FORSTEO 20 micrograms/80 microliters solution for injection inpre-filled pen

FORSTEO is used to make the bones stronger, and to reduce the risk of fractures (bone-formation agent).

This product is used to treat osteoporosis. 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 FORSTEO

• if you are allergic (hypersensitive) to teriparatide or any of the other ingredients of FORSTEO.
• 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. If you are not sure, ask your doctor.
• if you have had radiation therapy involving your bones.
• if you are pregnant or breast-feeding.

FORSTEO should not be used in children (less than 18 years) or in growing adults.

Take special care with FORSTEO

FORSTEO may cause an increase in the amount of calcium in your blood. Tell your doctor if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

FORSTEO may cause an increase in the amount of calcium in your urine. You should tell your doctor if you suffer from kidney stones or have a history of kidney stones.
You should tell your doctor 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 FORSTEO where you can sit or lie down right away if you get dizzy.
The recommended treatment time of 24 months should not be exceeded.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).

Using FORSTEO with food and drink

Forsteo can be given with or without food.

Pregnancy and breast-feeding

Do not use FORSTEO if you are pregnant or breast-feeding. Women of child-bearing potential should use effective methods of contraception during use of FORSTEO. If pregnancy occurs, FORSTEO 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 FORSTEO. If you feel dizzy you should not drive or use machines until you feel better.

Important information about some of the ingredients of FORSTEO:

This medicinal product contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially ?sodium-free?.

Always use FORSTEO exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.
Never share your FORSTEO pen with others

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

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

Read the user manual booklet, which is included in the carton for instructions on how to use the FORSTEO pen.

Injection needles are not included with the pen. You can use Becton Dickinson and Company?s insulin pen injection needles.

You should take your FORSTEO injection shortly after you take the pen out of the refrigerator as described in the user manual. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use. Never store your pen with the needle attached.

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

If you use more FORSTEO than you should

If, by mistake, you have used more FORSTEO 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 FORSTEO 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 have any further questions on the use of this product, ask your doctor or pharmacist.

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

The most common side effects (affects more than 1 user in 10) are:

• feeling sick,
• headache
• dizziness and
• pain in limb.

Common side effects (1 to 10 users in 100) are:

• 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.

Uncommon side effects (affects 1 to 10 users in 1000) are:

• increased heart rate,
• low blood pressure,
• shortness of breath,
• heartburn (painful or burning sensation just below the breast bone),
• haemorrhoids (piles),
• accidental loss or leakage of urine,
• increased need to pass water,
• weight increase.

Other uncommon side effects reported include pain in the muscles and pain in the joints. Some people may experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection. This should clear up in a few days or weeks. Otherwise tell your doctor as soon as possible.

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.

Some patients treated with FORSTEO have had an increase in their blood calcium level.

Rare side effects (affects 1 to 10 users in 10,000): Some patients have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain.

Cases of reduced kidney function, including renal failure have been reported in association with teriparatide use.

Other rare side effects include swelling, mainly in the hands, feet and legs.

Some patients have experienced severe back cramps or pain, which led to hospitalisation.

FORSTEO may also cause an increase in an enzyme called alkaline phosphatase

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use FORSTEO after the expiry date which is stated on the carton and pen.

FORSTEO should be stored in a refrigerator (2°C and 8°C) at all times. You can use FORSTEO 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 FORSTEO. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use FORSTEO if it is, or has been, frozen.

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

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

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

What FORSTEO contains

• The active substance is teriparatide. Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
• The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol 3.0 mg/ml (preservative), and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added to adjust the acidity.

What FORSTEO looks like and contents of the pack

FORSTEO is a colourless and clear solution for injection under the skin (subcutaneous use). It is supplied in a cartridge contained in a pre-filled disposable pen. Each pen contains 2.4 ml of solution enough for 28 doses. The pens are available in cartons containing one or three pens. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten, The Netherlands
Manufacturer: Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France, or Lilly S.A., Avda de la Industria 30, 28108 Alcobendas (Madrid), Spain

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

BelgiëBelgiqueBelgien Eli Lilly Benelux S.A. TélTel 32-02 548 84 84 LuxembourgLuxemburg Eli Lilly Benelux S.A. TélTel 32-02 548 84 84

.. - . 359 2 491 41 40 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100

eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Malta Charles de Giorgio Ltd. Tel 356 25600 500

Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800

Deutschland Lilly Deutschland GmbH Tel. 49-0 6172 273 2222 Norge Eli Lilly Norge A.S. Tlf 47 22 88 18 00

Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 3726817280 Österreich Eli Lilly Ges.m.b.H. Tel 43-0 1 711 780

- .... 30 210 629 4600 Polska Eli Lilly Polska Sp. z o.o. Tel 48 0 22 440 33 00

España Elanco Valquímica S.A. Tel 34-91 623-1732 Portugal Lilly Portugal - Produtos Farmacêuticos, Lda Tel 351-21-4126600

France Lilly France SAS. Tél 33-0 1 55 49 34 34 România Eli Lilly România S.R.L. Tel 40 21 4023000

Ireland Eli Lilly and Company Ireland Limited. Tel 353-0 1 661 4377 Slovenija Eli Lilly farmacevtska druba, d.o.o Tel 386 01 580 00 10

Ísland Icepharma hf. Sími 354 540 80 00 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111

Italia Eli Lilly Italia S.p.A. Tel 39- 055 42571 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250

Phadisco Ltd Sverige Eli Lilly Sweden AB

357 22 715000 Tel 46-0 8 7378800

Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 67364000 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315999

Lietuva
Eli Lilly Holdings Limited atstovyb-
Tel. + 370 (5) 2649600

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PEN USER MANUAL

Forsteo
FORSTEO, 20 micrograms (µg) 80 microlitres solution for injection, in pre-filled pen

Instructions for Use

Before you use your new FORSTEO, please read the sectionInstructions for Usecompletely. Follow the directions carefully when using the FORSTEO.
Also read the package leaflet provided.

Your FORSTEO contains 28 days of medication.

Forsteo Parts*

Yellow Shaft Black Injection button Red Stripe Blue Body Medicine Cartridge White Cap

Paper Tab Needle Large Needle Cover Small Needle Protector Needles not included. Becton, Dickinson and Company pen needles 29 to 31 gauge diameter 0.25-0.33 mm and 12.7, 8 or 5 mm length can be used. Ask your healthcare professional which needle gauge and length are best for you.

Always wash your hands before every injection. Prepare the injection site as directed by your healthcare professional.

1 Pull off white cap

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

Red stripe 3 Set dose Small needle protector Pull out black injection button until it stops. Check to make sure red stripe shows. Pull off small needle protector and throw away. If you cannot pull out the black injection button see Troubleshooting, Problem E.

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

IMPORTANT 5 After 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 FORSTEO see Troubleshooting Problem A. Confirm completing the dose 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.

6 Remove needle Put large needle cover on needle. Pull off needle and throw away as directed by your healthcare professional. Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns. Push white cap back on. Place FORSTEO in the refrigerator immediately after use.

Forsteo FORSTEO, 20 microgram g 80 microlitres solution for injection, in pre-filled pen

Troubleshooting Problem A. The yellow shaft is still showing after I push in the black injection button. How do I reset my FORSTEO Solution To reset the FORSTEO, 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 healthcare professional 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 healthcare professional. Push the white cap back on, and place FORSTEO 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 FORSTEO works The FORSTEO is designed to inject the full dose every time it is used according to the directions in the section Instructions for Use. The black injection button will be all the way in to show that the full dose

has been injected from the FORSTEO.

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

C. I see an air bubble in my FORSTEO. 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 E. What should I do if I Change to a new FORSTEO to take your dose as cannot pull out the directed by your healthcare professional. black injection button This indicates that you have now used all the medication that can be injected accurately even though you may still see some medication left in the medicine cartridge.

Cleaning and Storage

Cleaning Your FORSTEO

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

Storing Your FORSTEO

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

Disposal of Pen Needles and Device

Disposal of Pen Needles and FORSTEO Device

• Before disposing of the FORSTEO device, be sure to remove the pen needle.
• Dispose of your FORSTEO and used needles as directed by your healthcare professional.
• Dispose of the device 28 days after first use.

Other Important Notes

• The FORSTEO contains 28 days of medication.
• Do not transfer the medication 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 medication.
• Check the FORSTEO label to make sure you have the correct medication and that it has not expired.
• Contact your healthcare professional if you notice any of the following:
• The FORSTEO appears damaged
• The medication 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.
• Do not share your medication.
• The FORSTEO 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 FORSTEO out of the reach and sight of children.

Manufactured by Lilly France, F-67640 Fegersheim, France
for Eli Lilly and Company.