Menorrhagia. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Primolut N (r) คือ norethisterone ขนาดยาที่มีจำหน่ายในประเทศไทย คือ 5 mg. ข้อบ่งใช้.


Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of COCs.Crohn's disease and ulcerative colitis have been associated with COC use.During clinical trials with patients treated for hepatitis C virus infections (HCV) with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequent in women using ethinylestradiol-containing medications such as combined hormonal contraceptives (CHCs). Norethisterone is 17 β-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one . By continuing to browse the site you are agreeing to our policy on the use of cookies. The frequencies are based on reporting rates from postmarketing experience and literature.General disorders and administration site conditions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Primolut n and amenorrhea . Special care should be taken when prescribing norethisterone in patients with conditions which might be aggravated by this factor:If menstrual bleeding should fail to follow a course of Primolut N, or if the patient wishes to postpone menstruation in special circumstances, the possibility of pregnancy must be excluded before a further course is given.After oral administration, norethisterone is partly metabolised to ethinylestradiol resulting in an equivalent dose of about 4-6 micrograms ethinylestradiol per 1 milligram of orally administered norethisterone or norethisterone acetate (see section 5.2)Due to the partial conversion of norethisterone to ethinylestradiol, administration of Primolut N is expected to result in similar pharmacological effects as seen with COCs. after accidents)

Positive personal or family history (VTE in a sibling or a parent at a relatively early age)Patients with a history of VTE or known thrombophilic states have an increased risk of VTE. Pharmacotherapeutic group: sex hormones and modulators of the genital system, progestogens; Estren derivatives Norethisterone has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak oestrogenic and androgenic properties. DESCRIPTION . Known, past or suspected sex hormone-dependent malignancies, including of the genital organs or breast cancer.13. 0
Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thromboembolic predisposition. However, if a sustained clinically significant hypertension develops during the use of a COC then it is prudent for the physician to withdraw the COC and treat the hypertension. endstream endobj 607 0 obj <>stream Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. There have been no reports of ill-effects from overdosage and treatment is generally unnecessary.

As norethisterone is partly metabolized into ethinylestradiol, this warning applies to women using norethisterone (see sections 4.3 and 4.5).Note: the prescribing information of concomitant medications should be consulted to identify interactions.Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of sex hormones and which may lead to changes in the uterine bleeding profile and/or reduction of the therapeutic effect. C 20H 260 2 MW=298.4 . Some epidemiological studies have indicated that long-term use of COCs may further contribute to this increased risk but there continues to be controversy about the extent to which this finding is attributable to confounding effects, e.g., cervical screening and sexual behaviour including use of barrier contraceptives.A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs. The tablets are to be swallowed whole with some liquid. • Prolonged immobilisation, major surgery, any surgery to the legs, or major trauma. If a hereditary predisposition is known or suspected, the woman should be referred to a specialist for advice before deciding about any COC use %PDF-1.5 %����

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.

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