Page 5 - P4304.1-V91_PS-Magazine-November 2023 PRINT

Benilexa One Handed Intrauterine Delivery System Prescribing and endometrial biopsy considered. Irregular bleeding/spotting may occur
The material is intended for UK healthcare professionals only and has been co-developed by Gedeon Richter and PSUK Information during the first months of therapy in pre-menopausal women therefore
Prescribing information can be found on the following page. Please refer to the Summary of Product Characteristics before prescribing. endometrial pathology should be excluded before insertion. The possibility
and endometrial biopsy considered. Irregular bleeding/spotting may occur
Benilexa One Handed Intrauterine Delivery System Prescribing
Product name and active ingredients: Benilexa One Handed 20 of pregnancy should be considered and expulsion excluded if menstruation
during the first months of therapy in pre-menopausal women therefore
Information
micrograms/24 hours Intrauterine Delivery System. The intrauterine delivery does not occur within six weeks of the onset of previous menstruation. In
endometrial pathology should be excluded before insertion. The possibility
Please refer to the Summary of Product Characteristics before prescribing.
system contains 52 mg levonorgestrel. Indications: Contraception. menorrhagia, if significant reduction in menstrual blood loss is not achieved
of pregnancy should be considered and expulsion excluded if menstruation
Product name and active ingredients: Benilexa One Handed 20
Treatment of heavy menstrual bleeding. Benilexa One Handed may be within 3 to 6 months, alternative treatments should be considered. The
micrograms/24 hours Intrauterine Delivery System. The intrauterine delivery
does not occur within six weeks of the onset of previous menstruation. In
particularly useful in women with heavy menstrual bleeding requiring possibility of ectopic pregnancy should be considered in the case of lower
system contains 52 mg levonorgestrel. Indications: Contraception.
menorrhagia, if significant reduction in menstrual blood loss is not achieved
(reversible) contraception. Dosage and administration: Starting treatment: abdominal pain - especially in connection with missed periods or if an
Treatment of heavy menstrual bleeding. Benilexa One Handed may be
within 3 to 6 months, alternative treatments should be considered. The
In women of fertile age, Benilexa One Handed is inserted into the uterine amenorrhoeic woman starts bleeding. Women with a previous history of
particularly useful in women with heavy menstrual bleeding requiring
possibility of ectopic pregnancy should be considered in the case of lower
cavity within seven days of the onset of menstruation. It can be replaced by ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk
abdominal pain - especially in connection with missed periods or if an
(reversible) contraception. Dosage and administration: Starting treatment:
a new system at any time of the cycle. Post-partum insertion: To reduce the of ectopic pregnancy. Ovarian cysts have been reported. Most of these
amenorrhoeic woman starts bleeding. Women with a previous history of
In women of fertile age, Benilexa One Handed is inserted into the uterine
risk of perforation, postpartum insertions should be postponed until the follicles are asymptomatic, although some may be accompanied by pelvic
ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk
cavity within seven days of the onset of menstruation. It can be replaced by
uterus is fully involuted. Do not insert earlier than six weeks after delivery. If pain or dyspareunia. If ovarian cysts do not disappear spontaneously during
of ectopic pregnancy. Ovarian cysts have been reported. Most of these
a new system at any time of the cycle. Post-partum insertion: To reduce the
the patient is experiencing significant postpartum bleeding and/or pain two to three months observation, continued ultrasound monitoring and
follicles are asymptomatic, although some may be accompanied by pelvic
risk of perforation, postpartum insertions should be postponed until the
then infection or other causes should be excluded before insertion. Benilexa other diagnostic/therapeutic measures are recommended. Some studies
uterus is fully involuted. Do not insert earlier than six weeks after delivery. If
pain or dyspareunia. If ovarian cysts do not disappear spontaneously during
One Handed can also be inserted immediately after the first trimester suggest a slightly increased relative risk of breast cancer in women using
two to three months observation, continued ultrasound monitoring and
the patient is experiencing significant postpartum bleeding and/or pain
combined oral contraceptives (COC). The risk may be of similar magnitude
abortion.
other diagnostic/therapeutic measures are recommended. Some studies
then infection or other causes should be excluded before insertion. Benilexa
Benilexa One Handed One Handed can also be inserted immediately after the first trimester suggest a slightly increased relative risk of breast cancer in women using

for progestogen-only methods such as Benilexa but the evidence is based
®
indication heavy menstrual bleeding. Therefore, Benilexa One Handed
on much smaller population of users and so is less conclusive. Blood glucose
combined oral contraceptives (COC). The risk may be of similar magnitude
abortion.
concentrations should be monitored in diabetic patients. Benilexa should
should be removed or exchanged after 6 years of use, or earlier if heavy or
for progestogen-only methods such as Benilexa but the evidence is based
not be used as a post-coital contraceptive. Interactions: Metabolism of
bothersome menstrual bleeding returns. If the user wishes to continue using
indication heavy menstrual bleeding. Therefore, Benilexa One Handed
on much smaller population of users and so is less conclusive. Blood glucose
the same method, a new system can be inserted at the same time, in which
concentrations should be monitored in diabetic patients. Benilexa should
should be removed or exchanged after 6 years of use, or earlier if heavy or
of drug-metabolising enzymes, specifically cytochrome P450 enzymes. The
case no additional protection is required. Benilexa One Handed has blue
not be used as a post-coital contraceptive. Interactions: Metabolism of
bothersome menstrual bleeding returns. If the user wishes to continue using
threads and the T-frame contains barium sulphate so that it can be seen on
New MDS the same method, a new system can be inserted at the same time, in which known but it is not believed to be of major importance due to the local
X-rays. Paediatric population: Benilexa One Handed has not been studied in
of drug-metabolising enzymes, specifically cytochrome P450 enzymes. The
case no additional protection is required. Benilexa One Handed has blue
mechanism of action. Fertility, Pregnancy & Lactation: Should not be used
patients below 16 years of age. Benilexa One Handed should not be used
threads and the T-frame contains barium sulphate so that it can be seen on
during an existing or suspected pregnancy. If pregnancy occurs with
before menarche. Consult the SmPC for full information on instruction
X-rays. Paediatric population: Benilexa One Handed has not been studied in
known but it is not believed to be of major importance due to the local
Benilexa in situ, ectopic pregnancy should be excluded, the system removed
for use and handling, insertion and removal. Contraindications: Known
mechanism of action. Fertility, Pregnancy & Lactation: Should not be used
patients below 16 years of age. Benilexa One Handed should not be used
or suspected pregnancy, current or recurrent pelvic inflammatory disease,
and termination of the pregnancy considered. Removal or probing of the
before menarche. Consult the SmPC for full information on instruction
lower genital tract infection, postpartum endometritis, infected abortion
uterus may result in spontaneous abortion. If removal is not possible or if
for use and handling, insertion and removal. Contraindications: Known
Benilexa in situ, ectopic pregnancy should be excluded, the system removed
during the past three months, cervicitis, cervical dysplasia, suspected or during an existing or suspected pregnancy. If pregnancy occurs with
the woman wishes to continue the pregnancy, the pregnancy should be
and termination of the pregnancy considered. Removal or probing of the
or suspected pregnancy, current or recurrent pelvic inflammatory disease,
monitored closely and the woman should be informed about the risks and
confirmed uterine or cervical malignancy, liver tumour or other acute or
‘In partnership with Gedeon Richter, we are pleased lower genital tract infection, postpartum endometritis, infected abortion uterus may result in spontaneous abortion. If removal is not possible or if
severe liver disease, congenital or acquired abnormality of the uterus
instructed to report all symptoms suggesting complications, like cramping
the woman wishes to continue the pregnancy, the pregnancy should be
during the past three months, cervicitis, cervical dysplasia, suspected or
including fibroids if they distort the uterine cavity, undiagnosed abnormal
abdominal pain with fever. Due to intrauterine administration and local
monitored closely and the woman should be informed about the risks and
confirmed uterine or cervical malignancy, liver tumour or other acute or
to announce the first discount available via PSUK to uterine bleeding, conditions associated with increased susceptibility to instructed to report all symptoms suggesting complications, like cramping
severe liver disease, congenital or acquired abnormality of the uterus
foetus should be taken into consideration. There is a risk of masculinisation
infections, current or suspected hormone dependent tumours such as
abdominal pain with fever. Due to intrauterine administration and local
including fibroids if they distort the uterine cavity, undiagnosed abnormal
dispensing doctors on an intrauterine system. uterine bleeding, conditions associated with increased susceptibility to of the external genitalia of the female foetus when the levonorgestrel intra-
when in remission, recent trophoblastic disease while hCG levels remain
uterine device remains during pregnancy. Levonorgestrel is excreted in very
infections, current or suspected hormone dependent tumours such as
elevated, hypersensitivity to the active substance or to any of the foetus should be taken into consideration. There is a risk of masculinisation
small quantities in breast milk and breast feeding can be continued during
of the external genitalia of the female foetus when the levonorgestrel intra-
excipients. Warnings and precautions: Before insertion, a complete use. Uterine bleeding has been reported rarely during lactation. The use of
when in remission, recent trophoblastic disease while hCG levels remain
uterine device remains during pregnancy. Levonorgestrel is excreted in very
levonorgestrel IUS does not alter the course of female fertility after the
personal and family medical history should be taken. Pulse and blood
Net
removal of the IUS
pressure should be measured and a bimanual pelvic examination performed
Very common (≥ 1/10): Vaginal bacterial
PIP Code Product NHS Price MDS WD Total Price Profit elevated, hypersensitivity to the active substance or to any of the small quantities in breast milk and breast feeding can be continued during
use. Uterine bleeding has been reported rarely during lactation. The use of
excipients. Warnings and precautions: Before insertion, a complete
to establish the orientation of the uterus. Re-examine six weeks after
infections, vulvovaginal mycotic infections, acne, uterine/vaginal bleeding
personal and family medical history should be taken. Pulse and blood
levonorgestrel IUS does not alter the course of female fertility after the
Very common (≥ 1/10): Vaginal bacterial
pressure should be measured and a bimanual pelvic examination performed
removal of the IUS
4195178 BENILEXA 52MG IUS £71.00 20% 0% 20% £56.80 £14.20 insertion and where clinically indicated. Use with caution after specialist including spotting, oligomenorrhoea, amenorrhoea, benign ovarian cysts,
consultation, or removal of the system should be considered, if any of the
procedural pain, procedural bleeding. Common (≥ 1/100 to < 1/10):
to establish the orientation of the uterus. Re-examine six weeks after
infections, vulvovaginal mycotic infections, acne, uterine/vaginal bleeding
following conditions exist or arise for the first time during treatment: Depressive mood, nervousness, decreased libido, headache, migraine,
including spotting, oligomenorrhoea, amenorrhoea, benign ovarian cysts,
insertion and where clinically indicated. Use with caution after specialist
migraine, focal migraine with asymmetrical visual loss or other symptoms presyncope, abdominal pain/discomfort, nausea, abdominal distension,
consultation, or removal of the system should be considered, if any of the
procedural pain, procedural bleeding. Common (≥ 1/100 to < 1/10):
Depressive mood, nervousness, decreased libido, headache, migraine,
following conditions exist or arise for the first time during treatment:
Gedeon Richter offer product demonstrations, demonstration placebo devices and indicating transient cerebral ischemia; unusually severe or unusually vomiting, back pain, pelvic pain, dysmenorrhoea, vaginal discharge,
vulvovaginitis, breast tenderness, breast pain, dyspareunia, uterine spasm,
frequent headache; jaundice; marked increase of blood pressure;
migraine, focal migraine with asymmetrical visual loss or other symptoms
presyncope, abdominal pain/discomfort, nausea, abdominal distension,
support materials for both healthcare professionals and patients. Please contact indicating transient cerebral ischemia; unusually severe or unusually intrauterine contraceptive device expelled, weight increase. Uncommon (≥
vomiting, back pain, pelvic pain, dysmenorrhoea, vaginal discharge,
corticosteroid therapy; past history of symptomatic functional ovarian
1/1,000 to < 1/100): syncope, alopecia, hirsuitism, pruritus, eczema, chloasma/
devicesupport@gedeonrichter.com to order any of these items/services. frequent headache; jaundice; marked increase of blood pressure; vulvovaginitis, breast tenderness, breast pain, dyspareunia, uterine spasm,
cysts; active or previous severe arterial disease, such as stroke or myocardial
skin hyperpigmentation, uterine perforation, pelvic inflammatory disease,
intrauterine contraceptive device expelled, weight increase. Uncommon (≥
infarction; severe or multiple risk factors for arterial disease; thrombotic endometritis, cervicitis, Papanicolaou smear normal, class II, ectopic
1/1,000 to < 1/100): syncope, alopecia, hirsuitism, pruritus, eczema, chloasma/
corticosteroid therapy; past history of symptomatic functional ovarian
arterial or any current embolic disease; acute venous thromboembolism; pregnancy, oedema. Rare ≥ 1/10,000 to < 1/1,000: Hypersensitivity including
cysts; active or previous severe arterial disease, such as stroke or myocardial
skin hyperpigmentation, uterine perforation, pelvic inflammatory disease,
congenital heart disease or valvular heart disease at risk of infective rash, urticaria and angioedema, rash, urticaria
endometritis, cervicitis, Papanicolaou smear normal, class II, ectopic
infarction; severe or multiple risk factors for arterial disease; thrombotic
endocarditis; irregular bleedings as these may mask some symptoms and pregnancy, oedema. Rare ≥ 1/10,000 to < 1/1,000: Hypersensitivity including
arterial or any current embolic disease; acute venous thromboembolism;
signs of endometrial polyps or cancer. Women should be encouraged to rash, urticaria and angioedema, rash, urticaria
congenital heart disease or valvular heart disease at risk of infective
stop smoking. Depression and depressed mood are well known undesirable Legal category: POM
endocarditis; irregular bleedings as these may mask some symptoms and
signs of endometrial polyps or cancer. Women should be encouraged to Pack size and NHS price: One Intrauterine System with the inserter device.
physician in case of mood changes, depressive symptoms or suicidal Multipack containing five packs of one Intrauterine System with the inserter
stop smoking. Depression and depressed mood are well known undesirable
Legal category: POM
thoughts. Insertion/removal may be associated with some pain and device. NHS list price for one pack: £71.
Pack size and NHS price: One Intrauterine System with the inserter device.
bleeding and may result in fainting as a vasovagal reaction or seizure in Marketing Authorization Number: PL 04854/0179
physician in case of mood changes, depressive symptoms or suicidal
Multipack containing five packs of one Intrauterine System with the inserter
epileptics. In cases of severe pain and continued bleeding during or after Marketing Authorization Holder: Gedeon Richter Plc., Gyömrői út 19-21.
thoughts. Insertion/removal may be associated with some pain and
device. NHS list price for one pack: £71.
insertion, exclude perforation of the uterine corpus or cervix. If perforation 1103 Budapest, Hungary.
bleeding and may result in fainting as a vasovagal reaction or seizure in
Marketing Authorization Number: PL 04854/0179
is suspected the system should be removed. Risk of perforation may be Further information available from: Gedeon Richter UK Ltd, 127 Shirland
epileptics. In cases of severe pain and continued bleeding during or after
Marketing Authorization Holder: Gedeon Richter Plc., Gyömrői út 19-21.
increased in post-partum insertions, in lactating women and in women with Road, London W9 2EP. Tel: +44 (0) 207 604 8806. Email: medinfo.uk@
insertion, exclude perforation of the uterine corpus or cervix. If perforation
1103 Budapest, Hungary.
a fixed retroverted uterus. If pelvic infection is suspected, appropriate gedeonrichter.eu
is suspected the system should be removed. Risk of perforation may be
Further information available from: Gedeon Richter UK Ltd, 127 Shirland
antibiotics should be started. Remove Benilexa, if the woman experiences Date of Authorisation: 21 May 2021
increased in post-partum insertions, in lactating women and in women with
Road, London W9 2EP. Tel: +44 (0) 207 604 8806. Email: medinfo.uk@
recurrent endometritis, pelvic infection or if an acute infection is severe. The Date of Preparation: February 2023
a fixed retroverted uterus. If pelvic infection is suspected, appropriate
gedeonrichter.eu
woman should be advised on how to check the Benilexa threads and to Job number: UK--2300025
Date of Authorisation: 21 May 2021
antibiotics should be started. Remove Benilexa, if the woman experiences
immediately see her doctor if she cannot feel the threads. If the threads Date of Preparation: February 2023
recurrent endometritis, pelvic infection or if an acute infection is severe. The
woman should be advised on how to check the Benilexa threads and to Job number: UK--2300025
system may have been expelled, or rarely the device may be extra-uterine
immediately see her doctor if she cannot feel the threads. If the threads
after having perforated the uterus. An ultrasound should be arranged and Adverse events should be reported. Reporting forms and information
alternative contraception should be advised in the meantime. If an
system may have been expelled, or rarely the device may be extra-uterine
ultrasound cannot locate the device and there is no evidence of expulsion, can be found at https://yellowcard.mhra.gov.uk/, or you can report via
after having perforated the uterus. An ultrasound should be arranged and
a plain abdominal X-ray should be performed to exclude an extra-uterine Adverse events should be reported. Reporting forms and information
the Yellow Card app which is available to download from the Apple
alternative contraception should be advised in the meantime. If an
can be found at https://yellowcard.mhra.gov.uk/, or you can report via
device. Symptoms of partial or complete expulsion of the IUS may include App Store or Google Play Store. Adverse events should also be reported
ultrasound cannot locate the device and there is no evidence of expulsion,
bleeding or pain. Increased menstrual flow may be indicative of expulsion. the Yellow Card app which is available to download from the Apple
a plain abdominal X-ray should be performed to exclude an extra-uterine
to Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or by email to
Women with a history of heavy menstrual bleeding or a greater than normal App Store or Google Play Store. Adverse events should also be reported
device. Symptoms of partial or complete expulsion of the IUS may include
BMI carry an increased risk of expulsion. If menorrhagia persists, an drugsafety.uk@gedeonrichter.eu
bleeding or pain. Increased menstrual flow may be indicative of expulsion.
assessment of the uterine cavity using ultrasound scan should be performed to Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or by email to
Women with a history of heavy menstrual bleeding or a greater than normal
BMI carry an increased risk of expulsion. If menorrhagia persists, an drugsafety.uk@gedeonrichter.eu
assessment of the uterine cavity using ultrasound scan should be performed
Order now or call:
online at: 01904 558 360
Adverse events shou ld be reported. Reporting forms and information can be fo und at
https:ljyellowcard.mhra.gov.uk/, or you can report via t he Yellow Card app which is available to
download from the Apple App Store or Google Play St ore. Adverse events should also be reported to UK--2300181
Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or by emai l to drugsafety.uk@gedeonrichter.eu October 2023
P4260.306-V1
or call us on 01904 558 350 Gedeon Richter | PS Magazine 5
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