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Esmya 5 mg Tablets (ulipristal acetate)

Last Updated on eMC 29-Nov-2016 View document  | Gedeon Richter (UK) Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 29-Nov-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Improved presentation of SPC

Date of revision of text on the SPC: 14-Nov-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0$0Tracked changes shown in redbelow wit specifics for each section as necessary:$0$04.2         Posology andmethod of administration$0$0Posology$0$0The treatment consists of onetablet of 5 mg to be taken orally once dailyfor treatment courses of up to 3 months each. Tablets may be taken with or without food.$0$0…….$0$0Method of administration$0$0Oraluse. Tablets maybe taken with or without food should be swallowed with water.$0$04.4Special warnings and precautions for use$0$0……..$0$0Contraception$0$0Concomitantuse of progestagen‑only pills, a progestagen‑releasing intrauterine device or combined oralcontraceptive pills is not recommended (see section 4.5).Although a majority of women taking a therapeutic dose of ulipristal acetatehave anovulation, a non hormonal contraceptive method is recommended duringtreatment.$0$0Endometrial changes$0$0.......$0$0If endometrial thickening is noted,which persists after return of menstruations during off‑treatment periods orbeyond 3 months following the end of treatment courses, and/or an alteredbleeding pattern is noted (see section "Bleeding pattern" belowbleedingpattern’), investigation including endometrial biopsyshould be performed in order to exclude other underlying conditions, includingendometrial malignancy.$0$0……………….$0$04.5Interaction with other medicinal products and other forms of interaction$0$0……………..$0$0Potential for ulipristalacetate to affect other medicinal products:$0$0Hormonal contraceptives$0$0Ulipristal acetate may interferewith the action of hormonal contraceptive medicinal products(progestagen only, progestagen releasing devices or combined oral contraceptivepills) and progestagen administered for other reasons. Therefore concomitantadministration of medicinal products containing progestagen is not recommended(see sections 4.4 and 4.6). Medicinal products containing progestagenshould not be taken within 12 days after cessation of ulipristal acetatetreatment.$0$0……$0$0In 4.6, Breast feeding changed to Breastfeeding$0$04.6     Fertility, pregnancy and lactation$0$0……..$0$0Breastfeeding$0$0Available toxicological data in animals have shownexcretion of ulipristal acetate in milk (for details see section 5.3).Ulipristal acetate is excreted in human milk. The effecton newborn/infants has not been studied. Arisk to the newborns/infants cannot be excluded. Ulipristal acetate is contraindicated during breastfeeding (see sections 4.3 and 5.2).$0$0……$0$0In 4.8, formatting changes to ensure '3 months' appears on oneline in A4 printed SPC$0$04.8         Undesirableeffects$0$0Summary of the safety profile$0$0..............$0$0Among these 1,053 women, the safetyof repeated intermittent treatment courses (each limited to 3 3 months) hasbeen evaluated in 551 women with uterine fibroids treated with 5 or10 mg ulipristal acetate in two phase III studies (including 446 womenexposed to four intermittent treatment courses of whom 53 were exposed to eightintermittent treatment courses) and demonstrated a similar safety profile tothat observed for one treatment course.$0$0…………..$0$0In 5.1, reformatting thewording in different paragraphs for improved presentation of information andspacing amends in tables 1 and 2 for N numbers; other tracked changes below inred $0$05.1Pharmacodynamic properties$0$0Mechanismof action$0$0Ulipristalacetate exerts a direct effect on the endometrium.$0$0Ulipristal acetate exerts adirect action on fibroids reducing their size through inhibition of cellproliferation and induction of apoptosis.$0$0Pharmacodynamiceffects$0$0Endometrium$0$0Ulipristalacetate exerts a direct effect on the endometrium. When dailyadministration of a 5 mg dose is commenced during a menstrual cycle mostsubjects (including patients with myoma) will complete their first menstruationbut will not menstruate again until after treatment is stopped. When ulipristalacetate treatment is stopped, menstrual cycles generally resume within4 weeks.$0$0……………………..$0$0Fibroids$0$0Ulipristalacetate exerts a direct action on fibroids reducing their size throughinhibition of cell proliferation and induction of apoptosis.$0$0Pituitary$0$0A daily dose of ulipristal acetate5 mg inhibits ovulation in the majority of patients as indicated byprogesterone levels maintained at around 0.3 ng/ml.$0$0………….$0$0Clinical efficacy and safety$0$0Pre-operative use:$0$0The efficacy of fixed doses ofulipristal acetate 5 mg and 10 mg once daily was evaluated in twoPhase 3 randomised, double-blind, 13 week studies recruiting patientswith very heavy menstrual bleeding associated with uterine fibroids.Study 1 was double-blind placebo controlled. Patients in this study wererequired to be anaemic at Study entry (Hb < 10.2 g/dl) and all patientswere to receive oral iron 80 mg Fe++ in addition to study drugmedicinal product.Study 2 contained the active comparator, leuprorelin 3.75 mg givenonce per month by intramuscular injection. In Study 2, a double‑dummymethod was used to maintain the blind. In both studies menstrual blood loss wasassessed using the Pictorial Bleeding Assessment Chart (PBAC). A PBAC >100within the first 8 days of menses is considered to represent excessivemenstrual blood loss.$0$0……$0$0Endometrialfindings:$0$0In all Phase III studies includingrepeated intermittent treatment studies, a total of 7 cases of hyperplasia wereobserved out of 789 patients with adequate biopsies (0.89%). The vast majorityspontaneously reversed to normal endometrium after resumption of menstruationduring the off‑treatment period. The incidence of hyperplasia did not increasewith repeated treatment courses, including data on 340 women who received up to4 courses of ulipristal acetate 5 or 10 mg and limited data of 43 women whoreceived up to 8 courses of ulipristal acetate 10 mg. The observed frequency isin line with control groups and prevalence reported in literature for symptomaticpre-menopausal women of this age group (mean of 40 years).$0$0Paediatric population$0$0The European Medicines Agency has waived theobligation to submit the results of studies with Esmya in all subsets of thepaediatric population in leiomyoma of uterus (see section 4.2 forinformation on paediatric use).$0$0 $0$0In5.2 Pharmacokinetic properties,  minor formatting change tobring text within section (Distrbution) on one page for improvedpresentation of information in A4 printed SPC$0$09.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION$0$0Date offirst authorisation: 23 February 2012$0$0Dateof latest renewal: 14 November 2016$0$010.DATE OF REVISION OF THE TEXT $0$014/11/2016$0$0Detailed information on this medicinal product isavailable on the website of the European Medicines Agency http://www.ema.europa.eu$0$0

Updated on 08-May-2016 and displayed until 29-Nov-2016

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Apr-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0$0$0$0In section 4.8 (undesirable effects), an amend and some text addition on numbers from safety database, as below:$0$0$0$0$0''Among these 1,053 women, thesafety of repeated intermittent treatment courses (each limited to 3 months)has been evaluated in 551 women with uterine fibroids treated with 5 or 10 mgulipristal acetate in two phase III studies (including 457 446 women exposed to fourintermittent treatment courses of whom 53 were exposed to eight intermittenttreatment courses) and demonstrated a similar safety profile to that observedfor one treatment course.''$0$0$0$0$0In section 5.1 (Pharmacodynamicproperties) under Endometrialfindings, text added as below:$0$0$0$0''The incidence of hyperplasia did not increasewith repeated treatment courses., including data on 340 women who received up to4 courses of ulipristal acetate 5 or 10 mg and limited data of 43 women whoreceived up to 8 courses of ulipristal acetate 10 mg.''$0

Updated on 05-Jun-2015 and displayed until 08-May-2016

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 27-May-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes are shown as - additions in red, deletions crossed out

 
Section 4.1     Therapeutic indications (addition of indication)

Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

 

Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

 

Section 4.2         Posology and method of administration (additions in red, deletions crossed out)

 

Posology

The treatment consists of one tablet of 5 mg to be taken orally once daily for treatment courses of up to 3 months each.

This 3-month treatment course can be repeated once.Treatments should only be initiated when menstruation has occurred:

- The first treatment course should start during the first week of menstruation.

- Re-treatment courses should start at the earliest during the first week of the second menstruation following the firstprevious treatment course completion.

Treatments should always be started during the first week of menstruation.

Due to the lack of long term safety data, the duration of treatment should not exceed two treatment courses of 3 months. The treating physician should explain to the patient the requirement for treatment free intervals.

Repeated intermittent treatment has been studied up to 4 intermittent courses.

Section 4.4     Special warnings and precautions for use (additions in red, deletions crossed out)

 

Ulipristal acetate should only be prescribed after careful diagnosis. Pregnancy should be precluded prior to treatment. If pregnancy is suspected prior to initiation of a new treatment course, a pregnancy test should be performed.

 

Endometrial changes

Ulipristal acetate has a specific pharmacodynamic action on the endometrium:

Changes in the histology of the endometrium may be observed in patients treated with ulipristal acetate. These changes are reversible after treatment cessation.

These histological changes are denoted as “Progesterone Receptor Modulator Associated Endometrial Changes” (PAEC) and should not be mistaken for endometrial hyperplasia (see sections 4.8 and 5.1).

In addition, reversible increase of the endometrium thickness may occur under treatment.

 

In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended. This includes annual ultrasound to be performed after resumption of menstruation during off-treatment period.

 

If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted (see ‘bleeding pattern’), investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.

 

In case of hyperplasia (without atypia), monitoring as per usual clinical practice (e.g. a follow-up control 3 months later) would be recommended. In case of atypical hyperplasia, investigation and management as per usual clinical practice should be performed.

 

The treatment courses should each not exceed 3 months as the risk of adverse impact on the endometrium is unknown if treatment is continued without interruption.

 

Bleeding pattern

Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician. Menstrual periods generally return within 4 weeks after the end of each treatment course.

If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding, investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.

 

Repeated intermittent treatment has been studied up to 4 intermittent treatment courses.

 

Endometrial changes

Ulipristal acetate has a specific pharmacodynamic action on the endometrium. Increase in thickness of the endometrium may occur. If the endometrial thickening persists beyond 3 months following the end of treatment and return of menstruations, this may need to be investigated as per usual clinical practice to exclude underlying conditions.

 

Changes in the histology of the endometrium may be observed in patients treated with ulipristal acetate. These changes are reversible after treatment cessation.

These histological changes are denoted as “Progesterone Receptor Modulator Associated Endometrial Changes” (PAEC) and should not be mistaken for endometrial hyperplasia (see sections 4.8 and 5.1)

Only two treatment courses are recommended. The two treatment courses should each not exceed 3 months as the risk of adverse impact on the endometrium is unknown if treatment is continued.

Bleeding pattern

Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician. Menstrual periods will generally return within 4 weeks after the end of the treatment course.

Section 4.8         Undesirable effects (additions in red, deletions crossed out)

 

 

Summary of the safety profile


The safety of ulipristal acetate has been evaluated in 602 1,053 women with uterine fibroids treated with 5 mg or 10 mg ulipristal acetate during Phase III studies. The most common finding in clinical trials was amenorrhea (80.8 79.2%), which is considered as a desirable outcome for the patients (see section 4.4).

The most frequent adverse reaction was hot flush. The vast majority of adverse reactions were mild and moderate (935.60%), did not lead to discontinuation of the medicinal product (998.50%) and resolved spontaneously.

Among these 1,053 women, tThe safety of two repeated intermittent treatment courses (each limited to 3 months) has been evaluated in 131551 women with uterine fibroids treated with 5 or 10 mg ulipristal acetate in atwo phase III studyies (including 457 women exposed to four intermittent treatment courses) and demonstrated a similar safety profile to that observed for one treatment course.

 

Tabulated list of adverse reactions

Based on pooled data from three fourphase III studies in patients with uterine fibroids treated for 3 months, the following adverse reactions have been reported. Adverse reactions listed below are classified according to frequency and system organ class. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as very common (³1/10), common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100), rare (³1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).

 

 

System Organ Class

Adverse reactions during treatment course 1

Very common

 

Common

 

Uncommon

 

Rare

 

Psychiatric disorders

 

 

Anxiety

Emotional disorder

 

Nervous system disorders

 

Headache*

Dizziness

 

Ear and labyrinth disorders

 

Vertigo

 

 

Respiratory, thoracic and mediastinal disorders

 

 

Epistaxis

 

Epistaxis

 

Gastrointestinal disorders

 

Abdominal pain

Nausea

Dyspepsia

Dry mouth

Flatulence

Constipation

Dyspepsia

Flatulence

Skin and subcutaneous tissue disorders

 

Acne

Hyperhidrosis

Alopecia**

Dry skin

Hyperhidrosis

 

Musculoskeletal and connective tissue disorders

 

Musculoskeletal pain

Back pain

 

Renal and urinary disorders

 

 

Urinary incontinence

 

Reproductive system and breast disorders

Amenorrhea

Endometrial thickening*

 

Uterine haemorrhage*

Hot flush*

Pelvic pain

Ovarian cyst*

Breast tenderness/pain

Uterine haemorrhage*

Metrorrhagia

Ovarian cyst ruptured

Genital discharge

Breast swelling

Breast discomfort

Ovarian cyst ruptured*

Breast swelling

 

General disorders and administration site conditions

 

Oedema
Fatigue

Oedema

Asthenia

 

Investigations

 

Weight increased Blood cholesterol increased

Blood cholesterol increased

Blood triglycerides increased Weight increased

 

* see section "Description of selected adverse reactions"

** The verbatim term “mild hair loss” was coded to the term “alopecia”

 

When comparing repeated treatment courses, overall adverse reactions rate was less frequent in subsequent treatment courses than during the first one and each adverse reaction was less frequent or remained in the same frequency category (except for dyspepsia which was classified as uncommon in treatment course 3 based on one patient occurence).


Description of selected adverse reactions

  

Endometrial thickening

In 10-15% of patients, thickening of the endometrium (> 16 mm by ultrasound or MRI at end of treatment) was observed with ulipristal acetate by the end of the first 3-month treatment course. In subsequent treatment courses, endometrial thickening was less frequently observed (4.9% and 3.5% of patients by the end of second and fourth treatment course, respectively). The endometrial thickening this reverses when treatment is stopped and menstrual periods resume.

 

In addition, reversible changes to the endometrium are denoted PAEC and are different from endometrial hyperplasia. If hysterectomy or endometrial biopsy specimens are sent for histology, then the pathologist should be informed that the patient has taken ulipristal acetate (see sections 4.4 and 5.1).

 

Hot flush

Hot flushes were reported by 9.8 8.1% of patients but the rates varied across trials. In the active comparator controlled study the rates were 24% (10.5% moderate or severe) for ulipristal acetate and 60.4% (39.6% moderate or severe) for leuprorelin‑treated patients. In the placebo‑controlled study, the rate of hot flushes was 1.0% for ulipristal acetate and 0% for placebo. In the first 3-month treament course of the two long term Phase III trials, open-label phase III clinical trial, the frequency was 45.3% and 5.8% for ulipristal acetate, respectively.

Headache
Mild or moderate severity headache was reported in 6 5.8% of patients.

Section 5.1     Pharmacodynamic properties (additions in red, deletions crossed out)


Endometrium

About 5% of patients of reproductive age experiencing heavy menstrual bleeding have an endometrial thickness of greater than 16 mm. In about 10‑15% of patients treated with ulipristal acetate the endometrium may thicken (> 16 mm) during the first 3-month treatment course. In case of repeated treatment courses, endometrial thickening was less frequently observed (4.9% of patients after second treatment course and 3.5% after fourth treatment course). This thickening disappears after treatment is withdrawn and menstruation occurs. If endometrial thickness persists after return of menstruations during off-treatment periods or beyond the3 months following the end of treatment courses and return of menstruations then this , it may need to be investigated as per usual clinical practice to exclude other underlying conditions.

 

Ulipristal acetate does not affect serum levels of TSH, ACTH or prolactin during 3 months of treatment.

 

Clinical efficacy and safety

Pre-operative use:

The efficacy of fixed doses of ulipristal acetate 5 mg and 10 mg once daily was evaluated in two Phase 3 randomised, double-blind, 13 week studies recruiting patients with very heavy menstrual bleeding associated with uterine fibroids.....

 

Repeated intermittent use:

In a phase III study in 131 women with uterine fibroids receiving two intermittent 3-month treatment courses of ulipristal acetate 10 mg, amenorrhea was achieved at the end of the first treatment course in 79.5% of subjects. The second treatment course provided comparable results (88.5% of subjects). Myoma volume reduction (mean [median] change from screening) observed during the first treatment course (‑41.9% [-49.9%]) was maintained during the second one (-43.7% [-63.2%]).

In view of studies 1 and 2 results, it is expected that similarly to the 10 mg dose the efficacy of the 5 mg dose in the first treatment course will be maintained in the second treatment course.

Although the number of patients that completed the four treatment courses of 3 months is limited, i.e. 99 patients, the safety data are sufficient to support one additional 3-month treatment course in a pre-operative setting.

The efficacy of repeated treatment courses fixed doses of ulipristal acetate 5 mg or 10 mg once daily was evaluated in two Phase 3 studies assessing up to 4 intermittent 3-month treatment courses in patients with heavy menstrual bleeding associated with uterine fibroids. Study 3 was on open-label study assessing ulipristal acetate 10 mg, where each of the 3-month treatment was followed by 10 days of double-blind treatment with progestin or placebo. Study 4 was a randomized, double-blind clinical study assessing ulipristal acetate 5 or 10 mg.

 

Studies 3 and 4 showed efficacy in controlling uterine fibroid symptoms (e.g. uterine bleeding) and reducing fibroid size after 2 and 4 courses.

In study 3, treatment efficacy has been shown over > 18 months of repeated intermittent treatment (4 courses of 10 mg once daily), 89.7% of patients were in amenorrhea at the end of the treatment course 4.

In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose, respectively, p=0.027). At the end of treatment course 4, 158 (69.6%) subjects and 164 (74.5%) subjects were assessed as being in amenorrhea, in the 5 mg dose and 10 mg dose respectively (p=0.290).

 

Table 2: Results of primary and selected secondary efficacy assessments in long term Phase III studies

Parameter

After treatment course 2

(two times 3 months of treatment)

After treatment course 4

(four times 3 months of treatment)

 

Study 3a

Study 4

Study 3

Study 4

Patients starting treatment course 2 or 4

10 mg/day

N=132

5 mg/day

N= 213

10 mg/day

N=207

10 mg/day

N=107

5 mg/day

N=178

10 mg/day

N=176

Patients in amenorrheab,c

N=131

N = 205

N = 197

N=107

N =227

N =220

116

(88.5%)

152

(74.1%)

162

(82.2%)

96

(89.7%)

158 (69.6%)

164 (74.5%)

Patients with controlled bleedingb,c, d

NA

N=199

N=191

NA

N= 202

N=192

175 (87.9%)

168 (88.0%)

148 (73.3%)

144 (75.0%)

Median change in myoma volume from baseline

-63.2%

-54.1%

-58.0%

-72.1%

-71.8%

-72.7%

a Treatment course 2 assessment corresponds to Treatment course 2 plus one menstrual bleeding.

b Patients with missing values were exluded from the analysis.

c N and % include withdrawn patients

d Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding (not including days of spotting) during the last 2 months of a treatment course.

 

Endometrial findings:

In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%). The vast majority spontaneously reversed to normal endometrium after resumption of menstruation during the off-treatment period. The incidence of hyperplasia did not increase with repeated treatment courses. The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).

Endometrial findings:

In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%). The vast majority spontaneously reversed to normal endometrium after resumption of menstruation during the off-treatment period. The incidence of hyperplasia did not increase with repeated treatment courses. The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).

Section 5.2     Pharmacokinetic properties (additions in red)

 

Absorption

Following oral administration of a single dose of 5 or 10 mg, ulipristal acetate is rapidly absorbed, with a Cmax of 23.5 ± 14.2 ng/ml and 50.0 ± 34.4 ng/ml occurring approximately 1 h after ingestion, and with an AUC0-∞ of 61.3 ± 31.7 ng.h/ml and 134.0 ± 83.8 ng.h/ml, respectively. Ulipristal acetate is rapidly transformed into a pharmacologically active metabolite with a Cmax of 9.0 ± 4.4 ng/ml and 20.6 ± 10.9 ng/ml also occurring approximately 1 h after ingestion, and with an AUC0-∞ of 26.0 ± 12.0 ng.h/ml and 63.6 ± 30.1 ng.h/ml respectively.

Section 6.5         Nature and contents of container (addition in red)

 

Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.

Pack of 28, 30 and 84 tablets.

Not all pack sizes may be marketed.

 

Section 8.       MARKETING AUTHORISATION NUMBER(S) (additions in red)

 

EU/1/12/750/001

EU/1/12/750/002

EU/1/12/750/003

EU/1/12/750/004

EU/1/12/750/005

  

Section 10.     DATE OF REVISION OF THE TEXT (new date)

 

27/05/2015

 

 

Updated on 14-Jan-2014 and displayed until 05-Jun-2015

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC: 18-Dec-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1 - Removal of statement limiting treatment to a single 3 month course.
Section 4.2 - Removal of text limiting treatment to a single course. Change to two courses.
Section 4.3 - Change to contraindications to allow a further 3 month course.
Section 4.4 - Clarification of CYP3A4 inducer interaction.
Section 4.5 - Clarification of interaction with CYP3A4 inducers
Section 4.8 - Comment on additional safety data available from PEARL III and post-marketing surveillance to permit additional 3 month course.
Section 4.8 - Addition of text to encourage adverse event reporting via national authorities.
Section 5.1 - Efficacy data from PEARL III supporting additional 3 month course
Section 5.1 - Addition of ATC Code
Section 5.3 - Update demonstrating results of carcinogenicity studies in mice (not carcinogenic).

Updated on 30-Apr-2013 and displayed until 14-Jan-2014

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 21-Mar-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Drug Drug Interaction study with PgP substrate (fexofenadine): PgP substrates which were previously not recommended can now be taken concomitantly with Esmya if their administration is separated by at least 1.5 hours.
• Drug Drug Interaction study with potent CYP3A4 inhibitor (ketoconazole): confirmed interaction therefore no change for the prescriber, still not recommended.
• Study in Lactating women: confirmed excretion in breast milk therefore no change for the prescriber, breast feeding is still a contra-indication.
A review of section 4.8 was also carried out to include the results of clinical trial data which is currently in publication

Updated on 05-Oct-2012 and displayed until 30-Apr-2013

Reasons for adding or updating:

  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 05-Sep-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



6.5         Nature and contents of container

 

Alu‑PVC/PE/PVDC blister.

Pack of 28 and 84 tablets.

Not all pack sizes may be marketed.

7.       MARKETING AUTHORISATION HOLDER

 

Gedeon Richter Plc.

Gyömrői út 19-21.

1103 Budapest

Hungary

 

 

8.       MARKETING AUTHORISATION NUMBER(S)

 

EU/1/12/750/001

EU/1/12/750/002


10.     DATE OF REVISION OF THE TEXT

 

05 September 2012

Updated on 09-Mar-2012 and displayed until 05-Oct-2012

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 23-Feb-2012

Legal Category:POM

Black Triangle (CHM): YES

Updated on 02-Mar-2012 and displayed until 09-Mar-2012

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES

Company contact details

Gedeon Richter (UK) Ltd

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Address

127 Shirland Road, London, W9 2EP

E-mail
Medical Information e-mail
Telephone

+44(0)207 604 8800

Medical Information Direct Line

+44 (0)207 604 8806

Customer Care direct line

+44 (0)207 604 8800

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Active ingredients

ulipristal acetate

Legal categories

POM - Prescription Only Medicine

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