FOLLICLE STIMULATING HORMONE SOLUTION FOR INJECTION

NAME OF THE MEDICINAL PRODUCT

Follice Stimulating Hormone Solution For Injection 150 IU/0.18 ml,

Follicle Stimulating Hormone Solution For Injection 300 IU / 0.36 ml,

Follice Stimulating Hormone solution for Injection 600 IU/0.72 ml,

Follice Stimulating Hormone solution for Injection 900 IU/1.08 ml

 

follitropin beta

Package leaflet

Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

From here on Follicle Stimulating Hormone is refered to as FSH

What is in this leaflet
1. What FSH is and what it is used for
2. What you need to know before you take FSH
3.How to take FSH
4. Possible side effects
5. How to store FSH
6. Other information

WHAT FSH IS AND WHAT IT IS USED FOR

Here the active ingredient is follitropin beta.
FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. In men, FSH is needed for the production of sperm.
FSH is used to treat infertility in any of the following situations:

Women
In women who do not ovulate and do not respond to treatment with clomifene citrate, FSH can be used to cause ovulation.
In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, FSH can bring about the development of multiple follicles.

Men
In men who are infertile due to lowered hormone levels, FSH can be used for the production of sperm.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE FSH

Do not use FSH

If you:
~are allergic to follitropin beta or any of the other ingredients of FSH (listed in section 6)
~have a tumour of the ovary, breast, uterus, testis or brain (pituitary gland or hypothalamus)
~have heavy or irregular vaginal bleeding where the cause is unknown
~have ovaries that do not work because of a condition called primary ovarian failure
~have ovarian cysts or enlarged ovaries not caused by polycystic ovarian syndrome (PCOS)
~have malformations of the sexual organs which make a normal pregnancy impossible
~have fibroid tumours in the uterus which make a normal pregnancy impossible
~are a man and are infertile because of a condition called primary testicular failure.

Warnings and precautions

Talk to your doctor before using FSH if you:
~have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
~have uncontrolled pituitary gland or hypothalamic problems
~have an underactive thyroid gland (hypothyroidism)
~have adrenal glands that are not working properly (adrenocortical insufficiency)
~have high prolactin levels in the blood (hyperprolactinemia)
~have any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).

If you are a woman:

Ovarian hyperstimulation syndrome (OHSS)
Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of FSH from day to day. You may regularly have ultrasound scans of the ovaries. Your doctor may also check blood hormone levels. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries are overly stimulated and the growing follicles become larger than normal. This serious medical condition is called ovarian hyperstimulation syndrome (OHSS). In rare cases, severe OHSS may be life-threatening. OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. Call your doctor right away if you notice severe abdominal swelling, pain in the stomach area (abdomen), feeling sick (nausea), vomiting, sudden weight gain due to fluid buildup, diarrhoea, decreased urine output or trouble breathing (see also section 4 on Possible side effects).
Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation.
Contact your doctor immediately if you are experiencing stomach pains, also if this occurs some days after the last injection has been given.

Multiple Pregnancy or birth defects
After treatment with gonadotrophin preparations, there is an increased chance of having multiple pregnancies, even when only one embryo is transferred into the uterus. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth. Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics, genetic background of both parents) may be associated with an increased risk of birth defects.

Pregnancy complications
There is a slightly increased risk of a pregnancy outside the uterus (an ectopic pregnancy). Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.
In women undergoing fertility treatment there may be a slightly higher chance of a miscarriage.

Blood clot (Thrombosis)
Treatment with FSH, just as pregnancy itself, may increase the risk of having a blood clot (thrombosis). Thrombosis is the formation of a blood clot in a blood vessel.

Blood clots can lead to serious medical conditions, such as:
~blockage in your lungs (pulmonary embolus)
~stroke
~heart attack
~blood vessel problems (thrombophlebitis)
~a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.

Please discuss this with your doctor, before starting treatment, especially:
~if you already know you have an increased chance of having thrombosis
~if you, or anyone in your immediate family, have ever had a thrombosis
~if you are severely overweight.

Ovarian torsion
Ovarian torsion has occurred after treatment with gonadotropins including FSH. Ovarian torsion is the twisting of an ovary. Twisting of the ovary could cause the blood flow to the ovary to be cut off.

Before starting to use this medicine, tell your doctor if you:
~have ever had ovarian hyperstimulation syndrome OHSS
~are pregnant or think that you may be pregnant
~have ever had stomach (abdominal) surgery
~have ever had a twisting of an ovary
~have past or current cysts in your ovary or ovaries.

Ovarian and Other Reproductive System Tumours
There have been reports of ovarian and other reproductive system tumors in women who have had infertility treatment. It is not known if treatment with fertility medicines increases the risk of these tumors in infertile women.

Other medical conditions
In addition, before starting to use this medicine, tell your doctor if you:
~have been told by a doctor that pregnancy would be dangerous for you.

If you are a man:

Men with too much FSH in their blood
Increased FSH blood levels are a sign of damage to the testicles. FSH is usually not effective in such cases. To check the effects of treatment, your doctor may ask you for a semen sample to be analysed, four to six months after the start of treatment.

Other medicines and FSH
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If FSH is used in a combination with clomifene citrate, the effect of FSH may be increased. If a GnRH agonist (a medicine used to prevent early ovulation) has been given, higher doses of FSH may be needed.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. You should not use FSH if you are already pregnant, or think you might be pregnant.

FSH may affect milk production. It is unlikely that FSH is passed into breast milk. If you are breast-feeding, tell your doctor before using FSH.

Driving and using machines
FSH is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of FSH
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free’.

Children
There is no relevant use of FSH in children.

HOW TO TAKE FSH
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage in women
Your doctor will decide on your starting dose. This dose may be adjusted during your treatment period. Further details on the treatment schedule are given below.
There are large differences between women in the response of the ovaries to FSH, which makes it impossible to set a dosage schedule which is suitable for all patients. To find the right dosage, your doctor will check your follicle growth by means of ultrasound scanning, and measurement of the amount of oestradiol (female sex hormone) in the blood.
Women who are not ovulating
A starting dose is set by your doctor. This dose is continued for at least seven days. If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/or plasma oestradiol levels indicate a proper response. The daily dose is then maintained until a follicle of proper size is present. Usually, 7 to 14 days of treatment are sufficient. FSH treatment is then stopped and ovulation will be induced by giving human chorionic gonadotrophin (hCG).
Medically assisted reproduction programs, for instance IVF
A starting dose is set by your doctor. This dose is continued for at least the first four days. After this, your dose may be adjusted, based upon your ovarian response. When a sufficient number of follicles of proper size are present, the final phase of maturation of the follicles is induced by giving hCG. Retrieval of the egg(s) is performed 34-35 hours later.

Dosage in men
FSH is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months. The treatment period equals the development time of sperm and the time in which improvement can be expected. If your sperm production has not started after this period, your treatment may carry on for at least 18 months.

How are the injections given
FSH solution for injection in cartridges has been developed for use in the FSH Pen. The separate instructions for using the pen must be followed carefully. Do not use the cartridge if the solution contains particles or if the solution is not clear.
Using the pen, injections just under the skin (in the lower stomach, for example) can be given by yourself or your partner. Your doctor will tell you when and how to do this. If you inject yourself with FSH, follow the instructions carefully to give FSHproperly and with minimal discomfort.
The very first injection of FSH should only be given in the presence of a doctor or nurse.

If you use more FSH than you should
Tell your doctor immediately.
Too high a dose of FSH may cause hyperstimulation of the ovaries (OHSS). This may be noticed as pain in the stomach. If you are troubled by stomach pains, tell your doctor immediately. See also section 4 on possible side effects.

If you forget to use FSH
If you forget a dose do not use a double dose to make up for a missed dose.

  • Contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects in women
A complication with FSH treatment is hyperstimulation of the ovaries. Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem. The risk can be reduced by careful monitoring of follicular development during treatment. Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles. Your doctor may also check blood hormone levels. Pain in the stomach, feeling sick or diarrhoea are the first symptoms. In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest (which may cause sudden weight gain due to fluid buildup) and the occurrence of blood clots in the circulation.

~Contact your doctor immediately if you are experiencing stomach pains, or any of the other symptoms of ovarian hyperstimulation, also if this occurs some days after the last injection.

If you are a woman:

Common side effects (may affect up to 1 in 10 people):
Headache
Injection site reactions (such as bruising, pain, redness, swelling and itching)
Ovarian hyperstimulation syndrome (OHSS)
Pelvic pain
Stomach pain and/or bloating

Uncommon side effects (may affect up to 1 in 100 people):
Breast complaints (including tenderness)
Diarrhoea, constipation or stomach discomfort
Enlargement of the uterus
Feeling sick
Hypersensitivity reactions (such as rash, redness, hives and itching)
Ovarian cysts or enlargement of the ovaries
Ovarian torsion (twisting of the ovaries)
Vaginal bleeding

Rare side effects (may affect up to 1 in 1,000 people):
Blood clots (this may also occur in the absence of unwanted overstimulation of the ovaries, see warnings and precautions in section 2)

Pregnancy outside the uterus (an ectopic pregnancy), miscarriage and multiple pregnancies have also been reported. These side effects are not considered to be related to the use of FSH, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.

If you are a man:

Common side effects (may affect up to 1 in 10 people):
Acne
Injection site reactions (such as hardening and pain)
Headache
Rash
Some breast development
Testicular cyst

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

HOW TO STORE FSH
Keep this medicine out of the sight and reach of children.
Storage by the pharmacist
Store at 2°C – 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C (at room temperature) for a single period of not more than 3 months.

Make a note of when you start storing the product out of the refrigerator.
Keep the cartridge in the outer carton.
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the FSH Pen.
Do not use FSH after the expiry date which is stated on the label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Discard used needles immediately after injection.
Do not mix any other drug into the cartridges. Empty cartridges must not be refilled.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

OTHER INFORMATION

What FSH contains
~Each cartridge contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/mL aqueous solution.
~
The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

What FSH looks like and contents of the pack

FSH solution for injection (injection) is a clear, colourless liquid. It is supplied in a glass cartridge. It is available in packs of 1 cartridge.

Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar

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