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SOLTEL CFC-FREE INHALER 25 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance(s): SALMETEROL XINAFOATE

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Soltel CFC-free Inhaler 25 micrograms
per actuation pressurised inhalation, suspension
salmeterol (as xinafoate)
The name of this medicine is Soltel CFC-free Inhaler 25 micrograms per
actuation pressurised inhalation, suspension which will be referred to as
Soltel Inhaler throughout this leaflet.
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 Soltel Inhaler is and what it is used for
2. Before you use Soltel Inhaler
3. How to use Soltel Inhaler
4. Possible side effects
5. How to store Soltel Inhaler
6. Further information

1. WHAT SOLTEL INHALER IS AND WHAT IT IS USED
FOR
• Soltel Inhaler 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 get in and out. The effects can usually be noticed within 10
to 20 minutes and last for 12 hours or more.
• The doctor has prescribed Soltel Inhaler to help prevent breathing problems.
These could be caused by asthma. Taking Soltel Inhaler regularly will
prevent asthma attacks including asthma brought on by exercise or at
night.
• Taking Soltel Inhaler regularly will also help prevent breathing problems
caused by other chest illnesses such as chronic obstructive pulmonary
disease (COPD).
• Soltel Inhaler helps to stop breathlessness and wheezing coming on. It
does not work once you are breathless or wheezy. If that happens you need
to use a fast-acting „reliever‰ medicine, such as salbutamol.
• Your medicine is supplied to you in an inhaler. You breathe the medicine
through your mouth directly into your lungs.
• Soltel Inhaler contains norflurane and does not contain any
chlorofluorocarbons (CFCs). Norflurane-containing inhalers are less
harmful to the environment than older CFC-containing inhalers. Soltel
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
Soltel Inhaler and a steroid inhaler (or rarely steroid tablets) to use
together. Both inhalers must be used regularly.

2. BEFORE YOU USE SOLTEL INHALER

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Soltel CFC-free Inhaler

Soltel CFC-free Inhaler

Do not use Soltel Inhaler
• If you are allergic (hypersensitive) to salmeterol xinafoate or any of the
other ingredients in this medicine.
• If you are allergic to peanut or soya, do not use Soltel Inhaler as it contains
soya lecithin.
Take special care with Soltel Inhaler
• 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, do not increase your number of puffs of Soltel Inhaler.
Your chest condition may be getting worse and you could become seriously
ill. See your doctor or asthma nurse as you may need a change in asthma
treatment.
• If you have been prescribed Soltel Inhaler for your asthma, continue to use
any other asthma medication you are already taking including your 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 taking any steroid tablets) when
you start using Soltel Inhaler.
• Your doctor may want to check your health more regularly if you have an
overactive thyroid gland, heart disease, including an irregular or fast
heartbeat, or diabetes mellitus (as salmeterol may increase your 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.

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Taking other medicines
Please tell your doctor, pharmacist or asthma nurse if you are taking or have
recently taken any other medicines, including asthma medicines and any inhalers,
and including medicines obtained without a prescription. This is because Soltel
Inhaler may not be suitable to be taken with other medicines.
• Please inform your doctor or asthma nurse before using Soltel 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 salmeterol, including irregular heart beats, or may make side
effects worse.
• Beta blockers should be avoided when using Soltel Inhaler, unless your
doctor tells you to take them. Beta blockers, including atenolol, propranolol
and sotalol, are mostly used for the treatment of high blood pressure or other
heart conditions. Please tell your doctor or asthma nurse if you are taking β
blockers or have recently been prescribed β blockers as they may reduce or
abolish the effects of salmeterol.
• Salmeterol can reduce the amount of potassium in your blood. If this happens,
you may notice an uneven heartbeat, muscle weakness or cramp. This is more
likely to happen if you use salmeterol 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 from time to time.
If you have any concerns discuss them with your doctor or asthma nurse.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, planning to get pregnant or
breast-feeding, you should talk to your doctor or asthma nurse before starting to
use Soltel Inhaler. They will assess if you can use Soltel Inhaler during this
time.
Driving and using machines
The possible side effects associated with Soltel Inhaler are unlikely to affect
your ability to drive or use machines.

3. HOW TO USE SOLTEL INHALER
• If you are being treated for asthma, you should always be given both a
Soltel Inhaler and a steroid inhaler to use together.
• Use Soltel Inhaler every day until your doctor advises you to stop.
• You will start to feel your medicine working within the first day of use.
Soltel Inhaler should be inhaled through the mouth.
Children
The safety and efficacy of Soltel Inhaler have not been demonstrated in
children. Therefore Soltel Inhaler should not be used in children 12 years
of age and younger.
Dosage for adults and adolescents over 12 years of age with asthma
• The usual starting dose is 2 puffs twice a day.
• If you have more severe asthma, your doctor may increase your dose to 4 puffs
twice a day.
Dosage for adults with chronic obstructive pulmonary disease (COPD)
including bronchitis and emphysema
• The usual starting dose is 2 puffs twice a day.
• Not for use in children and adolescents.
Instructions for use
Your doctor, asthma nurse or pharmacist should show you how to use your
inhaler. They should check how you use it from time to time. Incorrect use, not
using the inhaler as prescribed or not using it as described in this Leaflet, may
mean that the medicine will not work as it should and so will not help your
asthma or COPD.
The medicine is contained in a pressurised canister in a plastic casing 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 mouthpiece cover by gently pressing the sides with your thumb
and index finger.
2. Shake the inhaler, 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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

1

2

3

4

5

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 it is clean (figure 1).
3. Shake the inhaler well before use (figure 2) to ensure that any loose objects
are removed and that the contents of the inhaler are evenly mixed.
4. Hold the inhaler upright with your thumb on the base, below the mouthpiece.
5. Breathe out as far as is comfortable (figure 3).
6. Place the mouthpiece in your mouth between your teeth and close your lips
around it but do not bite it (figure 4).
7. Just after starting to breathe in as slowly as you can through your mouth, press
down on top of the inhaler to release a puff into your mouth while still
breathing in steadily and deeply (figure 4).
8. 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 (figure 5).
9. If you are to take a second puff, wait about half a minute before repeating
steps 3 to 8.
10.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 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 find it difficult to use the inhaler, a Volumatic® spacer device may help to
overcome this problem. Contact your doctor, asthma nurse or pharmacist. If you
do need to use the Volumatic® spacer device, please refer to the instruction
leaflet provided with the spacer device, which includes all the information you
need to use the spacer correctly.
If the inhaler gets very cold, take the metal canister out of the plastic case and
warm it in your hands for a few minutes. Never use anything else to warm it up.
After warming up the inhaler, spray one puff in the air before use.
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 take more Soltel Inhaler than you should
It is important to use the inhaler as instructed. If you accidentally take a larger
dose than recommended you should contact your doctor, asthma nurse or
pharmacist. You may notice your heart beating faster than usual and that you
feel shaky and/or dizzy. You may also have a headache, muscle weakness and
aching joints.
If you forget to use Soltel 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 dose you have forgotten.
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, Soltel Inhaler can cause side effects, although not everybody
gets them. To reduce the chance of side effects your doctor will prescribe
the lowest 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 gets worse
after using salmeterol. You may experience:
• Wheezing or coughing.
• Rash, itching, 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 tell your doctor immediately. These reactions to
salmeterol are very rare (occurring in less than 1 in 10,000 patients).
Other side effects are:
Common (less than 1 in 10 patients, but more than 1 in 100)
• Muscle cramps.

• Feeling shaky, fast or irregular heartbeat (palpitations), headache, shaking
hands (tremor). Tremors are more likely to occur if you are taking more 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 1,000)
• Rash.
• Very fast heart rate (tachycardia). This is more likely to occur if you are
taking more than two puffs twice daily.
• Feeling nervous.
Rare (less than 1 in 1,000 patients, but more than 1 in 10,000)
• Dizziness.
• Difficulty in sleeping (insomnia).
• A fall in the amount of potassium in the blood (you may notice an irregular
heartbeat, muscle weakness and/or muscle cramps). Your doctor may ask
you to have blood tests to check the amount of potassium in your blood from
time to time. If you have any concerns discuss them with your doctor or
asthma nurse.
Very rare (less than 1 in 10,000 patients)
• Breathing difficulties or wheezing that gets worse straight after using
Soltel Inhaler. If this happens stop using your Soltel Inhaler. Use your
fast-acting „reliever‰ inhaler to help your breathing and tell your doctor
straight away.
• Irregular heartbeat or your heart gives an extra beat (arrhythmia). If this
happens do not stop using Soltel Inhaler but tell your doctor or asthma nurse.
• An increase in the amount of sugar (glucose) in your blood
(hyperglycaemia). 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.
• Sore mouth or throat.
• Feeling sick (nausea).
• Aching, swollen joints.
• Chest pain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine.

5. HOW TO STORE Soltel INHALER
Keep out of sight and reach of children.
Store below 30ÀC.
Do not freeze.
This canister contains a pressurised liquid. Do not expose to temperatures
higher than 50ÀC.
• Do not puncture, break or burn the canister, even when apparently empty.
Do not use Soltel 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.





6. FURTHER INFORMATION
What Soltel Inhaler contains
• The active substance is salmeterol (as 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 Soltel Inhaler looks like and contents of the pack
Soltel Inhaler is a mid-green inhaler holding an aluminium canister with a pale
green mouthpiece cover. Each canister contains 120 actuations, each actuation
containing 25 micrograms salmeterol (as xinafoate).
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: Cipla (EU) Limited, Hillbrow House,
Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
Manufacturer:
Cipla (EU) Limited, 20 Balderton Street, London, W1K 6TL, United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium.
This leaflet was last revised in 05/2016.
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Using your inhaler

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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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