Sanofi Lantus SoloStar User manual

Legende / Legend
SAP-Nr. / Plant PM code: 541512
Sprachvariante / Country code: 103
Version: 1
Datum / Date: 13.04.2018 PE
Abmessungen / Dimensions: 628 × 296 mm
Schriftgröße / Font size: 10 Pt
Zeilenabstand / Line spacing: 11 Pt
Seite / Page: 1/2
Druckbare Farben / Printing colours
Pantone Reex Blue C
Technische Information / Technical information
Kontur / Outline
Package leaflet: Information for the user
Lantus® SoloStar®
100 units/ml
solution for injection
in a pre-filled pen
insulin glargine
Talk to your doctor, pharmacist or nurse
before using Lantus.
Follow closely the instructions for posology,
monitoring (blood and urine tests), diet and
physical activity (physical work and exercise),
injection technique as discussed with your
doctor.
If your blood sugar is too low (hypoglycaemia),
follow the guidance for hypoglycaemia (see
box at the end of this leaflet).
Travel
Before travelling consult your doctor. You may
need to talk about
– the availability of your insulin in the
country you are visiting,
– supplies of insulin, needles etc.,
– correct storage of your insulin while
travelling,
– timing of meals and insulin administration
while travelling,
– the possible effects of changing to different
time zones,
– possible new health risks in the countries to
be visited,
– what you should do in emergency situations
when you feel unwell or become ill.
Illnesses and injuries
In the following situations, the management
of your diabetes may require a lot of care (for
example, adjustment to insulin dose, blood
and urine tests):
– If you are ill or have a major injury then
your blood sugar level may increase
(hyperglycaemia).
– If you are not eating enough your
blood sugar level may become too low
(hypoglycaemia).
In most cases you will need a doctor. Make
sure that you contact a doctor early.
If you have type 1 diabetes (insulin dependent
diabetes mellitus), do not stop your insulin
and continue to get enough carbohydrates.
Always tell people who are caring for you or
treating you that you require insulin.
Insulin treatment can cause the body to
produce antibodies to insulin (substances
that act against insulin). However, only very
rarely, this will require a change to your
insulin dose.
Some patients with long-standing type2
diabetes mellitus and heart disease or
previous stroke who were treated with
pioglitazone (oral anti-diabetic medicine used
to treat type2 diabetes mellitus) and insulin
experienced the development of heart failure.
Inform your doctor as soon as possible if
you experience signs of heart failure such as
unusual shortness of breath or rapid increase
in weight or localised swelling (oedema).
Children
There is no experience with the use of Lantus
in children below the age of 2years
Other medicines and Lantus
Some medicines cause changes in the blood
sugar level (decrease, increase or both
depending on the situation). In each case, it
may be necessary to adjust your insulin dose
to avoid blood sugar levels that are either too
low or too high. Be careful when you start or
stop taking another medicine.
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. Before taking a medicine ask
your doctor if it can affect your blood sugar
level and what action, if any, you need to
take.
Medicines that may cause your blood sugar
level to fall (hypoglycaemia) include:
– all other medicines to treat diabetes,
– angiotensin converting enzyme (ACE)
inhibitors (used to treat certain heart
conditions or high blood pressure),
– disopyramide (used to treat certain heart
conditions),
– fluoxetine (used to treat depression),
– fibrates (used to lower high levels of blood
lipids),
– monoamine oxidase (MAO) inhibitors (used
to treat depression),
– pentoxifylline, propoxyphene, salicylates
(such as acetylsalicylic acid, used to relieve
pain and lower fever),
– sulfonamide antibiotics.
Medicines that may cause your blood sugar
level to rise (hyperglycaemia) include:
– corticosteroids (such as “cortisone” used to
treat inflammation),
– danazol (medicine acting on ovulation),
– diazoxide (used to treat high blood
pressure),
– diuretics (used to treat high blood pressure
or excessive fluid retention),
– glucagon (pancreas hormone used to treat
severe hypoglycaemia),
– isoniazid (used to treat tuberculosis),
– oestrogens and progestogens (such as in the
contraceptive pill used for birth control),
– phenothiazine derivatives (used to treat
psychiatric disorders),
– somatropin (growth hormone),
– sympathomimetic medicines (such as
epinephrine [adrenaline], salbutamol,
terbutaline used to treat asthma),
– thyroid hormones (used to treat thyroid
gland disorders),
– atypical antipsychotic medicines (such as
clozapine, olanzapine),
– protease inhibitors (used to treat HIV).
Your blood sugar level may either rise or
fall if you take:
– beta-blockers (used to treat high blood
pressure),
– clonidine (used to treat high blood
pressure),
– lithium salts (used to treat psychiatric
disorders).
Pentamidine (used to treat some infections
caused by parasites) may cause hypoglycaemia
which may sometimes be followed by
hyperglycaemia.
Beta-blockers like other sympatholytic
medicines (such as clonidine, guanethidine,
and reserpine) may weaken or suppress
entirely the first warning symptoms which
help you to recognise a hypoglycaemia.
If you are not sure whether you are taking
one of those medicines ask your doctor or
pharmacist.
Lantus with alcohol
Your blood sugar levels may either rise or fall
if you drink alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
Inform your doctor if you are planning to
become pregnant, or if you are already
pregnant. Your insulin dose may need to be
changed during pregnancy and after giving
birth. Particularly careful control of your
diabetes, and prevention of hypoglycaemia, is
important for the health of your baby.
If you are breast-feeding consult your doctor
as you may require adjustments in your
insulin doses and your diet.
Driving and using machines
Your ability to concentrate or react may be
reduced if:
– you have hypoglycaemia (low blood sugar
levels),
– you have hyperglycaemia (high blood sugar
levels),
– you have problems with your sight.
Keep this possible problem in mind in all
situations where you might put yourself and
others at risk (such as driving a car or using
machines). You should contact your doctor for
advice on driving if:
– you have frequent episodes of
hypoglycaemia,
– the first warning symptoms which help you
to recognise hypoglycaemia are reduced or
absent.
Important information about some of the
ingredients of Lantus
This medicine contains less than 1mmol
(23mg) sodium per dose, i.e. it is essentially
‘sodium-free’.
3. How to use Lantus
Always use this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Although Lantus contains the same active
substance as Toujeo (insulin glargine
300units/ml), these medicines are not
interchangeable. The switch from one
insulin therapy to another requires medical
prescription, medical supervision and blood
glucose monitoring. Please, consult your
doctor for further information.
Dose
Based on your life-style and the results of your
blood sugar (glucose) tests and your previous
insulin usage, your doctor will
– determine how much Lantus per day you
will need and at what time.
– tell you when to check your blood sugar
level, and whether you need to carry out
urine tests,
– tell you when you may need to inject a
higher or lower dose of Lantus.
Lantus is a long-acting insulin. Your doctor
may tell you to use it in combination with a
short-acting insulin or with tablets used to
treat high blood sugar levels.
Many factors may influence your blood sugar
level. You should know these factors so that
you are able to react correctly to changes in
your blood sugar level and to prevent it from
becoming too high or too low. See the box at
the end of this leaflet for further information.
Use in children and adolescents
Lantus can be used in adolescents and
children aged 2 years and above. Use this
medicine exactly as your doctor has told you.
Frequency of administration
You need one injection of Lantus every day, at
the same time of the day.
Method of administration
Lantus is injected under the skin. Do NOT
inject Lantus in a vein, since this will change
its action and may cause hypoglycaemia.
Your doctor will show you in which area of
the skin you should inject Lantus. With each
injection, change the puncture site within the
particular area of skin that you are using.
How to handle SoloStar
SoloStar is a pre-filled disposable pen
containing insulin glargine. Lantus in
pre-filled pen is only suitable for injecting
just under the skin. Speak to your doctor if
you need to inject your insulin by another
method.
Read carefully the “SoloStar Instructions
for Use” included in this package leaflet.
You must use the pen as described in these
Instructions for Use.
A new needle must be attached before each
use. Only use needles that are compatible for
use with SoloStar (see “SoloStar Instructions
for Use”).
A safety test must be performed before each
injection.
Look at the cartridge before you use the pen.
Do not use SoloStar if you notice particles in
it. Only use SoloStar if the solution is clear,
colourless and waterlike. Do not shake or mix
it before use.
To prevent the possible transmission of
disease, never share your pen with anyone
else. This pen is only for your use.
Make sure that neither alcohol nor other
disinfectants or other substances contaminate
the insulin.
Always use a new pen if you notice that your
blood sugar control is unexpectedly getting
worse. If you think you may have a problem
with SoloStar, consult your doctor, pharmacist
or nurse.
Empty pens must not be re-filled and must be
properly discarded.
Do not use SoloStar if it is damaged or not
working properly, it has to be discarded and a
new SoloStar has to be used.
Insulin Mix-ups
You must always check the insulin label
before each injection to avoid mix-ups
between Lantus and other insulins.
If you use more Lantus than you should
– If you have injected too much Lantus,
your blood sugar level may become too
low (hypoglycaemia). Check your blood
sugar frequently. In general, to prevent
hypoglycaemia you must eat more food and
monitor your blood sugar. For information
on the treatment of hypoglycaemia, see box
at the end of this leaflet.
If you forget to use Lantus
– If you have missed a dose of Lantus or if
you have not injected enough insulin,
your blood sugar level may become too
high (hyperglycaemia). Check your blood
sugar frequently. For information on the
treatment of hyperglycaemia, see box at the
end of this leaflet.
– Do not take a double dose to make up for a
forgotten dose.
If you stop using Lantus
This could lead to severe hyperglycaemia (very
high blood sugar) and ketoacidosis (build-up
of acid in the blood because the body is
breaking down fat instead of sugar). Do not
stop Lantus without speaking to a doctor, who
will tell you what needs to be done.
If you have any further questions on the use
of this medicine, ask your doctor, pharmacist
or nurse.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
If you notice signs of your blood sugar
being to low (hypoglycaemia), take action
to increase your blood sugar level straight
away (see the box at the end of this leaflet).
Hypoglycaemia (low blood sugar) can be
very serious and is very common with
insulin treatment (may affect more than
1in 10people). Low blood sugar means that
there is not enough sugar in your blood.
If your blood sugar level falls too low, you
may pass out (become unconscious). Serious
hypoglycaemia may cause brain damage and
may be life-threatening. For more information,
see the box at the end of this leaflet.
Severe allergic reactions (rare, may affect up
to 1 in 1,000 people) - the signs may include
large-scale skin reactions (rash and itching
all over the body), severe swelling of skin or
mucous membranes (angiooedema),
shortness of breath, a fall in blood pressure
with rapid heart beat and sweating. Severe
allergic reactions to insulins may become
life-threatening. Tell a doctor straight away if
you notice signs of severe allergic reaction.
Common reported side effects (may affect
up to 1 in 10 people)
• Skin changes at the injection site
If you inject your insulin too often at the
same skin site, fatty tissue under the skin
at this site may either shrink (lipoatrophy,
Read all of this leaflet carefully including
the Instructions for Use of Lantus
SoloStar, pre- filled pen, before you start
using this medicine because it contains
important information for you.
– 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
may affect up to 1 in 100 people) or thicken
(lipohypertrophy). The insulin may not work
very well. Change the injection site with each
injection to help prevent these skin changes.
• Skin and allergic reactions at the
injection site
(The signs may include reddening, unusually
intense pain when injecting, itching, hives,
swelling or inflammation). This can spread
around the injection site. Most minor
reactions to insulins usually disappear in a
few days to a few weeks.
Rare reported side effects (may affect up to
1 in 1,000 people)
• Eye reactions
A marked change (improvement or worsening)
in your blood sugar control can disturb your
vision temporarily. If you have proliferative
retinopathy (an eye disease related to
diabetes) severe hypoglycaemic attacks may
cause temporary loss of vision.
• General disorders
In rare cases, insulin treatment may also
cause temporary build-up of water in the
body, with swelling in the calves and ankles.
Very rare reported side-effects (may affect
up to 1 in 10,000 people)
In very rare cases, dysgeusia (taste disorders)
and myalgia (muscular pain) can occur.
Use in children and adolescents
In general, the side effects in children and
adolescents of 18 years of age or less are
similar to those seen in adults.
Complaints of injection site reactions
(injection site reaction, injection site pain) and
skin reactions (rash, urticaria) are reported
relatively more frequently in children and
adolescents of 18 years of age or less than in
adults.
There is no experience in children under
2years.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
United Kingdom
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.
Ireland
You can also report side effects directly via
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2;
Tel: [phone];
Fax: [phone].
Website: www.hpra.ie;
E-mail: [email protected]
Malta
You can also report side effects directly via
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide
more information on the safety of this
medicine.
5. How to store Lantus
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton and on the label
of the pen after “EXP”. The expiry date refers
to the last day of that month.
Not in-use pens
Store in a refrigerator (2°C-8°C). Do not freeze
or place next to the freezer compartment or a
freezer pack.
Keep the pre-filled pen in the outer carton in
order to protect from light.
In-use pens
Pre-filled pens in use or carried as a spare
may be stored for a maximum of 4 weeks
not above 30°C and away from direct heat or
direct light. The pen in use must not be stored
in the refrigerator. Do not use it after this time
period.
Do not throw away any 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 Lantus contains
– The active substance is insulin glargine.
Each ml of the solution contains 100 units
of insulin glargine (equivalent to 3.64 mg).
– The other ingredients of Lantus are: zinc
chloride, metacresol, glycerol, sodium
hydroxide (see section2 “Important
information about some of the ingredients
of Lantus”) and hydrochloric acid (for pH
adjustment) and water for injections.
What Lantus looks like and contents of the
pack
Lantus SoloStar 100 units/ml solution for
injection in a pre-filled pen, is a clear and
colourless solution.
Each pen contains 3 ml of solution for
injection (equivalent to 300 units). Packs sizes
of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Sanofi-Aventis Deutschland GmbH,
D-65926 Frankfurt am Main, Germany.
This leaflet was last revised in
April 2018
Other source of information
Detailed information on this medicine is
available on the European Medicines Agency
web site: http://www.ema.europa.eu/
For any information about this medicine,
please contact the local representative of the
Marketing Authorisation Holder.
Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: [phone]
Malta
Sanofi Malta Ltd., Tel: [phone]
United Kingdom
Sanofi, Tel: [phone]
What is in this leaflet
1. What Lantus is and what it is used for
2. What you need to know before you use
Lantus
3. How to use Lantus
4. Possible side effects
5. How to store Lantus
6. Contents of the pack and other information
1. What Lantus is and what it is used
for
Lantus contains insulin glargine. This is a
modified insulin, very similar to human
insulin.
Lantus is used to treat diabetes mellitus in
adults, adolescents and children aged 2years
and above. Diabetes mellitus is a disease
where your body does not produce enough
insulin to control the level of blood sugar.
Insulin glargine has a long and steady
blood-sugar-lowering action.
2. What you need to know before you
use Lantus
Do not use Lantus
If you are allergic to insulin glargine or to
any of the other ingredients of this medicine
(listed in section6).
Warnings and precautions
Lantus in pre-filled pen is only suitable
for injecting just under the skin (see also
section3). Speak to your doctor if you need to
inject your insulin by another method.
<MAT>541512
<MAT>541512

Legende / Legend
SAP-Nr. / Plant PM code: 541512
Sprachvariante / Country code: 103
Version: 1
Datum / Date: 13.04.2018 PE
Abmessungen / Dimensions: 628 × 296 mm
Schriftgröße / Font size: 9 Pt
Zeilenabstand / Line spacing: 10 Pt
Seite / Page: 2/2
Druckbare Farben / Printing colours
Pantone Black C
Pantone Reex Blue C
Pantone 186 C
Pantone 423 C
Technische Information / Technical information
Kontur / Outline
10 secs
Step 3. Perform a Safety test
Always perform the safety test before each injection. This ensures that you get an
accurate dose by:
• ensuring that pen and needle work properly
• removing air bubbles
A. Select a dose of 2units by turning the dosage selector.
B. Take off the outer needle cap and keep it to remove the used needle after
injection. Take off the inner needle cap and discard it.
C. Hold the pen with the needle pointing upwards.
D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
E. Press the injection button all the way in. Check if insulin comes out of the needle
tip.
You may have to perform the safety test several times before insulin is seen.
• If no insulin comes out, check for air bubbles and repeat the safety test two
more times to remove them.
• If still no insulin comes out, the needle may be blocked. Change the needle and
try again.
• If no insulin comes out after changing the needle, your SoloStar may be
damaged. Do not use this SoloStar.
Lantus® SoloStar® solution for injection in a pre-filled pen INSTRUCTION FOR USE
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are diabetic.
HYPERGLYCAEMIA
(high blood sugar levels)
If your blood sugar is too high (hyperglycaemia), you may not
have injected enough insulin.
Why does hyperglycaemia occur?
Examples include:
– you have not injected your insulin or not injected enough, or
if it has become less effective, for example through incorrect
storage,
– your insulin pen does not work properly,
– you are doing less exercise than usual, you are under stress
(emotional distress, excitement), or you have an injury,
operation, infection or fever,
– you are taking or have taken certain other medicines (see
section 2, “Other medicines and Lantus”).
Warning symptoms of hyperglycaemia
Thirst, increased need to urinate, tiredness, dry skin, reddening of
the face, loss of appetite, low blood pressure, fast heart beat, and
glucose and ketone bodies in urine. Stomach pain, fast and deep
breathing, sleepiness or even loss of consciousness may be signs of
a serious condition (ketoacidosis) resulting from lack of insulin.
What should you do if you experience
hyperglycaemia?
Test your blood sugar level and your urine for ketones as soon
as any of the above symptoms occur. Severe hyperglycaemia
or ketoacidosis must always be treated by a doctor, normally in a
hospital.
HYPOGLYCAEMIA
(low blood sugar levels)
If your blood sugar level falls too much you may become
unconscious. Serious hypoglycaemia may cause a heart attack or
brain damage and may be life-threatening. You normally should
be able to recognise when your blood sugar is falling too much so
that you can take the right actions.
Why does hypoglycaemia occur?
Examples include:
– you inject too much insulin,
– you miss meals or delay them,
– you do not eat enough, or eat food containing less carbohydrate
than normal (sugar and substances similar to sugar are
called carbohydrates; however, artificial sweeteners are NOT
carbohydrates),
– you lose carbohydrates due to vomiting or diarrhoea,
– you drink alcohol, particularly if you are not eating much,
– you are doing more exercise than usual or a different type of
physical activity,
– you are recovering from an injury or operation or other stress,
– you are recovering from an illness or from fever,
– you are taking or have stopped taking certain other medicines
(see section 2, “Other medicines and Lantus”).
Hypoglycaemia is also more likely to occur if
– you have just begun insulin treatment or changed to another
insulin preparation (when changing from your previous basal
insulin to Lantus hypoglycaemia, if it occurs, may be more likely
to occur in the morning than at night),
– your blood sugar levels are almost normal or are unstable,
– you change the area of skin where you inject insulin (for
example from the thigh to the upper arm),
– you suffer from severe kidney or liver disease, or some other
disease such as hypothyroidism.
Warning symptoms of hypoglycaemia
– In your body
Examples of symptoms that tell you that your blood sugar level
is falling too much or too fast: sweating, clammy skin, anxiety,
fast heart beat, high blood pressure, palpitations and irregular
heartbeat. These symptoms often develop before the symptoms
of a low sugar level in the brain.
– In your brain
Examples of symptoms that indicate a low sugar level in
the brain: headaches, intense hunger, nausea, vomiting,
tiredness, sleepiness, sleep disturbances, restlessness, aggressive
behaviour, lapses in concentration, impaired reactions,
depression, confusion, speech disturbances (sometimes total
loss of speech), visual disorders, trembling, paralysis, tingling
sensations (paraesthesia), numbness and tingling sensations in
the area of the mouth, dizziness, loss of self-control, inability to
look after yourself, convulsions, loss of consciousness.
The first symptoms which alert you to hypoglycaemia (“warning
symptoms”) may change, be weaker or may be missing
altogether if
– you are elderly, if you have had diabetes for a long time or
if you suffer from a certain type of nervous disease (diabetic
autonomic neuropathy),
– you have recently suffered hypoglycaemia (for example the day
before) or if it develops slowly,
– you have almost normal or, at least, greatly improved blood
sugar levels,
– you have recently changed from an animal insulin to a human
insulin such as Lantus,
– you are taking or have taken certain other medicines (see
section 2, “Other medicines and Lantus”).
In such a case, you may develop severe hypoglycaemia (and
even faint) before you are aware of the problem. Be familiar
with your warning symptoms. If necessary, more frequent blood
sugar testing can help to identify mild hypoglycaemic episodes
that may otherwise be overlooked. If you are not confident about
recognising your warning symptoms, avoid situations (such as
driving a car) in which you or others would be put at risk by
hypoglycaemia.
What should you do if you experience hypoglycaemia?
1. Do not inject insulin. Immediately take about 10 to 20 g
sugar, such as glucose, sugar cubes or a sugar-sweetened
beverage. Caution: Artificial sweeteners and foods with artificial
sweeteners (such as diet drinks) are of no help in treating
hypoglycaemia.
2. Then eat something that has a long-acting effect in raising
your blood sugar (such as bread or pasta). Your doctor or nurse
should have discussed this with you previously. The recovery
of hypoglycaemia may be delayed because Lantus has a long
action.
3. If the hypoglycaemia comes back again take another 10 to 20 g
sugar.
4. Speak to a doctor immediately if you are not able to control the
hypoglycaemia or if it recurs.
Tell your relatives, friends and close colleagues the following:
If you are not able to swallow or if you are unconscious, you will
require an injection of glucose or glucagon (a medicine which
increases blood sugar). These injections are justified even if it is
not certain that you have hypoglycaemia.
It is advisable to test your blood sugar immediately after taking
glucose to check that you really have hypoglycaemia.
SoloStar is a pre-filled pen for the injection of insulin. Your doctor
has decided that SoloStar is appropriate for you based on your
ability to handle SoloStar. Talk with your doctor, pharmacist or
nurse about proper injection technique before using SoloStar.
Read these instructions carefully before using your SoloStar. If
you are not able to use SoloStar or follow all the instructions
completely on your own, you must use SoloStar only if you
have help from a person who is able to follow the instructions
completely. Hold the pen as shown in this leaflet. To ensure that
you read the dose correctly, hold the pen horizontally, with the
needle on the left and the dosage selector to the right as shown in
the illustrations below.
You can set doses from 1 to 80units in steps of 1unit. Each pen
contains multiple doses.
Keep this leaflet for future reference.
If you have any questions about SoloStar or about diabetes, ask
your doctor, pharmacist or nurse or call the local Sanofi number
on the front of this leaflet.
Important information for use of SoloStar:
• Always attach a new needle before each use. Only use needles that are
compatible for use with SoloStar.
• Do not select a dose and/or press the injection button without a needle
attached.
• Always perform the safety test before each injection (see Step3).
• This pen is only for your use. Do not share it with anyone else.
• If your injection is given by another person, special caution must be taken by
this person to avoid accidental needle injury and transmission of infection.
• Never use SoloStar if it is damaged or if you are not sure that it is working
properly.
• Always have a spare SoloStar in case your SoloStar is lost or damaged.
Step 1. Check the insulin
A. Check the label on your SoloStar to make sure you have the correct insulin. The
Lantus Solostar is grey with a purple injection button.
B. Take off the pen cap.
C. Check the appearance of your insulin. Lantus is a clear insulin. Do not use this
SoloStar if the insulin is cloudy, coloured or has particles.
Step 2. Attach the needle
Always use a new sterile needle for each injection. This helps prevent
contamination, and potential needle blocks.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as you attach it (screw or
push on, depending on the needle type).
• If the needle is not kept straight while you attach it, it can damage the rubber
seal and cause leakage, or break the needle.
Step 4. Select the dose
You can set the dose in steps of 1unit, from a minimum of 1unit to a maximum of
80units. If you need a dose greater than 80units, you should give it as two or more
injections.
A. Check that the dose window shows “0” following the safety test.
B. Select your required dose (in the example below, the selected dose is 30units).
Ifyou turn past your dose, you can turn back down.
• Do not push the injection button while turning, as insulin will come out.
• You cannot turn the dosage selector past the number of units left in the pen. Do
not force the dosage selector to turn. In this case, either you can inject what is
remaining in the pen and complete your dose with a new SoloStar or use a new
SoloStar for your full dose.
Step 6. Remove and discard the needle
Always remove the needle after each injection and store SoloStar without a needle
attached.
This helps prevent:
• Contamination and/or infection,
• Entry of air into the insulin reservoir and leakage of insulin, which can cause
inaccurate dosing.
A. Put the outer needle cap back on the needle, and use it to unscrew the needle
from the pen. To reduce the risk of accidental needle injury, never replace the
inner needle cap.
• If your injection is given by another person, or if you are giving an injection to
another person, special caution must
be taken by this person when removing
and disposing of the needle.
• Follow recommended safety measures
for removal and disposal of needles
(contact your doctor, pharmacist
or nurse) in order to reduce the
risk of accidental needle injury and
transmission of infectious diseases.
B. Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.
C. Always put the pen cap back on the pen, then store the pen until your next
injection.
Storage instructions
See the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow
it to warm up. Cold insulin is more painful to inject.
Discard your used SoloStar as required by your local authorities.
Maintenance
Protect your SoloStar from dust and dirt.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
It should be handled with care. Avoid situations where SoloStar might be damaged.
If you are concerned that your SoloStar may be damaged, use a new one.
Step 5. Inject the dose
A. Use the injection method as instructed by your doctor, pharmacist or nurse.
B. Insert the needle into the skin.
C. Deliver the dose by pressing the injection button in all the way. The number in
the dose window will return to “0” as you inject.
D. Keep the injection button pressed all the way in. Slowly count to 10 before
you withdraw the needle from the skin. This ensures that the full dose will be
delivered.
The pen plunger moves with each dose. The plunger will reach the end of the
cartridge when the total of 300units of insulin has been used.
Keep Discard
Pen cap
Schematic diagram of the pen
Pen needle (not included) Pen body
Insulin reservoir Dose
window
Protective seal
Outer
needle
cap
Inner
needle
cap Needle Rubber seal
Dosage
selector
Injection
button