SIDE EFFECTS: Hot flashes (flushing), increased sweating, night sweats, headache, upset stomach, nausea/vomiting, weight gain, breast changes (such as tenderness, pain), acne, joint/muscle aches, trouble sleeping, reduced sexual interest, hair loss, abnormal vaginal bleeding, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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: mental/mood changes (such as new or worsening depression, thoughts of suicide, mood swings, memory problems), bone pain, easily broken bones, swelling of the hands/feet, vaginal pain/itching/discharge, frequent/burning/painful urination, yellowing eyes/skin, dark patches on the skin or face (melasma). Get medical help right away if you have any very serious side effects, including: seizures. Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first 2 weeks after your first injection of leuprolide. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (such as severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting. Norethindrone may rarely cause very serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden severe headaches, slurred speech, weakness on one side of the body, sudden vision changes. A very serious allergic reaction to this product 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. 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.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to leuprolide or norethindrone; or to other drugs similar to leuprolide (GnRH or GnRH-like hormones such as goserelin); 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 product, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, high blood fat levels (high cholesterol/triglycerides), heart disease (such as heart attack, coronary artery disease, heart failure), high blood pressure, obesity, diabetes, stroke, your family medical history (especially breast lumps/cancer or blood clots), depression, cancer of the breast or other female organs, liver disease (such as liver cancer), kidney disease, blood clots, migraine headaches, asthma, seizures, lupus. Leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time, because it reduces estrogen levels. Therefore, it is recommended that you do not use this medication for more than a total of 12 months. Your doctor will monitor the health of your bones closely. Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors for osteoporosis: long-term alcohol use, smoking, family history of osteoporosis and broken bones, use of certain medications (for example, corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin). The medications in this kit may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Tell your doctor if you will be having surgery or will be confined to a chair or bed for a long time (such as on a long plane flight). You may need to stop norethindrone for a time or take special precautions. Do not smoke. Smoking combined with norethindrone further increases your risk for strokes, blood clots, high blood pressure, and heart attacks. Norethindrone may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. This kit must not be used during pregnancy. Leuprolide and norethindrone may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. Consult your doctor for more details and to discuss reliable forms of birth control. Non-hormonal birth control methods (such as condoms, diaphragm with spermicide) are recommended during treatment. It is unknown if leuprolide passes into breast milk. Norethindrone passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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. The medications in this kit may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.

OVERDOSE: 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.