Depo-Provera 150mg/1ml suspension for injection pre-filled syringes

Depo-Provera contains a hormone which is similar to the hormone progesterone that is produced by the body. It is used to prevent women from becoming pregnant. Depo-Provera is a long-term contraceptive and is given as an injection once every 12 weeks. Depo-Provera is only used as a short-term method of contraception in certain circumstances. These circumstances include those women who are awaiting sterilisation, have just had a rubella vaccine or women whose partners are waiting to find out if their vasectomy has been successful.

Depo-Provera is usually given during the first five days of a menstrual period, or for contraception within five days of your baby's birth if you are not breast feeding. If given at any other time, then you may need to take extra contraceptive precautions until it starts to work. Ask your prescriber or family planning nurse or read the patient information leaflet that comes with your medicine for more information.

Further injections are usually given at intervals of 12 weeks and within 89 days of the previous injection to prevent the need for further contraceptive measures. If given at any other time, then you may need to take extra contraceptive precautions until Depo-Provera starts to work. Ask your prescriber or family planning nurse or read the patient information leaflet that comes with your medicine for more information.

You and your prescriber or family planning nurse should carefully weigh the risks and benefits of having this form of contraception. It is important you understand that the effects of Depo-Provera last for 12 weeks and it is impossible to immediately reverse the effects of the medicine once you have been given an injection.

Once the effect of the injection has worn off, it may take time for fertility to return. This means it may take a while before you can conceive. The time it takes for women to become pregnant when they stop having Depo-Provera varies in different women. For more information ask your prescriber or family planning nurse or read the patient information leaflet that comes with your medicine.

Depo-Provera helps provide contraception but it may also increase the chances of getting breast cancer. Depo-Provera also causes bone loss as it reduces levels of oestrogens in the body. Oestrogens help prevent bone loss and slow down the development of osteoporosis. Depo-Provera is not suitable as a contraceptive in children and adolescents or for women who want to use it for long periods of time. If you are at risk of having osteoporosis or bone fractures, it is important you discuss with your doctor if there are any other forms of contraception you could use instead of Depo-Provera.

Depo-Provera is usually given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber or someone involved in your medical care.

Your prescriber or family planning nurse will advise you when you need to have your injections. It is usually only given every 12 weeks. It is a good idea to make a note of the date that your next injection is due so that you do not miss any of your appointments.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Depo-Provera, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

If you are not having any problems with this medicine, keep having the injections until you no longer need this form of contraception.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

The medical team will often be responsible for looking after this medicine. However, if you are responsible for looking after this medicine make sure that you store it properly and safely. Check the label and Patient Information leaflet for details or ask a member of your medical team.

Depo-Provera is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for females under the age of 18 years.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Depo-Provera can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Depo-Provera has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Depo-Provera:

• headaches – seek immediate medical advice if you have an unusually bad headache
• stomach pain or discomfort

Common: More than 1 in 100 people who have Depo-Provera:

• acne
• appetite changes
• backache
• breast pain or tenderness
• decreased libido or anorgasmia
• depression
• difficulty sleeping
• emotional disturbances
• feeling dizzy
• feeling irritable
• feeling nervous
• feelings of fullness in the stomach
• hair loss
• heavy periods or bleeding for long periods of time - this is more likely to happen in women who have Depo-Provera immediately after giving birth or after an abortion. Seek medical advice if your periods are heavy and the bleeding continues for long periods of time
• hot flushes
• injection site problems including pain or abscess
• irritation or inflammation of the vagina
• lack of hair growth
• leg cramps
• menstrual problems including bleeding or spotting in between menstrual periods, irregular menstrual periods or not having a menstrual period
• mood changes
• nausea
• oedema
• paraesthesiae
• pelvic pain
• skin rash or rashes
• vaginal discharge
• weakness or tiredness

Uncommon: More than 1 in 1000 people who have Depo-Provera:

• abnormal laboratory test results
• breast problems - changes in breast size, bleeding from the nipples or lumps in the breast
• breathing difficulties
• bruising
• changes to weight
• chest pain
• chloasma
• convulsions
• dermatitis
• difficult or painful sexual intercourse
• distension of the stomach
• dryness in the vagina
• feeling anxious
• fluid retention
• gastrointestinal problems
• genital or urinary infections
• hair overgrowth
• high temperature
• hypersensitivity reactions - such as anaphylactic reactions, anaphylactic shock or angioedema
• itching
• jaundice
• joint pain
• may affect the results for certain tests
• melasma
• migraine
• muscle cramps
• ovarian cyst
• painful limbs
• painful periods
• pulmonary embolism
• raised blood pressure
• sleepiness
• thrombophlebitis
• urticaria
• uterine hyperplasia
• varicose veins
• vertigo

Rare: More than 1 in 10,000 people who have Depo-Provera:

• anaemia
• bleeding from the back passage
• breast cancer
• decreased glucose tolerance
• faster heart rate
• hoarse voice
• paralysis
• thirst

The frequency of these side-effects is unknown:

• blood problems
• bone fractures
• cerebrovascular problems
• changes in levels of cholesterol or other lipids in the blood
• deep vein thrombosis
• eye or eyesight problems - seek medical advice if you get eye or eyesight problems
• facial palsy
• fainting or brief loss of consciousness
• feeling of being pregnant
• feelings of premenstrual-type depression
• galactorrhoea
• lack of return to fertility
• liver problems
• lowering of bone mineral density
• osteoporosis
• prevention of breast milk production
• skin problems
• striae
• swelling under the armpits
• thromboembolism
• vaginal cysts

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Depo-Provera:

The following types of medicine may interact with Depo-Provera:

If you are taking Depo-Provera and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Depo-Provera.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Depo-Provera can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Depo-Provera:

Alcohol can interact with certain medicines.

In the case of Depo-Provera:

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Depo-Provera:

This medicine is not suitable during pregnancy. Your prescriber will only start your treatment with this medicine once they are certain that you are not pregnant. If you are planning to become pregnant you should discuss with your prescriber or family planning nurse when it is best to stop Depo-Provera. This is because it may take some time for your periods to become regular again.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Depo-Provera:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Depo-Provera contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Depo-Provera before, do not have Depo-Provera. Talk to your prescriber, pharmacist or nurse as soon as possible.