Page 37 - P4304.1-V104_PS Magazine - December 24

The material is intended for UK healthcare professionals only and has been co-developed by Gedeon Richter and PSUK
Prescribing information can be found on the following page.

Benilexa One Handed Intrauterine Delivery System Prescribing device. Symptoms of partial or complete expulsion of the IUS may include
Information bleeding or pain. Increased menstrual flow may be indicative of expulsion.
Please refer to the Summary of Product Characteristics before prescribing. Women with a history of heavy menstrual bleeding or a greater than
normal BMI carry an increased risk of expulsion. If menorrhagia persists, an
Product name and active ingredients: Benilexa One Handed 20
Benilexa micrograms/24 hours Intrauterine Delivery System. The intrauterine assessment of the uterine cavity using ultrasound scan should be performed
and endometrial biopsy considered. Irregular bleeding/spotting may occur
delivery system contains 52 mg levonorgestrel. Presentation: Intrauterine
delivery system (IUS) containing 52mg levonorgestrel. Indications:
during the first months of therapy in pre-menopausal women therefore
One Handed Contraception. Treatment of heavy menstrual bleeding. Benilexa One endometrial pathology should be excluded before insertion. The possibility
Handed may be particularly useful in women with heavy menstrual
of pregnancy should be considered and expulsion excluded if menstruation
does not occur within six weeks of the onset of previous menstruation. In
bleeding requiring (reversible) contraception. Dosage and administration:
levonorgestrel a PHOENIX service Starting treatment: A bimanual pelvic examination should be performed to menorrhagia, if significant reduction in menstrual blood loss is not achieved
within 3 to 6 months, alternative treatments should be considered. The
establish the orientation of the uterus. Pregnancy should be excluded and
genital infection should be successfully treated. In women of fertile age, possibility of ectopic pregnancy should be considered in the case of lower
Benilexa One Handed is inserted into the uterine cavity within seven days abdominal pain - especially in connection with missed periods or if an
amenorrhoeic woman starts bleeding. Women with a previous history of
of the onset of menstruation. It can be replaced by a new system at any
Benilexa One Handed postpartum insertions should be postponed until the uterus is fully of ectopic pregnancy. Ovarian cysts have been reported. Most of these

time of the cycle. Post-partum insertion: To reduce the risk of perforation,
ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk
®
follicles are asymptomatic, although some may be accompanied by pelvic
involuted. Do not insert earlier than six weeks after delivery. If the patient
is experiencing significant postpartum bleeding and/or pain then infection
pain or dyspareunia. If ovarian cysts do not disappear spontaneously during
two to three months observation, continued ultrasound monitoring and
or other causes should be excluded before insertion. Benilexa One Handed
other diagnostic/therapeutic measures are recommended. Some studies
can also be inserted immediately after the first trimester abortion. Benilexa
New MDS One Handed is effective for eight years in the indication contraception suggest a slightly increased relative risk of breast cancer in women using
combined oral contraceptives (COC). The risk may be of similar magnitude
and has a demonstrated efficacy for 3 years for the indication heavy
menstrual bleeding. Therefore, Benilexa One Handed should be removed
for progestogen-only methods such as Benilexa but the evidence is based
or exchanged after 8 years of use, or earlier if heavy or bothersome
on much smaller population of users and so is less conclusive. Blood glucose
concentrations should be monitored in diabetic patients. Benilexa should
menstrual bleeding returns. If the user wishes to continue using the same
method, a new system can be inserted at the same time, in which case
not be used as a post-coital contraceptive. Interactions: Metabolism of
no additional protection is required. Benilexa One Handed has blue threads
and the T-frame contains barium sulphate so that it can be seen on X-rays.
of drug-metabolising enzymes, specifically cytochrome P450 enzymes. The
influence of these drugs on the contraceptive efficacy of Benilexa is not
Paediatric population: Benilexa One Handed has not been studied in progestogens may be affected by concomitant use of inducers or inhibitors
In partnership with Gedeon Richter, we are pleased patients below 16 years of age. Benilexa One Handed should not be used known but it is not believed to be of major importance due to the local
mechanism of action. Fertility, Pregnancy & Lactation: Should not be
before menarche. Consult the SmPC for full information on instruction
to announce the first discount available via PSUK to for use and handling, insertion and removal. Contraindications: Known used during an existing or suspected pregnancy. If pregnancy occurs with
or suspected pregnancy, current or recurrent pelvic inflammatory disease,
Benilexa in situ, ectopic pregnancy should be excluded, the system removed
dispensing doctors on an intrauterine system. lower genital tract infection, postpartum endometritis, infected abortion and termination of the pregnancy considered. Removal or probing of the
during the past three months, cervicitis, cervical dysplasia, suspected
uterus may result in spontaneous abortion. If removal is not possible or if
or confirmed uterine or cervical malignancy, liver tumour or other acute the woman wishes to continue the pregnancy, the pregnancy should be
or severe liver disease, congenital or acquired abnormality of the uterus monitored closely and the woman should be informed about the risks and
including fibroids if they distort the uterine cavity, undiagnosed abnormal instructed to report all symptoms suggesting complications, like cramping
abdominal pain with fever. Due to intrauterine administration and local
Net
PIP Code Product NHS Price MDS WD Total Price Profit uterine bleeding, conditions associated with increased susceptibility to exposure to hormone, the possible occurrence of virilising effects in the
infections, current or suspected hormone dependent tumours such as
breast cancer, acute malignancies affecting the blood or leukaemias except foetus should be taken into consideration. There is a risk of masculinisation
4195178 BENILEXA 52MG IUS £71.00 20% 0% 20% £56.80 £14.20 when in remission, recent trophoblastic disease while hCG levels remain of the external genitalia of the female foetus when the levonorgestrel
intra-uterine device remains during pregnancy. Levonorgestrel is excreted
elevated, hypersensitivity to the active substance or to any of the excipients.
Warnings and precautions: Before insertion, a complete personal and in very small quantities in breast milk and breast feeding can be continued
family medical history should be taken. Pulse and blood pressure should be during use. Uterine bleeding has been reported rarely during lactation.
Gedeon Richter offer product demonstrations, demonstration placebo devices and measured and a bimanual pelvic examination performed to establish the The use of levonorgestrel IUS does not alter the course of female fertility
orientation of the uterus. Re-examine six weeks after insertion and where
after the removal of the IUS. Side effects: Very common (≥ 1/10): Vaginal
support materials for both healthcare professionals and patients. Please contact clinically indicated. Use with caution after specialist consultation, or removal bacterial infections, vulvovaginal mycotic infections, acne, uterine/vaginal
of the system should be considered, if any of the following conditions exist
bleeding including spotting, oligomenorrhoea, amenorrhoea, benign
devicesupport@gedeonrichter.com to order any of these items/services. or arise for the first time during treatment: migraine, focal migraine with ovarian cysts, procedural pain, procedural bleeding. Common (≥ 1/100 to <
asymmetrical visual loss or other symptoms indicating transient cerebral 1/10): Depressive mood, nervousness, decreased libido, headache, migraine,
ischemia; unusually severe or unusually frequent headache; jaundice; presyncope, dizziness, abdominal pain/discomfort, nausea, abdominal
marked increase of blood pressure; malignancies affecting the blood distension, vomiting, back pain, pelvic pain, dysmenorrhoea, vaginal
or leukaemias in remission; use of chronic corticosteroid therapy; past discharge, vulvovaginitis, breast tenderness, breast pain, dyspareunia,
history of symptomatic functional ovarian cysts; active or previous severe uterine spasm, intrauterine contraceptive device expelled, weight increase.
arterial disease, such as stroke or myocardial infarction; severe or multiple Uncommon (≥ 1/1,000 to < 1/100): syncope, alopecia, hirsuitism, pruritus,
risk factors for arterial disease; thrombotic arterial or any current embolic eczema, chloasma/ skin hyperpigmentation, uterine perforation, pelvic
disease; acute venous thromboembolism; congenital heart disease or inflammatory disease, endometritis, cervicitis, Papanicolaou smear
valvular heart disease at risk of infective endocarditis; irregular bleedings normal, class II, ectopic pregnancy, oedema. Rare ≥ 1/10,000 to < 1/1,000:
as these may mask some symptoms and signs of endometrial polyps Hypersensitivity including rash, urticaria and angioedema, rash, urticaria.
or cancer. Women should be encouraged to stop smoking. Depression Consult SmPC for further information regarding side effects.
and depressed mood are well known undesirable effects of hormonal Legal category: POM.
contraceptives. Advise women to contact their physician in case of mood Pack size and NHS price: One Intrauterine System with the inserter device.
intrauterine changes, depressive symptoms or suicidal thoughts. Insertion/removal may Multipack containing five packs of one Intrauterine System with the inserter
One Handed delivery system be associated with some pain and bleeding and may result in fainting as device. NHS list price for one pack: £71.
a vasovagal reaction or seizure in epileptics. In cases of severe pain and
Marketing Authorization Number: PL 04854/0179.
20 micrograms/24 hours continued bleeding during or after insertion, exclude perforation of the Marketing Authorization Holder: Gedeon Richter Plc., Gyömrői út 19-21.
uterine corpus or cervix. If perforation is suspected the system should be 1103 Budapest, Hungary.
removed. Risk of perforation may be increased in post-partum insertions, Further information available from: Gedeon Richter UK Ltd, 127 Shirland
Delivery System in lactating women and in women with a fixed retroverted uterus. If pelvic Road, London W9 2EP. Tel: +44 (0) 207 604 8806. Email: medinfo.uk@
infection is suspected, appropriate antibiotics should be started. Remove gedeonrichter.eu
Benilexa, if the woman experiences recurrent endometritis, pelvic infection Date of Preparation: September 2024.
or if an acute infection is severe. Use of sanitary pads is recommended. If Job number: UK--2400292
tampons or menstrual cups are used, the woman should change them with
care so as not to pull the threads of Benilexa.
\ntrauterine use The woman should be advised on how to check the Benilexa threads and
GEDEON RICHTER to immediately see her doctor if she cannot feel the threads. If the threads Adverse events should be reported. Reporting forms and information
cannot be found, first exclude pregnancy. They may have broken off, the can be found at www.mhra.gov.uk/yellowcard or search for MHRA
system may have been expelled, or rarely the device may be extra-uterine Yellow Card in the Google Play or Apple App Store. Adverse events
after having perforated the uterus. An ultrasound should be arranged should also be reported to Women’s Health Division of Gedeon Richter
and alternative contraception should be advised in the meantime. If an
ultrasound cannot locate the device and there is no evidence of expulsion, (UK) Ltd on +44 (0) 207 604 8806 or drugsafety.uk@gedeonrichter.eu
a plain abdominal X-ray should be performed to exclude an extra-uterine
Order now or call:
online at: 01904 558 360
Adverse events should be reported. Reporting forms and information can be found 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--2400225
Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or by email to drugsafety.uk@gedeonrichter.eu October 2024
P4260.306-V3
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