Novarel

Headache, restlessness, tiredness, or pain at injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling of the hands/ankles/feet, mental/mood changes (such as depression, irritability), signs of early puberty in boys (such as facial/pubic hair, voice change, acne), pain/swelling of the breast (in boys), unusual vaginal bleeding (women).

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or decreased urination.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, sudden severe headache, confusion, weakness on one side of the body, trouble speaking, sudden vision changes, pain/redness/swelling in the legs.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, shortness of breath.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: early puberty (in boys), blood clots, heart disease (such as chest pain, heart attack), high blood pressure, kidney disease, liver disease, lung problems (such as asthma), migraine, seizure disorder, stroke, unusual vaginal bleeding, problems of the uterus, unexplained ovarian cyst/enlargement, certain type of fertility problem (primary ovarian failure), thyroid problem, adrenal gland problem, cancer of the reproductive organs (breast, uterus, ovary, prostate), brain tumor.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

When this medication is used in women to treat infertility, it may cause multiple births (such as twins, triplets).

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: gonadorelin.

This medication may interfere with certain lab tests (including luteinizing hormone-LH/follicle stimulating hormone-FSH levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store the vials of powder at room temperature away from light and moisture. Store the mixed medication in the refrigerator. Write the date when the medication was mixed on the vial. The mixed medication must be used within 1 to 2 months, depending on the product. Check the product package for the storage time for your product. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.