Teriparatide Sun

Package leaflet: Information for the user

Teriparatide SUN 20 micrograms/80 microlitres solution for injection in a pre-filled pen

teriparatide
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Teriparatide SUN is and what it is used for

Teriparatide SUN contains the active substance teriparatide, which is used to strengthen bones and reduce the risk of fractures by stimulating new bone formation.
Teriparatide SUN is used to treat osteoporosis in adults. Osteoporosis is a disease that causes bones to become thin and fragile. This condition is particularly common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroid treatment.

2. What you need to know before using T eriparatide SUN

Do not use Teriparatide SUN

• 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 tumours that have spread (metastasized) to the bones.
• If you have other bone diseases. If you have a bone disease, inform your doctor.
• If you have high blood levels of alkaline phosphatase of unknown origin, which may indicate Paget's disease of the bone (a disorder causing abnormal bone changes). If you are unsure, consult your doctor.
• If you have undergone radiation therapy involving the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
Teriparatide SUN may cause an increase in the amount of calcium in the blood or urine.
Talk to your doctor or pharmacist before or during treatment with Teriparatide SUN:

• if you constantly experience nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs of too much calcium in the blood
• if you suffer from kidney stones or have had kidney stones in the past
• if you have kidney problems (moderate renal impairment)

Some patients may experience dizziness or a rapid heartbeat after taking the first doses. During the initial doses, if you feel dizzy, inject Teriparatide SUN in a place where you can sit or lie down.
The recommended treatment period of 24 months must not be exceeded.
Teriparatide SUN must not be used in adults who are still growing.
Children and adolescents
Teriparatide SUN must not be used in children and adolescents (under 18 years of age).
Other medicines and Teriparatide SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may occasionally interact (e.g. digoxin/digitalis, a medicine used to treat heart conditions).
Pregnancy and breastfeeding
Do not use Teriparatide SUN if you are pregnant or breastfeeding. If you are a woman of childbearing potential, you must use effective contraceptive methods during treatment with Teriparatide SUN. If you become pregnant, Teriparatide SUN must be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some patients may experience dizziness after injection of Teriparatide SUN. If you feel dizzy, do not drive or operate machinery until you feel better.
Teriparatide SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to use Teriparatide SUN

Use this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen. To help you remember to take the medicine, inject it at the same time each day.
Inject Teriparatide SUN every day for the entire duration prescribed by your doctor. The total duration of treatment with Teriparatide SUN must not exceed 24 months. You must not receive more than one 24-month course of treatment in your lifetime.
Teriparatide SUN may be injected at mealtimes.
Read the user manual included in the package for instructions on how to use the pen containing Teriparatide SUN, section as provided at the end of this leaflet.
Injection needles are not included in the pen package. You may use pen needles with gauge 31, 5 mm in length.
You must inject Teriparatide SUN shortly after removing the pen from the refrigerator, as described in the user manual at the end of this leaflet. After use, immediately return the pen to the refrigerator.
For instructional video usage, scan the QR code included in the Pen User Manual or use the link: https://www.pharmaqr.info/tptit .
Use a new needle each time, gauge 31, 5 mm in length, and dispose of it after each use.
Never store the pen with the needle attached. Never share your Teriparatide SUN pen with other people.
Your doctor may advise you to take Teriparatide SUN together with calcium and vitamin D. Your doctor will tell you how much calcium and vitamin D you should take each day.
Teriparatide SUN can be taken regardless of meals.
If you use more Teriparatide SUN than you should
If you have accidentally used more Teriparatide SUN than you should, contact your doctor or pharmacist.
Effects that may occur with overdose include nausea, vomiting, dizziness, and headache.
If you forget or are unable to take Teriparatide SUN at your usual time, take it during the day as soon as possible. Do not take a double dose to make up for a forgotten dose. Do not administer more than one injection in the same day. Do not try to recover a missed dose.
If you stop treatment with Teriparatide SUN
If you are considering stopping treatment with Teriparatide SUN, please discuss this with your doctor. Your doctor will advise you and decide how long your treatment with Teriparatide SUN should continue.
If you have any doubts about how to use this medicine, consult 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 limb pain (very common frequency, may affect more than 1 in 10 people) and nausea, headache, and dizziness (common frequency).
If you feel dizzy after the injection, you should sit or lie down until you feel better. If you do not feel better, you must contact a doctor before continuing treatment. Cases of fainting have been reported in association with the use of teriparatide.
If you experience discomfort, as well as redness of the skin, pain, swelling, itching, a small localized bruise, or minor bleeding around the injection site (common frequency), this should resolve within a few days or weeks. Otherwise, inform your doctor as soon as possible.
Some patients have experienced allergic reactions shortly after injection, including shortness of breath, facial swelling, skin rash, and chest pain (rare frequency, may affect up to 1 in 1,000 people). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis may occur.

Other side effects include:

Common (may affect up to 1 in 10 people):

• increased cholesterol levels in the blood
• depression
• neuralgic leg pain
• feeling of weakness
• irregular heartbeat
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• tiredness
• chest pain
• decrease in blood pressure
• heartburn (a sensation of pain or burning felt just below the breastbone)
• general feeling of malaise (vomiting)
• presence of hernia in the duct carrying food to the stomach
• decrease in haemoglobin or number of red blood cells in the blood (anaemia)

Uncommon (may affect up to 1 in 100 people):

• increased heart rate
• abnormal heart sounds
• laboured breathing
• haemorrhoids
• involuntary loss or leakage of urine
• increased need to eliminate fluids
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients experienced severe cramps or back pain requiring hospitalization.
• increased calcium levels in the blood
• increased uric acid levels in the blood
• increase in an enzyme called alkaline phosphatase

Rare (may affect up to 1 in 1,000 people):

• reduced kidney function, including kidney impairment
• development of swelling, particularly in the hands, feet, and legs

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriparatide SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the pen after
Exp.. The expiry date refers to the last day of that month.
Teriparatide SUN may be stored before first use at 25°C for up to 24 hours.
Teriparatide SUN must always be stored in a refrigerator (between 2°C and 8°C). You may use Teriparatide
SUN for up to 28 days after the first injection; during this period, the pen must be stored in the
refrigerator (2°C–8°C).
Do not freeze Teriparatide SUN. Avoid placing the pens near the freezer compartment in the
refrigerator to prevent freezing. Do not use Teriparatide SUN if it has been frozen.
After 28 days, each pen must be properly disposed of, even if it is not completely empty.
Teriparatide SUN contains a colourless and clear solution. Do not use Teriparatide
SUN if you notice the presence of solid particles or if the solution appears cloudy or discoloured.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Teriparatide SUN contains

• The active substance is teriparatide. Each 80 microlitre dose contains 20 micrograms of teriparatide. Each 2.4 ml pre-filled pen contains 600 micrograms of teriparatide (equivalent to 250 micrograms per ml).
• The excipients are glacial acetic acid (E260), anhydrous sodium acetate (E262), mannitol (E421), metacresol, and water for injections. Additionally, hydrochloric acid solution (E507) and/or sodium hydroxide solution (E524) may have been added to adjust the pH. (See section 2: Teriparatide SUN contains sodium.)

Description of the appearance of Teriparatide SUN and contents of the pack
Teriparatide SUN is a clear, colourless solution. Teriparatide SUN is supplied in a cartridge contained within a pre-filled pen. Each pre-filled pen contains 2.4 ml of solution, sufficient for 28 doses. It is available in packs containing 1 or 3 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, 400632
Romania

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien/България/Česká republika/Danmark/Eesti/Ελλάδα/Hrvatska/Ísland/Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/Malta/Nederland/Norge/Österreich/Portugal/Slovenija/Slovenská republika/Suomi/Finland/Sverige
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/Nederlandene/Ολλανδία/Nizozemska/Holland/Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/L-Olanda/Nederland/Niederlande/Países Baixos/Nizozemska/Holandsko/Alankomaat/Nederländerna
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./ +31 (0)23 568 5501

Deutschland
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Deutschland
tel. +49 214 403 990

España
LABORATORIOS RUBIÓ, S.A.
Industria, 29. Pol. Ind. Comte de Sert
08755 Castellbisbal - Barcelona – España
tel. +34 937 722 509

France
Sun Pharma France
31 Rue des Poissonniers
92200 Neuilly-Sur-Seine
France
tel. +33 1 41 44 44 50

Italia
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milano
Italia
tel. +39 02 33 49 07 93

Polska
Ranbaxy (Poland) Sp. Z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Polska
tel. +48 22 642 07 75

România
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, 400632
România
tel. +40 (264) 501 500

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

USER INSTRUCTION LEAFLET FOR THE PEN
Teriparatide SUN 20 micrograms (mcg)/80 microlitres, solution for injection in a pre-filled pen

Instructions for Use

Before using the new pen, read the section Instructions for Use completely.
Carefully follow the instructions when using the pen.
Additionally, read the package leaflet provided.
For video instructions, scan the QR code or use the link:
https://www.pharmaqr.info/tptit

Do not share the pen or needles, as there is a risk of transmitting infectious agents.
The pen contains enough medicine for 28 days.
Components of Teriparatide SUN*
Yellow band

Black injection
button
Red strip Body Cartridge with white
Green cartridge cap
Paper tab Needle Large needle
protector

Small needle protector
* Needles not included. You may use a 31 Gauge needle, 5 mm in length. Ask your
doctor or pharmacist which gauge and length of needle are most suitable for you.
Always wash your hands before each injection. Prepare the injection site according to the instructions given by your
doctor or pharmacist.
Step 1 Remove the white cap

Remove the white cap by pulling it straight off the pen
Step 2

Attach the
new needle
a) Remove the paper tab. b) Place the needle c) Screw the needle d) Remove the
onto the cartridge with onto the cartridge clockwise until it is large needle
the medicine in an upright firmly tightened. protector and
position. keep it.

Step 3
Set the dose
Red strip Small needle
protector

e) Pull out the f) Ensure that the g) Remove the small
injection button black red strip is visible. needle protector and
until it stops. discard it.
Note: After removing the
If you cannot pull out the inner needle cap, you may
black injection button see one or more drops of
read *Troubleshooting, medicine leaking from the
Problem E needle. This is normal and
will not affect the dose.

Step 4
Inject the dose
h) Gently pinch a fold of skin on your thigh or abdomen and i) Press fully the black
insert the needle perpendicularly into the skin. injection button until it stops.
Keep pressing and count slowly to 5. Then remove the
needle from the skin.
IMPORTANT

Step 5 j) After completing k) NO portion of the
Confirm the dose the injection: yellow band should be
Once the needle is visible. If it is visible
removed from the and you have already
skin, ensure that the administered the
black injection button injection, do not repeat
is fully pressed down. the injection a second
If the yellow band is time on the same day.
not visible, the steps Instead, you MUST
of injection have been reset the Teriparatide
completed correctly. SUN pen (see Troubleshooting, Problem A).

Step 6
Remove the needle
l) Place the large m) Unscrew the needle n) Remove and discard o) Replace the white
needle protector fully by turning the needle according cap on the pen.
onto the needle. counterclockwise until to instructions from Immediately after use,
loosen completely by your doctor or return Teriparatide SUN
making 3 to 5 full turns pharmacist. to the refrigerator.
with the large needle
protector.
Instructions regarding needle handling do not replace local institutional procedures or those indicated by healthcare professionals.
Troubleshooting
Problem Solution

A. The yellow band is To reset the Teriparatide SUN pen, follow the steps
still visible after I below.
pressed the black
injection button. How 1) The recommended dose is 20 micrograms once daily.
can I reset the If you have already administered the injection, DO NOT
Teriparatide SUN repeat the injection a second time on the same day.
pen?
2) Remove the needle.

3. Attach a new needle, remove the large needle protector and keep it.
4. Pull out the black injection button until it stops. Ensure that the red strip is visible. (See Step 3)
5. Remove the small needle protector and discard it.
6. Point the needle downward into an empty container. Press the black injection button fully until it stops. Keep it pressed and count slowly to 5. A small stream or drop of liquid should appear. When finished, the black injection button must be fully pressed down.
7. If the yellow band is still visible, contact your doctor or pharmacist.
8. Place the large needle protector onto the needle. Unscrew the needle fully by making 3 to 5 complete turns with the large needle protector. Remove and discard the needle according to instructions from your doctor or pharmacist. Replace the white cap on the pen and return Teriparatide SUN to the refrigerator. (See Step 6)
   You can avoid this issue by always using a NEW needle for each injection, pressing the black injection button fully and counting slowly to 5.

B. How can I tell if The Teriparatide SUN pen is designed to deliver the full
Teriparatide SUN is dose every time it is used according to the instructions
working properly? described in the section Instructions for Use. The black
injection button will appear fully pressed down, indicating
that the full dose of Teriparatide SUN has been injected.
Remember to use a new needle each time you inject to
ensure proper functioning of Teriparatide SUN.

C. I see air bubbles in Small air bubbles will not affect the dose nor pose any
Teriparatide SUN. danger. You may continue taking your dose as usual.

D. I cannot remove the 1) Place the large needle protector onto the needle. (See
needle. Step 6)
2) Use the large needle protector to unscrew the needle.
3) Unscrew the needle fully by making 3 to 5 complete turns with the large needle protector.
4) If you still cannot remove the needle, ask someone to help you.

E. What should I do if Use a new Teriparatide SUN pre-filled pen to take your
I cannot pull out the dose as instructed by your doctor or pharmacist.
black injection
button?
This means you have used all the medicine that can be
accurately delivered, even if you can still see some
medicine remaining inside the cartridge.

Cleaning and Storage
Cleaning of Teriparatide SUN

• Clean the outside of Teriparatide SUN with a damp cloth.
• Do not immerse Teriparatide SUN in water, nor wash or clean it with any liquid.

Storage of Teriparatide SUN

• Return Teriparatide SUN to the refrigerator immediately after use. Read and follow the instructions in the Package Leaflet: Information for the User regarding storage of the pen.
• Do not store Teriparatide SUN with a needle attached, as this may cause air bubbles to form in the cartridge.
• Store Teriparatide SUN with the white cap in place.
• If the medicine has been frozen, discard the pre-filled pen Teriparatide SUN and use a new one.
• If Teriparatide SUN has been left outside the refrigerator, do not discard the pen. Return it to the refrigerator and contact your doctor or pharmacist.

Disposal of Needles and the Pen
Disposal of needles and the pre-filled pen Teriparatide SUN

• Before disposing of the pre-filled pen Teriparatide SUN, ensure that the needle has been removed.
• Place used needles in a closable, dedicated sharps container or a hard plastic container with a secure lid. Do not dispose of needles directly into household waste.
• Do not reuse the container once it is filled with needles.
• Ask healthcare personnel about available options for proper disposal of this container.
• Instructions regarding needle handling must not replace local institutional regulations or those provided by healthcare professionals.
• Discard the pre-filled pen Teriparatide SUN 28 days after first use.

Other Important Notes

• The Teriparatide SUN pen contains 28 days’ supply of medicine.
• Do not transfer the medicine into a syringe.
• Write the date of your first injection on a calendar.
• Check the label of Teriparatide SUN to ensure you have the correct medicine and that it has not expired.
• During injection, you may hear one or more clicks – this is part of the normal functioning of the Teriparatide SUN pen.
• The Teriparatide SUN pen is not recommended for use by blind individuals or those with visual impairments without the assistance of someone trained in the proper use of the pen.