ULIPRISTAL SANDOZ

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. This 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 Sandoz Film-coated Tablets 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).

2). 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 (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 events, 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 Google play or Apple App store.

Ulipristal Sandoz Film-coated Tablets 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.

6). Ulipristal acetate 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. 6). 1). 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.

1). 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. 5). Contraception after ulipristal acetate 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. 5). Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using ulipristal acetate, however, she should be advised to use a reliable barrier method until the next menstrual period.

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Use in women with severe asthma treated by oral glucocorticoid is not recommended. This medicinal product contains lactose and sodium. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains less than 1 mmol (23 mg) sodium per tablet, that is to say essentially ‘sodium-free’.

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