This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use SONDELBAY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

Introduction

Package Leaflet: Information for the User

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

teriparatide

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

What is Sondelbay and what is it used for
What you need to know before you use Sondelbay
How to use Sondelbay
Possible side effects
Storage of Sondelbay
Contents of the pack and other information

1. What is Sondelbay and what is it 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 makes your bones waste away and become fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with corticosteroids.

2. What you need to know before you use Sondelbay

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

Do not use Sondelbay

if you are allergic to teriparatide or 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 high levels of alkaline phosphatase in your blood without apparent explanation, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are not sure, 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 amount of calcium in your blood or urine.

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

if you constantly have nausea, vomiting, constipation, low energy, or muscle weakness, tell your doctor. These may be symptoms of too much calcium in your blood.
if you have kidney stones or have a history of kidney stones.
if you have kidney problems (moderate renal insufficiency), you should tell your doctor.

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

The recommended treatment time of 24 months should not be exceeded. Sondelbay should not be used in growing adults.

Children and adolescents

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

Other medicines and Sondelbay

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, because occasionally interactions may occur (e.g., digoxin/digitalis, a medicine used to treat heart diseases).

Pregnancy and breastfeeding

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

Driving and using machines

Some patients may feel dizzy after the injection of Sondelbay. If you feel dizzy, do not drive or use machines until you feel better.

Sondelbay contains sodium

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

3. How to use Sondelbay

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

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

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

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

No needles are included with the pen. Pen needles (31G or 32G; 4mm, 5mm, or 8mm) may be used.

The injection of Sondelbay 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. You should use a new needle for each injection and discard it 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 to take each day.

Sondelbay can be used with or without food.

If you use more Sondelbay than you should

If you have accidentally administered more Sondelbay 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 forgotten doses. Do not inject more than once on the same day. Do not try to make up for the forgotten dose.

If you stop treatment with Sondelbay

If you are thinking of stopping treatment with Sondelbay, please consult your doctor. Your doctor will advise and decide how long you should be treated with Sondelbay.

If you have any other questions about 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.

The most common side effects are pain in the limbs (very common, may affect more than 1 in 10 patients), discomfort, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If it does 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 at the injection site (common), these should disappear within a few days or weeks. If not, tell your doctor as soon as possible.

Some patients may have experienced allergic reactions just after injection, consisting of difficulty breathing, swelling of the face, skin rash, and chest pain (rare). In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur.

Other side effects are:

Common: may affect up to 1 in 10 patients

increase in blood cholesterol levels
depression
neuralgic pain in the leg
feeling of fainting
irregular heartbeats
difficulty breathing
increased sweating
muscle cramps
loss of energy
fatigue
chest pain
low blood pressure
stomach acid (pain or burning sensation just below the breastbone)
vomiting
hernia of the tube that carries food to your stomach
low hemoglobin or low red blood cell count (anemia)

Uncommon: may affect up to 1 in 100 patients

increased heart rate
abnormal heart sound
shortness of breath
hemorrhoids
accidental loss or leakage of urine
increased need to urinate
weight gain
kidney stones
pain in the muscles and joints. Some patients have experienced severe back cramps or pain and had to be hospitalized.
increase in blood calcium levels
increase in blood uric acid levels
increase in the levels of an enzyme called alkaline phosphatase.

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

reduction of kidney function, including renal failure
swelling, mainly in the hands, feet, and legs.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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. Storage of Sondelbay

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 carton and pen after CAD and EXP respectively. The expiry date is the last day of the month stated.

Sondelbay should always be stored in a refrigerator (between 2°C and 8°C). Once opened, Sondelbay can be stored at temperatures up to 25°C for a maximum of three days when no refrigeration is available. After this period, the medicine should be returned to a refrigerator and used within 28 days of the first injection. The Sondelbay pen should be discarded if it has been out of the refrigerator at temperatures up to 25°C for more than three days.

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

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

Each pen should be discarded after 28 days, even if it is not empty.

Sondelbay contains a clear and colorless solution. Do not use Sondelbay if it has solid particles or if the solution is cloudy or discolored.

Never transfer the medicine to a syringe.

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

6. Contents of the pack and other information

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

Appearance of the product and pack contents

Sondelbay is a clear and colorless solution. It is presented in a cartridge contained in a disposable pre-filled pen. Each pre-filled pen contains 2.4 ml of solution sufficient for 28 doses. Sondelbay is available in packs containing one or three pre-filled pens. Some pack sizes may only be available.

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Centre,

Moll de Barcelona s/n, Edifici Est, 6ª Planta,

08039, Barcelona, Spain

Manufacturer

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 last revision of this leaflet:

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

Sondelbay20 micrograms/80 microliters solution for injection in pre-filled pen teriparatide

Instructions for use

Before using your new pen, please read both sides of these Instructions for use in their entirety. On the back, you will find information on troubleshooting and additional data.

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

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

Your pen contains medicine for 28 days.

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

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

Parts of the Sondelbay pen

Needles are not included
	Checkthe dose counter window to determine the number of doses remaining. The needle indicatesthe number of remaining doses. A new pen should contain 28 doses. The black dots that appear in the dose counter window indicatethe odd dose numbers remaining in the

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

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

Use a new needle for each injection.

pen.

Do not use the pen if the counter indicates '00' as this means that there are no doses left.

The Sondelbay pen does not need to be primed.

Preparation

Abdominal area with shaded zones indicating recommended injection sites in the lower and central part

Prepare the injection site (thigh or abdomen) according to your doctor's or pharmacist's instructions.

Alwayswash your hands before each injection.
Checkthe pen label to ensure it is the correct medication.
Checkthe expiration date to ensure it has not expired.
Checkthe dose counter window to ensure there are doses left in the pen.

A new pen should contain 28 doses.

Hand holding an injection device with an exposed needle and a black arrow indicating the direction of insertion

Remove the pen cap.

Checkthat the pen and cartridge are not damaged.
Checkthat the medication is transparent, colorless, and free of particles.

Place a new needle

Hands holding a white cream applicator with a conical end and a transparent protective cap

Find a new needle (see previous section).

Remove the paper tab.

Hands holding a white cylindrical device with metal ends, a black arrow indicates direction

Place the needle at pressure directlyonto the medication cartridge.

Applicator device with inserted cartridge held by two hands, arrow indicates direction of rotation

Screwthe needle until it is firmlysecured.

Gray adapter connected to a device with a black arrow indicating the direction of connection to a transparent needle

Remove the needle cap and saveit.

You will need it to remove the needle after use.

Program the dose

End of a white cylinder with stripes and a rectangular button with a circle in the center

Checkthat an empty circle appears

in the dose programming window.

Auto-injector device with transparent cartridge held by human fingers with black protective cover

Turnthe dose programming screw to the right; arrows appear in the dose programming window.

Hand holding an auto-injector with the button pressed to administer the medication dose

Keep turning until you hear a “click” and see a black circlein the dose programming window.

Medication cylinder with a retracted plunger showing the dose mark and inspection window

Release the dose programming screw. In the window, the black circle with a bar above appears. This confirms that the dose has been programmed.

Needle inserted into the skin at an ascending angle, syringe connected to the needle, and arrow indicating direction of insertion

Removethe needle protector and discardit.

Inject the dose

Hand holding an auto-injector at a 90-degree angle injecting into the abdominal skin

Gently pinch the skin of the thigh or abdomen and insert the needle directly into the skin, making sure to see the dose programming window.

dose.

Hand holding an auto-injector with a black arrow indicating the direction of injection in the abdomen

Keep the needle in the skin, pressthe injection button until it stops. This starts the injection.

Hand holding an auto-injector injecting into the abdominal skin with text indicating to hold for 5 seconds

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

Confirm the dose

Hypodermic needle with inclined bevel and rounded end showing the insertion area and gray textured cube

Once the injection is completeand the needle is removed from the skin, make surethat an empty circle appears in the dose programming window.

If the empty circle does not appearin the dose programming window, do not inject againon the same day.

Instead, you will need to reprogram the pen.

See section D of Troubleshooting.

Remove the needle

Hand holding an auto-injector with the needle exposed pointing towards the skin and an arrow indicating the direction of injection

Place the needle cap over the needle, as indicated, and then pushit to secure it in place. To avoid needlestick injuries, never attemptto put the needle protector back on, nor touch the

needle.

White auto-injector device with gray details held by a hand, black arrows indicate device rotation

Turn the needle cap to the left at least 5 times to unscrew it from the pen.

Applicator device with inserted cartridge held by a hand showing the activation button and exposed needle

Removethe needle and discard it according to your doctor's or pharmacist's instructions.

Hands holding an injection device with an exposed needle and a black arrow indicating direction

Put the cap back on the pen and secure it firmly.

Immediately 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, nor will it harm you. You can continue to administer the dose as usual.
B.	I cannot administer the dose.	Check the dose counter window to ensure that there is at least one dose left in the Sondelbay pen. If the window indicates 00, this means that there are no doses left in the Sondelbay pen. You may see that there is medication left in the cartridge, but it cannot be administered. You will need to use a new Sondelbay pen for your next dose. If there is at least one dose left in the Sondelbay pen, and you cannot turn the dose programming screw, make sure to turn it to the right until you hear a “click” and see a black circle in the dose programming window. Do not release the dose programming screw until you hear the “click”, because otherwise, the screw will return to its initial position. After hearing the “click”, release the dose programming screw; then you will see a black circle with a bar above in the dose programming window.
C.	I can see a drop of medication on the tip of the needle when I remove the needle protector to administer the injection.	A small drop of medication on the tip of the needle will not affect the dose. Continue to administer the dose as described in Step 4 of the Instructions for use.
D.	The empty circle did not appear in the dose programming window, even after pressing the injection button to the maximum and waiting. What should I do?	To reprogram the Sondelbay pen, you should follow the steps below: If you have already administered an injection, DO NOT inject again on the same day. Remove the used needle using the needle cap. Do nottouch the needle. Do not attemptto put the needle protector back on. Unscrew the needle and discard it according to your doctor's or pharmacist's instructions. Place a new needle, remove the needle cap, and save it. Point the needle protector towards an empty container. Remove the needle protector. Be careful; a little medication may come out. There may also be some medication inside the protector. Discard this protector. You should be able to see the empty circle in the dose programming window. If you still cannot see it, contact your doctor or pharmacist. Put the cap on the needle. Do not touch the needle. Do not attemptto put the needle protector back on.

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

Put the Sondelbay pen cap back on and store it in the refrigerator.
Wash your hands.

This problem can be avoided if you always use a NEW needle for each injection, and also by pressing the injection button to the maximum.

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

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

The Sondelbay pen is designed to inject a complete dose each time it is used according to the Instructions for use. After injection, the empty circle appears in the dose programming windowto indicate that the complete dose of medication has been administered.

The dose counter windowindicates the number of doses remaining in the pen. It shows the countdown each time a dose is administered. This also indicates that the pen is working properly.

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

I cannot remove the needle from the Sondelbay pen.

Place the needle cap over the needle as indicated in step 6 in the first tab.
To unscrew the needle, push it into the pen while turning it several times to the left.
Remove the needle and discard it according to your doctor's or pharmacist's instructions.
If you still cannot remove the needle, ask someone for help.

Cleaning and maintenance

Cleaning your Sondelbay pen:

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

Storing the Sondelbay pen:

To know the storage instructions for the Sondelbay pen, consult the leaflet in the package.

Disposal of the Sondelbay pen and needles

Disposal of the Sondelbay pen

Discard the Sondelbay pen after 28 days from the first injection, even if the pen is not completely empty.
Always remove the needle before discarding the Sondelbay pen.
Ask your doctor or pharmacist how to dispose of the Sondelbay pen.

White container for sharp objects with a red lid and explanatory text about its use and safe disposal

Additional information

Read and follow the instructions in the package leaflet for the use of the product.
The use of the Sondelbay pen is not recommended for blind or visually impaired people 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 to a syringe.
Use a new needle for each injection.
Check the Sondelbay pen label to ensure it is the correct medication and that it has not expired.
Contact your doctor or pharmacist if you notice the following:
- The Sondelbay pen appears to be damaged
- The medication does not appear transparent, colorless, or free of particles
The Sondelbay pen contains medication for 28 days.
Write the date of your first injection on the outer packaging of the Sondelbay pen (see the space provided: date of first use). You should discard the Sondelbay pen after 28 days from this first injection.

Date of the last revision of this manual:

How much does SONDELBAY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen cost in Spain ( 2025)?

The average price of SONDELBAY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen in October, 2025 is around 252.16 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

SONDELBAY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen