CLOSTILBEGYT 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Clostilbegyt, 50 mg, Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Clostilbegyt and What is it Used For
4. Important Information Before Taking Clostilbegyt
   1. When Not to Take Clostilbegyt
   2. Warnings and Precautions
   3. Before Taking Clostilbegyt, Discuss the Following with Your Doctor:
   4. Children and Adolescents
   5. Clostilbegyt and Other Medicines
   6. Pregnancy and Breastfeeding
   7. Driving and Operating Machines
   8. Clostilbegyt Contains Lactose Monohydrate
5. How to Take Clostilbegyt
   1. Use in Children and Adolescents
   2. Overdose of Clostilbegyt
   3. Missed Dose of Clostilbegyt
   4. Stopping Clostilbegyt
6. Possible Side Effects
   1. Stop Taking Clostilbegyt and Immediately Consult Your Doctor or Go to the Hospital if You Experience:
   2. Stop Taking Clostilbegyt and Immediately Consult Your Doctor if You Notice Any of the Following Serious Side Effects – You May Need Urgent Medical Attention:
   3. Tell Your Doctor or Pharmacist if Any of the Following Side Effects Get Worse or Last Longer Than a Few Days:
   4. Reporting Side Effects
7. How to Store Clostilbegyt
8. Contents of the Pack and Other Information
   1. What Clostilbegyt Contains
   2. What Clostilbegyt Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder:
   5. Manufacturer:
   6. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the User

Clostilbegyt, 50 mg, Tablets

Clomifene Citrate

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Clostilbegyt and What is it Used For
• 2. Important Information Before Taking Clostilbegyt
• 3. How to Take Clostilbegyt
• 4. Possible Side Effects
• 5. How to Store Clostilbegyt
• 6. Contents of the Pack and Other Information

1. What is Clostilbegyt and What is it Used For

The active substance of Clostilbegyt is clomifene - an anti-estrogen.
Clostilbegyt is used to treat infertility caused by lack of ovulation.

2. Important Information Before Taking Clostilbegyt

When Not to Take Clostilbegyt

• If you are allergic to clomifene (the active substance) or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant (see section on Pregnancy and Breastfeeding).
• If you have liver disease or liver function disorders.
• If you have an ovarian cyst (except for polycystic ovary syndrome) or pituitary gland dysfunction.
• If you have thyroid or adrenal gland disorders.
• If you have uterine bleeding of unknown cause or undiagnosed uterine bleeding.
• If you have visual disturbances (long-standing or recent).
• If you have a hormone-dependent tumor.
• If you have premature menopause or have been diagnosed with infertility.

Warnings and Precautions

Before starting treatment with Clostilbegyt, consult your doctor or pharmacist, especially:

• if you have had amenorrhea caused by weight loss,
• if you have had a history of seizures,
• if you have uterine fibroids,
• if you have polycystic ovaries,
• if you have primary ovarian or pituitary failure,
• if you have ovarian cysts or ovarian tumors,
• if you have hypertriglyceridemia (excess fat in the blood) or a family history of hypertriglyceridemia. Before starting treatment with Clostilbegyt, other possible causes of fertility problems should be excluded and/or treated.

Before Taking Clostilbegyt, Discuss the Following with Your Doctor:

• Multiple pregnancy (multiple gestations).
• Pregnancy outside the uterus (ectopic pregnancy).
• Possible increased risk of ovarian cancer.
• Ovarian hyperstimulation syndrome.
• Vision problems.

Any pregnancy can lead to fetal developmental disorders or miscarriage. This possibility exists regardless of taking Clostilbegyt.

Children and Adolescents

Children and adolescents should not take this medicine.

Clostilbegyt and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and Breastfeeding

Do not take this medicine if you are pregnant or think you may be pregnant. A pregnancy test should be performed before taking Clostilbegyt.
During breastfeeding, Clostilbegyt may only be used if the doctor decides that the potential benefits of the medicine outweigh the risks to the baby.
Clomifene may inhibit milk production.

Driving and Operating Machines

This medicine may cause blurred vision or other visual disturbances that can increase the risk of activities such as driving or operating machinery. These risks should be assessed by the doctor on an individual basis for each patient.

Clostilbegyt Contains Lactose Monohydrate

One tablet of Clostilbegyt contains 100 mg of lactose monohydrate.
If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to Take Clostilbegyt

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose should be taken once a day, before a meal.
Treatment should always be preceded by a thorough gynecological examination due to possible side effects. Clostilbegyt may only be used with a prescription from a gynecologist and under constant gynecological supervision.
The doctor will adjust the dosage individually, depending on the sensitivity (reactivity) of the ovaries.
In the case of regular menstrual cycles, treatment is recommended to start on the 5th day of the cycle (or on the 3rd day in the case of early ovulation (follicular phase lasting less than 12 days). In the absence of menstruation, treatment can be started on any day.
Scheme I: 50 mg daily for 5 days, during which time the ovarian response to the medicine should be checked by gynecological examination or laboratory tests. Ovulation usually occurs between the 11th and 15th day of the cycle. If ovulation does not occur, "Scheme II" should be applied.
Scheme II: A daily dose of 100 mg is used for 5 days, starting from the 5th day of the next cycle.
If ovulation still does not occur, the doctor may repeat the same treatment scheme (administering the dose of 100 mg again).
In the case of continued lack of ovulation, after a 3-month break, the doctor may decide on another 3-month treatment cycle. Further repetition of treatment is not recommended.
The dose should not be increased above 100 mg per day or the duration of administration extended beyond 5 days.
In polycystic ovary syndrome, due to the possibility of hyperstimulation, the initial dose should be lower (25 mg per day).
In the case of amenorrhea after contraception, a daily dose of 50 mg is used; usually, a 5-day treatment is effective, even during the first treatment cycle.
Clostilbegyt should not be used by women who have already gone through menopause (stopped menstruating).

Use in Children and Adolescents

The medicine should not be used in children and adolescents.

Overdose of Clostilbegyt

In case of overdose, immediately inform your doctor or go to the nearest hospital. Take the medicine packaging with you. This will help the doctor know what medicine was taken. Probably, there will be excessive ovarian stimulation (see section 4 below).
In case of overdose, the following symptoms may be observed: nausea, vomiting, vascular symptoms (hot flashes), flushing of the face, visual disturbances (visual acuity disturbances, flashing lights, visual field disturbances), ovarian enlargement with abdominal or pelvic pain.
In case of overdose, after removal of clomifene from the body, only supportive treatment is recommended. In case of overdose, immediately consult a doctor.

Missed Dose of Clostilbegyt

In case of a missed dose, consult your doctor, as the treatment cycle may need to be changed. Do not take a double dose to make up for the missed dose.
In case of irregular intake of the medicine, the desired therapeutic effect (ovarian follicle maturation) may not be achieved.

Stopping Clostilbegyt

In case of treatment with Clostilbegyt, the treatment lasts 5 days. If the treatment is stopped before this period, the effect of the medicine may not be achieved.
In case of any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible Side Effects

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

Stop Taking Clostilbegyt and Immediately Consult Your Doctor or Go to the Hospital if You Experience:

• An allergic reaction. Symptoms include: rash, difficulty swallowing or breathing, swelling of the face, lips, throat, or tongue (angioedema).
• Numbness, weakness, or paralysis of one side of the body, slurred speech, sudden vision loss, confusion, and tremors. These may be symptoms of a stroke.
• Uterine bleeding and abdominal pain during pregnancy. These may be symptoms of an ectopic pregnancy (see section 2 above).

The frequency of the above side effects is not known (cannot be estimated from the available data).

Stop Taking Clostilbegyt and Immediately Consult Your Doctor if You Notice Any of the Following Serious Side Effects – You May Need Urgent Medical Attention:

Common(may affect up to 1 in 10 people)

• Visual disturbances, spots, flashing lights, afterimages. These are usually reversible side effects, but in some cases, they may be permanent. Your doctor may recommend an eye examination. Frequency Not Known(cannot be estimated from the available data)
• Ovarian hyperstimulation. This may cause abdominal, pelvic, or calf pain, sweating, or a feeling of bloating, decreased urine output, difficulty breathing, or weight gain. In such cases, your doctor may recommend reducing the dose of Clostilbegyt.
• Liver disorders that may lead to yellowing of the whites of the eyes and skin (jaundice).
• Sudden and severe headaches.
• Psychiatric disorders such as paranoid psychosis.

Tell Your Doctor or Pharmacist if Any of the Following Side Effects Get Worse or Last Longer Than a Few Days:

Very Common(may affect more than 1 in 10 people)

• Flushing of the skin
• Pelvic or abdominal pain, weight gain, swelling. This may be a sign of ovarian enlargement Common(may affect up to 1 in 10 people)
• Nausea or vomiting
• Increased menstrual pain, heavy menstrual bleeding, or intermenstrual bleeding
• Breast pain
• Headaches
• Feeling bloated Uncommon(may affect up to 1 in 100 people)
• Feeling more tense than usual
• Balance disorders or dizziness (feeling of spinning)
• Feeling tired or having difficulty sleeping (insomnia)
• Feeling depressed Rare(may affect up to 1 in 1,000 people)
• Seizures
• Clouding of the lens of the eye (cataract)
• Worsening of vision, eye pain, and difficulty seeing certain colors (optic neuritis) Very Rare(may affect up to 1 in 10,000 people)
• Hair loss or thinning

Frequency Not Known(cannot be estimated from the available data)

• Pelvic or abdominal pain, weight gain, swelling. This may be a sign of endometriosis (a condition in which cells lining the uterus are present in other organs of the body, such as the uterine muscles) or worsening of endometriosis and ovarian cancer
• Massive ovarian enlargement
• Multiple pregnancies, e.g., twins
• Increased blood fat levels (hypertriglyceridemia)
• Abdominal or left upper quadrant pain. This may be a sign of pancreatitis, which may be caused by high blood fat levels
• Rapid or irregular heartbeat
• Skin changes on the legs, arms, hands, feet, and changes in the mouth (erythema multiforme)
• Vision problems
• Feeling faint or loss of consciousness
• Disorientation and speech disorders
• Rash and itching of the skin
• Bruises on the skin
• Swelling of the face, around the eyes, lips, or tongue
• Abnormal liver test results
• Tumors related to the endocrine system or hormone-dependent
• Increased liver enzyme levels in blood tests. This may indicate abnormal liver function.
• Numbness or tingling (paresthesia)
• Feeling anxious
• Mood or behavior changes

Hot flashes observed during treatment are temporary and disappear after the end of treatment.
There may be cystic ovarian enlargement, especially in the rare Stein-Leventhal syndrome. Your doctor may recommend measuring body temperature and, depending on the results, decide to stop treatment. The frequency of twin pregnancies during treatment may be higher than in the general population. During clomifene treatment, ectopic pregnancies may occur more frequently.
There have been reports of ovarian cancer cases associated with the use of fertility-enhancing products. Some studies suggest that prolonged use of clomifene may increase this risk. Therefore, the recommended treatment time should not be exceeded.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Clostilbegyt

Store in a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after the abbreviation "Lot".
Do not use this medicine if you notice any discoloration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Clostilbegyt Contains

• The active substance is 50 mg of clomifene citrate in each tablet.
• The other ingredients are: gelatin, magnesium stearate, stearic acid, talc, potato starch, lactose monohydrate (100 mg).

What Clostilbegyt Looks Like and Contents of the Pack

White or yellowish-white, flat tablets in the shape of a disk with beveled edges, odorless, with the inscription "CLO" on one side.
A brown glass bottle with a polyethylene (LDPE) cap and a safety seal, in a cardboard box.
10 tablets - 1 bottle of 10 tablets.
20 tablets - 1 bottle of 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

EGIS Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38.
Hungary

Manufacturer:

EGIS Pharmaceuticals PLC
H-9900 Körmend, Mátyás király út 65.
Hungary
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of Last Revision of the Leaflet: