In this leaflet:

1. What HCG-lepori 1000 UI is and what it is used for
2. Before you use HCG-lepori 1000 UI
3. How to use HCG-lepori 1000 UI
4. Possible side effects
5. Storing HCG-lepori 1000 UI

HCG-lepori 1000 UI, liofilizado y disolvente para solución inyectable
Human chorionic gonadotropin

The active substance is human chorionic gonadotropin (HCG) (DOE). Each vial of lyophilizate contains 1000 IU.
The other ingredients are: per vial of lyophilizate, lactose; per solvent ampoule, sterile physiological solution.

Marketing authorisation holder: FARMA-LEPORI, S.A. C. Osi, 7 - 08034 Barcelona

Manufacturer: LABIANA PHARMACEUTICALS, S.L. Gorcs i Lladó, 188. 08210 Barberà del Vallès (Barcelona)

1. WHAT HCG-lepori 1000 UI IS AND WHAT IT IS USED FOR
This medicine is presented in lyophilizate and solvent for injectable solution, in vials with 1000 IU. There is a presentation of 3 vials of lyophilizate + 3 solvent ampoules. It is included in the group of the gonadotropins and other ovulation stimulants.
It is indicated in:
• Functional female sterility
• Functional male sterility
• Cryptorchidism (testicles not palpable in scrotal bag)
• Functional menometrorrhagias (abundant loss of blood through the vagina)
• Threatened miscarriage and regular miscarriage

2. BEFORE YOU USE HCG-lepori 1000 UI
Before beginning treatment, the type of infertility of the couple and the possible existence of contraindications for pregnancy must be assessed. Particularly, the presence of hypothyroidism, suprarenal insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours must be ruled out, with the appropriate specific treatment instigated.
Levels of estradiol should be closely controlled, and ovarian response by means of ultrasound before and during stimulation treatment in all patients.

Do not use HCG-lepori 1000 UI:
- If you know you are allergic to any of the ingredients of the product.
- If you have a hypothalamus or hypophysis tumour.
- If there is an increase in your ovary size or cysts not due to a polycystic ovary disease.
- If you suffer from ovarian, uterine or breast carcinoma.
- If you have ever presented unknown gynaecological haemorrhages.
- If you had an extrauterine pregnancy 3 months ago.
- If you have active thromboembolic problems.
- If you have primary ovarian failure.
- If you have malformations of your sexual organs incompatible with pregnancy.
- If you have fibroid uterus tumours.
- If you are in the menopause.
- If you have prostate carcinoma or breast carcinoma in man.
- If you have precocious puberty.
- If you have thyroidal or suprarrenal dysfunction.

Be particularly careful with HCG-lepori 1000 UI, since:
There have been no cases of allergy reported with HCG-lepori. However, if you have shown allergy to other gonadotropins, you may present an anaphylactic reaction. The first injection given to you must be performed under direct medical supervision with availability of cardiopulmonary reanimation equipment.
Special caution should be taken before giving HCG-lepori in patients with a clinically significant disease that might be aggravated as a consequence of pregnancy.

Warnings:
• In women: Female infertility treatments with HMG and HCG-lepori must always be performed under strict medical monitoring (control of urine strogens or plasma estradiol, ultrasound) with a view to preventing possible ovarian hyperstimulation. Before giving HCG-lepori, an ultrasound examination and analyses must be performed.
-Ovarian hyperstimulation syndrome (OHSS) Patients undergoing ovarian stimulation have a greater risk of presenting OHSS due to the development of multiple follicles, whereby good strogen and follicular control is recommended.
Ovarian hyperstimulation syndrome may become a serious medical problem, characterised by marked ovarian growth or formation of large ovarian cysts that give rise to acute abdominal pain, ascitis (liquid in the abdominal cavity) caused by cyst ruptures, pleural effusion, hypovolemia (reduction in total blood volume), shock and thromboembolic disorders in serious cases.
If an excess of ovarian response is observed during treatment (excessive increase in levels of estradiol and/or appearance of several follicles) your doctor will recommend that you interrupt treatment. HCG-lepori must not be given and you should abstain from having sexual intercourse for 4 days following the interruption of treatment.
-Multiple pregnancies: The risk of multiple pregnancy in patients undergoing assisted reproduction techniques is related to the number of embryos implanted. In patients undergoing ovulation induction, the incident of multiple pregnancies and births (mostly twins) is higher than in the case of natural conception.
-Incidence of miscarriages: The incidence of miscarriages, both in patients with anovulation and those undergoing assisted reproduction techniques, is higher than that which is observed in the normal population, but comparable to the rates observed in women with fertility problems.
• In men: Since treatment with HCG-lepori causes an increase in the production of androgens, and the latter may give rise to liquid retention, if you have a background of epilepsy, headache, asthma, cardiovascular disorders such as heart failure or high blood pressure and renal impairment, inform your doctor and take extreme precautions during treatment.
• Use in athletes: Athletes are informed that this medicine contains an ingredient that may return a positive analysis in a doping control.
• Use in the elderly: HCG-lepori is not specifically indicated for this group of people, whereby its use is not recommended. In menopausal women the ovary may present a greater degree of sensitivity to HCG-lepori.
• Use in paediatrics: The paediatric indications of HCG-lepori must be evaluated by the specialist and are subject to endocrinological and clinical control to measure testicle evolution. If using the medicine for the treatment of cryptorchidism (normally in children), you must inform your doctor of the appearance of signs of precocious puberty (hairs, erection and ejaculation).
See your doctor, even if any of the above circumstances have only happened once.
Treatment with this preparation must be performed under strict medical control.

Pregnancy:
Ask your doctor or pharmacist for advice before taking any medicine.
It should not be used in pregnancy or partum, unless, in the doctor's opinion, it is clinically justified, as occurs with threatened miscarriage and regular miscarriage. There are no data on the exposure of HCG-lepori at foetal level.

Lactation:
Ask your doctor or pharmacist for advice before taking any medicine.
Since HCG is excreted by the mother's milk, HCG-lepori should not be given during lactation unless your doctor deems it necessary, as in the case of threatened miscarriage or regular miscarriage.

Driving and using machines:
No studies have been performed on the capacity to drive and use machines.

Important information on some of the ingredients of HCG-lepori 1000 UI:
This medicine contains lactose as excipient. If your doctor has told you that you have intolerance to some sugars, contact him before taking this medicine.

Use of other medicines:
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those not prescribed.
No clinically significant pharmacological interactions have been described during treatment with HCG-lepori.
Following its administration, it may interfere, for a period of up to 10 days, with the immunological determination of HCG in serum or urine, which may give rise to a false positive in the pregnancy test results.

3. HOW TO USE HCG-lepori 1000 UI
Follow these instructions unless told to do otherwise by your doctor:
The solution for injection is obtained by dissolving the content of the lyophilizate with 1 ml of solvent, which should be given immediately and exclusively by the intramuscular route. If the additional use of HMG is regarded as necessary, an injectable solution of HCG combined with the HMG in the same injection may be used, using only one solvent.
Remember to take your medicine.
In view of the characteristics of HCG-lepori, the posology to be given must follow a suitable schedule that takes individual indications and variations in response into consideration. The treatments should always be performed under strict and specialised medical control. Suitable facilities should be available for correct follow-up and patient control.

Female sterility:
The dosing schedule must be adapted to the ovarian cycle. There are several follicular stimulation protocols that your doctor must adapt to your personal circumstances. Once the required follicular response has been achieved, assessable by hormone determinations and the measurement of follicular development at ovary level, 5000 to 10000 IU of HCG-lepori will be given in a single dose after one day of rest (between 24 and 48 hours). Sexual intercourse is recommended on the same day and one day after the administration of HCG-lepori. As far as IVF techniques are concerned, ovocytes will also be collected in this period and always according to the established protocol.
The treatment with HMG and HCG-lepori should be repeated over several cycles, provided that there are signs that ovulation has occurred without a subsequent pregnancy or in case of lack of ovarian response. Woman undergoing IVF may require an average of 4 cycles to achieve pregnancy. The clinical orientation should be re-evaluated in the case of 6 cycles without pregnancy.

Male sterility:
Due to the physiological duration of spermatogenesis, the treatment must be continued for the time necessary to guarantee the culmination of a whole spermatogenic cycle, and these cycles may be repeated until the results desired are achieved. Hormone, spermatogenesis and glandular maturation controls must be carried out.
Dosage varies according to protocol, the most common being the use of 500 to 2000 IU of HCG-lepori daily or every second day. Due to the difficulty of guaranteeing testicular response to treatment with HCG alone, the regular use of joint posology schedules with HMG is recommended.

Cryptorchidism:
The treatment of cryptorchidism requires a prior medical and surgical assessment and the adaptation of posology according to age, in terms of clinical and analytical values. Usually, 500 IU- 1000 IU of HCG-lepori are given every second day for 4-6 weeks. If the additional use of HMG is regarded as necessary, particularly in adolescents, an injectable solution of HMG combined with one of HCG in the same injection may be used, using only one solvent.

Functional menometrorrhagias; threatened miscarriage and regular miscarriage:
The posology must be adapted to the doctor's criteria.
If you have impression that the effect of HCG-lepori is too strong or weak, talk to your doctor or pharmacist.
Your doctor will tell you the duration of your treatment with HCG-lepori. Do not interrupt the treatment before that, since it may eliminate the effect expected.

If you use more HCG-lepori 1000 UI than you should:
If you have used more HCG-lepori than you should, consult your doctor or pharmacist immediately.
At high doses, and depending on individual reaction, symptoms of ovarian hyperstimulation may appear in woman, in which case the administration must be interrupted.
In case of cryptorchidism, the treatment should be suspended if any type of precocious puberty appeared.
To minimise the risk of OHSS or multiple pregnancy, regular ovarian ultrasounds are recommended, as well as determinations of estradiol. In the event of any sign of ovarian hyperstimulation (excessive increase in the levels of estradiol and/or appearance of numerous ovarian follicles), the treatment must be interrupted immediately.

In case of overdose or accidental intake, go to a medical centre or call the Toxicology Information Service, Tel. 91 562 04 20, indicating the medicine and the amount taken.

If you forgot to take HCG-lepori 1000 UI:
Do not take a double dose to make up for the doses you forgot to take.

4. POSSIBLE SIDE EFFECTS
Like all medicines, HCG-lepori may have adverse effects.
HCG-lepori is used regularly in combination with other medicines, and it is difficult to attribute the adverse effects individually to any of the compounds used. The undesirable effects expected with the use of HCG-lepori are similar to those described with other medicinal products containing HCG as active substance.

General disorders
Frequent (>1/100, <1/10)
Headache, tiredness

Gastrointestinal disorders
Frequent (>1/100, < 1/10)
Vomiting, nausea, abdominal pain
Rather infrequent (>1/1000, <1/100)
Diarrhoea

Psychiatric disorders
Rather infrequent (>1/1000, <1/100)
Depression, irritability, restlessness

Disorders of the reproductive apparatus
Frequent (>1/100, <1/10)
Mild or moderate ovarian hyperstimulation syndrome
Rather infrequent (>1/1000, <1/100)
Serious ovarian hyperstimulation syndrome
Breast tension

Disorders in the injection area
Frequent (>1/100, <1/10)
Local reaction, pain in the injection area

For HCG, cases of thromboembolism, ectopic pregnancy, ovarian torsion and other complications have been described that may be regarded as concomitant and related to assisted reproduction techniques. Oedema has been described in men.
Stop taking the medicine if you notice any adverse effect.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING HCG-lepori 1000 UI
Keep HCG-lepori 1000 UI out of the reach and sight of children.
• No special storage conditions are required.

Expiry
Do not use HCG-lepori after the expiry date indicated on the box, in the vial or in the ampoule.

This leaflet was approved in May 2004.

FARMA-LEPORI
C. Osi, 7 - 08034 Barcelona

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