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ASTHALIN 100 MICROGRAMS INHALER

Active substance(s): SALBUTAMOL SULPHATE

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Package Leaflet: Information for the User

Asthalin 100 micrograms Inhaler
Salbutamol Sulphate
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
- The full name of this product is Asthalin 100 micrograms Inhaler.
However this name will be shortened within the text of this leaflet to Asthalin
Inhaler.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Asthalin Inhaler is and what it is used for
2. What you need to know before you use Asthalin Inhaler
3. How to use Asthalin Inhaler
4. Possible side effects
5. How to store Asthalin Inhaler
6. Contents of the pack and other information







metronidazole
steroids
long-term laxatives
medicines used to treat heart disease e. g. digoxin
tricyclic antidepressants e. g. amitriptyline or trazodone.

If you are having treatment that requires a general anaesthetic, please tell your
anaesthetist that you are taking this medicine. Do not use this medicine for at least six
hours before intended anaesthetic.
Salbutamol Sulphate Inhaler with food and drink
You can take Salbutamol Sulphate Inhaler at any time of day, with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine may cause dizziness. If you are affected, DO NOT drive or operate
machinery.
Asthalin Inhaler contains ethanol
This medicine contains a small amount of ethanol (alcohol)

3. How to use Asthalin Inhaler
Always use this medicine exactly as your doctor has told you. Check with your doctor,
nurse or pharmacist if you are not sure.

1. What Asthalin Inhaler is and what it is used for
Asthalin Inhaler is a pressurised inhalation suspension (inhaler) which
contains the active ingredient salbutamol (as salbutamol sulphate). Salbutamol belongs
to a group of medicines called fast acting bronchodilators.
- Bronchodilators help the airways in your lungs to stay open. This makes it easier for
air to get in and out.
- They help to relieve chest tightness, wheezing and cough.
Asthalin Inhaler is used:
- to treat breathing problems in people with asthma and similar conditions
- to prevent asthma following exercise or other “triggers” (These are things, which bring
on asthma symptoms in some people. Common triggers include house dust, pollen,
cats, dogs and cigarette smoke)
- for the relief of wheezing and shortness of breath caused by certain other chest
diseases.
Asthalin Inhaler cannot be used with any spacing device at this time.
If you need a spacing device, your doctor will need to prescribe another product, which
can be used with a spacing device, instead of Asthalin Inhaler.
Asthalin Inhaler contains a propellant called HFA 134a. This is less harmful to the
environment than older inhalers. Older inhalers may taste differently to Asthalin Inhaler.
This will make no difference to how your medicine works.

2. What you need to know before you use Asthalin Inhaler
Do not use Asthalin Inhaler:
• if you are allergic to salbutamol sulphate or any of the other ingredients of this
medicine (listed in section 6)
• in premature labour or have a threatened miscarriage.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine if:
• your asthma is active (for example you have frequent symptoms or flare ups or
limited physical ability). Your doctor may start or increase a medicine to control your
asthma such as an inhaled corticosteroid.
• you are taking xanthine derivatives (such as theophylline) or steroids to treat asthma.
• you have overactive thyroid gland
• you have a history of or have serious heart disease or angina.
• have hypoxia (a lack of oxygen in the body)
• you have diabetes
• you suffer from fast irregular heart rhythms or high blood pressure
• you are taking water tablets (diuretics), sometimes used to treat high blood pressure
or a heart condition.
All patients
Consult a doctor immediately if your usual treatment is not working or if you need more
than 8 puffs per day (adult) or 4 puffs per day (children) or in case of worsening asthma
symptoms.
Your dose or frequency should only be increased on medical advice.
Other medicines and Asthalin Inhaler
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular tell your doctor, nurse or pharmacist if you are taking:
• xanthines e. g. aminophylline or theophylline
• disulfiram
• water tablets (diuretics)
• beta-blockers e. g. propranolol
• monoamine oxidase-inhibitors (anti-depressants) e. g. phenelzine

The recommended dose is:
Adults and adolescents aged 12 years and over
• For the relief of symptoms such as wheezing and shortness of breath
Either one or two puffs as needed.
• For preventing asthma - Two puffs before exercising 10-15 minutes before exercise
or exposure to a “trigger”
• For regular treatment - Two puffs up to 4 times a day
Children (aged 4 to 11 years)
• For the relief of symptoms such as wheezing and shortness of breath-Usually
one puff. This may increased to two puffs if necessary.
• For preventing asthma - Usually one puff before exercising. This may increased to
two puffs if necessary.
• For chronic therapy - Usually up to two puffs four times daily
Children using this inhaler should be supervised by an adult and should use this inhaler
only as advised by the doctor.
All patients
- If you have taken a dose of two puffs, then you should wait four hours before
taking another dose. You should not take more than eight puffs in 24 hours.
- You should check with your doctor or pharmacist about when to use your
inhaler and how many puffs you must use each day if you are not sure.
- If your usual treatment is not working or you need more than eight puffs per day,
please tell your doctor. You should not increase your dose without consulting
your doctor.
How to use your inhaler:
1

2

3

4

5

1.If your inhaler is new, or if you have not used your inhaler for a week or more, shake
well, remove the mouthpiece cover and release two sprays into the air before using.
2.Remove the mouthpiece cover and check that the inside and outside of the
mouthpiece is clear of dust, dirt or foreign objects (figure 1).
3.If the inhaler is very cold, the canister should be taken out of the plastic actuator and
warmed in your hands for a few minutes before you use it. Do not use anything else to
warm the canister. Shake the inhaler before each use (figure 2).
4.Hold the inhaler upright with a thumb on the base. Breathe out as far as is comfortable
(it is important that you practice this before using the inhaler – see “ Breathing
technique” (figure 3).
5.and then immediately place the mouthpiece in your mouth and close your lips around
it (figure 4). Be careful not to bite the mouthpiece.
6.Breathe in slowly through your mouth. Just after starting to breathe in through your
mouth, press firmly down on the top of the inhaler to release an actuation (puff). Carry
on breathing in deeply and steadily (figure 4).
7.Hold your breath, take the inhaler from your mouth and take your finger away from the
top of the inhaler. Continue holding your breath for about 10 seconds, or for as long as
is comfortable (figure 5). Then breathe out slowly.

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8.If you are taking another puff, keep the inhaler upright and wait for at least 30 seconds
before repeating steps 3 – 7.
9.After use, replace the mouthpiece cover firmly, making sure it snaps into position.

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Date: 24/11/2017

1B Variation

Breathing technique
You must breathe in as slowly as possible just before using the inhaler. Do not rush steps
5 to 7. You should practice a few times in front of a mirror. If you see “mist” coming from
the inhaler or the sides of your mouth, then you need to start again from step 3.

Although it is not known exactly how often this happens, some people may experience
chest pain (due to heart problems such as angina). Tell your doctor as soon as possible
if you develop these symptoms whilst receiving treatment with this inhaler, but do not
stop taking this medicine unless told to do so.

People with weak hands may find it easier to hold the inhaler with two hands, with the two
forefingers on the top of the inhaler and both thumbs on the bottom under the
mouthpiece.

If you think this medicine is not working well enough for you

Cleaning your inhaler
You should follow the cleaning instructions described below very carefully in
order to ensure that your inhaler continues to work properly.
Clean your inhaler once a week, or if blocked.
1. First remove the metal can from the plastic actuator and take off the mouthpiece
cover.
2. Rinse the plastic actuator, mouthpiece and mouthpiece cover in tap water. DO NOT
place the metal can into water or clean the can using water. Make sure the water runs
through the actuator from both ends to ensure that the actuator orifice (the small hole
that can be seen through the mouthpiece) is clear and not blocked.
3. The plastic components (actuator and mouthpiece cover) should be placed in a warm
place to dry thoroughly before putting the inhaler back together. Avoid drying near
direct or excessive heat.
If you use more Asthalin Inhaler than you should
If you accidentally take more puffs than your doctor told you to, please contact your
nearest hospital casualty department or tell your doctor immediately. You may notice
that your heart is beating faster than usual, that you feel shaky or tense, you may
have a headache or your skin may look flushed and feel hot. These effects normally
wear off in a few hours. Your doctor may want to check your blood potassium levels.
If you have any further questions on the use of this medicine, ask your doctor, nurse
or pharmacist.

If your medicine does not seem to be working as well as usual, talk to your doctor
as soon as possible. Your chest problem may be getting worse and you may need
a different medicine. Do not take extra doses of Salbutamol Sulphate Inhaler unless
your doctor tells you to.
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 or search for MHRA Yellow
Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Asthalin Inhaler
Keep this medicine out of sight and reach of children.
Do not use Asthalin Inhaler after the “EXP” date which is stated on the canister and
carton. The “EXP” date refers to the last day of that month.
Do not store above 30°C.
The canister contains a pressurised liquid. Do not expose the canister to temperatures
higher than 50°C. Do not pierce the canister.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use.
These measures will help to protect the environment.

6. Contents of the pack and other information

4. Possible side effects
Like all medicines, Asthalin Inhaler can cause side effects, although not everybody
gets them.
If, immediately after inhaling a puff, your asthma worsens, do not take any more puffs
and contact your doctor straight away.
Stop using the Asthalin Inhaler and tell your doctor immediately or go to the casualty
department at your nearest hospital if the following happens:

What Asthalin Inhaler contains:
The active ingredient is salbutamol.
Each metered dose (ex-valve) contains 100 micrograms salbutamol (as sulphate).
The other ingredients are oleic acid, ethanol and norflurane (HFA 134a; a CFC-free
propellant).
What Asthalin Inhaler looks like and contents of the pack:

• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in
breathing; skin rash or hives, and a fall in blood pressure. You might collapse in very
are circumstances)
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.

The inhaler comprises an aluminium canister fitted with a metering valve, which is
inserted into a light blue standard plastic actuator fitted with a removable blue plastic
mouthpiece cover, embossed with "Cipla" logo and "Asthalin CFC-Free Salbutamol
100 mcg".

The following side effects have been reported:
Common (may affect up to 1 in 10 people):
• tremor (shakes – especially noticeable in your hands)
• headache
• feeling tense
• dizziness
• fast heartbeats

Marketing Authorisation Holder
Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park,
Addlestone, Surrey, KT15 2LE, United Kingdom

This inhaler contains 200 puffs.

Manufacturer
Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park,
Addlestone, Surrey, KT15 2LE, United Kingdom
Cipla Europe NV, De Keyserlei 58-60 bus 19, Antwerpen, 2018, Belgium.

Uncommon (may affect up to 1 in 100 people):
• muscle pain
• mouth and throat irritation
• muscle cramps.
• palpitation

This leaflet was last revised in 11/2017.

Rare (may affect up to 1 in 1,000 people):
• low blood levels of potassium which can cause muscle weakness, twitching or
abnormal heart rhythm
• sleep disturbances and sensing things that are not real have been reported especially
in children
• widening of blood vessels
• throat irritation
• feeling sick
• vomiting
• a dry, sore mouth
Very rare (may affect up to 1 in 10,000 people):
• difficulty in sleeping
• difficulty in breathing or wheezing
• irregular heart beat, especially when used with beta-blockers
• hyperactivity
• itching skin.
Not known (frequency can not be estimated from the available data)
• restriction of blood supply to the heart.

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Using this inhaler may rarely lead to a build up of lactic acid or low potassium levels in
your blood. Your doctor may wish you to have regular blood tests to check your blood
potassium levels.

Date: 24/11/2017

1B Variation

+ 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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