Label: information for the user

Omifin 50 mg tablets

Clomifene citrate

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Omifin is a treatment for female infertility due to ovulation insufficiency.andit can be used as a diagnostic and therapeutic test in certain amenorrheas (absence of menstruation). It is used in assisted reproduction to stimulate ovulation.

Do not take Omifin

Do not take Omifin in the presence of any of the following processes. If any of these processes appear during its use, suspend the treatment and consult with your doctor:

• Female infertility not due to the cause mentioned above.
• Alterations in the thyroid and adrenal glands.
• If you have or have had severe liver disease.
• Unexplained gynecological hemorrhage.
• Certain types of tumors.
• Ovarian cysts, except for polycystic ovary syndrome.
• Visual disturbances during treatment or during previous treatments.
• If you are allergic to clomifene citrate or to any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omifin.

Omifin should be used under medical supervision.

The 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 moderate and exceptionally severe. To avoid it, it is recommended to use the lowest effective doses. This hyperstimulation would arise a few days after completing the treatment with Omifin. Ovarian hyperstimulation with Omifin rarely complicates and usually resolves spontaneously. In these cases, the symptoms are pelvic and abdominal pain, distension, weight gain, and/or generalized swelling. In case of occurrence, do not repeat the treatment with Omifin until the ovary recovers its normal volume. Consult your doctor if symptoms occur.

In case of uterine fibroids, special vigilance should be made due to the potential increase in their size.

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

Other medications and Omifin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medications, including over-the-counter medications, homeopathic medications, herbal remedies, and other health-related products.

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

Use in athletes

Notify patients that this medication contains clomifene, which may produce a positive result in doping control tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Omifin is not indicated during pregnancy. Animal studies showed harmful effects on the fetus. The application of those results to humans is arbitrary. Currently, there is no clear data to evaluate the possibility of fetal malformations when administered during pregnancy. The incidence of fetal anomalies associated with the use of clomifene during pregnancy was within the communicated range for the general population. In case of administration during pregnancy, there is no basis to advise termination of pregnancy.

The excretion of clomifene citrate in human milk is unknown. It may reduce lactation.

Driving and operating machines

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

Omifin contains lactose and saccharose

This medication contains lactose and saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as 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 female infertility

Start with a cycle of 1 tablet (50 mg) per day for 5 days. Treatment should begin 2 to 5 days after the start of natural or induced menstrual bleeding (with progestogens), or if there is no menstruation on a day chosen by your doctor. The following situations may occur:

• If treatmentachieves ovulation, it is not necessary to increase the dose in subsequent cycles. If ovulation is achieved but no pregnancy occurs, the effective dose can be maintained for up to 6 cycles.

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

Some patients with polycystic 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 synchronize sexual intercourse correctly with ovulation.

In assisted reproduction, ovulation is induced with 2 tablets per day of Omifin 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 daysandfor a single cycle. Your doctor will evaluate the production of certain hormones (FSH) after treatment with this medication.

If you take more Omifin than you should

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

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

If you forgot to take Omifin

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose, it is unknown whether it can be compensated during the cycle, so it is recommended to consider canceling the cycle.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Malignant or benign tumors

• Isolated cases of the appearance of certain tumors, more frequently hormone-producing.

Metabolism and nutrition disorders

• Increased blood fats (triglycerides) associated with pancreatitis in cases of familial hypertriglyceridemia, related to 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 seizures have been described.

Vision disorders

• Blurred vision, persistence of luminous and sparkling images, in approximately 2% of cases. Their frequency increases with the increase in doses ingested. 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 medication. 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 (can affect up to 1 in 10 women).

Digestive disorders

• Nausea and vomiting, abdominal distension, and pancreatitis.

Skin and subcutaneous tissue disorders

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

Renal and urinary disorders

• Polyuria (increased frequency of urination).

Pregnancy, puerperium, and perinatal diseases

• Moderate risk of multiple and ectopic pregnancy.

Female reproductive system and breast disorders

• Ovarian hyperstimulation (see section 2. What you need to know before starting to take Omifin).
• Cervical mucus insufficiency due to antiestrogenic action, which may justify local estrogen treatment.
• Some cases of worsening of pre-existing endometriosis (inflammation or thickening of the endometrium) have been reported.
• Intermenstrual bleeding.
• Mammary pain.

Reporting of side effects

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

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

This medication does not require special storage conditions. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Deposit empty packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Omifin

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

The other components (excipients) are:monohydrate lactose, sucrose, cornstarch, pregelatinized cornstarch, magnesium stearate.

Appearance of the product and content of the packaging

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

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

Holder of the marketing authorization

Laboratorios Effik, S.A.

C/ San Rafael n° 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Cyndea Pharma, S.L.

Pol. Ind.Emiliano Revilla Sanz

Avenida de Ágreda, 31

42110 Ólvega, Soria

Spain

Last review date of this leaflet:November 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.