TOBI 300mg/5ml nebuliser solution 5ml ampoules

TOBI is used to treat certain types of lung infections in people with cystic fibrosis. It works by killing certain types of bacteria.

This medicine is usually given in cycles of 28 days. You will be given TOBI for 28 days and this will be followed by a break of 28 days before the next treatment session with TOBI.

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 have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. 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.

The person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times. 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.

This medicine needs to be inhaled through a nebuliser. Special instructions for preparing the medicine will be given to you by your prescriber and can be found in the Patient Information Leaflet that comes with this medicine. If you have any concerns about this medicine or how to use it, talk to someone who is involved in your medical care.

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.

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.

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 TOBI:

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.

TOBI 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 under six years of age.

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

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

The following side effects have also been reported in people who have TOBI. The reported frequency of these side-effects varies so the frequency is not included here.:

• difficulty speaking
• tinnitus - seek medical advice if you get tinnitus

The frequency of these side-effects is unknown:

• abnormal laboratory test results
• allergic reactions - seek medical advice if you have bronchospasm
• antibiotic resistance to tobramycin
• asthma
• breathing difficulties
• changes in sputum colour
• chest discomfort
• cough
• coughing blood
• diarrhoea
• ear or hearing problems including ear pain, vertigo or balance problems - seek medical advice if you develop ear or hearing problems such as loss of hearing
• faster breathing rate
• feeling dizzy
• fever
• general feeling of being unwell
• headaches
• hypersensitivity reactions
• hypoxia
• itching
• laryngitis
• loss of appetite
• loss of voice
• lung problems
• lymphadenopathy
• mouth ulcers
• muscle pain or tenderness
• nasal polyps
• nausea
• nose bleed
• other infections
• pain such as chest pain, back pain or stomach pain
• pharyngitis
• productive cough
• rhinitis
• sinusitis
• skin rash or rashes
• sleepiness
• taste changes
• urticaria
• vomiting
• weakness

The following side effects have been reported in people who have had medicines similar to TOBI. The frequency of these side-effects in people who have TOBI is not known:

• damage to the ear
• kidney problems
• worsening of muscle weakness

If you feel unwell or if you have concerns about a side-effect, tell the person looking after you immediately.

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 TOBI:

The following types of medicine may interact with TOBI:

If you are taking TOBI 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 TOBI.

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.

In the case of TOBI:

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.

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 TOBI:

Alcohol can interact with certain medicines.

In the case of TOBI:

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 TOBI:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have TOBI, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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

In the case of TOBI:

Before you have TOBI 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 having 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.

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