When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to leuprolide or norethindrone, or if you are pregnant or breastfeeding. You should not receive this medicine if you have liver disease, problems caused by blood clots, or a history of breast cancer or other hormone-sensitive cancer.

How to Use This Medicine:

• Lupaneta Pack® is a kit that contains 2 medicines that work together.
• Injection:
  
  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
  • A nurse or other health provider will give you this medicine.
  • This is a long-acting medicine that is given once a month or once every 3 months, for up to 6 months of treatment.
• Tablet:
  
  • Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine every day while you are being treated with the injection medicine, for up to 6 months.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how leuprolide works. Tell your doctor if you are using medicine to treat seizures or steroid medicine (such as hydrocortisone, methylprednisolone, prednisone, prednisolone, or dexamethasone).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control that does not contain hormones.
• Tell your doctor if you have kidney problems, osteoporosis, migraine headaches, or a history of seizures, depression, asthma, or allergies. Tell your doctor if you smoke or drink alcohol regularly. Tell your doctor if you have risk factors for heart attack or stroke, such as high blood pressure, diabetes, heart disease, high cholesterol, or family history of blood clots.
• This medicine may cause the following problems:
  
  • Weaker bones, which may lead to osteoporosis
  • Depression
• Endometriosis symptoms may get worse for a short time when you first start using this medicine. These symptoms should get better as your body gets used to the medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Rapid weight gain, swelling in your hands, ankles, or feet
• Seizures
• Severe depression, loss of interest in usual activities, trouble concentrating, mood swings
• Sudden loss of vision, double vision, bulging eyes, migraine headache
• Unusual or severe bone or back pain

If you notice these less serious side effects, talk with your doctor:

• Headache
• Hot flashes, warmth or redness in your face, neck, arms, or upper chest
• Nausea, vomiting
• Redness, pain, swelling, or itching where the shot was given
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088