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MENOPUR POWDER FOR INJECTION

Active substance(s): HUMAN FOLLICLE STIMULATING HORMONE / 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).

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.

Menopur helps reproductive organs to work normally in
both women and men. A fertility specialist should supervise
your treatment.
Pregnancy and breast-feeding
If you are already pregnant or breast-feeding, you must not
What Menopur is used for
use Menopur.
In women, Menopur is used for:
• Infertility caused by eggs not being produced properly in
Tests before you start treatment
the ovaries (anovulatory infertility). It works by helping
Before you start treatment with Menopur, your doctor will
follicles (which contain eggs) to mature in the ovaries.
normally do tests to check the following:
• IVF (in vitro fertilisation) and other types of ‘assisted
Men and women:
conception’. It works by helping multiple follicles and
• Your thyroid and adrenal glands are working properly.
eggs to develop. The eggs are then harvested and
• You do not have tumours of the pituitary gland or
fertilised outside the body.
hypothalamus.
Women only:
In men, Menopur is used for:
• Your ovaries are working properly.
• Low sperm count (oligospermia).
• You do not have higher than normal blood levels of a
hormone called prolactin.

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).

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.

2009053883

Common (affects less than 1 in 10 people):
Always use Menopur exactly as your doctor or nurse has told • Headache.
you. You should check with your doctor, nurse or pharmacist • Pain or inflammation where the injection was given.
Uncommon (affects less than 1 in 100 people):
if you are not sure.
Menopur is not recommended for children or elderly people. • Blood clots in the veins, usually of the leg (deep vein
thrombosis).
Using Menopur
Very rare (affects less than 1 in 10,000 people):
• You will have Menopur as an injection into a muscle or
• If Menopur is used for a long time, your body may make
under the skin.
antibodies which can stop the treatment from working.
• You will either be given Menopur by a doctor or nurse or
If treatment with Menopur results in pregnancy
you will be taught how to give it to yourself.
The following are more likely to happen in women
• Menopur comes as a dry powder in small bottles (vials).
who have had fertility treatment than in women who
• Once the dry powder has been mixed with the salt solution
have got pregnant (conceived) naturally:
(solvent) it should be used straight away.
• Being pregnant with more than one baby. This carries an
Please note: 1 drop of solvent can dissolve the powder
increased risk of problems for the mother during the
immediately, leading to the impression that no powder
pregnancy and at or around the time of birth.
was present in the vial. Check the vial for powder before
• The fertilised egg implanting outside the womb
mixing the solvent.
(ectopic pregnancy). This is more likely if you
have had tubal disease in the past (a condition
The dose and length of your treatment
where the fallopian tubes are blocked or damaged).
• The dose, and how long your treatment lasts, depends on
• Miscarriage or abortion.
why you are using Menopur and how well it works.
• A slightly higher risk of your baby being born with
• Your doctor or nurse will monitor how you respond to
physical defects.
your treatment.
Your
doctor will be able to discuss this with you
• This will help them to work out what dose you need and
before you start treatment.
how long you need to use Menopur for.
If any of the side effects become serious, or if you
In women:
notice any side effects not listed in this leaflet, please
Infertility (to help follicles to mature):
tell your doctor, nurse or pharmacist.
• If you are having periods, your treatment will start within
the first 7 days of your menstrual cycle.
5. How to store Menopur
• You may use Menopur daily for up to 3 weeks.

Keep out of the reach and sight of children.
• Or, you may use Menopur every other day for 6 days
• Do not use Menopur after the expiry date which
(three doses in total).
is stated on the packaging.
‘Assisted conception’ such as IVF:

Store
below 25°C.
• The usual dose is 75 to 300 IU each day.

Protect
from light.
• Your doctor will decide how long you need to use
• Medicines should not be disposed of via wastewater or
Menopur for.
household waste. Ask your pharmacist how to dispose
In men:
of medicines no longer required. These measures will
For low sperm count:
help to protect the environment.
• The usual dose is 75 or 150 IU two or three times a week.

3. How to use Menopur

• 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.

6. Further information

What Menopur contains
• Menopur is a sterile freeze dried powder for
injection. The active substance is menotrophin BP.
Each vial contains 75 IU of the active substance.
If you forget to use Menopur
• The other ingredients are lactose, sodium hydroxide
If you think you have missed a dose, tell your doctor, nurse
and hydrochloric acid.
or pharmacist.
• The solvent (Sodium Chloride Solution for Injections
4. Possible side effects
0.9% w/v) contains water for injection, sodium
chloride and hydrochloric acid.
Like all medicines, Menopur can cause side effects, although
not everybody gets them.
What Menopur looks like and contents of the pack
Menopur is supplied in boxes of 1, 5 and 10 vials of
Side effects that can happen in women:
If you notice any of the following signs, tell your
Menopur powder for injection with the corresponding
doctor immediately. It may mean that your ovaries
number of 1, 5 and 10 ampoules of 1ml Solvent (Sodium
have been stimulated too much and you may need
Chloride Solution for Injection 0.9%w/v). The solvent is
urgent medical treatment. This side effect is
used to dissolve the powder before it is injected.
common (affects less than 1 in 10 people).
Marketing Authorisation Holder and Manfacturer
• Feeling sick.
• Pain or swelling of the tummy.
The Marketing Authorisation Holder for Menopur
• Being sick.
• Weight gain.
and Sodium Chloride Solution for Injections 0.9%w/v
• Diarrhoea.
• Difficulty breathing.
Ferring Pharmaceuticals Ltd., Drayton Hall,
• Feeling more thirsty than usual.
Church Road, West Drayton, UB7 7PS, (UK).
• Producing less urine when you go to the toilet or
Menopur is manufactured by Dr. Rentschler
going to the toilet less often.
Biotechnologie GmbH, Erwin-Rentschler-Straße 21,
If you notice any of the above signs, tell your doctor
D-88471 Laupheim, Germany.
immediately.
Sodium Chloride Solution for Injection 0.9% w/v is
Side effects that can happen in both women and men:
manufactured by Weimer Pharma GmbH, Im
Steingerust 30, D-76437 Rastatt, Germany.
STOP USING Menopur if you experience allergic
reactions including; itching, skin rashes, swelling of the
Menopur® PL 03194/0074
face, lips or throat, difficulty in breathing, wheeziness,
chest tightness or coughing. If you experience any of these Sodium Chloride Solution for Injections 0.9%w/v PL
rare side effects, you should contact your doctor or go to 03194/0060
the nearest hospital immediately.
This leaflet was last revised August 2017.
Menopur is a registered Trademark.

+ Expand Transcript

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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