OMIFIN 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Omifin 50 mg Tablets

Clomifene, Citrate

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 any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to 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.

Contents of the pack

1. What Omifin is and what it is used for
2. What you need to know before you take Omifin
3. How to take Omifin
4. Possible side effects
5. Storage of Omifin
6. Contents of the pack and other information

1. What Omifin is and what it is used for

Omifin is a treatment for infertility in women due to ovulation insufficiency. It can be used as a diagnostic and therapeutic test in certain cases of amenorrhea (absence of periods). It is used in assisted reproduction to stimulate ovulation.

2. What you need to know before you take Omifin

Do not take Omifin

Do not take Omifin if you have any of the following conditions. If any of these conditions appear during treatment, stop treatment and consult your doctor:

• Female infertility not due to the cause mentioned above.
• Thyroid or adrenal gland disorders.
• If you have or have had severe liver disease.
• Gynecological bleeding of unknown origin.
• Certain types of tumors.
• Ovarian cysts, except for polycystic ovary.
• Visual disturbances during treatment or during previous treatments.
• If you are allergic to clomifene citrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Omifin.

Omifin should be used under medical supervision.

Treatment with Omifin in women provides a slightly higher than normal possibility of multiple pregnancy, with its consequences.

Pregnancy

In case of doubt, perform a pregnancy test. Verify that there is no pregnancy before repeating each cycle.

Omifin may cause ovarian hyperstimulation, which is usually mild and exceptionally severe. To avoid it, the use of the lowest effective doses is recommended. This hyperstimulation usually occurs a few days after finishing treatment with Omifin. Ovarian hyperstimulation with Omifin rarely complicates and usually resolves spontaneously. In these cases, the symptoms are pelvic abdominal pain, distension, weight gain, and/or a feeling of generalized bloating. If this occurs, do not repeat treatment with Omifin until the ovary returns to its normal size. Consult your doctor if this occurs.

In case of uterine fibroids, special monitoring is required due to the potential increase in their size.

Some cases of benign or malignant tumors have been reported with the use of infertility treatments, but there is no conclusive data on this risk to establish recommendations.

Other medicines and Omifin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products.

Concomitant use of clomifene with other selective estrogen receptor modulators (SERMs) is not recommended.

Use in athletes

Patients should be warned that this medicine contains clomifene, which may produce a positive result in doping tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Omifin is not indicated during pregnancy. Animal studies have shown harmful effects on the fetus. The application of these results to humans is random. Currently, there is no clear data to assess a possible risk of fetal malformation when administered during pregnancy. The incidence of fetal anomalies associated with the use of clomifene during pregnancy was within the range reported for the general population in clinical studies. In case of administration during pregnancy, there is no basis for recommending termination of pregnancy.

It is not known whether clomifene citrate is excreted in human milk. Breastfeeding may be reduced.

Driving and using machines

Visual adverse effects have been described, particularly in cases of variable light intensity, which may interfere with driving vehicles.

Omifin contains lactose and sucrose

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Omifin

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor again.

The tablets are taken with water. The tablet can be divided into equal doses. The recommended dose is:

Treatment of infertility in women

Start with a cycle of 1 tablet (50 mg) daily for 5 days. Treatment should start 2 to 5 days after the onset of natural or induced menstrual bleeding (progestogen), or on any day chosen by the doctor if there are no periods. The following situations may occur:

• When treatment achieves ovulation, it is not necessary to increase the dose in subsequent cycles. When ovulation is achieved but not pregnancy, the dose that has been effective can be maintained for up to 6 cycles.

• When ovulation is not achieved (no elevation of basal temperature, no elevation of progesterone measured in blood analysis on days 20 to 26 of the cycle), a new cycle with 100 mg (2 tablets in a single dose) is recommended for 5 days. In these cases, treatment with Clomifene should not exceed 3 cycles.

Some patients with micropolycystic ovaries may be hypersensitive to Omifin even at the initial dose of 50 mg per day. In this case, the dose can be reduced to half a tablet per day (25 mg) in subsequent cycles.

It is essential to correctly synchronize sexual intercourse with ovulation.

In assisted reproduction, ovulation is induced with 2 tablets of Omifin per day from the 2nd to the 6th day of the cycle, followed by hormone (hMG) for several days to achieve the maturation of several follicles.

Diagnostic test

Dose of 2 tablets of Omifin in a single dose per day for 5 consecutive days and for a single cycle. Your doctor will evaluate the production of certain hormones (FSH) after treatment with this medicine.

If you take more Omifin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount ingested.

No cases of acute intoxication have been reported. In case of overdose, nausea, vomiting, hot flashes, visual disturbances, ovarian enlargement with abdominal and pelvic pain may appear. In the treatment of overdose, symptomatic and supportive measures are recommended.

If you forget to take Omifin

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, it is unknown whether it can be made up for during the cycle, so the cycle should be considered canceled.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

For most side effects whose frequency is not indicated, no such information is available.

Benign or malignant tumors

• Isolated cases of certain tumors, more frequently dependent on hormone production.

Metabolism and nutrition disorders

• Increased blood fats (triglycerides) associated with pancreatitis in cases of familial hypertriglyceridemia, related to more prolonged use or higher doses than recommended.

Psychiatric disorders

• Cases of worsening of pre-existing psychosis, as well as asthenia-depression, nervousness, insomnia, have been reported.

Nervous system disorders

• Cases of dizziness, drowsiness, feeling of drunkenness, headache, and convulsions have been described.

Eyes disorders

• Blurred vision, persistence of luminous and sparkling images, in approximately 2% of cases. Their frequency increases with the increase in doses taken. They appear for the first time or intensify with exposure to bright light. They usually disappear within a few days to a few weeks after stopping the medicine. Their appearance contraindicates the use of clomifene in the future. Some rare cases of cataracts have been reported.

Heart disorders

• Tachycardia (increased heart rate), palpitations.

Vascular disorders

• Hot flashes (may affect up to 1 in 10 women).

Gastrointestinal disorders

• Nausea and vomiting, abdominal distension, and pancreatitis.

Skin and subcutaneous tissue disorders

• Urticaria, allergic dermatitis, alopecia (hair loss).

Kidney and urinary disorders

• Polyuria (increased frequency of urination).

Pregnancy, puerperium, and perinatal disorders

• Moderate risk of multiple and ectopic pregnancy.

Female reproductive system and breast disorders

• Ovarian hyperstimulation (see section 2. What you need to know before you take Omifin).
• Insufficiency of cervical mucus due to the anti-estrogenic action, which may justify local estrogen treatment.
• Some cases of worsening of pre-existing endometriosis have been reported.
• Intermenstrual bleeding.
• Breast pain.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omifin

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions. Keep in the original package to protect from light.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the package and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omifin

The active ingredient is clomifene citrate. Each tablet contains 50 mg of clomifene citrate.

The other ingredients (excipients) are: lactose monohydrate, sucrose, corn starch, pregelatinized corn starch, magnesium stearate.

Appearance of the product and contents of the pack

The tablets are presented in PVC/PVDC-Al blisters.

Each package contains 10 round, white, and scored tablets on one side.

Marketing authorization holder

Laboratorios Effik, S.A.

C/ San Rafael n° 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Cyndea Pharma, S.L.

Pol. Ind. Emiliano Revilla Sanz

Avenida de Ágreda, 31

42110 Ólvega, Soria

Spain

Date of last revision of this leaflet:November 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.