What is Diane-35® (cyproterone – ethinyl estradiol) used for?
Diane-35® is commonly used for the treatment of androgenization in women, such as severe acne when other treatments have not been successful, or excessive growth of facial or body hair from mild to moderate level, as underlying cause has not found.
Diane-35® ED can be used as a contraception because it contains a progestogen and an oestrogen hormone, works similarly to the combined oral contraceptive birth control pill. It should not be used in combination with another hormonal contraceptive.
How should I take Diane-35® (cyproterone – ethinyl estradiol)?
- Take one tablet daily at about the same time. You must take Diane-35® regardless of how often you have sex. This will help you remember when to take it.
- Swallow the tablet whole with water. It does not matter if you take it before or after food.
- Each blister pack is marked with the day of the week.
- Take your first tablet from the red area on the blister pack corresponding to the day of the week.
- Follow the direction of the arrows on the blister pack until all the tablets have been taken.
- Always start a new blister pack on the same day of the week as your previous pack.
How do I store Diane-35® (cyproterone – ethinyl estradiol)?
- Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
- Keep your tablets in a cool dry place where the temperature stays below 25°C.
- Do not store your tablets or any other medicine in the bathroom, near a sink, or on a window-sill. Do not leave medication in the car. Heat and damp can destroy some medicines.
- Keep Diane-35® ED where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Precautions & warnings
What should I know before using Diane-35 (cyproterone – ethinyl estradiol)?
Before you begin taking Diane-35, be sure to inform your doctor of any medical conditions or allergies you may have, any Diane-35s you are taking, whether you are pregnant or breastfeeding, and any other significant facts about your health.
Is it safe during pregnancy or breastfeeding?
Diane-35 should not be taken by pregnant women as it can cause harm to the developing baby. If you become pregnant or suspect that you may be pregnant while taking Diane-35, contact your doctor immediately. After stopping treatment, you should wait until at least one normal menstrual cycle has occurred before trying to get pregnant.
Diane-35 passes into breast milk and can reduce the amount and quality of breastmilk produced. Diane-35 is not recommended for women who are breastfeeding.
What side effects can occur from Diane-35® (cyproterone – ethinyl estradiol)?
The more common side effects are:
- Abdominal pain;
- Changes in weight;
- Headache, including migraines;
- Mood changes, including depression;
- Breast tenderness or pain.
You may need urgent medical attention or hospitalization if you meet some serious, rare side effects.
- Pain in the chest, arm, or below the breastbone;
- Discomfort radiating to the back;
- Swelling, pain or tenderness of one leg;
- Sudden weakness, numbness or bad “pins and needles” of the face, arm or leg, especially on one side of the body;
- Sudden trouble walking, dizziness, loss of balance or coordination;
- Severe, sudden abdominal pains;
- A fainting attack or you collapse;
- Unusual headaches or migraines that are worse than usual;
- Sudden problems with speech, understanding or eyesight.
What drugs may interact with Diane-35 (cyproterone – ethinyl estradiol)?
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interact with Diane-35, including:
- Medicines used to treat tuberculosis such as rifampicin, rifabutin.
- Medicines used to treat epilepsy such as phenytoin, primidone, barbiturates (e.g., phenobarbitone), carbamazepine, oxcarbazepine, topiramate, felbamate, lamotrigine.
- Medicines used to treat HIV, such as ritonavir or nevirapine.
- Some medicines used to treat Hepatitis C Virus (HCV) such as boceprevir, telaprevir.
- Antibiotics (penicillin, ampicillin, erythromycin, tetracycline).
- Medicines used to treat fungal infections, such as ketoconazole and griseofulvin.
- Cyclosporin, an immunosuppressant medicine.
- Herbal medicines containing St John’s Wort.
Does food or alcohol interact with Diane-35 (cyproterone – ethinyl estradiol)?
Diane-35 may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.
What health conditions may interact with Diane-35 (cyproterone – ethinyl estradiol)?
These health conditions may interact with Diane-35.
- Birth control. This medication should not be used only for the purpose of birth control. Women should use a non-hormonal method of birth control (such as condoms) while taking this medication. Birth control pills should not be taken at the same time as cyproterone – ethinyl estradiol.
- Blood clots. This medication increases the risk of developing blood clots.
- Breast cancer. All women who take this medication should practice breast self-examination.
- This medication can cause changes in blood sugars.
- Hormones, such as cyproterone – ethinyl estradiol have been known to cause mood swings and symptoms of depression.
- Blood pressure. You should not take this medication if you have high blood pressure that is not controlled by medication.
- Liver function. Like other hormones, cyproterone – ethinyl estradiol can decrease liver function and liver disease.
- Medical conditions. This medication can cause fluid retention, which may worsen conditions such as high blood pressure, heart disease, or kidney disease.
- Diane-35 may cause migraine headaches.
- Smoking increases the risk of serious side effects on the heart and blood vessels.
- Certain situations such as long-term bed confinement may make blood clots.
- Vaginal bleeding. Remember to report any unusual vaginal bleeding to your doctor.
- Vision and contact lenses. Cyproterone – ethinyl estradiol may cause changes to the shape of the eye.
The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Diane-35 (cyproterone – ethinyl estradiol).
What is the dose of Diane-35 (cyproterone – ethinyl estradiol) for an adult?
This medication is taken in 28-day cycles consisting of 1 tablet daily for 21 days, followed by a 7-day interval without medication.
What is the dose of Diane-35 (cyproterone – ethinyl estradiol) for a child?
The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.
How is Diane-35 (cyproterone – ethinyl estradiol) available?
Diane-35 is available in the following dosage forms and strengths:
- Each beige, round, biconvex, sugar-coated tablet contains cyproterone acetate 2 mg and ethinyl estradiol 0.035 mg.
What should I do in case of an emergency or overdose?
In case of an emergency or an overdose, call your local emergency services (115) or go to your nearest emergency room.
What should I do if I miss a dose?
It is important to take Diane-35 exactly as prescribed by your doctor. Diane-35 will be less effective if you miss doses. If you miss a dose of Diane-35, and you remember within 12 hours, take the missed dose. If more than 12 hours have passed, discard the missed tablet and continue to take the remaining tablets in the pack at the usual time.
An additional non-hormonal method of birth control (e.g., condoms) should be used until the pack is empty. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
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