MENOPUR contains the hormone menotrophin [highly purified menopausal gonadotrophin (HMG)], that is
extracted from female urine after the menopause.
MENOPUR is used for the treatment of female infertility in the following cases:
- MENOPUR is used in women without ovulation who have been unresponsive to treatment with clomiphene
citrate (an anti-oestrogen) in order to trigger ovulation.
- MENOPUR is used in women who undergo a treatment method of assisted reproduction (ART), for the
development of a number of follicles and therefore for the maturation of a number of ovums.

Do not use MENOPUR 75 I.U.
 if you are allergic to the active ingredient menotrophin or any of the other ingredients of this medicine
(listed in section 6)
 if you have tumours of the pituitary gland or of an area of the hypothalamus
 if you have tumours of the ovaries, uterus or mammary glands
 during pregnancy and lactation
 if you have gynaecological bleeding of unknown cause
 if you have ovarian cysts or enlarged ovaries not due to a functional disorder of the ovaries with increased
follicle formation [polycystic ovarian syndrome (PCOS)]
 if you have experienced an early menopause

In the following situations, you should not be treated with MENOPUR 75 I.U. because a successful treatment is
rather unlikely:
 if you have a fundamental malfunction of the ovaries
 if you have malformations of the reproduction organs incompatible with pregnancy
 if you have fibroid tumours of the uterus incompatible with pregnancy
Warnings and precautions
The treatment with MENOPUR 75 I.U. should only be performed under supervision of a doctor who is familiar
with the problems and the treatment of infertility.

The first MENOPUR 75 I.U .injection should be performed under direct medical supervision.
Prior to the treatment there should be evidence of your or your partner's infertility. Possible contraindications for
pregnancy should be excluded. You should have been examined for hypothroidism, reduced function of the
adrenal cortex, overproduction of the hormone prolactine and any tumours of the pituitary gland or the
hypothalamus and treated accordingly.
If you undergo stimulation of the follicular growth – within infertility treatment due to missing ovulation
(anovulation) or ART – enlargement of the ovaries or hyperstimulation may occur. These risks can be minimised
by adherence to the recommended dosage and administration regimen and thorough monitoring of the therapy.
Hyperstimulation of the ovaries (ovarian hyperstimulation syndrome (OHSS))
OHSS differs from uncomplicated ovarian enlargement and can manifest itself with increasing grades of
severance. It includes marked ovarian enlargement, high levels of sexual hormones and increase of the fluid
permeability of the vessels. The latter can lead to fluid accumulation in the peritoneal, pleural and in rare cases in
the pericardial cavities.
The following symptoms can be observed in severe cases of OHSS: stomach ache, distended abdomen, excessive
enlargement of the ovaries, increase in weight, shortness of breath, reduced urine formation, nausea, vomiting and
diarrhea. The clinical examination may reveal a reduction of the circulating amount of blood and blood
concentration, electrolyte balance disorders, accumulation of fluid and/or blood in the abdominal and chest cavities,
acute shortness of breath and thromboembolism (acute vascular obliteration caused by clotted blood).
Excessive response of the ovaries to MENOPUR 75 I.U. treatment seldom gives rise to OHSS unless hCG (Human
Chorionic Gonadotrophin, hormone formed in the placenta during pregnancy) is administered to trigger
ovulation. Therefore, your doctor must not give you hCG in cases of ovarian hyperstimulation. For at least 4
days, you should renounce sexual intercourse or use nonhormonal contraceptives. OHSS can progress very
quickly (between 24 hours and several days) and develop to serious symptoms. Therefore you should be closely
controlled for a period of at least 2 weeks following the hCG administration.
Ovarian hyperstimulation and multiple pregnancy may be reduced by adherence to the recommended dosage,
regimen of administration and careful monitoring of therapy. With assisted reproductive technologies (ART),
aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
OHSS may be more severe and more protracted if pregnancy occurs. Most often, OHSS occurs after hormonal
treatment has been discontinued and reaches its maximum severity at about seven to ten days following
treatment. Usually, OHSS resolves spontaneously with the onset of menses.
In cases of severe OHSS, your doctor should stop treatment with MENOPUR 75 I.U. (if this has not been done yet)
and admit you to hospital where you will receive a special OHSS treatment.
OHSS occurs with higher incidence with a functional defect of the ovaries with increased follicle formation
[polycystic ovarian disease (PCOD)].
Multiple pregnancy
Multiple pregnancy increases the risk of complications in the mother and the children. If you undergo an infertility
treatment with MENOPUR 75 I.U. due to missing ovulation, the risk of multiple pregnancy is increased
compared to natural conception. The majority of multiple pregnancies are twins. To minimise the risk of multiple
pregnancy, careful monitoring of ovarian response is recommended. Most cases of multiple pregnancy are twin
pregnancies. Your doctor should thoroughly monitor the reaction of your ovaries to MENOPUR 75 I.U.in order
to keep the risk of multiple pregnancy low.
If you undergo ART, the risk of multiple pregnancy depends on the number and the quality of transferred embryos
and your age.
Prior to the treatment, your doctor is to inform you about the potential risk of multiple pregnancy.
Premature birth/ miscarriage
Premature birth or miscarriage appear more frequently in patients who undergo ART.

Pregnancy outside the uterus (ectopic pregnancy)
If your history includes tubal diseases, there is a risk of ectopic pregnancy, no matter if pregnancy has been caused by
spontaneous conception or by infertility treatment.
Tumours (neoplasms) of the reproduction organs
In women who have undergone multiple infertility treatment cycles with hormones, benign and malignant tumours of
the ovaries and reproduction organs have been reported.
Congenital deformations
The occurrence of congenital deformations following ART can be slightly higher than with spontaneous conception.
This can probably be attributed to different parental prior encumbrance (e.g. mother's age, sperm characteristics) and
multiple pregnancy.
Risks of thrombosis and embolism
If general risk factors of blood clot formation (thromboses, embolisms) such as severe obesity or the tendency
towards thrombosis (thrombophilia) are involved or if a blood relative already has had blood clots, there might be an
increased risk of thromboembolism of the blood vessels (veins and arteries) during or after the MENOPUR 75
I.U. treatment. In these cases, your doctor has to weigh up the benefit of MENOPUR 75 I.U. treatment against
the risk. Please note that also pregnancy itself carries an increased risk of thrombosis.
Consequences of misuse for doping purposes
The use of MENOPUR 75 I.U. may lead to positive results in doping tests. The use of MENOPUR 75 I.U. for
doping purposes may endanger health.
Children and adolescents
The use of MENOPUR 75 I.U.in children and adolescents is not intended.
When using MENOPUR 75 I.U. with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other
medicines.
Pregnancy and lactation
Do not use MENOPUR 75 I.U. during pregnancy and lactation.
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However,
MENOPUR 75 I.U.is unlikely to have influence on the patient’s ability to drive and use machines.
Important information about some of the ingredients of MENOPUR 75 I.U.
MENOPUR contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free’.

Always use MENOPUR 75 I.U. exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
In different patients and even in the same patient, the ovaries respond in very different ways to MENOPUR
75 I.U. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted
individually depending on the ovarian response. For this purpose, the response is to be controlled by use of
ultrasound, preferably in combination with the measuring of the female hormone oestradiol.

Women without ovulation (including polycystic ovarian syndrome)
TheMENOPUR 75 I.U. therapy should be commenced within the first 7 days of the menstruation cycle. The
recommended initial dose of MENOPUR 75 I.U.is 75 -150 IU daily, which should be maintained for at least 7 days.
Subsequent treatment should be individually adapted to the results of the routine follow-up examinations. An
increase in dosage may be determined by your doctor if required. The dosage should not be increased after less than
7 days. The recommended dose increment is 37.5 IU per adjustment and should not exceed 75 IU. The maximum
daily dosage should not exceed 225 IU. In case there is no optimal reaction achieved after 4 weeks of treatment, the
treatment should be interrupted for this cycle.

Once an optimal stimulation has been achieved, one single injection of 5,000 to 10,000 IU chorion gonadotrophin
(hCG) should be administered one day after the lastMENOPUR 75 I.U. injection. You should have sexual
intercourse both on the day of hCG administration and on the following day. Alternatively, selected sperms may be
directly transferred into the uterus (intrauterine insemination). You should be closely followed up by your doctor for
at least 2 weeks following the hCG administration. If you show an excessive reaction to MENOPUR 75 I.U., the
treatment should be stopped, and no hCG should be administered. You should use non-hormonal contraceptives or
renounce sexual intercourse until the beginning of the next menstrual bleeding.
Development of several follicles for assisted reproduction (ART)
With blockage of the ovaries-stimulating hormones (downregulation by use of GnRH agonist), the MENOPUR
75 I.U. therapy should start approximately 2 weeks after the start of GnRH agonist treatment.
With blockage of the ovaries-stimulating hormones, (downregulation by use of GnRH-antagonist) MENOPUR 75
I.U. treatment should be started on day 2 or 3 of the menstrual cycle.
The recommended initial dose is 150 - 225 IU daily, which should be maintained for at least 5 days. Subsequent
treatment should be individually adapted to the results of the routine follow-up examinations and should not exceed
150 IU per adjustment. The maximum daily dosage should not exceed 450 IU and, generally, dosing beyond 20 days
is not recommended.
Once an optimal reaction has been achieved, one single injection of up to 10,000 IU chorion gonadotrophin (hCG)
should be administered to trigger the follicular maturation to prepare the oocytes' release. You should be controlled
tightly for at least 2 weeks following the hCG administration. If you show an excessive reaction to MENOPUR 75
I.U., the course of treatment should be stopped, and no hCG should be administered. You should use non-hormonal
contraceptives or renounce sexual intercourse until the beginning of the next menstrual bleeding.
Method of administration
MENOPUR is intended for subcutaneous or intramuscular injection after reconstitution with the solvent provided.
The powder should be reconstituted immediately prior to use. Up to 3 injection bottles of MENOPUR 75 I.U.
may be dissolved in 1 ampoule of the solvent provided. Do not shake the ampoule containing the solution and do
not use the solution if it contains particles or is not clear.
If you use more MENOPUR 75 I.U. than you should (overdose)
Overdoses are unknown, nevertheless hyperstimulation of the ovaries (ovarian hyperstimulation) may occur.
If you forget to take MENOPUR 75 I.U.
Do not inject the double amount, but please consult your doctor.
If you stop taking MENOPUR 75 I.U.:
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.
The most frequently reported adverse drug reactions reported during treatment with MENOPUR 75 I.U.in
clinical trials are ovarian hyperstimulation (OHSS), abdominal pain, headache, swelling in abdomen and
injection site pain, with an incidence rate of up to 5 %.
Medicinal products used in treatment of infertility such as MENOPUR 75 I.U. may cause high levels of activity
in the ovaries leading to a disease called Ovarian Hyperstimulation Syndrome (OHSS), especially in women
with polycystic ovaries. Symptoms include: pain in the abdomen, swelling in the abdomen, nausea, vomiting,
diarrhoea and weight gain. In cases of severe OHSS accumulation of fluid in abdomen, pelvis and/or chest
cavity, difficulty in breathing, decreased urination, formation of blood clots in blood vessels (thromboembolism)
and twisting of ovaries (ovarian torsion) have been reported as rare complications. If you experience any of these
symptoms contact your doctor immediately, even if they develop some days after the last injection has been
given.

Allergic (hypersensitivity) reactions may occur with the use of MENOPUR. Symptoms of these reactions might
include: rash, itching, swelling of the throat and difficulty in breathing. If you experience any of these symptoms,
contact your doctor immediately.
The following adverse drug reactions occurred in women treated with MENOPUR 75 I.U.in clinical trials:
Common (affects between 1 to 10 of every 100 patients treated)
 Pain in the abdomen
 Headache
 Nausea
 Swelling in the abdomen
 Pelvic pain
 Overstimulation of the ovaries resulting into high levels of activity (ovarian hyperstimulation
syndrome)
 Local reactions at the injection site (most common pain)
Uncommon (affect between 1 to 10 of every 1,000 patients treated)
 Vomiting
 Discomfort in abdomen
 Diarrhoea
 Fatigue
 Dizziness
 Sacs of fluid within ovaries (ovarian cysts)
 Breast complaints (include breast pain, breast tenderness, breast discomfort, nipple pain and
breast swelling)
 Hot flush
Rare (affect between 1 to 10 of every 10,000 patients treated)
 Acne
 Rash
Not known (adverse reactions post marketing: frequency cannot be estimated from the available data)
 Eyesight disturbances
 Fever
 Feeling sick (Malaise)
 Allergic reactions
 Increase in weight
 Pains in muscle and joint (e.g. back pain, neck pain and pain in arms and legs)
 Twisting of ovary (ovarian torsion) as a complication of increased activity of ovaries due to
overstimulation
 Itching
 Hives
 Blood clots as a complication of increased activity of ovaries due to overstimulation
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet.
Unwanted multiple pregnancy is more common during treatment with HMG.
Pregnancies which result from infertility treatment with gonadotrophins such as MENOPUR 75 I.U. may end more
frequently in spontaneous abortions than normal pregnancies.

Keep out of the sight and reach of children.
Do not use the medicinal product after the expiry date which is stated on the carton and the container. The expiry
date refers to the last day of that month.

Do not store above 30°C. Do not freeze. Store in the original container in order to protect from light. For
immediate use following reconstitution.
Do not throw away medicines via wastewater. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment