Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - teriparatide

Document Subject

Generated Narrative: MedicinalProductDefinition mp8e72e27852c8a54465539921267947b7

identifier: http://ema.europa.eu/identifier/EU/1/22/1697/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

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

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8e72e27852c8a54465539921267947b7

identifier: http://ema.europa.eu/identifier/EU/1/22/1697/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - teriparatide

Attesters

What is in this leaflet

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

Teriparatide SUN contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.

Teriparatide SUN is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.

Do not use Teriparatide SUN

• 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.

Warnings and precautions Teriparatide SUN 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 SUN

• 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 SUN 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 SUN should not be used in growing adults.

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

Other medicines and Teriparatide SUN 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).

Pregnancy and breast-feeding Do not use Teriparatide SUN 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 SUN. If you become pregnant, Teriparatide SUN should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.

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

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

Always use this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

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

Inject Teriparatide SUN each day for as long as your doctor prescribes it for you. The total duration of treatment with Teriparatide SUN should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime. Teriparatide SUN can be injected at meal times.

Carefully read how to use the pre-filled pen at the end of this package leaflet.

Injection needles are not included with the pen. Pen needles of 31 Gauge, 5 mm length can be used.

You should use your Teriparatide SUN injection shortly after you take the pen out of the refrigerator as described in Pen User Manual at the end of this package leaflet. For instructions for use video, please scan the QR code included in the Pen User Manual or use the link: https://www.pharmaqr.info/tptemaen. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle of 31 Gauge, 5 mm length for each injection and dispose of it after each use. Never store your pen with the needle attached. Never share your Teriparatide SUN pen with others.

Your doctor may advise you to use Teriparatide SUN with calcium and vitamin D. Your doctor will tell you how much you should take each day.

Teriparatide SUN can be given with or without food.

If you use more Teriparatide SUN than you should If, by mistake, you have used more Teriparatide SUN 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 SUN at your usual time, use it as soon as possible on that day. Do not use a double dose to make up for a forgotten dose. Do not use more than one injection in the same day. Do not try to make up for a missed dose.

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

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects are pain in limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common, may affect up to 1 in 10 people). If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel better, you should call a doctor before you continue treatment. Cases of fainting have been reported in association with teriparatide use.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks. Otherwise, tell your doctor as soon as possible.

Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare, may affect up to 1 in 1,000 people). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur.

Other side effects include

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.

Reporting of side effects 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 EXP. The expiry date refers to the last day of that month.

Teriparatide SUN should be stored in a refrigerator (2 C to 8 C) at all times. You can use Teriparatide SUN for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2 C to 8 C).

Do not freeze Teriparatide SUN. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use Teriparatide SUN if it is, or has been, frozen.

Each pen should be properly disposed of after 28 days, even if it is not completely empty.

Teriparatide SUN contains a clear and colourless solution. Do not use Teriparatide SUN if solid particles appear or if the solution is cloudy or coloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Teriparatide SUN contains

• 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. (See section 2 Teriparatide SUN contains sodium)

What Teriparatide SUN looks like and contents of the pack Teriparatide SUN 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 pre-filled pen or 3 pre-filled pens.

Not all package sizes may be marketed.

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

Manufacturers Sun Pharmaceutical Industries Europe B.V. Polarisavenue 2132 JH Hoofddorp The Netherlands

Terapia S.A. Str. Fabricii nr. Cluj-Napoca, 400Romania

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien/ / esk republika/ Danmark/Eesti/ /Hrvatska/United Kingdom (Northern Ireland)/ sland/ / Latvija/Lietuva/Luxembourg/Luxemburg/Magyarorsz g/ Malta/Nederland/Norge/ sterreich/Portugal/Slovenija/ Slovensk republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V. Polarisavenue 2132 JH Hoofddorp Nederland/Pays-Bas/Niederlande/ /Nizozemsko/ Nederlandene/ /Nizozemska/The Netherlands/Holland/ /N derlande/Nyderlandai/Pays-Bas/Niederlande/ Hollandia/L-Olanda/Nederland/Niederlande/Pa ses Baixos/ Nizozemska/Holandsko/Alankomaat/Nederl nderna Tel./ ./tlf./ ./S mi/ ./Tlf./Puh./ +31 (0)23 568 5Deutschland Sun Pharmaceuticals Germany GmbH Hemmelrather Weg 51377 Leverkusen Deutschland

tel. +49 214 403 Espa a Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-08007 Barcelona Espa a tel. +34 93 342 78 France Sun Pharma France 11-15, Quai de Dion Bouton 92800 Puteaux France tel. +33 1 41 44 44 Italia Sun Pharma Italia Srl Viale Giulio Richard, 3 20143 Milano Italia tel. +39 02 33 49 07 Polska Ranbaxy (Poland) Sp. Z. o. o. ul. Kubickiego 02-954 Warszawa
Polska tel. +48 22 642 07 Rom nia Terapia S.A. Str. Fabricii nr Cluj-Napoca, 400Rom nia tel. +40 (264) 501 This leaflet was last revised in

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

Black Injection button PEN USER MANUAL

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

Instructions for use

Before you use your new pen, please read the section Instructions for use completely. Follow the directions carefully when using the pen. Also read the package leaflet provided. For instructions for use video, please scan the QR code or use the link: https://www.pharmaqr.info/tptemaen.

Do not share your pen or your needles as this may risk transmission of infectious agents.

Your pen contains 28 days of medicine.

Teriparatide SUN Parts*

*Needles not included. The needle of 31 Gauge, 5 mm length can be used.
Ask your doctor or pharmacist which needle gauge and length are best for you.

Always wash your hands before every injection. Prepare the injection site as directed by your doctor or pharmacist.

Step 1 Pull off white cap

Remove the white cap by pulling it straight off the pen

Yellow Shaft Red Stripe Green Body Medicine Cartridge White Cap Paper Tab Needle Small Needle Protector Large Needle Cover

Step 2 Attach a new needle

a) b) c) d)

Pull off paper tab Push needle straight Screw on needle clockwise Pull off large needle onto medicine cartridge. firmly attached. cover and save it.

Step 3 Set dose e) f) g)

          Pull out black injection                      Check to make sure                Pull off small needle   
          button until it stops.                           red stripe shows.                     protector and throw away.  

If you cannot pull out the black injection button Note: After removal of inner needle protector, see Troubleshooting Problem E. you may see drop(s) of medicine coming out of the needle. It is normal and will not affect your dose.

Step 4 Inject dose

        h)
                    i)

      Gently hold a fold of skin from thigh                        Push in black injection button until it stops.  
      or abdomen and insert needle straight                       Hold it in and count to 5 s-l-o-w-l-y.  
      into skin.                                                                    Then pull the needle from skin. 

Red stripe Small needle protector Large needle protector

IMPORTANT Step 5 Confirm dose j)

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. k)

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 SUN (See Troubleshooting Problem A).

Step 6 Remove needle

l) m) n) o)

Put large needle Unscrew the needle anti-clockwise Pull off needle and throw Push white cap back on. cover on needle. all the way by giving the large away as directed by Place Teriparatide SUN
needle cover 3 to 5 complete your doctor or pharmacist. in the refrigerator turns. immediately after use.

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

Large needle
cover

Troubleshooting Problem A. The yellow shaft is still showing after I push
in the black injection button.
How do I reset my
Teriparatide SUN?

Solution

To reset the Teriparatide SUN, follow the steps below.

1. The recommended dose is 20 micrograms given once daily. 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. (See step 3)
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 SUN in the refrigerator. (See step 6)

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 do I know if my Teriparatide SUN works?

The Teriparatide SUN 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 SUN.

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

C. I see an air bubble in my Teriparatide SUN.

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. (See step 6)
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 SUN 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 and Storage Cleaning Your Teriparatide SUN

Wipe the outside of the Teriparatide SUN with a damp cloth.

Do not place the Teriparatide SUN in water, or wash or clean it with any liquid.

Storing Your Teriparatide SUN

Refrigerate the Teriparatide SUN 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 SUN with a needle attached as this may cause air bubbles to form in the cartridge.

Store the Teriparatide SUN with the white cap on.

If the medicine has been frozen, throw the pre-filled pen away and use a new Teriparatide SUN.

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

Before disposing of the Teriparatide SUN pre-filled pen, 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 pre-filled pen 28 days after first use.

Other Important Notes

The Teriparatide SUN contains 28 days of medicine.

Do not transfer the medicine into a syringe.

Write down your first injection date on a calendar.

Check the Teriparatide SUN label to make sure you have the correct medicine and that it has not expired.

During injection, you may hear one or more clicks this is a normal pre-filled pen operation.

The Teriparatide SUN 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 pre-filled pen.