Document: Relanio 50_250 microgram 50_500 microgram per dose inhalation powder pre-dispensed ENG PL change

• Relanio inhalation powder, pre-dispensed PL
• Relanio 50_250 microgram 50_500 microgram per dose inhalation powder pre-dispensed ENG PL

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Package Leaflet: Information for the User

Relanio 50 microgram/250 microgram/dose inhalation powder, pre-dispensed

Relanio 50 microgram/500 microgram/dose inhalation powder, pre-dispensed

salmeterol/fluticasone propionate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Relanio is and what it is used for

Relanio 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). Relanio at a dose of 50/ 500 micrograms, reduces the number of flare ups of COPD symptoms.

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

Relanio helps to stop breathlessness and wheeziness coming on. However, Relanio should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should always have your fast-acting ‘rescue’ inhaler with you.

2. What you need to know before you use Relanio

Do not take Relanio:

If you are allergic to salmeterol, fluticasone propionate or to the other ingredient lactose monohydrate.

Warnings and precautions

Talk to your doctor before using Relanio if you have:

• Heart disease, including an irregular or fast heart beat

• Overactive thyroid gland

• High blood pressure

• Diabetes mellitus (Relanio may increase your blood sugar)

• Low potassium in your blood

• Tuberculosis (TB) now or in the past, or other lung infections.

Other medicines and Relanio

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines for asthma or any other medicines obtained without prescription. This is because Relanio may not be suitable to be taken with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use Relanio:

• 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 ritonavir, ketoconazole, itraconazole and erythromycin). 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 Relanio, including irregular heart beats, or may make side effects worse.

• 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Relanio is not likely to affect your ability to drive or use machines.

Relanio contains lactose

If you have been told by your doctor that you have intolerance to lactose (a type of sugar), contact your doctor before taking this medicinal product.

3. How to use Relanio

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Use your Relanio every day until your doctor advises you to stop. Do not take more than the recommended dose. Check with your doctor or pharmacist if you are not sure.

• Do not stop taking Relanio or reduce the dose of Relanio without talking to your doctor first.

• Relanio should be inhaled through the mouth into the lungs.

• After use rinse your mouth with water and spit it out.

• For adults with asthma

• Relanio 50 microgram/250 microgram/ dose: One inhalation twice a day.

• Relanio 50 microgram /500 microgram/dose: One inhalation twice a day.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

Use in children and adolescents

Relanio should not be used in children and adolescents.

Your symptoms may become well controlled using Relanio twice a day. If so, your doctor may decide to reduce your dose to once 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 very important to follow your doctor’s instructions on how many inhalations to take and how often to take your medicine.

If you are using Relanio for asthma, your doctor will want to regularly check your symptoms.

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 Relanio 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.

Instructions for use

Your doctor, nurse or pharmacist should show you how to use your inhaler (Elpenhaler^®). They should check how you use it from time to time. Not using the Relanio properly or as prescribed may mean that it will not help your asthma or COPD as it should.

INSTRUCTIONS FOR USE AND HANDLING OF THE Elpenhaler^®

The following are instructions to the patient for the proper inhalation of the two medicines packed in the two blisters of the single dose strips (double-blister strips), which are stored in the Elpenhaler^®.

DESCRIPTION

The Elpenhaler^®is a device for inhaling at the same time two medicines which are in the form of powder. The two medicines form in one medicinal combination. Each medicine is packed separately from the other in one of the two blisters of the specially designed double-blister strip.

The double-blister strip contains one (1) dose of the medicinal combination.

The Elpenhaler^® is comprised of 3 parts:

- The mouthpiece and its protective cover (1).

- The surface (2) on which the double-blister strip is placed

(supporting surface).

- The storage compartment (3) which houses the double-blister

strips.

The three parts are connected to each other and can be

opened separately.

The supporting surface contains:

- An attachment point (2A) where the double-blister strip is

attached.

- Two cavities (2B) which accommodate the two blisters

of the strip.

- Two strip guides (2C) which firmly secure the

double-blister strip in the correct position on the

supporting surface.

The double blister strip contains:

- Two sheets (4).

- Two blisters (5), one containing salmeterol and

the other fluticasone propionate.

- A hole (6).

USE OF THE Elpenhaler^®

Α. Preparing the device

- Open the storage compartment, take a strip, and close the storage compartment again.

- Uncover the mouthpiece completely from its protective cover.

- Unlock and push the mouthpiece backwards as to reveal the supporting surface.

- Hold the double-blister strip with its shiny surface upwards.

- Place the strip on the attachment point of the supporting surface. By applying light pressure make sure the strip is securely attached on the attachment point.

- The two blisters of the strip will fit in the cavities of the supporting surface, and the guides will secure the strip in the correct position.

- Close the mouthpiece, and pull away the protruding end of the strip. The dose is now ready to be inhaled.

Β. Inhalation of the dose

Hold the device away from your mouth.

- Exhale completely. Be careful not to exhale on the

mouthpiece of the device.

- Bring the Elpenhaler^® to your mouth and place your lips

tightly around the mouthpiece.

- Breathe in slowly and deeply from your mouth (and not

from your nose) until your lungs are full.

- Hold in your breath approximately 5 seconds or as long as

you comfortably can and at the same time remove the

device from your mouth.

- Exhale and continue to breathe normally.

- Open the mouthpiece. You will notice that you have inhaled all the powder and that the blisters of the strip are empty.

- Remove the empty strip, and proceed to step C.

C. Cleaning the device

- Following each use, wipe the mouthpiece and the supporting surface with a dry cloth or dry paper tissue. Do not use water to clean the device.

- Close the mouthpiece and place the protective cover around it.

If you use more Relanio than you should

It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints.

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 Relanio may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Relanio

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

If you stop using Relanio

It is very important that you take your Relanio every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Relanio. This could make your breathingworse.

In addition, if you suddenly stop taking Relanio or reduce your dose of Relanio this may (very rarely) cause you to have problems with your adrenal gland (adrenal insufficiency) which sometimes causes side effects.

These side effects may include any of the following:

• Stomach pain

• Tiredness and loss of appetite, feeling sick

• Sickness and diarrhoea

• Weight loss

• Headache or drowsiness

• Low levels of potassium in your blood

• Low blood pressure and seizures (fits).

When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Relanio to control your asthma or COPD.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Relanio. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat) or you may suddenly feel your heart beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using Relanio, stop using Relanio and tell your doctor straight away. Allergic reactions to Relanio are uncommon (they may affect up to 1 in 100 people).

Other side effects are listed below:

Very common: may affect more than 1 in 10 people

• Headache – this usually gets better as treatment continues

• Increased number of colds have been reported in patients with COPD

Common side effects: may affect up to 1 in 10 people 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):

• Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increase in sputum production, change in sputum colour, fever, chills, increased cough, increased breathing problems.

• 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 heart beat, muscle weakness, cramp).

Uncommon: may affect up to 1 in 100 people

• 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).

• Very fast heart beat (tachycardia).

• Feeling shaky (tremor) and fast or uneven heart beat (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.

Rare: may affect up to 1 in 1,000 people

• Breathing difficulties or wheezing that get worse straight after taking Relanio. If this happens stop using Relanio inhaler. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.

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

• Slowing of growth in children and adolescents

• Thinning of the bones

• Glaucoma

• Weight gain

• Rounded (moon shaped) face (Cushing’s Syndrome).

Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of Relanio to control your asthma.

• Behavioural changes, such as being unusually active and irritable (these effects mainly occur in children).

• Uneven heart beat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Relanio unless your doctor tells you to stop.

• A fungal infenction in the oesophagus (gullet), which might take cause difficulties in swallowing.

Not known: frequency cannot be estimated from the available data

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Relanio

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

• Store below 25 °C.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Relanio contains

The active substances are

50 micrograms salmeterol (as salmeterol xinafoate) and 50 micrograms salmeterol (as salmeterol xinafoate) and 250 micrograms fluticasone propionate.

or

50 micrograms salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate.

The other ingredient is lactose monohydrate.

What Relanio looks like and contents of the pack

Relanio contains salmeterol and fluticasone propionate packed in the two blisters of the single dose foil strips (double-blister strips), which are stored in the inhalation device Elpenhaler^®.

The foil protects the powder for inhalation from the effects of the atmosphere.

Each dose is pre-dispensed in one double-blister strip.

Each carton box contains one inhalation device Elpenhaler^® with 30 alu-alu double blister strips. 30 doses per pack

Each carton box contains one inhalation device Elpenhaler^®with 30 double blister strips and one spare canister with 30 additional double blister strips. 60 doses per pack

Each carton box contains one inhalation device Elpenhaler^® with 60 alu-alu double blister strips. 60 doses per pack

Each carton box contains three inhalation devices Elpenhaler^®with 60 alu-alu double blister strips each. 180 doses per pack

Marketing Authorisation Holder and Manufacturer

ELPEN Pharmaceutical Co.Inc

95, Marathonos Ave., GR-19009 Pikermi, Attica

Greece

This leaflet was last revised in 25 May 2016

<To be completed nationally.>