Desogestrel Tablets BP 75 microgram Taj Pharma

Desogestrel Tablets BP 75 microgram Taj Pharma

1.Name of the medicinal product
Desogestrel Tablets BP 75 microgram Taj Pharma
2.Qualitative and quantitative composition

Each film-coated tablet contains of
Desogestrel                             75 microgram
Excipients                               q.s.

Excipients with known effect:

Lactose monohydrate
soybean oil.

For the full list of excipients, see section 6.1.

3.Pharmaceutical form
Tablet. White, round.

4.Clinical particulars

4.1 Therapeutic indications

Oral contraception

4.2 Posology and method of administration

Posology

How to take Desogestrel

Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one.

How to start Desogestrel

No preceding hormonal contraceptive use [in the past month]

Tablet taking has to start on day 1 of the woman’s natural cycle (day 1 is the first day of her menstrual bleeding).

Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.

Following first-trimester abortion:

After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.

Following delivery or second-trimester abortion:

Contraceptive treatment with Desogestrel after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed pregnancy ought to be ruled out and an additional method of contraception should be used for the first week.

For additional information for breastfeeding women see section 4.6.

How to start Desogestrel when changing from other contraceptive methods

Changing from a combined oral contraceptive (combined hormonal contraceptive (COC), vaginal ring or transdermal patch)

The woman should start with Desogestrel preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch. In these cases, the use of an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries.

The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.

Changing from a progestogen-only method (minipill, injection, implant or from a progestogen-releasing intrauterine system (IUS))

The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due).

Management of missed tablets

Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time. If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.

Advice in case of gastrointestinal disturbances

In case of severe gastrointestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3-4 hours after tablet taking absorption may not be complete. In such an event, the advice concerning missed tablets is applicable.

Treatment surveillance

Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease (see section 4.4), the control examinations should be timed accordingly.

Despite the fact that Desogestrel is taken regularly, bleeding disturbances may occur. If bleeding is very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out.

Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.

The treatment should be stopped if a pregnancy occurs.

Women should be advised that Desogestrel does not protect against HIV (AIDS) and other sexually transmitted diseases.

Paediatric population

The safety and efficacy of desogestrel in children below 18 years has not yet been established. No data are available.

Method of administration

Oral use

4.3 Contraindications

• Active venous thromboembolic disorder.
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Known or suspected sex-steroid sensitive malignancies.
• Undiagnosed vaginal bleeding.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• If you are allergic to peanut or soya.

4.4 Special warnings and precautions for use

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start taking Desogestrel. In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Desogestrel should be discontinued.

The risk for breast cancer increases in general with increasing age. During the use of combined oral contraceptives (COCs) the risk for having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC. The expected number of cases diagnosed per 10 000 women who use combined COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

The risk in users of progestogen-only contraceptives (POCs), such as Desogestrel, is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive. Compared to the risk of getting breast cancer even in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer.

When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, Desogestrel should be discontinued in the event of a thrombosis. Discontinuation of Desogestrel should also be considered in case of long-term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed during the first months of use.

If sustained hypertension develops during the use of Desogestrel, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Desogestrel should be considered.

Treatment with Desogestrel leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density.

The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills. Despite the fact that Desogestrel consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Desogestrel.

The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestations; otosclerosis-related hearing loss; (hereditary) angioedema.

Each tablet of this medicinal product contains 55.07 mg of lactose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions

Interactions between hormonal contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with progestogen-only contraceptives).

Hepatic metabolism: Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones (such as, hydantoins, (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, and possibly also for oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John’s wort (Hypericum perforatum))

Maximal enzyme induction is not seen for 2-3 weeks, but may then be sustained for at least 4 weeks after cessation of drug therapy. Women on treatment with any of these medicinal products should temporarily use a barrier method in addition to Desogestrel. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. For women on long-term treatment with hepatic enzyme inducers a non-hormonal method of contraception should be considered.

During treatment with medical charcoal, the absorption of the steroid in the tablet may be reduced and thereby the contraceptive efficacy. Under these circumstances, the advice as given for missed pills in section 4.2 is applicable.

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporin) or decrease.

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Laboratory tests

Data obtained with COCs have been shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.

4.6 Fertility, pregnancy and lactation

Pregnancy

Desogestrel is not indicated during pregnancy. If pregnancy occurs during treatment with Desogestrel, further intake should be stopped.

Animal studies have shown that very high doses of progestagenic substances might cause masculinisation of female foetuses.

Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy. Pharmacovigilance data collected with various desogestrel-containing combined COCs also do not indicate an increased risk.

Breastfeeding

Desogestrel does not influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, small amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 – 0.05 microgram etonogestrel per kg body weight per day might be ingested by the child (based on an estimated milk ingestion of 150 ml/kg/day).

Limited long-term follow up data are available on children, whose mothers started using Desogestrel during the 4^th to 8^th weeks post-partum. They were breast-fed for 7 months and followed up to 1.5 years (n = 32) or to 2.5 years (n = 14) of age. Evaluation of growth and physical and psychomotor development did not indicate any differences in comparison to nursing infants, whose mother used a copper IUD. Based on the available data Desogestrel may be used during lactation. The development and growth of a nursing infant, whose mother uses Desogestrel, should however, be carefully observed.

4.7 Effects on ability to drive and use machines

Desogestrel has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Desogestrel. Since Desogestrel causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills. In 20 – 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent. Information, counselling and a bleeding diary can improve the woman’s acceptance of the bleeding pattern.

The most commonly reported other undesirable effects in the clinical trials with Desogestrel (>2.5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.

All undesirable effects are listed by system organ class and frequency; common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000).

* MedDRA version 9.0

Breast discharge may occur during use of Desogestrel. On rare occasions, ectopic pregnancies have been reported (see section 4.4). In addition, (aggravation of) angioedema and/or aggravation of hereditary angioedema may occur (see section 4.4).

In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer) and chloasma some of which are discussed in more detail in section 4.4.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

4.9 Overdose

There have been no reports of serious adverse effects from overdose. Symptoms that may occur in these case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and the treatment should be symptomatic.

5.Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: hormonal contraceptives for systemic use.

Desogestrel is a progestogen-only pill, which contains the progestogen desogestrel. Like other progestogen-only pills, Desogestrel is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to traditional progestogen-only pills, the contraceptive effect of Desogestrel is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

When studied for 2 cycles, using a definition of ovulation as a progesterone level greater than 16 nmol/L for 5 consecutive days, the ovulation incidence was found to be 1% (1/103) with a 95% confidence interval of 0.02% -5.29% in the ITT group (user and method failures). Ovulation inhibition was achieved from the first cycle of use. In this study, when Desogestrel was discontinued after 2 cycles (56 continuous days) ovulation occurred on average after 17 days (range 7-30 days).

In a comparative efficacy trial (which allowed a maximum time of 3 hours for missed pills), the overall ITT Pearl–Index found for Desogestrel was 0.4 (95% confidence interval 0.09% – 1.20%), compared to 1.6 (95% confidence interval 0.42% – 3.96%) for 30 μg levonorgestrel.

The Pearl-Index for Desogestrel is comparable to the one historically found for COCs in the general COC-using population.

Treatment with Desogestrel leads to decreased estradiol levels, to a level corresponding to the early follicular phase. No clinically relevant effects on carbohydrate metabolism, lipid metabolism and haemostasis have been observed.

Paediatric population

No clinical data on efficacy and safety are available in adolescents below 18 years.

5.2 Pharmacokinetic properties

Absorption

After oral dosing of Desogestrel, desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%.

Distribution

ENG is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to SHBG.

BiotransformationDSG is metabolised via hydroxylation and dehydrogenation to the active metabolite ENG. ENG is metabolised via sulphate and glucuronide conjugation.

Elimination

ENG is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing. Steady-state levels in plasma are reached after 4-5 days. The serum clearance after IV administration of ENG is approximately 10 l per hour. Excretion of ENG and its metabolites either as free steroid or as conjugates, is with urine and faeces (ratio 1.5:1). In lactating women, ENG is excreted in breast milk with a milk/serum ratio of 0.37-0.55. Based on these data and an estimated milk intake of 150 ml/kg/day, 0.01 – 0.05 microgram etonogestrel may be ingested by the infant.

5.3 Preclinical safety data

Toxicological studies did not reveal any effects other than those, that can be explained from the hormonal properties of desogestrel.

6.Pharmaceutical particulars

6.1 List of excipients

Tablet core:

Lactose monohydrate, Maize starch, Povidone K30, d-α-Tocopherol, Soybean oil,  Silical, colloidal hydrated, Silica, colloidal anhydrous, Stearic acid,

Coating:

Hypromellose 2910, Polyethylene Glycol, Titanium Dioxide.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Blisters of aluminium push-through foil and PVC/PVDC film. The blister packs may come with a blister holder.

Pack sizes:

1 x 28 film-coated tablets

3 x 28 film-coated tablets

6 x 28 film-coated tablets

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

No special requirements.

7.Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Desogestrel Tablets BP 75 microgram Taj Pharma

Package leaflet: Information for the user

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It is not suitable for all women, so you should not give it to anyone else as it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1 What Desogestrel is and what it is used for
2 What you need to know before you take Desogestrel
3 How to take Desogestrel
4 Possible side effects
5 How to store Desogestrel
6 Contents of the pack and other information

1 What Desogestrel is and what it is used for

Desogestrel contains a small amount of one type of female sex hormone, the progestogen desogestrel.

Desogestrel is used to prevent pregnancy.

There are 2 main kinds of hormone contraceptive.

• The combined pill (COC), “The Pill“, which contains 2 types of female sex hormone an oestrogen and a progestogen.
• The progestogen-only pill, POP or mini-pill, which doesn‘t contain an oestrogen.

Desogestrel is a progestogen-only-pill (POP) or a mini-pill.

Most POPs or minipills work primarily by preventing the sperm cells from entering the womb but do not always prevent the egg cell from ripening, which is the main way that combined pills work.

Desogestrel is different from other mini-pills in having a dose that in most cases prevents the egg cell from ripening. As a result, Desogestrel is a highly effective contraceptive.

In contrast to the combined pill, Desogestrel can be used by women who do not tolerate oestrogens and by women who are breast feeding.

A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Desogestrel. On the other hand, you may not have any bleeding at all.

2 What you need to know before you take Desogestrel

Desogestrel like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Desogestrel

• If you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism))
• If you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver function is still not normal
• If you have or are suspected of having cancer that grows under the influence of sex-steroids, such as certain types of breast cancer
• If you have any unexplained vaginal bleeding
• If you are allergic to desogestrel, peanut, soya or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions applies to you, tell your doctor before you start to use Desogestrel. Your doctor may advise you to use a non-hormonal method of birth control.

If any of these conditions appear for the first time while using Desogestrel, consult your doctor immediately.

Warnings and precautions

Talk to your doctor before using Desogestrel

• if you have ever had breast cancer
• if you have liver cancer, since a possible effect of Desogestrel cannot be excluded
• if you have ever had a thrombosis
• if you have diabetes
• if you suffer from epilepsy (see section ‘Other medicines and Desogestrel’)
• if you suffer from tuberculosis (see section ‘Other medicines and Desogestrel’)
• if you have high blood pressure
• if you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so avoid too much exposure to the sun or ultraviolet radiation.

When Desogestrel is used in the presence of any of these conditions, you may need to be kept under close observation. Your doctor can explain what to do.

Breast cancer

• It is important to regularly check your breasts and you should contact your doctor as soon as possible if you feel any lump in your breasts.
• Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, this reduces the risk, so that 10 years after stopping the Pill, the risk is the same as for women who have never taken the Pill.

Breast cancer is rare under 40 years of age but the risk increases, as the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if a woman continues to take the Pill when she is older. How long she takes the Pill is less important.

• In every 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 20, there would be less than 1 extra case of breast cancer found up to 10 years after stopping, in addition to the 4 cases normally diagnosed in this age group.
• In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 30, there would be 5 extra cases in addition to the 44 cases normally diagnosed.
• In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed.

The risk of breast cancer in users of progestogen-only pills like Desogestrel is believed to be similar to that in women who use the Pill, but the evidence is less conclusive.

Breast cancers found in women who take the Pill, seem less likely to have spread than breast cancers found in women who do not take the Pill.

It is not certain whether the Pill causes the increased risk of breast cancer. It may be that the women were examined more often, so that the breast cancer is noticed earlier.

Thrombosis

See your doctor immediately, if you notice possible signs of a thrombosis (see also ‘Regular Check-ups’).

Thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called “pulmonary embolism”. A pulmonary embolism can cause chest pain, breathlessness, collapse or even death.

Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant.

The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills, like Desogestrel, is believed to be lower than in users of Pills that also contain oestrogens (combined Pills).

Children and adolescents

No clinical data on efficacy and safety are available in adolescents below 18 years.

Other medicines and Desogestrel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may stop Desogestrel from working properly. These include medicines used for the treatment of

• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and phenobarbital)
• tuberculosis (e.g. rifampicin)
• HIV infections (e.g. ritonavir) or other infectious diseases (e.g. griseofulvin)
• stomach upset (medical charcoal)
• depressive moods (the herbal remedy St John’s wort).

Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long.

Desogestrel may also interfere with how certain medicines work, causing either an increase in effect (e.g.medicines containing cyclosporine) or a decrease in effect.

Pregnancy and breast-feeding

Pregnancy

Do not use Desogestrel if you are pregnant, or think you may be pregnant.

Breast-feeding

Desogestrel may be used while you are breast-feeding. Desogestrel does not influence the production or the quality of breast milk. However, a small amount of the active substance of Desogestrel passes over into the milk.

The health of children breast-fed for 7 months while their mothers were using Desogestrel has been studied up until they were 2.5 years of age. No effects on the growth and development of the children were observed.

If you are breast-feeding and want to use Desogestrel, please contact your doctor.

Driving and using machines

Desogestrel has no known effect on the ability to drive or use machines.

Desogestrel contains lactose and soybean oil

Desogestrel contains lactose (milk sugar) and soybean oil.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you are allergic to peanut or soya, do not use this medicinal product.

Regular check ups

When you are using Desogestrel, your doctor will tell you to return for regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation.

Contact your doctor as soon as possible if:

• you notice possible signs of a blood clot e.g. severe pain or swelling in either of your legs; unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood
• you have a sudden, severe stomach ache or jaundice (you may notice yellowing of the skin, the whites of the eyes, or dark urine, possibly a sign of liver problems)
• you feel a lump in your breast
• you have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of a pregnancy outside the womb)
• you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance)
• you have unusual, heavy vaginal bleeding
• you suspect that you are pregnant.

3 How to take Desogestrel

When and how to take the tablets

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The Desogestrel pack contains 28 tablets.

Take your tablet each day at about the same time. Swallow the tablet whole, with water.

The days of the week are printed in the blister and also arrows are printed indicating the order to take the pills. Each day correspond with one tablet.

Every time you start a new pack of Desogestrel, take a tablet from the top row. Don’t start with just any tablet. For example if you start on a Wednesday, you must take the tablet from the top row marked with ‘WED’ (Wednesday).

Continue to take one tablet a day until the pack is empty, always following the direction indicated by the arrows.

By looking at the pill pack, you can easily check if you have already taken a tablet on a particular day.

You may have some bleeding during the use of Desogestrel, but you must continue to take your tablets as normal.

When a pack is empty, you must start with a new pack of Desogestrel on the next day – thus without interruption and without waiting for a bleed.

Starting your first strip of Desogestrel

• If you are not using hormonal contraception at present (or in the past month)
  • Wait for your period to begin.
  • On the first day of your period, take the first Desogestrel tablet. Additional contraceptive precautions are not necessary.
  • If you take your first tablet on days 2-5 of your period, use an additional barrier method contraception for the first 7 days of tablet-taking.
• When you change from a combined pill (COC), vaginal ring or transdermal patch
  If you have a tablet, ring or patch-free break
  • You can take the first Desogestrel tablet on the day after your tablet, ring or patch-free break, or when you have taken all the inactive tablets, of your present contraceptive.
  • If you follow these instructions, make sure you use an additional barrier method of contraception for the first 7 days of tablet-taking.
    If you don’t have a tablet, ring or patch-free break
  • Start taking Desogestrel on the day after you take the last tablet from your present Pill pack, or on the day of removal of your vaginal ring or patch, (this means no tablet, ring or patch-free break).
  • If your present Pill pack also contains inactive tablets, you can start Desogestrel on the day after taking the last active tablet (if you are not sure with this is, ask your doctor or pharmacist)
  • If you follow these instructions, additional contraceptive precautions are not necessary.
• When changing from another progestogen-only (mini-pill)
  Switch on any day from another mini-pill. Additional contraceptive precautions are not necessary.
• When changing from an injection or implant or hormonal IUS
  Start using Desogestrel when your next injection is due or on the day that your implant or your IUS is removed. Additional contraceptive precautions are not necessary.
• After having a baby
  • You can start Desogestrel between 21 and 28 days after the birth of your baby.
  • If you start later, make sure that during the first cycle you use an additional barrier method of contraception for the first 7 days of tablet-taking. However, if you have already had sex, check that you are not pregnant before starting Desogestrel.
  • Information for breast-feeding women can be found in section 2 ‘What you need to know before you take Desogestrel‘ in the paragraph ‘Pregnancy and breast-feeding’. Your doctor can also advise you.
• After a miscarriage or an abortion
  Your doctor will advise you.

If you forget to take Desogestrel

• If you are less than 12 hours late:
  • Take the missed tablet as soon as you remember and take the next tablets at the usual time. Desogestrel will still protect you from pregnancy.
• If you are more than 12 hours late:
  • If you are more than 12 hours late in taking any tablet, you may not be completely protected against pregnancy. The more consecutive tablets you have missed, the higher the risk that you might fall pregnant.
  • Take a tablet as soon as you remember and take the next one at the usual time. This may mean taking two in one day. This is not harmful. (If you have forgotten more than one tablet, you don’t need to take the earlier missed ones). Continue to take your tablets as usual but you must also use an extra method, such a condom, for the next 7 days.
  • If you are more than 12 hours late taking your tablet and have sex, it is safe to use emergency contraception; please consult your pharmacist or doctor.
  • If you missed one or more tablets in the very first week of tablet-intake and had intercourse in the week before missing the tablets, you may fall pregnant. Ask your doctor for advice.

If you vomit or use medical charcoal

If you vomit, or use medical charcoal within 3 – 4 hours after taking your Desogestrel tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed. Follow the advice for forgotten tablets in the section above.

If you take more Desogestrel than you should

There have been no reports of serious harmful effects from taking too many Desogestrel tablets at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding. For more information, ask your doctor for advice.

If you stop taking Desogestrel

You can stop taking Desogestrel whenever you want. From the day you stop, you are no longer protected against pregnancy.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you notice any unwanted effect, especially if severe or persistent.

Serious side effects associated with the use of Desogestrel are described in section 2 “What you need to know before you take Desogestrel”. Please read this section for additional information on “Breast Cancer” and “Thrombosis” and consult your doctor at once where appropriate.

You should see your doctor immediately if you experience symptoms of angioedema, such as (i) swollen face, tongue or pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties to breathe.

Vaginal bleeding may occur at irregular intervals while using Desogestrel. This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period. You may need to use tampons or sanitary towels. You may also not have any bleeding at all. Irregular bleeding is not a sign that Desogestrel is not working. In general, you need not take any action; just continue to take Desogestrel. If bleeding is heavy or prolonged, you should consult your doctor.

How often are other possible side effects seen?

Common (may affect up to 1 in 10 women): mood changes, decreased mood, decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no periods, weight increase.

Uncommon (may affect up to 1 in 100 women): infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful periods, ovarian cyst, tiredness.

Rare (may affect up to 1 in 1,000 women): rash, hives, painful blue-red skin lumps (erythema nodosum).

Apart from these side effects, breast secretion or leakage may occur.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5 How to store Desogestrel

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after” Do not use after:” or “EXP:” The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Desogestrel contains

The active substance is desogestrel (75 microgram).

The other ingredients are: lactose monohydrate, maize starch, povidone K30, d-α-tocopherol, soybean oil, silica, colloidal hydrated, silica, colloidal anhydrous, stearic acid, hypromellose, polyethylene glycol, titanium dioxide (see also “Desogestrel contains lactose and soybean oil” in section 2).

What Desogestrel looks like and contents of the pack

One blister pack of Desogestrel contains 28 white round film-coated tablets.

Each carton contains 3 blisters.

7.Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com