Symbicord ® Turbuhaler ® Inhaler

SYMBICORD TURBUHALER contains an inhalation powder. The powder is a mixture of the medicines budesonide and formoterol which have different ways of treating your disease (asthma or Chronic Obstructive Pulmonary Disease [COPD]). Asthma and COPD are caused by a type of chronic inflammation in the airways. Budesonide reduces and prevents this inflammation. Formoterol widens your airways and makes it easier for you to breathe. You should notice this within 1-3 minutes after you have inhaled the medicine and the effect lasts for up to 12 hours. When you breathe in through the mouthpiece of the inhaler, the medicine follows your breath to your lungs (see “Instructions for use” at the end of this leaflet).

Do not use SYMBICORD TURBUHALER:

• If you are hypersensitive (allergic) to budesonide or formoterol or any of the other ingredients of SYMBICORD TURBUHALER (listed in section 6).
• SYMBICORD TURBUHALER should not be used in children below the age of 12 years.

Warnings and precautions

Take special care with SYMBICORD TURBUHALER:

• if you currently have or have had, a heart disorder such as irregular heartbeat, high blood sugar (diabetes mellitus), problems with your thyroid (thyrotoxicosis) or low potassium in your blood (hypokalaemia).
• if you use SYMBICORD TURBUHALER to treat your COPD and you have any of the following symptoms, which could be signs of pneumonia (infection of the lung): fever or chills, increased mucus production or change in mucus colour, increased cough or increased breathing difficulties.
• if you are already taking any other medicines including those you have bought without a prescription.
• if you are already taking medicines for allergy, high blood pressure, heart conditions, fungal infections, depression and also some types eye drops. SYMBICORD TURBUHALER has been prescribed for your airway disease (asthma or COPD). Never lend your SYMBICORD TURBUHALER to someone else.

Other medicines and SYMBICORD TURBUHALER

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

• If you are taking ketoconazole (medicine for fungal infections) for longer than 2 weeks, it can increase the amount of the budesonide component of SYMBICORD TURBUHALER in the body.
• Quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors and tricyclic antidepressants can increase the risk of irregular heartbeat.
• Some medicines for high blood pressure, heart conditions, fungal infections, depression and some eye drops may alter the effect of SYMBICORD TURBUHALER if you use them at the same time.

Pregnancy and breastfeeding

Before you start using SYMBICORD TURBUHALER, tell your doctor if you are pregnant, trying to become pregnant or if you are breastfeeding. If you become pregnant while using SYMBICORD TURBUHALER, you should tell your doctor as soon as possible. You should not stop taking the medicine without discussing this with your doctor. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care professional for advice before using SYMBICORD TURBUHALER. Women who are using SYMBICORD TURBUHALER should not breastfeed their babies.

Driving and using machines

SYMBICORD TURBUHALER is not expected to affect your ability to drive or to operate any tools or machines.

SYMBICORD TURBUHALER contains lactose monohydrate (sugar) SYMBICORD TURBUHALER contains lactose. Patients with the rare hereditary conditions of lactose or galactose intolerance should not use SYMBICORD TURBUHALER. The lactose may contain milk protein.

• Do not share medicines prescribed for you with any other person.

• Always use SYMBICORD TURBUHALER exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Before you start using SYMBICORD TURBUHALER for the first time, it is important that you read the information “Instructions for use” at the end of this leaflet and follow the instructions carefully.

• The dosage of SYMBICORD TURBUHALER is individual. If you use SYMBICORD TURBUHALER as a maintenance therapy, the maintenance dose should be taken even when you have no symptoms. Your doctor will adjust your medicine to the lowest dose that controls your asthma or COPD. Follow your doctor’s directions carefully. The directions may be different from the information contained in this leaflet.

• If you have the impression that the effect of SYMBICORD TURBUHALER is too strong or too weak, tell your doctor or pharmacist.

• Do not increase the dose of SYMBICORD TURBUHALER without talking to your doctor.

• Remember: Rinse your mouth out with water after taking your regular morning and/or evening dose for your asthma or COPD. If you use SYMBICORD TURBUHALER for your asthma, you do not have to rinse your mouth if you have used reliever doses for your symptoms.

• Do not adjust or stop the dose without talking to your doctor first. If you are instructed by your doctor to discontinue treatment with SYMBICORD TURBUHALER, follow any directions on dose reduction carefully.

If you use more SYMBICORD TURBUHALER than you should

It is important to use only the number of puffs your doctor has prescribed. If you use more than the recommended dose you will increase the risk of side effects. The most common symptoms and signs that may occur after overdosage are: trembling, headache and rapid heartbeat. If you use too much SYMBICORD TURBUHALER over a longer period (months), it is possible that you may get side effects related to budesonide. If you think this may have happened to you or if any of the above-mentioned symptoms bother you, please discuss it with your doctor.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use SYMBICORD TURBUHALER

If you forget to take a maintenance dose of SYMBICORD TURBUHALER it is not necessary to compensate for the dose you missed. Just take the next dose as prescribed.

SYMBICORD TURBUHALER can have side effects. Not all side effects reported for SYMBICORD TURBUHALER are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SYMBICORD TURBUHALER, please consult your health care provider for advice. Contact your doctor if any of the following side effects bother you or if any other unusual effects bother you.

Frequent side effects:

• Irritation in the throat, coughing, hoarseness, thrush (fungal infection in the mouth and throat)
• headache
• trembling
• rapid heartbeat
• pneumonia in COPD patients

Less frequent side effects:

• sleep difficulties, restlessness and nervousness
• dizziness
• nausea
• muscle cramps and agitation
• skin rash
• itching
• spasm in the airways
• irregular heartbeats
• skin bruising
• severe allergic reactions
• high blood sugar levels
• facial swelling
• depression
• behavioural disturbances
• chest pain

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects you can help provide more information on the safety of SYMBICORD TURBUHALER.

Store all medicines out of reach of children. Store at or below 30 °C. Always replace the mouthpiece cover after using SYMBICORD TURBUHALER. Do not use SYMBICORD TURBUHALER after the shelf-life expiry date. Return all unused medicine to your pharmacist. Always be sure to dispose of your used SYMBICORD TURBUHALER responsibly, since some of the medicine will remain inside it. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).