MENOPUR POWDER FOR INJECTION

Active substance: HUMAN LUTEINISING HORMONE

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MENOPUR

®

HIGHLY PURIFIED MENOTROPHIN

Powder for Injection

• 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).

Also, if you are a woman do not use Menopur if:
• You have tumours of your womb (uterus), ovaries or
Patient Information
breasts.
• You have cysts on your ovaries or enlarged ovaries that
Read all of this leaflet carefully before you start
are not due to polycystic ovary syndrome (a condition
using this medicine.
that prevents eggs from being released from the ovaries).
• Keep this leaflet. You may need to read it again.
• You have bleeding from your vagina for an unknown
• If you have any further questions, ask your doctor, nurse or
reason.
pharmacist.
• You have primary ovarian failure (a condition in which
• This medicine has been prescribed for you. Do not pass it
the ovaries do not function properly).
on to others. It may harm them, even if their symptoms are
• You have blocked fallopian tubes, unless you are having
the same as yours.
IVF or ICSI (intracytoplasmic sperm injection).
• If any of the side effects become serious, or if you notice
• You are having an early (premature) menopause.
any side effects not listed in this leaflet, please tell your
• You have certain physical problems in your reproductive
doctor, nurse or pharmacist.
organs (womb, fallopian tubes, ovaries or cervix).
• Your womb has been removed (hysterectomy).
• You have fibroid tumours (tumours in your womb that are
In this leaflet:
not cancer).
1. What Menopur is and what it is used for
• You are pregnant or breast-feeding.
2. Before you use Menopur
3. How to use Menopur
Also, if you are a man do not use Menopur if:
4. Possible side effects
• You have cancer of your testicles.
5. How to store Menopur
• You have prostate cancer.
6. Further information
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.

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.

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).

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).

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.

If treatment with Menopur results in pregnancy
Always use Menopur exactly as your doctor or nurse has told The following are more likely to happen in women
you. You should check with your doctor, nurse or pharmacist who have had fertility treatment than in women who
have got pregnant (conceived) naturally:
if you are not sure.
Menopur is not recommended for children or elderly people. • Being pregnant with more than one baby. This
carries an increased risk of problems for the
Using Menopur
mother during the pregnancy and at or around the
• You will have Menopur as an injection into a muscle or
time of birth.
under the skin.
• The fertilised egg implanting outside the womb
• You will either be given Menopur by a doctor or nurse or
(ectopic pregnancy). This is more likely if you
you will be taught how to give it to yourself.
have had tubal disease in the past (a condition
• Menopur comes as a dry powder in small bottles (vials).
where the fallopian tubes are blocked or damaged).
• Once the dry powder has been mixed with the salt solution
• Miscarriage or abortion.
(solvent) it should be used straight away.
• A slightly higher risk of your baby being born with
The dose and length of your treatment
physical defects.
• The dose, and how long your treatment lasts, depends on
Your doctor will be able to discuss this with you
why you are using Menopur and how well it works.
before you start treatment.
• Your doctor or nurse will monitor how you respond to
If any of the side effects become serious, or if you
your treatment.
notice any side effects not listed in this leaflet, please
• This will help them to work out what dose you need and
tell your doctor, nurse or pharmacist.
how long you need to use Menopur for.
In women:
5. How to store Menopur
Infertility (to help follicles to mature):
• Keep out of the reach and sight of children.
• If you are having periods, your treatment will start within
• Do not use Menopur after the expiry date which
the first 7 days of your menstrual cycle.
is stated on the packaging.
• You may use Menopur daily for up to 3 weeks.
• Store below 25°C.
• Or, you may use Menopur every other day for 6 days
• Protect from light.
(three doses in total).
• Medicines should not be disposed of via
‘Assisted conception’ such as IVF:
wastewater or household waste. Ask your
• The usual dose is 75 to 300 IU each day.
pharmacist how to dispose of medicines no
• Your doctor will decide how long you need to use
longer required. These measures will help to
Menopur for.
protect the environment.
In men:
For low sperm count:
6. Further information
• The usual dose is 75 or 150 IU two or three times a week.
What Menopur contains
• Treatment is normally continued for at least 3 or 4 months. • Menopur is a sterile freeze dried powder for

3. How to use Menopur

If you use more Menopur than you should
If you think you have used too much Menopur, tell your
doctor, nurse or pharmacist.

injection. The active substance is menotrophin BP.
Each vial contains 75 IU of the active substance.
• The other ingredients are lactose, sodium hydroxide
and hydrochloric acid.
If you forget to use Menopur
• The solvent (Sodium Chloride Solution for Injections
If you think you have missed a dose, tell your doctor, nurse
0.9% w/v) contains water for injection, sodium
or pharmacist.
chloride and hydrochloric acid.
4. Possible side effects
What Menopur looks like and contents of the pack
Like all medicines, Menopur can cause side effects, although Menopur is supplied in boxes of 10 vials of Menopur
powder for injection and 10 ampoules of Solvent 1 ml
not everybody gets them.
(Sodium Chloride Solution for Injections 0.9%w/v).
Side effects that can happen in women:
The solvent is used to dissolve the powder before it
If you notice any of the following signs, tell your
is injected.
doctor immediately. It may mean that your ovaries
have been stimulated too much and you may need
Marketing Authorisation Holder and Manfacturer
urgent medical treatment. This side effect is
The Marketing Authorisation Holder for Menopur
common (affects less than 1 in 10 people).
and Sodium Chloride Solution for Injections 0.9%
• Feeling sick.
• Pain or swelling of the tummy.
w/v is Ferring Pharmaceuticals Ltd., The Courtyard,
• Being sick.
• Weight gain.
Waterside Drive, Langley, Berkshire, SL3 6EZ.
• Diarrhoea.
• Difficulty breathing.
Menopur is manufactured by Dr. Rentschler
• Feeling more thirsty than usual.
Biotechnologie GmbH, Erwin-Rentschler-Straße 21,
• Producing less urine when you go to the toilet or
D-88471 Laupheim, Germany.
going to the toilet less often.
Sodium Chloride Solution for Injection 0.9% w/v is
If you notice any of the above signs, tell your doctor
manufactured by Weimer Pharma GmbH, Im
immediately.
Steingerust 30, D-76437 Rastatt, Germany.
Side effects that can happen in both women and men:
Menopur® PL 03194/0074
STOP USING Menopur if you experience allergic
reactions including; itching, skin rashes, swelling of the
Sodium Chloride Solution for Injections 0.9%w/v PL
face, lips or throat, difficulty in breathing, wheeziness,
03194/0060
chest tightness or coughing. If you experience any of these
rare side effects, you should contact your doctor or go to This leaflet was last revised in 06/2011.
the nearest hospital immediately.
Menopur is a registered Trademark.
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.

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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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