DEPO-PROVERA 150 MG / ML VIAL - patient leaflet, side effects, dosage

Patient leaflet - DEPO-PROVERA 150 MG / ML VIAL

Depo-Provera® 150 mg/ml Vial

Medroxyprogesterone acetate

Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any of the side effects, talk to your doctor, nurse or healthcare provider. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Dep-Provera 150 mg/ml Vial but will be referred to as Depo-Provera throughout this leaflet.

IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT DEPO-PROVERA

Depo-Provera is a very effective injectable contraceptive which gives 12 weeks continuous contraception with each injection. The effect is not reversible once the injection is given.

You must have injections of this contraceptive regularly every 12 weeks; otherwise you may risk becoming pregnant (see section 3).
Depo-Provera may not be suitable for every woman. You will need to discuss with your doctor or healthcare professional providing your contraception on whether it is suitable for you, especially if you wish to use it for more than 2 years (See section 1).
Depo-Provera may not be suitable for you if you have a history of certain medical conditions (see section 2) or if you are taking a medicine called aminoglutethiamide that thins the blood (see section 2). Your doctor or nurse should take a full medical history before prescribing Depo-Provera.
Regular use of Depo-Provera causes a gradual loss of bone mineral density (see section 4). For a small number of patients that were followed-up, the average bone mineral density returned to average 1–3 years after they stopped using Depo-Provera. Teenagers who are rapidly developing their bones may be at particular risk and should only use Depo-Provera if other methods of contraception have been discussed and considered unsuitable or unacceptable.
Your doctor may plan to conduct a general medical as well as a gynaecological examination before they decide to prescribe Depo-Provera for you and may request you to visit the clinic for similar examinations at appropriate intervals thereafter.

What is in this leaflet

1. What Depo-Provera is and what it is used for
2. What you need to know before you use Depo-Provera
3. How to use Depo-Provera
4. Possible side effects
5. How to store Depo-Provera
6. Contents of the pack and other information

1. what depo-provera is and what it is used for

Depo-Provera is indicated for long-term female contraception for at least 12 weeks (+/- 5 days). This medicine contains the active substance medroxyprogesterone acetate (MPA), which is one of a group of medicines called ‘Progestogens’. It is similar to (but not the same as) the natural hormone, progesterone that is produced in the ovaries during the second half of your menstrual cycle.

Depo-Provera acts by preventing an egg from fully developing and being released from the ovaries during your menstrual cycle. If an egg is not released it cannot become fertilised by sperm and result in pregnancy. Depo-Provera also causes changes in the lining of your womb that makes it less likely for pregnancy to occur. It also thickens the mucus at the entrance of the womb, making it more difficult for sperm to enter.

Depo-Provera can be used:

For long-term contraception where you and the person who provides your contraception (e.g. your doctor or healthcare professional) have decided that this method is the most suitable for you.
If you wish to use Depo-Provera for more than 2 years your doctor or healthcare professional may wish to re-evaluate the risks and benefits of using Depo-Provera to make sure that it is still the best option for you.
In teenagers only after other methods of contraception have been discussed with the healthcare professional who provides your contraception and considered to be unsuitable or unacceptable.
For just one or two occasions in the following cases:
if your partner is undergoing a vasectomy, to give you protection until the vasectomy becomes effective
if you are being immunised against rubella, to prevent pregnancy during the period of activity of the virus
if you are awaiting sterilisation.

2. what you need to know before you use depo-provera do not use depo-provera

If you are allergic (hypersensitive) to the active ingredient (MPA) or any of the other ingredients (listed in section 6). There is a small risk of a severe allergic reaction to Depo-Provera that will require emergency medical treatment.
If you think you may be pregnant.
If you have had, or think you may have, hormone-dependent cancer of the breast or reproductive organs.
If you have unexplained bleeding from the womb (uterus).
If you have liver disease.
If you have not yet started your periods.

Warnings and precautions

Talk to your doctor or healthcare professional before using Depo-Provera.

Your doctor will ask about you and your family’s medical problems, check your blood pressure and exclude the likelihood of you being pregnant. You may also need other checks, such as a breast examination, but only if these examinations are necessary for you, or if you have any special concerns. It is important to tell your doctor or healthcare professional if you have, or have had in the past, any of the following conditions. Your doctor will then discuss with you whether Depo-Provera is suitable for you.

Migraine headaches – if you develop migraine you should consult your doctor before receiving further injections of Depo-Provera
Diabetes or a family history of diabetes
Severe pain or swelling in the calf (indicating a possible clot in the leg, which may be called phlebitis)
Blood clotting disorders such as deep vein thrombosis (blood clot in the legs), pulmonary embolus (blood clot in the lung) or a stroke you should not receive further injections of Depo-Provera
Problems with your eyesight while using Depo-Provera; for example a sudden partial or complete loss of vision or double vision
Past history of or current depression
Problems with your liver or liver disease
Problems with your kidneys or kidney disease
History of heart disease or cholesterol problems including any family history
If you have recently had a ‘hydatidiform mole’ which is a type of abnormal pregnancy
Asthma
Epilepsy
If you are using certain medicines such as high dose glucocorticoids (steroids), anti-epileptics, and thyroid hormones. Tell the person who provides your contraception if you are taking these or any other medicines – they may recommend a more suitable method of contraception.

Depo-Provera® 150 mg/ml (medroxyprogesterone acetate) Sterile Suspension for Injection

The following information is intended for medical or healthcare professionals only:

(For further information, consult the Summary of Product Characteristics.) Dosage:

Each ml of suspension contains 150 mg medroxyprogesterone acetate. The sterile aqueous suspension of Depo-Provera should be vigorously shaken just before use to ensure that the dose being given represents a uniform suspension of Depo-Provera. Doses should be given by deep intramuscular injection into the buttock or arm.

Care should be taken to ensure that the depot injection is given into the muscle tissue, preferably the gluteus maximus, but other muscle tissue such as the deltoid may be used and the site of injection should be cleansed using standard methods prior to administration of the injection.

Assembly of syringe for single use:

1. Shake the vial vigorously to give a uniform suspension.
2. Remove the protective cap from the vial. Wipe the top of the vial thoroughly with an alcohol swab.
3. Prepare a needle with syringe using aseptic technique.
4. Using the prepared syringe, draw out the suspension from the vial using aseptic technique.
5. The syringe is now ready for use.

Psychiatric disorders

Some women using hormonal contraceptives including Depo-Provera have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

Possible effect on your periods

Depo-Provera will usually disturb the pattern of a woman’s period. After the first injection it is most likely that you will have irregular, possibly lengthy bleeding or spotting. This will continue in some women. This is quite normal and nothing to worry about.

One third of women will not have any bleeding at all after the first injection. After 4 injections, most women find that their periods have stopped completely. Not having periods is nothing to worry about. If you experience very heavy or prolonged bleeding you should talk to your doctor. This happens rarely but can be treated.

When you stop taking Depo-Provera your periods will return to normal in a few months.

Possible effects on your bones

Depo-Provera works by lowering levels of oestrogen and other hormones. However, lower oestrogen levels can cause bones to become thinner (by reducing bone mineral density). Women who use Depo-Provera tend to have lower bone mineral density than women of the same age who have never used it. The effects of Depo-Provera are greatest in the first 2–3 years of use. Following this, bone mineral density tends to stabilise and there appears to be some recovery of bone density when Depo-Provera is stopped. It is not yet possible to say whether Depo-Provera increases the risk of osteoporosis (weak bones) and fractures in later life (after the menopause).

The following are risk factors in the development of osteoporosis in later life. You should discuss with your doctor before starting treatment if you have any of the following as an alternative contraceptive may be more suitable to your needs;

Chronic alcohol and/or tobacco use
Chronic use of drugs that can reduce bone mass, e.g. epilepsy medication or steroids
Low body mass index or eating disorder, e.g. anorexia nervosa or bulimia
Previous low trauma fracture that was not caused by a fall
Strong family history of osteoporosis.

Teenagers (up to 18 years)

Normally, the bones of teenagers are rapidly growing and increasing in strength. The stronger the bones are when adulthood is reached, the greater the protection against osteoporosis in later life. Since Depo-Provera may cause teenage bones to become thinner at a time when they should be growing, its effect may be particularly important in this age group. Bones start to recover when Depo-Provera is stopped, but it is not yet known whether the bone mineral density reaches the same levels as it would have if Depo-Provera had never been used. You should therefore discuss whether another form of contraception might be more suitable for you with the person who provides your contraception before starting Depo-Provera.

If you use Depo-Provera, it may help your bones if you take regular weight-bearing exercise and have a healthy diet, including an adequate intake of calcium (e.g. in dairy products) and vitamin D (e.g. in oily fish).

Possible risk of cancer

Studies of women who have used different forms of contraception found that women who used Depo-Provera for contraception had no increase in overall risk of developing cancer of the ovary, womb, cervix or liver.

Possible risk of breast cancer

Breast cancer is rare among women under 40 years of age whether or not they use hormonal contraceptives. Depo-Provera may increase the risk of breast cancer slightly compared with women who have never used it. However, any excess risk is small in relation to the overall risk of breast cancer, particularly in young women.

Older women have a higher baseline risk of breast cancer and therefore the increase in the number of cases due to Depo-Provera is greater in older women than in younger women.

In absolute terms this means that:

A 15 year old who uses Depo-Provera for 5 years increases her chance of developing breast cancer by a negligible amount by the age of 30.

A 25 year old who uses Depo-Provera for 5 years increases her chance of developing breast cancer by the age of 40 from 44 cases per 10,000 women (without Depo-Provera use) to up to 47 cases per 10,000 women i.e. an extra 3 cases/10,000.

A 35 year old who uses Depo-Provera for 5 years increases her chance of developing breast cancer by the age of 50 from 160 cases per 10,000 women (without Depo-Provera use) to 170 cases per 10,000 women i.e. an extra 10 cases/10,000.

Possible risk of forming an abscess at the injection site

As with any intramuscular injection, there is a risk of an abscess forming at the site of injection. This may require medical or surgical attention.

Possible risk of weight gain

Some women gained weight while using Depo-Provera. Studies show that over the first 1–2 years of use, the average weight gain was 5–8 lbs. Women completing 4–6 years of therapy gained an average of 14–16.5 lbs.

Cervical smear testing

The results of a cervical smear and some laboratory tests could also be affected if you are using Depo-Provera so it is important that you tell your doctor.

Protection against sexually transmitted infections

Depo-Provera does not protect against HIV infection, e.g. AIDS and other sexually transmitted infections.

Safer sex practices, including correct and consistent use of condoms, reduce the transmission of sexually transmitted infections through sexual contact, including HIV.

You should seek advice from your healthcare professional on how to decrease your risk of catching sexually transmitted infections including HIV.

Other medicines and Depo-Provera

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or healthcare professional if you are taking a medicine called aminoglutethiamide or other medicines that thin your blood (anticoagulants) as these may affect the way Depo-Provera works.
Always tell your doctor or healthcare professional who treats you that you are using Depo-Provera as a contraceptive if you are taking or have recently taken any other medicines, even those you bought yourself without a prescription, because medicines can sometimes interact with each other.

Pregnancy, breast-feeding and fertility

Your doctor will check that you are not pregnant before giving you the first injection and also if any following injection is delayed beyond 89 days (12 weeks and 5 days).
Depo-Provera must not be taken if you are pregnant as hormonal medicines can affect the developing baby.
If you think you may have become pregnant while using Depo-Provera for contraception, tell your doctor immediately.

Effect on future fertility

Your usual level of fertility should return when the effect of the injection has worn off.
This takes different amounts of time in different women, and does not depend on how long you have been using Depo-Provera.

Administration: Adults

First injection: To provide contraceptive cover in the first cycle of use, an injection of 150 mg i.m. should be given during the first five days of a normal menstrual cycle. If the injection is carried out according to these instructions, no additional contraceptive cover is required. Postpartum: To increase assurance that the patient is not pregnant at the time of first administration, this injection should be given within 5 days postpartum if not breast-feeding.

There is evidence that women prescribed Depo-Provera in the immediate puerperium can experience prolonged and heavy bleeding. Because of this, the drug should be used with caution in the puerperium. Women who are considering use of the product immediately following delivery or termination should be advised that the risk of heavy or prolonged bleeding may be increased.

Doctors are reminded that in the non breast-feeding postpartum patient, ovulation may occur as early as week 4. If the puerperal woman will be breast-feeding, the initial injection should be given no sooner than six weeks postpartum, when the infant’s enzyme system is more fully developed. Further injections should be given at 12 week intervals.

Further doses: These should be given at 12 week intervals, however, as long as the injection is given no later than five days after this time, no additional contraceptive measures (e.g. barrier) are required. (NB For partners of men undergoing vasectomy a second injection of 150 mg i.m. 12 weeks after the first may be necessary in a small proportion of patients where the partner’s sperm count has not fallen to zero.)

In studies, over 80% of women trying to get pregnant conceived within 15 months of the last injection; however this varied from 4 months after the last injection to more than two years.
Some women have got pregnant as early as 14 weeks after their last injection.

If you are breast-feeding

Depo-Provera does not prevent the breast from producing milk so nursing mothers can use it; however, it is better for the baby that for the first few weeks after birth its mother’s milk contains no traces of any medicines, including Depo-Provera.
Your doctor or healthcare professional may advise that you wait until at least 6 weeks after your baby has been born before you start using Depo-Provera for contraception.
If a baby is exposed to Depo-Provera in the breast milk, no harmful effects have been seen in babies and children.

Driving and using machines

Depo-Provera may cause headaches and dizziness. Therefore be careful until you know whether this medicine affects your ability to drive or use machines. If you have any concerns discuss them with your doctor.

Depo-Provera contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg/ml, i.e. essentially ‘sodium-free’.

3. how to use depo-provera

This medicine will be given to you by your doctor or healthcare professional.

(The last section of this leaflet contains instructions for your doctor or healthcare professional on how they should do this.)

Depo-Provera is given every 12 weeks as a single intramuscular injection of 1 ml (150 mg medroxyprogesterone acetate) into the buttock or upper arm. The injection is given during the first 5 days after the beginning of a normal menstrual period.

Following childbirth the first Depo-Provera injection can be given within 5 days after childbirth if you are not breast-feeding.

Provided that the injection is given at the times stated above, then you are protected from pregnancy straight away and there is no need to take extra precautions.

Depo-Provera works as a contraceptive for 12 weeks in your body. There is no way of reversing the injection once it is given.

For effective contraceptive cover, Depo-Provera MUST be given every 12 weeks. Make sure that you or your doctor makes your next appointment for 12 weeks time.

The risk of heavy or pro-longed vaginal bleeding may be increased if Depo-Provera is used immediately following childbirth or termination of pregnancy.

If you forget an injection of Depo-Provera

If you forget your injection or are late getting your next injection (i.e. wait longer than 12 weeks between injections), there is a greater risk that you could become pregnant. Ask your doctor or healthcare professional to find out when you should receive your next injection of Depo-Provera and which type of contraception should be used in the meantime.

Switching from other methods of contraception

When you switch from other contraceptive methods, your doctor will make sure you are not at risk of becoming pregnant by giving you your first injection at the appropriate time. If you switch from oral contraceptives, you should have your first injection of Depo-Provera within 7 days after taking your last pill.

If you have any further questions on the use of this medicine, ask your doctor or healthcare professional.

4. possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

Seek medical help immediately if you notice any of the following side effects:

Hypersensitivity (allergic) reaction (it is not known how frequently this occurs) Symptoms include sudden skin rash, swelling of the face, lips, tongue or throat, wheezing or difficulty in breathing.
A blood clot in the lungs (this occurs rarely – may affect up to 1 in 1000 people) Symptoms include o Shortness of breath

o Breath-related chest pains

o Coughing up blood

A blood clot in the leg (this occurs rarely – may affect up to 1 in 1000 people)

Deep vein thrombosis (DVT) is a condition in which a blood clot forms in one of your deep veins, usually in your leg.

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

– You have pain, tenderness or swelling in your calf, ankle or foot
– You have painful or inflamed veins in your leg
– You find it difficult to put full weight on the affected leg
– You have purple discolouration of the skin of the leg or the skin becomes red and warm to touch.
Jaundice (yellowing of the skin or the whites of the eyes). Women who use Depo-Provera tend to have lower bone mineral density than women of the same age who have never used it. The effects of Depo-Provera are greatest in the first 2–3 years of use. Following this, bone mineral density tends to stabilise and there appears to be some recovery when Depo-Provera is stopped. It is not yet possible to say whether Depo-Provera increases the risk of osteoporosis (weak bones) and fractures in later life.

Other side-effects include:

Very common: may affect more than 1 in 10 people

nervousness
headache
stomach pain or discomfort
weight increase or decrease Common: may affect up to 1 in 10 people
depression
libido decreased (reduced sex drive)
dizziness
feeling sick
feeling bloated
hair loss
acne
back pain
vaginal discharge
breast tenderness
difficult or painful period
urinary tract infection
oedema/fluid retention
weakness

Uncommon: may affect up to 1 in 100 people

appetite increased or decreased
difficulty sleeping
convulsions (fits)
drowsiness
tingling
hot flush
liver disorder
facial hair growth
nettle rash or hives

If the interval from the preceding injection is greater than 89 days (12 weeks and five days) for any reason, then pregnancy should be excluded before the next injection is given and the patient should use additional contraceptive measures (e.g. barrier) for fourteen days after this subsequent injection.

Paediatric population (12–18 years): Depo-Provera is not indicated before menarche. Data in adolescent females (12–18 years) is available. Other than concerns about loss of BMD, the safety and effectiveness of Depo-Provera is expected to be the same for adolescents after menarche and adult females.

Switching from other Methods of Contraception: Depo-Provera should be given in a manner that ensures continuous contraceptive coverage. This should be based upon the mechanism of action of other methods (e.g. patients switching from oral contraceptives should have their first injection of Depo-Provera within 7 days of taking their last active pill). Hepatic Insufficiency: The effect of hepatic disease on the pharmacokinetics of Depo-Provera is unknown. As Depo-Provera largely undergoes hepatic elimination it may be poorly metabolised in patients with severe liver insufficiency (see Contraindications).

itchy skin
temporary brown patches
difficult or painful period
unexpected or unusual vaginal bleeding or spotting
milky discharge from the breast when not pregnant or breasfeeding
pelvic pain
painful intercourse
prevention of lactation

Rare: may affect up to 1 in 1,000 people

breast cancer
reduction in red blood cell
blood disorder
difficulty reaching orgasm
behaviour change
mood change
irritability
anxiety
migraine
paralysis
fainting
feeling of dizziness or spinning
heart beats more rapidly
high blood pressure
varicose veins
rectal bleeding
digestive disorder
liver enzyme disorder
accumulation of fat (at injection site)
inflammation of the skin
scar tissue formation
stretch marks
pain in a joint
muscular cramps
bone density decreased (osteoporosis)
vaginal pain or inflammation
stopping or extended break of your periods
breast pain
inflammation of the vagina
stopping or extended break of your periods
uterine bleeding or excessive bleeding
periods with abnormally heavy or prolonged bleeding
vaginal dryness
change in breast size
ovarian or vaginal cyst
premenstrual syndrome
excessive thickening of the lining of the womb
breast lump
nipple bleeding
delayed egg release with longer menstrual cycles (periods)
feel pregnant
fever
tiredness
injection site pain or tenderness
injection site lump or dimple
feeling thirsty
hoarseness
facial nerve paralysis
decreased sugar tolerance
abnormal smear

5. how to store depo-provera

Keep out of sight and reach of children.

Do not store above 25°C.

Do not freeze

Do not use Depo-Provera after the last day of the month shown in the expiry date stated on the vial and the carton.

The expiry date refers to the last day of that month

If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice f your pharmacist who will tell you what to do.

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.

6. contents of the pack and other information

What Depo-Provera contains:

The active ingredient in Depo-Provera is medroxyprogesterone acetate (MPA). Each ml contains 150 mg of medroxyprogesterone acetate. Also contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, macrogol 4000, sodium chloride, polysorbate and water for injections. Hydrochloric acid or sodium hydroxide may also be added when the product is being made to adjust the acidity or alkalinity of the product to the correct level.

What Depo-Provera looks like and contents of the pack:

Depo-Provera is a white sterile suspension. Each vial contains 1 millilitre (ml) of Depo-Provera. Depo-Provera is supplied in cartons containing one vial.

Manufacturer:

Pfizer Manufacturing Belgium NV/SA, Rijksweg 12, B-2870 Puurs Belgium.

Procured from within the EU. _______

Product Licence Holder: Ecosse Pharmaceuticals Limited, POM 3 Young Place, East Kilbride, G75 0TD. ------

Re-packaged by: Munro Wholesale Medical Supplies Limited., 3 Young Place, East Kilbride, G75 0TD.

PL: 19065/0467 Depo-Provera® 150 mg/ml Vial

This leaflet was revised: 19.05.2021

E0467/7 10.20

If you are blind or partially sighted and require this leaflet in a different format, call 01355 574450 and ask for the Regulatory Department.

® is a registered trademark of Pharmacia Ltd

Renal Insufficiency. The effect of renal disease on the pharmacokinetics of Depo-Provera is unknown. No dosage adjustment should be necessary in women with renal insufficiency, since Depo-Provera is almost exclusively eliminated by hepatic metabolism.

For patient records:

Product Licence Holder: Ecosse Pharmaceuticals Limited, 3 Young Place, East Kilbride, G75 0TD.