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LUBION 25 MG SOLUTION FOR INJECTION

Active substance(s): PROGESTERONE

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Patient self-administration:
Subcutaneous injection only
Healthcare administration:
By s.c and i.m injection
Read all of this leaflet carefully 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 or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their symptoms 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.
• Lubion 25mg solution for injection will be
known as Lubion throughout this leaflet.

Package leaflet: Information for the user

Lubion®
25 mg
solution for injection
Progesterone

What is in this leaflet:
1. What Lubion is and what it is used for
2. What you need to know before you use
Lubion
3. How to use Lubion
4. Possible side effects
5. How to store Lubion
6. Contents of the pack and other information

FI/150 (UK) 21971 Ed. I/11.13

1. What Lubion is and what is it used for
Lubion contains the active ingredient
Progesterone. Progesterone is a naturally
occurring female sex hormone. The medicine
works on the lining of the womb and
helps you to become pregnant and to stay
pregnant.

suspects some tissue is still in the womb
• If you have had a pregnancy outside of the
womb (ectopic pregnancy)
• If you currently have or have had severe
liver problems
• If you have known or suspected breast
cancer or cancer of the reproductive tract
• If you have or have had blood clots in the
legs, lungs, eyes or elsewhere in the body
• If you have porphyria disorders (a group of
inherited or acquired disorders of certain
enzymes)
• If during pregnancy you have suffered from
jaundice (yellowing of eyes and skin due
to liver problems) severe itching and/or
blisters on the skin
• If you are under 18 years of age.
Take special care with Lubion
If you experience any of the following during
treatment tell your doctor immediately as
your treatment may need to be stopped. Also
tell your doctor immediately if you experience
these a few days after the last dosage:
• Heart attack (pains in the chest, or
back pain and/or deep aching and
throbbing in one or both arms, a sudden
shortness of breath, sweating, dizziness,
lightheadedness, nausea, palpitations)
• Stroke (severe headache or vomiting,
dizziness, faintness, or changes in vision or
speech, weakness or numbness of an arm
or leg.)
• Blood clots in the eyes or anywhere in
the body (pain in your eyes or pain and
swelling in your ankles, feet and hands)
• Worsening of depression
• Severe headaches, changes in vision.

2. What you need to know before you use
Lubion

Before treatment with Lubion
Tell your doctor if you have had or have any of
the following before using Lubion:
• Liver problems (mild or moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney problems
• Diabetes
• Depression
If any of the above applies to you, your doctor
will monitor you carefully during treatment.

Do not use Lubion
• If you are allergic (hypersensitive)
to progesterone or any of the other
ingredients of Lubion
• If you are suffering from vaginal bleeding
(other than normal periods) that has not
been evaluated by your doctor
• If you have had a miscarriage and your doctor

Other medicines and Lubion
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription and herbal medicines.
• Carbamazepine (used to treat seizures/fits)
• Rifamipicin (an antibiotic)
• Griseofulvin (an antifungal medicine)

Lubion is for women who need extra
progesterone while undergoing treatment in
an Assisted Reproductive Technology (ART)
programme who are unable to use or tolerate
vaginal preparations.

• Phenytoin and Phenobarbital (used to treat
epilepsy)
• St. John’s Wort-containing herbal products.
• Ciclosporine (a medicine for some types of
inflammation and after organ transplants)
• Diabetic medicines.
• Ketoconazole (an antifungal medicine)
Do not administer Lubion at the same time as
any other injectable medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
• Lubion can be used during the first three
months of pregnancy.
• This medicine should not be used during
breast-feeding.
Driving and using machines
Do not drive or use any tools or machines if
you feel drowsy and/or dizzy whilst taking
Lubion.

3. How to use Lubion
Always use Lubion exactly as your doctor
has told you. Remember Lubion should only
be used under the supervision of a doctor
experienced in treating fertility problems.
How much Lubion should you use and for
how long?
The usual dose is a once daily injection of
25 mg usually until 12 weeks of confirmed
pregnancy (i.e. 10 weeks of treatment).
How Lubion should be given
Lubion can be given either under your skin
(subcutaneous injection) or into a muscle
(intramuscular injection).
You will be able to administer 25 mg of
Lubion subcutaneously after suitable advice
and training by your doctor or healthcare
professional.
Before you inject Lubion you will receive the
following training and advice:
• Practice giving subcutaneous injections
• Where to inject your medicine
• How to prepare your solution for injection
• How to administer your medicine.
Please read instruction below on
preparation and administration of Lubion.

The steps for self administration are:
A. Preparing your injection
B. Checking pack
C. Preparing the vial and syringe
D. Filling the syringe
E. Changing the injecting needle
F. Removing air bubbles
G. Injection by subcutaneous administration
H. Disposal of used items.
These steps are explained in full below.
IMPORTANT: each vial should only be
used once. The solutions should be used
immediately after opening the vial. It should
not be stored in the syringe.
A. Preparing your injection
It is important to keep everything as clean
as possible, so start by washing your hands
thoroughly and drying on a clean towel.
Choose a clean area to prepare your
medicine:
• One vial containing Lubion solution for
injection
The following items are not supplied with
your medicine. Your doctor or pharmacist will
supply these items.
• One syringe
• One large needle (typically 21G green
needle; for intramuscular administration)
• One small fine needle (typically 27G grey
needle; for subcutaneous injection)
• Two alcohol wipes
• A sharps container (for safe disposal of
needles, vials etc.)
B. Checking pack
• The Lubion vial syringe and needles all
have protective covers.
• Check that all the covers are on firmly and
if they are not on properly or are damaged,
do not use them
• Make sure that the expiry date is still
valid on the vial of Lubion. Do not use the
products if outside the expiry date.
C. Preparing the vial and syringe
• Remove the plastic cap from the
top of a Lubion vial by gently
pushing it upwards.
• Wipe the rubber top with an
alcohol wipe and allow to dry
• Unpack the syringe, hold the syringe
• Take the packaging off the large 21G green
needle, but keep the needle cover on
• Hold the syringe in your hand, attach the
large 21G green needle to the syringe,
then remove the needle cover

D. Filling the syringe
• Push the large 21G green needle
through the rubber middle of
the Lubion vial top
• With the needle still inserted,
turn the vial upside down. The
needle should support the vial
unaided
• Make sure the large needle tip is
underneath the level of the liquid
• Gently pull the plunger to draw all the
mixture into the syringe
• Pull the large needle out of the vial.
E. Changing the injecting needle
This step is only required if you are doing a
subcutaneous administration; if your doctor is
performing an intramuscular injection they will
move on to set the dose and administer the
injection.
• Put the cap on the large 21G green needle
and then gently take the large needle off
the syringe
• Remove the smaller 27G grey injecting
needle, from its package, keeping the
needle cover on
• Attach the small 27G grey needle onto the
syringe then remove the needle cover.
F. Removing air bubbles
• Holding the syringe straight up
with the small 27G grey needle
pointing to the ceiling, draw
back slightly on the plunger and
tap the syringe so that any air
bubbles rise to the top.
• Slowly press the plunger until all the air is
out of the syringe and at least one drop of
solution comes out of the tip of the small
27G grey needle
G. Injection by subcutaneous administration
• Your doctor or healthcare professional will
have already shown you where to inject
Lubion (e.g. tummy or front of thigh)
• Open the alcohol wipe and carefully clean
the area of skin to be injected, and allow
it to dry
• Hold the syringe in one hand. Use the
other hand to gently pinch the skin in the
injection site area between your thumb
and index finger
• Using a dart–like motion insert
the fine grade small 27G grey
needle into the skin so the skin
and needle form a right angle.

• Insert the small 27G grey needle all the
way into the skin. Do not inject directly
into a vein
• Inject the solution by pushing gently on the
plunger in a slow and steady motion until
all the solution is injected beneath the skin.
Inject all of the prescribed solution
• Release the skin and pull the needle
straight out
• Wipe the skin at the injection site with an
alcohol swab using a circular motion.
H. Disposal of used items
• Once you have finished your injection, put
all needles, empty vials and syringes into a
sharps container.
• Any unused solution must also be thrown
away.
Injection by intramuscular administration
given by a doctor or healthcare professional
For all intramuscular injections, your doctor or
another healthcare professional will perform
the injection.
The Lubion injection will be given into the
side of the thigh or bottom. Your doctor or
healthcare professional will clean the area of
skin to be injected using an alcohol wipe, and
allow it to dry. Using a dart-like motion they
will insert the large needle into the muscle.
They will inject the solution by pushing gently
on the plunger in a slow and steady motion
until all the solution is injected into the
muscle. They will pull the needle straight out
and wipe the skin at the injection site with an
alcohol wipe.
If you use more Lubion than you should
Tell your doctor or pharmacist. The symptoms
of an overdose include drowsiness.
If you forget to use Lubion
Take the dose as soon as you remember and
then carry on as before. Do not take a double
dose to make up for a forgotten dose. Tell
your doctor what you have done.
If you stop using Lubion
Do not stop using Lubion without speaking
to your doctor or pharmacists first. Abrupt
discontinuation of Lubion may cause increased
anxiety, moodiness, and increase your risk of
having seizures (fits).
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Lubion can cause side
effects, although not everybody gets them.
Stop taking this medicine and seek
immediate medical help if you have any
of the following symptoms, you may be
suffering from overstimulation of the
ovaries:
• lower stomach pain
• feeling thirsty and sick, and sometimes
being sick
• passing reduced quantities of
concentrated urine
• weight gain
Very common side effects (affecting up to 1
in 10 of every patient treated):
• Pain, redness, itching, irritation or swelling
at the injection site
• Uterine spasm
• Vaginal bleeding.
Common side effects (affecting between 1 in
10 and 1 in 100 of patients treated):
•• Overstimulation of the ovaries (symptoms
include lower stomach pain, feeling thirsty
and sick, and sometimes being sick,
passing reduced quantities of concentrated
urine and weight gain)
•• Headache
•• Bloated stomach
•• Stomach pain
•• Constipation
•• Being sick and feeling sick
•• Breast tenderness and/or pain
•• Vaginal discharge
•• A tingling or uneasy irritation or itching of
the skin of the vagina and the surrounding
area
•• Hardening of area around injection site
•• Bruising around injection site
•• Fatigue (excessive tiredness, exhaustion,
lethargy).
Uncommon side effects (affecting between 1
in 100 and 1 in 1000 patients treated):
• Changes in mood
• Dizziness
• Insomnia
• Stomach and intestinal disturbance
(including stomach discomfort and/or
tenderness, wind, painful spasms and
retching)
• Skin rashes (including red warm skin,
or raised, itchy bumps or wheals or dry,
cracked or blistered or swollen skin)
• Breast swelling and/or enlargement
• Feeling hot
• General feeling of discomfort or “feeling
out of sorts”
• Pain.

The following disorders, although not
reported by patients in clinical studies using
Lubion, have been described with other
progestins: depression, yellowing of your
skin and the whites of your eyes (jaundice),
inability to sleep (insomnia), premenstrual
like syndrome and menstrual disturbances,
hives, acne, excessive hair growth, hair loss
(alopecia), weight gain and a severe allergic
reaction which may cause difficulty breathing,
swelling of the face and throat or a severe
rash (anaphylactoid reactions).

What Lubion looks like and contents of the
pack
Lubion is a clear colourless solution supplied
in a colourless glass vial.

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.

Manufacturer
Pharmasure Limited,
28 Watford Metro Centre,
Dwight Road, Watford,
WD18 9SB

5. How to store Lubion
Keep out of the sight and reach of children.
Store below 25oC.
Do not refrigerate or freeze.
Store in the original package in order to
protect from light.
This medicinal product must be used
immediately after first opening.
Any remaining solution must be discarded.
Do not use Lubion after the expiry date which
is stated on the label after Exp: The expiry
date refers to the last day of that month.
Do not use Lubion if you notice particles in
the solution or if the solution is not clear.
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. Contents of the pack and other
information
What Lubion contains
The active substance is Progesterone. Each
vial (1.119 ml) contains 25 mg progesterone
(theoretical concentration 22.35 mg/ml).
The other ingredients are:
Hydroxypropylbetadex, Water for injections

Each pack contains 1, 7 or 14 vials. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi (Italy)

This leaflet was last revised in 11/2013.
If this leaflet is difficult to see or read or you
would like it in a different format, please
contact Pharmasure Limited, 28 Watford
Metro Centre, Dwight Road, Watford, WD18
9SB (Tel: +44(0) 1923 233466,
email: info@pharmasure.co.uk)

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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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