of the
ingredients of Provera Tablets
Provera Tablets contain lactose and sucrose
which 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

If you experience any of the above side
effects or notice any other unusual effects
not mentioned in the leaflet, tell your doctor
at once.

5. Storing Provera Tablets
Provera tablets should not be used after the
expiry date printed on the carton or blister strip.
Do not store your tablets above 25°C, and keep
your blister strips securely in the outer carton.
As with all medicines, keep the tablets out of the
sight and reach of children.

Tell your doctor or pharmacist if you are taking
any of the following medicines, as the effect of
Provera may be altered when they are taken at
the same time:
• 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
Tell your doctor or pharmacist if you are taking
any other medicines not listed above, including
those bought without a prescription.

Pregnancy
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 reliable as a contraceptive.

Breast-feeding
If you are breast-feeding, speak to your doctor
who will advise whether you should use an
alternative method of feeding your baby.

Driving and using machinery
No effect on the ability to drive or use machinery
has been seen with Provera.

3. How to take Provera Tablets
You should follow your doctor’s instructions
carefully. 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 after your last period began.
A few days after you stop taking the tablets you
will usually have bleeding like a period.
To stop your periods causing problems again,
your doctor may tell you to repeat this dose of
Provera during your next cycle. In some cases,
your doctor may also prescribe oestrogen to be
taken at the same time as Provera at doses of
Continued over...
5-10mg for 10 days.
4202095.07.9

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.

Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, United Kingdom.

6. Further information

Manufacturer:

What Provera looks like and contents of the pack
Provera 2.5mg tablets are orange and are available
in packs of 30 tablets.
Provera 5mg tablets are blue and are available in
packs of 10 or 100 tablets.
Provera 10mg tablets are white and are available
in packs of 10, 90 or 100 tablets.

Company Contact Address:

What Provera Tablets contains
The active ingredient is medroxyprogesterone
acetate, the tablets also contain the following
inactive ingredients:

Pfizer Italia S.r.l.,
Località Marino del Tronto,
63100 Ascoli Piceno (AP), Italy.
For further information on your medicine please
contact Medical Information at the following
address: Pfizer Limited, Walton Oaks, Dorking
Road, Tadworth, Surrey, KT20 7NS, UK.
Telephone: 01304 616161.
This leaflet was last revised in 07/2012
Ref: PV 7_0
4202095.07.9

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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