Symbicort Turbuhaler (Budesonide/Formoterol)

The dosage of SYMBICORT INHALER is individual. It should be taken regularly (every day), even when you have no symptoms.

Follow your doctor's instructions carefully. Asthma and COPD treatment will differ from person to person. Therefore, your prescribed treatment may be different from the information in this leaflet.

Patients with Asthma:

Treatment with SYMBICORT should not be initiated to treat an asthma attack.

For the treatment of asthma, your doctor will instruct you to use SYMBICORT INHALERin one of two ways:

1. SYMBICORT maintenance therapy; or
2. SYMBICORT maintenance and reliever therapy.

Each of these treatment plans is described below.

1. SYMBICORT Maintenance Therapy for Asthma:

You take a regular daily dose from SYMBICORT TURBUHALER. In addition, you use a separate inhaler, containing a fast-acting bronchodilator (airway-widening medicine) for relief of asthma symptoms. This means that you need two separate inhalers.

Adults and adolescents (12 years and older):

• 1-2 inhalations SYMBICORT 100 INHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations.
• or
• 1-2 inhalations SYMBICORT 200 INHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations.
• or
• 1 inhalation SYMBICORT FORTE INHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations.

Always carry your fast-acting bronchodilator (rescue medication) with you for relief of symptoms.

During periods of worsening of asthma, the dose may temporarily be increased up to a maximum of 4 inhalations of SYMBICORT 100 INLAER or SYMBICORT 200 INHALER twice daily or 2 inhalations of SYMBICORT FORTE INAHLER twice daily.

Do NOT exceed the dose prescribed by your doctor.

2. SYMBICORT Maintenance and Reliever Therapy (SYMBICORT SMART) for Asthma:

You take a regular daily maintenance dose of SYMBICORT TURBUHALER. You also use SYMBICORT TURBUHALER if you need extra doses for relief of asthma symptoms. This means that you use one inhaler (SYMBICORT TURBUHALER) for both daily maintenance AND symptom relief.

Adults and adolescents (12 years and older):

• 1-2 inhalations SYMBICORT 100 TURBUHALER twice daily or 2 inhalations once daily. You should take 1 additional inhalation as-needed if you feel symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. The maximum recommended daily dose is 8 inhalations.
• or
• 1-2 inhalations SYMBICORT 200 TURBUHALER twice daily or 2 inhalations once daily. You should take 1 additional inhalation as-needed if you feel symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. The maximum recommended daily dose is 8 inhalations.

Always carry SYMBICORT TURBUHALER with you. You should use extra doses as needed to relieve your asthma symptoms, including periods when your asthma gets worse.

Do not exceed the maximum total number of daily inhalations (8 inhalations/day). If you exceed 8 inhalations/day please seek medical attention.

Patients with COPD:

Adults (18 years and older):

• 2 inhalations SYMBICORT 200 TURBUHALER twice daily. The maximum recommended daily dose is 4 inhalations.
• or
• 1 inhalation SYMBICORT FORTE TURBUHALER twice daily. The maximum recommended daily dose is 2 inhalations.

Treatment with SYMBICORT should not be initiated to treat a COPD attack.

How to prepare a new inhaler for use:

Before you start using SYMBICORT TURBUHALER for the first time it is important that you read the instructions below and follow them carefully.

TURBUHALER is an inhaler from which very small amounts of powder are administered. When you breathe in through the TURBUHALER, powder is delivered to the lungs. It is therefore important that you inhale as deeply and strongly as you can through the mouthpiece.

SYMBICORT TURBUHALER is simple to use.

A. Preparation before first use of a NEW (never been used) inhaler:

Before using your inhaler for the first time you need to prepare the inhaler for use. The preparation does not need to be repeated even if your inhaler is not used regularly.

STEP 1: Unscrew and lift off the cover. You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.

STEP 2: Holding the inhaler upright, turn the red grip as far as it will go in one direction (clockwise or counter-clockwise, it does not matter which way you turn it first); then you must turn it back again as far as it will go in the opposite direction. Do not hold the mouthpiece when turning the grip. The click you hear is part of the loading process.Once you perform this step twice, the inhaler is ready to use.

B. Using the inhaler:

To use your TURBUHALER properly, follow these 4 steps:

STEP 1: Unscrew and lift off the cover. You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.

STEP 2: Holding the inhaler upright, turn the red grip as far as it will go in one direction (clockwise or counter-clockwise, it does not matter which way you turn it first); then you must turn it back again as far as it will go in the opposite direction. Do not hold the mouthpiece when turning the grip. The click you hear is part of the loading process. The inhaler is now ready to use.

If you are not sure you heard the click, and you turn and click the inhaler a second time, you will not end up taking 2 doses by mistake. The TURBUHALER is designed to load only one dose at a time.

STEP 3: Breathe out, with your mouth away from the mouthpiece. Then, place the mouthpiece gently between your teeth.

STEP 4: Now close your lips over the mouthpiece. Inhale as deeply and strongly as you can. Before you exhale, remember to remove the inhaler from your mouth. Repeat this process from Step 1 if more than one dose has been prescribed. When you have taken the prescribed amount of maintenance doses, rinse your mouth with water, and do not swallow. Once you perform these steps, you have completed using SYMBICORT TURBUHALER.

You may not feel or taste the medication when inhaling. This is common.

Do not bite or chew the mouthpiece.

If you accidentally drop, shake or breathe out into SYMBICORT TURBUHALER after it is loaded, you will lose your dose. If this happens, you should load a new dose and inhale it.

Note: Always replace the cover properly after use. Do not try to remove the mouthpiece or to twist it unnecessarily; it is fixed to the inhaler and must not be taken off.

Stopping SYMBICORT TURBUHALER:

Talk to your doctor about how to gradually stop your medication if necessary. It is important that you do not suddenly stop taking SYMBICORT TURBUHALER as it may cause unwanted side effects.

Cleaning:

Clean the outside of the mouthpiece once a week with a dry tissue. Never use water or any other fluid when cleaning the mouthpiece. If fluid enters the inhaler it may not work properly.

When to Start a New Inhaler:

SYMBICORT TURBUHALER has a dose indicator. The dose indicator tells you approximately how many doses are left in the inhaler. The dose indicator moves slowly each time you load a dose. Every 20th dose is marked with a number and every 10th dose is marked with a dash (Figure 5). When the "0" on the red background has reached the middle of the window you should discard your inhaler. The sound you hear when you shake the inhaler is produced by a drying agent, not the medication. SYMBICORT TURBUHALER cannot be re-filled with drug and should be discarded.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

The most common signs and symptoms that may occur after overdosage are trembling, headache and rapid heartbeat.

Missed dose:

If you miss a dose, take it as soon as you remember and then go back to your regular schedule.

Never take a double dose to make up for missed doses. If you are still unsure, check with your doctor or pharmacist to see what you should do.

Common side effects are:

• Headache;
• Trembling;
• Sensation of heart beat;
• Cough;
• Irritation of mouth and/or throat;
• Hoarseness.

Less common side effects are:

• Nausea;
• Sleep difficulties;
• Agitation;
• Restlessness or nervousness;
• Dizziness;
• Muscle cramps.

If any of these side effects worry you, do not stop treatment, but tell your doctor about them.

Rare side effects are:

• Skin rash and bruising;
• Itching;
• Facial swelling;
• Increase in chest tightness, chest pain;
• Depression or behavioural disturbances;
• High blood sugar levels.

If you had been taking oral corticosteroids to treat your asthma and you suddenly have a severe asthma attack when starting SYMBICORT TURBUHALER, contact your doctor right away.

In patients with asthma, you should TELL YOUR DOCTOR if:

The relief of your asthma is not as good as usual or does not last as long as usual. A change from “usual” includes more wheezing, coughing, tightness or shortness of breath;

• You exceed the maximum total number of daily inhalations (8 inhalations/day);
• There is a constant increase in your use of fast-acting reliever medication;
• Your symptoms are waking you up at night;
• Measurement from your peak flow meter indicates a value between 60% and 80% of predicted or personal best.

These may be signs that your asthma is getting worse. Your doctor may adjust your treatment.

You should TELL YOUR DOCTOR RIGHT AWAY or go to the nearest hospital if you notice the following warning signs:

• A sudden worsening of your shortness of breath and wheezing shortly after using your fast-acting medication;
• You do not feel relief from additional doses of your fast-acting reliever medication;
• Measurement from your peak flow meter indicates a value less than 60 percent of predicted or personal best;
• You are breathless at rest;
• Your pulse is more than 120 beats per minute.

In patients with COPD, you should TELL YOUR DOCTOR RIGHT AWAY if you notice the following warning signs, which indicate your condition is worsening:

• Unusual increase in the severity of the breathlessness, cough, tiredness or wheeze;
• Unusual colour, level, consistency or stickiness of phlegm;
• Symptoms of a chest cold and/or chest tightness (e.g. indicating a chest infection);
• Unexplained swelling;
• Unexplained fever.

Serious Warnings for Asthma Patients

Formoterol, one of the medicines in SYMBICORT TURBUHALER, may increase the risk of asthma-related death. It may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. Therefore,

• Your doctor will assess your asthma control at regular intervals. SYMBICORT TURBUHALER should only be used when your doctor decides that other asthma medications (e.g. inhaled glucocorticosteroids along with an as needed relief medication) are not helping you enough, or that you need two maintenance medications to control your asthma.
• SYMBICORT TURBUHALER should not be the first medication you use, unless advised by your doctor.

For any concerns regarding the use of SYMBICORT TURBUHALER, consult your doctor.

BEFORE you use SYMBICORT TURBUHALER talk to your doctor or pharmacist if you:

• Have health problems now or have had in the past;
• Have heart problems;
• Have high blood sugar (diabetes);
• Have low blood potassium or any problems with your thyroid gland;
• Have seizures (epilepsy);
• Have severe liver problems (e.g. cirrhosis);
• Take, or have taken steroid medicines within the past several months;
• Have ever had a bad, unusual or allergic reaction to budesonide, formoterol or lactose or to other medicines for breathing problems;
• Are pregnant or planning to become pregnant;
• Are breast feeding;
• Have weak bones (osteoporosis).

Drugs like SYMBICORT can cause eye disorders:

• Cataracts: clouding of the lens in the eye, blurry vision, eye pain;
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.

You should therefore have regular eye exams.

You should avoid coming into contact with people who have measles or chicken pox while taking SYMBICORT TURBUHALER. If you are exposed, tell your doctor right away.

Special attention should be paid if you are an adolescent with asthma. Your growth should be monitored regularly by a doctor when being treated with corticosteroids. Studies have also shown that children whose asthma is not controlled do not grow as quickly as other children.

COPD:

Patients with COPD have a higher chance of getting pneumonia (a lung infection). Drugs like SYMBICORT TURBUHALER may increase the chance of getting pneumonia. It is very important that you tell your doctor immediately if you suspect an infection as even mild chest infections should be treated right away.

You should avoid close contact with people who have colds or the flu (influenza). Your doctor may also recommend that you receive a flu shot each year.

If you are using SYMBICORT TURBUHALER for COPD, tell your doctor if you have any of the following symptoms:

• Fever or chills;
• Increased mucus production or change in mucus colour;
• Increased cough;
• Increased breathing difficulties.

These all may be signs of pneumonia.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Drugs that may interact with SYMBICORT TURBUHALER are:

• Beta-blockers used to lower blood pressure (propranolol) or for other heart or eye problems (e.g. atenolol, timolol);
• Ketoconazole, itraconazole used to treat fungal infections;
• Ritonavir used to treat HIV or AIDS.