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ULIPRISTAL ACETATE is a brand name for Ulipristal. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. The tablet can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of the tablet intake, another tablet should be taken. If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before the tablet is administered. Special populations Renal impairment No dose adjustment is necessary.
Hepatic impairment In the absence of specific studies, no alternate dose recommendations for ulipristal acetate can be made. Severe hepatic impairment In the absence of specific studies, ulipristal acetate is not recommended. Paediatric population There is no relevant use of ulipristal acetate for children of prepubertal age in the indication emergency contraception.
Adolescents: ulipristal acetate for emergency contraception is suitable for any woman of child bearing age, including adolescents. 1). Method of administration Oral use. The tablet can be taken with or without food.
Summary of the safety profile The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea. Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
Tabulated list of adverse reactions The adverse reactions reported in the phase III program of 2,637 women are provided in the table below. Adverse reactions listed below are classified according to frequency and system organ class using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
MedDRA Adverse reactions (frequency) System organ class Common Uncommon Rare Infections and infestations Influenza Immune system disorders hypersensitivity reactions including rash, urticaria, angioedema** Metabolism and nutrition disorders Appetite disorders Psychiatric disorders Mood disorders Emotional disorder Anxiety Insomnia Hyperactivity disorder Libido changes Disorientation Nervous system disorders Headache Dizziness Somnolence Migraine Tremor Disturbance in attention Dysgueusia Syncope Eye disorders Visual disturbance Abnormal sensation in eye Ocular hyperaemia Photophobia Ear and labyrinth disorders Vertigo Respiratory, thoracic and mediastinal disorders Dry throat Gastrointestinal disorders Nausea* Abdominal pain* Abdominal discomfort Vomiting* Diarrhoea Dry mouth Dyspepsia Flatulence Skin and subcutaneous tissue disorders Acne Skin lesion Pruritus Musculoskeletal and connective tissue disorders Myalgia Back pain Reproductive system and breast disorders Dysmenorrhea Pelvic pain Breast tenderness Menorrhagia Vaginal discharge Menstrual disorder Metrorrhagia Genital pruritus Dyspareunia Ruptured ovarian cyst Vulvovaginal pain Vaginitis Hot flush Premenstrual syndrome Hypomenorrhea* General disorders and administration site conditions Fatigue Chills Malaise Pyrexia Thirst *Symptom which could also be related to an undiagnosed pregnancy (or related complications) **Adverse reaction from spontaneous reporting Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section Error!
Ulipristal Acetate 30 mg tablet is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception. Ulipristal acetate is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.
However, it does not interrupt an existing pregnancy (see section Error! ). Ulipristal Acetate 30 mg tablet does not prevent pregnancy in every case In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed.
As with any pregnancy, the possibility of an ectopic pregnancy should be considered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy. Women who become pregnant after taking ulipristal acetate should contact their doctor (see section Error!
). ulipristal acetate inhibits or postpones ovulation (see section Error! ). If ovulation has already occurred, it is no longer effective. The timing of ovulation cannot be predicted and therefore the tablet should be taken as soon as possible after unprotected intercourse.
No data are available on the efficacy of ulipristal acetate when taken more than 120 hours (5 days) after unprotected intercourse. Limited and inconclusive data suggest that there may be reduced efficacy of Ulipristal Acetate 30 mg tablet with increasing body weight or body mass index (BMI) (see section Error!
). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman’s body weight or BMI. After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected.
In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. 5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days. Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section Error!
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ulipristal in United Kingdom.
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). Post-marketing experience: the adverse reactions spontaneously reported in post- marketing experience were similar in nature and frequency to the safety profile described during the phase III program. 5% had a delay of more than 7 days beyond the anticipated onset of menses.
The delay was greater than 20 days in 4 % of the women. 4 days. 2%), this bleeding was reported as spotting. 4% reported heavy intermenstrual bleeding. In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of Ulipristal Acetate 30 mg tablet (73 women enrolled twice and 9 enrolled three times).
There were no safety differences in these subjects in terms of incidence and severity of adverse reactions, change in duration or volume of menses or incidence of intermenstrual bleeding. Reporting of suspected adverse reactions Reporting of 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 or search for MHRA Yellow Card in the Google Play or Apple App Store
). Contraception after Ulipristal Acetate 30 mg tablet intake Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse.
Therefore, after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period. Although the use of ulipristal acetate for emergency contraception does not contraindicate the continued use of regular hormonal contraception, Ulipristal Acetate 30 mg tablet may reduce its contraceptive action (see section Error!
). Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using Ulipristal Acetate 30 mg tablet, however, she should be advised to use a reliable barrier method until the next menstrual period.
g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicinal products containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long term use of ritonavir).
Use in women with severe asthma treated by oral glucocorticoid is not recommended. This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.