Clomid

Clomid

Active principles: Clomiphene Citrate

1. For this drug is indicated?

What’s the use of Clomid

ClomidClomid is used for the treatment of female infertility due to Anovulation, i.e. for those patients who fail to ovulate.

CLOMID is indicated only for patients who do not ovulate including under the conditions described in this package insert and for patients where the clomiphene citrate is not contraindicated. Other causes of infertility should be excluded or adequately treated before treatment.

2. How this medicine works?

Expected action of Clomid

Clomid helps the growth of eggs and this allows them to be released from the ovaries for fertilization. Ovulation usually occurs 6 to 12 days after administration of CLOMID.

3. When should I not use this medicine?

Contraindications and risks of Clomid

Clomid is contraindicated in patients with hypersensitivity (allergy) to clomiphene citrate or to any component of the formula.

Use during pregnancy and lactation

CLOMID should not be administered during pregnancy.

To avoid inadvertent CLOMID administration during early pregnancy, it must use the appropriate tests for each treatment cycle to determine if ovulation has occurred, for example, determine the basal body temperature in all cycles of treatment and observe the patient carefully to determine whether or not signs of ovulation. The patient should have a pregnancy test before the start of the next cycle of treatment with CLOMID.

In some patients, clomiphene citrate can reduce the accumulation of milk in certain regions of the postpartum tits and lactation.

Other contraindications

Treatment with CLOMID is contraindicated in patients with liver disease or a history of hepatic (liver) dysfunction in patients with hormone-dependent tumors or patients with abnormal metrorrhagia (uterine bleeding) of undetermined origin, ovarian cyst, polycystic ovary, except as it may be a further dilatation of the cyst. In patients who have thyroid or adrenal dysfunction (thyroid or adrenal gland problems, which are not controlled), patients with intracranial organic lesions, such as a tumor of the pituitary gland (gland located in the brain that produces hormones).

If you become pregnant during treatment, stop the medication and consult your doctor.Tell the doctor if you are breast-feeding.

Clomid should not be used by women who are pregnant or who could become pregnant during treatment.

This product contains yellow dye TARTRAZINE which may cause allergic reactions of nature, including bronchial asthma, especially in people allergic to acetylsalicylic acid.

Attention diabetics: contains sugar.

4. What should I know before I use this medicine?

Precautions and warnings of Clomid

Warnings and precautions

It is necessary to perform a gynecological exam before starting each treatment cycle.The incidence of endometrial carcinoma (cancer of the inner layer lining the uterus) and ovulatórias dysfunction increase with age, therefore, the endometrial biopsy should always rule out the presence of cancer.

Ovarian hyperstimulation syndrome (SHEO)

Ovarian hyperstimulation syndrome (SHEO) has been reported in patients receiving treatment with CLOMID alone or in combination with gonadotropins. Rare cases of severe forms of SHEO were reported, and the following symptoms occurred: pericardial effusion (excess fluid around the heart), anasarca (generalized swelling or edema), hydrothorax (excess fluid in the pleural cavity), acute abdomen, kidney failure (kidney function), pulmonary edema (accumulation of fluid in the lungs), ovarian hemorrhage (bleeding in the ovaries), deep vein thrombosis (the formation or presence of a blood clot in a vein) torsion of ovary, and acute respiratory stress. As a result of design, rapid progression can occur from severe form of the syndrome.

To minimize the possibility of an increase in abnormal ovarian associated with CLOMID therapy, it is recommended that you use the lowest dose consistent with the forecast of good results. The patient should be advised to seek your doctor in case of any abdominal or pelvic pain, weight gain, discomfort and/or abdominal volume increase during or after treatment with CLOMID. Maximum dilation of the ovary may not occur for several days after discontinuation of treatment with CLOMID. Some patients with Polycystic ovary syndrome that are so unusual, sensitive to gonadotropin may have exaggerated response to usual doses of CLOMID.

If you have any problems in using CLOMID, your doctor should examine you and assess whether there was emergence of ovarian cysts by gynecological examination of the pelvis. If this occurred the treatment will be suspended by the doctor until the full regression pretreatment size.

Visual symptoms

Turbidity may occur or other visual symptoms such as spots or flashes (scintillating scotoma) during or shortly after treatment with CLOMID. These visual disturbances are usually reversible; However, cases of prolonged visual disturbances have been reported even after the discontinuation of treatment with CLOMID. The visual disturbances may be irreversible, especially with increasing dose and duration of treatment. The significance of these visual symptoms has not been clarified. In the event of Visual abnormalities, you should discontinue treatment and conduct a detailed eye exam.

Other Precautions

One should be cautious when CLOMID is used in patients with uterine fibroids due to the potential for further increase of fibroids.

Cases of hypertriglyceridemia (increased triglyceride level) have been reported (see item 8. WHAT A BLESSING THIS MEDICATION CAN CAUSE ME?) in post-marketing experience of CLOMID. Family history or pre-existing Hyperlipidemia and the use of higher doses than those recommended and/or increased duration of treatment with CLOMID are associated with risk of hypertriglyceridemia. Periodic monitoring of the triglycerides in plasma can be indicative in these patients.

Changes in the ability to drive vehicles and operate machinery

Activities such as driving or operating machinery can be risky, particularly in poor lighting conditions. It is unknown if the source of such symptoms.

This product contains yellow dye TARTRAZINE which may cause allergic reactions of nature, including bronchial asthma, especially in people allergic to acetylsalicylic acid.

Attention diabetics: contains sugar.

Drug interactions of Clomid

There are no reports of specific interaction with other medications, however the doctor should be informed by the patient about other drugs in use, mainly drugs that act in the synthesis of cholesterol.

Use of Clomid in pregnancy and breastfeeding

CLOMID should not be used during pregnancy (see use during pregnancy and lactation).

Ectopic pregnancy (pregnancy that occurs outside the uterine cavity)

There is an increased chance of ectopic pregnancy (including ovarian and tubal) in women who conceived after CLOMID therapy.

Teratogenic effects/no teratogenic

The general incidence of reports of congenital abnormalities in pregnancies induced by treatment with CLOMID during clinical studies, is within the limits observed in the general population.

Based on population studies, were published reports of a possible elevation in risk of Down syndrome, in cases of induced ovulation, and increase of trisomy defects among fetuses spontaneously sub-férteis women, ovulation-inducing drugs (no case with CLOMID exclusively, no other drug induces). However, the reports are very small in number yet to confirm statistically a risk that justifies the amniocentesis, in addition to the usual indications due to age or family history.

Pregnancy loss

The experience of patients with all Diagnostics for clinical research of CLOMID demonstrated loss of pregnancy (single or multiple) or fetal loss rate of 21.4%.

Fertility effects: multiple pregnancy

There is an increased likelihood of multiple pregnancy related to treatment with CLOMID. The potential complications and hazards of multiple pregnancy should be discussed with the patient before treatment of clomid. During clinical trials, the incidence of multiple pregnancy was 7.9% (186 of 2369) patients who got pregnant in which results were reported.

Clomid should not be used by women who are pregnant or who could become pregnant during treatment.

Lactation

It is not known if CLOMID is excreted in human milk. CLOMID may reduce lactation.

Tell your doctor or dentist if you are using any other medicine.

Do not use medicine without your doctor’s knowledge. Can be dangerous to your health.

5. Where, how and for how long can I take this medicine?

Storage, production date, expiry date and physical aspect of Clomid

CLOMID should be kept at room temperature (between 15 and 30° C). Protect from light and moisture.

Do not use medicine with term of validity expired. Keep it in its original packaging.

Lot number and dates of manufacture and expiry date: see the packaging.

Features of clomid

Clomid is presented in tablet form circular, yellow, with beveled edges, with Groove on one side and the other Medley recording.

Before use, note the appearance of clomid. If it is within validity and you notice any change in appearance, see the pharmacist to find out if you can use it.

All medicine must be kept out of the reach of children.

6. How should I use this medicine?

Dosage, dosage and instructions for use of Clomid

The treatment consists of 3 cycles, which may be continuous or alternated, the medical criteria. After treatment, you should try to get pregnant. However, if you become pregnant during treatment, you should stop the medication (see item 3. WHEN SHOULD I NOT USE THIS MEDICINE?). The recommended dose for the first cycle of treatment is of 50 mg (1 tablet) daily for 5 days. In patients who do not menstruate treatment can be started in any period of the menstrual cycle. If scheduled induction of menstruation by using progesterone or spontaneous menstruation, CLOMID should be administered from the 5th day of the cycle. If ovulation occurs with this dosage, there is no advantage in increasing the dose in 2 cycles. If ovulation does not occur after the first treatment cycle, must be instituted a second cycle with 100 mg daily for 5 days, after 30 days of previous treatment.

The increased dosage should not exceed the dose and duration of 100 mg/day for 5 days. Most patients responsive to CLOMID, ovulate after the first treatment cycle and 3 cycles are sufficient for an evaluation of therapeutics. If menstruation does not occur in this time period, or the diagnosis should be reviewed. The continuation of the treatment after 3 cycles is not recommended in patients who do not demonstrate evidence of ovulation.

Since it was not demonstrated the harmlessness on cyclic extended treatment, it is not recommended to continue treatment after 6 cycles (including 3 ovulatory cycles).

Special populations

Special care with low doses or treatment cycle length are particularly recommended if there is suspicion of unusual sensitivity to pituitary gonadotropin, as for example, in patients with Polycystic Ovary Syndrome (see warnings and precautions).

When CLOMID is administered in an extended period of time, it may interfere with the synthesis of cholesterol.

Patients on prolonged treatment may show elevated blood levels of desmosterol, which is a precursor of cholesterol.

Follow your doctor’s guidance, always respecting the schedules, doses and duration of treatment.

Do not discontinue treatment without your doctor’s knowledge.

Clomid should not be broken, opened or chewed.

7. What should I do when I forget to use this medicine?

Do not take two tablets at the same time to make up for the forgotten pill. The oblivion of a dose could compromise the treatment and the ovulatório cycle. Notify your doctor as soon as possible to receive new guidelines.

If in doubt, seek advice from a pharmacist or your doctor or dentist.

8. What are the ills that this medication can cause me?

Side effects of Clomid

Clomid may cause some undesirable reactions. If you have an allergic reaction, you should stop using clomid and inform your doctor the appearance of undesirable reactions.

• Very common Reaction (occurs in 10% of patients using clomid): increase the size of the ovaries. There is an increased chance of ectopic pregnancy (including ovarian and tubal) in women who conceived after treatment with CLOMID. Hot flashes (sudden sensation of heat).

• Common reaction (occurs between 1% and 10% of patients using clomid): red-faced visual symptoms that disappear quickly with the interruption of treatment, abdominal discomfort, sore boobs, nausea and vomiting, insomnia, headache, dizziness, Vertigo, increased urination, pain urinating. There are new cases of endometriosis (a disease that affects women of reproductive age and the presence of endometrium in places outside of the uterus. The endometrium is the inner layer of the uterus which is renewed monthly by menstruation) and exacerbation of pre-existing endometriosis during treatment with CLOMID.

• Unusual Reaction (occurs between 0.1% and 1% of patients using clomid): abnormal uterine bleeding, depression and fatigue, itching and skin rash, weight gain, hair loss, dry hair, pimples, increased appetite, palpitation, chest pain, constipation, diarrhea, bloating, pain in the eyes, fever, high blood pressure, increased by, migraines, mood swings, worsening of cancers and also changes in the uterus as the appearance of fibroids brain tumors, pituitary tumors and boobs, bleeding, seizures, fainting ovarian, temporary loss of vision, thyroid gland disorders, buzz, increase in transaminases (liver enzymes), pregnancy in the fallopian tubes, increased heartbeat, inflammation of the pancreas and endometrial thickness reduction.

• Rare reaction (occurs between 0.01% and 0.1% of patients using clomid): cataract and optic neuritis.

• Very rare Reaction (occurs in less than 0.01% of patients using clomid): there are no reports of very rare reactions to clomid.

• Other possible reactions: vasomotor menopausal symptoms resemble heat waves, and are usually not serious. They quickly disappear after stopping treatment. The Visual symptoms generally described as blurred vision or spots or flashes [Visual scotomas (vision of bright dots)] increase in incidence with increasing total dose. These symptoms seem to be stemming from intensification or prolongation after images, which have also been reported. The symptoms often appear the first time or are accentuated with exposure to a bright environment. Scotoma set ophthalmologist, phosphenes and reduction of visual acuity were reported. These visual disturbances are usually reversible; However, cases of prolonged visual disturbances have been reported after discontinuation of treatment with CLOMID. The visual disturbances may be irreversible, especially with increased dose and duration of treatment.

Multiple pregnancy, including intrauterine pregnancy and simultaneous extrauterina was reported.

Reports were received from isolated occurrence of endocrine-dependent tumors/neoplasms or its aggravation.

Hypertriglyceridemia (increased level of triglycerides), in some cases pancreatites (inflammation of the pancreas), were observed in patients with pre-existing hipergliceridemia or with a family history and/or doses and duration of treatment exceeding posological recommendations described in the package insert.

Tell your doctor, dentist or pharmacist the appearance of unwanted reactions by the use of clomid. Notify the company via their service.

9. What to do if someone use a greater amount than indicated this medicine

Overdosage of Clomid

There were no reported cases of acute poisoning with CLOMID, but the number of registered cases of overdose is small. In case of overdose appropriate measures of support should be employed. Signs and symptoms of overdose can be nausea and vomiting, vasomotor symptoms, clouding of vision, scintillating scotomas (vision of bright dots), increase of the ovary with abdominal or pelvic pain. Intense hyperstimulation of the ovary may be accompanied by weight gain and ascites (accumulation of fluid in the stomach). Women of childbearing age who have taken an overdose of CLOMID should be observed during 2 or 3 weeks about the possibility of ovarian hypertrophy (increase in the size of the ovaries).