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MIFEPRISTONE LINEPHARMA is a brand name for Mifepristone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For termination of pregnancy, Mifepristone Linepharma 200mg tablet and prostaglandins can only be prescribed and administered in accordance with countries national laws and regulations. Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of…
Verbatim from this product's MHRA label. Tap a section to expand.
Medical termination of developing intra-uterine pregnancy up to 63 days of amenorrhea. The method of administration is 200 mg of mifepristone in a single oral dose, followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
5 Interaction with other medicinal products and other forms of interactions). Paediatric population No data are available for women under 18 years.
25%) Superficial thrombophlebitis Respiratory, thoracic and mediastinal disorders Bronchospasm Induced bronchial asthma Gastrointestinal disorders Nausea Vomiting Diarrhea Gastric discomfort Abdominal pain Cramping, light or moderate Gastric bleeding MedDRA Adverse events (frequency) System Organ Class Very common > 1/10 Common > 1/100 to < 1/10 Uncommon > 1/1000 to < 1/100 Rare > 1/10000 to < 1/1000 and very rare (< 1/10000)* Not known (cannot be estimated from the available data) Hepatobiliary disorders Abnormal liver function tests Hepatic failure Hepatorenal failure Skin and subcutaneous tissue disorders Skin rash / pruritus Urticarial reaction Toxic epidermal necrolysis Erythema nodosum Angioedema* Acute generalised exanthematous pustulosis Musculoskeletal and connective tissue disorders Limb spasm Renal and urinary disorders Renal failure Pregnancy, puerperium and perinatal conditions Very common uterine contractions or cramping (10 to 45%) in the hours following prostaglandin intake.
4% of the cases. Hydatiform mole Ectopic pregnancy Amniotic band syndrome Gestational trophoblastic tumor Uteroplacental apoplexy Reproductive system and breast disorders Vaginal bleeding Uterine spasm Prolonged post- abortion bleeding Spotting Severe hemorrhage Endometritis Breast tenderness Heavy bleeding Hemorragic shock Salpingitis Bilateral adnexal mass Intrauterine adhesion Ovarian cyst rupture Breast abscess Hematosalpynx Uterine rupture General disorders and administration site conditions Fatigue Chill / fever Dizziness Fainting Anaphylaxis Periorbital edema Malaise vagal symptoms * Including occasional case reports - Bleeding is an almost constant part of the procedure, whatever the prostaglandin use, and at any pregnancy term although it is usually more abundant when pregnancy age increases.
It can occur after mifepristone alone. When heavy, it often reflects incomplete abortion leading to a surgical procedure in approximately 5 percent of the cases. 5 to 1 percent of the cases. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization the medicinal product is important.
8). In patients who experience severe cutaneous adverse reactions, re-treatment with mifepristone is not recommended. The pharmacokinetics, safety and tolerability of Mifepristone Linepharma 200 mg were investigated in women with moderate hepatic impairment versus healthy women participants with normal hepatic function.
Statistical analyses of total AUC∞ and Cmax for the mifepristone, N-demethylated metabolite, hydroxylated metabolite and di-demethylated metabolite showed a decrease in both overall peak and exposure in patients with moderate hepatic impairment compared to healthy-matched participants.
This decrease in exposure could be caused by a decrease in absorption and/or protein binding. However, the possible consequences of moderate hepatic impairment on the unbound fraction could not be determined. In conclusion, the clinical consequences of 200 mg mifepristone administration in patient with moderate hepatic impairment are unknown.
In the absence of specific studies, Mifepristone Linepharma is not recommended in patients with: o Renal failure, o Hepatic failure o Malnutrition Medical termination of developing intra-uterine pregnancy This method requires the involvement of the woman who should be informed of the requirements of the method: o The necessity to combine treatment with prostaglandin to be administered at a second visit.
o The need for a follow up visit (3rd visit) within 14 to 21 days after intake of Mifepristone Linepharma in order to check for complete expulsion. 1) of the method which may require termination by another method. In the case of a pregnancy occurring with an intra-uterine device in situ, this device must be removed before administration of Mifepristone Linepharma.
The expulsion may take place before prostaglandin administration (in about 3% of cases). This does not preclude the control visit in order to check for the complete expulsion and the uterine vacuity. 6% of the cases, makes the control visit mandatory in order to check that the expulsion is completed.
1; o chronic adrenal failure; o asthma uncontrolled by therapy o inherited porphyria o pregnancy not confirmed by an ultrasound or biological test; o pregnancy beyond 63 days of amenorrhea; o suspected ectopic pregnancy; o contraindication to the prostaglandin analogue selected.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In rare case of non-complete expulsion, a surgical revision may be necessary. The efficacy of the method decreases with parity, and consequently increasing age of the woman. o Bleeding The patient must be informed of the occurrence of prolonged vaginal bleeding (an average of 10 to 16 days after Mifepristone Linepharma intake) which may be heavy.
Bleeding occurs in almost all cases and is not in any way proof of complete expulsion. 8). The patient should be informed not to travel far away from the prescribing center as long as complete expulsion has not been recorded. She will receive precise instructions as to whom she should contact and where to go, in the event of any problems emerging, particularly in the case of very heavy vaginal bleeding.
A follow-up visit must take place within a period of 14 to 21 days after administration of mifepristone to verify by the appropriate means (clinical examination, ultrasound scan, and beta-hCG measurement) that expulsion has been completed and that vaginal bleeding has stopped.
In case of persistent bleeding (even light) beyond the control visit, its disappearance should be checked within a few days. If an ongoing pregnancy is suspected, a further ultrasound scan may be required to evaluate its viability. Persistence of vaginal bleeding at this point could signify incomplete abortion, or an unnoticed extra-uterine pregnancy, and appropriate treatment should be considered.
In the event of an ongoing pregnancy diagnosed after the control visit, termination by another method will be proposed to the woman. Since heavy bleeding requiring haemostatic curettage occurs in up to 5 % of the cases during the medical method of pregnancy termination, special care should be given to patients with haemostatic disorders with hypocoagulability, or with anaemia.
The decision to use the medical or the surgical method should be decided with specialised consultants according to the type of haemostatic disorder and the level of anaemia. o Infection Very rare cases of fatal toxic shock caused by Clostridium sordellii endometritis presenting without fever or other obvious symptoms of infection, have been reported after medical abortion with the use of 200 mg mifepristone followed by non authorised vaginal administration of misoprostol tablets for oral use.
Clinicians should be aware of this potentially fatal complication. • In all instances The use of Mifepristone Linepharma requires rhesus determination and hence the prevention of rhesus allo-immunisation as well as other general measures taken usually during any termination of pregnancy.
During clinical trials, pregnancies occurred between embryo expulsion and the resumption of menses. To avoid potential exposure of a subsequent pregnancy to mifepristone, it is recommended that conception be avoided during the next menstrual cycle.
Reliable contraceptive precautions should therefore commence as early as possible after mifepristone administration. In case of suspected acute adrenal failure, dexamethasone administration is recommended. 1 mg of dexamethasone antagonises a dose of 400 mg of mifepristone.
Due to the antiglucocorticoid activity of mifepristone, the efficacy of long-term corticosteroid therapy, including inhaled corticosteroids in asthmatic patients, may be decreased during the 3 to 4 days following intake of Mifepristone Linepharma.
Therapy should be adjusted. A decrease of the efficacy of the method can theoretically occur due to the antiprostaglandin properties of non-steroidal anti-inflammatory […]