Diane-35 is used as a oral contraceptive as well for the 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.

1. Diane-35 Tablets
Diane-35 Tablets are used as a oral contraceptive as
well for the 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.
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2. Diane-35 Tablets
Active Ingredient
The active pharmaceutical ingredients
contained in Diane-35 Tablets are
2mg cyproterone acetate and 0.035mg
ethinyl estradiol.
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3. Diane-35 Tablets
Chemical Structure
Cyproterone Acetate Structure
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4. Diane-35 Tablets
Chemical Structure
Ethinylestradiol Structure
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5. Diane-35 Tablets
Recommended Dosage
One tablet is to be taken daily. The tablets must be
taken at about the same time every day, with some
liquid as needed. Tablet taking should be
continuous.
One tablet of Diane-35 is to be taken daily for 21
consecutive days. Withdrawal bleeding should
usually occur on day 2 to 3 after the last tablet is
taken. Each subsequent pack is started after a 7
day tablet free interval.
How to start Diane-35 Tablets:
taking has to start on day 1 of the woman's natural
cycle (i.e. the first day of her menstrual bleeding).
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6. Diane-35 Tablets
Recommended Dosage
Missed Dose:
If you forget to take your tablet at the usual time, you
must take it within the next 12 hours at the latest. If
more than 12 hours have passed from the time that
you normally take your tablet, you must discard the
missed tablet and continue to take the remaining
tablets in the pack at the usual time.
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7. Diane-35 Tablets
Contraindications
Generic Diane-35 Tablets are
contraindicated in patients with the
following conditions:
➔Hypersensitivity to cyproterone acetate and/or
ethinyl estradiol, or any inactive component of
this medication.
➔Personal or family history of confirmed, idiopathic
venous thromboembolism (VTE)
➔Sickle-cell anaemia
➔Presence or history of prodromi of a thrombosis
(e.g. transient ischaemic attack, angina pectoris).
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8. Diane-35 Tablets
Contraindications
➔Presence of a severe or multiple risk factor(s) for
venous or arterial thrombosis may also constitute a
contraindication
➔Diabetes mellitus with vascular involvement.
➔Pancreatitis or a history thereof if associated with
severe hypertriglyceridemia.Severe hepatic
disease as long as liver function values have not
returned to normal. Jaundice or persistent itching
during a previous pregnancy, Dubin-Johnson
syndrome, Rotor syndrome
➔History of deterioration of otosclerosis during
pregnanacy.
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9. Diane-35 Tablets
Contraindications
➔Presence or history of liver tumors (benign or
malignant).
➔Known or suspected sex steroid influenced
malignancies (e.g. of the genital organs or the
breasts).
➔Undiagnosed vaginal bleeding.
➔Known or suspected pregnancy.
➔Disorders of lipid metabolism.
➔History of herpes gestationis.
➔Lactation.
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10. Diane-35 Tablets
Side Effects of Diane-35 Pills
The most frequent side effects include
nausea, abdominal pain, weight
increased, headache,depressed
mood, mood altered, breast pain, and
breast tenderness
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11. Diane-35 Tablets
Warnings And Precautions
➔Circulatory Disorders:Epidemiological studies
have suggested an association between the use of
COCs and an increased risk of arterial and venous
thrombotic and thromboembolic diseases such as
myocardial infarction, stroke, deep venous
thrombosis, and pulmonary embolism. These events
occur rarely.
➔Tumors: Some epidemiological studies have
indicated that long-term use of COCs may further
contribute to increased risk of persistent HPV
infection.
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12. Diane-35 Tablets
Warnings And Precautions
➔Other conditions: Women with hypertriglyceridemia, or
a family history thereof, may be at an increase risk of
pancreatitis when using COCs. Crohn’s disease and
ulcerative colitis have been associated with COC use.
Chloasma may occasionally occur, especially in women
with a history of chloasma gravidarum.
➔Pregnancy and Lactation: The administration of Diane-
35 is contraindicated during pregnancy. If pregnancy
occurs during medication with Diane-35, the preparation is
to be withdrawn immediately. The administration of Diane-
35 is also contraindicated during lactation.
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13. Diane-35 Tablets
Overdose Symptoms
There have been no reports of serious
effects from overdose. Symptoms of
overdose may include nausea, vomiting, or
vaginal bleeding. In case of drug overdose,
contact a doctor, hospital emergency
department, or regional Poison Control
Center immediately, even if there are no
symptoms.
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14. Diane-35 Tablets
Overdose Treatment
There are no antidotes for Diane-35
overdose and further treatment should be
symptomatic.
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15. Diane-35 Tablets
Diane-35 Tablets Manufactured by
Bayer Schering Pharma
For more information click here
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