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Formulation : 
Description
Indications
This medication is prescribed to treat severe acne in women with an oily skin condition called seborrhea, as well as unwanted or excess hair growth on the body, including the face and chest. It contains two hormones: cyproterone, a progestin, and ethinyl estradiol, an estrogen. These hormones work together to reduce oil production on the skin, thereby clearing acne, and also to decrease excessive hair growth.
Cyproterone possesses anti-androgen (anti-testosterone) properties. Testosterone, a male hormone present in small amounts in women, can exacerbate acne and lead to excessive hair growth. Cyproterone functions by blocking the effects of testosterone. Ethinyl estradiol is included to counterbalance cyproterone’s impact on the menstrual cycle. This medication is typically prescribed when other acne treatments have proven ineffective.
Uses and Dosage
Take this medication orally as directed by your doctor, typically once daily.
Select a consistent time of day that is easy for you to remember, and take your medication at that same time each day.
Each package contains 21 tablets. If this is your first time using this medication, begin by taking the first tablet on the first day of your menstrual period. Continue taking one tablet daily for 21 consecutive days until the pack is depleted. Subsequently, abstain from taking any tablets for 7 days unless otherwise instructed by your doctor. You should experience your menstrual period during these 7 days without medication. Once you have completed 7 days without taking this medication, commence a new pack on the following day, regardless of whether your period has started.
Initiate each new pack/cycle on the same day of the week as you commenced the previous pack/cycle, even if you are still menstruating. If you do not experience menstruation, contact your doctor.
As per the manufacturer’s instructions, long-term use of this medication is not recommended. Discontinue this medication 3 to 4 cycles after improvement in acne symptoms.
It may take several months before you experience the full benefits of this drug. Inform your doctor if your condition persists or worsens.
The likelihood of pregnancy increases if you miss pills, start a new pack/cycle late, or take your pill at a different time of day than usual. Vomiting and diarrhea may also reduce the effectiveness of this medication. If you experience vomiting or diarrhea, consult your doctor to determine if additional forms of birth control are necessary.
Side Effects
Some side effects may occur that usually do not need medical attention:
- abdominal cramps and bloating
- appetite changes
- breast pain, tenderness, or swelling
- brown, blotchy spots on exposed skin
- discomfort wearing contact lenses
- dizziness
- excess hair growth on face, chest, legs
- hair loss
- headache
- increased or decreased interest in sexual intercourse
- irritability
- menstrual pain
- mood changes
- nausea
- nervousness
Inform your healthcare provider immediately if you experience any serious side effects:
- abnormal, uncontrollable movements of the arms or legs
- changes in the uterine bleeding pattern during or between menstrual periods
- decreased blood flow to the extremities (Raynaud’s syndrome)
- decreased milk supply if breast-feeding
- difficulty becoming pregnant after stopping the medication
- signs of depression
- for women with diabetes: mild increase of blood sugar, faintness, nausea, pale skin, or sweating
- for women with a history of breast disease: lumps in breast
- headaches or migraines (although headaches may lessen for many users, they may increase in number or become worse for others)
- hearing changes
- vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
- vision changes
- abdominal or stomach pain (sudden, severe, or continuing)
- shortness of breath
- sudden, partial, or complete loss of vision
- swelling of the face, hands, feet, or airways
Caution
- Before using this medication, inform your doctor or pharmacist if you are allergic to it, other birth control pills/patches/rings, or female hormone products (estrogens/progestins), or if you have any other allergies. This product may contain inactive ingredients that could trigger allergic reactions or other problems.
- Prior to using this medication, disclose your medical history to your doctor or pharmacist, especially if you have a history of blood clots, a close family history of blood clots, blood clotting disorders, stroke, high blood pressure, cancer, diabetes, headaches/migraines, heart problems, liver problems, jaundice during pregnancy or while using birth control pills, unexplained vaginal bleeding, a certain eye problem (vision loss caused by blood vessel disease in the eye), pregnancy-aggravated hearing loss (otosclerosis), high blood cholesterol/fat (triglyceride) levels, depression, swelling (edema), a family or personal history of a certain swelling disorder (angioedema), gallbladder problems, kidney disease, obesity, underactive thyroid (hypothyroidism), or uterine fibroids.
- If you have diabetes, this medication may affect your blood sugar levels. Monitor your blood sugar regularly as directed and inform your doctor of the results. Notify your doctor immediately if you experience symptoms of high blood sugar such as increased thirst or urination. Your doctor may need to adjust your diabetes medication, exercise regimen, or diet.
- Inform your doctor if you have recently had surgery, will be undergoing surgery, or will be immobilized for an extended period (such as during a long plane flight). These circumstances elevate your risk of developing blood clots, especially when using hormonal birth control. You may need to discontinue this medication temporarily or take special precautions.
- This medication may induce blotchy, dark areas on your face and skin (melasma). Sun exposure may exacerbate this effect. Minimize your time in the sun, avoid tanning booths and sunlamps, and use sunscreen and protective clothing when outdoors.
- If you are nearsighted or wear contact lenses, you may experience vision problems or difficulty wearing your contact lenses. Contact your eye doctor if such issues arise.
- It may take longer for you to conceive after discontinuing birth control pills. Consult your doctor for guidance.
- This medication should not be used during pregnancy. If you become pregnant or suspect you may be pregnant, notify your doctor immediately. If you have recently given birth or experienced a pregnancy loss/abortion after the first 3 months, discuss reliable forms of birth control with your doctor and determine when it is safe to start using estrogen-containing birth control, such as this medication.
- This medication passes into breast milk, which may affect milk production and harm a nursing infant. Breastfeeding is not recommended while using this product. Consult your doctor before breastfeeding.
Form and Strength
Diane 35 is available in the following forms and strengths:
- Diane 35 tablet:
- 2 mg / 0.035 mg
- cyproterone and ethinyl estradiol tablet:
- 2 mg / 0.035 mg
FAQ
Is weight gain a side effect of Diane 35?
Some patients reported gaining weight while taking this medication. There are ways to manage your weight if you are concerned about gaining weight on birth control. Eat a nutrient-rich diet, exercise regularly, and try reducing stress.
Does Diane 35 cause mood swings?
Mood swings and depression are possible but rare side effects of hormonal birth controls.
Resources
- https://www.health.com/condition/birth-control/birth-control-weight-gain#:~:text=There%20are%20ways%20to%20manage,and%20your%20overall%20well%2Dbeing
- https://myhealth.alberta.ca/Health/medications/Pages/conditions.aspx?hwid=fdb7115#fdb7115-03
- https://www.medbroadcast.com/drug/getdrug/diane-35#adverseeffects
- https://www.healthlinkbc.ca/medications/ethinyl-estradiolcyproterone-oral
- https://www.drugs.com/uk/cyproterone-acetate-ethinylestradiol-tablets-2mg-0-035mg-leaflet.html
