SALMETEDUR 50 MICROGRAMS Inhalation powder

Зміст інструкції

1. SALMETEDUR 25 micrograms/dose Pressurized suspension for inhalation
   1. What is SALMETEDUR pressurised suspension and what is it used for
   2. What you need to know before using SALMETEDUR pressurized inhalation suspension
   3. How to use SALMETEDUR pressurized suspension
   4. Possible side effects

SALMETEDUR 25 micrograms/dose Pressurized suspension for inhalation

salmeterol xinafoate
Read this leaflet carefully before you start to take this medicine as 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 SALMETEDUR pressurized suspension is and what it is used for
• 2. What you need to know before you use SALMETEDUR pressurized suspension
• 3. How to use SALMETEDUR pressurized suspension
• 4. Possible side effects
• 5. How to store SALMETEDUR pressurized
• 6. Contents of the pack and other information

1. What is SALMETEDUR pressurised suspension and what is it used for

• SALMETEDUR pressurised suspension contains the medicine salmeterol. It is a 'long-acting bronchodilator'. It helps the airways in the lungs to stay open. This makes it easier for air to enter and leave. The effects are usually felt within 10 - 20 minutes and last for 12 hours or more.
• Your doctor has prescribed this medicine to help you prevent breathing problems. These may be caused by asthma. Taking SALMETEDUR pressurised suspension regularly helps to prevent asthma attacks. This includes asthma caused by exercise or night-time asthma.
• Taking SALMETEDUR pressurised suspension regularly will also help to treat breathing problems caused by other lung diseases, such as chronic obstructive pulmonary disease (COPD).
• SALMETEDUR pressurised suspension helps to prevent shortness of breath and wheezing. It does not work once you are already breathless or wheezing. If this happens, you need to use a 'reliever' medicine that works quickly, such as salbutamol.
• SALMETEDUR pressurised suspension is supplied in an inhaler. The medicine is inhaled directly into the lungs.
• SALMETEDUR pressurised suspension contains norflurane. It is less harmful to the environment than older inhalers.

If you are being treated for asthma, you should always be given both SALMETEDUR and a steroid inhaler to use together.

2. What you need to know before using SALMETEDUR pressurized inhalation suspension

Do not use SALMETEDUR if:
you are allergic (hypersensitive) to salmeterol, or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions

• If you are using SALMETEDUR for asthma your doctor will want to check your symptoms withregularity.
• If your asthma or breathing gets worse tell your doctor immediately. You may feel your breathing becoming more wheezy, feel a tightness in your chest more often, or you may need to use your 'reliever' inhaler more often. If any of these happen, do not increase the number of puffs of SALMETEDUR. Your lung problems may be getting worse and you could become seriously ill. See your doctor, as a change in your asthma treatment may be needed.
• Once your asthma is well controlled your doctor may feel it is appropriate to gradually reduce the dose of SALMETEDUR.
• If you have been prescribed SALMETEDUR for asthma, continue to use any other asthma medicine that you are already taking. These medicines may include a steroid inhaler or steroids in tablet form. Continue to take the same doses as before, unless your doctor tells you to do otherwise. Do this even if you feel much better. Donot stop using your steroid inhaler (or steroid tablets) when you start usingSALMETEDUR.
• Your doctor may decide to check your health regularly if you have an overactive thyroid gland, diabetes mellitus (SALMETEDUR can increase your blood sugar level) or a heart condition, including an irregular or fast heartbeat.

Other medicines and SALMETEDUR

• Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. These include herbal medicines. This is because SALMETEDUR may not be suitable to be taken with other medicines.
• Tell your doctor before using SALMETEDUR if you are currently being treated for a fungal infection with medicines containing ketoconazole or itraconazole, or if you are being treated with ritonavir for HIV infection. These medicines can increase the risk that you have unwanted effects with SALMETEDUR, including irregular heartbeats, or they can make unwanted effects worse.
• During the taking of SALMETEDUR beta-blockers should be avoided, unless your doctor tells you to take them. Beta-blockers including atenolol, propranolol and sotalol,

are mainly used for high blood pressure or other heart conditions.
Tell your doctor if you are taking beta-blocker medicines or if they have been prescribed to
you recently as they can reduce or cancel out the effect of salmeterol.

• SALMETEDUR can reduce the amount of potassium in your blood. In this case you may notice an abnormal heartbeat, muscle weakness or cramps. This is more likely to happen if you take SALMETEDUR with some medicines used to treat high blood pressure (diuretics) and other medicines used to treat breathing problems such as theophylline or steroids. Your doctor may ask you to have blood tests to check the amount of potassium in your blood. If you are worried, ask your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that the possible effects of SALMETEDUR will affect your ability to drive or
use machines.

For athletes
The use of the drug without therapeutic need constitutes doping and may still
result in a positive doping test.

3. How to use SALMETEDUR pressurized suspension

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

• If you are being treated for asthma, you should always be given both SALMETEDUR and asteroid inhaler to use together.
• Use SALMETEDUR every day, until your doctor advises you to stop.
• You will start to feel the medicine working from the first day of use.

SALMETEDUR must only be administered by inhalation through the mouth.

Adults with asthma

• The usual starting dose is 2 puffs twice a day.
• For people with more severe asthma, your doctor may increase the dose to 4 puffs twice a day.

Children over 4 years of age

• In children aged between 4 and 12 years, the usual dose is 2 puffs twice a day.
• SALMETEDUR is not recommended in children under 4 years of age.

Adults with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema

• The usual starting dose is 2 puffs twice a day.
• Not applicable to children and adolescents.

Instructions for use

• Your doctor, nurse or pharmacist should show you how to use the inhaler. If you do not use the inhaler correctly or as prescribed, it may mean that the medicine does not provide relief from asthma or COPD as it should. The medicine is contained in a pressurized canister in a plastic container with a mouthpiece.

Checking the inhaler is working

	1 When you use the inhaler for the first time, check if it works. Remove the mouthpiece cover by pressing gently on the sides with your thumb and index finger and pull it off. 2 To make sure it works, shake well, point the mouthpiece away from you and spray i a dose into the air. If you have not used l the inhaler for a week or more, spray into the air twice.	a n a d e
	a Using the inhaler t Before using the inhaler it is important to I start breathing as slowly as possible. a 1 When using the inhaler remain in i an upright position, standing or sitting. z 2 Remove the mouthpiece cover n (as shown in the first image). Check inside and outside that the mouthpiece is clean and free from objects.

3Shake the inhaler 4 or 5 times to
ensure that any objects are removed and that the contents of the inhaler
are mixed evenly.

4Hold the inhaler in an upright position
with your thumb on the base, under the mouthpiece.
Exhale until you feel comfortable. Do not inhale yet.

5Position the mouthpiece in your mouth between
your teeth. Close your lips around it
without biting it.

6Inhale through your mouth. Immediately after
starting to inhale, press down on the
canister cover to release
a puff of medicine. Do this
while inhaling steadily and
deeply.

7Hold your breath; remove the inhaler
from your mouth and your finger from the top
of the inhaler.
Continue to hold your breath for a few
seconds or longer if you feel comfortable.

8Wait about half a minute before inhaling another dose repeating steps from 3 to

• 7. 9After use, replace the mouthpiece cover to prevent dust from settling on it. Close the cover securely by pressing it until you hear a click when it is in position.

For the first few times, practice in front of a mirror. If you see a 'mist'

Cleaning the inhaler
To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.
To clean the inhaler:

• remove the mouthpiece cover.
• Never remove the metal canister from the plastic casing.
• Clean the inside and outside of the mouthpiece and the plastic casing with a dry cloth or a paper handkerchief.
• Replace the mouthpiece cover.

Do not put the metal canister in water.

If you use more SALMETEDUR pressurized suspension than you should
It is important to use the inhaler following the instructions. If you accidentally take a dose
higher than the recommended one, contact your doctor or pharmacist. You may feel your heart beating
faster than usual and experience tremors and/or dizziness. You may have a headache, muscle weakness
and joint pain.

If you forget to use SALMETEDUR pressurized suspension
Do not take a double dose to make up for a missed dose. Take the next
dose at the scheduled time.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
To reduce the likelihood of side effects, your doctor will prescribe the lowest dose of
SALMETEDUR to control asthma or COPD. These are the side effects reported by
people taking SALMETEDUR.

Allergic reactions: you may notice that after using SALMETEDUR your breathing suddenly
worsens.You may be very short of breath and have a cough. You may also notice itching and swelling
(usually of the face, lips, tongue or throat). If you have these reactions or if they occur
suddenly after using SALMETEDUR, tell your doctor immediately. Allergic reactions to SALMETEDUR are very rare (affecting less than 1 in 10,000 people).
Other side effects are listed below:

Common (may affect less than 1 in 10 people)

• muscle cramps

• tremors; fast or irregular heartbeat (palpitations), headache. Tremor is more likely if the dose you are taking is greater than one spray twice a day. These side effects do not last long and are less likely with continued treatment with SALMETEDUR.

Uncommon (may affect less than 1 in 100 people)

• Skin rash
• Very fast heartbeat (tachycardia). This is more likely to happen if you are taking more than one spray twice a day
• Nervousness

Rare (may affect less than 1 in 1,000 people)

• Dizziness
• Inability or difficulty sleeping
• Reduced levels of potassium in the blood (you may have an irregular heartbeat, muscle weakness or cramps).

Very rare (may affect less than 1 in 10,000 people)

• Difficulty breathing or wheezing that gets worse immediately after taking SALMETEDUR. If this happens, stop using SALMETEDUR pressurized suspension. Use your 'reliever' inhaler to help your breathing and tell your doctor immediately.
• Irregular heartbeat or the heart beats too fast (arrhythmias). If this happens, do not stop using SALMETEDUR but tell your doctor
• Increased amount of sugar (glucose) in the blood (hyperglycemia). If you have diabetes, you may need to check your blood sugar more frequently and, possibly, adjust your usual diabetes treatment
• Irritation of the mouth or throat
• Nausea
• Joint pain, or chest pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more
information on the safety of this medicine.

5How to store SALMETEDUR pressurized suspension
Keep this medicine out of the sight and reach of children.
Immediately after use, firmly reposition the mouthpiece cover and snap it
into place. Do not use excessive force.
Do not store above 30°C.
The metal canister contains a liquid under pressure. Do not expose to temperatures
above 50°C. Do not puncture, break or burn even when it is thought to be empty.
Do not use this medicine after the expiry date which is stated on the label and on the pack
after 'EXP'. The expiry date refers to the last day of that month.
Do not throw away any medicines via water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help to protect the environment.

6 Content of the pack and other information
What SALMETEDUR pressurized suspension contains

• The active ingredient is salmeterol xinafoate.
• Each spray delivers 25 micrograms of the active ingredient salmeterol.
• Each canister contains 120 sprays equal to 60 metered doses.
• The other ingredient is norflurane (HFA 134a).

Description of the appearance of SALMETEDUR pressurized suspension and contents of the
pack
Pressurized suspension for inhalation. The pressurized canister contains a suspension
for inhalation ranging in colour from white to off-white.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi 3, Florence Concessionary for the sale:Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Building
• L - Rozzano (MI)

Manufacturer
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France.
GlaxoSmithKline Manufacturing SpA – Strada Provinciale Asolana 90, San Polo di Torrile Parma
Italy.

• A. Menarini Manufacturing Logistics and Services srl - Via Sette Santi 3 Florence.