Dydron®
Dydrogesterone USP 10mg
Dosage Form: TabletPack Size: 3x10's Tablets
Composition: Dydron® Tablet: A White color round film coated standard convex tablet plain on both sides. Each film coated tablet contains Dydrogesterone USP 10mg.
Description: Dydron® (Dydrogesterone) is a synthetic progestogen and has a similar action to the female hormone, progesterone. It is used to treat menstrual disorders in women caused due to a lack of hormones. It is also used to reduce the risk of miscarriages or abortions.
Mechanism of Action: Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, Dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, Dydrogesterone is non-androgenic, nonestrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol. Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis. Dydrogesterone is a progestogen that works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus.
Pharmacokinetics: Absorption: Rapidly absorbed in the gastrointestinal tract with a bioavailability of 28%. Distribution: After intravenous administration of Dydrogesterone the steady-state distribution volume is around 1400 L. More than 90% of Dydrogesterone and DHD are bound to plasma-proteins. Metabolism: Metabolism is complete to a 20-dihydrodydro gesterone (DHD) metabolite. Elimination: After oral administration of labelled Dydrogesterone on average 63% of the dose is excreted in the urine. The total plasma clearance is 6.41/minute. Within 72 hours the excretion is complete, DHD is present in the urine mainly as the conjugated glucuronic acid.
Indications: Hormone replacement therapy Dydron® is indicated to counteract the effects of unopposed estrogen on the endometrium (inner lining of the uterus) in hormone replacement therapy for women with disorders due to naturally or surgically induced menopause with an intact uterus. Progesterone deficiencies Dydron® is indicated for the treatment of progesterone deficiencies such as: • Treatment of dysmenorrhea (painful menstruation) • Treatment of endometriosis (growth of uterine tissues outside the uterus with associated symptoms) • Treatment of secondary amenorrhea (cessation of menstruation) • Treatment of irregular cycles • Treatment of dysfunctional uterine bleeding • Treatment of premenstrual syndrome • Treatment of threatened and habitual abortion, associated with proven progesterone deficiency • Treatment of infertility due to luteal (ovarian yellow body) insufficiency Limitation of Use Dydron® is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
Dosage & Administration: For hormone replacement therapy: •In combination with continuous estrogen therapy, take one tablet daily for 14 consecutive days of a 28 day cycle. • In combination with cyclical estrogen therapy, take one tablet daily during the last 12 to 14 days of estrogen therapy. •For doctors: If endometrial biopsies or ultrasound reveal inadequate progestational response, 20 mg dydrogesterone should be prescribed. If you are not sure what type of estrogen therapy you are on, talk to your doctor before taking Dydron®. Posology for specific indications: Dysmenorrhea (painful menstruation) Take one tablet twice daily from day 5 to day 25 of the cycle. Endometriosis (abnormal growth of uterine tissues outside the uterus) Take one tablet two or three times daily from day 5 to day 25 of the cycle or continuously (as prescribed by your doctor). Dysfunctional bleeding (to stop bleeding) Take one tablet twice daily for five to seven days. Dysfunctional bleeding (to prevent bleeding) Take one tablet twice dally from day 11 to day 25 of the cycle. Amenorrhea (cessation of menstruation). Your doctor should prescribe an estrogen along with DydronTM. Then take the estrogen once daily from day 1 to day 25 of the cycle, together with one tablet of dydrogesterone twice daily from day 11 to day 25 of the cycle. Premenstrual syndrome Take one tablet twice daily from day 11 to day 25 of the cycle. Irregular cycles Take one tablet twice daily from day 11 to day 25 of the cycle. Threatened abortion Take four tablets at once, then one tablet every eight hours until symptoms abate. Habitual abortion Take one tablet twice daily until the twentieth week of pregnancy. Infertility due to luteal (yellow body) insufficiency Take one tablet daily from day 14 to 25 of the cycle. Continue the treatment for at least six consecutive cycles. In addition, it is advisable to continue treatment for the first few months of pregnancy as described under 'Habitual abortion'. If you are uncertain about how long to continue the treatment, talk to your doctor.
Contraindications: Do not take Dydron® if you •are hypersensitive (allergic) to the active substance or to any of the excipients •have a known or suspected progestogen dependent neoplasm • have undiagnosed vaginal bleeding • are using this medicine to prevent endometrial hyperplasia (abnormal growth of the lining of the uterus), specifically if patient is also taking estrogens: See Contraindications for use of estrogens in combination with progestagens, such as Dydrogesterone
Warning & Precautions: The cause of abnormal bleeding must be investigated (and found if possible) before your doctor can prescribe this medication to you to treat this problem. Treatment with dydrogesterone has infrequently been associated with alterations in liver function, sometimes accompanied by clinical symptoms if you suffer from acute liver disease, or have a history of liver disease your doctor will carefully evaluate your case before, prescribing this medicine to you. This is particularly necessary, if your liver function tests continue to be abnormal. In cases of severe hepatic impairment your doctor will stop the treatment. Some people experience breakthrough bleeding when treated with dydrogesterone. Conditions which need supervision If you have a history of (or currently suffer from porphyria (inherited or acquired disorder, preventing the proper development of hemoglobin) or depression, and/or if these conditions have been aggravated during pregnancy or previous hormone treatment, you should be closely supervised by your doctor while taking Dydron®. This is necessary because these conditions may recur or be aggravated during treatment with dydrogesterone. Other conditions Do not take this medicine if you suffer from any of the following rare hereditary problems: Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. If you have been prescribed dydrogesterone for the prevention of endometrial hyperplasia (abnormal growth of the inner lining of the uterus) while using estrogens, be sure to read the "Warnings and precautions" section in the product information leaflet of the estrogen preparation. If you suffer from the symptoms of postmenopausal estrogen deficiency, your doctor can only start you on hormone replacement therapy (HRT) if your symptoms adversely affect your quality of life. Furthermore, you should see your doctor periodically (at least annually). He will reassess the advantages and disadvantages of HRT to you and continue the treatment only if the advantages continue to outweigh the disadvantages. Endometrial hyperplasia (abnormal growth of the inner lining of the uterus) • Long-term use of estrogens without the addition of a progestogen increases the chance of endometrial hyperplasia and endometrial carcinoma (cancer) in women with an intact uterus. This risk may largely be prevented by combining the estrogen therapy for at least 12 days per cycle with a progestagen, such as dydrogesterone, the active ingredient in Dydron®. Mammary cancer • A randomized placebo-controlled study, the Women's Health Initiative Study (WHI) and epidemiological studies, including the Million Women Study (MWS) have shown that in women who have taken estrogen, estrogen-progestagen combinations or tibolone as hormone replacement therapy for a number of years there is a relative increased risk of breast cancer. For all HRT this increased risk occurs within a couple of years of use and increases as the treatment period continues. The risk returns to pretreatment level within a couple of years (a maximum of five) after the treatment is discontinued. The MWS showed that the relative risk of breast cancer in women who were treated with conjugated equine estrogen (CEE) or oestradiol (E2) was higher when a progestagen was added. This risk was independent of the dosage schedule used (sequential or continuous administration of progestogen) and the type of progestogen. Venous thromboembolism • Hormone replacement therapy is associated with a higher relative risk for the occurrence of a venous thromboembolism (VTE), that is deep vein thrombosis or pulmonary embolism. One randomized controlled study and epidemiological studies report a two to three times higher risk of VTE among users of HRT compared with women who do not use HRT. The chance of VTE is greater during the first year of HRT treatment than thereafter. • General risk factors for the occurrence of VTE are: • A positive personal history; • A positive family history; • Serious obesity (Body Mass Index greater than 30 kg/m2); • Systemic lupus erythematosus (SLE) There is no consensus regarding the possible role of varicosis in VTE. • If you have a previous history of repeated VTE or have thrombophilia (a blood disorder in which there is an increased tendency to form blood Clots), you are at an increased risk of VTE. Hormone replacement could increase this risk even further. If you have a previous personal or clear family history of VTE or have suffered repeated spontaneous abortions, your doctor must carry out an investigation to ensure you do not have a thrombophilic predisposition. Until a thorouqh evaluation of the thrombophilic factors have been carried out or anticoagulant therapy has been started, the use of HRT is contraindicated. If you are already being treated with anticoagulant therapy, your doctor must carefully assess the advantages and disadvantages of HRT treatment before starting you on it. The chance of VTE may be increased temporarily from long-term immobilization, serious trauma or major surgical operation. If you are a postoperative patient, your doctors will do all that is necessary to help prevent the occurrence of a VTE after your surgery. If you are to undergo an elective surgery (in particular abdominal or orthopedic surgery of the lower limbs), after which long-term immobilization is anticipated, your doctor will likely stop your HRT four to six weeks before the operation. Your doctor can restart your HRT when you are fully mobile again. • If a VTE develops after starting the therapy, you must stop taking Dydron® (your doctor will discontinue the prescription). Also, contact your doctor immediately if any potentially thromboembolic symptoms occur (for example: painful swelling of a leg, sudden pain in the chest, shortness of breath). Coronary heart disease Randomized controlled studies have not provided any evidence of a favourable effect of continuous combined conjugated estrogen and medroxyprogesterone acetate on the risk of coronary heart disease (i.e.: no positive influence on the risk of coronary heart disease seen during HRT). Two large clinical studies (WHI and HERS (Heart and estrogen/progestin Replacement Study)) showed a possible increased risk of cardiovascular morbidity during the first year of use and no indications of an overall favorable effect. Cerebrovascular accident (CVA) In one large randomized clinical trial (WHI study) in healthy women, as a secondary outcome, an increased risk of ischemic CVA was reported during treatment with continuous combined conjugated estrogen with medroxyprogesterone acetate. Drug Interactions Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. No interaction studies have been performed. PREGNANCY AND LACTATION Ask your doctor or pharmacist for advice before taking any medicine during pregnancy. It is estimated that altogether roughly 35 million women have been treated with dydrogesterone. Although the number of pregnancies is difficult to estimate, as an approximation it can be assumed that fetuses were exposed to dydrogesterone in around nine million pregnancies (this high exposure in pregnancy is due to the fact that dydrogesterone has pregnancy related indications in large parts of the world). From spontaneous surveillance systems to date, there is no evidence that dydrogesterone cannot be used during pregnancy. No other relevant epidemiological data on dydrogesterone are available. The limited animal safety data suggest that Dydron® s’ active ingredient dydrogesterone has delaying effects on parturition, which is consistent with its progestogenic activity. There is no evidence that dydrogesterone decreases fertility. Dydrogesterone is excreted in the milk of nursing mothers. A risk to the suckling child cannot be excluded. Dydrogesterone should not be used during breast-feeding. Effects on ability to drive and use machines Dydrogesterone has no or negligible influence on the ability to drive and use machines. Important information about the ingredients Lactose monohydrate: If you have been told by your doctor that you have an intolerance to some sugars, especially lactose, contact your doctor before taking this medicinal product. Undesirable effects Like all medicines, Dydron® may cause side effects. If you notice any side effects not mentioned in this leaflet, or if any of the side effects gets serious, please inform your doctor or pharmacist. The frequencies of study related side effects are ranked according to the following: Common: Between 1 and 10 cases in 100 treated patients Uncommon: Less than one case in 100 treated patients Rare: Less than one case in 1000 treated patients Very Rare: Less than one case in 10 000 treated patients The undesirable effects reported in clinical trials and/or in post marketing experience following dydrogesterone therapy are (according to the MedDRA organ classification system): Blood and the lymphatic system disorders Very rare: Haemolytic anaemia (low red blood cell count due to destruction of red blood cells) Immune system disorders Very rare: Hypersensitivity (allergy) Nervous system disorders Common: Migraines/ headache Hepatobiliary disorders Uncommon: Abnormal hepatic function (with jaundice, asthenia (weakness) or malaise, and abdominal pain) Skin and subcutaneous tissue disorders Uncommon: Allergic dermatitis (e.g. rash, pruritus (itching), urticaria (hives)) Very rare: Angioedema (sudden, non-painful accumulation of fluid under the skin) Reproductive system and breast disorders Common: Metrorrhagia (uterine bleeding not associated with menstruation) Uncommon: Breast pain/ tenderness General disorders and administration site conditions Very rare: Edema (swelling) Other adverse reactions obtained from the market with unknown frequency in association with dydrogesterone treatment: Neoplasms benign, malignant and unspecified (incl. cysts and polyps) • Increase in size of progestogen dependent neoplasms (e.g. meningioma; see section “Contraindications”) Psychiatric disorders • Depressed mood Reproductive system and breast disorders • Breast swelling Undesirable effects that are associated with an estrogen-progestogen treatment (see also section "Warnings and special precautions for use"): Breast cancer • Endometrial hyperplasia (abnormal growth of the inner lining of the uterus), endometrial carcinoma (cancer) • Sex hormone dependent tumors (malignant/benign) • Venous thrombosis • Myocardial infarction (heart attack), cardiovascular accident
Overdose: 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). There are no specific antidotes and treatment should be symptomatic. Aforementioned information is also applicable for overdosing in children.
Storage Conditions: Store below 30℃ & dry place. Keep away from light and out of the reach of children.
Commercial Pack: Dydron® Tablet: Each box contains 3x10 tablets in Alu-PVDC blister strip.
Mechanism of Action: Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, Dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, Dydrogesterone is non-androgenic, nonestrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol. Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis. Dydrogesterone is a progestogen that works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus.
Pharmacokinetics: Absorption: Rapidly absorbed in the gastrointestinal tract with a bioavailability of 28%. Distribution: After intravenous administration of Dydrogesterone the steady-state distribution volume is around 1400 L. More than 90% of Dydrogesterone and DHD are bound to plasma-proteins. Metabolism: Metabolism is complete to a 20-dihydrodydro gesterone (DHD) metabolite. Elimination: After oral administration of labelled Dydrogesterone on average 63% of the dose is excreted in the urine. The total plasma clearance is 6.41/minute. Within 72 hours the excretion is complete, DHD is present in the urine mainly as the conjugated glucuronic acid.
Indications: Hormone replacement therapy Dydron® is indicated to counteract the effects of unopposed estrogen on the endometrium (inner lining of the uterus) in hormone replacement therapy for women with disorders due to naturally or surgically induced menopause with an intact uterus. Progesterone deficiencies Dydron® is indicated for the treatment of progesterone deficiencies such as: • Treatment of dysmenorrhea (painful menstruation) • Treatment of endometriosis (growth of uterine tissues outside the uterus with associated symptoms) • Treatment of secondary amenorrhea (cessation of menstruation) • Treatment of irregular cycles • Treatment of dysfunctional uterine bleeding • Treatment of premenstrual syndrome • Treatment of threatened and habitual abortion, associated with proven progesterone deficiency • Treatment of infertility due to luteal (ovarian yellow body) insufficiency Limitation of Use Dydron® is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
Dosage & Administration: For hormone replacement therapy: •In combination with continuous estrogen therapy, take one tablet daily for 14 consecutive days of a 28 day cycle. • In combination with cyclical estrogen therapy, take one tablet daily during the last 12 to 14 days of estrogen therapy. •For doctors: If endometrial biopsies or ultrasound reveal inadequate progestational response, 20 mg dydrogesterone should be prescribed. If you are not sure what type of estrogen therapy you are on, talk to your doctor before taking Dydron®. Posology for specific indications: Dysmenorrhea (painful menstruation) Take one tablet twice daily from day 5 to day 25 of the cycle. Endometriosis (abnormal growth of uterine tissues outside the uterus) Take one tablet two or three times daily from day 5 to day 25 of the cycle or continuously (as prescribed by your doctor). Dysfunctional bleeding (to stop bleeding) Take one tablet twice daily for five to seven days. Dysfunctional bleeding (to prevent bleeding) Take one tablet twice dally from day 11 to day 25 of the cycle. Amenorrhea (cessation of menstruation). Your doctor should prescribe an estrogen along with DydronTM. Then take the estrogen once daily from day 1 to day 25 of the cycle, together with one tablet of dydrogesterone twice daily from day 11 to day 25 of the cycle. Premenstrual syndrome Take one tablet twice daily from day 11 to day 25 of the cycle. Irregular cycles Take one tablet twice daily from day 11 to day 25 of the cycle. Threatened abortion Take four tablets at once, then one tablet every eight hours until symptoms abate. Habitual abortion Take one tablet twice daily until the twentieth week of pregnancy. Infertility due to luteal (yellow body) insufficiency Take one tablet daily from day 14 to 25 of the cycle. Continue the treatment for at least six consecutive cycles. In addition, it is advisable to continue treatment for the first few months of pregnancy as described under 'Habitual abortion'. If you are uncertain about how long to continue the treatment, talk to your doctor.
Contraindications: Do not take Dydron® if you •are hypersensitive (allergic) to the active substance or to any of the excipients •have a known or suspected progestogen dependent neoplasm • have undiagnosed vaginal bleeding • are using this medicine to prevent endometrial hyperplasia (abnormal growth of the lining of the uterus), specifically if patient is also taking estrogens: See Contraindications for use of estrogens in combination with progestagens, such as Dydrogesterone
Warning & Precautions: The cause of abnormal bleeding must be investigated (and found if possible) before your doctor can prescribe this medication to you to treat this problem. Treatment with dydrogesterone has infrequently been associated with alterations in liver function, sometimes accompanied by clinical symptoms if you suffer from acute liver disease, or have a history of liver disease your doctor will carefully evaluate your case before, prescribing this medicine to you. This is particularly necessary, if your liver function tests continue to be abnormal. In cases of severe hepatic impairment your doctor will stop the treatment. Some people experience breakthrough bleeding when treated with dydrogesterone. Conditions which need supervision If you have a history of (or currently suffer from porphyria (inherited or acquired disorder, preventing the proper development of hemoglobin) or depression, and/or if these conditions have been aggravated during pregnancy or previous hormone treatment, you should be closely supervised by your doctor while taking Dydron®. This is necessary because these conditions may recur or be aggravated during treatment with dydrogesterone. Other conditions Do not take this medicine if you suffer from any of the following rare hereditary problems: Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. If you have been prescribed dydrogesterone for the prevention of endometrial hyperplasia (abnormal growth of the inner lining of the uterus) while using estrogens, be sure to read the "Warnings and precautions" section in the product information leaflet of the estrogen preparation. If you suffer from the symptoms of postmenopausal estrogen deficiency, your doctor can only start you on hormone replacement therapy (HRT) if your symptoms adversely affect your quality of life. Furthermore, you should see your doctor periodically (at least annually). He will reassess the advantages and disadvantages of HRT to you and continue the treatment only if the advantages continue to outweigh the disadvantages. Endometrial hyperplasia (abnormal growth of the inner lining of the uterus) • Long-term use of estrogens without the addition of a progestogen increases the chance of endometrial hyperplasia and endometrial carcinoma (cancer) in women with an intact uterus. This risk may largely be prevented by combining the estrogen therapy for at least 12 days per cycle with a progestagen, such as dydrogesterone, the active ingredient in Dydron®. Mammary cancer • A randomized placebo-controlled study, the Women's Health Initiative Study (WHI) and epidemiological studies, including the Million Women Study (MWS) have shown that in women who have taken estrogen, estrogen-progestagen combinations or tibolone as hormone replacement therapy for a number of years there is a relative increased risk of breast cancer. For all HRT this increased risk occurs within a couple of years of use and increases as the treatment period continues. The risk returns to pretreatment level within a couple of years (a maximum of five) after the treatment is discontinued. The MWS showed that the relative risk of breast cancer in women who were treated with conjugated equine estrogen (CEE) or oestradiol (E2) was higher when a progestagen was added. This risk was independent of the dosage schedule used (sequential or continuous administration of progestogen) and the type of progestogen. Venous thromboembolism • Hormone replacement therapy is associated with a higher relative risk for the occurrence of a venous thromboembolism (VTE), that is deep vein thrombosis or pulmonary embolism. One randomized controlled study and epidemiological studies report a two to three times higher risk of VTE among users of HRT compared with women who do not use HRT. The chance of VTE is greater during the first year of HRT treatment than thereafter. • General risk factors for the occurrence of VTE are: • A positive personal history; • A positive family history; • Serious obesity (Body Mass Index greater than 30 kg/m2); • Systemic lupus erythematosus (SLE) There is no consensus regarding the possible role of varicosis in VTE. • If you have a previous history of repeated VTE or have thrombophilia (a blood disorder in which there is an increased tendency to form blood Clots), you are at an increased risk of VTE. Hormone replacement could increase this risk even further. If you have a previous personal or clear family history of VTE or have suffered repeated spontaneous abortions, your doctor must carry out an investigation to ensure you do not have a thrombophilic predisposition. Until a thorouqh evaluation of the thrombophilic factors have been carried out or anticoagulant therapy has been started, the use of HRT is contraindicated. If you are already being treated with anticoagulant therapy, your doctor must carefully assess the advantages and disadvantages of HRT treatment before starting you on it. The chance of VTE may be increased temporarily from long-term immobilization, serious trauma or major surgical operation. If you are a postoperative patient, your doctors will do all that is necessary to help prevent the occurrence of a VTE after your surgery. If you are to undergo an elective surgery (in particular abdominal or orthopedic surgery of the lower limbs), after which long-term immobilization is anticipated, your doctor will likely stop your HRT four to six weeks before the operation. Your doctor can restart your HRT when you are fully mobile again. • If a VTE develops after starting the therapy, you must stop taking Dydron® (your doctor will discontinue the prescription). Also, contact your doctor immediately if any potentially thromboembolic symptoms occur (for example: painful swelling of a leg, sudden pain in the chest, shortness of breath). Coronary heart disease Randomized controlled studies have not provided any evidence of a favourable effect of continuous combined conjugated estrogen and medroxyprogesterone acetate on the risk of coronary heart disease (i.e.: no positive influence on the risk of coronary heart disease seen during HRT). Two large clinical studies (WHI and HERS (Heart and estrogen/progestin Replacement Study)) showed a possible increased risk of cardiovascular morbidity during the first year of use and no indications of an overall favorable effect. Cerebrovascular accident (CVA) In one large randomized clinical trial (WHI study) in healthy women, as a secondary outcome, an increased risk of ischemic CVA was reported during treatment with continuous combined conjugated estrogen with medroxyprogesterone acetate. Drug Interactions Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. No interaction studies have been performed. PREGNANCY AND LACTATION Ask your doctor or pharmacist for advice before taking any medicine during pregnancy. It is estimated that altogether roughly 35 million women have been treated with dydrogesterone. Although the number of pregnancies is difficult to estimate, as an approximation it can be assumed that fetuses were exposed to dydrogesterone in around nine million pregnancies (this high exposure in pregnancy is due to the fact that dydrogesterone has pregnancy related indications in large parts of the world). From spontaneous surveillance systems to date, there is no evidence that dydrogesterone cannot be used during pregnancy. No other relevant epidemiological data on dydrogesterone are available. The limited animal safety data suggest that Dydron® s’ active ingredient dydrogesterone has delaying effects on parturition, which is consistent with its progestogenic activity. There is no evidence that dydrogesterone decreases fertility. Dydrogesterone is excreted in the milk of nursing mothers. A risk to the suckling child cannot be excluded. Dydrogesterone should not be used during breast-feeding. Effects on ability to drive and use machines Dydrogesterone has no or negligible influence on the ability to drive and use machines. Important information about the ingredients Lactose monohydrate: If you have been told by your doctor that you have an intolerance to some sugars, especially lactose, contact your doctor before taking this medicinal product. Undesirable effects Like all medicines, Dydron® may cause side effects. If you notice any side effects not mentioned in this leaflet, or if any of the side effects gets serious, please inform your doctor or pharmacist. The frequencies of study related side effects are ranked according to the following: Common: Between 1 and 10 cases in 100 treated patients Uncommon: Less than one case in 100 treated patients Rare: Less than one case in 1000 treated patients Very Rare: Less than one case in 10 000 treated patients The undesirable effects reported in clinical trials and/or in post marketing experience following dydrogesterone therapy are (according to the MedDRA organ classification system): Blood and the lymphatic system disorders Very rare: Haemolytic anaemia (low red blood cell count due to destruction of red blood cells) Immune system disorders Very rare: Hypersensitivity (allergy) Nervous system disorders Common: Migraines/ headache Hepatobiliary disorders Uncommon: Abnormal hepatic function (with jaundice, asthenia (weakness) or malaise, and abdominal pain) Skin and subcutaneous tissue disorders Uncommon: Allergic dermatitis (e.g. rash, pruritus (itching), urticaria (hives)) Very rare: Angioedema (sudden, non-painful accumulation of fluid under the skin) Reproductive system and breast disorders Common: Metrorrhagia (uterine bleeding not associated with menstruation) Uncommon: Breast pain/ tenderness General disorders and administration site conditions Very rare: Edema (swelling) Other adverse reactions obtained from the market with unknown frequency in association with dydrogesterone treatment: Neoplasms benign, malignant and unspecified (incl. cysts and polyps) • Increase in size of progestogen dependent neoplasms (e.g. meningioma; see section “Contraindications”) Psychiatric disorders • Depressed mood Reproductive system and breast disorders • Breast swelling Undesirable effects that are associated with an estrogen-progestogen treatment (see also section "Warnings and special precautions for use"): Breast cancer • Endometrial hyperplasia (abnormal growth of the inner lining of the uterus), endometrial carcinoma (cancer) • Sex hormone dependent tumors (malignant/benign) • Venous thrombosis • Myocardial infarction (heart attack), cardiovascular accident
Overdose: 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). There are no specific antidotes and treatment should be symptomatic. Aforementioned information is also applicable for overdosing in children.
Storage Conditions: Store below 30℃ & dry place. Keep away from light and out of the reach of children.
Commercial Pack: Dydron® Tablet: Each box contains 3x10 tablets in Alu-PVDC blister strip.