Serophene (Oral)

Clomiphene is a fertility medicine used by some women who have difficulty getting pregnant.

Clomiphene likely works by altering the hormone balance in the body. In women, this helps trigger ovulation and readies the body for pregnancy.

Clomiphene may also be used for other conditions in both females and males as decided by your doctor.

The following information is only for female patients taking clomiphene. If you are a male and have questions about using clomiphene, talk to your doctor.

Clomiphene is available only with a prescription from your doctor.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working and to look for unwanted effects.

At certain times in your menstrual cycle, your doctor may want you to use an ovulation prediction test kit. Follow your doctor's instructions carefully. Ovulation is controlled by luteinizing hormone (LH). LH is found in the blood and urine in very small amounts during most of the menstrual cycle but rises suddenly for a short time in the middle of the cycle. This sharp rise, known as the LH surge, usually leads to ovulation within about 30 hours. A woman is most likely to become pregnant if she has intercourse within the 24 hours after detecting the LH surge. Ovulation prediction test kits are used to check for this large amount of LH in the urine. This method is better for predicting ovulation than measuring daily basal body temperature. It is important that intercourse occurs at the correct time to give you the best chance of becoming pregnant.

There is a chance that clomiphene may cause birth defects if taken after you become pregnant. Stop taking this medicine and tell your doctor immediately if you think you have become pregnant while still taking clomiphene.

This medicine may cause blurred vision, difficulty reading, or other changes in vision. It may also cause some people to feel dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not clear-headed or able to see well. If these reactions are especially bothersome, check with your doctor.

In deciding to use a medicine, it is important to consider the risks against the benefits. This is a choice you will make with your doctor. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. Let your healthcare professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods, as interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Unusually large ovary or
• Cyst on ovary—Clomiphene may cause the cyst to grow larger

• Endometriosis—Inducing ovulation (including using clomiphene) may make endometriosis worse because the body's estrogen level increases; estrogen can lead to growth of endometriosis implants

• Fibroid tumors of the uterus—Clomiphene may cause fibroid tumors to grow larger

• Inflamed veins due to blood clots—Clomiphene may worsen this condition

• Liver disease (or a history of it)—Clomiphene may worsen any liver disease

• Mental depression—Existing depression may worsen due to hormone changes caused by clomiphene

• Unusual vaginal bleeding—Some irregular vaginal bleeding may indicate that the lining of the uterus is growing too much or could signal cancer of the uterus lining; these issues must be checked before using clomiphene, as it can aggravate these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating
• stomach or pelvic pain

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Blurred vision
• decreased or double vision or other vision problems
• seeing flashes of light
• sensitivity of eyes to light
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Hot flashes

Less common or rare

• Breast discomfort
• dizziness or lightheadedness
• headache
• heavy menstrual periods or bleeding between periods
• mental depression
• nausea or vomiting
• nervousness
• restlessness
• tiredness
• trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Clomid
• Serophene

Available Dosage Forms:

• Tablet

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Gonadotropin

Take this medicine only as directed by your doctor. If you are to begin on Day 5, count the first day of your menstrual period as Day 1. Beginning on Day 5, take the correct dose every day for as many days as your doctor ordered. To help you to remember to take your dose of medicine, take it at the same time every day.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For treating infertility: Adults—50 milligrams (mg) a day for five days of a menstrual cycle. The treatment is usually started on the fifth day of your menstrual period. If you do not have menstrual cycles, you can begin taking your medicine at any time. If you do not become pregnant after the first course, your doctor may increase your dose a little at a time up to 250 mg a day. Your treatment may be repeated until you do become pregnant or for up to four treatment cycles.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• What are the uses and side effects of enclomiphene capsules?