NORMOLUTE N

Description

COMPOSITION:

NORETHISTERONE IS USED FOR:

TREATING CERTAIN MENSTRUAL PROBLEMS OR UTERINE PROBLEMS (EG, ABNORMAL BLEEDING, ENDOMETRIOSIS). IT MAY ALSO BE USED FOR OTHER CONDITIONS AS DETERMINED BY YOUR DOCTOR.

NORETHISTERONE IS A PROGESTIN HORMONE. IT WORKS BY ALTERING THE LINING OF THE UTERUS.

DO NOT USE NORETHISTERONE IF:

YOU ARE ALLERGIC TO ANY INGREDIENT IN NORETHISTERONE

YOU ARE PREGNANT OR THINK YOU MAY BE PREGNANT

YOU HAVE UNDIAGNOSED ABNORMAL VAGINAL BLEEDING OR ARE POSTMENOPAUSAL

YOU HAVE A HISTORY OF BLOOD CLOTTING PROBLEMS, SEVERE BLOOD CLOTS (EG, IN THE LUNGS, LEGS, EYES), CERTAIN BLOOD VESSEL PROBLEMS (EG, BLEEDING IN THE BRAIN, HEART ATTACK, STROKE), OR BREAST CANCER

YOU HAVE DECREASED LIVER FUNCTION OR ACTIVE LIVER DISEASE

CONTACT YOUR DOCTOR OR HEALTH CARE PROVIDER RIGHT AWAY IF ANY OF THESE APPLY TO YOU.

BEFORE USING NORETHISTERONE:

TELL YOUR HEALTH CARE PROVIDER IF YOU HAVE ANY MEDICAL CONDITIONS, ESPECIALLY IF ANY OF THE FOLLOWING APPLY TO YOU:

IF YOU ARE PLANNING TO BECOME PREGNANT OR ARE BREAST-FEEDING

IF YOU ARE TAKING ANY PRESCRIPTION OR NONPRESCRIPTION MEDICINE, HERBAL PREPARATION, OR DIETARY SUPPLEMENT

IF YOU HAVE ALLERGIES TO MEDICINES, FOODS, OR OTHER SUBSTANCES

IF YOU HAVE SEIZURES (EG, EPILEPSY), MIGRAINES, HEART PROBLEMS, KIDNEY PROBLEMS, OR A HISTORY OF DEPRESSION

IF YOU HAVE A HISTORY OF HIGH BLOOD PRESSURE, DIABETES, HIGH BLOOD CHOLESTEROL, LUPUS, OR BLOOD CLOTS, OR IF A MEMBER OF YOUR FAMILY HAS HAD THESE PROBLEMS

IF YOU SMOKE OR ARE VERY OVERWEIGHT

SOME MEDICINES MAY INTERACT WITH NORETHISTERONE. TELL YOUR HEALTH CARE PROVIDER IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES:

APREPITANT, CARBAMAZEPINE, FELBAMATE, GRISEOFULVIN, HIV PROTEASE INHIBITORS (EG, RITONAVIR), HYDANTOINS (EG, PHENYTOIN), MODAFINIL, NEVIRAPINE, RIFAMPIN, ST. JOHN’S WORT, OR TETRACYCLINES BECAUSE THEY MAY DECREASE NORETHISTERONE’S

EFFECTIVENESS :

CORTICOSTEROIDS (EG, PREDNISONE), THEOPHYLLINE, OR TROLEANDOMYCIN BECAUSE THE RISK OF THEIR SIDE EFFECTS MAY BE INCREASED BY NORETHISTERONE

BETA-ADRENERGIC BLOCKERS (EG, PROPRANOLOL), LAMOTRIGINE, OR THYROID MEDICINES BECAUSE THEIR EFFECTIVENESS MAY BE DECREASED BY NORETHISTERONE

THIS MAY NOT BE A COMPLETE LIST OF ALL INTERACTIONS THAT MAY OCCUR. ASK YOUR HEALTH CARE PROVIDER IF NORETHISTERONE MAY INTERACT WITH OTHER MEDICINES THAT YOU TAKE. CHECK WITH YOUR HEALTH CARE PROVIDER BEFORE YOU START, STOP, OR CHANGE THE DOSE OF ANY MEDICINE.

HOW TO USE NORETHISTERONE:

USE NORETHISTERONE AS DIRECTED BY YOUR DOCTOR. CHECK THE LABEL ON THE MEDICINE FOR EXACT DOSING INSTRUCTIONS.

AN EXTRA PATIENT LEAFLET IS AVAILABLE WITH NORETHISTERONE. TALK TO YOUR PHARMACIST IF YOU HAVE QUESTIONS ABOUT THIS INFORMATION.

TAKE NORETHISTERONE BY MOUTH WITH OR WITHOUT FOOD.

TAKE NORETHISTERONE AT THE SAME TIME EVERY DAY, WITH DOSES NOT MORE THAN 24 HOURS APART.

IF YOU MISS A DOSE OF NORETHISTERONE, TAKE IT AS SOON AS POSSIBLE. IF IT IS ALMOST TIME FOR YOUR NEXT DOSE, SKIP THE MISSED DOSE AND GO BACK TO YOUR REGULAR DOSING SCHEDULE. DO NOT TAKE 2 DOSES AT ONCE.

ASK YOUR HEALTH CARE PROVIDER ANY QUESTIONS YOU MAY HAVE ABOUT HOW TO USE NORETHISTERONE.

IMPORTANT SAFETY INFORMATION:

NORETHISTERONE MAY CAUSE DIZZINESS. THIS EFFECT MAY BE WORSE IF YOU TAKE IT WITH ALCOHOL OR CERTAIN MEDICINES. USE NORETHISTERONE WITH CAUTION. DO NOT DRIVE OR PERFORM OTHER POSSIBLY UNSAFE TASKS UNTIL YOU KNOW HOW YOU REACT TO IT.

NORETHISTERONE MAY CAUSE DARK SKIN PATCHES ON YOUR FACE. AVOID THE SUN, SUNLAMPS, OR TANNING BOOTHS UNTIL YOU KNOW HOW YOU REACT TO NORETHISTERONE. USE A SUNSCREEN OR WEAR PROTECTIVE CLOTHING IF YOU MUST BE OUTSIDE FOR MORE THAN A SHORT TIME.

NORETHISTERONE MAY INTERFERE WITH CERTAIN LAB TESTS. BE SURE YOUR DOCTOR AND LAB PERSONNEL KNOW YOU ARE TAKING NORETHISTERONE.

DIABETES PATIENTS – NORETHISTERONE MAY AFFECT YOUR BLOOD SUGAR. CHECK BLOOD SUGAR LEVELS CLOSELY. ASK YOUR DOCTOR BEFORE YOU CHANGE THE DOSE OF YOUR DIABETES MEDICINE.

NORETHISTERONE SHOULD NOT BE USED IN CHILDREN; SAFETY AND EFFECTIVENESS IN CHILDREN HAVE NOT BEEN CONFIRMED.

PREGNANCY AND BREAST-FEEDING: DO NOT USE NORETHISTERONE IF YOU ARE PREGNANT. IF YOU THINK YOU MAY BE PREGNANT, CONTACT YOUR DOCTOR RIGHT AWAY. NORETHISTERONE IS FOUND IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING WHILE YOU USE NORETHISTERONE, CHECK WITH YOUR DOCTOR. DISCUSS ANY POSSIBLE RISKS TO YOUR BABY.