Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets)

Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets)
© The Swiss Pharmacy

Diane-35 (Cyproterone Acetate and Ethinyl Estradiol
tablets) is used for the treatment of signs of
androgenisation in women, such as severe acne
(involving inflammation or nodularity or risk of scarring)
where prolonged oral antibiotics or local treatment alone
has not been successful, or idiopathic hirsutism of mild
to moderate degree.
Effective oral contraception in this group of women
requiring treatment for these androgen-dependent
diseases is an indication for treatment with Diane-35
tablets.

Diane 35 Tablets are manufactured by Bayer AG, Berlin,
Germany in the strength of 2.035mg (2 mg of Cyproterone
Acetate and 0.035 mg of Ethinyl Estradiol).
They are marketed by Bayer Zydus Pharma Private Limited, India.

Chemical Structure - Cyproterone Acetate

Chemical Structure-Ethinyl Estradiol

The active ingredients contained in Diane-35
tablets are Cyproterone Acetate and Ethinyl
Estradiol.
Each film-coated Diane-35 tablet contains 2 mg
of Cyproterone Acetate and 0.035 mg of
Ethinylestradiol.

Uses of Diane-35 tablets:
is used for treatment of women with severe acne, especially
pronounced forms of acne that may be accompanied by
inflammation or formation of nodes (acne nodulocystica, acne
papulopustulosa), with associated symptoms of androgenization,
including seborrhea and mild hirsutism and/or androgenic alopecia.
Diane-35 should be used only when acne is unresponsive to topical
therapy and oral antibiotic treatments.
Oral contraception in women requiring treatment for these androgen-
dependent diseases is an indication for treatment with Diane-35.
However, Diane-35 is not recommended in women solely for
contraception.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html

Uses of Diane-35 tablets:
It should not be used in combination with other
hormonal contraceptives. Diane-35 is also used for the relief of
symptoms of polycystic ovary syndrome.
However, when taken as recommended, Diane-35 will provide
reliable contraception in patients treated for the above clinical
conditions. If patient compliance is uncertain and contraception
is necessary, then a supplementary non-hormonal
contraceptive method should be considered.

Recommended Adult Dosage
Diane-35 Tablets (Ethinylestradiol and Cyproterone Acetate
tablets) inhibits ovulation and, thereby, prevents conception.
Patients who are using Diane-35 should not, therefore, use an
additional hormonal contraceptive, as this will expose the
patient to an excessive dose of hormones and is not necessary
for effective contraception.
First Treatment Course: One tablet daily for 21 days following
the arrows, starting on the first day of the menstrual cycle (the
first day of menstruation counting as day 1).
Subsequent Courses: Each subsequent course is started after 7
tablet-free days have followed the preceding course.

When the contraceptive action of Diane-35 is also to be employed, it is
essential that the above instructions be rigidly adhered to. Should bleeding
fail to occur during the tablet-free interval, the possibility of pregnancy must
be excluded before the next pack is started.
When changing from an oral contraceptive and relying on the contraceptive
action of Diane-35, follow the instructions given below.
Changing from 21-Day Combined Oral Contraceptives (COCs): The first tablet
of Diane-35 should be taken on the first day immediately after the end of the
previous COC course. Additional contraceptive precautions are not required.
Changing from a Combined Every Day Pill (28 day tablets): Diane-35 should
be started after taking the last hormone containing tablet from the Every
Day Pill pack. The first tablet of Diane-35 is taken the next day. Additional
contraceptive precautions are not then required.

Postpartum and Post-abortum Use: After pregnancy, Diane-35 can be
started 21 days after a vaginal delivery, provided that the patient is fully
ambulant and there are no puerperal complications. Additional
contraceptive precautions will be required for the first 7 days of tablet
taking. Since the first postpartum ovulation may precede the first bleeding,
another method of contraception should be used in the interval between
childbirth and the first course of tablets. Lactation is contraindicated with
Diane-35. After a first trimester abortion, Diane-35 may be started
immediately, in which case no additional contraceptive precautions are
required.
Duration of Use: Time to relief of symptoms is at least three months. The
need to continue treatment should be evaluated periodically by the treating
physician.

Contraindications
➔
Diane-35 is contraindicated in patients with a known hypersensitivity to
Ethinylestradiol, Cyproterone Acetate or any component of the tablet.
➔
Presence or a history of a cerebrovascular accident or venous
or arterial thrombotic/thromboembolic events (e.g. deep venous
thrombosis, pulmonary embolism, myocardial infarction)
➔
Presence or history of prodromi for a thrombosis (e.g. angina
pectoris, transient ischaemic attack)
➔
The presence of a severe or multiple risk factor(s) for venous or arterial
thrombosis may also constitute a contraindication
➔
Diabetes mellitus with vascular involvement

Contraindications
➔
History of epilepsy
➔
Presence or history of liver tumours (benign or malignant)
➔
Known or suspected sex-steroid influenced malignancies (e.g. of the
breasts or the genital organs)
➔
History of migraine with focal neurological symptoms
➔
Presence or history of severe hepatic disease as long as liver
function values have not returned to normal
➔
Pancreatitis or a history of pancreatitis if associated with severe
hypertriglyceridemia

Contraindications
➔
Undiagnosed vaginal bleeding.
➔
Concomitant use with another hormonal contraceptive.
➔
Known or suspected pregnancy.
➔
Lactation.
➔
Meningioma or a history of meningioma.
➔
Diane-35 is contraindicated for use with the Hepatitis C
combination drug regimen Ombitasvir/Paritaprevir/Ritonavir and
Dasabuvir with or without Ribavirin.

Storage Instructions
Diane-35 Tablets (Cyproterone Acetate and Ethinyl
Estradiol Tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
Time to relief of symptoms is at least 3 months. The need to continue
treatment should be evaluated periodically by the treating physician.
Women should be advised that Ethinylestradiol and Cyproterone Acetate
does not protect against HIV infection (AIDS) and other sexually transmitted
diseases.
Assessment of women prior to starting oral contraceptives (and at regular
intervals thereafter) should include a personal and family medical history of
each woman. Physical examination should be guided by this and by the
contraindications and warnings for this product.
The likelihood of pregnancy should be excluded before starting treatment.
Undiagnosed vaginal bleeding that is suspicious for underlying conditions
should be investigated.

Warnings
Conditions That Require Strict Medical Supervision: If any of the
conditions / risk factors mentioned below is present, the benefits of the use
of Cyproterone Acetate and Ethinylestradiol (CPA+EE) should be weighed
against the possible risks for each individual woman and discussed with the
woman before she decides to start using CPA+EE. In the event of
aggravation, exacerbation or first appearance of any of these conditions or
risk factors, the woman should contact her physician. Diabetes mellitus,
with mild vascular disease or mild nephropathy, retinopathy or neuropathy,
Hypertension that is adequately controlled, i.e. systolic greater than 140 to
159 mmHg or diastolic greater than 90 to 94 mmHg, Porphyria, Clinical
depression, Obesity, Migraine, Cardiovascular diseases, Chloasma.
Patients with a history of depression or any condition mentioned above
should be monitored during treatment with CPA+EE.

Warnings
Diane-35 users appear to have an elevated risk of venous
thromboembolic events compared to users of Levonorgestrel-containing
combined oral contraceptives.
Diane-35 should not be prescribed for the purpose of contraception alone.
Estrogens or progestogens should not be taken during treatment with
Bayer Schering Pharma Germany. The need to continue treatment with
Diane 35 should be evaluated periodically by the treating physician.
Diane 35 should be discontinued 3 to 4 cycles after signs have completely
resolved. Cigarette smoking increases the risk of serious adverse effects
on the heart and blood vessels from the use of Diane-35. This risk
increases with age and heavy smoking (15 or more cigarettes per day) and
is more marked in women over 35 years of age. Women who use this
medication should not smoke.

Warnings
Discontinue Medication at the Earliest Manifestation of the Following:
Thromboembolic and Cardiovascular Disorderssuch asthrombophlebitis,
pulmonary embolism, cerebrovascular disorders, myocardial ischemia,
mesenteric thrombosis, and retinal thrombosis.
Conditions that predispose to Venous Stasis and to Vascular
Thrombosis(eg, immobilization after accidents or confinement to bed
during long-term illness). Non-hormonal treatment for acne should be
used until regular activities are resumed.
Visual Defects -Partial or Complete Papilledema, or Ophthalmic Vascular
Lesions
Severe Headache of Unknown Etiology, or Worsening of Pre-existing
Migraine Headache

Warnings
Discontinue Medication at the Earliest Manifestation of the Following:
Onset of Jaundice or Hepatitis
Itching of the Whole Body
Significant Rise in Blood Pressure
Onset of Severe Depression
Severe Upper Abdominal Pain or Liver Enlargement
A liver tumor should be considered in the differential diagnosis when
severe upper abdominal pain, liver enlargement, or signs of intra-
abdominal hemorrhage occur in women taking estrogen / progestogen
combinations.

Warnings
Carcinogenesis and Mutagenesis: Malignancies may be life-threatening or
may have a fatal outcome.
Breast Cancer: Increasing age and a strong family history are the most
significant risk factors for the development of breast cancer. Other
established risk factors include obesity, nulliparity, and late age for first full-
term pregnancy. The identified groups of women that may be at increased
risk of developing breast cancer before menopause are long-term users of
estrogen / progestogen combinations (more than eight years) and starters at
early age.
Cervical Cancer: The most important risk factor for cervical cancer is
persistent HPV infection. Some epidemiological studies have indicated that
long-term use of COCs may further contribute to this increased risk but there
continues to be controversy about the extent to which this finding is
attributable to confounding effects, e.g., cervical screening and sexual
behaviour including use of barrier contraceptives.

Warnings
Patients with fibroids (leiomyomata) should be carefully observed.
Sudden enlargement, pain, or tenderness requires discontinuation of the
use of the medication.
Persistent irregular vaginal bleeding requires special diagnostic
judgement to exclude the possibility of pregnancy or neoplasm
Epidemiological studies have suggested an association between the use
of estrogen/progestogen combinations and an increased risk of arterial
and venous thrombotic and thromboembolic diseases such as myocardial
infarction, deep venous thrombosis, pulmonary embolism, and of
cerebrovascular accidents. These events occur rarely.

Warnings
Diane-35 must be discontinued prior to starting therapy with the Hepatitis
C virus (HCV) combination drug regiment Ombitasvir, Paritaprevir,
Ritonavir, with or without Dasabuvier
If there is a clear-cut history of cholestatic jaundice, especially if it
occurred during pregnancy, other methods of treatment should be
prescribed. The development of severe generalized pruritus or icterus
requires that the medication be withdrawn until the problem is resolved.
Exogenous estrogens may induce or exacerbate symptoms of
angioedema, in particular in women with hereditary angioedema.
Discontinuation of this medication should be considered.

Warnings
The use of estrogen / progestogen combinations in some women has
been associated with positive lupus erythematous cell tests and with
clinical lupus erythematosus. In some instances exacerbation of
rheumatoid arthritis and synovitis have been observed.
The onset or exacerbation of migraine or the development of headache of
a new pattern that is recurrent, persistent, or severe, requires
discontinuation of medication and evaluation of the cause.
Progressive astigmatic error, possibly leading to keratoconus, has been
noted in some myopic women receiving drugs of the
estrogen/progestogen class.
There is an increased risk of thromboembolic complications in estrogen /
progestogen combination users after major surgery.

Warnings
Patients with a history of emotional disturbances, especially the depressive
type, are more prone to have a recurrence of depression while taking
estrogen / progestogen combinations.
Diane-35 may cause fluid retention. Conditions such as epilepsy, asthma, and
cardiac or renal dysfunction require careful observation.
Women having a history of oligomenorrhea, secondary amenorrhea, or
irregular cycles may remain anovulatory or become amenorrheic following
discontinuation of estrogen / progestogen combination therapy. Amenorrhea,
especially if associated with breast secretion, that continues for 6 months or
more after withdrawal, warrants a careful assessment of hypothalamic-
pituitary function.
After discontinuing therapy, the patient should delay pregnancy until at least
one normal spontaneous cycle has occurred in order to date the pregnancy.
The patient should be instructed to use a non-hormonal method of
contraception during this time period.

Diane-35 and Alcohol
Alcohol doesn’t affect the overall effectiveness of your birth control. But alcohol
consumption can affect your behavior and judgment, increasing the likelihood of
contraceptive failure.
Alcohol doesn’t have a direct effect on how your birth control works. However, the
effects of alcohol can increase your risk of birth control failure.
First, if you’re drinking heavily or become intoxicated, the odds that you’ll forget to take
your medicine on time increase. You’re more likely to forget to take your birth control
pill if you started drinking before the time you normally take it.
The hormones in birth control may affect your body water distribution which can
change the rate the alcohol you drink is eliminated. This could lead to higher blood
alcohol levels and may increase your level of intoxication if you’re on the pill.
In other words, you may become intoxicated more quickly than you did before you
started the pill. This may also increase your likelihood of missing a dose or forgetting to
use protection if you choose to have sex.

Possible Side Effects
Most common Cyproterone Acetate and Ethinyl Estradiol tablets
(Diane-35) side effects reported during clinical trials with an
incidence rate of greater than or equal to 1% are nausea, abdominal
pain, increased weight, headache, depressed mood, altered mood,
breast pain, breast tenderness.
The Uncommon Diane-35 side effects included Vomiting, Diarrhoea,
Fluid retention, Migraine, Libido decreased, Breast hypertrophy, Rash
and Urticaria.

Possible Side Effects
The rare Diane-35 side effects included Contact lens
intolerance, Hypersensitivity, Weight decreased, Libido
increased, Vaginal discharge, breast discharge, Erythema
nodosum, Erythema multiforme and Thromboembolism.

Diane-35 Tablets Overdosage
Diane-35 Overdose may cause nausea, vomiting and withdrawal
bleeding. Withdrawal bleeding may even occur in girls before their
menarche, if they accidentally take the medicinal product. There are
no specific antidotes and further treatment should be symptomatic.

Diane-35 Tablets During Pregnancy
Cyproterone Acetate and Ethinyl Estradiol tablets (Diane-35) has been
classified by the US FDA as Pregnancy Category X.
Administration of Diane-35 ( Cyproterone Acetate and Ethinyl Estradiol
Tablets) is contraindicated in pregnancy. If pregnancy occurs during
treatment with Diane-35 tablets, use is to be stopped immediately.
Estrogen/progestogen combinations must not be taken by pregnant
women. Rule out pregnancy before treatment is begun. Because of
the antiandrogenic action of Diane-35, feminization of male fetuses has
occurred in animal studies and may possibly occur in humans. Fetal
abnormalities have been reported to occur in the offspring of women
who have taken estrogen / progestogen combinations in early
pregnancy. Rule out pregnancy as soon as it is suspected.

Diane-35 Tablets (Cyproterone Acetate and Ethinyl
Estradiol Tablets) are manufactured by Bayer AG,
Berlin, Germany and marketed by Bayer Zydus Pharma
Private Limited, India.

Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets)

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