Seretide® (fluticasone propionate / salmeterol xinafoate)

Respiratory  

Consumer Medicine Information


Product Information (Intended for Healthcare Professional)

 

Seretide Accuhaler®


What Seretide Accuhaler is used for?
Before you use Seretide Accuhaler
While you are using Seretide Accuhaler
Side-Effects?

The following text appears in the Seretide Accuhaler Consumer Medicine Information. This information is intended for patients who have been prescribed Seretide Accuhaler. Please view Consumer Medicine Information and see your doctor for more information.

What is Seretide Accuhaler used for?

Seretide Accuhaler is used tohelp with asthma and chronicobstructive pulmonary disease(COPD) in people who need regular treatment.

Asthma is a condition affecting the lungs. Symptoms of asthma include shortness of breath, wheezing, chest tightness and cough. Two main causes of asthma symptoms are bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation (swelling and irritation of the airways).

Chronic obstructive pulmonary disease (COPD) is a long-term condition affecting the lungs, resulting from chronic bronchitis or emphysema. Symptoms of COPD include shortness of breath, cough, chest discomfort and coughing up phlegm. The COPD symptoms are mainly due to bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation (swelling and irritation of the airways).

Seretide Accuhaler contains two medicines, fluticasone propionate and salmeterol xinafoate.

Fluticasone propionate belongs to a group of medicines known as corticosteroids, frequently called ‘steroids’. They are not ‘anabolic steroids’ which are the steroids sometimes misused by athletes. Corticosteroids have an antiinflammatory action. They reduce the swelling and irritation in the walls of the small air passages in the lungs and so help you to breathe more easily. Coticosteroids are used to treat asthma and COPD.

Salmeterol xinafoate is known as a bronchodilator. A bronchodilator keeps the breathing tubes in your lungs open and relieves the symptoms of asthma and other chest conditions. The effects of salmeterol xinafoate last for up to twelve hours.

When taken together regularly fluticasone propionate and salmeterol help to control your breathing difficulties.

Your doctor may have prescribed Seretide Accuhaler for another reason.

Ask your doctor if you haveany questions about whySeretide Accuhaler has been prescribed for you.

The medicine in Seretide Accuhaler is not addictive.

Back to Top

 

 
Before you use Seretide Accuhaler

When you must not use it

  • Do not use Seretide Accuhaler if you have ever had an allergic reaction to fluticasone propionate (Flixotide), salmeterol xinafoate (Serevent), lactose or milk protein.

    Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.

     

  • Do not use Seretide Accuhaler if you are pregnant, trying to become pregnant or breast-feeding, unless your doctor says you should.

    Your doctor will discuss the risks and benefits of using Seretide Accuhaler if you are pregnant or breastfeeding.


     

  • Do not use Seretide Accuhaler after the expiry date (EXP) printed on the pack.


    If you use it after the expiry date has passed, it may not work as well.

     

  • Do not use Seretide Accuhaler if the packaging is torn or shows signs of tampering.

    If you're not sure whether you should be using Seretide Accuhaler, talk to your doctor.

     

Before you start to use it

You must tell your doctor if:

 

  • you are allergic to foods, dyes, preservatives or any other medicines

     

  • you are pregnant or likely to become pregnant

     

  • you are breast-feeding

     

  • you have ever had thrush in your mouth

     

  • you are being or have ever been treated for tuberculosis (TB)

     

  • you are having treatment for a thyroid condition

     

  • you are having treatment for high blood pressure or a heart problem

       

      Using other medicines


      Tell your doctor if you are using any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.


      Some medicines may affect the way others work. For example, a class of medicines known as “beta-blockers” used to treat hypertension should be avoided. Other medicines like ketoconazole, used to treat fungal infection, and ritonavir used to treat HIV infection, may also affect how Seretide Accuhaler works. If you are taking these medicines, consult your doctor or pharmacist who will advise on what you should do.

       

      Back to Top

       

       

      While you are using Seretide Accuhaler

      Things you must do


      Tell your doctor or pharmacist that you are using Seretide Accuhaler if you are about to be started on any new medicines.


      Tell your doctor if you become pregnant or are trying to become pregnant.


      Tell your doctor if, for any reason, you have not used your medicine exactly as prescribed.


      Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.


      Things you must not do


      Do not stop using Seretide, or change the dose without first checking with your doctor.


      Do not give this medicine to anyone else, even if their symptoms seem similar to yours.


      Do not use Seretide Accuhaler to treat any other complaints unless your doctor says to.


      Do not use Seretide Accuhaler after the expiry date shown on the carton and label.


      Things to be careful of


      Be careful driving or operating machinery until you know how Seretide Accuhaler affects you.


      Seretide Accuhaler generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Seretide Accuhaler may cause dizziness/drowsiness/tiredness in some people.


      Back to Top
       

      What are the side-effects?

      Check with your doctor as soon as possible if you have any problems while using Seretide Accuhaler, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.


      Most people using this medicine find that it causes no problem. Like other medicines, Seretide Accuhaler can cause some side-effects. If side effects occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.


      The most commonly reported side-effects are:

       

      • soreness of the throat or tongue
      • hoarseness
      • headache
      • muscle cramps
      • pains in joints
      • skin rash or trembling
      • ncrease in heart rate

       

      Pneumonia (lung infection) has been reported commonly in patients with COPD.

       

      It is possible that some people, particularly those taking higher doses of Seretide Accuhaler for a long time, may rarely suffer from the following side effects:

       

      • rounded face
      • loss of bone density
      • eye problems (eg. cataract, glaucoma)
      • slowing of growth in children. It is unclear what, if any, difference this makes to a child’s final height.

         

        Taking high doses of steroids for a long time could affect the adrenal glands, which make the body's own steroid. Your doctor may do tests to check how the adrenal glands are working. Your doctor will be able to answer any questions you may have.


        It is important that:

         

      • treatment with your Seretide Accuhaler is not stopped suddenly.
      • all doctors treating you are aware that you are on inhaled steroids. If your body is stressed by, for example, severe infection, surgical operation, an accident etc, you may need steroid tablets or injections for a time.

         

        Very rarely the person taking the medicine may feel anxious, have disturbed sleep or notice increased irritability (mainly in children).


        Ask your doctor or pharmacist to answer any questions you may have.


        If you think you are having an allergic reaction to Seretide Accuhaler, STOP using this medicine and TELL YOUR DOCTOR IMMEDIATELY or go to the casualty department at your nearest hospital. Symptoms of an allergic reaction usually include some or all of the following:

         

        • wheezing
        • swelling of the lips, mouth, tongue or throat
        • difficulty in breathing
        • hay fever
        • lumpy rash ("hives")
        • fainting

         

        This is not a complete list of all possible side-effects. Others may occur in some people and there may be some sideeffects not yet known.


        Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

        Ask your doctor or pharmacist if you don't understand anything in this list.


        Do not be alarmed by this list of possible side-effects. You may not experience any of them.

         


         

        Back to Top
 
 
Key Products in the Respiratory range are: