Dydrogesterone Tablet USP 10mg Taj Pharma

Dydrogesterone Tablet USP 10mg Taj Pharma

COMPOSITION

Dydrogesterone tablets 10mg tablets:
Each film coated tablet contains
Dydrogesterone U.S.P.             10mg
Excipients                                   q.s.

Excipient(s) with known effect: Each tablet contains Lactose monohydrate

DESCRIPTION

Dydrogesterone is an orally-active progestogen which produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection for oestrogen induced increased risk for endometrium hyperplasia and/or carcinogenesis.

Dydrogesterone has no oestrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.

Excipients: Lactose monohydrate, Hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000 hite (hypromellose, macrogol 400, titanium dioxide).

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Pharmacotherapeutic group: Genito Urinary system and sex hormones

Dydrogesterone is an orally-active progestogen which produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection for estrogen induced increased risk for endometrium hyperplasia and/or carcinogenesis. It is indicated in all cases of endogenous progesterone deficiency. Dydrogesterone has no estrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.

Pharmacokinetics

After oral administration of labelled dydrogesterone on average 63% of the dose is excreted into the urine. Within 72 hours excretion is complete. Dydrogesterone is completely metabolized. The main metabolite of dydrogesterone is 20a-dihydrodydrogesterone (DHD) and is present in the urine predominantly as the glucuronic acid conjugate. A common feature of all metabolites characterized is the retention of the 4,6-diene-3-one configuration of the parent compound and the absence of 17a-hydroxylation. This explains the lack of estrogenic and androgenic effects of dydrogesterone. After oral administration of dydrogesterone, plasma concentrations of DHD are substantially higher as compared to the parent drug. The AUC and Cmax ratios of DHD to dydrogesterone are in the order of 40 and 25 respectively. Dydrogesterone is rapidly absorbed. The T values of max dydrodesterone and DHD vary between 0.5 and 2.5 hours. Mean terminal half lives of dydrogesterone and DHD vary between 5 to 7 and 14 to 17 hours respectively. Dydrogesterone is not excreted in urine as pregnanediol, like progesterone. Analysis of endogenous progesterone production based on pregnanediol excretion therefore remains possible.

INDICATIONS

Hormone replacement therapy

To counteract the effects of unopposed oestrogen on the endometrium in hormone replacement therapy for women with disorders due to natural or surgical induced menopause with an intact uterus.

Progesterone deficiencies

Treatment of progesterone deficiencies such as:

• Treatment of dysmenorrhoea
• Treatment of endometriosis
• Treatment of secondary amenorrhoea
• Treatment of irregular cycles
• Treatment of dysfunctional uterine bleeding
• Treatment of pre-menstrual syndrome
• Treatment of threatened and habitual abortion, associated with proven progesterone deficiency
• Treatment of infertility due to luteal insuRciency

DOSAGE AND ADMINISTRATION

Dosages, treatment schedule and duration of treatment may be adapted to the severity of the dysfunction and the clinical response. Dysmenorrhoea: 10 or 20mg mg dydrogesterone per day from day 5 to day 25 of the menstrual cycle.

Endometriosis: 10 to 30 mg dydrogesterone per day from day 5 to day 25 of the cycle or continuously.

Dysfunctional uterine bleeding: When treatment is started to arrest a bleeding episode, 20 or 30 mg dydrogesterone per day is to be given for up to 10 days.

For continuous treatment, 10 or 20 mg dydrogesterone per day should be given during the second half of the menstrual cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Withdrawal bleeding occurs if the endometrium has been adequately primed with either endogenous or exogenous estrogen.

Secondary amenorrhoea: 10 or 20 mg dydrogesterone per day, to be given daily for 14 days during the second half of the theoretical menstrual cycle to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Pre-menstrual syndrome: 10 mg dydrogesterone twice daily starting with the second half of the menstrual cycle until the first day of the next cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Irregular cycles: 10 or 20 mg dydrogesterone per day starting with the second half of the menstrual cycle until the first day of the next cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Threatened abortion: An initial dose of up to 40 mg dydrogesterone may be given followed by 20 or 30mg per day until symptoms remit.

Habitual abortion: 10 mg dydrogesterone twice daily until the twelfth week of pregnancy.

Infertility due to luteal insuRciency: 10 or 20 mg dydrogesterone daily starting with the second half of the menstrual cycle until the first day of the next cycle. Treatment should be maintained for at least three consecutive cycles.

Hormone replacement therapy:

Continuous sequential therapy: An estrogen is dosed continuously and one tablet of 10 mg dydrogesterone is added for the last 14 days of every 28 day cycle, in a sequential manner.

Cyclic therapy: When an estrogen is dosed cyclically with a treatment free interval, usually 21 days on and 7 days off. One tablet of 10 mg dydrogesterone is added for the last 12 -14 days of estrogen therapy.

Depending on the clinical response, the dosage can subsequently be adjusted to 20 mg dydrogesterone per day.

There is no relevant use of dydrogesterone before menarche. The safety and eRcacy of dydrogesterone in adolescents aged 12-18 years has not been established. Currently available data are described in section 4.8 and 5.1, but no recommendation on a posology can be made.

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients.
• Known or suspected progestogen dependent neoplasms (e.g. meningioma)
• Undiagnosed vaginal bleeding
• If used to prevent endometrial hyperplasia (in women using estrogens): Contraindications for use of oestrogens in combination with progestagens, such as Dydrogesterone.

WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Before initiating dydrogesterone treatment for abnormal bleeding the etiology for the bleeding should be clarified. Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.

Conditions which need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with dydrogesterone and ceasing the treatment should be considered:

• porphyria
• depression
• abnormal liver function values caused by acute or chronic liver disease

Other conditions

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

The following warnings and precautions apply when using dydrogesterone in combination with estrogens for hormone replacement therapy (HRT):

See also the warnings and precautions in the product information of the estrogen preparation.

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favorable than in older women.

Medical examination / follow-up

Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below).

Investigations, including appropriate imaging tools, e.g., mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Endometrial hyperplasia

• Long-term use of oestrogens without addition of progestagens increases the change of endometrial hyperplasia and endometrial carcinoma in women with a uterus. This risk may largely be prevented by combining the oestrogen therapy for at least 12 days per cycle with a progestagen, such as dydrogesterone.

Breast cancer

• The overall evidence suggests an increased risk of breast cancer in women taking combined estrogen-progestogen and possibly also estrogen-only HRT, that is dependent on the duration of taking HRT. Combined estrogen-progestogen therapy: The randomized placebo-controlled trial, Women’s Health Initiative study (WHI), and epidemiological studies are consistent in finding an increased risk of breast cancer in women taking combined estrogen-progestogen for HRT that becomes apparent after about 3 years. The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment. HRT, especially estrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the detection of breast cancer.

Ovarian cancer

• Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping. Some other studies including the WHI trial suggest that use of combined HRTs may be associated a similar, or slightly smaller, risk.

Venous thrombo-embolism

• HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e., deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of HRT than later. Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk. HRT is therefore contraindicated in these patients. Generally recognized risk factors for VTE include, use of estrogens, older age, major surgery, prolonged immobilization, obesity (BMI > 30 kg/m2), pregnancy/ postpartum period, systemic lupus erythematosus (SLE), and cancer. There is no consensus about the possible role of varicose veins in VTE.

As in all postoperative patients, prophylactic measures need be

considered to prevent VTE following surgery. If prolonged immobilization is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended. Treatment should not be restarted until the woman is completely mobilized.

In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counseling regarding its

limitations (only a proportion of thrombophilic defects are identified by screening).

If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe’ (e.g., antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT is contraindicated.

Women already on chronic anticoagulant treatment require careful consideration of the benefit risk of use of HRT.

If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they are aware of a potential thromboembol- ic symptom (e.g.,painful swelling of a leg, sudden pain in the chest, dyspnea).

Coronary artery disease (CAD)

There is no evidence from randomized controlled trials of protection against myocardial infarction in women with or without existing CAD who received combined estrogen-progestogen or

estrogen-only HRT.

Combined estrogen-progestogen therapy: The relative risk of CAD during use of combined estrogenprogestogen HRT is slightly increased. As the baseline absolute risk of CAD is strongly dependent on age, the number of extra cases of CAD due to estrogen-progestogen use is very low in healthy women close to menopause, but will rise with more advanced age.

Cerebrovascular accident (CVA)

• Combined estrogen-progestogen and estrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischemic stroke. The relative risk does not change with age or time since menopause. However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age.

Excipients:

This medicinal product contains Lactose monohydrate.

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

INTERACTIONS

Interaction with other medicinal products and other forms of interaction. In vitro data show that the major metabolic pathway generating the main pharmacologically active metabolite 20α dihydrodydrogesterone (DHD) is catalyzed by aldo-keto reductase 1C (AKR 1C) in human cytosol. Next to the cytosolic metabolism there are metabolic transformations by cytochrome P450

iso-enzymes (CYPs), nearly exclusively via CYP3A4, resulting in several minor metabolites. The main active metabolite DHD is substrate for metabolic transformation by CYP3A4. Therefore, the metabolism of dydrogesterone and DHD may be increased by concomitant use of substances known to induce CYP enzymes such as anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine), anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz) and herbal preparations containing e.g. St John’s Wort (Hypericum perforatum), valerian root, sage, or gingko biloba. Ritonavir and nelfinavir, although known as strong cytochrome enzyme inhibitors, by contrast exhibit enzyme-inducing properties when used concomitantly with steroid hormones.

Clinically, an increased metabolism of dydrogesterone may lead to a decreased effect. In vitro studies have shown that dydrogesterone and DHD do not inhibit or induce CYP drug metabolizing enzymes at clinically relevant concentrations.

PREGNANCY

It is estimated that more than 10 million pregnancies have been exposed to dydrogesterone. So far there were no indications of a harmful effect of dydrogesterone use during pregnancy.

Some progestogens have been reported in the literature to be associated with an increased risk of hypospadias. However due to confounding factors during pregnancy, no definitive conclusion can be drawn regarding the contribution of progestogens to hypospadias. Clinical studies, where a limited number of women were treated with dydrogesterone early in pregnancy, have not shown any increase

in risk. No other epidemiological data are hitherto available. Effects in non-clinical embryo-fetal and post-natal development studies were in line with the pharmacological profile. Untoward effects occurred only at exposures which exceeded the maximum human exposure considerably, indicating little relevance to clinical use.

Dydrogesterone can be used during pregnancy if clearly indicated.

Breastfeeding

No data exist on excretion of dydrogesterone in mother’s milk. Experience with other progestogens indicates that progestogens and the metabolites pass to mother’s milk in small quantities. Whether there is a risk to the child is not known. Therefore, dydrogesterone should not be used during the lactation period.

Fertility

There is no evidence that dydrogesterone decreases fertility at therapeutic dose.

Effects on ability to drive and use machines

Dydrogesterone has minor influence on the ability to drive and use machines. Infrequently, dydrogesterone may cause mild somnolence and/or dizziness, especially within the first few hours after intake. Therefore, care should be taken when driving or using machines.

UNDESIRABLE EFFECTS

Like all medicines, Dydrogesterone tablets may have side effects. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

The frequencies of study related adverse events are ranked according to the following: common (frequency 1.10%), uncommon (frequency <1%), rare (frequency <0.1%), very rare (frequency

<0.01%), including isolated reports.

The most commonly reported adverse drug reactions of patients treated with dydrogesterone in clinical trials of indications without estrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.

The following undesirable effects have been observed with the frequencies indicated below during clinical trials using dydrogesterone (n=3483) in indications without estrogen treatment and from spontaneous reporting:

* Undesirable effects from spontaneous reporting which have not been observed in clinical trials have been attributed to the frequency ‘rare’ based on the fact that the upper limit of the 95% confidence interval of the frequency estimate is not higher than 3/x where x =3483 (total number of subjects observed in clinical trials).

Undesirable effects in adolescent population

Based on spontaneous reports and limited clinical trial data, the adverse reaction profile in adolescents is expected to be similar to that seen in adults.

Undesirable effects that are associated with an estrogen-progesto- gen treatment (see product information of the estrogen preparation):

• Breast cancer, endometrial hyperplasia, endometrial carcinoma, ovarian cancer
• Venous thromboembolism
• Myocardial infarction, coronary artery disease, ischemic stroke

OVERDOSAGE

Limited data are available with regard to overdose in humans. Dydrogesterone was well tolerated after oral dosing (maximum daily dose taken to date in humans 360 mg). No reports of ill-effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic.

STORAGE

Store below 25˚C in a dry place. Protect from light.

PRESENTATION

Dydrogesterone tablets 10 mg film coated tablets:

Blister pack of 2 x 10 tablets. (List No. W 156)

MORE INFORMATION

Information in this leaflet is limited. Further information is available on request.

To be sold on the prescription of a registered medical practitioner only.

Keep all medicines out of the reach of children.

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

Dydrogesterone tablets 10mg film-coated tablets Taj Pharma

Package Leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 

In this leaflet:

1 What Dydrogesterone tablets 10mg is and what it is used for

2 Before you take Dydrogesterone tablets 10mg

3 How to take Dydrogesterone tablets 10mg

4 Possible side effects

5 How to store Dydrogesterone tablets 10mg

6 Further information

1.What Dydrogesterone tablets 10mg is and what it is used for

What Dydrogesterone tablets 10mg is

Dydrogesterone tablets 10mg contains a medicine called “dydrogesterone”. Dydrogesterone is a man-made hormone.

It is very similar to the hormone “progesterone” made by your body. Medicines like Dydrogesterone tablets 10mg are called “progestogens”

1.What Dydrogesterone tablets 10mg is used for

Dydrogesterone tablets 10mg can be used alone or with an estrogen. Whether you take an estrogen as well, depends on what you are taking the medicine for.

Dydrogesterone tablets 10mg is used:

For problems you may get when your body does not produce enough progesterone:

to relieve painful periods

to relieve the symptoms of endometriosis (a problem caused by growth of the womb lining outside the womb) to treat infertility due to low level of progesterone

to control irregular periods (that come at the wrong time or not at all) to relieve the symptoms of premenstrual syndrome (PMS).

to re-start periods that have stopped before the menopause (amenorrhoea)

to stop or prevent unusually heavy or long periods (often due to the start of the menopause).

To treat the signs of your menopause – this treatment is called Hormone Replacement Therapy or ‘HRT’. Dydrogesterone tablets 10mg is used with an estrogen to treat the signs of your menopause. These signs vary from woman to woman.

How Dydrogesterone tablets 10mg works

Dydrogesterone tablets 10mg is used to treat problems which you may get when your body is not making enough of its own progestogen hormone.

This is normally produced in your ovaries from puberty until your menopause. The progestogen (dydrogesterone) in Dydrogesterone tablets 10mg replaces this missing hormone.

In your body, progestogen is normally balanced against the major female hormone estrogen.

Your doctor may also have prescribed an estrogen medicine for you so that you get the right balance of hormones.

For some women using HRT, taking only an estrogen can cause an abnormal thickening of the womb lining. This may also be the case if you do not have your womb and have a history of endometriosis. Taking dydrogesterone for part of your monthly cycle helps to prevent a build up of your womb lining.

2.Before you take Dydrogesterone tablets 10mg

If you are just taking Dydrogesterone tablets 10mg

Before taking your medicine, you should make sure it is safe for you to do so.

Do not take Dydrogesterone tablets 10mg if:

you have a tumour that is made worse by progestogens (such as meningioma)

you have irregular or unusually heavy periods that your doctor does not already know about

you are allergic (hypersensitive) to any of the ingredients of this medicine listed in Section 6.

Do not take Dydrogesterone tablets 10mg if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dydrogesterone tablets 10mg.

If you are taking Dydrogesterone tablets 10mg together with an estrogen for example part of a HRT, please also read the “Do not take” section on the information leaflet that comes with your estrogen medicine.

Before taking your medicine you should also make sure that it is safe for you to take the estrogen product at the same time

Take special care with Dydrogesterone tablets 10mg

If you need to take Dydrogesterone tablets 10mg for abnormal bleeding, your doctor will find the cause of the bleeding before you start taking this medicine.

If you get unexpected vaginal bleeding or spotting it is usually nothing to worry about. It is especially likely during the first months of taking Dydrogesterone tablets 10mg.

However, make an appointment to see your doctor straight away if bleeding or spotting:

carries on for more than a few months

starts after you have been on treatment for a while

carries on even after you have stopped treatment.

This may be a sign that your womb lining has become thicker. Your doctor will look into the cause of the bleeding or spotting and may do a test to find out if you have cancer of the womb lining.

Check with your doctor or pharmacist before taking Dydrogesterone tablets 10mg if you have any of the following:

depression

liver problems

a rare blood problem passed down in families (inherited) called “porphyria”.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Dydrogesterone tablets 10mg. It is particularly important to tell them if the problems above have ever got worse during pregnancy or previous hormone therapy. Your doctor may want to monitor you more closely during treatment. If they get worse or reappear while taking Dydrogesterone tablets 10mg, your doctor may stop treatment.

Dydrogesterone tablets 10mg and HRT

As well as benefits, HRT has some risks which you and your doctor need to consider when youare deciding whether to take these medicines. If you are taking Dydrogesterone tablets 10mg with an estrogen as part of HRT, the following information is important. Please also read the information leaflet that comes with your estrogen medicine.

Early menopause

There is limited evidence about the risks of HRT when it is used to treat early menopause. There is a low level of risk in younger women. This means that the balance of benefits and risks for younger women using HRT for early menopause may be better than in older women.

Medical check-ups

Before you start taking HRT, your doctor should ask about you and your family’s medical history. Your doctor may decide to examine your breasts or your tummy (abdomen) and may do an internal examination. They will only do this if it is necessary for you or if you have any special concerns.

Once you have started on HRT, see your doctor for regular check-ups (at least once a year), he may do screening tests such as a mammogram (an X-ray of the breasts). At these check-ups, your doctor may discuss the benefits and risks of continuing to take HRT.

Make sure that you:

go for regular breast screening and cervical smear tests

regularly check your breasts for any changes such as dimpling ofthe skin, changes in the nipple, or any lumps you can see or feel.

Heart disease

HRT will not help to prevent heart disease. HRT is not recommended for women who have heart disease or have had heart disease recently.

The risk of heart disease also increases with age. The number of extra cases of heart disease due to use of estrogen-progestogen HRT is very low in healthy women close to menopause. The number of extra cases increases with age. If you have ever had heart disease, talk to your doctor to see if you should take HRT.

If you get a pain in your chest that spreads to your arm or neck:

see a doctor as soon as possible

do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke

Taking estrogen-progesterone HRT and estrogen- only HRT increases the risk of having a stroke.

The risk is up to one and a half times that of people not taking HRT. The comparable risk for users, versus non- users, does not change with age or time since menopause. The risk of stroke increases with age. This means that the general risk of stroke in women who use HRT will increase with age.

If you get an unexplained headache or migraine (which can include disturbed vision):

see a doctor as soon as possible

do not take any more HRT until your doctor says you can. This may be an early warning sign of a stroke.

Blood clots

HRT increases the risk of blood clots in the veins (a deep vein thrombosis or DVT) the risk is up to 3 times higher than that of people not taking HRT, especially during the first year of taking it.

You are more likely to get a blood clot if:

you are older

you have cancer

you are very overweight

you are taking an estrogen

you are pregnant or have recently had a baby

you (or close family) have had a blood clot before, including in the leg or lung

you have been off your feet for a long time because of major surgery, injury or illness (see information under “Operations”)

you have systemic lupus erythematosus (SLE). This is a problem that causes joint pain, skin rashes and fever. If any of these things apply to you, talk to your doctor to see if you should take HRT.

If you get painful swelling in your leg, sudden chest pain or have difficulty breathing:

see a doctor as soon as possible

do not take any more HRT until your doctor says you can.

These may be signs of a blood clot.

Also, tell your doctor or pharmacist if you are taking medicines to prevent blood clots (anti-coagulants) – such as warfarin. Your doctor will pay special attention to the benefits and risks of you taking HRT.

Breast cancer

Women who take estrogen-progestogen HRT and possibly estrogen-only HRT have a higher risk of breast cancer. The risk depends on how long you take HRT.

The extra risk of breast cancer goes up the longer you take it, after about 3 years. However, it returns to normal within about 5 years after stopping.

If you notice any changes in your breast, such as:

dimpling of the skin

changes in the nipple

any lumps you can see or feel.

Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb) and endometrial hyperplasia

Women who have womb and take estrogen-only HRT for a long time have a higher risk of cancer of the lining of the womb (the endometrium) and endometrial hyperplasia (abnormal thickening of the womb lining).

Taking Dydrogesterone tablets 10mg as well as an estrogen (for at least 12 days per month – or 28 day cycle) or as continuous combined estrogen-progestogen therapy can prevent this extra risk.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose. This is because there are often no obvious signs of the disease. Taking estrogen-only HRT for more than 5 years is thought to slightly increase the risk of ovarian cancer. Some studies suggest that long-term use of estrogen- progestogen HRT may have the same (or slightly smaller) risk.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription or herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following: These medicines may lower the effect of Dydrogesterone tablets 10mg and lead to bleeding or spotting

medicines for fits (epilepsy) such as phenobarbital, phenytoin or carbamazepine

medicines for infection such as rifampicin, rifabutin, nevirapine, efavirenz

medicines for HIV infection (AIDS) such as ritonavir or nelfinavir

medicines for diabetes such as insulin

herbal medicines containing St John’s Wort (Hypericum perforatum), valerian root, sage, or ginkgo biloba If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Dydrogesterone tablets 10mg.

Operations or tests

Tell your doctor if you are going to have surgery. Do this well before the operation. You may need to stop taking HRT about 4 to 6 weeks before the operation to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

If you visit a hospital or your family doctor for a blood or urine test, tell them that you are taking Dydrogesterone tablets 10mg. This is because this medicine may affect the results of these tests.

Children and young people

Dydrogesterone tablets 10mg is not for use in children before their first menstrual bleed. It is not known how safe or effective Dydrogesterone tablets 10mg is in young people aged 12-18 years.

Fertility, Pregnancy and breast-feeding Fertility

There is no evidence that dydrogesterone decreases your fertility, if taken as recommended by your doctor.

Pregnancy

There may be an increased risk of hypospadias (a birth defect of the penis involving the urinary opening) in children whose mothers have taken certain progestogens. However, this increased risk is not yet certain. So far, there is no evidence that taking dydrogesterone during pregnancy is harmful. More than 10 million pregnant women have taken Dydrogesterone tablets 10mg.

Talk to your doctor before taking Dydrogesterone tablets 10mg if you are pregnant.

If you become pregnant or think you might be pregnant see your doctor. Your doctor will discuss with you the benefits and risks of taking Dydrogesterone tablets 10mg while you are pregnant.

Breast-feeding

Do not take Dydrogesterone tablets 10mg if you are breast-feeding. It is not known if Dydrogesterone tablets 10mg passes into mother’s milk and affects the child. Studies of other progestogens show small amounts pass into the mother’s milk.

Driving and using machines

You may feel slightly sleepy or dizzy after taking Dydrogesterone tablets 10mg. This is more likely in the first few hours after taking it. If this happens, do not drive or use any tools or machines. Wait to see how Dydrogesterone tablets 10mg affects you, before you drive or use any tools or machines.

Important information about some of the ingredients of Dydrogesterone tablets 10mg

Dydrogesterone tablets 10mg contains milk sugar (lactose). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. This includes rare problems passed down in families that affect how the body uses lactose, such as “Lapp lactase deficiency” or “glucose-galactose malabsorption”.

3.How to take Dydrogesterone tablets 10mg

Always take Dydrogesterone tablets 10mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will adjust the dose to suit you.

While you are taking Dydrogesterone tablets 10mg, you should see your doctor regularly (at least once a year). Your doctor may wish to carry out medical checks, including breast examinations.

Taking this medicine

Swallow the tablet with water

You can take your tablet with or without food.

If you have to take more than one tablet, spread them evenly over the day. For example, take one tablet in the morning and one in the evening.

Try to take your tablet at the same time each day. This will make sure that there is a constant amount of the medicine in your body. This will also help you remember to take your tablets.

The score line on each tablet is only to help break the tablets so they are easier to swallow. It should not be used in order to take half a tablet.

How much to take

The number of tablets you take and the days you take them on will depend on what you are being treated for. Your doctor will decide the best time for you to take Dydrogesterone tablets 10mg. If you are still having natural periods, day 1 of your cycle is when you start bleeding. If you are not having natural periods, your doctor will decide with you when to start day 1 of the cycle and when to start taking your tablets.

To relieve the symptoms of pre-menstrual syndrome

Take 2 tablets a day.

Do this from the second half of your cycle until the first day of your next cycle.

The starting day and number of days you take your tablets for will depend on the length of your cycle.

Your doctor may decide to give you a higher dose.

To relieve the symptoms of endometriosis

Take 1 to 3 tablets a day.

You will either be asked to take your tablets:

On every day of your cycle or only on cycle days 5 to 25.

To treat infertility due to low levels of progesterone

Take 1 or 2 tablets a day.

Do this from the second half of your cycle until the first day of your next cycle.

The starting day and number of days you take your tablets for will depend on the length of your cycle.

Continue treatment for at least three cycles in a row.

If you become pregnant, tell your doctor. You may need to take one tablet twice a day until you are 20 weeks pregnant. After that, you may be asked to take the tablets less often.

For irregular periods

Take 1 or 2 tablets a day.

Do this from the second half of your cycle until the first day of your next cycle.

The starting day and number of days you take your tablets for will depend on the length of your cycle.

To re-start periods that have stopped before the menopause

Take 1 or 2 tablets a day.

Do this for fourteen days during the second half of your expected cycle.

For menstrual bleeding that is unusually heavy or happens between periods

When treatment is started to stop bleeding:

Take 2 or 3 tablets a day

Do this for up to ten days.

For continuous treatment:

Take 1 or 2 tablets a day

Do this during the second half of your cycle.

The starting day and number of days you take your tablets for will depend on the length of your cycle.

To relieve painful periods

Cycle days 5 to 25: Take 1 or 2 tablets a day.

For hormone replacement therapy (HRT)

If you are on ‘sequential’ HRT (you take an estrogen tablet or use a patch for your whole cycle):

Take 1 tablet a day

Do this for the last fourteen days of every twenty eight day cycle.

If you are on ‘cyclic’ HRT (you take an estrogen tablet or use a patch usually for 21 days, followed by a treatment-free interval of 7 days):

Take 1 tablet a day

Do this for the last twelve to fourteen days of the estrogen therapy.

If necessary, your doctor may increase your dose to 2 tablets a day.

Children and young people

Dydrogesterone tablets 10mg is not for use in children before their first menstrual bleed. It is not known how safe or effective Dydrogesterone tablets 10mg is in young people aged 12-18 years.

Older people (over 65)

You can use this medicine for HRT. Follow the instructions above for adults.

If you take more Dydrogesterone tablets 10mg than you should

If you (or someone else or a child) take too many Dydrogesterone tablets 10mg tablets, they are unlikely to do any harm. No treatment is necessary. You may feel sick (nauseous), sleepy, dizzy or be sick (vomit). If you are worried, talk to your doctor for advice.

If you forget to take Dydrogesterone tablets 10mg

If you forget to take today’s tablet and it is less than 12 hours late, take it as soon as you remember. Take the next day’s tablet at the normal time.

If it is more than 12 hours since you should have taken your tablet, miss this tablet out. Take the next day’s tablet at the usual time and continue taking your tablets as normal.

Do not take a double dose to make up for a forgotten dose.

If you miss a tablet, it is more likely that you will have irregular bleeds or spotting.

If you stop taking Dydrogesterone tablets 10mg

Do not stop taking Dydrogesterone tablets 10mg without talking to your doctor first.

4.Possible side effects

Like all medicines, Dydrogesterone tablets 10mg can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Side effects of taking Dydrogesterone tablets 10mg alone

Stop taking Dydrogesterone tablets 10mg and see a doctor straight away or go to hospital, if you notice or suspect any of the following. You may need urgent medical treatment:

swelling of the skin around the face and throat which may cause difficulty breathing (angioedema) – affect less than 1 in 1,000 people).

liver problems – the signs may include yellowing of the skin or eyes (jaundice), feeling generally unwell with abdominal pain or other liver related changes – affect less than 1 in 100 people.

allergic reactions – the signs may include difficulty breathing or reactions involving the whole body such as feeling sick, being sick, diarrhoea or low blood pressure (affects less than 1 in 1,000 people)

If you notice or suspect any of the above, stop taking Dydrogesterone tablets 10mg and see a doctor straight away.

Other side effects of taking Dydrogesterone tablets 10mg alone:

Common (affects less than 1 in 10 people)

headache,

migraine

feeling sick (nausea)

breast pain/tender breasts

painful, heavy or irregular periods

no periods or periods happening less often than normal

Uncommon (affects less than 1 in 100 people)

weight gain

rash, severe itching or hives

feeling depressed

feeling dizzy

being sick (vomiting)

Rare (affects less than 1 in 1,000 people)

low levels of red blood cells (haemolytic anaemia)

hypersensitivity reactions

your body holding onto more water than usual (fluid retention)

swelling of the breasts

feeling sleepy

increase in the size of tumours affected by progestogens (such as meningioma). Side effects in younger patients are expected to be similar to those seen in adults.

Side effects of taking Dydrogesterone tablets 10mg with an estradiol (estrogen-progestogen HRT)

If you are taking Dydrogesterone tablets 10mg together with an estrogen please also read the information leaflet that comes with your estrogen medicine. See Section 2 “Before you take Dydrogesterone tablets 10mg” for more information on the side effects below.

Stop taking Dydrogesterone tablets 10mg and see a doctor straight away, if you notice any of the following side effects:

painful swelling in your leg, sudden chest pain or difficulty breathing. These could be signs of a blood clot

pain in your chest that spreads to your arm or neck. This could be a sign of a heart attack

severe, unexplained headache or migraine (with or without vision problems). These could be signs of a stroke.

Stop taking Dydrogesterone tablets 10mg and see a doctor straight away, if you notice any of the side effects above.

Make an appointment to see a doctor straight away if you notice:

dimpling of the skin in your breast, changes in the nipple or lumps you can see or feel. These could be signs of breast cancer.

Other side effects of taking Dydrogesterone tablets 10mg with an estrogen include abnormal thickening or cancer of the lining of the womb and ovarian cancer.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.How to store Dydrogesterone tablets 10mg

Keep out of the reach and sight of children.

Do not take the tablets after the expiry date shown on the outer carton and blister strip. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Take any unused tablets back to a pharmacy (chemist).

This medicinal product does not require any special storage condition

6.Further information

What Dydrogesterone tablets 10mg contains

The active substance is dydrogesterone. Each tablet contains 10mg dydrogesterone.

The other ingredients are lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate, and macrogol 400. The colour used is titanium dioxide (E171).

What Dydrogesterone tablets 10mg looks like and contents of the pack

The tablets are round, biconvex, scored, film-coated and white. They are marked on one side with the inscription “155”, on both sides of the score line.

Dydrogesterone tablets 10mg is available as a pack containing 42 or 60 tablets. Not all pack sizes may be marketed.

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