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The eMC  

Last Updated 14 Jan 2013

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Otosporin ear drops

Otosporin (Otto-spor-rin) is a medicine which is used in treating inflammation and infections of the outer ear. Otosporin contains hydrocortisone/neomycin sulphate/polymyxin b sulphate. It is supplied by GlaxoSmithKline UK.

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

Otosporin ear drops

Information specific to Otosporin ear drops when used in treating inflammation and infections of the outer ear

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Your medicine

Otosporin contains three different medicines - neomycin sulphate, polymyxin B sulphate and hydrocortisone. These medicines work together to help treat inflammation and infections of the ear.

Other information about Otosporin:

  • this medicine is usually used for a maximum of seven days. If your symptoms do not improve or get worse within seven days of starting treatment with Otosporin you should contact your prescriber

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.

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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. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Otosporin:

  • gently clean and dry the affected area before using Otosporin. You should not use soap to clean the area
  • place the dropper of the bottle over the ear opening and squeeze the recommended number of drops into the ear. Alternatively you can use a gauze wick that has been medicated with Otosporin and put this into the ear. If a wick is used you can keep it in the ear for between 24 and 48 hours
  • this medicine is not to be used in the eyes

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. You may need a test to assess the effect of taking extra doses. 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

If you are not having any problems with this medicine, do not stop using it unless you have completed the course or you are advised to stop using it 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 Otosporin:

  • do not store in temperatures above 25°C
  • protect your medicine from light

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

Otosporin 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 neonates and infants under the age of three years.

Over time it is possible that Otosporin can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Otosporin 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:

  • allergic hypersensitivity reactions - some of these reactions may be delayed. The ingredient neomycin may lead to an eczema-type reaction with redness, scaling, swelling, itching or a failure of the lesion to heal
  • if Otosporin is used in large amounts or for a long period of time, the amount of Otosporin which is absorbed into the body may be increased and certain side-effects may occur. This may lead to adrenal problems, skin sensitivity reactions, resistance to the antibiotic component neomycin, hiding or worsening of the symptoms of infection, deafness or damage to the ear, kidneys or nerves
  • stinging and burning sensations if Otosporin ear drops get into the middle ear

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 following types of medicine may interact with Otosporin:

If you are taking Otosporin and one of the above 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. 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 Otosporin.

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.

Like all medicines Otosporin 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 Otosporin:

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

Alcohol can interact with certain medicines.

In the case of Otosporin:

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

  • the use of this medicine during pregnancy is not recommended

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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Breast-feeding

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

In the case of Otosporin:

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

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 taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Otosporin contains:

  • cetostearyl alcohol EP
  • dilute sulphuric acid BP
  • hydrocortisone, neomycin sulphate and polymyxin b sulphate
  • methyl hydroxybenzoate EP
  • polysorbate 20 EP
  • purified water EP
  • sorbitan laurate BP

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

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Otosporin, Version 4, last updated 14 Jan 2013