Seretide Evohaler contains two medicines, salmeterol and fluticasone propionate: 

·       Salmeterol is a (long-acting beta2 agonist) bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours.

·       Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

The doctor has prescribed this medicine to help prevent breathing problems such as:

·       Asthma.

You must use Seretide every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. 

Seretide helps to stop breathlessness and wheeziness coming on. It does not work once you are breathless or wheezy. If that happens, you need to use a fast acting ‘reliever’ medication, such as salbutamol.

Ask your doctor or pharmacist if you would like any further explanation about these uses.

Do not take Seretide Evohaler:

You are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient in Seretide Evohaler.

If you are not sure, talk to your doctor or pharmacist before taking Seretide Evohaler.

Take special care with Seretide Evohaler

Check with your doctor or pharmacist before taking Seretide Evohaler if:

·       You have acute symptoms (use fast reliever bronchodilator).

·       You have overactive thyroid gland.

·       You are using asthma relievers so frequent.

·       You have or previously had tuberculosis.

·       You have high blood pressure.

·       You have Heart disease, including an irregular or fast heart beat.

·       You have kidney problems, if your doctor transferring you from oral to inhaled cortisone.

·       You have diabetes mellitus.

·       You have low potassium in your blood.

·       The current dose of Seretide failed to give adequate control of asthma.

If you are stopping the treatment do not to stop abruptly due to the risk of the symptoms worsening.

If you have sudden and progressive deterioration in control of asthma (it is life threatening), you should contact your doctor and he might increase the cortisone dose.

Increasing the use of fast reliever bronchodilator is indicator for case deterioration.

Your treatment plan will be titrated to the lowest dose that gives an effective control and maintain it.

If your child is asthmatic and treated with Seretide, his height will be monitored by his doctor.

You should carry steroid warning card if you are transferring from systemic to inhaled therapy.

You should discontinue Seretide if you feel increase in wheezing after taking dose and take immediately fast and short acting bronchodilator.

If your heart rate gets faster, this will be transient effect and tend to reduce with regular therapy.

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

Giving other medicines, herbal or dietary supplements

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines for asthma or any medicines that you buy without a prescription and herbal medicines. This is because Seretide Evohaler can affect the way some medicines work. Also some other medicines can affect the way Seretide Evohaler works.

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

·       Beta blockers, such as propranolol used to treat irregular or fast heart beats.

·       Antiviral and antifungal medicines (such as ritonavir, and ketoconazole).

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

Pregnancy and breast-feeding

As with all medicines, do not use Seretide if you are pregnant, especially in the first 3 months, unless considered essential by your doctor.

Talk to your doctor or pharmacist before taking Seretide if you are or might be pregnant or lactating.

Ask your doctor for advice before taking any medicine.

Effects on ability to drive and use machines

Seretide has no reports on affecting your ability to drive or use any tools or machines.

Always take Seretide Evohaler exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose has been prescribed will depend on the treatment plan.

How to take Seretide Evohaler

·       Do not increase the dose without medical advice.

·       Seretide Evohaler is administered by the oral inhaled route only.

·       Use Seretide Evohaler regularly for optimum benefit.

·       Use a spacer device if you find it difficult to synchronize aerosol actuation with inspiration of breath.

Changing from corticosteroid alone to combination therapy will make you benefit either by more control of asthma or decreasing the dose of corticosteroid.

Asthma

Adults and adolescents 12 years and older:-

·       Seretide 25mcg/50 mcg Evohaler - Two inhalations twice a day.

·       Seretide 25mcg/125mcg Evohaler - Two inhalations twice a day.

·       Seretide 25mcg/250mcg Evohaler - Two inhalations twice a day.

Children 4 years and older:-

·       Seretide 25mcg/50mcg Evohaler - Two inhalations twice a day.

Children under 4 years:

No data available for use of SERETIDE in children aged less than 4 years.

Your symptoms may become well controlled using Seretide twice a day. If so, your doctor may decide to reduce your dose to once a day.

It is very important to follow your doctor’s instructions on how many inhalations to take and how often to take your medicine.

If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast acting ‘reliever’ medicine. If any of these happen, you should continue to take Seretide but do not increase the number of puffs you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.

Special patient group

There is no need to adjust the dose in the elderly or in those with kidney or liver problems.

If you use more Seretide Evohaler than you should

If you use more Seretide Evohaler than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

The following effects may happen:

Effects due to Salmeterol

-        Your heart beating may be faster than usual.

-        You feel shaky.

-        Your blood pressure becomes high.

-        You may have headache, muscle weakness, and joints ache.

-        Your blood potassium becomes low.

Effects due to Fluticasone

-        Temporary suppression to HPA axis.

Seretide Evohaler may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time particularly in children. The effects include:

-        Your blood glucose becomes low (lead to unconsciousness and convulsions) this is triggered by stress (Trauma, Surgery, Infection or rapid reduction in dosage of corticosteroid.

Your doctor will check you regularly for any of these side effects to give you the lowest dose of Seretide to control your asthma.

If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Seretide may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to take Seretide Evohaler     

If you miss a dose:

·       take Seretide Evohaler as soon as possible, then

·       take your next dose at the usual time.

·       Do not give a double dose to make up for a forgotten dose.

Stopping taking Seretide Evohaler    

Do not stop taking Seretide Evohaler without talking to your doctor. Continue until the treatment is finished, even if you feel better.

If you have any further question on the use of this product, ask your doctor or pharmacist.

Like all medicines, Seretide Evohaler can cause side effects, although not everybody gets them.

Allergic reactions

If you have an allergic reaction, stop taking Seretide and see a doctor straight away. The signs may include:

·       sudden wheezing and chest pain or chest tightness.

·       swelling of your eyelids, face, lips, mouth or tongue.

Other side effects are listed below:

Very common (affects more than 1 in 10 people)

·       Headache.

Common (affects more than 1 in 100 people and less than 1 in 10 people)

·       Fungal infection caused by Candida in the mouth (Thrush) and throat. Muscle cramps, joints pain.

Uncommon (affects more than or equal to 1 in 1000 people and less than 1 in 100 people)

·       Rash

·       Skin allergic reactions.

·       shortness of breath.

·       increased blood sugar.

·       Collection of blood in the tissue (contusions).

·       Increased and irregular heartbeats.

·       Tremors.

·       Anxiety, sleep disorder.

·       Low potassium in blood.

·       Opacity in eye lens.

·       Horse voice, Throat irritation.

Rare (affects more than or equal to 1 in 10000 people and less than 1 in 1000 people)

·       Allergic reactions including serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing, itchy, bumpy rash (hives), chest tightness causing difficulty in breathing, Low blood pressure that can cause light-headedness on standing up and collapse.

·       Pressure in the eye.

·       Change in mood including irritability and increased activity (mainly in children).

·       Chest tightness causing difficulty in breathing or wheezing.

·       Fast heartbeats.

·       Swelling in the face and neck.

·       Cushing’s syndrome, Cushingoid features, adrenal suppression, slowing the growth in children and adolescents, bone thinning.

·       Fungal infection caused by Candida in the oesophagus (gullet), which might cause difficulties in swallowing.

If your asthma gets worse straight after taking Seretide, stop using your Seretide Evohaler. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist.

·       Keep out of the reach and sight of children.

·       Straight after use, replace the mouthpiece cover firmly and snap it into position.

·       Do not use Seretide Evohaler after the expiry date which is stated on the pack after ‘Exp’.

·       Store Seretide Evohaler in dry place below 30°C.

·       Protect from frost and direct heat or sunlight.

·       Do not cool the canister, since cooling decreases the therapeutic effect.

·       The container contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn the inhaler even when it is apparently empty.

·       If your doctor tells you to stop taking Seretide Evohaler, it is important to return any remnants which are left over 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.