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The eMC  

Last Updated 17 May 2013

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Prostap SR DCS 3.75mg powder and solvent for suspension for injection pre-filled syringes

Prostap (Proh-stap) is a medicine which is used in endometriosis, preparation for endometrial surgery, prostate cancer and uterine fibroids. Prostap contains leuprorelin acetate. It is supplied by Takeda UK Ltd.

The information in this Medicine Guide for Prostap varies according to the condition being treated and the particular preparation used.

Prostap SR DCS 3.75mg powder and solvent for suspension for injection pre-filled syringes

Information specific to Prostap SR DCS 3.75mg powder and solvent for suspension for injection pre-filled syringes when used in preparation for endometrial surgery

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Your medicine

Prostap prevents the production of certain types of hormones in the body. It is used to treat prostate cancer. Prostap is also used in women who have uterine fibroids or endometriosis.

Other information about Prostap:

  • this medicine should only be used for a maximum of six months
  • it is important to have Prostap on either the third, fourth or fifth day of your menstrual cycle. For more information read the Patient Information Leaflet or talk to your prescriber

Prostap 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.

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When to take your medicine

The person with responsibility for giving you your medicine will make sure that you have your medicine before you have surgery.

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How to take your medicine

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.

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Taking too much of your medicine

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

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

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Stopping your medicine

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

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Looking after your medicine

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.

In the case of Prostap:

  • store the medicine in the original container to protect it from light
  • do not store in temperatures above 25°C
  • do not store this medicine in a fridge or a freezer

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Prostap 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 a child.

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

  • to check that this medicine is not having any undesired effects

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

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Side-effects

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.

The following side effects have also been reported in children who have Prostap. The frequency of these side-effects is unknown. :

  • acne
  • allergic reactions such as anaphylactic reactions, fever, rash or itching
  • changes in emotions
  • headaches
  • injection site problems
  • nausea
  • stomach cramps
  • stomach pain
  • vaginal bleeding, spotting or discharge - seek medical advice if you get vaginal bleeding, spotting or discharge
  • vomiting
  • worsening of pituitary problems

The frequency of these side-effects is unknown:

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.

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Taking other medicines

There are no known important interactions between Prostap and other medicines. If you experience any unusual symptoms while having Prostap and other medicines you should tell your prescriber.

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Complementary preparations and vitamins

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 Prostap.

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.

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Driving and operating machinery

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

In the case of Prostap:

  • this medicine could affect your ability to drive or operate machinery

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

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Diet

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 Prostap:

  • there are no specific foods that you must exclude from your diet when having Prostap
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Alcohol

Alcohol can interact with certain medicines.

In the case of Prostap:

  • there are no known interactions between alcohol and Prostap
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Family planning and pregnancy

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 Prostap:

  • you must not use Prostap during pregnancy as it may harm the baby. If you could become pregnant, you must use effective non-hormonal contraception or abstain from penetrative sex
  • your prescriber will only start your treatment with Prostap once they are certain that you are not pregnant. For more information talk to your prescriber

This medicine is not suitable during pregnancy. It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.

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Breast-feeding

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

In the case of Prostap:

  • women who are breast-feeding must not have this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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Ingredients of your medicine

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.

Prostap 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 Prostap before, do not have Prostap. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Prostap, Version 8, last updated 17 May 2013