Gallifrey is a brand name for Norethindrone Acetate Tablets, which contain norethindrone acetate as the active ingredient in the form of an acetic acid ester. This drug is part of the progestin class and comes in tablet form for oral administration, with a dosage strength of 5 mg per tablet. Key inactive ingredients include anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

How should I use this medication?

Take this medication by mouth with a glass of water. You may take this medication with or without food. Follow the directions on the prescription label. Take this medication at the same time each day. Do not take your medication more often than directed.

A patient information sheet will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• New or worsening migraines or headaches
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual vaginal discharge, itching, or odor
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Hair loss
• Irregular menstrual cycles or spotting
• Nausea
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood vessel disease or blood clots
• Breast, cervical, or vaginal cancer
• Depression
• Diabetes
• Heart disease
• Kidney disease
• Liver disease
• Migraine
• Seizures
• Stroke
• Vaginal bleeding
• An unusual or allergic reaction to norethindrone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Amprenavir or fosamprenavir
• Bosentan

This medication may also interact with the following:

• Antibiotics or medications for infections, such as rifampin, rifabutin, rifapentine, and griseofulvin
• Aprepitant
• Barbiturate medications, such as phenobarbital
• Carbamazepine
• Felbamate
• Modafinil
• Oxcarbazepine
• Phenytoin
• Ritonavir or other medications for HIV infection or AIDS
• St. John's Wort
• Topiramate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication.

If you have any reason to think you are pregnant, stop taking this medication right away and contact your care team.

If you are taking this medication for hormone-related problems, it may take several cycles of use to see improvement in your condition.