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The eMC  

Last Updated 20 Nov 2013

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Saflutan 15micrograms/ml eye drops 0.3ml unit dose

Saflutan (saff-loo-tan) is a medicine which is used in ocular hypertension and open-angle glaucoma. Saflutan contains tafluprost. It is supplied by Merck Sharp & Dohme Limited.

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

Saflutan 15micrograms/ml eye drops 0.3ml unit dose

Information specific to Saflutan 15micrograms/ml eye drops 0.3ml unit dose when used in Ocular hypertension

Your medicine

Saflutan is used in conditions such as ocular hypertension or open-angle glaucoma where there is increased pressure inside the eye. It reduces the pressure inside the eye by increasing the drainage of fluid from the eye into the blood stream.

Other information about Saflutan:

  • this medicine may lead to discolouration of the eye - this discolouration may be permanent

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 Saflutan:

  • to get the best results from Saflutan use it in the evening
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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 Saflutan:

  • detailed advice on how to use Saflutan can be found in the Patient Information Leaflet that comes with this medicine
  • press down on the inner part of the eye for about a minute immediately after Saflutan has been put into the eye. This will help to reduce the amount of Saflutan that gets into the general circulation of the body after putting Saflutan into the eye
  • if you are using other eye medicines do not use one immediately after each other. You must wait at least five minutes between using each medicine. This is to stop the second medicine from washing the first medicine out of the eye
  • wipe away any excess drops with a clean tissue

If you are having problems taking this medicine, 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 medicines 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 call 111 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

If you are having any problems using your medicine you must speak to your prescriber. If you are not having any problems using 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 call 111.

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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 Saflutan:

  • the eye drop containers come inside a foil pack
  • before opening the foil pack you must keep it in a fridge at temperatures between 2 – 8°C
  • after opening a foil pack it can be stored at room temperature below 25°C for up to four weeks
  • you must dispose of unused eye drop containers four weeks after opening the foil pack. It is a good idea to make a note of the date that you opened the foil pack

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

Saflutan 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 someone under the age of 18 years.

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

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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.

Common: More than 1 in 100 people who use Saflutan

  • a feeling of something in the eye
  • blurred vision
  • dry eye
  • eye colour changes
  • eye pain
  • eyelash changes including: colour; increased length; increased thickness; or increased number of eyelashes
  • increased tear production
  • itchy eye
  • other eye or eyesight problems
  • over-sensitivity or fear of light
  • red eye
  • redness of the eyelids

Uncommon: More than 1 in 1000 people who use Saflutan

  • discharge from the eye
  • eye discomfort
  • eye strain
  • eyelid colour changes
  • eyelid swelling
  • hair growth on the eyelid
  • inflammation or infection of the eye or eyelid

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 111.

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Taking other medicines

There are no known important interactions between Saflutan and other medicines. If you experience any unusual symptoms while using Saflutan 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 Saflutan.

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 Saflutan:

  • after putting Saflutan into your eye you may have blurred vision for a short time

You must not drive or operate machinery unless your vision has returned to normal after using Saflutan.

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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 Saflutan:

  • there are no specific foods that you must exclude from your diet when using Saflutan
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Alcohol can interact with certain medicines.

In the case of Saflutan:

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

  • if you could become pregnant, you must use effective contraception or abstain from penetrative sex. You must contact your prescriber if you become pregnant, or think you have become pregnant, while using Saflutan
  • you should only use this medicine during pregnancy if your doctor thinks that you need it

You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant. This is so that together you can make a decision about what treatment you may need during your pregnancy.

You should discuss whether there are any other medicines which you could take during pregnancy which would treat your condition.

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

In the case of Saflutan:

  • women who are using Saflutan should not breast-feed

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. 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. 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.

Saflutan contains:

  • disodium edetate
  • glycerol
  • hydrochloric acid and sodium hydroxide if pH adjusted
  • polysorbate 80
  • sodium dihydrogen phosphate dihydrate
  • water for injections

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

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Saflutan, Version 5, last updated 20 Nov 2013