Eladynos 80 microgramos/dosis solucion inyectable en pluma precargada

Leaflet: information for the user

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

abaloparatida

This medicine is subject to additional monitoring, which will speed up the detection of any new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Eladynos contains the active ingredient abaloparatide. It is used to treat osteoporosis in women after menopause.

Osteoporosis is especially common in women after menopause. This disease causes thinning and fragility of the bones. If you have osteoporosis, you are more likely to suffer bone fractures, especially in the spine, hips, and wrists.

This medication is used to strengthen bones and reduce the likelihood of them breaking.

Do not use Eladynos if

• you are allergic to abaloparatide or any of the other components of this medication (listed in section 6)
• you are pregnant or breastfeeding
• you may become pregnant
• you have high levels of calcium in your blood
• your kidney function is significantly reduced
• you have high levels of the alkaline phosphatase enzyme in your blood without apparent cause
• you have received radiation therapy to your bones
• you have been diagnosed with any type of bone cancer or other cancers that have spread to your bones

Warnings and precautions

Consult your doctor or pharmacist before starting to use Eladynos or during its use if:

• you experience dizziness when standing up, which may be due to a drop in blood pressure. Some patients may experience dizziness or a rapid heartbeat within 4 hours after the injection of Eladynos. The first injection(s) should be administered under the guidance of a healthcare professional, who may keep you under observation for the first hour after the injection. Always inject Eladynos in a place where you can sit or lie down if you feel dizzy.
• you have a heart condition or high blood pressure. Your doctor may want to monitor you more closely.
• you experience continuous nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs of high levels of calcium in your blood.
• you have high levels of calcium in your urine, or you have or have had kidney stones. Eladynos may worsen your condition.

Before starting treatment with Eladynos, blood pressure and heart function tests will be performed.

Do not exceed the recommended treatment time of 18 months.

Children and adolescents

Abaloparatide should not be used in children and adolescents under 18 years old.

Other medications and Eladynos

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking:

• digoxin or digitalis: medications used to treat heart weakness, as calcium levels in the blood may increase with the use of abaloparatide;
• medications to control high blood pressure, as they may worsen symptoms of low blood pressure, such as dizziness.

Pregnancy and breastfeeding

Do not use Eladynos if you are pregnant, may become pregnant, or are breastfeeding.

Driving and operating machines

Some patients may experience dizziness after the injection of this medication. If you feel dizzy, do not drive or operate machines until you feel better.

Eladynos contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose isone injection (80 µg)once a dayunder the skin in the lower abdominal region (belly). See the shaded area in gray in the first figure in step 5 of the "Usage Instructions" section at the end of the prospectus.

It is preferable to inject Eladynos at the same time every day to help you remember to use the medication.

Do not inject Eladynos in the same place on the abdomen on consecutive days. Change the injection site of this medication every day to reduce the risk of reactions at the injection site. Administer the injection only on normal skin. Do not administer the injection in areas where the skin is painful to the touch, has a hematoma, or is red, scaly, or hardened. Avoid areas with scars or stretch marks.

Follow carefully the«Usage Instructions»at the end of the prospectus.

Your doctor may advise you to take calcium and vitamin D supplements. Your doctor will indicate how much you should take per day.

Duration of use

Inject Eladynos daily for the period indicated 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, inform your doctor or pharmacist. The effects that could be expected from an overdose include, among others, nausea, vomiting, dizziness (especially when getting up quickly), rapid heart rate, and headache.

If you forgot to use Eladynos

If you forgot a dose, administer it as soon as possible within 12 hours of the scheduled time. Then, inject the next dose the following day at the usual time.

If more than 12 hours have passed since the time you should have used Eladynos, omit the missed dose. Then, inject the next dose the following day at the usual scheduled time.

Do not use a double dose to compensate for the missed doses. Do not use more than one injection on the same day.

If you interrupt treatment with Eladynos

Consult your doctor before interrupting treatment. Your doctor will advise you and decide for how long you should receive treatment with Eladynos.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop treatment with Eladynos and contact your doctor immediately or seek emergency care if you experience the following symptoms (severe allergic reaction):

Swelling of the face or tongue, wheezing and difficulty breathing, hives, itching, and red skin, intense vomiting or diarrhea, and dizziness or loss of consciousness (unknown frequency). These symptoms can be severe 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 levels in urine tests
• Dizziness; see section 2 "Warnings and precautions"

Common(may affect up to 1 in 10 people)

• Increased calcium levels in blood tests
• Increased uric acid levels in blood tests
• Headache
• Palpitations, rapid heartbeat
• Increased blood pressure
• Abdominal pain
• Constipation, diarrhea
• Nausea, vomiting
• Weakness, fatigue, discomfort
• Reactions at the injection site, such as hematoma formation, skin rash, and pain
• Pain in bones, joints, hands, feet, or back
• Muscle spasms (in the back and legs)
• Difficulty sleeping
• Kidney stones
• Itching, skin rash

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions
• Sensation of abdominal distension
• Pain
• Sensation of dizziness or lightheadedness when standing or sitting due to a drop in blood pressure

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the pen after CAD. The expiration date is the last day of the month indicated.

Before first use, store in the refrigerator (between 2 °C and 8 °C). Do not freeze. Avoid placing the pens near the freezer compartment of the refrigerator to prevent them from freezing. Do not use Eladynos if it is or has been frozen.

After first use, store below 25 °C and discard after 30 days.

Eladynos must only be stored at room temperature (below 25 °C) for 30 days. Note the date of day 1 in the space provided on the box. Day 1 is the date of the first use or the date the pen was removed from the refrigerator. The purpose is to ensure that you do not use the pen for more than 30 consecutive days or store the pen for more than 30 days. After 30 days, dispose of the pen in accordance with local requirements, even if it still contains unused medication.

• Dispose of the used pen before opening a new Eladynos pen to avoid possible confusion.
• Do not store the pen with the needle attached.
• Do not use this medication if the solution is cloudy, has a color, or contains visible particles.

Medicines and needles should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Eladynos

• The active principle is abaloparatide.

Each dose of 40 microliters contains 80 micrograms of abaloparatide.

Each pre-filled pen contains 3 mg of abaloparatide in 1.5 ml of solution (which is equivalent to 2 mg per milliliter).

• The other components are:

• phenol
• water for injection
• sodium acetate trihydrate (see section 2 "Eladynos contains sodium") and acetic acid (both for pH adjustment)

Appearance of the product and contents of the pack

Eladynos is a colourless and transparent injectable solution. It is supplied in a carton box containing a multi-dose pre-filled pen with 30 doses.

Marketing authorisation holder and responsible person

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturing

Cilatus Manufacturing Services Ltd

Pembroke House, 28-32 Pembroke Street

Dublin, D02 EK84, Ireland

Last update date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu/.

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Instructions for use

Do not inject Eladynos until you or your carer have received training from a doctor, nurse or pharmacist on how to use the Eladynos pen.

DO NOT start the administration procedure until you have read this leaflet and the instructions for use that are included in the Eladynos pack. Follow the instructions carefully every time you use the Eladynos pen.

Consult your doctor, nurse or pharmacist if you have any doubts about the use of the Eladynos pen.

Important information before using the Eladynos pen

• Do not share needles with other people. They may transmit a serious infection. Do not share the Eladynos pen, even if you have changed the needle.
• 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. The correct needles to use with the Eladynos pen are 8 mm needles and 31 gauge.

• 1 alcohol wipe
• 1 cotton ball or 1 gauze
• 1 sharps container for disposal of needles and Eladynos pens. See section 5 of the leaflet for information on disposal.

Components of the Eladynos pen

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

How to inject Eladynos

Troubleshooting

What should I do if the needle bends?

• Remove the bent needle carefully and follow step 2 to attach a new needle to the pen. The needle on the pen has a visible part that enters the skin and an internal part that enters the membrane of the pen.
• Examine the parts of the needle on the pen, paying particular attention to the internal part of the needle. The visible part of the needle may appear straight, but the internal part of the needle may bend when attaching the needle 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 needle tip when testing the pen on day 1?

• If you do not see liquid coming out of the needle tip, the pen preparation has not been completed. The needle may be blocked, bent, or attached incorrectly.
• Follow step 2 to attach a new needle to the pen and repeat step 3 "Checking the Eladynos pen before the first injection".
• If you still do not see a drop of liquid, contact your pharmacist, nurse, or doctor.

What should I do if I cannot turn the white dose dial to adjust the Eladynos pen to «?80»?

• There is not enough medicine in the pen to administer a full dose. You will need a new pen.

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

• If you cannot press the green injection button or it stops before «?0» appears in the dose indicator window, the pen test has not been completed. The needle may be blocked or attached incorrectly.
• Follow step 2 to attach a new needle to the pen.
• If you still cannot press the green injection button or it stops before «?0» appears in the dose indicator window, contact your pharmacist, nurse, or doctor.