Salmetedur

Patient Information Leaflet

SALMETEDUR 25 micrograms/dose Pressurised Suspension for Inhalation

salmeterol xinafoate
Please read this leaflet carefully before using 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 other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SALMETEDUR pressurised suspension is and what it is 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, making it easier for air to flow in and out. Effects are usually felt within 10–20 minutes and last for 12 hours or longer.
• Your doctor has prescribed this medicine to help prevent breathing problems, which may be caused by asthma. Taking SALMETEDUR pressurised suspension regularly helps prevent asthma attacks, including those triggered by exercise or occurring during the night.
• Regular use of SALMETEDUR pressurised suspension also helps treat breathing difficulties caused by other lung diseases, such as chronic obstructive pulmonary disease (COPD).
• SALMETEDUR pressurised suspension helps prevent breathlessness and wheezing. It does not work once you are already short of breath or wheezing. If this happens, you must use a fast-acting 'reliever' medicine, such as salbutamol.
• SALMETEDUR pressurised suspension is supplied in an inhaler. The medicine is inhaled directly into the lungs.
• SALMETEDUR pressurised suspension contains norflurane. This is less harmful to the environment than older inhalers.

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

2. What you should know before using SALMETEDUR pressurized suspension

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

Warnings and precautions

• If you are using SALMETEDUR for asthma, your doctor will want to monitor your symptoms regularly.
• If your asthma or breathing worsens, inform your doctor immediately. You may feel more breathless, experience chest tightness more frequently, or find you need to use your fast-acting 'reliever' medicine more often. If any of these occur, do not increase the number of puffs of SALMETEDUR. Your lung problems may be getting worse and you could become seriously ill. Consult your doctor, as your asthma treatment may need to be changed.
• Once your asthma is well controlled, your doctor may consider gradually reducing your dose of SALMETEDUR.
• If SALMETEDUR has been prescribed for your asthma, continue using any other asthma medicines you are already taking. These may include a steroid inhaler or steroid tablets. Continue taking the same doses as before, unless your doctor tells you otherwise. Do this even if you feel much better. Do not stop using your steroid inhaler (or steroid tablets) when you start using SALMETEDUR.
• Your doctor may decide to monitor your health regularly if you have an overactive thyroid gland, diabetes mellitus (SALMETEDUR may increase blood sugar levels), or a heart condition, including irregular or rapid heartbeat.

Other medicines and SALMETEDUR

• Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This includes herbal remedies. The reason is that SALMETEDUR may not be suitable to take with certain other medicines.

• Inform 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 may increase the risk of experiencing side effects with SALMETEDUR, including irregular heartbeats, or may worsen side effects.

• Beta-blockers should be avoided during treatment with SALMETEDUR, unless your doctor specifically instructs you otherwise. Beta-blockers, including atenolol, propranolol, and sotalol,
  are mainly used for high blood pressure or other heart conditions.
  Inform your doctor if you are taking beta-blocker medicines or have recently been prescribed them, as they may reduce or block the effect of salmeterol.

• SALMETEDUR may reduce the amount of potassium in your blood. If this occurs, you may notice an abnormal heartbeat, muscle weakness, or cramps. This is more likely if you are taking SALMETEDUR together with certain medicines used to treat high blood pressure (diuretics), or other medicines used for respiratory problems such as theophylline or steroids. Your doctor may ask you to have blood tests to monitor your potassium levels. If in doubt, consult your doctor.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicinal product.

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

For athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use SALMETEDUR pressurised suspension

Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

• If you are being treated for asthma, you must always be prescribed both SALMETEDUR and a steroid 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 be administered only by inhalation through the mouth.
Adults with asthma

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

Children above 4 years of age

• In children aged 4 to 12 years, the usual dose is 2 sprays twice daily.
• 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 sprays twice daily.
• Not applicable in children and adolescents.

Instructions for use

• Your doctor, nurse, or pharmacist should show you how to use the inhaler. Not using the inhaler correctly or as prescribed may result in the medicine not providing the expected relief from asthma or COPD. The medicine is contained in a pressurised canister inside a plastic container with a mouthpiece.

Checking the inhaler function

	1 When using the inhaler for the first time, test to see if it works. Remove the mouthpiece cap by gently pressing the sides with your thumb and index finger and pulling it off. 2 To ensure it works, shake it well, point the mouthpiece away from you, and spray one dose into the air. If you have not used the inhaler for one week or more, spray into the air twice.
	Using the inhaler Before using the inhaler, it is important to begin breathing in as slowly as possible. 1 When using the inhaler, remain standing or sitting in an upright position. 2 Remove the mouthpiece cap (as shown in the first image). Check inside and outside to ensure the mouthpiece is clean and free of any objects.

3 Shake the inhaler 4 or 5 times
to make sure any foreign particles are removed
and the contents are evenly mixed.

4 Hold the inhaler upright,
with your thumb on the base, below the mouthpiece.
Breathe out fully until comfortable.
Do not inhale yet.
5 Place the mouthpiece in your mouth, between your

teeth. Close your lips around it
without biting it.
6 Breathe in through your mouth. Immediately after
starting to inhale, press down on the canister cap
to release a spray of medicine. Do this
while breathing in steadily and deeply.

7 Hold your breath; remove the inhaler
from your mouth and your finger from the top
of the inhaler.
Continue holding your breath for a few
seconds, or longer if comfortable.
8 Wait about half a minute before inhaling a second dose, repeating steps 3 to 7.
9 After use, replace the mouthpiece cover to prevent dust from entering.
Close the cover firmly by pressing it until you hear the click indicating it is properly closed.
For the first few times, practice in front of a mirror. If you see a 'mist' escaping,

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 cap.
• Never remove the metal canister from the plastic holder.
• Clean the inside and outside of the mouthpiece and the plastic holder with a dry cloth or paper tissue.
• Replace the mouthpiece cap.

Do not immerse the metal canister in water.
If you use more SALMETEDUR pressurised suspension than you should
It is important to use the inhaler as directed. If you accidentally take a higher dose than recommended, contact your doctor or pharmacist. You may feel your heart beating faster than usual and may experience tremors and/or dizziness. You may also have headache, muscle weakness, and joint pain.
If you forget to use SALMETEDUR pressurised suspension
Do not take a double dose to make up for a forgotten dose. Take the next dose at the scheduled time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To reduce the likelihood of side effects, your doctor will prescribe the lowest dose of SALMETEDUR needed to control your asthma or COPD. The following are side effects reported in people taking SALMETEDUR.
Allergic reactions: you may notice that after using SALMETEDUR your breathing suddenly worsens.
You may become very wheezy and develop coughing. You may also notice itching and swelling (usually of the face, lips, tongue or throat). If you experience these reactions or if they occur suddenly after using SALMETEDUR, contact your doctor immediately. Allergic reactions to SALMETEDUR are very rare (affecting fewer than 1 in 10,000 people).
Other side effects are listed below:
Common (may affect up to 1 in 10 people)

• Muscle cramps
• Tremor; fast or irregular heartbeat (palpitations), headache. Tremor is more likely if the dose you are taking is higher than one puff twice daily. These side effects do not last long and become less frequent with continued use of SALMETEDUR.

Uncommon (may affect up to 1 in 100 people)

• Rash
• Very fast heart rate (tachycardia). This is more likely if you are taking more than one puff twice daily
• Nervousness

Rare (may affect up to 1 in 1,000 people)

• Dizziness
• Difficulty or inability to sleep
• Decreased levels of potassium in the blood (you may experience irregular heartbeat, muscle weakness or cramps).

Very rare (may affect up to 1 in 10,000 people)

• Breathing difficulties or wheezing that worsen immediately after taking SALMETEDUR. If this occurs, do not use SALMETEDUR pressurized suspension again. Use your rapid-acting 'reliever' inhaler to help breathing and contact your doctor immediately.
• Irregular heartbeat or extra heartbeats (arrhythmias). If this occurs, do not stop using SALMETEDUR but inform your doctor
• Increase in the amount of sugar (glucose) in the blood (hyperglycaemia). If you have diabetes, you may be required to monitor your blood sugar levels 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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

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

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

• The active substance is salmeterol xinafoate.
• Each puff delivers 25 micrograms of the active substance salmeterol.
• Each canister contains 120 puffs equivalent to 60 single doses.
• The other component 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 white to almost white inhalation suspension.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi 3, Florence
Sales licensee: Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio 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.