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MENOPUR 75IU

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(leaflet continued)
You have blocked fallopian tubes, unless
you are having IVF or ICSI
(intracytoplasmic sperm injection).
You are having an early (premature)
menopause.
You have certain physical problems in your
reproductive organs (womb, fallopian tubes,
ovaries or cervix).
Your womb has been removed
(hysterectomy).
You have fibroid tumours (tumours in your
womb that are not cancer).
You are pregnant or breast-feeding
Also, if you are a man do not use Menopur
if:
You have cancer of your testicles.
You have prostate cancer.
Do not use Menopur if any of the above
applies to you. If you are not sure, talk to your
doctor, nurse or pharmacist before you start
using Menopur.
Take special care
Check with your doctor or nurse before using
this medicine if:
You have had infertility treatment in the
past.
You or someone in your family has had
blood clots. This is because treatment with
Menopur may increase the risk of having a
clot. Pregnancy also increases the risk of
having clots.
If any of the above applies to you (or if you are
not sure), talk to your doctor, nurse or
pharmacist before using Menopur.
Pregnancy and breast-feeding
If you are already pregnant or breast-feeding,
you must not use Menopur.
Tests before you start treatment
Before you start treatment with Menopur, your
doctor will normally do tests to check the
following:
Men and women:
Your thyroid and adrenal glands are
working properly.
You do not have tumours of the pituitary
gland or hypothalamus.
Women only:
Your ovaries are working properly.
You do not have higher than normal blood
levels of a hormone called prolactin.

Important information about some of the
ingredients of Menopur
Menopur contains lactose (which is a type of
sugar). If you have been told by your doctor
that you cannot tolerate or digest some sugars
(have an intolerance to some sugars), talk to
your doctor before using this medicine.
3. How to use Menopur
Always use Menopur exactly as your doctor or
nurse has told you. You should check with your
doctor, nurse or pharmacist if you are not sure.
Menopur is not recommended for children or
elderly people.
Using Menopur
You will have Menopur as an injection into
a muscle or under the skin.
You will either be given Menopur by a
doctor or nurse or you will be taught how to
give it to yourself.
Menopur comes as a dry powder in small
bottles (vials).
Once the dry powder has been mixed with
the salt solution (solvent) it should be used
straight away.
The dose and length of your treatment
The dose, and how long your treatment
lasts, depends on why you are using
Menopur and how well it works.
Your doctor or nurse will monitor how you
respond to your treatment.
This will help them to work out what dose
you need and how long you need to use
Menopur for.
In women:
Infertility (to help follicles to mature):
If you are having periods, your treatment
will start within the first 7 days of your
menstrual cycle.
You may use Menopur daily for up to 3
weeks.
Or, you may use Menopur every other day
for 6 days (three doses in total). ‘Assisted
conception’ such as IVF:
The usual dose is 75 to 300 IU each day.
Your doctor will decide how long you need
to use Menopur for.
In men:
For low sperm count:
The usual dose is 75 or 150 IU two or three
times a week.

Treatment is normally continued for at least
3 or 4 months.
If you use more Menopur than you should
If you think you have used too much Menopur,
tell your doctor, nurse or pharmacist.
4. Possible side effects
If you forget to use Menopur
If you think you have missed a dose, tell your
doctor, nurse or pharmacist Like all medicines,
Menopur can cause side effects, although not
everybody gets them.
Side effects that can happen in women: If
you notice any of the following signs, tell
your doctor immediately. It may mean that
your ovaries have been stimulated too much
and you may need urgent medical treatment.
This side effect is common (affects less than 1
in 10 people).
Feeling sick.
Pain or swelling of the tummy.
Being sick.
Weight gain.
Diarrhoea.
Difficulty breathing.
Feeling more thirsty than usual.
Producing less urine when you go to the
toilet or going to the toilet less often.
If you notice any of the above signs, tell your
doctor immediately.
Side effects that can happen in both women
and men: STOP USING Menopur if you
experience allergic reactions including;
itching, skin rashes, swelling of the face,
lips or throat, difficulty in breathing,
wheeziness, chest tightness or coughing. If
you experience any of these rare side
effects, you should contact your doctor or
go to the nearest hospital immediately.
Common (affects less than 1 in 10 people):
Headache.
Pain or inflammation where the injection
was given.
Uncommon (affects less than 1 in 100
people):
Blood clots in the veins, usually of the leg
(deep vein thrombosis).

Very rare (affects less than 1 in 10,000
people):
If Menopur is used for a long time, your
body may make antibodies which can stop
the treatment from working.
If treatment with Menopur results in
pregnancy
The following are more likely to happen in
women who have had fertility treatment than in
women who have got pregnant (conceived)
naturally:
Being pregnant with more than one baby.
This carries an increased risk of problems
for the mother during the pregnancy and at
or around the time of birth.
The fertilised egg implanting outside the
womb (ectopic pregnancy). This is more
likely if you have had tubal disease in the
past (a condition where the fallopian tubes
are blocked or damaged).
Miscarriage or abortion.
A slightly higher risk of your baby being
born with physical defects.
Your doctor will be able to discuss this with you
before you start treatment. If any of the side
effects become serious, or if you notice any
side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.
5. How to store Menopur
Keep out of the sight and reach of children.
Do not use Menopur after the expiry date
which is stated on the packaging.
Do not store above 25°C.
Store in the original container in order to
protect from light.
If the powder or solvent shows any signs of
discolouration or deterioration consult your
pharmacist for advice.
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. Further information
What Menopur contains
Menopur is a sterile freeze dried white powder
for injection in a 2ml glass vial. Each vial with
powder for injection contains: (Menotrophin
(human menopausal gonadotrophin, HMG)
equivalent to 75 IU FSH (Follicle stimulating
hormone) and 75 IU LH (Luteinising hormone).
leaflet continued overleaf)

PP1/1239/V3
(leaflet continued overleaf)
1. What Menopur is and what it is used for
What Menopur is
Menopur contains a medicine called
menotrophin. This is a mixture of hormones
obtained from the urine of women who have
passed the menopause.
The dose of these hormones is given in
International Units (IU).
Each bottle (vial) contains the equivalent of
75 IU of FSH (follicle stimulating hormone)
and 75 IU of LH (luteinising hormone).
Menopur helps reproductive organs to work
normally in both women and men. A fertility
specialist should supervise your treatment.
In this leaflet:
1. What Menopur is and what it is used for
2. Before you use Menopur
3. How to use Menopur
4. Possible side effects
5. How to store Menopur
6. Further information

Menopur is a registered trademark of Ferring
B.V.
Date of preparation 28 August 2012
th

PL 20774/1239

Menopur 75IU

Read all of this leaflet carefully before you
start using this medicine.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor, nurse or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
If any of the side effects become serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor, nurse or
pharmacist.
The name of your medicine is Menopur 75IU
but will be referred to as Menopur throughout
the leaflet. Your medicine is also available in
the following strengths Menopur 600IU and
Menopur 1200IU.

POM

Manufactured by Ferring GmbH, Kiel,
Germany. Procured from within the EU.
Product Licence Holder: Quadrant
Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd, Bolton,
BL6 4SA.
Menopur is supplied in boxes of 10 vials of
Menopur powder for injection and 10 ampoules
of Solvent 1 ml (Sodium Chloride Solution for
injections 0.9%w/v).
The solvent is used to dissolve the powder
before it is injected.
Also contains lactose monohydrate,
polysorbate 20, sodium hydroxide and
hydrochloric acid.
One glass ampoule contains 1ml of solvent
(Sodium Chloride Solution for injections 0.9%
w/v) contains water for injection, sodium
chloride and hydrochloric acid.

Also, if you are a woman do not use
Menopur if:
You have tumours of your womb (uterus),
ovaries or breasts.
You have cysts on your ovaries or enlarged
ovaries that are not due to polycystic ovary
syndrome (a condition that prevents eggs
from being released from the ovaries).
You have bleeding from your vagina for an
unknown reason.
You have primary ovarian failure (a
condition in which the ovaries do not
function properly).
2. Before you use Menopur
Do not use Menopur if:
You are allergic (hypersensitive) to
menotrophin or any of the other ingredients
of Menopur (listed in Section 6).
You have a tumour in your pituitary gland (a
gland located on the base of the brain
which produces certain hormones,
including growth hormones).
You have a tumour in a part of your brain
called the hypothalamus (part of the brain
which controls the conditions within your
body including body temperature and blood
pressure).
You have high levels of a hormone called
prolactin (hyperprolactinaemia
What Menopur is used for
In women, Menopur is used for:
Infertility caused by eggs not being
produced properly in the ovaries
(anovulatory infertility). It works by helping
follicles (which contain eggs) to mature in
the ovaries.
IVF (in vitro fertilisation) and other types of
‘assisted conception’. It works by helping
multiple follicles and eggs to develop. The
eggs are then harvested and fertilised
outside the body.
In men, Menopur is used for:
Low sperm count (oligospermia).

(Highly Purified Menotrophin)
Powder for Injection

Menopur® 75IU
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP1/1239/V3

(leaflet continued)

(leaflet continued)
You have blocked fallopian tubes, unless
you are having IVF or ICSI
(intracytoplasmic sperm injection).
You are having an early (premature)
menopause.
You have certain physical problems in your
reproductive organs (womb, fallopian tubes,
ovaries or cervix).
Your womb has been removed
(hysterectomy).
You have fibroid tumours (tumours in your
womb that are not cancer).
You are pregnant or breast-feeding
Also, if you are a man do not use Menopur
if:
You have cancer of your testicles.
You have prostate cancer.
Do not use Menopur if any of the above
applies to you. If you are not sure, talk to your
doctor, nurse or pharmacist before you start
using Menopur.
Take special care
Check with your doctor or nurse before using
this medicine if:
You have had infertility treatment in the
past.
You or someone in your family has had
blood clots. This is because treatment with
Menopur may increase the risk of having a
clot. Pregnancy also increases the risk of
having clots.
If any of the above applies to you (or if you are
not sure), talk to your doctor, nurse or
pharmacist before using Menopur.
Pregnancy and breast-feeding
If you are already pregnant or breast-feeding,
you must not use Menopur.
Tests before you start treatment
Before you start treatment with Menopur, your
doctor will normally do tests to check the
following:
Men and women:
Your thyroid and adrenal glands are
working properly.
You do not have tumours of the pituitary
gland or hypothalamus.
Women only:
Your ovaries are working properly.
You do not have higher than normal blood
levels of a hormone called prolactin.

Important information about some of the
ingredients of Menopur
Menopur contains lactose (which is a type of
sugar). If you have been told by your doctor
that you cannot tolerate or digest some sugars
(have an intolerance to some sugars), talk to
your doctor before using this medicine.
3. How to use Menopur
Always use Menopur exactly as your doctor or
nurse has told you. You should check with your
doctor, nurse or pharmacist if you are not sure.
Menopur is not recommended for children or
elderly people.
Using Menopur
You will have Menopur as an injection into
a muscle or under the skin.
You will either be given Menopur by a
doctor or nurse or you will be taught how to
give it to yourself.
Menopur comes as a dry powder in small
bottles (vials).
Once the dry powder has been mixed with
the salt solution (solvent) it should be used
straight away.
The dose and length of your treatment
The dose, and how long your treatment
lasts, depends on why you are using
Menopur and how well it works.
Your doctor or nurse will monitor how you
respond to your treatment.
This will help them to work out what dose
you need and how long you need to use
Menopur for.
In women:
Infertility (to help follicles to mature):
If you are having periods, your treatment
will start within the first 7 days of your
menstrual cycle.
You may use Menopur daily for up to 3
weeks.
Or, you may use Menopur every other day
for 6 days (three doses in total). ‘Assisted
conception’ such as IVF:
The usual dose is 75 to 300 IU each day.
Your doctor will decide how long you need
to use Menopur for.
In men:
For low sperm count:
The usual dose is 75 or 150 IU two or three
times a week.

Treatment is normally continued for at least
3 or 4 months.
If you use more Menopur than you should
If you think you have used too much Menopur,
tell your doctor, nurse or pharmacist.
4. Possible side effects
If you forget to use Menopur
If you think you have missed a dose, tell your
doctor, nurse or pharmacist Like all medicines,
Menopur can cause side effects, although not
everybody gets them.
Side effects that can happen in women: If
you notice any of the following signs, tell
your doctor immediately. It may mean that
your ovaries have been stimulated too much
and you may need urgent medical treatment.
This side effect is common (affects less than 1
in 10 people).
Feeling sick.
Pain or swelling of the tummy.
Being sick.
Weight gain.
Diarrhoea.
Difficulty breathing.
Feeling more thirsty than usual.
Producing less urine when you go to the
toilet or going to the toilet less often.
If you notice any of the above signs, tell your
doctor immediately.
Side effects that can happen in both women
and men: STOP USING Menopur if you
experience allergic reactions including;
itching, skin rashes, swelling of the face,
lips or throat, difficulty in breathing,
wheeziness, chest tightness or coughing. If
you experience any of these rare side
effects, you should contact your doctor or
go to the nearest hospital immediately.
Common (affects less than 1 in 10 people):
Headache.
Pain or inflammation where the injection
was given.
Uncommon (affects less than 1 in 100
people):
Blood clots in the veins, usually of the leg
(deep vein thrombosis).

Very rare (affects less than 1 in 10,000
people):
If Menopur is used for a long time, your
body may make antibodies which can stop
the treatment from working.
If treatment with Menopur results in
pregnancy
The following are more likely to happen in
women who have had fertility treatment than in
women who have got pregnant (conceived)
naturally:
Being pregnant with more than one baby.
This carries an increased risk of problems
for the mother during the pregnancy and at
or around the time of birth.
The fertilised egg implanting outside the
womb (ectopic pregnancy). This is more
likely if you have had tubal disease in the
past (a condition where the fallopian tubes
are blocked or damaged).
Miscarriage or abortion.
A slightly higher risk of your baby being
born with physical defects.
Your doctor will be able to discuss this with you
before you start treatment. If any of the side
effects become serious, or if you notice any
side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.
5. How to store Menopur
Keep out of the sight and reach of children.
Do not use Menopur after the expiry date
which is stated on the packaging.
Do not store above 25°C.
Store in the original container in order to
protect from light.
If the powder or solvent shows any signs of
discolouration or deterioration consult your
pharmacist for advice.
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. Further information
What Menopur contains
Menopur is a sterile freeze dried white powder
for injection in a 2ml glass vial. Each vial with
powder for injection contains: (Menotrophin
(human menopausal gonadotrophin, HMG)
equivalent to 75 IU FSH (Follicle stimulating
hormone) and 75 IU LH (Luteinising hormone).
leaflet continued overleaf)

PP1/1239/V3
(leaflet continued overleaf)
1. What Menopur is and what it is used for
What Menopur is
Menopur contains a medicine called
menotrophin. This is a mixture of hormones
obtained from the urine of women who have
passed the menopause.
The dose of these hormones is given in
International Units (IU).
Each bottle (vial) contains the equivalent of
75 IU of FSH (follicle stimulating hormone)
and 75 IU of LH (luteinising hormone).
Menopur helps reproductive organs to work
normally in both women and men. A fertility
specialist should supervise your treatment.
Menopur is a registered trademark of Ferring
B.V.
Date of preparation 28th August 2012
PL 20774/1239

Menopur 75IU

POM

Manufactured by Ferring GmbH, Kiel,
Germany. Procured from within the EU.
Product Licence Holder: Quadrant
Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd, Bolton,
BL6 4SA.
Menopur is supplied in boxes of 10 vials of
Menopur powder for injection and 10 ampoules
of Solvent 1 ml (Sodium Chloride Solution for
injections 0.9%w/v).
The solvent is used to dissolve the powder
before it is injected.
Also contains lactose monohydrate,
polysorbate 20, sodium hydroxide and
hydrochloric acid.
One glass ampoule contains 1ml of solvent
(Sodium Chloride Solution for injections 0.9%
w/v) contains water for injection, sodium
chloride and hydrochloric acid.

In this leaflet:
1. What Menopur is and what it is used for
2. Before you use Menopur
3. How to use Menopur
4. Possible side effects
5. How to store Menopur
6. Further information
Read all of this leaflet carefully before you
start using this medicine.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor, nurse or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
If any of the side effects become serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor, nurse or
pharmacist.
The name of your medicine is Menopur 75IU
but will be referred to as Menopur throughout
the leaflet. Your medicine is also available in
the following strengths Menopur 600IU and
Menopur 1200IU.

Also, if you are a woman do not use
Menopur if:
You have tumours of your womb (uterus),
ovaries or breasts.
You have cysts on your ovaries or enlarged
ovaries that are not due to polycystic ovary
syndrome (a condition that prevents eggs
from being released from the ovaries).
You have bleeding from your vagina for an
unknown reason.
You have primary ovarian failure (a
condition in which the ovaries do not
function properly).
2. Before you use Menopur
Do not use Menopur if:
You are allergic (hypersensitive) to
menotrophin or any of the other ingredients
of Menopur (listed in Section 6).
You have a tumour in your pituitary gland (a
gland located on the base of the brain
which produces certain hormones,
including growth hormones).
You have a tumour in a part of your brain
called the hypothalamus (part of the brain
which controls the conditions within your
body including body temperature and blood
pressure).
You have high levels of a hormone called
prolactin (hyperprolactinaemia
What Menopur is used for
In women, Menopur is used for:
Infertility caused by eggs not being
produced properly in the ovaries
(anovulatory infertility). It works by helping
follicles (which contain eggs) to mature in
the ovaries.
IVF (in vitro fertilisation) and other types of
‘assisted conception’. It works by helping
multiple follicles and eggs to develop. The
eggs are then harvested and fertilised
outside the body.
In men, Menopur is used for:
Low sperm count (oligospermia).

(Highly Purified Menotrophin)
Powder for Injection

Menopur® 75IU
PACKAGE LEAFLET: INFORMATION FOR THE USER

(leaflet continued)

PP1/1239/V3

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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