Loading…
SAWIS is a brand name for Dienogest. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of endometriosis.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage of Sawis is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food. Tablets must be taken continuously without regard to vaginal bleeding.
When a pack is finished the next one should be started without interruption. Treatment can be started on any day of the menstrual cycle. Any hormonal contraception needs to be stopped prior to initiation of Sawis. g. barrier method). Management of missed tablets The efficacy of Sawis may be reduced in the event of missed tablets, vomiting and/or diarrhoea (if occuring within 3-4 hours after tablet taking).
In the event of one or more missed tablets, the woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet.
Additional information on special populations Paediatric population Sawis is not indicated in children prior to menarche. 1). Elderly There is no relevant indication for use of Sawis in the geriatric population. 3). Renal impairment There are no data suggesting the need for a dosage adjustment in patients with renal impairment.
Method of administration For oral use.
Presentation of undesireable effects is based on MedDRA. The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions. Undesirable effects are more common during the first months after the start of treatment with dienogest 2 mg tablet, and subside with continued treatment.
There may be changes in bleeding pattern, such as spotting, irregular bleeding or amenorrhea. The following undesirable effects have been reported in users of dienogest 2 mg tablet. 1%). In addition, the majority of patients treated with dienogest 2 mg tablet experience changes in their menstrual bleeding pattern.
Menstrual bleeding patterns were assessed systematically using patient diaries and were analysed using the WHO 90 days reference period method. e. 7%). e. 8%). Changes in menstrual bleeding patterns were only occasionally reported as adverse event by the patients (see adverse event table).
The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with dienogest 2 mg tablet are summarized in the table below. Within each frequency grouping, undesirable effects are presented in order of decreasing frequency.
Frequencies are defined as common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). The frequencies are based on pooled data of four clinical trials, including 332 patients (100%). Table 1, Adverse reactions table, phase III clinical trials, N= 332 System Organ Class (MedDRA) Common Uncommon Blood and lymphatic system disorders anaemia Metabolism and nutrition disorders weight increase weight decrease, increased appetite Psychiatric disorders depressed mood, sleep disorder, nervousness, loss of libido, altered mood anxiety, depression, mood swings Nervous system disorders headache, migraine autonomic nervous system imbalance, disturbance in attention Eye disorders dry eye Ear and labyrinth disorders tinnitus Cardiac disorders unspecific circulatory system disorder, palpitations Vascular disorders hypotension Respiratory, thoracic and mediastinal disorders dyspnoea Gastrointestinal disorders nausea, abdominal pain, flatulence, abdominal distension, vomiting diarrhoea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis Skin and subcutaneous tissue disorders acne, alopecia dry skin, hyperhidrosis, pruritus, hirsutism, onychoclasis, dandruff, dermatitis, System Organ Class (MedDRA) Common Uncommon abnormal hair growth, photosensitivity reaction pigmentation disorder Musculoskeletal and connective tissue disorders back pain bone pain, muscle spasms, pain in extremity, heaviness in extremities Renal and urinary disorders urinary tract infection Reproductive system and breast disorders breast discomfort, ovarian cyst, hot flushes, uterine / vaginal bleeding including spotting vaginal candidiasis, vulvovaginal dryness, genital discharge, pelvic pain, atrophic vulvovaginitis, breast mass, fibrocystic breast disease, breast induration General disorders and administration site conditions asthenic conditions, irritability oedema Decrease of bone mineral density In an uncontrolled clinical trial with 111 adolescent women (12 to <18 years) who were treated with dienogest 2 mg tablet, 103 had BMD measurements.
Warnings As Sawis is a progestogen-only preparation it can be assumed that the special warnings and precautions for use of progestogen-only preparations are also valid for the use of Sawis although not all of the warnings and precautions are based on respective findings in the clinical studies with dienogest 2 mg tablet.
If any of the conditions/risk factors mentioned below is present or deteriorates, an individual risk-benefit analysis should be done before treatment with Sawis can be started or continued. Serious uterine bleeding Uterine bleeding, for example in women with adenomyosis uteri or uterine leiomyomata, may be aggravated with the use of Sawis.
If bleeding is heavy and continuous over time, this may lead to anaemia (severe in some cases). In the event of anaemia, discontinuation of Sawis should be considered. 8). Circulatory disorders From epidemiological studies there is little evidence for an association between progestogen-only preparations and an increased risk of myocardial infarction or cerebral thromboembolism.
Rather, the risk of cardiovascular and cerebral events is related to increasing age, hypertension and smoking. In women with hypertension the risk of stroke may be slightly enhanced by progestogen-only preparations. Although not statistically significant, some studies indicate that there may be a slightly increased risk of venous thromboembolism (deep venous thrombosis, pulmonary embolism) associated with the use of progestogen-only preparations.
Generally recognized risk factors for venous thromboembolism (VTE) include a positive personal or family history (VTE in a sibling or a parent at a relatively early age), age, obesity, prolonged immobilization, major surgery or major trauma.
In case of long-term immobilization it is advisable to discontinue the use of Sawis (in the case of elective surgery at least four weeks in advance) and not to resume treatment until two weeks after complete remobilization. The increased risk of thromboembolism in the puerperium must be considered.
Sawis should not be used in the presence of any of the conditions listed below, which are partially derived from information on other progestogen-only preparations. g. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dienogest in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof. 24) of having breast cancer diagnosed in women who are currently using oral contraceptives (OCs), mainly using estrogen-progestogen preparations.
The excess risk gradually disappears during the course of the 10 years after cessation of combined OC (COC) use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer.
The risk of having breast cancer diagnosed in users of progestogen-only preparations is possibly of similar magnitude to that associated with COC. However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs.
These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The breast cancers diagnosed in users of OCs tend to be less advanced clinically than the cancers diagnosed in those who have never used OCs.
In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of hormonal substances such as the one contained in Sawis. In isolated cases, these tumours have led to life- threatening intra-abdominal haemorrhages.
A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in women taking Sawis. Osteoporosis Changes in bone mineral density (BMD).
The use of dienogest 2 mg tablet in adolescents (12 to <18 years) over a treatment period of 12 months was associated with a decrease in bone mineral density (BMD) in the lumbar spine (L2-L4). 78%, n=103). Repeated measurement at 6 months after the EOT in a subgroup with decreased BMD values showed a trend towards recovery.
06% (n=60). Loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. 1). 1). Adequate intake of calcium and Vitamin D, whether from the diet or from supplements, is important for bone health in women of all ages.
Other conditions Patients who have a history of depression should be carefully observed and the drug should be discontinued if the depression recurs to a serious degree. Dienogest generally does not appear to affect blood pressure in normotensive women.
However, if a sustained clinically significant hypertension develops during the use of Sawis, it is advisable to withdraw Sawis and treat the hypertension. Recurrence of cholestatic jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of Sawis.
Dienogest may have a slight effect on peripheral insulin resistance and glucose tolerance. Diabetic women, […]