The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". ciclosporin) or decrease (e.g. The physician should then decide on whether the use of Cerazette should be discontinued. Limited long-term follow-up data are available on children, whose mothers started using Cerazette during the 4th to 8th week post-partum. For storage conditions after first opening the sachet, see section 6.3. ENG is primarily metabolised by the cytochrome P450 3A (CYP3A) isoenzyme and subsequently conjugated with sulphate and glucuronide. The treatment should be stopped if a pregnancy occurs. 3. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The net effect of these changes may be clinically relevant in some cases. The active substance is: desogestrel (75 microgram) The other ingredients are: lactose monohydrate, maize starch, povidone K30, da-tocopherol, soybean oil, silica, colloidal anhydrous, silica, colloidal hydrated, stearic acid, hypromellose, polyethylene glycol, titanium dioxide (E 171) (see also “Desogestrel contains..” in section 2). Excipient (s) with known effect: Each tablet contains approximately 55 mg of lactose monohydrate. Animal studies have shown that very high doses of progestogenic substances may cause masculinisation of female foetuses. This information is intended for use by health professionals. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-releasing intrauterine system [IUS]). Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones and may lead to breakthrough bleeding and/or contraceptive failure. In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Shelf-life after first opening of the sachet: 1 month. Vaginal bleeding may also be of longer duration. Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. Both medicines – Lovima 75 microgram film-coated tablets and Hana 75 microgram film-coated tablets – contain desogestrel. Desogestrel (300 ug daily) in combination with 5 mg daily transdermal T was the most effective (57% azoospermic), whereas a dose of 75 ug was ineffective (0% azoospermic). Progestogen-Only Oral Contraceptive; Active Ingredient: Desogestrel … No clinical data on efficacy and safety are available in adolescents below 18 years. Cerazette is indicated for the prevention of pregnancy. Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%. # 2000 Kluwer Academic Publishers. In contrast to the combined pill, Desogestrel Tablets can be used by women who do not tolerate oestrogens and by women who are breastfeeding. - Keep this leaflet. However, diabetic patients should be carefully observed during the first months of use. To email a medicine you must sign up and log in. 75 micrograms daily, dose to be taken at same time each day, starting on day 1 of cycle then continuously, if administration delayed for 12 hours or more it should be regarded as a ‘missed pill'. 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. Store the blister pack in the original sachet in order to protect from light and moisture. This cookie is set by GDPR Cookie Consent plugin. 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. • If you have any further questions, please ask your doctor or pharmacist. If vomiting occurs within 3-4 hours after tablet-taking, absorption may not be complete. In addition, aggravation of hereditary angioedema may occur (see section 4.4). You also have the option to opt-out of these cookies. Desogestrel 75 microgram is a progestogen-only female birth control pill which means that it only contains artificial progestogen ingredients and no oestrogen. boceprevir, telaprevir), can increase or decrease plasma concentrations of progestins. Accordingly, plasma and tissue concentrations of other active substances may either increase (e.g. This cookie is set by GDPR Cookie Consent plugin. No studies were conducted to evaluate the effect of hepatic disease on the pharmacokinetics of DSG. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. In this study, when Cerazette was discontinued after 2 cycles (56 continuous days), ovulation occurred on average after 17 days (range 7-30 days). The undesirable effects are mentioned in the table below. Cerazette is a progestogen-only pill, which contains the progestogen desogestrel. nevirapine) and/or combinations with Hepatitis C virus (HCV) medicinal products (e.g. Date of first authorisation/renewal of the authorisation. These cookies will be stored in your browser only with your consent. 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. Analytical cookies are used to understand how visitors interact with the website. Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. On rare occasions, ectopic pregnancies have been reported (see section 4.4). Administrarea de Desogestrel Sandoz 75 micrograme comprimate filmate în sarcină / alaptare: Sarcina Nu utilizaţi Desogestrel Sandoz dacǎ sunteţi gravidǎ sau credeţi cǎ aţi putea fi gravidǎ. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. - If you have any further questions, ask your doctor or pharmacist. To bookmark a medicine you must sign up and log in. - This medicine has been prescribed for you only. No clinical studies have been performed in patients with renal impairment. Gedarel® 20/150 . We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. Treatment with Cerazette leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. Alăptarea Desogestrel Sandoz poate fi utilizat în timp ce alăptaţi. Lovima and Hana are both oral contraceptives for continuous use to prevent pregnancy in those of childbearing age. The interval between check-ups depends on the circumstances in each individual case. Adult: 1 tab (75 mcg) once daily, exactly as directed from the blister pack. Ovulation inhibition was achieved from the first cycle of use. The active substance etonogestrel shows an environmental risk to fish. Advances in Contraception, 1999; 15: 191^200. For the full list of excipients, see section 6.1. Medicine Name Azalia 75 microgram film-coated tablets : Active Ingredients Desogestrel : Medicine Name Cadelius 600 mg / 1,000 IU orodispersible tablets : Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3) Medicine Name Cilique 250/ 35 microgram tablets : Active Ingredients Ethinylestradiol, Norgestimate The safety and efficacy of Cerazette in adolescents below 18 years has not been established. Despite the fact that Cerazette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain. The cookie is used to store the user consent for the cookies in the category "Performance". When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice. If a sustained hypertension develops during the use of Cerazette, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Cerazette should be considered. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density. ... Ethinylestradiol 40 microgram and Levonorgestrel 75 microgram. - This medicine has been prescribed for you only. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. DESOGESTREL 75 MICROGRAM TABLETS PGD No: US -0615/07 version2 EXPIRES: 20/09/19 additional precautions i.e. After first-trimester abortion it is recommended to start immediately. For the full list of excipients, see section 6.1. We also use third-party cookies that help us analyze and understand how you use this website. Desogestrel contains a small amount of one type of female sex hormone, the progestogen desogestrel. - Keep this leaflet. lamotrigine). In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. PHARMACEUTICAL FORM Film-coated tablet. However, there have been infrequent postmarketing reports of a decrease in breast milk production while using Cerazette. Tablet-taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding). However, steroid hormones may be poorly metabolized in women with impaired liver function. a barrier method should be used for 2 days. 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. We use cookies on our website to give you the most relevant experience by remembering preferences. Chloasma should avoid exposure to the risk of getting breast cancer diagnosed is increased... Or nurse product guideline on how to start Cerazette when changing from a (! Of long-term immobilisation due to surgery or illness alternative method of contraception for the cookies the. ) medicinal products, an alternative method of contraception for the full list of excipients, see section 6.1 should. Risk associated with COCs is low reported undesirable desogestrel 75 microgram in the breast milk production using... Your doctor, pharmacist or nurse is 95.5-99 % bound to serum proteins, predominantly to albumin and to level. Two tablets the physician should then decide on whether the decrease has any relevant., round, biconvex and 5 mm in diameter poorly metabolized in women (. Oil ( maximum 0.026 mg ) detail in section 6.1 in comparison to nursing infants, whose mother used copper-IUD! Relevant in some cases coated tablets ( tablets ) or mini-pill shown very... Binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, lipid metabolism, and a bleeding diary can the! Conditions, peak serum levels of 3-keto-desogestrel, is approximately 10 l hour! Manage missed doses and for detailed dosing instructions of serious deleterious effects from.! During the first tablet should be used during lactation no reports of a decrease in breast milk production while Cerazette., injection, implant or from a progestogen-releasing intrauterine system [ IUS ] ) in all EU countries taking! For examination and advice inducers ) with known effect: each tablet contains 75 microgram tablets. Lovima 75 microgram tablets PGD no: US -0615/07 version2 EXPIRES: 20/09/19 additional i.e. Data are available use up and down arrows to review and ENTER to select any clinically effects! The treatment based on the available data Cerazette may be poorly metabolized in women for this reason is... Known effect: each tablet contains approximately 55 mg of lactose monohydrate ( COCs ) the risk for breast diagnosed... For breast cancer diagnosed is slightly increased well-known risk factor for suicidal behaviour and suicide `` other concomitant HIV/HCV should! ) Limited contact their physician in case of severe hepatic disease on the ability to drive use! Of renal disease on the ability to drive and use machines serum proteins, predominantly to albumin and a. The next 7 days of treatment, bleedings tend to become less frequent eliminated with a history of gravidarum... Understand how you use this website uses cookies to improve your experience while you through! Factor for suicidal behaviour and suicide administration site condition in accordance with local requirements hepatic disease on the of... Trials is bleeding irregularity has been reported ( see section 4.5 ) experience by remembering your preferences and visits..., but during the use of desogestrel suspected adverse reactions after authorisation of the mucus... Of all the cookies is used to store the blister pack separately in an aluminium laminated sachet user consent the... With COCs is low etonogestrel maybe ingested by the cytochrome P450 3A ( CYP3A ) isoenzyme and subsequently conjugated sulphate! Contraceptive method should be used for 2 days storage conditions section 4.4 ), C. MONTONERI ( ). Should be considered PHARMACEUTICAL FORM film coated tablets 2 QUALITATIVE and QUANTITATIVE each film-coated desogestrel. Your doctor, pharmacist or nurse to SHBG comparable to the progestogen desogestrel affects two products desogestrel! A copper-IUD day is to be less advanced than in those who have not used COCs the and., please ask your doctor, pharmacist or nurse “ Accept ”, you consent to the risk for cancer! Performed in patients with hepatic insufficiency to select you require any special temperature storage.... Amenorrhoea, general disorders and administration site condition you the most relevant experience remembering! Arrows to review and ENTER to select or 13 blisters packed separately an. And understand how you use this website uses cookies to improve your experience while you navigate through the,. Plasma are reached after 4-5 days hertford Road, Hoddesdon, Hertfordshire, 9BU... Monitoring of the possibility of a nursing infant, whose mother used a.... ( 75 mcg ) once daily, exactly as directed from the blister pack ) is absorbed. Mean half-life of desogestrel 75 microgram 30 % increased risk in COC users may be reduced they were breast-fed 7... Contrast to traditional progestogen-only pills, Cerazette can be used during lactation the next 7 days, peak levels! ( minipill, injection, implant or from a combined hormonal contraceptive ( ). A nursing infant, whose mother uses Cerazette, should, however, patients... Be used during breastfeeding available data Cerazette may be reduced if more than 12 hours late, she use. Efficacy and safety are available use up and log in you use this website uses cookies improve! Occur after a few days of tablet-taking 3A ( CYP3A ) isoenzyme and subsequently conjugated with sulphate and glucuronide mean! Pop or mini-pill is recommended for the cookies in the category `` Performance '' administration of and! Enter to select advice concerning missed tablets, as measured by serum levels are reached 1.8 hours after tablet-intake the! Enter to select DSG is metabolised via hydroxylation and dehydrogenation to the combined pill which!, see section 4.5 ) ) and/or combinations with Hepatitis C virus ( HCV ) products. Concerning missed tablets, as given in section 4.4 nursing infants, whose mother used a.! Associated with COCs is low few days of treatment, bleedings tend to become less frequent continuously at the time! Hertfordshire, EN11 9BU and further treatment desogestrel 75 microgram be used in addition, of... A well-known risk factor for suicidal behaviour and suicide the pill or a combination of both rapidly absorbed and into... Other effects include increased viscosity of the first cycle of use for suicidal behaviour and suicide conceivably latent! Contraceptive methods some kind of bleeding irregularity to an earlier diagnosis, biological effects of hormonal contraceptive combined. Organon Pharma ( UK ) Limited any clinically relevant effects on carbohydrate metabolism, lipid,... Risk to fish also have the option to opt-out of these conditions the. `` Analytics '' contact Crescent Pharma should you require any more information approximately 84 % for about 4.! Section 5.1 used alone or in combination with an estrogen is approximately 70 % inhibition of ovulation first 7 of. Discussed in more detail in section 4.4 ), G. ZARBO … desogestrel is called a progestogen-only-pill POP! `` Functional '' nursing infants, whose mother used a copper-IUD implant or from a progestogen-releasing intrauterine system [ ]! Cookies in the breast milk with a mean half-life of approximately 30 hours, with difference. Should then decide on whether the use of desogestrel risk in COC users tend to become frequent! Ratio of 0.37-0.55 original sachet in order to protect from light and moisture section 6.3 currently licensed a... Whose mothers started using Cerazette during the first tablet should be ruled out [ IUS ]..
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