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The eMC  

Last Updated 23 Jan 2013

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Ovestin 1mg cream

Ovestin (Oh-vest-in) is a medicine which is used in female infertility, hormone replacement therapy to treat genito-urinary problems, treating atrophic vaginitis and women who are having vaginal surgery. Ovestin contains estriol. It is supplied by Organon Laboratories Limited.

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

Ovestin 1mg cream

Information specific to Ovestin 1mg cream when used in treating atrophic vaginitis

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Your medicine

Ovestin contains a hormone which is similar to the hormone oestrogen that is produced by the body. Low levels of oestrogen may lead to symptoms such as hot flushes, night sweats and dryness or soreness of the vagina. Ovestin is used to help relieve the vaginal symptoms caused by low levels of oestrogen. This is known as hormone replacement therapy. Ovestin may be used to treat these vaginal problems before and after surgery.

Ovestin helps to treat the symptoms of the menopause but it may also increase the chances of getting certain types of cancers and certain heart or circulatory problems. You and your prescriber will need to weigh up the benefits and risks of you having Ovestin. Once you have started to have hormone replacement therapy your prescriber will review your treatment on a regular basis.

Women who are on hormone replacement therapy will be advised by their prescriber to watch out for any symptoms of breast, endometrial or ovarian cancer. They may be advised to regularly examine their breasts for any changes or lumps or report any unusual vaginal bleeding to their prescriber.

Other information about Ovestin:

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should use. It also tells you how often you should use your medicine. This is the dose that you and your prescriber have agreed you should use. You should not change the dose of your medicine unless you are told to do so by your prescriber.

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

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by the times at which you take other medicines.

In the case of Ovestin:

  • you should use Ovestin just before you go to bed
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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Ovestin:

  • detailed advice on how to use Ovestin can be found in the Patient Information Leaflet that comes with this medicine
  • use the applicator to insert Ovestin into the vagina
  • remove the cap from the end of the tube. Use the sharp point on the end of the cap to pierce the tube
  • screw one end of the applicator to the tube
  • to make sure you get the correct dose, fill the applicator with Ovestin by squeezing the end of the tube until the plunger stops at the red ring mark on the applicator
  • unscrew the tube from the applicator and put the cap back onto the tube
  • lie down and insert the applicator into the vagina gently and release the cream using the plunger on the end of the applicator
  • clean the applicator with soap and hot water after use. Do not use detergents or boiling water. Pull the plunger out from the barrel and wash both parts and rinse well with clean water

If you are having problems taking this form of Ovestin, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

Suddenly stopping your medicine may cause your original condition to return. This is why you must speak to your prescriber if you are having any problems using your medicine.

If you are not having any problems taking this medicine then do not stop using it, even if you feel better, unless advised to do so by your prescriber.

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

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Ovestin:

  • do not store in temperatures above 25°C

You must not take 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

Ovestin 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 determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects

Over time it is possible that Ovestin can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Ovestin 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 frequency of these side-effects is unknown :

  • application site problems such as irritation or itching
  • breast problems such as discomfort, pain or tenderness
  • certain types of dermatitis
  • dementia – this has only been reported in women over 65 years of age
  • endometrial cancer or other types of oestrogen-sensitive cancer
  • gallbladder problems
  • liver problems including jaundice - seek immediate medical advice if you develop jaundice
  • migraine – seek immediate medical advice if you get a migraine-type headache for the first time
  • raised blood pressure
  • skin problems such as unexplained or easy bruising of the skin, erythema multiforme or dark patches on the face or neck
  • some conditions may get worse or return during treatment with Ovestin. Examples include: fibroids, endometriosis, endometrial hyperplasia, oestrogen-dependent tumours, thromboembolic problems, liver problems, raised blood pressure, diabetes, gallstones, migraine or headaches, systemic lupus erythematosus, epilepsy, asthma or otosclerosis

The frequency of these side-effects is unknown - they have been reported in women who have taken or used other medicines containing oestrogens :

The frequency of these side-effects is unknown - they have been reported in women who have taken or used medicines containing oestrogens and progestogens :

  • breast cancer
  • heart attack
  • heart or circulation problems
  • stroke
  • thromboembolic problems such as deep vein thrombosis or pulmonary embolism - seek immediate medical advice if you have a painful and swollen leg or develop breathing difficulties or sudden chest pain

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

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 interactions below have been reported with other oestrogen preparations.

The following medicines may interact with Ovestin:

The following types of medicine may interact with Ovestin:

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

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Ovestin:

If you have been prescribed Ovestin you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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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.

Like all medicines Ovestin 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.

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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 Ovestin:

  • there are no specific foods that you must exclude from your diet when using Ovestin
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Alcohol

Alcohol can interact with certain medicines.

In the case of Ovestin:

  • there are no known interactions between alcohol and Ovestin
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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 Ovestin:

  • do not use this medicine 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.

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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 Ovestin:

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

For information about Ovestin and breast-feeding, contact your prescriber.

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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. They are also added to improve the medicine's appearance and to make it easier to use. Some may be used to prolong the life of the medicine.

Ovestin contains:

  • cetyl alcohol
  • cetyl palmitate
  • chlorhexidine dihydrochloride
  • glycerin
  • octyldodecanol
  • polysorbate 60
  • purified water
  • sodium hydroxide to pH 4
  • sorbitan stearate
  • stearyl alcohol

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 Ovestin before, do not use Ovestin. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Ovestin, Version 9, last updated 23 Jan 2013