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SOLMEVENT 25 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Solmevent 25 micrograms per actuation pressurised inhalation, suspension
Salmeterol xinafoate
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, asthma nurse or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, asthma nurse or pharmacist.
In this leaflet:
1.
What Solmevent Inhaler is and what it is used for
2.
Before you use Solmevent Inhaler
3.
How to use Solmevent Inhaler
4.
Possible side effects
5.
How to store Solmevent Inhaler
6.
Further information
The name of this medicine is Solmevent 25 micrograms per actuation pressurised inhalation,
suspension. However the inhaler will be referred to as Solmevent Inhaler within the text of the
leaflet
1.

WHAT SOLMEVENT INHALER IS AND WHAT IT IS USED FOR

Solmevent Inhaler contains the medicine salmeterol. This is a long-acting bronchodilator. It helps
to keep the airways in your lungs open, making it more easy to breath in and out.
Your doctor prescribed this medicine to help prevent breathing problems. These can be caused by
asthma. Using Solmevent Inhaler regularly will help to prevent asthma attacks. This is also true
for excercise induced asthma and nocturnal (nighttime) asthma.
The regular use of Solmevent Inhaler will also help prevent breathing problems caused by other
chest illnesses, such as chronic obstructive pulmonary disease (COPD).
Solmevent Inhaler will prevent shortness of breath and wheezing. It does not work if you are
already experiencing shortness of breath or wheezing. In that case, you should use a fast-acting
medicine, like salbutamol.
Solmevent is presented in an inhaler. You will breathe the medicine through your mouth directly
into your lungs.
Solmevent Inhaler contains norflurane and does not contain any chlorofluorocarbons (CFCs).
Norfluorane-containing inhalers are less harmful to the environment than older CFC-containing
inhalers.
Solmevent Inhaler may taste differently to older CFC-containing inhalers. This will make no
difference to how your medicine works.
If you are being treated for asthma you should always be given both a Solmevent Inhaler
and a steroid inhaler (or rarely steroid tablets) to use together. Both inhalers must be used
regularly.

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Solmevent Inhaler helps to stop you becoming breathless and wheezy; however, it does not
work once you are breathless and wheezy. If you become breathless and wheezy you need to
use a fast-acting “reliever” medicine such as salbutamol, a “blue” inhaler.
2.

BEFORE YOU USE SOLMEVENT INHALER

Do not use Solmevent Inhaler:
• If you are allergic to salmeterol xinafoate or any of the other ingredients of Solmevent
Inhaler.
• If you are allergic to peanut or soya, as Solmevent Inhaler contains soya lecithin.
Solmevent Inhaler should not be used by children 12 years of age and younger.
Take special care with Solmevent Inhaler:


If your asthma or breathing gets worse tell your doctor or asthma nurse 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, do
not increase your number of puffs of Solmevent Inhaler. Your chest condition may be
getting worse and you could become seriously ill. See your doctor as you may need a
change in asthma treatment.



If Solmevent Inhaler is prescribed for your asthma, continue to use any other asthma
medication you are already taking including your steroid inhaler and/or any steroid
tablets. Keep taking the same doses as before, unless your doctor tells you to change it.
Continue doing this, even if you feel much better. Do not stop using your steroid
inhaler (or steroid tablets) when you start using Solmevent Inhaler.



Your doctor may want to check your health more regularly if you have an overactive
thyroid gland, a heart condition, including an irregular or rapid heartbeat or diabetes
mellitus (salmeterol may increase your blood glucose levels). If you have diabetes your
doctor may want to monitor your blood sugar more frequently than usual and may need to
adjust the treatment you take for your diabetes.

Taking other medicines
Please tell your doctor, asthma nurse or pharmacist if you are taking or have recently taken any
other medicines, including asthma medicines and any inhalers, and including medicines obtained
without a prescription. Solmevent Inhaler may not be suitable for use in combination with other
medicines.


Please inform your doctor before using Solmevent Inhaler if you are currently being
treated for any fungal infections with medicines containing ketoconazole or
itraconazole, or if you are being treated for HIV with ritonavir. These medicines may
increase the risk of you experiencing side effects with Solmevent Inhaler, including
irregular heart beats, or may make side effects worse.



Beta-blocking medicines should be avoided when you use Solmevent Inhaler, unless
your doctor tells you to use them. Beta-blocking medicines, such as atenolol,
propranolol and sotalol, are usually used for high blood pressure or other heart
conditions. Inform your doctor if you use beta-blocking medicines or have used them
recently. They may reduce or even abolish the effects of salmeterol.



Solmevent may reduce the amount of potassium in your blood. If this happens, you may
feel an irregular heartbeat, muscle weakness or cramps. This is more likely to occur if you

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use Solmevent Inhaler in combination with some medicines that are used to treat high
blood pressure (diuretics) and other medicines that are used for the treatment of
breathing problems, such as theophylline or steroids.
Your doctor may ask you to have blood tests carried out from time to time to check the amount of
potassium in your blood. If you have any concerns at all please discuss them with your doctor or
asthma nurse.
Pregnancy and breastfeeding
If you are pregnant, think that you might be pregnant, planning to get pregnant or breastfeeding,
you should tell your doctor before starting to use Solmevent Inhaler. Your doctor will decide if
you can use salmeterol.
Ask your doctor, asthma nurse or pharmacist for advise before taking any medicine.
Driving and using machines
It is not likely that Solmevent Inhaler will influence your ability to drive or use machines.
3.

HOW TO USE SOLMEVENT INHALER

Always use Solmevent Inhaler exactly as your doctor has told you. You should check
with your doctor, asthma nurse or pharmacist if you are not sure.
If you are being treated for asthma you should always be given both a Solmevent Inhaler
and a steroid inhaler to use together.
Use Solmevent Inhaler every day until your doctor advises you to stop.
You will notice on the first day of use that the medicine is beginning to work.
Solmevent should be inhaled through the mouth.
Adults and adolescents over 12 years of age with asthma:



the usual starting dose is 2 puffs twice daily.
for more severe asthma, your doctor may increase your dose to 4 puffs twice daily.

Children 12 years of age and younger:
The safety and efficacy of Solmevent Inhaler have not been demonstrated in children.
Therefore Solmevent Inhaler should not be used in children 12 years of age and younger.

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


the usual starting dose is 2 puffs twice daily.

Not for use in children and adolescents.
Instructions for use
Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check
how you use your inhaler from time to time. Incorrect use, not using the inhaler as prescribed or
not using it as described in this leaflet, may mean that your medicine will not work as it should
and so will not help asthma or COPD.

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The medicine is in a pressurised canister in a plastic holder with a mouthpiece.
Testing your inhaler
When you use the inhaler for the first time you should test if it works properly.
1. Remove the protective cover of the mouthpiece by gently pressing the sides with your
thumb and index finger and removing the cap.
2. To make sure that the inhaler works properly you should shake it, point the mouthpiece
away from you and press the canister twice to release two puffs into the air. If you have
not used the inhaler for a week or more or if you have cleaned the inhaler, you should
release one puff into the air.
Using your inhaler
Before you use your inhaler it is important to start breathing as slowly as you possibly can.
1. You should either stand up or sit upright when using the inhaler.
2. Remove the mouthpiece cover. Check the mouthpiece
inside and outside to see that is clean.

3. Shake the inhaler well before use.

4. Hold the inhaler upright with your thumb on the base,
below the mouthpiece. Breathe out as far as is
comfortable.

5. Place the mouthpiece in your mouth between your teeth
and close your lips around it but do not bite it.

6. Breathe in through your mouth. Just after starting to
breathe in press down on top of the inhaler to release a
puff of medicine into your mouth. Do this while still
breathing in steadily and deeply.

7. While holding your breath, take the inhaler from your
mouth and take your finger from the top of the inhaler.
Continue holding your breath for as long as is
comfortable.

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8. If you are to take a second puff, wait about half a minute before repeating steps 3 to 7.
9. After use always replace the mouthpiece cover to keep out dust and fluff. The mouthpiece
cover is replaced by firmly pushing and snapping it into position.
Practise in front of a mirror for the first few times. If you see “mist” coming from the top of your
inhaler or the sides of your mouth you should start again.
If you have been prescribed a Volumatic spacing device to use with your Solmevent Inhaler
please refer to the Volumatic instruction leaflet on how to use the device correctly.
If your inhaler gets very cold you should take the metal canister out of the plastic case and warm
it in your hands for a few minutes. Once warmed, release one puff into the air before using.
Cleaning your inhaler
To prevent your inhaler from getting blocked up, it should be cleaned at least once a week.
Cleaning your inhaler:
• Remove the mouthpiece cover.
• Do not remove the canister from the plastic casing at any time.
• Wipe the inside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Release one puff into the air before next using the inhaler to test the inhaler.
• Replace the mouthpiece cover.
Do not put the metal canister into water.

If you use more Solmevent than you should
It is important that you use the inhaler according to the instructions. If you accidentally take a
larger dose than recommended you should contact your doctor, asthma nurse or pharmacist. You
may notice that your heart is beating faster than usual and that you feel shaky and/or dizzy. You
may also experience headache, muscle weakness or painful joints.
If you forget to use your Solmevent Inhaler
If you forget to use your inhaler you should take the next dose when it is due.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, asthma nurse or
pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Solmevent Inhaler can cause side effects, although not everybody gets them.
To reduce the chance for side effects your doctor will prescribe the lowest possible dose to control
your asthma or COPD. The following side effects have been reported by patients using salmeterol.
Allergic reactions: you may notice that your breathing suddenly worsens after use of
salmeterol. You may experience wheezing or coughing. You may develop a rash, itching or
swelling (usually of the face, lips, tongue or throat). If you experience any of these side effects or
if they occur suddenly after using salmeterol you should immediately inform your doctor.
Allergic reactions to salmeterol are very rare (occurring in less than 1 in 10,000 patients).
Other side effects are mentioned below:

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Common (less than 1 in 10 patients but more than 1 in 100 patients):
• Muscle cramps.
• Fast or irregular heart beat (palpitations), headache, feeling shaky, often shaking of the
hands (tremor). Tremors are more likely to occur if you are taking more than than two
puffs twice daily. These side effects do not last long and occur less as treatment with
salmeterol continues.
Uncommon (less than 1 in 100 patients but more than 1 in 1000 patients):
• Skin rash.
• Very fast heart rate (tachycardia). This is more likely to occur if you are taking more than
two puff twice daily.
• Nervousness.
Rare (less than 1 in 1000 patients but more than 1 in 10,000 patients):
• Dizziness.
• Difficulty in sleeping (insomnia).
• Low potassium in the blood (you may experience an irregular heart beat, muscle
weakness and/or cramps).
Your doctor may ask you to have blood tests carried out from time to time to check the
amount of potassium in your blood. If you have any concerns at all please discuss them
with your doctor or asthma nurse.
Very rare (less than 1 in 10,000 patients):
• Breathing difficulties or wheezing that worsen immediately after use of Solmevent
Inhaler. If this happens you should stop using your Solmevent inhaler. Use your fastacting ‘reliever’ inhaler to help your breathing and tell your doctor immediately.
• The heartbeat becomes uneven or the heart gives an extra beat (arrhythmia). If this
occurs, tell your doctor but do not stop using this medicine.
• Sore mouth or throat.
• Nausea (feeling sick).
• Painful, aching, swollen joints.
• Chest pain.
• High blood sugar. If you have diabetes your doctor may want to monitor your blood sugar
more frequently than usual and may need to adjust the treatment you take for your
diabetes.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor, asthma nurse or pharmacist.
5.

HOW TO STORE SOLMEVENT INHALER




Keep out of the reach and sight of children.
Store below 30ºC.
Do not freeze.

The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than
50°C. Do not try to open, break, puncture or burn the canister, even when apparently empty.
Do not use Solmevent Inhaler after the expiry date which is stated on the label and the carton after
the letters EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

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6.

FURTHER INFORMATION

What Solmevent Inhaler contains



The active substance is salmeterol xinafoate.
Each metered dose (ex-valve) contains 25 micrograms salmeterol (as xinafoate). This is
equivalent to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate).
The other ingredients are anhydrous ethanol, soya lecithin (E322) and norflurane (HFA
134a).

What Solmevent Inhaler looks like and contents of the pack
A pressurised aluminium canister sealed with a metering valve. The aluminium canister is fitted
into a white plastic actuator with a green dust cap. Each canister contains 120 actuations, each
actuation containing 25 micrograms salmeterol (as xinafoate).
Marketing Authorisation Holder and Manufacturer
Pharmaceutical Works POLPHARMA S.A.,
19 Pelplińska Str.,
83-200 Starogard Gdański,
Poland

This medicinal product is authorised in the Member States of the EEA under the following
names:
<{Name of the Member State}> <{Name of the medicinal product}>
<{Name of the Member State}> <{Name of the medicinal product}>
This leaflet was last approved in
The Leaflet was last revised 02/2012

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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