Serehale

SEREHALE contains two medicines, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting 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
• Chronic Obstructive Pulmonary Disease (COPD).

SEREHALE Accuhaler, at a dose of 50/500 micrograms, reduces the number of flare ups of COPD symptoms. You must use SEREHALE every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD.

Do not take SEREHALE:

• If you are allergic to salmeterol, fluticasone propionate or to the other ingredient of SEREHALE (listed in section 6).

Warnings and precautions

Take special care with SEREHALE:

• If you have a heart disease, including an irregular or fast heartbeat
• If you have an overactive thyroid gland
• If you have high blood pressure
• If you have diabetes mellitus (SEREHALE may increase your blood sugar)
• If you have low potassium in your blood
• If you have tuberculosis (TB) now or in the past, or other lung infections
• SEREHALE may cause blurred visions or visual disturbances.

Children and adolescents:

SEREHALE should not be used in children below 4 years.

Other medicines and SEREHALE:

Always tell your health care provider if you are taking any other medicines. This includes all complementary or traditional medicines. Tell your doctor if you are taking the following medicines, before starting to use SEREHALE:

• β blockers (such as atenolol, propranolol and sotalol). β blockers are mostly used for high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for HIV treatment (such as ritonavir, cobicistat containing products). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This can increase your risk of experiencing side effects with SEREHALE, including irregular heartbeats, or may make side effects worse. Your doctor may wish to monitor you carefully if you are taking these medicines.
• Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.
• Diuretics, also known as ‘water tablets’ used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to treat asthma.

SEREHALE with food, drink, and alcohol:

SEREHALE can be administered irrespective of whether food is taken or not.

Pregnancy and breastfeeding and fertility:

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 provider for advice before taking this medicine.

Driving and using machines:

SEREHALE is not likely to affect your ability to drive or use machines. It is not always possible to predict to what extent SEREHALE may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which SEREHALE affects them.

SEREHALE contains: Sugar (Lactose monohydrate) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Do not share medicines prescribed for you with any other person. Always take SEREHALE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

For Asthma:

Adults and adolescents aged 12 years and over

• SEREHALE Accuhaler 50/100 - One inhalation twice a day
• SEREHALE Accuhaler 50/250 - One inhalation twice a day
• SEREHALE Accuhaler 50/500 - One inhalation twice a day

Children 4 to 12 years of age

• SEREHALE Accuhaler 50/100 - One inhalation twice a day
• SEREHALE is not recommended for use in children below 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• SEREHALE Accuhaler 50/500 - One inhalation twice a day

The dose may change to:

• once at night - if you have night-time symptoms
• once in the morning - if you have daytime symptoms.

It is important to follow your doctor’s instructions on how many inhalations to take and how often to take your medicine. If you are using SEREHALE for asthma, your doctor will want to regularly check your symptoms.

SEREHALE can have side effects. Not all side effects reported for SEREHALE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SEREHALE, please consult your health care provider for advice.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• fever or chills
• increased mucus production, change in mucus colour
• increased cough or increased breathing difficulties

These are all profoundly serious side effects. If you have them, you may have had a serious reaction to SEREHALE. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache - this usually gets better as treatment continues.
• Increased number of colds have been reported in patients with COPD.
• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also, sore tongue and hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out immediately and/or brushing your teeth after taking each dose of your medicine may help. Your doctor may prescribe an anti-fungal medication to treat the thrush.
• Aching, swollen joints and muscle pain.
• Muscle cramps.

The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Bruising and fractures.
• Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).
• A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle weakness, cramp).

Less frequent side effects:

• Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
• Cataract (cloudy lens in the eye).
• Fast heartbeat (tachycardia).
• Feeling shaky (tremor) and fast or uneven heartbeat (palpitations) - these are usually harmless and get less as treatment continues.
• Chest pain.

Feeling worried (this effect mainly occurs in children).

• Disturbed sleep.
• Allergic skin rash.

Frequency unknown side effects:

• Low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm (hypokalaemia).

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 SEREHALE.

SEREHALE should be stored in the original packaging (keep blisters in the carton until required for use).

Store at or below 30 °C. Protect from moisture and sunlight.

STORE ALL MEDICINE OUT OF REACH OF CHILDREN

Do not use after the expiry date stated on the label and carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).