SYMBICORT TURBOHALER 400/12 INHALATION POWDER - patient leaflet, side effects, dosage

1. what symbicort turbohaler is and what it is used for

Symbicort Turbohaler is an inhaler that is used to treat asthma in adults and adolescents aged 12–17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily.

Asthma

For asthma, your doctor will prescribe two asthma inhalers: Symbicort Turbohaler and a separate ‘reliever inhaler’.

• Use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening.
• Use your ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

Do not use Symbicort Turbohaler 400/12 as a ‘reliever inhaler’.

Chronic obstructive pulmonary disease (COPD)

Symbicort Turbohaler can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.

2. what you need to know before you use symbicort turbohaler

Do not use Symbicort Turbohaler:

• if you are allergic to budesonide, formoterol or the other ingredient of this medicine (listed in section 6), which is lactose (which contains small amounts of milk protein).

Warnings and precautions

Talk to your doctor or pharmacist before using Symbicort Turbohaler if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or you have ever had a heart problem (including an uneven heart beat, a very fast pulse, narrowing of the arteries or heart failure).
• You have problems with your thyroid or adrenal glands.
• You have low levels of potassium in your blood.
• You have severe liver problems.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Symbicort Turbohaler

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist if you are using any of the following medicines:

• Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such as quinidine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
• Steroid medicines that you take by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic anti-depressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called ‘HIV-protease inhibitors’ (such as ritonavir) to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as leva-dopa).
• Medicines for thyroid problems (such as levo-thyroxine).

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Symbicort Turbohaler.

Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.

Pregnancy breast-feeding and fertility

• If you are pregnant, or planning to get pregnant, talk to your doctor before using Symbicort Turbohaler – do not use Symbicort Turbohaler unless your doctor tells you to.
• If you get pregnant while using Symbicort Turbohaler, do not stop using Symbicort Turbohaler but talk to your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Symbicort Turbohaler.

Driving and using machines

Symbicort Turbohaler has no or negligible effect on your ability to drive or to use tools or machines.

Symbicort Turbohaler contains lactose

Symbicort Turbohaler contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. how to use symbicort turbohaler

• Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• It is important to use Symbicort Turbohaler every day, even if you have no asthma or COPD symptoms at the time.
• If you are using Symbicort Turbohaler for asthma, your doctor will want to regularly check your symptoms.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Symbicort Turbohaler. If you have been taking oral steroid tablets for a long time, your doctor may want you to have blood tests from time to time.

When reducing oral steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medication if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use Symbicort Turbohaler.

Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Symbicort Turbohaler, you should continue to use Symbicort Turbohaler but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• Your breathing is getting worse or you often wake up at night with asthma.
• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Asthma

Use your Symbicort Turbohaler 400/12 every day. This helps to prevent asthma symptoms from happening.

Adults (18 years and above)

• The usual dose is 1 inhalation, twice a day.
• Your doctor may increase this to 2 inhalations, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

Adolescents (12 to 17 years)

• The usual dose is 1 inhalation, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

A lower strength of Symbicort Turbohaler is available for children aged from 6 to 11 years.

Symbicort Turbohaler is not recommended to be used in children who are younger than 6 years.

Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not adjust the dose without talking to your doctor (or asthma nurse) first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Symbicort Turbohaler 400/12 to treat asthma symptoms – use your separate ‘reliever inhaler’.

Chronic Obstructive Pulmonary Disease (COPD)

• Only to be used by adults (aged 18 years and above).
• The usual dose is 1 inhalation twice a day.

Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (such as tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new Symbicort Turbohaler

Before using your new Symbicort Turbohaler for the first time , you need to prepare it for use as follows:

• Unscrew the cover and lift it off. You may hear a rattling sound.
• Hold your Turbohaler upright with the red grip at the bottom.
• Turn the red grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound. It does not matter whether the click comes on the first or the second twist.
• Do this again, turning the red grip in both directions.
• Your Turbohaler is now loaded and ready for use.