Juliana

Each pink active film-coated tablet contains Drospirenone (Juliana) 3 mg and Ethinylestradiol (Juliana) 20 mcg as active substances. The white film-coated tablets do not contain active substances. It also contains the following ingredients: Pink active film-coated tablets: Tablet Core: Lactose monohydrate, pregelatinized starch (maize), povidone, croscarmellose sodium, polysorbate 80, magnesium stearate. Coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). White film-coated tablets: Tablet Core: Anhydrous lactose, povidone, magnesium stearate. Coating: Partially hydrolized polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Each blister contains 28 tablets, 24 pink, active film-coated tablets in the 1st, 2nd, 3rd and 4th rows of the strip and 4 white placebo film-coated tablets in row 4. The core of the tablet is coated.

Each of the 24 active tablet contains a small quantity of 2 different female hormones, called Drospirenone (Juliana) (a progestogen) and Ethinylestradiol (Juliana) (an estrogen). Due to the small quantity of the hormones, Juliana is considered a low-dose oral contraceptive. Since all tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.

The 4 tablets do not contain active ingredients and are called placebo tablets.

Contraceptive used to prevent pregnancy.

Oral contraceptives are very effective method of birth control. The chance of becoming pregnant is very low when the pill is taken correctly.

Juliana may also have non-contraceptive health benefits: Prevent weight gain and other symptoms eg, bloating and swelling which are related to fluid retention.

Drospirenone (Juliana) also has antiandrogenic activity which can help to reduce acne and greasiness of the skin and hair. With these special properties, Drospirenone (Juliana) is similar to the natrual progesterone hormone produced by the body.

The risk of anemia may be lower since the period may be lighter and shorter. The menstrual pains may also become less severe and completely disappear.

Juliana combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and Drospirenone (Juliana), and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

Juliana is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

Juliana does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Juliana is available only with your doctor's prescription.

2.1 How to Take Juliana

Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

To achieve maximum contraceptive effectiveness, Juliana must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

How to Start Juliana

Instruct the patient to begin taking Juliana either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start

During the first cycle of Juliana use, instruct the patient to take one yellow Juliana daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one yellow Juliana daily for 21 consecutive days, followed by one white tablet daily on Days 22 through 28. Juliana should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Juliana can be taken without regard to meals. If Juliana is first taken later than the first day of the menstrual cycle, Juliana should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of Juliana use, instruct the patient to take one yellow Juliana daily, beginning on the first Sunday after the onset of her menstrual period. She should take one yellow Juliana daily for 21 consecutive days, followed by one white tablet daily on Days 22 through 28. Juliana should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Juliana can be taken without regard to meals. Juliana should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of Juliana on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her yellow tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Juliana is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a yellow Juliana daily for seven consecutive days.

When switching from a different birth control pill

When switching from another birth control pill, Juliana should be started on the same day that a new pack of the previous oral contraceptive would have been started.

When switching from a method other than a birth control pill

When switching from a transdermal patch or vaginal ring, Juliana should be started when the next application would have been due. When switching from an injection, Juliana should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Juliana should be started on the day of removal.

Withdrawal bleeding usually occurs within 3 days following the last yellow tablet. If spotting or breakthrough bleeding occurs while taking Juliana, instruct the patient to continue taking Juliana by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

Although the occurrence of pregnancy is low if Juliana is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Juliana if pregnancy is confirmed.

The risk of pregnancy increases with each active yellow tablet missed. For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the FDA-Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of yellow tablets on the proper day.

For postpartum women who do not breastfeed or after a second trimester abortion, start Juliana no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts Juliana postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Juliana for 7 consecutive days.

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet.

See also:
What is the most important information I should know about Juliana?

Hypersensitivity to Drospirenone (Juliana) or Ethinylestradiol (Juliana) or any other ingredient in Juliana. This could cause itching, a rash or inflammation.

Patients that have (or have had in the past) blood clots (thrombosis) in a blood vessel of the leg, lungs (embolsim) or other organs; a heart attack or stroke; any illness which could lead to a heart attack (eg, angina pectoris which causes serious pain in the chest) or a stroke (eg, a temporary or minor stroke without residual effects); certain form of migraine (focal neurological symptoms); inflammation of the pancreas (pancreatitis); liver illness and hepatic function have not yet normalized; kidneys do not work well (kidney failure); liver tumor; suspect breast cancer or cancer of the sexual organs.

Any illness which could increase the risk of developing artery thrombosis eg, diabetes with damaged blood vessels, very high blood pressure, very high fat levels in the blood (cholesterol or triglycerides); disturbance of blood clotting (eg, protein C deficiency); vaginal bleeding and the cause is unknown.

Use in pregnancy: If the patient is pregnant, do not take Juliana. If the patient is pregnant when taking Juliana, stop taking it immediately and contact the doctor.

Consult the doctor or pharmacist before taking any medicine.

Use Juliana as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Juliana. Talk to your pharmacist if you have questions about this information.
• Take Juliana by mouth with or without food.
• Talk with your doctor about how you should start to take your first pack of Juliana. If you begin to take Juliana during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take Juliana on the Sunday after your period starts, you will need to use an extra form of birth control for 7 days after you start taking Juliana.
• If you are switching from another birth control pill to Juliana, start Juliana on the same day that would have started a new pack of your previous birth control pills. Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to Juliana.
• Take Juliana at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
• For Juliana to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
• If you miss 1 dose of Juliana, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup form of birth control if you only miss 1 pill. If you miss more than 1 dose, read the extra patient leaflet that comes with Juliana or contact your doctor for instructions. You must use a backup form of birth control if you miss more than 1 dose. If you are not sure how to handle missed doses, use an extra form of birth control (eg, condoms) until you talk with your doctor.

Ask your health care provider any questions you may have about how to use Juliana.

Use: Labeled Indications

Acne vulgaris (Gianvi, Loryna, Nikki, Vestura, Yaz): Treatment of moderate acne vulgaris in women 14 years and older only if the patient desires an oral contraceptive for birth control

Contraception: Prevention of pregnancy

Premenstrual dysphoric disorder (Gianvi, Yaz): Treatment of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception

Off Label Uses

Abnormal uterine bleeding

Based on the American College of Obstetricians and Gynecologists committee opinion on the management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women, ethinyl estradiol and Drospirenone (Juliana) (among other oral contraceptive combinations) is effective and recommended for the management of abnormal uterine bleeding.

See also:
What other drugs will affect Juliana?

Always inform the prescriber about the medications or herbal preparations the patient are taking. Also inform any other health professional that has prescribed other medication (or the pharmacist) that the patient is taking Juliana. The healthcare professional may inform the patient the need to use additional contraceptives (eg, condom) and inform the patient the duration.

Some medicine can cause Juliana to lose its contraceptive effect or can cause unexpected bleeding. This applies to medicines used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (eg, rifampicin), HIV (ritonavir), other infectious disease (griseofulvin, ampicillin, tetracyclines) and the medicinal herb St. John's wort.

If the patient wants to use herbal preparations which contain St. John's wort while taking Juliana, she should consult the doctor beforehand. Juliana can affect other medicines eg, those which contain ciclosporin or the anticonvulsant drug lamotrigine (this can increase the frequency of convulsions).

Consult the doctor or pharmacist before taking any medicine. Inform the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Juliana with Food and Drink: Take Juliana tablet everyday with some water if needed. The patient can take the tablets with or without food, but should take Juliana approximately at the same time everyday.

Laboratory Tests: If the patient need a blood analysis, inform the doctor or laboratory staff that the patient is taking a contraceptive, as oral contraceptives can affect the results of some test.

See also:
What are the possible side effects of Juliana?

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

• Serious cardiovascular events and stroke
• Vascular events
• Liver disease

Adverse reactions commonly reported by COC users are:

• Irregular uterine bleeding
• Nausea
• Breast tenderness
• Headache

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

The data provided reflect the experience with the use of Juliana (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18 -35 who were treated for up to 13 cycles. The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of Juliana vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17-40 who were treated for up to 26 cycles.

The most common adverse reactions ( ≥ 2% of users) were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%) abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%).

Adverse Reactions ( ≥ 1%) Leading to Study Discontinuation

Of 2,837 women, 6.7% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was headache/migraine (1.5%).

Serious Adverse Reactions

Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Juliana. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.

Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension

Hepatobiliary disorders: Gallbladder disease

Immune system disorders: Hypersensitivity

Metabolism and nutrition disorders: Hyperkalemia

Skin and subcutaneous tissue disorders: Chloasma