Package Insert: Information for the User

FORSTEO 20 micrograms/80 microliters Pre-filled Syringe Solution

teriparatida

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

FORSTEO contains the active ingredient teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.

FORSTEO is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes bones to weaken and become fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with corticosteroids.

Your healthcare professional will teach you how to use the FORSTEO pen.

Do not use FORSTEO

• if you are allergic to teriparatide or any of the other ingredients in this medicine (listed in section 6).
• if you have high levels of calcium in your blood (pre-existing hypercalcemia).
• if you have severe kidney problems.
• if you have ever been diagnosed with bone cancer or other types of cancer that have spread (metastasized) to your bones.
• if you have certain bone diseases. If you have a bone disease, consult your doctor.
• if you have high levels of alkaline phosphatase in your blood without an apparent explanation, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are unsure, consult your doctor.
• if you have received radiation therapy that may have affected your bones.
• if you are pregnant or breastfeeding.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to use or while using FORSTEO:

Some patients experience dizziness or increased heart rate after the first doses. For the first doses, use FORSTEO in a place where you can sit or lie down immediately if you feel dizzy.

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

FORSTEO should not be used in adults in growth.

Children and adolescents

FORSTEO should not be used in children and adolescents (under 18 years).

Other medicines and FORSTEO

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, as occasional interactions may occur (e.g. digoxin/digitals, a medicine used to treat heart diseases).

Pregnancy and breastfeeding

Do not use FORSTEO if you are pregnant or breastfeeding. If you are a fertile woman, you should use effective contraceptive methods during treatment with FORSTEO. If you become pregnant, treatment with FORSTEO should be discontinued. Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Some patients may feel dizzy after the FORSTEO injection. If you feel dizzy, do not drive or operate machines until you feel better.

FORSTEO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms administered once a day via a subcutaneous injection under the skin in the thigh or abdomen. To help you remember to inject your medication, inject it at the same time every day.

Inject FORSTEO every day for as long as your doctor prescribes. The total duration of treatment with FORSTEO should not exceed 24 months. You should not receive more than one 24-month treatment cycle with FORSTEO throughout your life.

FORSTEO can be injected at mealtime.

Refer to the User Manual included in the package with instructions on how to use the FORSTEO pen.

No needles are included with the pen. Becton, Dickinson and Company needles can be used.

The FORSTEO injection should be administered shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. Use a new needle for each injection and discard it after use. Do not store the pen with the needle attached. Never share your FORSTEO pen with others.

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

FORSTEO can be used with or without food.

If you use more FORSTEO than you should

If you accidentally administer more FORSTEO than prescribed, consult your doctor or pharmacist.

The expected effects of an overdose may include nausea, vomiting, dizziness, and headache.

If you forget or are unable to inject FORSTEO at the usual time, do it as soon as possible that same day. Do not administer a double dose to compensate for missed doses. Do not inject more than once in the same day. Do not attempt to compensate for missed doses.

If you interrupt treatment with FORSTEO

If you are thinking of interrupting treatment with FORSTEO, please consult with your doctor. Your doctor will advise you and decide how long you should be treated with FORSTEO.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The most common side effects are pain in the extremities (very common, may affect more than 1 in 10 patients), discomfort, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If you do not improve, consult your doctor before continuing treatment. Cases of fainting associated with the use of teriparatide have been reported.

If you experience discomfort such as skin redness, pain, swelling, itching, bruises, or light bleeding around the injection site (common), these should disappear in a few days or weeks. If not, tell your doctor as soon as possible.

Some patients may have experienced allergic reactions just after the injection, which consist of difficulty breathing, facial swelling, skin rash, and chest pain (rare frequency). In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur.

Other side effects are:

Common: may affect up to 1 in 10 patients

• increase in blood cholesterol levels
• depression
• neuropathic pain in the leg
• sensation of fainting
• irregular heart palpitations
• difficulty breathing
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• low blood pressure
• gastric acidity (pain or burning sensation just below the sternum)
• vomiting
• hernia of the tube that carries food to the stomach
• low hemoglobin or low red blood cell count (anemia)

Less common: may affect up to 1 in 100 patients

• increased heart rate
• abnormal heart sound
• shortness of breath
• hemorrhoids (piles)
• accidental loss or leakage of urine
• increased need to urinate
• weight gain
• kidney stones
• pain in the muscles and joints.Some patients have experienced severe back cramps or pain and had to be hospitalized.
• increase in blood calcium levels
• increase in blood uric acid levels
• increase in levels of an enzyme called alkaline phosphatase.

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

• kidney function reduction, including renal insufficiency
• swelling, mainly in the hands, feet, and legs.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the pen after CAD and EXP respectively. The expiration date is the last day of the month indicated.

FORSTEO must be stored always in the refrigerator (between 2°C and 8°C). FORSTEO can be used for 28 days after the first injection while the pen is stored in the refrigerator (between 2°C and 8°C).

Do not freeze FORSTEO. Avoid placing the pens near the freezer of the refrigerator to prevent freezing. Do not use FORSTEO if it is or has been frozen.

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

FORSTEO contains a transparent and colorless solution. Do not use FORSTEO if it has solid particles or if the solution is cloudy or has color.

Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help to protect the environment.

Composition of FORSTEO

• The active ingredient is teriparatide. Each milliliter of injectable solution contains 250 micrograms of teriparatide.
• The other components are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injectable preparations. Additionally, a solution of hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.

Appearance of the product and contents of the package

FORSTEO is a transparent and colorless solution. It is presented in a cartridge included in a preloaded disposable pen. Each pen contains 2.4 ml of solution sufficient for 28 doses. The pens are available in packages containing one or three pens. Some package sizes may only be available.

Marketing Authorization Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands

Manufacturer

Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

USER MANUAL FOR THE PEN

Forsteo

FORSTEO 20 micrograms (µg) 80 microliters injectable solution in preloaded pen

Instructions for use

Before using your new pen, please read the entire sectionInstructions for Use.Follow the instructions carefully when using the pen.

Also read the leaflet includedin the package.

Do not share your pen or needles as this may pose a risk of infection transmission.

Your pen contains medicine for 28 days.

Wash your hands before each injection. Prepare the injection site as instructed by your doctor or pharmacist.