BENILEXA ONE HANDED

Benilexa One Handed is effective for eight years in the indication contraception and has a demonstrated efficacy for three years for the indication heavy menstrual bleeding. Therefore, Benilexa One Handed should be removed or exchanged after 8 years of use, or earlier if heavy or bothersome 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 no additional protection is required. Starting treatment In women of fertile age, Benilexa One Handed is inserted into the uterine cavity within seven days of the onset of menstruation.

It can be replaced by a new system at any time of the cycle.

Post-partum insertion:

To reduce the risk of perforation, postpartum insertions should be postponed until the uterus is fully involuted. Do not insert earlier than six weeks after delivery. If the patient is experiencing significant postpartum bleeding and/or pain then infection or other causes should be excluded before insertion.

Benilexa One Handed can also be inserted immediately after the first trimester abortion. Paediatric population Benilexa One Handed has not been studied in patients below 16 years of age. Benilexa One Handed should not be used before menarche.

3). Instructions for use and handling Benilexa One Handed is supplied in a sterile pack which should not be opened until required for insertion. The exposed product should be handled with aseptic precautions. 6 for disposal instructions).

How to insert Benilexa One Handed It is strongly recommended that Benilexa One Handed should only be inserted by physicians/health care professionals who are experienced in levonorgestrel IUS insertions and/or have undergone sufficient training for levonorgestrel IUS insertion.

In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, please refer to section

Undesirable effects are more common during the first months after the insertion, and subside during prolonged use. 1) and benign ovarian cysts. The frequency of benign ovarian cysts depends on the diagnostic method used, and in clinical trials enlarged follicles have been diagnosed in 12% of the subjects using a levonorgestrel IUS.

Most of the follicles are asymptomatic and disappear within three months. The table 2. below reports adverse reactions by MedDRA system organ class (MedDRA SOCs). The frequencies are based on clinical trial data. 4). In clinical trials with levonorgestrel IUS that excluded breastfeeding women the frequency of perforation was "rare".

4). Pregnancy, puerperium and perinatal conditions When a woman becomes pregnant with Benilexa One Handed in situ, the relative risk of ectopic pregnancy is increased (see ‘Special warnings and precautions for use’ and ‘Fertility, pregnancy and lactation’).

4). 4). The procedure may also precipitate a seizure in patients with epilepsy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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4. Benilexa One Handed is supplied sterile having been sterilised with ethylene oxide. Do not resterilise. For single use only. Do not use if the inner package is damaged or open. Insert before the last day of the month shown on the label.

Benilexa One Handed (figure 1a) is provided in a tray sealed with a peel-off lid, and is inserted with the provided inserter (figure 1b) into the uterine cavity by carefully following the insertion instructions. The following insertion instruction will be provided in the box containing the IUS.

Please read the following instructions for use carefully as there may be some difference in the type of inserter device compared with other intrauterine devices (IUDs) you have used previously.

Description Figure 1a:

Benilexa One Handed Intrauterine Contraceptive System (IUS) Figure 1b: Benilexa One Handed IUS with inserter T-shaped plastic frame Hormone reservoir with membrane Blue removal threads Benilexa One Handed IUS Insertion tube Flange BLUE slider GREEN slider Handle Cleft Threads Figure 2: Inserter sliders Conditions for use 1.

In women of fertile age, Benilexa One Handed is inserted within seven days of the onset of menstruation. It can be replaced by a new system at any time of the cycle. 2. It is strongly recommended that Benilexa One Handed should only be inserted by physicians/health care professionals who have undergone sufficient training and have read carefully these instructions before Benilexa One Handed insertion.

3. Benilexa One Handed is supplied in a sterile pack which should not be opened until required for insertion. The exposed product should be handled with aseptic precautions. Do not use if the inner package is damaged or open. 4. Determine the position (anteversion, retroversion) and size of the uterus by a gynaecological examination.

Exclude pregnancy and contraindications. 5. Place a speculum, use appropriate antiseptic solution to clean the vagina and cervix. 6. Use cervical dilators if cervical stenosis is diagnosed. Do not force to overcome resistance. If cervical dilatation is required, consider using analgesics and/or a paracervical block.

7. Grasp the cervix with a Tenaculum forceps and apply a gentle traction in order to straighten alignment of the cervical canal and uterine cavity. 8. Determine the uterine depth by hysterometry. 5 cm discontinue the procedure.

Preparation for insertion Step 1:

Opening the sterile Benilexa One Handed packaging - Remove the sealed tray containing Benilexa One Handed from the box. - Inspect the sealed tray and do not use the product if the packaging, inserter or IUS is damaged. - Lay the tray on a flat surface with the peel-off lid side up.

• Benilexa One Handed is packaged partially preloaded within the inserter. The threads are passed through the insertion tube, and exit through an opening in the handle at the cleft. • The handle of the inserter contains a BLUE slider labelled with the number 1 and a GREEN slider labelled with the number 2, and the handle is labelled with the number 3 to assist with the insertion process.

• Moving the sliders achieves the positions required to complete the insertion process. - Remove peel-off lid.

Step 2:

Removing inserter from tray (Figure 3) Figure 3 Step 3: Sliders completely forward for loading Benilexa One Handed (Figure 4) Figure 4 Maintain forward pressure on the BLUE slider • To remove the inserter from the tray, grasp the handle below the sliders and twist gently (Figure 3).

NOTE:

Do not attempt to remove the inserter by pulling on the tube. • The BLUE slider (labelled with the number 1) has a single line marking that will align with the handle’s single line marking. • The GREEN slider (labelled with the number 2) has a double line marking that will align with the handle’s double line marking.

• Grip the handle keeping your thumb or finger in the groove of the BLUE slider (over the numeral 1) and apply forward pressure while ensuring both sliders are fully forward.

Step 4:

Load Benilexa One Handed into the inserter - Ensure the arms of the IUS are horizontal (aligned to the horizontal plane of the handle and flange); adjust the rotation of the IUS as needed using the flat sterile surface of the tray.

- While maintaining forward pressure on the blue slider, gently pull the threads straight back to load Benilexa One Handed into the insertion tube. Ensure even tension is applied to both threads when pulling. Pull the threads upward or downward to lock the threads into the cleft at the bottom end of the handle (Figure 5); you must lock the threads in the cleft to prevent the IUS from moving out of the top of the insertion tube.

Once the threads are locked in the cleft, stop holding the threads.

Figure 5:

Locking the threads in cleft - After the IUS is loaded, continue to sustain forward pressure on the BLUE slider to maintain a hemispherical dome with the tips of the IUS. - When correctly loaded, the IUS is completely within the insertion tube with the tips of the arms forming a hemispherical dome at the top of the tube (Figure 6, Zoom 1).

Figure 6:

Position of the IUS in the insertion tube Zoom 1 The knobs of the lateral arms must be closely opposed to each other, slightly above the upper extremity of the insertion tube (Zoom 1).

Zoom 2 Step 5:

Adjusting the flange (Figure 7) Figure 7 Tray notch • If the IUS is not correctly loaded (Zoom 2), do not attempt insertion. • To re-load Benilexa One Handed: - Pull the BLUE slider back with your thumb until the groove becomes aligned with the GREEN slider to release the IUS.

- Manually pull the threads out of the cleft. - Return the BLUE slider to the forward position and repeat the loading steps. • Adjust the flange to the measured uterine depth based on sounding. To adjust, place the flat side of the flange in the tray notch (Figure 7) or against a sterile edge inside of the tray.

Slide the insertion tube as necessary to move the flange to the correct measurement. Ensure the flat […]

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