РОЛЕНИУМ 50 МКГ/250 МКГ Ингаляционный порошок

Содержание инструкции

1. ROLENIUM 50 micrograms/250 micrograms/dose powder for inhalation in container
2. ROLENIUM 50 micrograms/500 micrograms/dose powder for inhalation in container
   1. What is ROLENIUM and what is it used for
3. ROLENIUM helps to prevent the onset of shortness of breath and wheezing. However, ROLENIUM
   1. What you need to know before you take ROLENIUM
   2. How to take ROLENIUM
   3. Possible side effects
   4. How to store ROLENIUM
   5. Package Contents and Other Information

ROLENIUM 50 micrograms/250 micrograms/dose powder for inhalation in container

single dose

ROLENIUM 50 micrograms/500 micrograms/dose powder for inhalation in container

single dose
salmeterol/fluticasone propionate
Read this leaflet carefully before you start to take this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ROLENIUM is and what it is used for
• 2. What you need to know before you use ROLENIUM
• 3. How to take ROLENIUM
• 4. Possible side effects
• 5. How to store ROLENIUM
• 6. Contents of the pack and other information

1. What is ROLENIUM and what is it used for

ROLENIUM contains two medications, 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 enter and exit. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation of the lungs.

Your doctor has prescribed this medication to help prevent breathing problems, such as:

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD). ROLENIUM at a dose of 50 / 500 micrograms reduces the number of exacerbations of COPD symptoms.

You need to use ROLENIUM every day, as directed by your doctor. This will ensure that the medication works correctly in controlling asthma or COPD.

ROLENIUM helps to prevent the onset of shortness of breath and wheezing. However, ROLENIUM

cannot be used to provide relief from sudden attacks of shortness of breath and wheezing. If this
happens, it is necessary to use fast-acting reliever inhalers, such as salbutamol. You should always have a fast-acting reliever inhaler with you.

2. What you need to know before you take ROLENIUM

Do not take ROLENIUM:
if you are allergic to salmeterol, fluticasone propionate or the excipient lactose monohydrate.

Warnings and precautions
Talk to your doctor before using ROLENIUM if you have:

• Heart conditions, including an irregular or fast heartbeat
• overactive thyroid gland
• High blood pressure
• diabetes mellitus (ROLENIUM may increase blood sugar levels).
• Hypokalemia (low potassium levels in the blood)
• tuberculosis (TB), currently or in the past, or other lung infections.

Other medicines and ROLENIUM
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. This includes medicines for asthma or any other medicine without
a prescription. This is because ROLENIUM may not be suitable for taking with some
other medicines.
Tell your doctor if you are taking the following medicines, before starting to use
ROLENIUM:

• β blockers (such as atenolol, propranolol and sotalol). Beta-blockers are used mainly for high blood pressure or other heart conditions.
• Medicines for the treatment of infections (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines can increase the amount of fluticasone propionate or salmeterol in your body. This can increase the risk of developing unwanted effects with ROLENIUM, including irregular heartbeat, or can worsen unwanted effects.
• Corticosteroids (by mouth or parenterally). If you have taken these medicines recently, this could increase the risk that this medicine affects the adrenal gland.
• Diuretics used for the treatment of high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine-based medicines. These are often used for the treatment of asthma.

Pregnancy, breastfeeding and fertility
If you are pregnant, or if you are breastfeeding, suspect or are planning a pregnancy, ask your doctor for
advice before taking this medicine.

Driving and using machines
ROLENIUM does not affect your ability to drive or operate machinery.

ROLENIUM contains lactose.
If your doctor has told you that you are intolerant to lactose (a type of sugar), contact them before
taking this medicine.

3. How to take ROLENIUM

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

• Use ROLENIUM every day until your doctor tells you to stop. Do not take a higher dose than recommended. If you have doubts, consult your doctor or pharmacist.
• Do not stop ROLENIUM or reduce the dose of ROLENIUM without first talking to your doctor.
• ROLENIUM must be inhaled into the lungs through the mouth.
• After use, rinse your mouth with water and spit it out.

For adults with asthma

• ROLENIUM 50 micrograms /250 micrograms / dose: One inhalation twice a day.
• ROLENIUM 50 micrograms / 500 micrograms / dose: One inhalation twice a day.

For adults with chronic obstructive pulmonary disease (COPD)
ROLENIUM 50 micrograms / 500 micrograms / dose: One inhalation twice a day.

Use in children and adolescents
ROLENIUM should not be used in children and adolescents.
Your symptoms may be well controlled with the use of ROLENIUM twice a day. If this is
the case, your doctor may decide to reduce the dose to once a day. The dose may change to:

• once at night - if you have symptoms at night
• once in the morning - if you have symptoms during the day

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

Tell your doctor immediately if your asthma or breathing gets worse.You may find
that you feel more breathless, that more often your chest is tighter or you may need to
use your fast-acting ‘rescue’ medicine more often. If any of these happens, you should continue to take ROLENIUM, but do not increase the number of inhalations. Your chest condition may worsen and you could become seriously ill. Consult your doctor as further treatment may be needed.

Instructions for use
Your doctor, nurse or pharmacist must show you how to use your inhaler
( Elpenhaler). They should also check how you use it from time to time.
Incorrect use of ROLENIUM or use different from what is prescribed may mean that
it will not help your asthma or COPD as it should.

INSTRUCTIONS FOR THE USE AND HANDLING OF Elpenhaler
The following are patient instructions for the correct inhalation of the two medicines
packaged in a strip of two blisters (double blister), stored in the Elpenhalerdevice.

DESCRIPTION
Elpenhaleris a device for the simultaneous inhalation of two medicines that are in powder form. The two drugs form a medicinal combination. Each drug is packaged
separately in each blister of the special strip of two blisters.
The double blister contains one (1) dose of the medicinal combination.

Elpenhalerconsists of three parts:

• The mouthpiece and its protective cover (1).
• The surface (2)on which the double blister is placed (support surface).
• The container (3)in which the strips are stored.

The three parts are connected to each other and can be opened
separately.
The support surface contains:

• An attachment point (2A)where the double blister strip is fixed.
• Two cavities (2B)that house the two blisters of the strip.
• Two guides (2C)that firmly fix the strip in the correct position on the support surface.

The double blister stripcontains:

• Two foils (4)

• Two blisters (5),one containing salmeterol and the other fluticasone propionate
• A hole (6)

USE OF Elpenhaler

• A. Preparing the device

Open the container, take a strip and close it
again.

• Remove the cap from the mouthpiece completely.
• Unlock and press the mouthpiece backwards to reveal the support surface.
• Hold the strip with its shiny side facing up.
• Place the strip on the attachment point of the surface. Applying slight pressure, make sure the strip is firmly attached to the attachment point.
• The double blister fits into the cavities of the surface, and the guides will ensure that the strip is in the correct position.

• Close the mouthpiece and pull away the protruding part of the strip. The dose is now ready to be inhaled.

• B. Inhaling the doseHold the device away from your mouth.
• Exhale completely. Be careful not to exhale on the mouthpiece of the device.
• Bring Elpenhalerto your mouth and keep your lips tight around the mouthpiece.
• Inhale slowly and deeply from your mouth (not your nose) until your lungs are full.
• Hold your breath for about 5 seconds or as long as you can comfortably and at the same time remove the device from your mouth.
• Exhale and continue to breathe normally.

• Open the mouthpiece. You will notice that all the powder has been inhaled and that the two blisters are empty.
• Remove the empty strip and proceed to step C.

• C. Cleaning the device
• C. Cleaning the device
• After each use, clean the mouthpiece and support surface with a dry cloth or a dry tissue. Do not use water to clean the device.
• Close the mouthpiece and put the protective cap back on.

If you take more ROLENIUM than you should
It is important to use the inhaler as indicated. If you accidentally take a higher dose than
recommended, contact your doctor or pharmacist. You may notice that your heart beats faster
than usual and that you feel shaky. You may also feel dizzy, headache, muscle weakness and joint pain.
If you have used higher doses for a long period of time, you should talk to your doctor or
pharmacist. This is because higher doses of ROLENIUM can reduce the amount of steroid hormones
produced by the adrenal gland.

If you forget to take ROLENIUM
Do not take a double dose to make up for a missed dose. Take the next dose
as usual.

If you stop taking ROLENIUM
It is very important that you take ROLENIUM every day as prescribed.

Continue to take it until your doctor tells you to stop. Do not stop or
suddenly reduce the dose of ROLENIUM.This could worsen your breathing problem.
Also, if you stop or suddenly reduce the dose of ROLENIUM this can cause (very
rarely) problems with the adrenal glands (adrenal insufficiency) which can sometimes cause
adverse effects.
These side effects may include any of the following:

• Stomach pain
• Fatigue and loss of appetite, feeling unwell
• Nausea and diarrhea
• Weight loss
• Headache or drowsiness
• Low potassium levels in the blood
• Low blood pressure and convulsions (seizures).

When the body is under stress following fever, trauma (e.g. after a road accident), an infection or surgery, adrenal insufficiency can worsen and can
manifest one of the adverse effects listed below.
If you experience any of the side effects, contact your doctor or pharmacist.
To avoid the development of these symptoms, your doctor may prescribe other corticosteroids in the form of
tablets (such as prednisolone).
If you have any further questions about the use of this inhaler, ask your doctor, nurse or
pharmacist.

4. Possible side effects

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

Allergic reactions: you may notice a sudden worsening of your breathing
immediately after using ROLENIUM.You may be very short of breath, have a cough or
wheezing. You may also notice itching, rash (hives) and swelling (usually of the face,
lips, tongue or throat) or you may suddenly feel your heart beating very
fast or feel weak and dizzy (which may cause you to collapse or
lose consciousness). If you develop any of these effects or if they occur suddenly after
using ROLENIUM, stop using ROLENIUM and tell your doctor immediately.
Allergic reactions to ROLENIUM are uncommon (affect up to 1 in 100 people).
Other side effects are listed below:

Very common(affect more than 1 in 10 people)

• Headache - this usually improves as treatment continues.
• Increased number of colds have been reported in patients with COPD.

Common(affect up to 1 in 10 people)

• Thrush (plaque, raised spot, yellowish-cream in color) in the mouth and throat. Also pain in the tongue, hoarseness and irritation of the throat. Rinsing your mouth with water and spitting it out immediately and/or brushing your teeth after each dose of the medicine may help. Your doctor may prescribe an antifungal medicine to treat thrush.
• Swollen and painful joints and muscle aches.
• Muscle cramps.

The following side effects have also been reported in patients with chronic obstructive
pulmonary disease (COPD):

• Pneumonia (lung infection), in patients with COPD (common side effect) Tell your doctor if you have any of the following symptoms while taking Rolenium, they could be symptoms of a lung infection:
• fever or chills.
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing.
• Bruising and fractures.
• Inflammation of the sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing pain).
• Decreased amount of potassium in the blood (you may have an irregular heartbeat, muscle weakness, cramps).

Uncommon(affect up to 1 in 100 patients)

• Increased amount of sugars (glucose) in the blood (hyperglycemia). If you have diabetes, more frequent blood sugar checks and possibly an adjustment of your usual diabetes treatment are required.
• Cataract (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Shaking sensation (tremor) and fast or irregular heartbeat (palpitations) - these are usually harmless and decrease as treatment continues.
• Chest pain.
• Shortness of breath (this effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rashes.

Rare(affect up to 1 in 1,000)

• Difficulty breathing or wheezing that gets worse immediately after taking ROLENIUM. If this happens stop using ROLENIUM. Use your fast-acting “rescue” inhaler to help your breathing and tell your doctor immediately.
• ROLENIUM can affect the normal production of steroid hormones in the body, especially if you have taken high doses for long periods of time. The effects include:
• Slowed growth in children and adolescents
• Thinning of the bones
• Glaucoma
• Weight gain
• Round face (moon-shaped) (Cushing's Syndrome) Your doctor will check you regularly for any of these side effects and will ensure that you are taking the lowest dose of ROLENIUM to control your asthma.
• Changes in behavior, e.g. being unusually active and irritable (these effects occur mainly in children).
• Irregular heartbeat or the heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking ROLENIUM unless your doctor tells you to stop.
• Fungal infection in the esophagus (throat), which may cause difficulty swallowing.

Not known: frequency cannot be estimated based on available data

• Depression or aggression. These effects are more likely in children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly to
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store ROLENIUM

• 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 packaging. The expiry date refers to the last day of the month.
• Store at a temperature below 25°C.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ROLENIUM contains
The active ingredients are
50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone
propionate.
or
50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone
propionate.
The excipient is lactose monohydrate.

Description of the appearance of ROLENIUM and package contents
ROLENIUM contains salmeterol and fluticasone propionate packaged in a double-
blister strip, stored in the inhalation device Elpenhaler.
The foil (Alu-Alu) protects the inhalation powder from the effects of the atmosphere.
Each dose is a single dose in a double-blister strip.
Each pack contains one Elpenhalerinhalation device with 30 double blister strips
Alu-Alu. 30 doses per pack.
Each pack contains one Elpenhalerinhalation device with 30 double blister strips
and a spare metal container with another 30 double blister strips. 60 doses per pack.
Each pack contains one Elpenhalerinhalation device with 60 double blister strips
Alu-Alu. 60 doses per pack.
Each pack contains three Elpenhalerinhalation devices with 60 double blister strips
Alu-Alu. 180 doses per pack.

Marketing Authorisation Holder and Manufacturer
ELPEN Pharmaceutical Co. Inc.
95, Marathonos Ave., GR-19009 Pikermi, Attica
Greece