Treats pain caused by endometriosis.

Brand Name(s):

When This Medicine Should Not Be Used:

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.
• 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.
• 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/norethindrone works. Tell your doctor if you are using seizure medicine or steroid medicine.

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 (including diaphragm with spermicide, condoms with spermicide, IUD) to keep from getting pregnant.
• Tell your doctor if you have kidney disease, heart or blood vessel problems, osteoporosis, migraine headaches, or a history of seizures, depression, or asthma. Tell your doctor if you have high blood pressure, diabetes, heart disease, high cholesterol, or family history of blood clots, or if you smoke or drink alcohol regularly.
• This medicine may cause the following problems:
  • Weaker bones, which may lead to osteoporosis
  • Increased risk for seizures
  • 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
• Blurred or change in vision, eye pain, severe headache, fainting, dizziness, lightheadedness
• Rapid weight gain, swelling in your hands, ankles, or feet
• Seizures
• Severe depression, loss of interest in usual activities, trouble concentrating, mood swings
• 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