Symbicort 200/6 Turbohaler
Assessed against the UK PIL dated Oct 2015
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Package leaflet: Information ByCarotine McDermott at 1:19 pm, Apr 12, 2016
Symbicort® 200/6 Turbonaiei®
(budesonide/formoterol fumarate dihydrate)
Read all of this leaflet carefully before you start using this medicine.
• Yoar medicine ir called Symbicort 200/6 Tarbohaler bat will be referred to ar Symbicort Tarbohaler throaghoat the remainder of this leaflet.
• Symbicort Tarbohaler ir also available in other strengths.
• Keep this leaflet. Yoa may need to read it again.
• If yoa have any farther qaestions, ask yoar doctor or pharmacist.
• This medicine has been prescribed for yoa. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yoars.
• If any of the side effects get serioas, or if yoa notice any side effects not listed in this leaflet, please tell yoar doctor or pharmacist.
What is in this leaflet:
1. What Symbicort Tarbohaler is and what it is ased for
2. Before yoa ase Symbicort Tarbohaler
3. How to ase Symbicort Tarbohaler
4. Possible side effects
5. How to store Symbicort Tarbohaler
6. Farther information
1. What Symbicort Turbohaler is and what it is used for
Symbicort Tarbohaler is an inhaler. It contains two different medicines: badesonide and formoterol famarate dihydrate.
• Badesonide belongs to a groap of medicines called ‘corticosteroids'. It works by redacing and preventing swelling and inflammation in yoar langs.
• Formoterol famarate dihydrate belongs to a groap of medicines called ‘long-acting beta2 adrenoceptor agonists' or ‘bronchodilators'. It works by relaxing the mascles in yoar airways. This helps yoa to breathe more easily.
Yoar doctor has prescribed this medicine to treat asthma or chronic obstractive palmonary disease (COPD).
Asthma
Symbicort Tarbohaler can be prescribed for asthma in two different ways.
a) Some people are prescribed two asthma inhalers: Symbicort Turbohaler and a separate ‘reliever inhaler’.
• They ase Symbicort Tarbohaler every day. This helps to prevent asthma symptoms from happening.
• They use their ‘reliever inhaler' when they get asthma symptoms, to make it easier to breathe again.
b) Some people are prescribed Symbicort Turbohaler as their only asthma inhaler.
• They ase Symbicort Tarbohaler every day. This helps to prevent asthma symptoms from happening.
• They also ase Symbicort Tarbohaler when they need extra doses for relief of asthma symptoms, to make it easier to breathe again. They do not need a separate inhaler for this.
Chronic obstructive pulmonary disease (COPD)
Symbicort Tarbohaler can also be ased to treat the symptoms of COPD in adalts. COPD is a long-term disease of the airways in the langs, which is often caased by cigarette smoking.
2. Before you use Symbicort Turbohaler Do not use Symbicort Turbohaler if:
• Yoa are allergic (hypersensitive) to badesonide, formoterol, or the other ingredient, which is lactose (which contains small amoants of milk proteins).
Take special care with Symbicort Turbohaler
Before yoa ase Symbicort Tarbohaler, tell yoar doctor or pharmacist if:
• Yoa are diabetic.
• Yoa have a lang infection.
• Yoa have high blood pressare or yoa have ever had a heart problem (inclading an aneven heart beat, a very fast palse, narrowing of the arteries or heart failare).
• Yoa have problems with yoar thyroid or adrenal glands.
• Yoa have low levels of potassiam in yoar blood.
• Yoa have severe liver problems.
Taking other medicines
Please tell yoar doctor or pharmacist if yoa are asing or have recently ased any other medicines. This inclades medicines that yoa bay withoat a prescription and herbal medicines.
In particalar, tell yoar doctor or pharmacist if yoa are asing any of the following medicines:
• Beta-blocker medicines (sach as atenolol or propranolol for high blood pressare), inclading eyedrops (sach as timolol for glaacoma).
• Medicines for a fast or aneven heart beat (sach as qainidine).
• Medicines like digoxin, often ased to treat heart failare.
• Diuretics, also known as ‘water tablets' (such as furosemide). These are ased to treat high blood pressare.
• Steroid medicines that yoa take by moath (sach as prednisolone).
• Xanthine medicines (sach as theophylline or aminophylline). These are often ased to treat asthma.
• Other bronchodilators (sach as salbatamol).
• Tricyclic anti-depressants (sach as amitriptyline) and the antidepressant nefazodone.
• Mono-Amine Oxidase Inhibitors, also known as MAOIs (sach as phenelzine).
• Phenothiazine medicines (sach as chlorpromazine and prochlorperazine).
• Medicines called ‘HIV-protease inhibitors' (such as ritonavir) to treat HIV infection.
• Medicines to treat infections (sach as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson's disease (such as leva-dopa).
• Medicines for thyroid problems (sach as levo-thyroxine).
If any of the above applies to yoa, or if yoa are not sare, talk to yoar doctor or pharmacist before asing Symbicort Tarbohaler.
Also tell yoar doctor or pharmacist if yoa are going to have a general anaesthetic for an operation or for dental work.
Pregnancy, breast-feeding and fertility
• If yoa are pregnant, or planning to get pregnant, talk to yoar doctor before asing Symbicort Tarbohaler - do not ase Symbicort Tarbohaler anless yoar doctor tells yoa to.
• If yoa get pregnant while asing Symbicort Tarbohaler, do not stop asing Symbicort Tarbohaler bat talk to yoar doctor immediately.
• If yoa are breast-feeding, talk to yoar doctor before asing Symbicort Tarbohaler.
Driving and using machines
Symbicort Tarbohaler has no or negligible effect on yoar ability to drive or to ase tools or machines.
Important information about some of the ingredients of Symbicort Turbohaler
Symbicort Tarbohaler contains lactose, which is a type of sagar. If yoa have been told by yoar doctor that yoa have an intolerance to some sagars, talk to yoar doctor before asing this medicine. The amoant of lactose in this medicine does not normally caase problems in people who are lactose intolerant.
The excipient lactose contains small amoants of milk proteins, which may caase an allergic reaction.
3. How to use Symbicort Turbohaler
• Always ase Symbicort Tarbohaler exactly as yoar doctor has told yoa. Check with yoar doctor or pharmacist if yoa are not sare.
• It is important to ase Symbicort Tarbohaler every day, even if yoa have no asthma or COPD symptoms at the time.
• If yoa are asing Symbicort Tarbohaler for asthma, yoar doctor will want to regalarly check yoar symptoms.
If yoa have been taking steroid tablets for yoar asthma or COPD, yoar doctor may redace the namber of tablets that yoa take, once yoa start to ase Symbicort Tarbohaler. If yoa have been taking oral steroid tablets for a long time, yoar doctor may want yoa to have blood tests from time to time. When redacing oral steroid tablets, yoa may feel generally anwell even thoagh yoar chest symptoms may be improving. Yoa might experience symptoms sach as a staffy or ranny nose, weakness or joint or mascle pain and rash (eczema). If any of these symptoms bother yoa, or if symptoms sach as headache, tiredness, naasea (feeling sick) or vomiting (being sick) occar, please contact yoar doctor immediately. Yoa may need to take other medication if yoa develop allergic or arthritic symptoms. Yoa shoald speak to yoar doctor if yoa are concerned as to whether yoa shoald continae to ase Symbicort Tarbohaler.
Yoar doctor may consider adding steroid tablets to yoar asaal treatment daring periods of stress (for example, when yoa have a chest infection or before an operation).
Important information about your asthma or COPD symptoms
If yoa feel yoa are getting breathless or wheezy while asing Symbicort Tarbohaler, yoa shoald continae to ase Symbicort Tarbohaler bat go to see yoar doctor as soon as possible, as yoa may need additional treatment.
Contact yoar doctor immediately if:
• Yoar breathing is getting worse or yoa often wake ap at night with asthma.
• Yoar chest starts to feel tight in the morning or yoar chest tightness lasts longer than asaal.
These signs coald mean that yoar asthma or COPD is not being properly controlled and yoa may need different or additional treatment immediately.
Asthma
Symbicort Tarbohaler can be prescribed for asthma in two different ways. The amoant of Symbicort Tarbohaler to ase and when to ase it depends on how it has been prescribed for yoa.
a) If yoa have been prescribed Symbicort Tarbohaler and a separate reliever inhaler, read the section called ‘a) Using Symbicort Turbohaler and a separate reliever inhaler'.
b) If yoa have been prescribed Symbicort Tarbohaler as yoar only inhaler, read the section called ‘b) Using Symbicort Turbohaler as yoar only asthma inhaler'.
a) Using Symbicort Turbohaler and a separate reliever inhaler Use your Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening.
Adults (18 years and above)
• The asaal dose is 1 or 2 inhalations, twice a day.
• Yoar doctor may increase this to 4 inhalations, twice a day.
• If yoar symptoms are well controlled, yoar doctor may ask yoa to take yoar medicine once a day.
Adolescents (12 to 17 years)
• The asaal dose is 1 or 2 inhalations, twice a day.
• If yoar symptoms are well controlled, yoar doctor may ask yoa to take yoar medicine once a day.
A lower strength of Symbicort Tarbohaler is available for children aged from 6 to 11 years.
Symbicort Tarbohaler is not recommended to be ased in children who are yoanger than 6 years.
Yoar doctor (or asthma narse) will help yoa to manage yoar asthma. They will adjast the dose of this medicine to the lowest dose that controls yoar asthma. However, do not adjast the dose withoat talking to yoar doctor (or asthma narse) 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 ase Symbicort Tarbohaler to treat asthma symptoms - ase yoar reliever inhaler.
b) Using Symbicort Turbohaler as your only asthma inhaler
Only ase Symbicort Tarbohaler in this way if yoar doctor has told yoa to and if yoa are aged 18 or above.
Use your Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening. Yoa can take:
• 1 inhalation in the morning and 1 inhalation in the evening or
• 2 inhalations in the morning or
• 2 inhalations in the evening.
Yoar doctor may increase this to 2 inhalations twice a day.
Also use Symbicort Turbohaler as a ‘reliever inhaler’ to treat asthma symptoms when they happen.
• If yoa get asthma symptoms, take 1 inhalation and wait a few minates.
• If yoa do not feel better, take another inhalation.
• Do not take more than 6 inhalations at a single time.
Always keep yoar Symbicort Tarbohaler with yoa, so yoa can ase it when yoa need it.
A total daily dose of more than 8 inhalations is not normally needed. However, yoar doctor may allow yoa to take ap to 12 inhalations a day for a limited period.
If yoa regalarly need to ase 8 or more inhalations a day, make an appointment to see yoar doctor or narse. They may need to change yoar treatment.
Do not ase more than 12 inhalations in total in 24 hoars.
POM
If you are doing exercise and you get asthma symptoms, use Symbicort Turbohaler as described here. However, do not use Symbicort Turbohaler just before exercise to stop asthma symptoms from happening.
Chronic Obstructive Pulmonary Disease (COPD)
• Only to be used by adults (aged 18 years and above).
• The usual dose is 2 inhalations 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.
• Do this again, turning the red grip in both directions.
• Your Turbohaler is now ready for use.
How to take an inhalation
Every time you need to take an inhalation, follow the instructions below.
1. Unscrew the cover and lift it off. You may hear a rattling sound.
2. Hold your Turbohaler upright with the red grip at the bottom.
3. Do not hold the mouthpiece when you load your Turbohaler. To load your Turbohaler with a dose, 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. Your Turbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.
4. Hold your Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Turbohaler.
5. Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply and as hard as you can through your mouth.
Do not chew or bite on the mouthpiece.
6. Remove your Turbohaler from your mouth.
Then breathe out gently. The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.
7. If you are to take a second inhalation, repeat steps 2 to 6.
8. Replace the cover tightly after use.
9. Rinse your mouth with water after your daily morning and/or evening doses, and spit it out.
Do not try to remove or twist the mouthpiece. It is fixed to your Turbohaler and must not be taken off. Do not use your Turbohaler if it has been damaged or if the mouthpiece has come apart from your Turbohaler.
As with all inhalers, caregivers should ensure that children prescribed Symbicort Turbohaler use correct inhalation technique, as described above.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.
When to start using a new Turbohaler
• The dose indicator tells you how many doses (inhalations) are left in your Turbohaler, starting with either 60 or 120 doses when it is full.
• The dose indicator is marked in intervals of 10 doses. Therefore it does not show every dose.
• When you first see a red mark at the edge of the indicator window, there are approximately 20 doses left. For the last 10 doses, the background of the dose indicator is red. When the ‘0' on the red background has reached the middle of the window, you must start using your new Turbohaler.
Note:
• The grip will still twist and ‘click' even when your Turbohaler is empty.
• The sound that you hear as you shake your Turbohaler is produced by a drying agent and not the medicine. Therefore the sound does not tell you how much medicine is left in your Turbohaler.
• If you load your Turbohaler more than once by mistake before taking your dose, you will still only receive one dose. However, the dose indicator will register all the loaded doses.
If you use more Symbicort Turbohaler than you should
It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.
The most common symptoms that may occur if you use more Symbicort Turbohaler than you should are trembling, headache or a rapid heart beat.
If you forget to use Symbicort Turbohaler
• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Symbicort Turbohaler can cause side effects, although not everybody gets them.
If either of the following happen to you, stop using Symbicort Turbohaler and talk to your doctor immediately:
• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty swallowing) or hives together with difficulty breathing (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.
• Sudden acute wheezing or shortness of breath immediately after using your inhaler. If either of these symptoms occur, stop using your Symbicort Turbohaler straightaway and use your ‘reliever’ inhaler. Contact your doctor immediately as you may need to have your treatment changed. This happens very rarely, affecting less than 1 in 10,000 people.
Other possible side effects:
Common (affects less than 1 in 10 people)
• Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use Symbicort Turbohaler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Symbicort Turbohaler.
• Mild sore throat, coughing and a hoarse voice.
• Headache.
Uncommon (affects less than 1 in 100 people)
• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heart beat.
• Bruising of the skin.
• Muscle cramps.
Rare (affects less than 1 in 1,000 people)
• Rash, itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing). If the wheezing comes on suddenly after using Symbicort Turbohaler stop using Symbicort Turbohaler and talk to your doctor immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.
Very rare (affects less than 1 in 10,000 people)
• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness in the chest (angina pectoris).
• An increase in the amount of sugar (glucose) in your blood.
• Taste changes, such as an unpleasant taste in the mouth.
• Changes in your blood pressure.
• Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include: changes in bone mineral density (thinning of the bones).
• cataract (clouding of the lens in the eye).
• glaucoma (increased pressure in the eye).
• a slowing of the rate of growth of children and adolescents.
• an effect on the adrenal gland (a small gland next to the kidney).
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Symbicort Turbohaler
• Keep out of the sight and reach of children.
• Do not store above 30oC.
• Keep container tightly closed in order to protect from moisture.
• Do not use Symbicort Turbohaler after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Symbicort Turbohaler contains
• Each metered dose contains 200 micrograms budesonide and 6 micrograms formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (which contains milk proteins).
What Symbicort Turbohaler looks like and contents of the pack
• The Symbicort Turbohaler contains a white powder contained within a breath actuated metered dose powder inhaler.
• The inhaler has a red turning grip and a white plastic body and cover, sealed with a tamper-evident strip. A Braille code is embossed at the bottom of the turning grip.
• The devices are available in pack sizes of one (60 doses) and two (2 x 60 doses) Turbohalers.
Manufactured by
• AstraZeneca AB, Kvarnbergagatan 12, 151 85, Sodertalje, Sweden.
• AstraZeneca Farmaceutica Spain, La Relva s/n 36400 Porrino, Pontevedra, Spain.
• AstraZeneca GmbH, Tinsdaler Weg, 183 D-22880, Wedel, Germany.
• AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA UK.
• N.V AstraZeneca S.A. Shaessestraat 15, B-9070 Destelbergen, Belgium.
• Corden Pharma GmbH, Otto-Hahn-Strasse 68-723 Plankstadt, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXX PL: 33532/0222
Leaflet dated 12th April 2016 Leaflet coded xxxxxxxxxxxx
Symbicort® and Turbohaler® are registered trademarks of AstraZeneca group of companies.