• 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 signs of illness 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.

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

• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from high calcium levels (pre-existing hypercalcaemia)
• if you suffer from serious kidney problems
• if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones
• if you have certain bone diseases. If you have a bone disease, tell your doctor
• if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor
• if you have had radiation therapy involving your bones - if you are pregnant or breast-feeding.

Teriparatide may cause an increase in the amount of calcium in your blood or urine.

Talk to your doctor or pharmacist before or while using Teriparatide

• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood
• if you suffer from kidney stones or have a history of kidney stones- if you suffer from kidney problems (moderate renal impairment).

Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject Teriparatide where you can sit or lie down right away if you get dizzy.

The recommended treatment time of 24 months should not be exceeded.

Teriparatide should not be used in growing adults.

Teriparatide should not be used in children and adolescents (less than 18 years).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).

Do not use Teriparatide if you are pregnant, think you may be pregnant, or if you are breast-feeding. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Teriparatide. If you become pregnant, Teriparatide should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.

Some patients may feel dizzy after injecting Teriparatide. If you feel dizzy you should not drive or use machines until you feel better.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium- free”.

If, by mistake, you have used more Teriparatide than you should, contact your doctor or pharmacist. The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.

If you forget or cannot take Teriparatide at your usual time, take it as soon as possible on that day. Do not take a double dose to make up for a forgotten dose. Do not take more than one injection in the same day. Do not try to make up for a missed dose.

If you are considering stopping Teriparatide treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Teriparatide.

Common (may affect up to 1 in 10 people)

• increase in blood cholesterol levels
• depression
• neuralgic pain in the leg
• feeling faint
• irregular heart beats
• breathlessness
• increased sweating
• muscle cramps
• loss of energy
• tiredness
• chest pain
• low blood pressure
• heartburn (painful or burning sensation just below the breast bone)
• being sick(vomiting)
• a hernia of the tube that carries food to your stomach
• low haemoglobin or red blood cell count (anaemia)

Uncommon (may affect up to 1 in 100 people)

• increased heart rate
• abnormal heart sound
• shortness of breath
• haemorrhoids (piles)
• accidental loss or leakage of urine
• increased need to pass water
• weight increase
• kidney stones
• pain in the muscles and pain in the joints. Some patients have experienced severe back cramps or pain which lead to hospitalisation
• increase in blood calcium level
• increase in blood uric acid level
• increase in an enzyme called alkaline phosphatase.

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

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is teriparatide. Each dose of 80 microliters contains 20 micrograms of teriparatide.
  Each pre-filled pen of 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml.
• The other ingredients are glacial acetic acid (E260), anhydrous sodium acetate (E262), mannitol (E421), metacresol, and water for injections. In addition, hydrochloric acid (E507) and/or sodium hydroxide (E524) solution may have been added for pH adjustment.

Teriparatide is a clear and colourless solution. It is supplied in a cartridge contained in a disposable pre-filled pen. Each pen contains 2.4 ml of solution enough for 28 doses.

It is available in packs of 1 or 3 pens.

Not all package sizes may be marketed.

Great Britain

5

Confirm dose

After completing the injection

Once the needle is removed from the skin, check to make sure the black injection button is all the way in. If the yellow shaft does not show, you have completed the injection steps correctly.

You should NOT see any of the yellow shaft. If you do and have already injected, do not inject yourself a second time on the same day. Instead, you MUST reset Teriparatide (See Troubleshooting Problem A).

6

Remove needle

Put large needle Cover on needle.

Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.

Pull off needle and throw away as directed by your doctor or pharmacist.

Push white cap back on. Place Teriparatide in the refrigerator immediately after use.

The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

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

Problem

A. The yellow shaft is still showing after I push in the black injection button.

How do I reset my Teriparatide ?

Solution

To reset the Teriparatide, follow the steps below.

1) If you have already injected, DO NOT inject yourself a second time on the same day.
2) Remove the needle.
3) Attach a new needle, pull off the large needle cover and save it.
4) Pull out the black injection button until it stops. Check to make sure the red stripe shows.
5) Pull off the small needle protector and throw away.
6) Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in and count to 5 s-l-o-w-l-y. You may see a small stream or drop of fluid. When you have finished, the black injection button should be all the way in.
7) If you still see the yellow shaft showing, please contact your doctor or pharmacist
8) Put the large needle cover on needle. Unscrew the needle all the way by giving the needle cover 3 to 5 complete turns. Pull off needle cover and throw away as directed by your doctor or pharmacist. Push the white cap back on, and place Teriparatide in the refrigerator.

You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and counting to 5 s-l-o-w-l-y.

B. How can I tell if my Teriparatide works?

The Teriparatide is designed to inject the full dose every time it is used according to the directions in the section How to use. The black injection button will be all the way in to show that the full dose has been injected from the Teriparatide.

Remember to use a new needle every time you inject to be sure your Teriparatide will work properly.

C. I see an air bubble in my Teriparatide.

A small air bubble will not affect your dose nor will it harm you. You can continue to take your dose as usual.

D. I cannot get the needle off.

1) Put the large needle cover on the needle.
2) Use the large needle cover to unscrew the needle.
3) Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
4) If you still cannot get the needle off, ask someone to help you.

E. What should I do if I cannot pull out the black injection button?

Change to a new Teriparatide to take your dose as directed by your doctor or pharmacist.

This indicates that you have now used all the medicine that can be injected accurately even though you may still see some medicine left in the cartridge.

Cleaning Your Teriparatide

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

Storing Your Teriparatide

• Refrigerate the Teriparatide immediately after every use. Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
• Do not store the Teriparatide with a needle attached as this may cause air bubbles to form in the cartridge.
• Store the Teriparatide with the white cap on.
• Never store the Teriparatide in the freezer.
• If the medicine has been frozen, throw the device away and use a new Teriparatide.
• If the Teriparatide has been left out of the refrigerator, do not throw the pen away. Place the pen back in the refrigerator and contact your doctor or pharmacist.

Disposal of Pen Needles and Teriparatide Device

• Before disposing of the Teriparatide device, be sure to remove the pen needle.
• Put used needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into your household waste.
• Do not recycle the filled sharps container.
• Ask your healthcare professional about options to dispose of the pen and the sharps container properly.
• The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
• Dispose of the device 28 days after first use.

• The Teriparatide contains 28 days of medicine.
• Do not transfer the medicine into a syringe.
• Write down your first injection date on a calendar.
• Read and follow the instructions in the Information for the Patient leaflet for using the medicine.
• Check the Teriparatide label to make sure you have the correct medicine. and that it has not expired.
• Contact your doctor or pharmacist if you notice any of the following:
  • The Teriparatide appears damaged
  • The solution is NOT clear, colourless and free of particles
• Use a new needle for each injection.
• During injection, you may hear one or more clicks – this is a normal device operation.
• The Teriparatide is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device.
• Keep the Teriparatide out of the sight and reach of children.