What is this medicine?

Enclomiphene Citrate (en KLOE mi teen SIT rate).

• Enclomiphene citrate is a selective estrogen receptor modulator (SERM)
• It is the trans isomer of clomiphene citrate
• It may affect pituitary gonadotropin release
• It may be used to impact fertility.
• It may also be used for other conditions as determined by your doctor.

Compounded Drug Forms: Oral Dissolving tablet

What should I tell my health care provider before I take this medicine?

• Allergy to clomiphene
• History of liver disease or dysfunction
• History or presence of abnormal uterine bleeding
• History or presence of ovarian cancer or cysts
• History or presence of uterine fibroids
• History or presence of PCOS
• Thyroid or adrenal function problems
• History or presence of hypertipidemia
• Pregnant or breastfeeding

How should I use this medicine?

• Follow the package directions provided by the pharmacy and by your prescriber. Your dosage ls based on your medical condition and response to therapy. Follow the dosing schedule provided carefully.
• Oral dosage forms may be taken with or without food. If It upsets your stomach take it with a small meal.
• Sublingual formulations should be placed under the tongue or between the cheek and gums and held In place until fully dissolved. Avoid swallowing saliva to ensure the best absorption into the blood stream. Avoid eating or drinking 15 minutes before or after taking sublingual formulations.

What should I watch for while using this medicine?

• Signs of an allergic reaction: hives blistering, swelling of the mouth, face, lips tongue throat, trouble breathing.
• Prior to initiating therapy, triglyceride levels and serum estrogen levels (In female patients)
• Regular check-ups with your provider are recommended.

What side effects or adverse drug reactions may I notice from receiving this medicine?

Side effects that may occur and may go away as your body gets used to the medication include:

• GI upset (bloating, nausea, vomiting)
• Headache
• Hot flashes
• Increased estrogen levels

What serious events prompt immediate attention?

Contact your doctor immediately or seek medical attention if you experience:

• Pancreatitis like symptoms, including severe abdominal or back pain, nausea or vomiting
• Extreme dizziness
• Passing out
• Changes in extremities like swelling, numbness, color change, warmth, pain In leg or arm
• Vision problems
• Signs of ovarian hyperstimulation syndrome
• Severe gastrointestinal distress, weight gain, shortness of breath, urine output changes

You may experience side effects not listed. Contact your doctor with questions. An allergic reaction to this medication is unlikely but seek medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, and/or trouble breathing.

Contraindications:

History of liver disease or dysfunction, abnormal uterine bleeding, ovarian cyst enlargement or development (not related to PCOS), uncontrolled thyroid or adrenal dysfunction, presence of organic intracranial lesion (ex: pituitary tumor), pregnancy.

Where should I keep my medicine?

• Follow the storage recommendations found on your prescription label.
• Store tablets at room temperature between 59- and 86-degrees F, unless otherwise specified on the packaging.

Additional Information:

• Do not share this medication with others to whom It was not prescribed.
• Keep out of reach of children and pets.
• If an overdose is suspected contact your local poison control center at 1-800-222-1222 or go to the nearest emergency room.

NIOSH Drug: Observe special handling and disposal requirements.

This product contains medications deemed hazardous by the National Institute for Occupational Safety & Health (NIOSH) and require special precaution when handling or disposing. If possible, use latex (or similar) gloves when handling/applying this medication or disposing of the medication. Wash your hands thoroughly after use. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them, preferably in a sealed container (zip-lock bag). However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication Is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs In your community. See the FOA's Safe Disposal of Medicines website for more information if you do not have access to a take-back program.

If you have any questions concerning this or any of your medications, a pharmacist is available during normal business hours to answer your questions. You may report side effects to the FDA at 1-800-FDA-1088.

What is compounding?

Compounding is the preparation of medicine by a pharmacist for an individual patient according to a doctor's prescription. The practice predates the manufacture by mass production of drugs. In every field of medicine, there are some patients who don't respond to traditional methods of treatment. Sometimes they need medicine at strengths that are not manufactured by drug companies. Sometimes they simply need a different method of ingesting a medication.