Sondelbay 20 micrograms/80 microliters solution for injection in pre-filled pen

Spain
Brand name Sondelbay 20 micrograms/80 microliters solution for injection in pre-filled pen
Form solution for injection in pre-filled pen
Active substance / Dosage
TERIPARATIDE · 0,25 mg
Prescription type Prescription Only Medicine
ATC code
H05A H05AA H05AA02
Registration number 1221628001
Manufacturer Accord Healthcare S.L.U.
Sondelbay 20 micrograms/80 microliters solution for injection in pre-filled pen solution for injection in pre-filled pen

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sondelbay 20 micrograms/80 microliters injectable solution in a pre-filled pen

teriparatide

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read the entire leaflet carefully before you start using this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Sondelbay is and what it is used for

Sondelbay contains the active substance teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.

Sondelbay is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes your bones to weaken and become fragile. This condition is particularly common in women after menopause, but can also occur in men. Osteoporosis is also common in patients being treated with corticosteroids.

2. What you need to know before you start using Sondelbay

Your healthcare professional will show you how to use the Sondelbay pen.

Do not use Sondelbay

  • if you are allergic to teriparatide or to any of the other ingredients of this medicine (listed in section 6).
  • if you have high levels of calcium (pre-existing hypercalcemia).
  • if you have severe kidney problems.
  • if you have ever been diagnosed with bone cancer or other types of cancer that have spread (metastasized) to your bones.
  • if you have certain bone diseases. If you have a bone disease, consult your doctor. If you have elevated levels of alkaline phosphatase in your blood without apparent reason, this could indicate that you have Paget's disease of the bone (a disorder involving abnormal bone changes). If you are unsure, consult your doctor.
  • if you have received radiation therapy that may have affected your bones.
  • if you are pregnant or breastfeeding.

Warnings and precautions

Sondelbay may cause an increase in the level of calcium in your blood or urine.

Consult your doctor or pharmacist before starting or while using Sondelbay:

  • if you continuously experience nausea, vomiting, constipation, low energy, or muscle weakness, inform your doctor. These may be symptoms of having too much calcium in your blood.
  • if you have kidney stones or a history of kidney stones.
  • if you have kidney problems (moderate renal insufficiency), you must inform your doctor.

Some patients may experience dizziness or increased heart rate after the first doses. For the initial doses, use Sondelbay in a place where you can sit or lie down immediately if you feel dizzy.

The recommended treatment duration of 24 months must not be exceeded. Sondelbay must not be used in growing adults.

Children and adolescents

Sondelbay must not be used in children and adolescents (under 18 years of age).

Other medicines and Sondelbay

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, because interactions may occasionally occur (e.g. digoxin/digitalis glycosides, a medicine used to treat heart conditions).

Pregnancy and breastfeeding

Do not use Sondelbay if you are pregnant or breastfeeding. If you are a woman of childbearing age, you must use effective contraceptive methods during treatment with Sondelbay. If you become pregnant, treatment with Sondelbay must be discontinued. Consult your doctor or pharmacist before using this medicine.

Driving and use of machines

Some patients may experience dizziness after receiving Sondelbay injection. If you feel dizzy, you must not drive or operate machinery until you feel better.

Sondelbay contains sodium

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

3. How to use Sondelbay

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms (in 80 microliters) administered once daily by subcutaneous injection (injection under the skin) in the thigh or abdomen. To help you remember to take your medicine, inject it at approximately the same time each day.

Inject Sondelbay every day for as long as your doctor prescribes it. The total duration of treatment with Sondelbay must not exceed 24 months. You must not receive more than one 24-month treatment cycle with Sondelbay during your lifetime.

Refer to the instructions for use on how to use the Sondelbay pen.

Needles are not included with the pen. Pen needles (31G or 32G; 4 mm, 5 mm, or 8 mm) may be used.

The Sondelbay injection should be performed shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. A new needle must be used for each injection and discarded after each use. Do not store the pen with the needle attached. Never share your Sondelbay pen with others.

Your doctor may recommend that you take calcium and vitamin D with Sondelbay. Your doctor will tell you how much you should take each day.

Sondelbay may be used with or without food.

If you use more Sondelbay than you should

If more Sondelbay has been administered by mistake than prescribed, consult your doctor or pharmacist.

The effects that could be expected from an overdose include nausea, vomiting, dizziness, and headache.

If you forget or are unable to inject Sondelbay at the usual time, do so as soon as possible on the same day. Do not administer a double dose to make up for missed doses. Do not inject more than once on the same day. Do not attempt to make up for a missed dose.

If you interrupt treatment with Sondelbay

If you are considering stopping treatment with Sondelbay, please consult your doctor. Your doctor will advise you and decide for how long you should continue treatment with Sondelbay.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most common adverse effects are limb pain (very common, may affect more than 1 in 10 patients), malaise, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If you do not improve, consult your doctor before continuing treatment. Cases of fainting associated with the use of teriparatide have been reported.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising, or slight bleeding around the injection site (common), these should disappear within a few days or weeks. If they do not, inform your doctor as soon as possible.

Some patients may have experienced allergic reactions immediately after injection, consisting of difficulty breathing, facial swelling, skin rash, and chest pain (rare frequency). On rare occasions, severe and potentially life-threatening allergic reactions may occur, including anaphylaxis.

Other adverse effects include:

Common: may affect up to 1 in 10 patients

  • increased blood cholesterol levels
  • depression
  • leg nerve pain
  • feeling faint
  • irregular palpitations
  • difficulty breathing
  • increased sweating
  • muscle cramps
  • loss of energy
  • fatigue
  • chest pain
  • low blood pressure
  • acid indigestion (pain or burning sensation just below the sternum)
  • vomiting
  • hernia of the tube carrying food to your stomach (hiatal hernia)
  • low hemoglobin or low red blood cell count (anemia)

Uncommon: may affect up to 1 in 100 patients

  • increased heart rate
  • abnormal heart sounds
  • shortness of breath
  • hemorrhoids
  • accidental leakage or loss of urine
  • increased need to urinate
  • weight gain
  • kidney stones
  • muscle and joint pain. Some patients have experienced severe back cramps or pain and required hospitalization.
  • increased blood calcium levels
  • increased blood uric acid levels
  • increase in levels of an enzyme called alkaline phosphatase

Rare: may affect up to 1 in 1,000 patients

  • reduced kidney function, including renal failure
  • swelling, mainly in the hands, feet, and legs.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Sondelbay

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

Do not use this medicine after the expiry date stated on the pack and pen, indicated as CAD and EXP respectively. The expiry date refers to the last day of the month indicated.

Sondelbay must always be stored in a refrigerator (between 2 °C and 8 °C). Once opened, Sondelbay may be stored at temperatures up to 25 °C for a maximum of three days when refrigeration is not available. After this period, the medicine must be returned to a refrigerator and used within 28 days from the first injection. The Sondelbay pen must be discarded if it has been kept outside the refrigerator at temperatures up to 25 °C for more than three days.

Do not freeze Sondelbay. Avoid placing pens near the freezer compartment of the refrigerator to prevent freezing. Do not use Sondelbay if it has been frozen or shows signs of having been frozen.

Store in the original packaging (the outer cardboard box) to protect from light.

Each pen must be properly discarded after 28 days, even if it is not completely empty.

Sondelbay contains a clear, colourless solution. Do not use Sondelbay if it contains solid particles, or if the solution is cloudy or discoloured.

Never transfer the medicine into a syringe.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the container and other information

  • The active substance is teriparatide. Each millilitre of injectable solution contains 250 micrograms of teriparatide. Each 80 microlitre dose contains 20 micrograms of teriparatide. A 2.4 ml pre-filled pen contains 600 micrograms of teriparatide.
  • The other components are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections. Additionally, a solution of hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH (see section 2 “Sondelbay contains sodium”).

Appearance of the product and contents of the container

Sondelbay is a clear, colourless solution. It is supplied in a cartridge contained within a pre-filled, single-use pen. Each pre-filled pen contains 2.4 ml of solution, sufficient for 28 doses. Sondelbay is available in pack sizes containing one or three pre-filled pens. Some pack sizes may not be available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Centre,

Moll de Barcelona s/n, Edifici Est, 6th Floor,

08039, Barcelona, Spain

Manufacturer Responsible

Accord Healthcare BV,

Netherlands Winthontlaan 200,

Utrecht, 3526KV, Netherlands

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50,

95-200 Pabianice, Poland

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/

User Manual for the Pen

Sondelbay 20 micrograms/80 microliters injectable solution in a prefilled pen
Teriparatide

Instructions for Use

Before using your new pen, please read both sides of these Instructions for Use in their entirety. On the reverse side, you will find information on problem detection and troubleshooting, as well as additional data.

Follow these instructions carefully each time you use the Sondelbay pen. Also read the package leaflet provided in the packaging, which contains information for the patient.

Do not share the Sondelbay pen or its needles with third parties, as this may pose a risk of transmitting infections or other conditions.

Your pen contains medication for 28 days.

Dispose of the Sondelbay pen 28 days after the first injection, even if the cartridge is not completely empty.

Do not inject more than one dose of Sondelbay in the same day.

Parts of the Sondelbay pen

Diagram of an injection pen with labels indicating cap, injection button, cartridge, dose window, and dose counter

Needles are not included

Two white rounded-corner boxes display the numbers 28 and 26 with black arrows indicating direction towards the numbers

Technical diagram of a needle with cap and safety shield

Check the dose counter window

to determine the number of doses remaining. The arrow indicates the number of doses left. A new pen should contain 28 doses.

The black dots appearing in the dose counter window indicate the

remaining odd dose numbers in the

Must be used with pen needles (31G or 32G; 4mm, 5mm, or 8mm).

Ask your pharmacist for the appropriate needle gauge and length for you.

Use a new needle for each injection.

pen.

Do not use the pen if the counter displays '00' as this means no doses remain.

The Sondelbay pen does not require priming.

1

Preparation

Diagram of a person's torso and legs with three gray areas indicating injection sites

Prepare the injection site (thigh or abdomen) as instructed by your doctor or pharmacist.

  • Always wash your hands before each injection.
  • Check the pen label to make sure it is the correct medication.
  • Verify the expiration date to ensure the product has not expired.
  • Check the dose counter window to confirm that doses remain in the pen.

A new pen should contain 28 doses.

Two hands separate a white medical device into two parts using a pulling motion indicated by a black arrow pointing to the right

Remove the pen cap.

  • Check that the pen and cartridge are not damaged.
  • Verify that the medication is clear, colorless, and free of particles.

2

Attach a new needle

Two hands hold and rotate a small white container with a screw-top to open or close it

Obtain a new needle (see previous section).

Remove the paper tab.

Two hands connect a cylindrical medical device to a cap, with a black arrow indicating movement to the left

Place the needle straight onto the medication cartridge directly.

Two hands hold an injection pen while a black arrow indicates rotating the end part for preparation

Screw the needle on until it is firmly secured.

Two hands demonstrate how to grip a white and gray cylindrical medical device, with a black arrow indicating movement to the right

Remove the needle cap and keep it.

You will need it to remove the needle after use.

3

Set the dose

Black-and-white technical drawing of a medical device with a central square button and a ribbed section on the right

Check that an empty circle appears

in the dose selection window.

Two hands hold a white injection pen while one hand rotates a black protective cap located at the end

Turn the dose selector to the right; arrows appear in the dose selection window.

Two hands hold a white cylindrical medical device for administration

Continue turning until you hear a "click" and see a solid black circle in the dose selection window.

Technical drawing of a medical device with a striped oval button and a small square window showing a black circular indicator

Release the dose selector. The solid black circle with a bar above appears in the window, confirming that the dose has been set.

A hand holds a pre-filled syringe and pushes it to the right to attach the needle

Remove the needle cap and discard it.

4

Inject the dose

A hand holds an injection pen and presses it against the skin of the patient

Gently pinch the skin on your thigh or abdomen and insert the needle directly into the skin, making sure you can see the dose programming window.

A hand holds an injection pen and presses it against the skin of the patient

Keep the needle in the skin and press the injection button until it stops. This starts the injection.

A hand holds an injection pen against the skin of the patient

Keep the needle in the skin and wait until an empty circle appears in the dose programming window. Then count slowly to 5 and remove the needle from the skin.

5

Confirm the Dose

Technical drawing of a white medical device with a central circular button and a terminal section with horizontal grooves

After completing the injection and removing the needle from the skin, make sure that an empty circle appears in the dose programming window.

If an empty circle does not appear in the dose programming window: Do not inject again the same dose on the same day. Instead, you must reprogram the pen. See Section D, Troubleshooting.

6

Remove the needle

A hand holds a white and gray cylindrical medical device while the end part is rotated to the right following a black arrow

Place the needle cap over the needle as shown, and then push it on to secure it in place. To avoid injury from needlestick, never attempt to recap the needle, and do not touch the

needle.

Two hands hold a white injection pen with curved black arrows indicating rotational movement of the end part for preparation

Turn the needle cap to the left at least five times to unscrew the needle from the pen.

Two hands remove the protective cap from the tip of a medical injection pen for medication in a cartridge

Remove the needle and dispose of it according to your doctor’s or pharmacist’s instructions.

Two hands hold a white and gray injection pen and separate it transversely to the left as indicated by a black arrow

Replace the cap on the pen and secure it tightly.
After use, store the pen in the refrigerator.

Troubleshooting

Problem

Solution

A.

I can see an air bubble in the Sondelbay pen.

A small air bubble will not affect the dose or harm you. You may continue administering your dose as usual.

B.

I cannot administer the dose.

  1. Check the dose counter window to make sure there is at least one dose remaining in the Sondelbay pen. If the window shows 00, this means there is no dose left in the pen. You may still see medication in the cartridge, but it cannot be administered. You will need to use a new Sondelbay pen for your next dose.
  2. If there is at least one dose remaining in the Sondelbay pen and you are unable to turn the dose selector knob, ensure you turn it clockwise until you hear a "click" and see a black circle in the dose selection window. Do not release the dose selector knob until you hear the "click," as otherwise it will return to its initial position. After hearing the "click," release the dose selector knob; you should then see a black circle with a bar above it in the dose selection window.

C.

I can see a drop of medication at the needle tip when I remove the needle cap to administer the injection.

A small drop of medication at the needle tip will not affect the dose. Continue administering your dose as described in Step 4 of the Instructions for Use.

D.

The empty circle did not appear in the dose selection window, even after fully pressing the injection button and waiting. What should I do?

To reprogram the Sondelbay pen, follow the steps below:

  1. If you have already administered an injection, DO NOT inject a second dose on the same day.
  2. Remove the used needle using the needle cap.

Do not touch the needle.

Do not attempt to re-cover the needle with the needle cap. Unscrew the needle and dispose of it according to your doctor’s or pharmacist’s instructions.

  1. Attach a new needle, remove the needle cap, and keep it aside.
  2. Point the needle cap toward an empty container.
  3. Remove the needle cap. Be very careful; a small amount of medication may come out. There may also be some medication inside the cap. Dispose of this cap.
  4. You should now be able to see the empty circle in the dose selection window. If you still cannot see it, contact your doctor or pharmacist.
  5. Place the cap over the needle. Do not touch the needle.

Do not attempt to re-cover the needle with the needle cap.

Unscrew the needle and dispose of it according to your doctor's or pharmacist's instructions.

  1. Replace the cap on the Sondelbay pen, and return it to the refrigerator.
  2. Wash your hands.

This problem can be avoided by always using a NEW needle for each injection and by fully pressing the injection button.

Wait until the empty circle appears, then count to 5 before removing the needle from the skin.

E.

How can I tell that my Sondelbay pen is working properly?

The Sondelbay pen is designed to deliver a complete dose each time it is used according to the Instructions for Use. After injection, the empty circle appears in the dose setting window to indicate that the full dose of medication has been administered.

The dose counter window shows the number of doses remaining in the pen. It counts down each time a dose is delivered. This also indicates that the pen is functioning properly.

Use a new needle for each injection to ensure the Sondelbay pen works correctly.

F.

I cannot remove the needle from the Sondelbay pen.

  1. Place the needle cap onto the needle as shown in step 6 on the first page.
  2. To unscrew the needle, push it into the pen while turning it several times to the left.
  3. Remove the needle and dispose of it according to your doctor's or pharmacist's instructions.
  4. If you still cannot remove the needle, ask someone for help.

Cleaning and storage

Cleaning your Sondelbay pen:

  • Clean the outside of the Sondelbay pen with a damp cloth.
  • Do not immerse the Sondelbay pen in water or clean it with any other liquid.

Storage of the Sondelbay pen:

  • For storage instructions for the Sondelbay pen, refer to the package leaflet in the package.

Disposal of the Sondelbay pen and needles

Disposal of the Sondelbay pen

  • Dispose of the Sondelbay pen 28 days after the first injection, even if the pen is not completely empty.
  • Always remove the needle before disposing of the Sondelbay pen.
  • Ask your doctor or pharmacist how to properly dispose of the Sondelbay pen.
Spanish text on a white background providing instructions for the safe disposal of used needles into sharps containers

Additional Information

  • Read and follow the instructions in the package leaflet for using the product.
  • Use of the Sondelbay pen is not recommended for blind or visually impaired individuals without the assistance of a person properly trained in the correct use of this device.
  • Keep the Sondelbay pen out of sight and reach of children.
  • Never transfer the medication into a syringe.
  • Use a new needle for each injection.
  • Check the label on the Sondelbay pen to ensure you have the correct medicine and that it has not expired.
  • Contact your doctor or pharmacist if you notice any of the following:
    • The Sondelbay pen appears damaged
    • The medicine does not appear clear, colorless, and free of particles
  • The Sondelbay pen contains 28 days' worth of medication.
  • Record the date of your first injection on the outer carton of the Sondelbay pen (see the space provided: date of first use). You must discard the Sondelbay pen 28 days after this first injection.

Date of last review of this manual: