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SALAMOL CFC-FREE INHALER 100 MICROGRAMS PRESSURISED INHALATION SUSPENSION

Active substance(s): SALBUTAMOL SULPHATE

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SAP CODE: PE3160
Product Name: SAL HFA MDI 100MCG 200 IUK

Artwork Co-ordinator:

Job No.: 360351

Date: 07/10/2015

Perigord Premedia Job No: 259156

Component: Leaflet

Template: LF16.1

Barcode: N/A

Pharmacode: 1460

Dimensions (mm): 447 x 160

Software Used: Adobe Indesign CS6
COLOURS USED

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TINTS USED

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Draft: 04

Signature: .........................................

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Package leaflet: Information for the patient

Salbutamol Sulphate

100 micrograms Pressurised Inhalation Suspension

Salamol CFC-Free Inhaler

- Keep this leaflet.
You may need to
read it again.
- If you have any
further questions,
ask your doctor,
pharmacist or nurse.
- 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,
pharmacist or
nurse. This includes
any possible side
effects not listed
in this leaflet. See
section 4.

Date:

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Date:

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Subject to Regulatory Authority Approval
Approved by Reg. Dept. for print
Signature: .........................................

Final Review:
PAGE NO:

What Salamol is and what it is used for
What you need to know before you use Salamol
How to use Salamol
Possible side effects
How to store Salamol
Contents of the pack and other information

1. What Salamol is and what it is
used for
Effect
Salamol contains salbutamol sulphate, which
belongs to a group of medicines called beta
agonists. Salbutamol is a bronchodilator and works
by widening the airways in your lungs to allow air
in and out. This helps you to feel less breathless,
wheezy or tight-chested.
Usage
Salamol is used to treat asthma in adults,
adolescents and children aged 4 to 11 years. It can
also be used to prevent asthma caused by exercise
or asthma caused by a reaction to allergens
(substances to which you are allergic to e.g. house
dust, pollen, dog hair, cat hair, cigarette smoke,
etc.) or to treat breathing difficulties associated
with reversible airways obstruction (e.g. chronic
obstructive pulmonary disease [COPD]).
This type of medicine is known as a ‘reliever’. You
may be using another medicine to prevent you
from having an asthma attack (“preventer”). You
can safely use your preventer with this medicine.

2. What you need to know before
you use Salamol

PE3160

Signature: .........................................

The approval of all text including Braille contained in this artwork
is the responsibility of the Regulatory Affairs Department

What is in this leaflet
1.
2.
3.
4.
5.
6.

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Regulatory:

PMS 2768 - Various tints used within illustrations

Read all of this leaflet
carefully before
you start using this
medicine because it
contains important
information for you.

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FONT INFORMATION

PMS 5483 - 10%

PMS Warm Red - Various tints used within illustrations

Date:

Packaging Technologist:

Other Information: Black coding panel on labels are varnish free areas
PMS 2768

FP code: FA0627

Do not use Salamol
- If you are allergic to salbutamol or any of the
other ingredients of this medicine (listed in
section 6).

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Signature: .........................................

Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Salamol
- if you suffer from thyroid problems, diabetes,
serious heart disease, fast irregular heart
rhythms or high blood pressure.
- if you have a condition known as hypoxia
(a disorder where the oxygen level in the blood
is low and may cause breathlessness) or if you
have a history of heart disease or angina.
Consult a doctor immediately if your usual treatment
is not working or you need more than 8 puffs per day
(for adults) or 4 puffs per day (for children) or in case
of worsening asthma symptoms. Your dosage should
only be increased on medical advice.
Other medicines and Salamol
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
If you are having treatment that requires a general
anaesthetic, please tell your anaesthetist that you
are taking Salamol. Do not use this medicine for at
least six hours before the intended anaesthetic.
Salbutamol can reduce the amount of potassium
in your blood. If this happens, you may notice an
irregular heartbeat, muscle weakness or cramp. This
is more likely to happen if you use salbutamol with
some medicines used to treat high blood pressure,
other medicines used to treat breathing problems
(e.g. steroids), stimulants (e.g. xanthines) and
long-term laxatives.
The following medicines may influence the effect of
Salamol:
• Some medicines for the treatment of high blood
pressure such as beta-blockers (e.g. propranolol);
• Medicines used to treat heart disease (e.g. digoxin);
• Medicines for the treatment of depression
(from the monoamine oxidase inhibitor group
e.g. phenelzine or tricyclic antidepressants
e.g. amitriptyline or trazodone);
• Water tablets (diuretics);
• Medicines for the treatment of chronic
alcoholism (e.g. disulfiram);
• The anti-microbial drug metronidazole.

Date:

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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 or pharmacist for advice before
taking this medicine.
Driving and using machines
Salamol does not affect your ability to drive or to
use machinery.

3. How to use Salamol
Always use this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
The dosage is individually adjusted according
to your doctor’s instructions, based on previous
asthma therapy.
For the best results with this medicine you should
use it when required to relieve symptoms of asthma
and other chest conditions with similar symptoms,
such as wheezing, breathlessness and tightness in
your chest. Take one puff as a starting dose. This may
be increased to two puffs if necessary.
To prevent asthma caused by exercise or allergens
(e.g. house dust, pollen etc), take two puffs
10-15 minutes before you exercise or before
exposure to known allergens.
Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.
Use in children and adolescents
The usual dose for children under the age of
12 years to relieve asthma symptoms such as
wheezing, breathlessness and tightness in the
chest, is one puff as a starting dose. This may be
increased to two puffs if necessary.
Children over the age of 12 should refer to the
adult dosage instructions above.
The usual dose for children under the age of 12 years
to prevent asthma caused by exercise or allergens
(e.g. house dust, pollen etc), is one puff 10-15 minutes
before exercise or before exposure to known allergens.

This can be increased to two puffs if necessary.
Children over the age of 12 should refer to the
adult dosage instructions above.
The usual dose for children under the age of
12 years for regular treatment of asthma is up
to 2 puffs, 4 times a day.
Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.
Instructions for use
Important
Before using this medicine, please read this leaflet
carefully and follow the instructions.
An adult should always supervise children when
they use Salamol. Children may need help to use
their inhaler. Parents can help by spraying the
aerosol when the child begins to breathe in.
Always remember the following:
• Wait four hours between doses.
• Tell your doctor if your asthma gets worse or
if the inhaler does not provide as much relief
from your asthma as before.
• You should sit or stand upright while taking
this medicine. It is important when using
this medicine to hold the inhaler upright
as it will not work if it is not held in this
position.
Test spray the inhaler by firing two shots into the
air before you use it for the first time and also
if you have not used it for a period of five days
or more.

Using the Inhaler
If you or your child find it difficult to use the
inhaler, your doctor or healthcare provider may
be recommend using the Volumatic® spacer
device with the inhaler. Your doctor, nurse,
pharmacist, or other healthcare provider should
show you how to use the Volumatic® spacer
with your inhaler and show you how to care
for your Volumatic spacer, and will answer any
questions that you may have. It is important
that if you are using the Volumatic spacer

with your inhaler that you do not stop using it
without talking to your doctor or nurse first. If
you stop using a spacer device your doctor may
need to change the dose of medicine required
to control your asthma. Always talk to your
doctor before making any changes to your
asthma treatment.
If you are not using a Volumatic spacer, ignore
the steps specifically marked for Patients using
a Volumatic spacer and continue to the next
step.
If you are using a Volumatic spacer follow all the
steps below including the ones for Patients using a
Volumatic spacer.
1. Take the cap off the
inhaler. Make sure the
mouthpiece is clean and
clear of fluff and dirt.

Patients using a Volumatic spacer - Fit the
two halves of the Volumatic device together.
Line up the notch on one half with the slot on
the other (these are marked with small arrows),
then press the two halves firmly together.
2. Hold the inhaler upright,
with your thumb on
the base and your first
finger on the top of the
canister*. Now shake
the inhaler vigorously up
and down.
Patients using a Volumatic spacer - Fit the
inhaler into the end of the Volumatic, opposite
the mouthpiece. Check the mouthpiece of the
Volumatic inside and outside to make sure that
it is clean

3. Breathe out normally as
far as you comfortably
can. Then hold the
mouthpiece of the inhaler
firmly between your lips.

4. Breathe in slowly and
deeply. At the same time
as you start to breathe in,
press the aerosol canister
with your first finger to
spray the aerosol and
release the medicine.
Continue to breathe in
slowly and deeply.
Patients using a Volumatic spacer - Press
down with your finger(s) on the top of the
inhaler to release one puff of medicine. Straight
away take one deep steady breath or 5 normal
breaths to make sure that the medicine goes
into your lungs.
You do not need to take the Volumatic out of
your mouth to breathe out. You should hear
the mouthpiece valve ‘click’ or rattle as you
breathe through it. If you do not hear it, tilt the
Volumatic up slightly and try again.
5. Take the inhaler out of your mouth and hold
your breath for 10 seconds, or for as long as you
comfortably can. Breathe out slowly.
Patients using a Volumatic spacer - Take the
Volumatic spacer out of your mouth and take
your finger from the top of the inhaler. Continue
holding your breath for a few seconds, or as
long as is comfortable. Breathe out slowly.
6. If you need more than one puff, wait about one
minute and then start again from step 2. Put the
cap back on the inhaler.
7. You must keep your inhaler clean, especially in
the mouthpiece. This will prevent deposits from
the aerosol building up. To prevent your inhaler
becoming blocked you must clean it once a week.

TEVA Pharmaceuticals Ireland,
IDA Industrial Park, Cork Road, Waterford, Ireland.
SAP:

PE3160

JOB NO:

360351

DRAFT:

✓This product can be used with the Volumatic®
Spacer. Please refer to the instruction leaflet for the
Volumatic spacer device for further information.

Cleaning the inhaler
Keeping the plastic mouthpiece clean is very
important as it will help prevent your inhaler
becoming blocked. You must clean your inhaler once
a week.
A To clean your inhaler
first remove the
mouthpiece cap.

A

B Remove the metal
canister from the plastic
mouthpiece. Do not
put the metal canister
into water.

C Rinse the inhaler
mouthpiece and the
mouthpiece cap with
warm running water for
at least 30 seconds.

D Shake off any excess
water and dry the
plastic mouthpiece
and mouthpiece cap
thoroughly (leave to dry
overnight if possible)
but do not use direct
heat. Put the metal
canister back in your
inhaler. Replace the cap.

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B

C

D

Failure to allow the mouthpiece to dry properly
will result in an increase in blockage problems.
If you need to use your inhaler before it is dry, shake
off any water from the plastic mouthpiece and put the
canister back in. Test spray the inhaler by firing two
puffs in the air before taking your usual dose. Wash and
dry the mouthpiece again as described above.
Cleaning the Volumatic spacer

• Wheezing, coughing and difficulty breathing;
• Rash, swelling of the face and throat and a fall
in blood pressure.
You might collapse in very rare circumstances.
If you experience any of these side effects or if they
occur suddenly after using salbutamol you should
stop using your medication straightaway and tell
your doctor immediately. Allergic reactions to
salbutamol are very rare (occurring in less than
1 in 10,000 patients).
Other side effects:
Common (may affect up to 1 in 10 people):
• Feeling tense and getting headaches (which
are more likely with higher doses);
• Feeling shaky (muscle tremors);
• Dizziness.

Children can assembly the Volumatic and clean
it as necessary under adult supervision.

Uncommon (may affect up to 1 in 100 people):

The Volumatic may need to be replaced after
about 6 to 12 months of use.

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

If you use more Salamol than you should
It is important that you take your dose as stated
on the pharmacist’s label or as advised by your
doctor. You should not increase or decrease your
dose without seeking medical advice.
If you accidentally take a larger dose than
recommended, you may notice that your heart
is beating faster than usual, that you feel shaky
or tense, you may have a headache and your skin
may look flushed and feel hot. These effects usually
wear off in a few hours, but you should tell your
doctor as soon as possible. Your doctor may want
to check your blood potassium levels.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Contact your doctor immediately if you experience
allergic (hypersensitivity) reactions. These include

• Muscle pain (myalgia).
• Reduction in the amount of potassium in your
blood (if this happens, you may notice an
irregular heartbeat, muscle weakness or cramp);
• Increase in lactate levels and acid levels in the
blood (you may experience symptoms such as
persistent nausea and vomiting, unexplained
tiredness, shortness of breath and rapid
breathing, cold or blue hands and feet);
• Sleep disturbances and sensing things that are
not real;
• Rapid or irregular heart beat (tachycardia or
palpitations);
• Increased blood flow to your extremities
(peripheral dilatation)
• Mouth and throat irritations, nausea, vomiting
and dry and sore mouth;
• Muscle cramps.
Very rare (may affect up to 1 in 10,000 people):
• Difficulty in sleeping (insomnia);
• Itching of your skin;
• Trembling (particularly your hands).

Not known (frequency cannot be estimated
from the available data):
• Chest pain (due to heart problems such as
angina).
Additional side effects in children
• Sleep disturbances and sensing things that are
not real have been reported.
• Hyperactivity.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist, but do not stop using
this medicine unless you are told to do so.
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 Salamol
Keep this medicine out of the sight and reach of
children.
Do not store above 25°C.
Do not refrigerate or freeze. If this medicine
gets very cold, remove the metal canister from
the inhaler and warm it in your hands for a few
minutes before you use it. Do not warm the
canister in any other way.
Pressurised aerosol canister. Do not puncture,
break or burn the canister, even if it seems empty.
Do not use this medicine after the expiry date
which is stated on the label and carton after
EXP. The expiry date refers to the last day of
that month.
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Salamol contains
- The active substance is salbutamol sulphate
equivalent to 100 micrograms of salbutamol in
each puff (metered dose).
- The other ingredients are ethanol anhydrous
(alcohol) and the propellant norflurane (HFA-134a).
This medicine does not contain any CFCs.
What Salamol CFC-Free Inhaler lookls like and
contents of the pack
• The name of your medicine is Salamol
CFC-Free Inhaler 100 micrograms Pressurised
Inhalation Suspension.
• Each pack of Salamol contains a single inhaler
and canister which supplies 200 metered doses.
Marketing Authorisation Holder:
Norton Healthcare Ltd.,
T/A IVAX Pharmaceuticals UK,
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX,
United Kingdom
Manufacturer:
IVAX Pharmaceuticals Ireland
IDA Industrial Park
Waterford
Ireland
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Germany: Salbutamol Teva 100 Mikrogramm
Dosieraerosol Druckgasinhalation, Suspension
Luxembourg: ECOSAL 100 mcg suspension pour
inhalation en flacon pressurise
Belgium: ECOSAL 100 μg aërosol, suspensie
This leaflet was last revised in 09/2015

PE3160

Your Volumatic should be cleaned regularly,
preferably twice a week.
A Gently pull the two halves of the Volumatic
apart. Do not take the valve apart.

B Wash the two halves of the Volumatic in warm
water, which can contain a mild detergent or
a sterilising solution of the type used to clean
babies’ bottles. You can use a soft toothbrush
or bottle to help remove any film which forms
on the valve or the inside of the Volumatic. As
long as the valve still moves when you breathe
in and out, this deposit will not affect the
working of the Volumatic.
C Rinse thoroughly with clean water. Leave
the parts at room temperature until they
are completely dry. Do not rub the inside of
your Volumatic with a cloth or polish as this
may cause static electricity which can affect
the medicine. Do not put the Volumatic in
a heated place to dry more quickly.
D Store the Volumatic in the carton to
keep clean.

Salamol CFC-Free Inhaler

*Note: Children and people with weak hands may
find it easier to hold the inhaler with both hands, in
this case for step 2 put your two first fingers on the
top of the canister and both thumbs on the base of
the inhaler.

07/10/2015

100 micrograms Pressurised Inhalation Suspension

Important: Do not rush steps 3 and 4. It is important
that you start to breathe in as slowly as possible
just before using your inhaler. Practice in front of
the mirror for the first few times. If you see ”mist”
coming from the top of the inhaler or the sides of
your mouth you should start again from step 2.

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Salbutamol Sulphate

8. What to do if your inhaler stops working properly?
It is important to clean your inhaler regularly
to prevent deposits from the aerosol building
up and blocking the inhaler. If your inhaler
does not seem to be working, it may be that
your inhaler has become blocked and you
should clean your inhaler according to the
section ”Cleaning the inhaler”.
If your inhaler still does not work, return it to
your doctor or pharmacist.

DATE:

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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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