Lunelle

What is the most important information I should know about Lunelle?

· Cigarette smoking increases the risk of serious cardiovascular (heart and circulatory system) side effects from contraceptives containing estrogen. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite significant in women over 35 years of age. Women who use Lunelle are strongly advised not to smoke.

· Lunelle does not protect you from sexually transmitted diseases including HIV and AIDS, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. Using a condom is the only way to protect yourself from these diseases.

· Your doctor, nurse, or other health care provider will inject this medication monthly, every 28 to 30 days and no later than 33 days after the last injection. Lunelle can only be effective in preventing pregnancy if you receive the injections at the proper times.

· Do not take Lunelle if you are pregnant.

 

What is Lunelle?

· Estradiol is a form of estrogen and medroxyprogesterone is a form of progesterone, which are both female hormones involved in conception. The combination of Lunelle prevents ovulation (the release of an egg from the ovaries). Lunelle also causes the cervical mucous to thicken, which makes it harder for sperm to move toward the uterus, and it prevents the attachment of an egg to the uterus.

· Lunelle are used together to prevent pregnancy.

· Lunelle may also be used for purposes other than those listed in this medication guide.

 

Who should not use Lunelle?

· Do not use Lunelle without first talking to your doctor if you     ·have angina;     ·have had a heart attack or stroke;     ·have a bleeding or blood-clotting disorder such as blood clots in the legs, lungs, or eyes;     ·have breast, uterine, cervical, or vaginal cancer;     ·have liver disease or a history of jaundice (yellowing of the skin and eyes) caused by use of birth control in the past;     ·have undiagnosed, abnormal vaginal bleeding;     ·smoke 15 or more cigarettes per day and are over age 35.

· Before using Lunelle, tell your doctor if you     ·have breast nodules, fibrocystic breast disease, an abnormal breast x-ray or mammogram, or a strong family history of breast cancer;     ·have gallbladder disease;     ·have migraines;     ·have diabetes;     ·have high blood pressure or heart disease;     ·have elevated cholesterol or triglycerides;     ·have epilepsy;     ·have mental depression;     ·have kidney disease;     ·have a history of scanty or irregular menstrual periods; or     ·smoke.

· You may not be able to use Lunelle, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· Lunelle is in the FDA pregnancy category X. This means that this medication will cause birth defects in an unborn baby. Do not use Lunelle if you are pregnant or if you are planning a pregnancy.

· Lunelle may affect milk flow and milk composition. Do not use Lunelle without first talking to your doctor if you are breast-feeding a baby.

 

How should I use Lunelle?

· Use Lunelle exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

· Your doctor, nurse, or other health care provider will inject this medication monthly, every 28 to 30 days and no later than 33 days after the last injection. Lunelle can only be effective in preventing pregnancy if you receive the injections at the proper times.

· The first injection should be given within the first 5 days of the start of your normal menstrual period. If you are presently using another type of birth control, your doctor will decide the best time for you to start Lunelle.

· If you have recently been pregnant or had a baby, discuss with your doctor the best time for you to start Lunelle.

· The next injections must be given monthly, every 28 to 30 days and no longer than 33 days after the last injection. The time for the next injection is determined by the number of days since the previous injection, and not by the timing or amount of your menstrual bleeding. Even if you do not have any menstrual bleeding, you should still return once a month for your Lunelle injection.

· It is important that you receive the next injections at the right time. If you cannot receive the injection on time, contact you doctor to receive an earlier injection.

· If you decide that you want to become pregnant, you will need to stop the monthly injections of Lunelle. Most women begin to produce eggs again (and could become pregnant) about two to three months after the last injection of this medication. There may be some delay in becoming pregnant after you stop using this medication, especially if you had irregular menstrual cycles before you started using this medication. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping hormonal contraceptives.

· Your doctor will store Lunelle at room temperature away from moisture and heat.

 

What happens if I miss a dose?

· You could become pregnant if you miss an injection or wait longer than 33 days between injections. The more days you wait, the greater the risk that you could become pregnant. Ask your doctor to recommend another type of birth control such as condoms or spermicide for you to use if an injection is missed or delayed. Talk to you doctor to find out when you should receive the next injection.

 

What happens if I overdose?

· An overdose of Lunelle is unlikely to occur since the injection is given by a health care professional.

· An overdose of Lunelle may cause nausea and menstrual bleeding in females.

 

What should I avoid while using Lunelle?

· Lunelle does not protect you from sexually transmitted diseases including HIV and AIDS, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. Using a condom is the only way to protect yourself from these diseases.

· Cigarette smoking increases the risk of serious cardiovascular (heart and circulatory system) side effects from contraceptives containing estrogen. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite significant in women over 35 years of age. Women who use Lunelle are strongly advised not to smoke.

 

What are the possible side effects of Lunelle?

· If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:     ·an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);     ·shortness of breath, coughing of blood, or pain or heaviness in the chest;     ·a painful, red, swollen leg;     ·weakness or numbness in an arm or leg;     ·pain, swelling, or tenderness in the abdomen;     ·severe headache, dizziness, or faintness;      ·vomiting;     ·changes in vision or speech;     ·yellowing of the skin or eyes;     ·a lump in a breast;     ·persistent pain, pus, or bleeding at the injection site; or     ·unusually heavy vaginal bleeding.

· Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience     ·nausea;     ·changes in appetite;     ·weight gain;     ·changes in sexual desire;     ·tenderness or enlargement of the breasts;     ·acne;     ·changes in menstrual bleeding;     ·fluid retention or swelling;     ·headache; or     ·depression (including difficulty sleeping, sleeping too much, weakness, lack of energy, fatigue, or change in mood).

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Lunelle?

· Before using Lunelle, tell your doctor if you are taking any of the following medicines:     ·rifampin (Rifadin);     ·a seizure medication such as phenytoin (Dilantin), carbamazepine (Tegretol), or phenobarbital (Luminal);     ·an herbal product containing St. John's Wort or Hypericum perforatum; or     ·an antibiotic.

· You may not be able to use Lunelle, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

· Drugs other than those listed here may also interact with Lunelle. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

 

Where can I get more information?

· Your pharmacist has additional information about Lunelle written for health professionals that you may read.