ELLA

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
ULIPRISTAL ACETATE 30 MG
Available from:
CTS LTD
ATC code:
G03AD02
Pharmaceutical form:
TABLETS
Administration route:
PER OS
Manufactured by:
LABORATOIRE HRA PHARMA , FRANCE
Therapeutic group:
ULIPRISTAL
Therapeutic indications:
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Authorization number:
146323329900
Authorization date:
2011-06-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

25-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

25-01-2021

PAGE 1

PAGE 2

117 mm

117 mm

72,5 mm

250 mm

250 mm

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS

(PREPARATIONS) – 1986

Ella

Tablet

1

2

Folder n° : 190330

PRODUCT NAME

ELLA OTC

NEW ITEM CODE

28054890

OLD ITEM CODE

TYPE

Leaflet

STRENGTH(S)

30 mg

PHARMA. FORM

Tablet

ZONE

COUNTRY

ISRAEL

LANGUAGE

1. Enlish 2. Hebrew 3. Arabic

MANUFACTURER

Cenexi

FORMAT

250 x (4 x 117) mm

TECH. LAYOUT REF.

PRINTED COLOURS: 1

Black

TECHNICAL COLOURS

Technical data

FONT

MIN. FONT SIZE

8 pts

SOFTWARE

Indesign CC

BAR CODES

28054890

DATE

(day/month/year)

20/02/2019

VERSION

Mor Nitzan

Approved

27-Feb-2019

PAGE 1

PAGE 2

117 mm

117 mm

72,5 mm

250 mm

250 mm

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS

(PREPARATIONS) – 1986

Ella

Tablet

1

2

Folder n° : 190330

PRODUCT NAME

ELLA OTC

NEW ITEM CODE

28054890

OLD ITEM CODE

TYPE

Leaflet

STRENGTH(S)

30 mg

PHARMA. FORM

Tablet

ZONE

COUNTRY

ISRAEL

LANGUAGE

1. Enlish 2. Hebrew 3. Arabic

MANUFACTURER

Cenexi

FORMAT

250 x (4 x 117) mm

TECH. LAYOUT REF.

PRINTED COLOURS: 1

Black

TECHNICAL COLOURS

Technical data

FONT

MIN. FONT SIZE

8 pts

SOFTWARE

Indesign CC

BAR CODES

28054890

DATE

(day/month/year)

20/02/2019

VERSION

Mor Nitzan

Approved

27-Feb-2019

250 mm

PAGE 3

117 mm

3

time

Folder n° : 190330

PRODUCT NAME

ELLA OTC

NEW ITEM CODE

28054890

OLD ITEM CODE

TYPE

Leaflet

STRENGTH(S)

30 mg

PHARMA. FORM

Tablet

ZONE

COUNTRY

ISRAEL

LANGUAGE

1. Enlish 2. Hebrew 3. Arabic

MANUFACTURER

Cenexi

FORMAT

250 x (4 x 117) mm

TECH. LAYOUT REF.

PRINTED COLOURS: 1

Black

TECHNICAL COLOURS

Technical data

FONT

MIN. FONT SIZE

8 pts

SOFTWARE

Indesign CC

BAR CODES

28054890

DATE

(day/month/year)

20/02/2019

VERSION

1.

NAME OF THE MEDICINAL PRODUCT

Ella 30 mg tablet

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 30 mg ulipristal acetate.

Excipients with known effect: each tablet contains 237 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Tablet

White to marble creamy, round curved tablet of 9 mm diameter engraved with code

“еllа”

on both

sides.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive

failure.

4.2

Posology and method of administration

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.

Method of administration:

Oral use

The tablet can be taken with or without food.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use

Ella 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, Ella does not interrupt an existing pregnancy (see

section 4.6).

Ella 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 4.6).

ulipristal acetate inhibits or postpones ovulation (see section 5.1). 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.

Limited and inconclusive data suggest that there may be reduced efficacy of Ella with increasing body

weight or body mass index (BMI) (see section 5.1). 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. In 18.5% 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 4.5).

Contraception after Ella 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, Ella may reduce its contraceptive action (see section

4.5). Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so

after using Ella, however, she should be advised to use a reliable barrier method until the next

menstrual period.

Specific populations

Concomitant use of Ella with CYP3A4 inducers is not recommended due to interaction (e.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 medicinal product contains lactose. Patients with rare hereditary problems of galactose

intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this

medicinal product.

4.5

Interaction with other medicinal products and other forms of interaction

Potential for other medicinal products to affect ulipristal acetate:

Ulipristal acetate is metabolized by CYP3A4

in vitro

CYP3A4 inducers:

In vivo results show that the administration of ulipristal acetate with a strong CYP3A4

inducer such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or

more and decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately

10-fold decrease of ulipristal acetate exposure. Concomitant use of Ella with CYP3A4

inducers (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin,

carbamazepine, oxcarbazepine, herbal medicines containing

Hypericum perforatum

(St.

John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces

plasma concentrations of ulipristal acetate and may result in a decreased efficacy of Ella. For

women who have used enzyme-inducing drugs in the past 4 weeks, Ella is not recommended

(see section 4.4) and non-hormonal emergency contraception (i.e. a copper intrauterine device

(Cu-IUD)) should be considered.

CYP3A4 inhibitors:

In vivo results show that administration of ulipristal acetate with a potent and a moderate

CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and

5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinical

consequences.

The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir

is used for a longer period. In such cases ritonavir might reduce plasma concentrations of

ulipristal acetate. Concomitant use is therefore not recommended (see section 4.4). Enzyme

induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may

occur even if a woman has stopped taking an enzyme inducer in the past 4 weeks.

Medicinal products affecting gastric pH:

Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor

esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean C

, a delayed

(from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of

this interaction for single dose administration of ulipristal acetate as emergency contraception is not

known.

Potential for ulipristal acetate to affect other medicinal products:

Hormonal contraceptives:

Because ulipristal acetate binds to the progesterone receptor with high affinity, it may interfere with

the action of progestogen-containing medicinal products:

Contraceptive action of combined hormonal contraceptives and progestogen-only contraception

may be reduced

Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is

not recommended (see section 4.4).

In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit

CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations. After single dose

administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not

likely. Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products

that are metabolised by these enzymes.

P-gp (P-glycoprotein) substrates:

In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant

concentrations. Results in vivo with the P-gp substrate fexofenadine were inconclusive. The effects of

the P-gp substrates are unlikely to have any clinical consequences.

4.6

Fertility, pregnancy and lactation

Pregnancy

Ella is not intended for use during pregnancy and should not be taken by any woman suspected or

known to be pregnant (see section 4.2).

Ulipristal acetate does not interrupt an existing pregnancy.

Pregnancy may occasionally occur after ulipristal acetate intake. Although no teratogenic potential has

been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).

Limited human data regarding pregnancy exposure to Ella do not suggest any safety concern.

Nevertheless it is important that any pregnancy in a woman who has taken Ella be reported.

HRA Pharma maintains a pregnancy registry to monitor outcomes of pregnancy in women exposed to

Ella. Patients and health care providers are encouraged to report any exposure to Ella by contacting the

License Holder/Importer or the Manufacturer (see section 7 and 8).

patient data collected will

remain anonymous.

Breast-feeding

Ulipristal acetate is excreted in breast milk (see section 5.2). The effect on newborn/infants has not

been studied. A risk to the breastfed child cannot be excluded. After intake of ulipristal acetate for

emergency contraception, breastfeeding is not recommended for one week.

During this time it is

recommended to express and discard the breast milk in order to stimulate lactation.

Fertility

A rapid return of fertility is likely following treatment with ulipristal acetate for emergency

contraception. Women should be advised to use a reliable barrier method for all subsequent acts of

intercourse until the next menstrual period.

4.7

Effects on ability to drive and use machines

Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild to

moderate dizziness is common after Ella intake, somnolence and blurred vision are uncommon;

disturbance in attention has been rarely reported. The patient should be informed not to drive or use

machines if they are experiencing such symptoms (see section 4.8).

4.8

Undesirable effects

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

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

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

Urticaria

Musculoskeletal and

connective tissue

disorders

Myalgia

Back pain

Reproductive system and

breast disorders

Dysmenorrhea

Pelvic pain

Breast tenderness

Menorrhagia

Vaginal discharge

Menstrual disorder

Metrorrhagia

Vaginitis

Hot flush

Premenstrual syndrome

Genital pruritus

Dyspareunia

Ruptured ovarian cyst

Vulvovaginal pain

Hypomenorrhea*

General disorders and

administration site

conditions

Fatigue

Chills

Malaise

Pyrexia

Thirst

*Symptoms which could also be related to an undiagnosed pregnancy (or related complications)

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 4.2).

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.

Description of selected adverse reactions:

The majority of women (74.6%) in the phase III studies had their next menstrual period at the

expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than

expected and 18.5% 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.

A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days. In a

majority of cases (88.2%), this bleeding was reported as spotting. Among the women who received

Ella in the phase III studies, only 0.4% 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 Ella (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.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic

@moh.gov.il

4.9

Overdose

Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg have been used in

women without safety concern. Such high doses were well-tolerated; however, these women had a

shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in

some women, the duration of bleeding was prolonged, although not excessive in amount (spotting).

There are no antidotes and further treatment should be symptomatic.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency

contraceptives . ATC code. G03AD02.

Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via

high-affinity binding to the human progesterone receptor. When used for emergency contraception the

mechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone

(LH) surge. Pharmacodynamic data show that even when taken immediately before ovulation is

scheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone

follicular rupture for at least 5 days in 78.6% of cases (p<0.005 vs. levonorgestrel and vs. placebo)

(see Table).

Prevention of ovulation

1,§

Placebo

n=50

Levonorgestrel

n=48

Ulipristal acetate

n=34

Treatment before LH

surge

n=16

0.0%

n=12

25.0%

100% p<0.005*

Treatment after LH surge

but before LH peak

n=10

10.0%

n=14

14.3%

NS†

n=14

78.6% p<0.005*

Treatment after LH peak

n=24

4.2%

n=22

9.1%

NS†

n=12

8.3%

1: Brache et al, Contraception 2013

§: defined as presence of unruptured dominant follicle five days after late follicular-phase treatment

*: compared to levonorgestrel

NS: non statistically significant

†: compared to placebo

Ulipristal acetate also has high affinity for the glucocorticoid receptor and

in vivo

, in animals,

antiglucocorticoid effects have been observed. However, in humans, no such effect has been observed

even after repeat administration at the daily dose of 10 mg. It has minimal affinity to the androgen

receptor and no affinity for the human estrogen or mineralocorticoid receptors.

Results from two independent randomized controlled trials (see Table) showed the efficacy of

ulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency

contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure. When the

data from the two trials were combined via meta-analysis, the risk of pregnancy with ulipristal acetate

was significantly reduced compared to levonorgestrel (p=0.046).

Randomized

controlled trial

Pregnancy rate (%)

within 72h of unprotected intercourse or contraceptive

failure

Odds ratio [95% CI] of pregnancy

risk, ulipristal acetate vs

levonorgestrel

Ulipristal acetate

Levonorgestrel

HRA2914-507

0.91

(7/773)

1.68

(13/773)

0.50 [0.18-1.24]

HRA2914-513

1.78

(15/844)

2.59

(22/852)

0.68 [0.35-1.31]

Meta-analysis

1.36

(22/1617)

2.15

( 35/1625)

0.58 [0.33-0.99]

2 – Glasier et al, Lancet 2010

Two trials provide efficacy data on Ella used up to 120 hours after unprotected intercourse. In an

open-label clinical trial, which enrolled women who presented for emergency contraception and were

treated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rate

of 2.1% (26/1241) was observed. In addition, the second comparative trial described above also

provides data on 100 women treated with ulipristal acetate from 72 to 120 hours after unprotected

intercourse, in whom no pregnancies were observed.

Limited and inconclusive data from clinical trials suggest a possible trend for a reduced contraceptive

efficacy of ulipristal acetate with high body weight or BMI (see section 4.4). The meta-analysis of the

four clinical studies conducted with ulipristral acetate presented below excluded women who had

further acts of unprotected intercourse.

BMI (kg/m

2

)

Underweight

0 - 18.5

Normal

18.5-25

Overweight

25-30

Obese

30-

N total

1866

N pregnancies

Pregnancy rate

0.00%

1.23%

1.29%

2.57%

Confidence

interval

0.00 – 2.84

0.78 – 1.84

0.59 – 2.43

1.34 - 4.45

A post-marketing observational study evaluating efficacy and safety of Ella in adolescents aged 17 and

younger showed no difference in the safety and efficacy profile compared to adult women aged 18 and

older.

5.2

Pharmacokinetic properties

Absorption

Following oral administration of a single 30 mg dose, ulipristal acetate is rapidly absorbed, with a

peak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) after

ingestion, and with an AUC

0-∞

of 556 ± 260 ng.h/ml.

Administration of ulipristal acetate together with a high-fat breakfast resulted in approximately 45%

lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean

0-∞

compared with administration in the fasted state. Similar results were obtained for the active

mono-demethylated metabolite.

Distribution

Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid

glycoprotein, and high density lipoprotein.

Ulipristal acetate is a lipophilic compound and is distributed in breast milk, with a mean daily

excretion of 13.35 µg [0-24 hours], 2.16 µg [24-48 hours], 1.06 µg [48-72 hours], 0.58 µg [72-96

hours], and 0.31 µg [96-120 hours].

In vitro data indicate that ulipristal acetate may be an inhibitor of BCRP (Breast Cancer Resistance

Protein) transporters at the intestinal level. The effects of ulipristal acetate on BCRP are unlikely to

have any clinical consequences.

Ulipristal acetate is not a substrate for either OATP1B1 or OATP1B3.

Biotransformation /elimination

Ulipristal acetate is extensively metabolized to mono-demethylated, di-demethylated and hydroxylated

metabolites. The mono-demethylated metabolite is pharmacologically active. In vitro data indicate

that this is predominantly mediated by CYP3A4, and to a small extent by CYP1A2 and CYP2A6. The

terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ±

6.3 hours, with a mean oral clearance (CL/F) of 76.8 ± 64.0 L/h.

Special populations

No pharmacokinetic studies with ulipristal acetate have been performed in females with impaired renal

or hepatic function.

5.3

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety

pharmacology, repeated dose toxicity, and genotoxicity. Most findings in general toxicity studies were

related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with

antiprogesterone activity observed at exposures similar to therapeutic levels.

Information from reproductive toxicity studies is limited due to the absence of exposure measurement

in these studies. Ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1

mg/kg) and in monkeys. At these repeated doses, the safety for a human embryo is unknown. At doses

which were low enough to maintain gestation in the animal species, no teratogenic effects were

observed.

Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate

Povidone K30

Croscarmellose sodium

Magnesium stearate

6.2

Incompatibilities

Not applicable

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials

6.4

Special precautions for storage

Store below 25°C in the original package to protect from light and moisture. Keep the blister in the

outer carton in order to protect from light.

6.5

Nature and contents of container

PVC-PE-PVDC-Aluminium blister of 1 tablet.

PVC-PVDC-Aluminium blister of 1 tablet.

The carton contains one blister of one tablet.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements

7.

MANUFACTURER

Laboratoire HRA Pharma,

France

200 avenue de Paris 92320 Chatillon, France

8.

LICENSE HOLDER/IMPORTER.

CTS Ltd,

4 Haharash St.,

Hod-|Hasharon 45240

The content of this leaflet was approved by the Ministry of Health in February 2016 and updated

according to the guidelines of the Ministry of Health in January 2019.

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