GONAL-f contains a medicine called “follitropin alfa”. Follitropin alfa is a type of “Follicle
Stimulating Hormone” (FSH) which belongs to the family of hormones called “gonadotropins”.
Gonadotropins are involved in reproduction and fertility.

What GONAL-f is used for
In adult women, GONAL-f is used:
 to help release an egg from the ovary (ovulation) in women that cannot ovulate and that did not
respond to treatment with a medicine called “clomiphene citrate”.
 together with another medicine called “lutropin alfa” (“Luteinising Hormone” or LH) to help
release egg from the ovary (ovulation) in women that are not ovulating because their body is
producing very little gonadotropins (FSH and LH).
 to help develop several follicles (each containing an egg) in women undergoing assisted
reproductive technology procedures (procedures that may help you to become pregnant) such as
“in vitro fertilisation”, “gamete intra-fallopian transfer” or “zygote intra-fallopian transfer”.
In adult men, GONAL-f is used:
 together with another medicine called “human Chorionic Gonadotropin” (hCG) to help produce
sperm in men that are infertile due to a low level of certain hormones.

You and your partner’s fertility should be evaluated before the treatment is started by a doctor
experienced in treating fertility disorders.

Do not use GONAL-f
 if you are allergic to Follicle Stimulating Hormone or any of the other ingredients of this
medicine (listed in section 6).
 if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain).
 If you are a woman:
- with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
- with unexplained vaginal bleeding.
- with cancer in your ovaries, womb or breasts.
- with a condition that usually makes normal pregnancy impossible, such as ovarian failure
(early menopause), or malformed reproductive organs.
 If you are a man:
- with damaged testicles that cannot be healed.
Do not use GONAL-f if any of the above applies to you. If you are not sure, talk to your doctor before
using this medicine.
Warnings and precautions
Porphyria
Tell your doctor before you start treatment, if you or any member of your family have porphyria (an
inability to break down porphyrins that may be passed on from parents to children).
Tell your doctor straight away if:
 your skin becomes fragile and easily blistered, especially skin that has been frequently in the
sun, and/or
 you have stomach, arm or leg pain.
In case of the above events your doctor may recommend that you stop treatment.
Ovarian Hyper-Stimulation Syndrome (OHSS)
If you are a woman, this medicine increases your risk of developing OHSS. This is when your
follicles develop too much and become large cysts. If you get lower abdominal pain, gain any weight
rapidly, feel sick or are vomiting or if you have difficulty in breathing, talk to your doctor straight
away who might ask you to stop using this medicine (see section 4).
In case you are not ovulating, and if the recommended dose and schedule of administration are
adhered to, the occurrence of OHSS is less likely. GONAL-f treatment seldom causes severe OHSS
unless the medicine that is used for final follicular maturation (containing human Chorionic
Gonadotropin, hCG) is administered. If you are developing OHSS your doctor may not give you any
hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive
method for at least four days.
Multiple pregnancy
When using GONAL-f, you have a higher risk of being pregnant with more than one child at the same
time (“multiple pregnancy”, mostly twins), than if you conceived naturally. Multiple pregnancy may
lead to medical complications for you and your babies. You can reduce the risk of multiple pregnancy
by using the right dose of GONAL-f at the right times. When undergoing assisted reproductive
technology the risk of having a multiple pregnancy is related to your age, the quality and the number
of fertilised eggs or embryos placed inside you.

Miscarriage
When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs,
you are more likely to have a miscarriage than the average woman.
Blood clotting problems (thromboembolic events)
If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if
those happened in your family, then you might have a higher risk that these problems occur or become
worse with GONAL-f treatment.
Men with too much FSH in their blood
If you are a man, having too much FSH in your blood can be a sign of damaged testicles. GONAL-f
usually does not work if you have this problem.
If your doctor decides to try GONAL-f treatment, to monitor the treatment, they may ask you to
provide semen for analysis 4 to 6 months after starting treatment.
Children
GONAL-f is not indicated for use in children.
Other medicines and GONAL-f
Tell your doctor if you are taking, have recently taken or might take any other medicines.
 If you use GONAL-f with other medicines which help ovulation (such as hCG or clomiphene
citrate), this may increase the response of your follicles.
 If you use GONAL-f at the same time as a “gonadotropin-releasing hormone” (GnRH) agonist
or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you
may need a higher dose of GONAL-f to produce follicles.
Pregnancy and breast-feeding
Do not use GONAL-f if you are pregnant or breast-feeding.
Driving and using machines

It is not expected that this medicine will affect your ability to drive and use machines.
Important information about some of the ingredients of GONAL-f
This medicine contains less than 1 mmol sodium (23 mg) per dose, therefore it is considered
essentially “sodium-free”.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.

Using this medicine
GONAL-f is intended to be given by injection just under the skin (subcutaneously).
 The first injection of GONAL-f should be given under supervision of your doctor.
 Your doctor or nurse will show you how to inject GONAL-f before you can inject yourself.
 If you administer GONAL-f to yourself, please carefully read and follow the instructions at the
end of this leaflet called “How to prepare and use the GONAL-f powder and solution”.
How much to use
Your doctor will decide how much medicine you will take and how often. The doses described below
are stated in International Units (IU) and millilitres (mL).
Women
If you are not ovulating and have irregular or no periods.
 GONAL-f is usually given every day.
 If you have irregular periods, start using GONAL-f within the first 7 days of your menstrual
cycle. If you do not have periods you can start using the medicine on any convenient day.
 The usual starting dose of GONAL-f is 75 to 150 IU (0.12 to 0.24 mL) each day.
 Your dose of GONAL-f may be increased every 7 or every 14 days by 37.5 to 75 IU, until you
get the desired response.
 The maximum daily dose of GONAL-f is usually not higher than 225 IU (0.36 mL).
 When you get the desired response, you will be given a single injection of 250 micrograms of
“recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or
5,000 to 10,000 IU of hCG, 24 to 48 hours after your last GONAL-f injection. The best time to
have sex is on the day of the hCG injection and the day after.
If your doctor cannot see a desired response after 4 weeks, that treatment cycle with GONAL-f should
be stopped. For the following treatment cycle, your doctor will give you a higher starting dose of
GONAL-f than before.
If your body responds too strongly, your treatment will be stopped and you will not be given any hCG
(see section 2, OHSS). For the following cycle, your doctor will give you a lower dose of GONAL-f
than before.
If you are not ovulating, having no periods and have been diagnosed with very low levels of FSH
and LH hormones
 The usual starting dose of GONAL-f is 75 to 150 IU (0.12 to 0.24 mL) together with 75 IU
(0.12 mL) of lutropin alfa.
 You will use these two medicines each day for up to five weeks.
 Your dose of GONAL-f may be increased every 7 or every 14 days by 37.5 to 75 IU, until you
get the desired response.
 When you get the desired response, you will be given a single injection of 250 micrograms of
“recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or
5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of GONAL-f and lutropin
alfa. The best time to have sex is on the day of the hCG injection and the day after.
Alternatively, intrauterine insemination may be performed by placing the sperm into the womb
cavity.
If your doctor cannot see a response after 5 weeks, that treatment cycle with GONAL-f should be
stopped. For the following cycle, your doctor will give you a higher starting dose of GONAL-f than
before.

given any hCG (see section 2, OHSS). For the following cycle, your doctor will give you a lower dose
of GONAL-f than before.
If you need to develop several eggs for collection prior to any assisted reproductive technology
 The usual starting dose of GONAL-f is 150 to 225 IU (0.24 to 0.36 mL) each day, from day 2
or 3 of your treatment cycle.
 GONAL-f dose may be increased, depending on your response. The maximum daily dose is
450 IU (0.72 mL).
 Treatment is continued until your eggs have developed to a desired point. This usually takes
about 10 days but can take any time between 5 and 20 days. Your doctor will use blood tests
and/or an ultrasound machine to check when this is.
 When your eggs are ready, you will be given a single injection of 250 micrograms
“recombinant hCG” (r-hCG, an hCG made in a laboratory by a special recombinant DNA
technique), or 5,000 IU to 10,000 IU of hCG, 24 to 48 hours after the last GONAL-f injection.
This gets your eggs ready for collection.
In other cases, your doctor may first stop you from ovulating by using a gonadotropin-releasing
hormone (GnRH) agonist or antagonist. Then GONAL-f is started approximately two weeks after start
of agonist treatment. The GONAL-f and GnRH agonist are then both given until your follicles
develop as desired. For example, after two weeks of GnRH agonist treatment, 150 to 225 IU GONALf
is administered for 7 days. The dose is then adjusted according to your ovarian response.
Men
 The usual dose of GONAL-f is 150 IU (0.24 mL) together with hCG.
 You will use these two medicines three times a week for at least 4 months.
 If you have not responded to treatment after 4 months, your doctor may suggest that you
continue using these two medicines for at least 18 months.
If you use more GONAL-f than you should
The effects of taking too much GONAL-f are unknown, Nevertheless one could expect Ovarian
Hyper-Stimulation Syndrome (OHSS) to occur, which is described in section 4. However the OHSS
will only occur if hCG is also administered (see section 2, OHSS).
If you forget to use GONAL-f
If you forget to use GONAL-f, do not take a double dose to make up for a forgotten dose. Please talk
to your doctor as soon as you notice that you forgot a dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects in women
 Lower abdominal pain together with nausea or vomiting may be the symptoms of Ovarian
Hyper-Stimulation Syndrome (OHSS). This may indicate that the ovaries over-reacted to the
treatment and that large ovarian cysts developed (see also in section 2. under “Ovarian Hyper-
Stimulation Syndrome”). This side effect is common (may affect up to 1 in 10 people).

The OHSS may become severe with clearly enlarged ovaries, decreased urine production,
weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
This side effect is uncommon (may affect up to 1 in 100 people).
 Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may
affect up to 1 in 1,000 people).
 Serious blood clotting complications (thromboembolic events) independent of OHSS may be
found very rarely (may affect up to 1 in 10,000 people). This could cause chest pain,
breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Serious side effects in men and women
 Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing
can sometimes be serious. This side effect is very rare (may affect up to 1 in 10,000 people).
If you notice any of the above-listed side effects you should immediately contact your doctor
who might ask you to stop using GONAL-f.
Other side effects in women
Very common (may affect more than 1 in 10 people):
 Sacs of fluid within the ovaries (ovarian cysts)
 Headache
 Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Common (may affect up to 1 in 10 people):
 Abdominal pain
 Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
Very rare (may affect up to 1 in 10,000 people):
 Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing
may occur. These reactions can sometimes be serious.
 Your asthma may get worse
Other side effects in men
Very common (may affect more than 1 in 10 people):
 Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Common (may affect up to 1 in 10 people):
 Swelling of the veins above and behind the testicles (varicocele).
 Breast development, acne or weight gain.
Very rare (may affect up to 1 in 10,000 people):
 Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty in
breathing may occur. These reactions can sometimes be serious.
 Your asthma may get worse.

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 vial after EXP. The expiry date
refers to the last day of that month.
.Do not store above 30°C
Store in the original package, in order to protect from light.
Do not use GONAL-f if you notice any visible signs of deterioration, if the liquid contains particles or
is not clear.
The medicine must be administered immediately after preparation.
Do not throw away any medicines via wastewater . Ask your pharmacist how to throw away
medicines you no longer use.These measures will help to protect the environment.
GONAL-f should not be administered as a mixture with other medicines in the same injection, except
for lutropin alfa. Studies have shown that these two medicines can be mixed and injected together,
without either product being adversely affected.