ELADYNOS 80 mcg Pre-filled pen injectable solution

Зміст інструкції

1. Eladynos 80 micrograms/dose injectable solution in pre-filled pen
   1. What is Eladynos and what is it used for
   2. What you need to know before using Eladynos
   3. How to use Eladynos
   4. Possible side effects
   5. How to store Eladynos
   6. Content of the pack and other information

Eladynos 80 micrograms/dose injectable solution in pre-filled pen

abaloparatide

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced
during the use of this medicinal product. See the end of section 4 for information on how
to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Eladynos is and what it is used for
• 2. What you need to know before you use Eladynos
• 3. How to use Eladynos
• 4. Possible side effects
• 5. How to store Eladynos
• 6. Contents of the pack and other information

1. What is Eladynos and what is it used for

Eladynos contains the active substance abaloparatide, which is used to treat osteoporosis in women after
menopause.
Osteoporosis is particularly common in women after menopause. It is a disease that causes the
bones to become thin and fragile. If you suffer from osteoporosis, you are more prone to fractures,
especially in the spine, hips and wrists.
This medicine is used to make bones stronger and reduce the risk of fractures.

2. What you need to know before using Eladynos

Do not use Eladynos

• if you are allergic to abaloparatide or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding
• if there is still a possibility that you may become pregnant
• if you have high levels of calcium in your blood
• if you have severely reduced kidney function
• if you have high levels of the alkaline phosphatase enzyme of unknown origin in your blood
• if you have undergone radiation therapy involving the bones
• if you have ever been diagnosed with bone cancer or other cancers that have spread to the bones

Warnings and precautions
Talk to your doctor or pharmacist before using Eladynos, or during treatment:

• if you feel dizzy when standing up, which may be caused by a drop in blood pressure. Some patients may experience dizziness or an increased heart rate within 4 hours of injecting Eladynos. The first injection(s) must always be performed under the supervision of a healthcare professional who can monitor you for the first hour after the injection. Always inject Eladynos in a place where you can sit or lie down immediately if you feel dizzy;
• if you have heart disease or if you suffer from high blood pressure. Your doctor may decide to monitor you more closely;
• if you continuously experience nausea, vomiting, constipation, low energy or muscle weakness. These may be signs that there is too much calcium in your blood;
• if you have high levels of calcium in your urine, if you suffer from kidney stones or if you have had kidney stones in the past. Eladynos may worsen your condition.

Before starting treatment with Eladynos, your blood pressure and your heart condition will be examined.
The recommended treatment period of 18 months should not be exceeded.

Children and adolescents
Eladynos should not be used in children and adolescents under 18 years of age.

Other medicines and Eladynos
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist if you are taking:

• digoxin or digitalis, medicines used to treat heart failure, because calcium levels in the blood may increase with the use of abaloparatide
• medicines used to control high blood pressure, because they may worsen the symptoms of low blood pressure, including dizziness Pregnancy and breastfeedingDo not use Eladynos if you are a woman of childbearing potential or are pregnant, or if you are breastfeeding.

Driving and using machines
Some patients may experience dizziness after the injection of the medicine. If you feel dizzy,
do not drive and do not use machines until you feel better.

Eladynos contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to use Eladynos

Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is an injection(80 micrograms) once a dayunder the skin, in the lower
part of the abdomen (stomach). See the grey area in the first figure at step 5 of the
To help you remember to take the medicine, it is preferable to inject Eladynos every day at the
same time.
Do not inject Eladynos in the same area of the abdomen on consecutive days. Alternate the injection site
of the medicine every day to reduce the risk of reactions at the injection site. Inject only
on clean skin. Do not inject in areas where the skin is painful, bruised, red, scaly or
hardened. Avoid areas where there are scars or stretch marks.
Your doctor may advise you to take a calcium and vitamin D supplement. Your doctor will tell you the
amount to take each day.

Duration of use
Inject Eladynos every day for the entire period of time prescribed by your doctor. The maximum total duration
of treatment with Eladynos should not exceed 18 months.

If you use more Eladynos than you should
If you accidentally use more Eladynos than you should, contact your doctor or pharmacist. Possible expected
effects of an overdose include nausea, vomiting, dizziness (especially when getting up quickly),
fast heartbeat and headache.

If you forget to use Eladynos
If you forget a dose, take it as soon as possible within 12 hours of when you usually take it.
Then, inject the next dose at the usual time the following day.
If more than 12 hours have passed since you should have used Eladynos, skip the forgotten dose.
Then, inject the next dose as usual, on the next scheduled day. Do not use a double dose to make up for a
missed dose. Do not have more than one injection in the
same day.

If you stop using Eladynos
Do not stop treatment without first talking to your doctor. Your doctor will advise you and
decide how long you should be treated with Eladynos.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop treatment with Eladynos and contact your doctor immediately or go to the emergency room if you experience the following symptoms (severe allergic reaction):
swelling of the face or tongue, wheezing and difficulty breathing, hives, itching and redness of the
skin, severe vomiting or diarrhea, dizziness or loss of consciousness (frequency not known). These symptoms
can be serious and potentially life-threatening.
Other side effects may occur with the following frequencies:

Very common(may affect more than 1 in 10 people)

• increased calcium level observed in urine tests
• dizziness, see section 2 “Warnings and precautions”

Common(may affect up to 1 in 10 people)

• increased calcium level observed in blood tests
• increased uric acid level observed in blood tests
• headache
• palpitations, increased heart rate
• increased blood pressure
• abdominal pain
• constipation, diarrhea
• nausea, vomiting
• weakness, fatigue, feeling unwell
• reactions at the injection site, such as bruising, rash and pain
• bone, joint, hand, foot or back pain
• muscle spasms (in the back and legs)
• difficulty sleeping
• kidney stones
• itching, rash

Uncommon(may affect up to 1 in 100 people)

• allergic reactions
• feeling of swelling
• pain
• feeling dizzy or lightheaded when standing up or sitting down due to a drop in blood pressure

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Eladynos

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the pen after Exp.
The expiry date refers to the last day of that month.
Before use, store in a refrigerator (2 °C-8 °C). Do not freeze. Avoid placing the pens near the
freezer compartment in the refrigerator to prevent freezing. Do not use Eladynos if it is or has been
frozen.
After first use, store at a temperature below 25 °C and dispose of after 30 days.
Eladynos can only be stored at room temperature (below 25 °C) for 30 days.
Note the date of day 1 in the appropriate space on the pack. Day 1 indicates the date of first use
or the date the pen was removed from the refrigerator. This ensures that you do not use the pen for
more than 30 consecutive days or store it for more than 30 days. After 30 days, the pen must be
disposed of in accordance with local regulations, even if it still contains unused medicine.

• Throw away the old pen before opening a new Eladynos pen, to avoid any confusion.
• Do not store the pen with a needle inserted.
• Do not use this medicine if the solution appears cloudy, discoloured, or if it contains particles.

Do not dispose of any medicines or needles in the drain or in household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Eladynos contains

• The active substance is abaloparatide. Each dose of 40 microlitres contains 80 micrograms of abaloparatide. Each pre-filled pen contains 3 mg of abaloparatide in 1.5 mL of solution (corresponding to 2 milligrams per mL).
• The other ingredients are:
• phenol
• water for injections
• sodium acetate trihydrate (see section 2 “Eladynos contains sodium”) and acetic acid (both for pH adjustment)

Description of Eladynos and content of the pack
Eladynos is a clear and colourless injectable solution (injectable). It is supplied in a box
containing one or three multi-dose pre-filled pens, each with 30 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

Manufacturer
Theramex Poland Sp. z o. o.
Amsterdam Building,
ul. Poleczki 35,
02-822 Warszawa
Poland

Other source of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.

Instructions for use
Do not inject Eladynos until your doctor, nurse or pharmacist has shown you, or has shown your caregiver, how to use the Eladynos pen.
these instructions for use contained in the Eladynos pack. Follow the instructions carefully each time
you use the Eladynos pen.
If you have any doubts about using the Eladynos pen, contact your doctor, nurse or pharmacist.

Important information before using the Eladynos pen

• Do not share needles with other people: there is a risk of serious infections being transmitted. Never share your Eladynos pen, even if the needle has been changed.
• Always use a new needle for each injection. Materials needed for each injection with the Eladynos pen
• 1 needle Needles are not included with the Eladynos pen. Suitable needles for use with the Eladynos pen are 8 mm, 31 G.
• 1 alcohol swab
• 1 cotton ball or gauze
• 1 sharps container for disposing of needles and Eladynos pens.

Components of the Eladynos pen

Green injection button
Pen
cap
Medicine
cartridge holder
Dose
knob
Dose
display window
Lot / Exp.
Piston Seal
Medicine cartridge

Components of the needle (not included with the pen) to be used with the pen

Protective
paper
Needle
Needle cap Internal needle
protection
Needle hub

How to inject Eladynos
Step 1Checking the Eladynos pen
Wash your hands.

Check the pen labelto make sure it is the correct medicine.

Check the expiry date (Exp.)on the pen to make sure it has not passed.

Note the date of day 1 to make sure you do not use the pen for more than 30 consecutive days.
Remove the cap from the pen.

Check that the pen and medicine cartridge are not damaged.
The liquid should be clear, colourless and free of particles. If not, it should not be
used.
It is normal for small air bubbles to be present in the liquid.

Step 2 Attaching the needle to the Eladynos pen
Remove the protective paper from a new needle.

Insert the needle, still with the needle cap on, straight onto the pen, and screw it on until it is
tightly fixed. Make sure the needle is straight, so it does not bend when inserted. The
pen will not work if the needle is not correctly inserted. Do not overtighten; this could
make it difficult to remove the needle.
If the needle bends, refer to “Troubleshooting” later.

Pull off the needle capand keep it for re-use after the injection.

Carefully pull off the internal needle protectionand discard it.

Step 3Only on day 1 – Checking the Eladynos pen before the first injection
The pen contains medicine for 30 days, plus a small amount to test each pen once to confirm it is
working correctly.
Caution: if you test the pen before each injection, the medicine in the pen will run out sooner than
expected. Therefore, step 3 should only be carried out on day 1, before the first
injection with each pen.
From day 2 to day 30, the pen should not be tested again. Go straight to
step 4 to set the dose for the injection.
Holding the pen as shown, turn the dose setting knob on the pen forward until it stops.
In the dose display window you will see “•80”.

Hold the pen with the needle pointing upwards.
Press the green injection button all the way down.
You should see one or more drops of liquid coming out of the tip of the needle.

The dose display window should show “●0”.
Note: if no liquid comes out of the tip of the needle, refer to “Troubleshooting”.

Step 4Setting the dose on the Eladynos pen
Turn the white knob on the pen forward until it stops, and until the display window shows “●80”. The pen is now ready for injection.

Note: if you cannot set the pen to “●80”, refer to “Troubleshooting” later.

Step 5 Choosing and cleaning the injection site
The injection should be given in the lower abdomen, as indicated by the grey area, avoiding the area within 5 cm around the navel.

Choose a different injection site on the abdomen each day. Inject only into clean skin.
Do not inject into areas where the skin is sore, bruised, red, scaly or hardened.
Avoid areas where there are scars or stretch marks.
Clean the injection site with an alcohol swab and let it dry.
Do not touch, blow or puff on the injection site after cleaning it.

Note: your doctor, nurse or pharmacist may advise you to pinch up a fold of skin
at the injection site.
After inserting the needle, you can release the skin.

Step 6Giving the injection with the Eladynos pen
Insert the needle perpendicularly into the skin.

Press and HOLD the green buttonuntil ALLof the following steps are completed

• “●0” is displayed
• hold for 10 seconds to deliver the full dose
• lift the pen from the skin and THEN release the button.

Do not press the green button unless a needle is inserted.

Note: do not move the pen after insertion. If the green injection button cannot be
pressed all the way down, or if it stops before “●0” is shown, refer to
“Troubleshooting” later.
Slowly remove the pen from the injection site, pulling the needle out straight.
It is normal for there to be slight bleeding. Do not rub the injection site. If there is
slight bleeding, press a cotton ball or gauze onto the injection site, if needed. You can also cover the area with a small plaster.

Step 7Removing the needle from the pen
Caution: to avoid needle stick injuries, follow this step carefully.
Carefully put the needle cap back on the needle. Then, press gently on
the needle cap to snap it on and lock it in place.

After putting the cap back on, unscrew the needle.To unscrew the needle, grip the cap at the
base, towards the needle, and turn it at least 8 times, before gently pulling to remove the needle
with the cap.
Note: do not press on the needle cap while unscrewing the needle.

Note: the distance between the needle cap and the pen should increase as you unscrew the needle.

Step 8After the injection
Firmly replace the capon the Eladynos pen.
Between injections, keep the cap on the Eladynos pen.

Troubleshooting
What should I do if the needle is bent?

• Carefully remove the bent needle, and attach a new needle to the pen following step 2. The pen needle consists of a visible part that enters the skin and a hidden part that enters the pen seal.
• Examine the components of the pen needle, paying particular attention to the hidden part of the needle. Even if the visible part of the needle appears straight, the internal part may bend when the needle is attached to the pen.

Make sure to keep the entire needle straight when attaching it to the pen, to avoid bending the internal part of the needle.

What should I do if no liquid comes out of the tip of the needle when checking the pen
on day 1?

• If no liquid comes out of the needle, the pen is not primed. The needle may be blocked, bent or not correctly attached.
• Attach a new needle to the pen following step 2, then repeat step 3 “Checking the Eladynos pen before the first injection”.
• If you still do not see a drop of liquid, contact your pharmacist, doctor or nurse.

What should I do if I cannot turn the white dose knob to set “●80” on the
Eladynos pen?

• The pen does not contain enough medicine to deliver a full dose. You will need to get a new pen.

What should I do if the green injection button is difficult to press?

• If the green injection button cannot be pressed all the way down, or if it stops before the dose display window shows “●0”, the pen priming is not complete. The needle may be blocked or not correctly attached.
• Attach a new needle to the pen following step 2.
• If the green injection button still cannot be pressed all the way down, or continues to stop before the dose display window shows “●0”, contact your pharmacist, doctor or nurse.