Droscon 0.03/3 mg Tablet

Droscon 0.03/3 mg Tablet

COMPOSITION

Each film-coated tablet contains Drospirenone USP 3 mg & Ethinyl Estradiol USP 0.030 mg.

PHARMACOLOGY

Droscon contains two active ingredients, Ethinyl Estradiol and Drospirenone. Ethinyl

Estradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of Droscon inhibit ovulation by suppressing

gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of Droscon as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).

Drospirenone has antimineralocorticoid activity, counteracting oestrogen related sodium retention. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens.

INDICATIONS

Droscon is indicated for prevention of pregnancy.

DOSAGE AND ADMINISTRATION

Route of administration : Oral.

How to taken Droscon To achieve maximum contraceptive effectiveness. Droscon must be taken in the order directed on the package and at intervals not exceeding 24 hours. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. One tablet is to be taken daily for 21 consecutive days.

1. If you have decided to take Droscon for contraception, wait for your next menstruation begins.

2. From the first day of your menstruation, start taking the first light yellow tablet from the left comer of the top row (with arrow mark) of your Droscon tablet pack.

3. Continue taking one light yellow tablet each day along the arrow mark.

• If you forget to take a tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should used some other method of contraception while you are taking the tablets & until your next menstruation.

• If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the very first white tablet of the top row from a fresh pack from the first day of next menstruation.

How to Delay a Period

To delay a period you should continue with another new pack of Droscon just after finishing the light yellow active tablet of the present pack (that is no need to take white placebo tablet of present pack).The extension can be carried on for as long as wished until the end of the second pack. When you wish your period to begin, just stop tablet taking. White using the second pack woman may have some break through bleeding or spotting. Start with your next pack after the usual 7 days white inactive tablet interval.

Advice in Case of Vomiting

If vomiting occurs within 4 hours after white active tablet taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablets is applicable. The woman must take the extra active tablet (s) needed from a back up pack after vomiting.

CONTRAINDICATIONS

Droscon should not be used :

• If you are pregnant

• If you are over 45 years of age

• If you are a heavy smoker (more than 20 cigarettes/day)

• If you have got heart disease, clotting of blood in the vein

• If you suffer from liver disease or jaundice

• If your are suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained

• Hypersensitivity to any of the components of Droscon

WARNING AND PRECAUTION

Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These event occur rarely. Venous thromboembolism (VTE) manifesting as deep venous thrombosis and /or pulmonary embolism may occur during the use of all COCs. In a clinical study it has been found that after the use of drospirenon containing COCs cause the prevalence of VTE & ATE may be upto 9.8 for 10,000 women/year.

SIDE EFFECTS

Common : Different types of tablet suit different types of woman. At the initial stage some women may experience side-effects like dizziness, headache, nausea or inter menstrual bleeding. If taken regularly, such types of side effects normally go away after 2-3 months. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor.

After starting one brand of oral contraceptive tablets if you feel any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pain or shortness of breath, yellow skin or a rise in blood pressure take advice from your doctor or contact the nearest family planning center.

Rare: Pulmonary embolism, Stroke, Heart attack.

USE IN PREGNANCY AND LACTATION

Use During Pregnancy : The administration of Droscon is contraindicated during pregnancy. Pregnancy must be excluded before starting Droscon. If pregnancy occurs during use of Droscon the preparation must be withdrawn immediately. Oral Contraceptives have not been shown to have any deleterious effects on the foetus or to increase the incidence of miscarriage in women who discontinue their use prior to conception. However, in women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.

Use during lactation : Oestrogen containing oral contraceptives given in the postpartum period may interfere with lactation. There may be a decrease in the quantity and a change in the composition of the breast milk. Furthermore, small amounts of contraceptive steroids and /or metabolites have been identified in the milk of mothers receiving them. A few adverse effects have been reported, including jaundice and breast enlargement. The use of oestrogen containing oral contraceptives should be deferred until the infant has been completely weaned.

Use in children and adolescents

Droscon is only indicated after menarche.

Use in the Elderly

Droscon is not indicated after menopause.

DRUG INTERACTION

With medicine : Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive.

Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates.

Certain antibiotics including ampicillin, other penicillin’s and tetracycline’s may reduce the efficacy of oral contraceptive. During concomitant use of Droscon & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non-hormonal back-up method of contraception to be used in addition to the regular intake of Droscon.

With food & others : Interaction with food not known.

OVERDOSE

Symptoms of oral contraceptive over dosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

STORAGE

Store below 300  C, protected from light & moisture. Keep all medicines out of reach of children.

PACKING

Each box contains 1x21 tablets in blister strip.