Sanofi Lantus SoloStar Package Leaflet/Information For The User

Package leaflet: Information for the user Talk to your doctor, pharmacist or nurse
before using Lantus.
Lantus®
SoloStar®
Follow closely the instructions for posology,
monitoring (blood and urine tests), diet and
100 units/ml physical activity (physical work and exercise),
solution for injection injection technique as discussed with your
in a pre-filled pen doctor.
insulin glargine If your blood sugar is too low (hypoglycaemia),
follow the guidance for hypoglycaemia (see
box at the end of this leaflet).
Travel
Read all of this leaflet carefully including Before travelling consult your doctor. You may
the Instructions for Use of Lantus need to talk about
SoloStar, pre- filled pen, before you start – the availability of your insulin in the
using this medicine because it contains country you are visiting,
important information for you. – supplies of insulin, needles etc.,
– Keep this leaflet. You may need to read it – correct storage of your insulin while
again. travelling,
– If you have any further questions, ask your – timing of meals and insulin administration
doctor, pharmacist or nurse. while travelling,
– This medicine has been prescribed for you – the possible effects of changing to different
only. Do not pass it on to others. It may time zones,
harm them, even if their signs of illness are – possible new health risks in the countries to
the same as yours. be visited,
– If you get any side effects, talk to your – what you should do in emergency situations
doctor or pharmacist. This includes any when you feel unwell or become ill.
possible side effects not listed in this
leaflet. See section 4. 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).
<MAT>541512
– If you are not eating enough your
What is in this leaflet
blood sugar level may become too low
1. What Lantus is and what it is used for (hypoglycaemia).
2. What you need to know before you use In most cases you will need a doctor. Make
Lantus sure that you contact a doctor early.
3. How to use Lantus If you have type 1 diabetes (insulin dependent
4. Possible side effects diabetes mellitus), do not stop your insulin
5. How to store Lantus and continue to get enough carbohydrates.
6. Contents of the pack and other information Always tell people who are caring for you or
treating you that you require insulin.
1. What Lantus is and what it is used
Insulin treatment can cause the body to
for
produce antibodies to insulin (substances
that act against insulin). However, only very
Lantus contains insulin glargine. This is a rarely, this will require a change to your
modified insulin, very similar to human insulin dose.
insulin. Some patients with long-standing type 2
Lantus is used to treat diabetes mellitus in diabetes mellitus and heart disease or
adults, adolescents and children aged 2 years previous stroke who were treated with
and above. Diabetes mellitus is a disease pioglitazone (oral anti-diabetic medicine used
where your body does not produce enough to treat type 2 diabetes mellitus) and insulin
insulin to control the level of blood sugar. experienced the development of heart failure.
Insulin glargine has a long and steady Inform your doctor as soon as possible if
blood-sugar-lowering action. you experience signs of heart failure such as
unusual shortness of breath or rapid increase
2. What you need to know before you
in weight or localised swelling (oedema).
use Lantus
Children
Do not use Lantus There is no experience with the use of Lantus
If you are allergic to insulin glargine or to in children below the age of 2 years
any of the other ingredients of this medicine
(listed in section 6). Other medicines and Lantus
Some medicines cause changes in the blood
Warnings and precautions sugar level (decrease, increase or both
Lantus in pre-filled pen is only suitable depending on the situation). In each case, it
for injecting just under the skin (see also may be necessary to adjust your insulin dose
section 3). Speak to your doctor if you need to to avoid blood sugar levels that are either too
inject your insulin by another method. low or too high. Be careful when you start or
stop taking another medicine.
Tell your doctor or pharmacist if you are Lantus with alcohol
taking, have recently taken or might take any Your blood sugar levels may either rise or fall
other medicines. Before taking a medicine ask if you drink alcohol.
your doctor if it can affect your blood sugar
level and what action, if any, you need to Pregnancy and breast-feeding
take. Ask your doctor or pharmacist for advice
before taking any medicine.
Medicines that may cause your blood sugar Inform your doctor if you are planning to
level to fall (hypoglycaemia) include: become pregnant, or if you are already
– all other medicines to treat diabetes, pregnant. Your insulin dose may need to be
– angiotensin converting enzyme (ACE) changed during pregnancy and after giving
inhibitors (used to treat certain heart birth. Particularly careful control of your
conditions or high blood pressure), diabetes, and prevention of hypoglycaemia, is
– disopyramide (used to treat certain heart important for the health of your baby.
conditions), If you are breast-feeding consult your doctor
– fluoxetine (used to treat depression), as you may require adjustments in your
– fibrates (used to lower high levels of blood insulin doses and your diet.
lipids),
– monoamine oxidase (MAO) inhibitors (used Driving and using machines
to treat depression), Your ability to concentrate or react may be
– pentoxifylline, propoxyphene, salicylates reduced if:
(such as acetylsalicylic acid, used to relieve – you have hypoglycaemia (low blood sugar
pain and lower fever), levels),
– sulfonamide antibiotics. – you have hyperglycaemia (high blood sugar
levels),
Medicines that may cause your blood sugar – you have problems with your sight.
level to rise (hyperglycaemia) include: Keep this possible problem in mind in all
– corticosteroids (such as "cortisone" used to situations where you might put yourself and
treat inflammation), others at risk (such as driving a car or using
– danazol (medicine acting on ovulation), machines). You should contact your doctor for
– diazoxide (used to treat high blood advice on driving if:
pressure), – you have frequent episodes of
– diuretics (used to treat high blood pressure hypoglycaemia,
or excessive fluid retention), – the first warning symptoms which help you
– glucagon (pancreas hormone used to treat to recognise hypoglycaemia are reduced or
severe hypoglycaemia), absent.
– isoniazid (used to treat tuberculosis),
Important information about some of the
– oestrogens and progestogens (such as in the
contraceptive pill used for birth control), ingredients of Lantus
– phenothiazine derivatives (used to treat This medicine contains less than 1 mmol
psychiatric disorders), (23 mg) sodium per dose, i.e. it is essentially
– somatropin (growth hormone), 'sodium-free'.
– sympathomimetic medicines (such as
3. How to use Lantus
epinephrine [adrenaline], salbutamol,
terbutaline used to treat asthma),
– thyroid hormones (used to treat thyroid Always use this medicine exactly as your
gland disorders), doctor has told you. Check with your doctor or
– atypical antipsychotic medicines (such as pharmacist if you are not sure.
clozapine, olanzapine),
– protease inhibitors (used to treat HIV). Although Lantus contains the same active
substance as Toujeo (insulin glargine
Your blood sugar level may either rise or
300 units/ml), these medicines are not
fall if you take: interchangeable. The switch from one
– beta-blockers (used to treat high blood insulin therapy to another requires medical
pressure), prescription, medical supervision and blood
– clonidine (used to treat high blood glucose monitoring. Please, consult your
pressure), doctor for further information.
– lithium salts (used to treat psychiatric
disorders). Dose
Pentamidine (used to treat some infections Based on your life-style and the results of your
caused by parasites) may cause hypoglycaemia blood sugar (glucose) tests and your previous
which may sometimes be followed by insulin usage, your doctor will
hyperglycaemia. – determine how much Lantus per day you
Beta-blockers like other sympatholytic will need and at what time.
medicines (such as clonidine, guanethidine, – tell you when to check your blood sugar
and reserpine) may weaken or suppress level, and whether you need to carry out
entirely the first warning symptoms which urine tests,
help you to recognise a hypoglycaemia. – tell you when you may need to inject a
higher or lower dose of Lantus.
If you are not sure whether you are taking Lantus is a long-acting insulin. Your doctor
one of those medicines ask your doctor or may tell you to use it in combination with a
pharmacist. short-acting insulin or with tablets used to
treat high blood sugar levels.
<MAT>541512
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 If you use more Lantus than you should
becoming too high or too low. See the box at – If you have injected too much Lantus,
the end of this leaflet for further information. your blood sugar level may become too
low (hypoglycaemia). Check your blood
Use in children and adolescents sugar frequently. In general, to prevent
Lantus can be used in adolescents and hypoglycaemia you must eat more food and
children aged 2 years and above. Use this monitor your blood sugar. For information
medicine exactly as your doctor has told you. on the treatment of hypoglycaemia, see box
at the end of this leaflet.
Frequency of administration
You need one injection of Lantus every day, at If you forget to use Lantus
the same time of the day. – If you have missed a dose of Lantus or if
you have not injected enough insulin,
Method of administration your blood sugar level may become too
Lantus is injected under the skin. Do NOT high (hyperglycaemia). Check your blood
inject Lantus in a vein, since this will change sugar frequently. For information on the
its action and may cause hypoglycaemia. treatment of hyperglycaemia, see box at the
Your doctor will show you in which area of end of this leaflet.
the skin you should inject Lantus. With each – Do not take a double dose to make up for a
injection, change the puncture site within the forgotten dose.
particular area of skin that you are using.
If you stop using Lantus
How to handle SoloStar This could lead to severe hyperglycaemia (very
SoloStar is a pre-filled disposable pen high blood sugar) and ketoacidosis (build-up
containing insulin glargine. Lantus in of acid in the blood because the body is
pre-filled pen is only suitable for injecting breaking down fat instead of sugar). Do not
just under the skin. Speak to your doctor if stop Lantus without speaking to a doctor, who
you need to inject your insulin by another will tell you what needs to be done.
method.
If you have any further questions on the use
Read carefully the "SoloStar Instructions of this medicine, ask your doctor, pharmacist
for Use" included in this package leaflet. or nurse.
You must use the pen as described in these
4. Possible side effects
Instructions for Use.
A new needle must be attached before each Like all medicines, this medicine can cause
use. Only use needles that are compatible for side effects, although not everybody gets them.
use with SoloStar (see "SoloStar Instructions
for Use"). If you notice signs of your blood sugar
A safety test must be performed before each being to low (hypoglycaemia), take action
injection. to increase your blood sugar level straight
Look at the cartridge before you use the pen. away (see the box at the end of this leaflet).
Do not use SoloStar if you notice particles in Hypoglycaemia (low blood sugar) can be
it. Only use SoloStar if the solution is clear, very serious and is very common with
colourless and waterlike. Do not shake or mix insulin treatment (may affect more than
it before use. 1 in 10 people). Low blood sugar means that
To prevent the possible transmission of there is not enough sugar in your blood.
disease, never share your pen with anyone If your blood sugar level falls too low, you
else. This pen is only for your use. may pass out (become unconscious). Serious
Make sure that neither alcohol nor other hypoglycaemia may cause brain damage and
disinfectants or other substances contaminate may be life-threatening. For more information,
the insulin. see the box at the end of this leaflet.
Always use a new pen if you notice that your
blood sugar control is unexpectedly getting Severe allergic reactions (rare, may affect up
worse. If you think you may have a problem to 1 in 1,000 people) - the signs may include
with SoloStar, consult your doctor, pharmacist large-scale skin reactions (rash and itching
or nurse. all over the body), severe swelling of skin or
Empty pens must not be re-filled and must be mucous membranes (angiooedema),
properly discarded. shortness of breath, a fall in blood pressure
Do not use SoloStar if it is damaged or not with rapid heart beat and sweating. Severe
working properly, it has to be discarded and a allergic reactions to insulins may become
new SoloStar has to be used. life-threatening. Tell a doctor straight away if
you notice signs of severe allergic reaction.
Insulin Mix-ups
You must always check the insulin label Common reported side effects (may affect
before each injection to avoid mix-ups up to 1 in 10 people)
between Lantus and other insulins. • 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,
may affect up to 1 in 100 people) or thicken By reporting side effects you can help provide
(lipohypertrophy). The insulin may not work more information on the safety of this
very well. Change the injection site with each medicine.
injection to help prevent these skin changes.
5. How to store Lantus
• Skin and allergic reactions at the
injection site
(The signs may include reddening, unusually Keep this medicine out of the sight and reach
intense pain when injecting, itching, hives, of children.
swelling or inflammation). This can spread Do not use this medicine after the expiry date
around the injection site. Most minor which is stated on the carton and on the label
reactions to insulins usually disappear in a of the pen after "EXP". The expiry date refers
few days to a few weeks. to the last day of that month.
Rare reported side effects (may affect up to Not in-use pens
1 in 1,000 people) Store in a refrigerator (2°C-8°C). Do not freeze
• Eye reactions or place next to the freezer compartment or a
A marked change (improvement or worsening) freezer pack.
in your blood sugar control can disturb your Keep the pre-filled pen in the outer carton in
vision temporarily. If you have proliferative order to protect from light.
retinopathy (an eye disease related to
diabetes) severe hypoglycaemic attacks may In-use pens
cause temporary loss of vision. Pre-filled pens in use or carried as a spare
• General disorders may be stored for a maximum of 4 weeks
In rare cases, insulin treatment may also not above 30°C and away from direct heat or
cause temporary build-up of water in the direct light. The pen in use must not be stored
body, with swelling in the calves and ankles. in the refrigerator. Do not use it after this time
period.
Very rare reported side-effects (may affect
up to 1 in 10,000 people) Do not throw away any medicines via
In very rare cases, dysgeusia (taste disorders) wastewater or household waste. Ask your
and myalgia (muscular pain) can occur. pharmacist how to throw away medicines
you no longer use. These measures will help
Use in children and adolescents protect the environment.
In general, the side effects in children and
6. Contents of the pack and other
adolescents of 18 years of age or less are
information
similar to those seen in adults.
Complaints of injection site reactions
What Lantus contains
(injection site reaction, injection site pain) and
skin reactions (rash, urticaria) are reported – The active substance is insulin glargine.
relatively more frequently in children and Each ml of the solution contains 100 units
adolescents of 18 years of age or less than in of insulin glargine (equivalent to 3.64 mg).
adults. – The other ingredients of Lantus are: zinc
There is no experience in children under chloride, metacresol, glycerol, sodium
2 years. hydroxide (see section 2 "Important
information about some of the ingredients
Reporting of side effects of Lantus") and hydrochloric acid (for pH
If you get any side effects, talk to your doctor adjustment) and water for injections.
or pharmacist. This includes any possible side
effects not listed in this leaflet. What Lantus looks like and contents of the
pack
United Kingdom Lantus SoloStar 100 units/ml solution for
You can also report side effects directly via the injection in a pre-filled pen, is a clear and
Yellow Card Scheme at: colourless solution.
www.mhra.gov.uk/yellowcard Each pen contains 3 ml of solution for
or search for MHRA Yellow Card in the Google injection (equivalent to 300 units). Packs sizes
Play or Apple App Store. of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens.
Not all pack sizes may be marketed.
Ireland
You can also report side effects directly via Marketing Authorisation Holder and
HPRA Pharmacovigilance, Earlsfort Terrace, Manufacturer
IRL - Dublin 2; Sanofi-Aventis Deutschland GmbH,
Tel: +353 1 6764971; D-65926 Frankfurt am Main, Germany.
Fax: +353 1 6762517.
Website: www.hpra.ie; This leaflet was last revised in
April 2018
E-mail: medsafety@hpra.ie
Malta Other source of information
You can also report side effects directly via Detailed information on this medicine is
ADR Reporting available on the European Medicines Agency
www.medicinesauthority.gov.mt/adrportal 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: +353 (0) 1 403 56 00
Malta
Sanofi Malta Ltd., Tel: +356 21493022
United Kingdom
Sanofi, Tel: +44 (0) 845 372 7101