FOSTIMON 75 IU POWDER AND SOLVENT FOR SOLUTION FOR 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, please 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 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.
What is in this leaflet:
1. What Fostimon is and what it is used for
2. What you need to know before you use Fostimon
3. How to take Fostimon
4. Possible side-effects
5. How to store Fostimon
6. Content of the pack and other information
1. WHAT FOSTIMON IS AND WHAT IT IS
USED FOR

Fostimon 75 IU
Fostimon® 150 IU
®

powder and solvent for
solution for injection

FI/150 (UK/Irl) 17891 Ed. V/04.16

Urofollitropin (FSH)

-- Fostimon is used to promote ovulation in women who are not ovulating and who have not responded to other treatment (clomifene citrate).
-- It is used to bring about the development of
several follicles (and therefore several eggs) in
women receiving fertility treatment.
Urofollitropin is a highly purified human follicle
stimulating hormone, belonging to a group of
medicines called gonadotropins.
This medicinal product must be used under the
supervision of your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE FOSTIMON
You and your partner’s fertility will be evaluated
before your treatment is started.
DO NOT USE FOSTIMON if you have any of
the following:
-- Enlarged ovaries or cysts not caused by a
hormonal disorder (polycystic ovarian disease).
-- Bleeding of unknown cause.
-- Cancer of the ovaries, uterus or breast.
-- Abnormal swelling (tumour) of the pituitary
gland or hypothalamus (brain).
-- Hypersensitivity (allergy) to Urofollitropin or
any of the ingredients in Fostimon.
This medicine should not be used if you have an
early menopause, a malformation of the sexual
organs or certain tumours of the womb that
would make a normal pregnancy impossible.
TAKE SPECIAL CARE WITH FOSTIMON
Although no allergic reactions to Fostimon have
yet been reported, you should tell your doctor if
you have an allergic reaction to similar medicines.
This treatment increases your risk of developing
a condition known as ovarian hyperstimulation
syndrome (OHSS) (see Possible side effects).
If ovarian hyperstimulation occurs then your

treatment will be stopped and pregnancy will be
avoided. The first signs of ovarian hyperstimulation
are pain in the lower abdominal region as well as
nausea (feeling sick), vomiting and weight gain. If
these symptoms occur you should be examined
by your doctor as soon as possible. In serious, but
rare cases, the ovaries can become enlarged and
fluid can build up in the abdomen or chest.
The drug used to bring about the final release
of mature eggs (containing human chorionic
gonadotropin-hCG) can increase the likelihood of
OHSS. It is therefore not advisable to use hCG in
cases where OHSS is developing and you should
not have sexual intercourse even if using a barrier
methods of contraception for at least 4 days.
It should be noted that women with fertility
problems have a higher rate of miscarriages than
the normal population.
In patients having treatment to help ovulation,
the occurrence of multiple pregnancies and births
is increased compared to natural conception.
However, this risk can be minimised by using the
recommended dose.
There is a slightly increased risk of extra-uterine
pregnancy (an ectopic pregnancy) in women with
damaged fallopian tubes.
Multiple pregnancies and characteristics of the
parents undergoing fertility treatments (e.g.
maternal age, sperm characteristics) may be
associated with an increased risk of birth defects.
Treatment with Fostimon, just as pregnancy itself,
may increase the chance of having thrombosis.
Thrombosis is the formation of a blood clot in a
blood vessel, most often in the veins of the legs
or the lungs.
Please discuss this with your doctor, before
starting treatment, especially:
-- if you already know you have an increased
chance of having thrombosis
-- if you, or anyone in your immediate family, have
ever had a thrombosis
-- if you are severely overweight.
This medicine is prepared from human urine.
The risk of passing on an organism that could
cause an infection or disease cannot be definitely
excluded; however, this is limited by steps in
the manufacturing process to remove viruses,
especially HIV, Herpes virus and Papillomavirus.
No cases of viral contamination have been reported.
Other medicines and Fostimon
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines.
Pregnancy and breast-feeding
Fostimon should not be used if you are pregnant
or breast-feeding.
3. HOW TO USE FOSTIMON
Dosage and duration of the treatment:
Always take this medicine exactly as your doctor
has told you. Check with your doctor if you are
not sure.

Women who are not ovulating and are having
irregular periods or no periods at all:

for the first 7 days. The dose will then be adjusted
according to the ovarian response.

If you are having periods, the treatment should
start within 7 days of the start of your period (the
first 7 days of the menstrual cycle).
You will be given 1 injection per day under your
skin (subcutaneous).
The usual starting dose is 75 to 150 IU of FSH
(Fostimon) every day. This dose may be increased,
if necessary, by 37.5 to 75 IU at 7 or preferably 14day intervals, to get the right response.
The maximum daily dose of FSH is usually not
higher than 225 IU.
If your doctor cannot see a response after 4
weeks of treatment, that treatment cycle will be
stopped. For the following cycle, your doctor will
prescribe a higher starting dose.
When you get a good response (satisfying follicle
growth) you will be given a single injection of
another medicine (hCG), which is used to bring
about the final maturing of the follicle and release
of eggs. This will be given 24 to 48 hours after the
last Fostimon injection. You should have sexual
intercourse the day hCG is given and again on the
following day.

How Fostimon should be given:

If you have too great a response, treatment will be
stopped and hCG will not be given (see Possible
side effects). For the following cycle, your doctor
will prescribe a lower starting dose.
Women undergoing ovarian stimulation for
multiple follicular development prior to in vitro
fertilisation or other assisted reproductive
techniques:
Situation 1 - If you are having periods
The treatment should start 2 or 3 days after the
start of your periods (the first 2 or 3 days of the
menstrual cycle).
You will be given 1 injection per day by the
subcutaneous route.
The usual starting dose for superovulation is 150
to 225 IU of Fostimon every day. Treatment is
continued, with the dose adjusted according to
your response, until you are achieving adequate
follicular development. This is usually achieved on
average by the 10th day of treatment (range 5 to
20 days) and is measured by taking blood samples
and/or ultrasound examinations.
The maximum dosage is in general of 450 IU/day.
Once adequate follicular development is achieved
you will be given a single injection of a medicine
used to bring about final maturing of the follicle;
this medicine contains up to 10,000 IU human
chorionic gonadotropin (hCG). It will be given 24
to 48 hours after the last Fostimon injection.
Oocytes will be punctured about 35 hours later.
Situation 2 - When a gonadotropin-releasing
hormone (GnRH) agonist is used
Fostimon will be given approximately 2 weeks after
the start of this treatment. Both treatments are
continued until adequate follicular development
is achieved. Fostimon will be given as 1 injection
per day by the subcutaneous route. For example,
following two weeks of treatment with an agonist
of GnRH, 150 to 225 IU of Fostimon will be given

Fostimon is given by injection either under your
skin (by the subcutaneous route) or into a muscle
(by the intramuscular route).
Each vial should be used only once and the
injection should be used as soon as it is prepared.
After suitable advice and training your doctor
may ask you to inject Fostimon yourself.
For the first time, your doctor must:
-- let you practise giving yourself a subcutaneous
injection,
-- have shown you the possible places where you
can inject yourself,
-- have shown you how to prepare the solution
for injection,
-- have explained how to prepare the right dose
of injection.
Presentations other than ampoules should be
considered for self-administration by patients.
Before injecting Fostimon yourself, read the
following instructions carefully.
How to prepare and inject Fostimon, using 1
vial of powder:
The solution must be prepared just before
injection. One vial is for single use only.
The medicinal product must be reconstituted
under aseptic conditions.
Fostimon must only be reconstituted with the
solvent provided in the package.
Prepare a clean surface and wash your hands
before the solution is reconstituted. It is important
that your hands and the items you use are as clean
as possible.
Set out all the following items on the clean
surface:
-- two cotton wool alcohol swabs (not provided),
-- one vial containing Fostimon powder,
-- one solvent ampoule,
-- one syringe (not provided)
-- one needle for preparing the injection (not provided),
-- a fine bore needle for subcutaneous injection
(not provided).
Reconstitution of the solution for injection
using 1 vial of powder
Prepare the solution for injection:
1.
• The ampoule
neck is specifically
designed to break
more easily below
the coloured dot.
Gently flick the top
of the ampoule
to dislodge any liquid remaining in the tip.
Hold the ampoule with the coloured dot
facing away from you and snap off the top of
the ampoule as shown in the picture.

Using a cloth or ampoule-snapper to hold the
ampoule will help protect your fingers.
• Carefully place the syringe on the clean
surface and avoid touching the needle.
• Remove the protective cap
of the needle. Attach the
reconstitution needle (large
needle) to the syringe.
• With the syringe in one hand,
pick up the opened solvent
ampoule, insert the needle and draw up the all
the solvent into the syringe.
• Attach the protective cap of the needle.
Carefully set the syringe down on the surface.
2.
• Remove the coloured plastic
cap from the powder vial by
gently pushing it upwards.
• Disinfect the top of the rubber
stopper by wiping it with an
alcohol wipe and allow to dry.
3.
• Pick up the syringe, remove the
needle shield and slowly inject
the solvent into the powder
vial through the middle of the
top of the rubber stopper.
• Press the plunger down firmly to squirt all the
solution onto the powder.
DO NOT SHAKE, but gently roll the vial between
the hands until the powder is completely
dissolved, taking care to avoid creating foam.
4.
Once the powder is dissolved
(which, in general, occurs
immediately), slowly draw the
solution into the syringe:
• With the needle still inserted,
turn the vial upside down.
• Make sure the needle tip is underneath the
level of the liquid.
• Gently pull the plunger to draw all the solution
up into the syringe.
• Check that the reconstituted solution is clear
and colourless.
Preparation of higher doses, using more than 1
vial of powder
If your doctor has recommended higher doses for
you, this can be achieved by using more than one
vial powder with one ampoule of solvent.
When reconstituting more than 1 vial of Fostimon,
at the end of step 4 above, draw the reconstituted
contents of the first vial back into the syringe and
slowly inject into a second vial. Repeat steps 2
to 4 for the second and subsequent vials, and
until the contents of the required number of vials
equivalent to the prescribed dosage are dissolved
(within the limit of the maximum total dosage of

450 IU, corresponding to a maximum of 6 vials of
Fostimon 75 IU or3 vials of Fostimon 150 IU).
Your doctor may increase your dose by 37.5 IU
which represents half a vial of FOSTIMON 75 IU.
For this you should reconstitute the contents of
the 75 IU vial according to steps 2 to 3 described
above and draw half of this reconstituted solution
(0.5 ml) back into the syringe according to step 4.
In that situation you will have two preparations to
be injected: the first preparation reconstituted in
1 ml and the second containing 37.5 IU in 0.5 ml.
Both preparations will be injected with their own
syringe according to the following steps.
The solution must be clear and colourless.
Injecting your medicine subcutaneously:
• When the syringe contains
the described dose, attach
the protective cap of the
needle. Remove the needle
from the syringe and replace
it with the fine bore needle
for subcutaneous injection
including its protective cap.
• Push the fine bore needle
firmly onto the syringe barrel,
then twist it slightly to ensure
it is fully screwed on and to
create a firm seal.
• Remove the protective cap of
the needle. Hold the syringe
with the needle pointing upwards and gently
tap the side of the syringe to force any air
bubbles up to the top;
• Push the plunger until a bead of liquid appears
at the tip of the needle.
• Do not use if it contains any particles or is
cloudy.
The injection site:
• Your doctor or nurse will have already advised
you where on your body to inject your
medicine. The usual places are the thigh or the
lower abdominal wall below the navel.
• Wipe the injection site with an alcohol swab.
Inserting the needle:
• Firmly pinch the skin together.
With the other hand, insert the
needle with a dart-like motion
at an angle of 45° or 90°.
Injecting the solution:
• Inject under the skin as you were shown. Do
not inject directly into a vein. Push the plunger
slowly and steadily, so the solution is correctly
injected and the skin tissues are not damaged.
Take as much time as you need to inject the
volume of solution prescribed. As described for
the preparation of the solution, depending on the
dosage prescribed by your doctor, you may not
use the entire volume of the solution.

Removing the needle:
• Pull the syringe out quickly and apply pressure
to the injection site with a swab containing
disinfectant. A gentle massage of the site
– while still maintaining pressure – helps
disperse the Fostimon solution and relieve any
discomfort.
Dispose of all used items:
Any unused product or waste material should be
disposed of in accordance with local requirements
(once the injection is ended, all the needles and
empty syringes should be disposed of in an
appropriate container).
If you use more Fostimon than you should:
The effects of an overdose of Fostimon are
unknown, nevertheless, one could expect ovarian
hyperstimulation syndrome to occur (see Possible
side effects). If you use more Fostimon than you
should, speak to your doctor or pharmacist.
If you forget to use Fostimon:
Take it at the next normal time for an injection. Do
not take a double dose to make up for a forgotten
dose.
If you stop using Fostimon:
Do not stop on your own initiative: Always
consult your doctor if you are considering
stopping this medicine. If you have any further
questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fostimon can cause side effects, although not everybody gets them.
The following side effect is important and will
require immediate action if you experience it.
You should stop taking Fostimon and see your
doctor immediately if the following occurs:
Common, affects 1 to 10 users in 100:
• Ovarian Hyperstimulation Syndrome
(see Section 2 for additional information)
The following side-effects have also been
reported:
Common, affects 1 to 10 users in 100:
• Headache
• bloated abdomen
• constipation
• pain at the injection site.
Uncommon, affects 1 to 10 users in 1,000:
• Overactive thyroid gland
• Mood swings
• Tiredness
• Dizziness
• Breathlessness
• Nose bleeds
• Nausea, indigestion, abdominal pain
• Skin rash, itch,
• Hot flush
• Cystitis
• Breast enlargement, breast pain
• Difficulty stopping bleeding
Redness, pain and bruising at the injection site
may occur (frequency not stated).
See section 2 for additional information on risk of
blood clots, ectopic pregnancy, multiple

pregnancy and miscarriage.
If any of the side effects gets serious, or if you
notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.
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 direct (see details below).
IRELAND: HPRA Pharmacovigiliance
Earlsfort Terrace, IRL – Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517;
Website: www.hpra.ie
Email: [email protected]
UNITED KINGDOM: Yellow Card Scheme.
Website: 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 FOSTIMON
Keep this medicine out of the sight and reach of
children.
Do not store above 25° C. Keep the vial and the
ampoule of solvent in the outer carton in order to
protect from light.
Do not use this medicine after the expiry date
which is stated on the outer carton, the vial, and
the ampoule of solvent. The expiry date refers to
the last day of the month.
Use immediately after reconstitution.
Do not use Fostimon if you notice the solution
does not look clear. After reconstitution the
solution must be clear and colourless.
Do not throw away any medicines via
wastewater. Ask your pharmacist how to safely
dispose of medicines you no longer use. These
measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Fostimon contains
The active substance is
Urofollitropin
One vial contains 75 IU of urofollitropin
(follicle-stimulating hormone FSH): 1 ml of
reconstituted solution contains either 75 IU, 150
IU, 225 IU, 300 IU, 375 IU or 450 IU of urofollitropin when respectively 1, 2, 3, 4, 5 or 6 vials are
reconstituted in 1 ml of solvent.
One vial contains 150 IU of urofollitropin
(follicle-stimulating hormone FSH): 1 ml of
reconstituted solution contains either 150 IU, 300
IU or 450 IU of urofollitropin when respectively 1,
2, or 3 vials are reconstituted in 1 ml of solvent.
The specific in vivo activity is equal or superior to
5000 IU of FSH per mg of protein.
The other excipients are
For the powder: lactose monohydrate.
For the solvent: sodium chloride and water for injections

What Fostimon looks like and contents of the pack
Fostimon is presented as a powder and solvent
for solution for injection. 1 set contains powder
in vial (75 IU or 150 IU) and solvent in an
ampoule (1ml) - Pack size of 1, 5 or 10 sets.
The powder is a white to off-white caked mass
and the solvent is clear and colourless.
Marketing Autorisation Holder:
IBSA Farmaceutici Italia S.r.l
Via Martiri di Cefalonia, 2
26900 Lodi
ITALY
Manufacturer
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia, 2
26900 LODI - ITALY
Batch Release (UK and Ireland):
PHARMASURE LIMITED
4-6 Colonial Business Park
Colonial Way
Watford WD24 4PR
UNITED KINGDOM
This medicinal product is authorized in the
Member States of the EEA under the following
names: (The strength and pharmaceutical form
are identical in all countries, only the trade name
changes)
Austria: Fostimon
Belgium: Fostimon
Cyprus: Fostimon
Denmark: Fostimon
Finland: Fostimon
France: Fostimon
Luxembourg: Fostimon
Ireland: Fostimon
The Netherlands: Fostimon
Norway: Fostimon
Spain: Fostipur
Sweden: Fostimon
United Kingdom: Fostimon
This leaflet was last approved in April 2016