Teriparatide Teva

Package leaflet: Information for the user

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

teriparatide
Generic medicine
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Teriparatide Teva contains the active substance teriparatide, which is used to strengthen bones and reduce the risk of fractures by stimulating bone formation.
Teriparatide Teva 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 Teriparatide Teva

Do not use Teriparatide Teva

• 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 cancers 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 unexplained high levels of alkaline phosphatase in the blood, as this may indicate Paget's disease of the bone (a disease causing abnormal bone changes). If you are unsure, ask your doctor.
• If you have undergone radiation therapy to the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
Teriparatide Teva 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 Teva:

• if you have persistent nausea, vomiting, constipation, low energy, or muscle weakness. These symptoms may indicate high calcium levels in the blood.
• if you have 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 the first few doses. For the initial doses, administer Teriparatide Teva in a place where you can sit or lie down if dizziness occurs.
The recommended treatment period of 24 months must not be exceeded.
Teriparatide Teva must not be used in adults who are still growing.
Children and adolescents
Teriparatide Teva must not be used in children and adolescents (under 18 years of age).
Other medicines and Teriparatide Teva
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, breastfeeding and fertility
Do not take Teriparatide Teva if you are pregnant or breastfeeding. If you are a woman of childbearing age, you must use effective contraception during treatment with Teriparatide Teva. If you become pregnant, Teriparatide Teva 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 Teva. If you feel dizzy, do not drive or operate machinery until you feel better.
Important information on certain excipients of Teriparatide Teva:
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically “sodium-free”.

3. How to use Teriparatide Teva

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 20 micrograms administered once daily by subcutaneous injection (under the skin) in the thigh or abdomen.
To help you remember to take your medicine, inject it at the same time each day.
Inject Teriparatide Teva every day for the entire duration prescribed by your doctor. The total duration of treatment with Teriparatide Teva must not exceed 24 months. You must not receive more than one 24-month course of treatment in your lifetime.
Teriparatide Teva may be injected at mealtimes.
Read the user manual included in the package for instructions on how to use the pen containing Teriparatide Teva.
Injection needles are not included in the pen package. You may use pen needles from Becton, Dickinson and Company with gauge sizes from 29 to 31 (diameter from 0.25 to 0.33 mm) and lengths of 12.7, 8, or 5 mm.
You should administer the Teriparatide Teva injection shortly after removing the pen from the refrigerator, as described in the user manual. After use, immediately return the pen to the refrigerator.
Use a new needle for each injection and dispose of it after use. Never store the pen with the needle attached. Never share your Teriparatide Teva pen with other people.
Your doctor may advise you to take Teriparatide Teva with calcium and vitamin D. Your doctor will tell you how much calcium and vitamin D you should take each day.
Teriparatide Teva may be taken regardless of meals.

If you use more Teriparatide Teva than you should
If you accidentally use more Teriparatide Teva than you should, contact your doctor or pharmacist.
Effects expected with overdose may include nausea, vomiting, dizziness, and headache.

If you forget or are unable to take Teriparatide Teva at your usual time, take it during the day as soon as possible. Do not take a double dose to make up for the missed dose. Do not administer more than one injection in the same day. Do not try to make up for a missed dose.

If you stop treatment with Teriparatide Teva
If you are considering stopping treatment with Teriparatide Teva, please discuss this with your doctor.
Your doctor will advise you and decide how long you should continue taking Teriparatide Teva.
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 (frequency: very common, may affect more than 1 in 10 people) and feeling unwell, headache, and dizziness (frequency: common). 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 such as redness of the skin, pain, swelling, itching, a small localized bruise, or mild bleeding around the injection site (frequency: common), this should resolve within a few days or weeks. In rare cases, 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 (frequency: rare). In rare cases, serious and potentially fatal allergic reactions including anaphylaxis may occur. If you notice any of these symptoms, STOP treatment with Teriparatide Teva and contact your doctor IMMEDIATELY.
Other side effects include:
Common: may affect up to 1 in 10 people

• increased cholesterol levels in the blood
• depression
• neuralgic leg pain
• feeling faint
• irregular heartbeat
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• decreased blood pressure
• heartburn (a sensation of pain or burning felt just below the breastbone)
• feeling unwell (vomiting)
• hernia of the duct carrying food to the stomach (hiatal hernia)
• low levels of haemoglobin or number of red blood cells (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 urinate
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients have experienced severe cramps or back pain requiring hospitalization.
• increased levels of calcium in the blood
• increased levels of uric acid in the blood
• increased levels of an enzyme called alkaline phosphatase

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

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Teriparatide Teva

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

6. Package contents and other information

What Teriparatide Teva contains

• The active substance is teriparatide. One pre-filled pen containing 2.4 mL delivers 600 micrograms of teriparatide (corresponding to a concentration of 250 micrograms per millilitre).
• The excipients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injections. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.

Description of the appearance of Teriparatide Teva and contents of the pack
Teriparatide Teva is a clear, colourless solution. Teriparatide Teva is supplied in a cartridge contained in a disposable pre-filled pen. Each pen contains 2.4 mL of solution, sufficient for 28 doses. Pens are available in cartons containing one or three pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4, Milan
20123 Italy

Responsible manufacturers for batch release:
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.) Prilaz baruna Filipovica 25, Zagreb 10000 – Croatia
TEVA Gyógyszergyár Zrt. Gödöllő, Táncsics Mihály út 82 H-2100 – Hungary (Headquarters: H-4042 Debrecen, Pallagi út 13)
Teva Pharma B.V. Swensweg 5, Haarlem 2031 GA – Netherlands

USER MANUAL FOR THE PRE-FILLED PEN
Teriparatide Teva solution for injection in pre-filled pen
Important: read the package leaflet inside the Teriparatide Teva packaging first.
Before using the Teriparatide Teva pen, read the entire front and back of this User Manual carefully. Follow the instructions closely
for using the Teriparatide Teva pen.
The Teriparatide Teva pen contains enough medicine for 28 days. Dispose of the pen after 28 days, even if it is not completely
empty. Do not inject more than one dose of Teriparatide Teva on the same day.
Do not transfer Teriparatide Teva into a syringe.

Components of the Teriparatide Teva pen*

* Needles not included. With this device, needles with a gauge from 29 to 31 are recommended (pen needles from Becton, Dickinson and Company).
Ask your doctor or pharmacist which needle gauge and length are most suitable for you. Always use a NEW needle for each injection.
Always wash your hands before each injection. Prepare the injection site according to your doctor’s or pharmacist’s instructions.

1. Remove the blue cap

Check the label on the Teriparatide Teva pen to make sure you have the correct medicine and that it has not expired.
Do not use the Teriparatide Teva pen if it appears damaged or if the solution in the cartridge does not appear clear, colourless and free from particles.

2. Insert the new needle

Remove the paper tab.

Insert the needle straight onto the medicine cartridge.

Screw the needle on completely until it stops (3 to 5 turns clockwise). Make sure the needle is securely attached.

Remove the outer needle cap and keep it.

3. Setting the dose

Pull out the black injection button until it stops and the red stripe appears.
If you cannot pull out the black injection button, see Troubleshooting, Problem E at the end of these instructions.

Make sure that the red stripe is visible.

Remove the small needle cover and dispose of it.

4. Inject the dose

Gently pinch a portion of the skin on the thigh or abdomen and insert the needle perpendicularly into the skin.

Press the black injection button fully down until it stops. Keep the button pressed and count slowly to 5. You must wait and count to 5 to ensure the full dose has been delivered. Then remove the needle from the skin.

5. Confirm the dose

IMPORTANT

After completing the injection:
Once the needle has been removed from the skin, remove your thumb from the black injection button. Make sure that the black injection button is fully
depressed. If the yellow band is not visible, the injection steps have been completed correctly.

NO portion of the yellow band should be visible. If the yellow band is visible and the injection has already been administered, do not repeat the injection on the same day. Instead, the Teriparatide Teva pen MUST be zeroed (see Troubleshooting, Problem A, at the end of these instructions).

6. Remove the needle

Place the large needle cap over the needle. Do not attempt to re-cover the needle with your hands.

Unscrew the needle completely by turning the large needle cap 3 to 5 full turns.

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

Replace the blue cap on the pen. Immediately after use, store the Teriparatide Teva pen in the refrigerator.
For more information, or if you have any questions, refer to the end of these instructions.
Teriparatide Teva solution for injection in a pre-filled pen

Problem solving

Problem	Solution
A. The yellow band is still visible after pressing the black injection button. How can the Teriparatide Teva pen be zeroed?	This issue can be resolved by always using a NEW needle for each injection, ensuring the needle is properly attached, and fully pressing the black injection button. To zero the Teriparatide Teva pen, follow the steps below.
	1) If the injection has already been administered, DO NOT repeat the injection a second time on the same day. 2) Remove the needle. 3) Repeat step 2 “Attach a new needle” and step 3 “Set the dose” of the instructions. 4) Point the needle downward into an empty container. Press the black injection button fully until it stops. Keep it pressed. A small stream or drop of liquid should appear. When finished, the black injection button must be fully pressed down. Proceed to step 6 “Remove the needle”. 5) If the yellow band is still visible, contact your doctor or pharmacist. Repeated zeroing of the Teriparatide Teva pen may result in loss of the daily dose.
B. How can one determine if the Teriparatide Teva pen is working properly?	The black injection button will appear fully pressed, indicating that the full dose of medication has been delivered by the Teriparatide Teva pen. Use a new needle each time you administer an injection to ensure the Teriparatide Teva pen functions correctly.
C. Air bubbles are visible in the Teriparatide Teva pen.	A small air bubble will not alter the dose nor pose any danger. You may continue to take your dose as usual.
D. The needle cannot be removed.	1) Place the large needle cap onto the needle. 2) Use the large needle cap to unscrew the needle. 3) Unscrew the needle completely by turning the large needle cap 3 to 5 full turns. 4) If you still cannot remove the needle, ask someone to assist you.
E. What should be done if the black injection button cannot be pulled out?	Consult your doctor; you may need to use a new Teriparatide Teva pen. If the black injection button cannot be pulled out, it means there is not enough medicine left in the Teriparatide Teva pen for another dose. You may still see some medicine remaining in the cartridge.

Cleaning and Storage
Cleaning the Teriparatide Teva pen

• Clean the outside of the Teriparatide Teva pen with a damp cloth.
• Do not place the Teriparatide Teva pen in water, or wash or clean it with any liquid.

Storage of the Teriparatide Teva pen

• Store the Teriparatide Teva pen in the refrigerator immediately after each use. Read and follow the instructions provided in the Package Leaflet: Patient Information Leaflet, section “How to store Teriparatide Teva”.
• Do not store the Teriparatide Teva pen with the needle attached, as this may cause air bubbles to form in the cartridge.
• Store the Teriparatide Teva pen with the blue cap in place.
• Do not freeze teriparatide. If the Teriparatide Teva pen has been frozen, discard the device and use a new Teriparatide Teva pen.
• If the Teriparatide Teva pen has been left outside the refrigerator, do not discard it. Return the pen to the refrigerator and contact your doctor or pharmacist.

Other Important Notes

• The Teriparatide Teva pen contains 28 days of medication.
• Do not transfer the medication into a syringe. Doing so may result in an incorrect dose.
• Write the date of the first injection on a calendar.
• Read and follow the instructions in the User Manual to ensure correct use of the Teriparatide Teva pen.
• Check the label on the Teriparatide Teva pen to make sure you have the correct medicine and that it has not expired.
• Do not use the Teriparatide Teva pen if it appears damaged. Check the teriparatide solution in the cartridge. If the solution is NOT clear, colourless, and free from particles, do not use it. Contact your doctor or pharmacist if you observe any of these conditions.
• Use a new needle for each injection.
• During injection, you may hear one or more clicks – this is part of the normal functioning of the pen.
• The Teriparatide Teva pen is not recommended for use by people who are blind or have visual impairments without the assistance of someone trained in the proper use of the pen.
• Keep the Teriparatide Teva pen out of sight and reach of children.

Disposal of Pen Needles and the Teriparatide Teva Pen

• Before disposing of the Teriparatide Teva pen, make sure to remove the needle from the pen.
• Dispose of the used Teriparatide Teva pen and used needles as instructed by your doctor or pharmacist.
• Dispose of the Teriparatide Teva pen 28 days after first use.

Date of first use: _ /_/_
Dispose by: _/_/_
Contacts
Manufactured by: Teva Italia S.r.l.
This User Manual was last revised in April 2022