FORSTEO 20 MCG/80 MCL Roztwór do wstrzykiwań

Treść ulotki

1. FORSTEO 20 micrograms/80 microliters injectable solution in pre-filled pen
   1. What is FORSTEO and what is it used for
   2. What you need to know before using FORSTEO
   3. How to use FORSTEO
   4. Possible side effects
   5. How to store FORSTEO
   6. Content of the pack and other information

FORSTEO 20 micrograms/80 microliters injectable solution in pre-filled pen

teriparatide

Read this leaflet carefully before you start using this medicine as 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is FORSTEO and what is it used for

FORSTEO contains the active ingredient teriparatide which is used to make bones stronger and reduce the
risk of fractures by stimulating bone rebuilding.
FORSTEO is used to treat osteoporosis in adults. Osteoporosis is a disease that causes
bones to become thin and fragile. This disease is particularly common in women after
menopause, but can also occur in men. Osteoporosis is also common in patients
treated with corticosteroids.

2. What you need to know before using FORSTEO

Do not use FORSTEO

• If you are allergic to teriparatide or 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, tell your doctor.
• If you have high levels of alkaline phosphatase of unknown origin in your blood, this may mean you have Paget's disease of the bone (a condition with abnormal bone changes). If you are not sure, ask your doctor.
• If you have undergone radiation therapy involving the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
FORSTEO can cause an increase in the amount of calcium in the blood or urine.
Talk to your doctor or pharmacist before or during the use of FORSTEO:

• if you continuously experience nausea, vomiting, constipation, low energy or muscle weakness. These may be signs that there is too much calcium in your blood.
• if you suffer from kidney stones or if you have had kidney stone experiences.
• if you suffer from kidney problems (moderate renal impairment).

Some patients experience dizziness or an acceleration of the heartbeat after taking the
first doses. During the administration of the first doses, if you experience dizziness, inject FORSTEO in a
place where you can sit or lie down.
The recommended treatment period of 24 months should not be exceeded.
FORSTEO should not be used in adults who are still growing.

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

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

Pregnancy and breastfeeding
Do not use FORSTEO if you are pregnant or if you are breastfeeding. If you are a woman of
childbearing potential, you should use effective methods of contraception during the use of FORSTEO. In case of
pregnancy, FORSTEO should be stopped. Ask your doctor or pharmacist for advice before
taking any medicine.

Driving and operating machinery
Some patients may experience dizziness after the injection of FORSTEO. If you experience dizziness do not
drive and do not use machinery until you feel better.

FORSTEO contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use FORSTEO

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 20 micrograms administered once a day via injection under the
skin (subcutaneous injection) in the thigh or abdomen. To help you remember to take the
medicine, inject it every day at the same time.
Inject FORSTEO every day for the entire period of time prescribed by your doctor. The total duration
of treatment with FORSTEO must not exceed 24 months. You must not receive more than one
treatment lasting 24 months during your lifetime.
FORSTEO can be injected at mealtimes.
Read the user manual, which is included in the package, for instructions on how to use the pen
containing FORSTEO.
Injection needles are not included in the pen package. You can use injection needles for
pens from Becton, Dickinson and Company.
You must inject FORSTEO shortly after taking the pen out of 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 each time after use. Never store the pen with
the needle inserted. Never share your FORSTEO pen with other people.
Your doctor may advise you to take FORSTEO with calcium and vitamin D. Your doctor will tell you how much
calcium and vitamin D you need to take each day.
FORSTEO can be taken independently of meals.

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

If you forget or are unable to take FORSTEO at the time you usually do,take it
during the day as soon as possible. Do not take a double dose to make up for a missed dose.
Do not have more than one injection on the same day. Do not try to make up for a missed dose.

If you stop taking FORSTEO
If you are thinking of stopping treatment with FORSTEO, we invite you to discuss this with your doctor.
Your doctor will advise you and decide how long you should be treated with FORSTEO.
If you have any further questions on the use of this medicine, ask 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 pain in the limbs (the frequency is very common, may affect more than 1 in 10 people) and feeling of nausea, headache and dizziness (the frequency is
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 should call a doctor before continuing treatment. Cases of
fainting have been reported in association with the use of teriparatide.
If you experience discomfort as well as redness of the skin, pain, swelling, itching, a small
bruise around the injection area or slight bleeding around the injection site (the frequency is
common), this should resolve within a few days or weeks. Otherwise, inform your doctor as
soon as possible.
Some patients have experienced allergic reactions shortly after the injection, including
shortness of breath, facial swelling, rash and chest pain (the frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis may
occur.
Other side effects include:
Common: may affect up to 1 in 10 people

• increased levels of cholesterol in the blood
• depression
• neuralgic pain in the legs
• feeling of weakness
• irregular heartbeats
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• decreased blood pressure
• heartburn (a feeling of pain or burning just below the breastbone)
• feeling unwell (vomiting)
• the presence of a hernia of the channel leading food into the stomach
• decreased hemoglobin or number of red blood cells (anemia)

Uncommon: may affect up to 1 in 100 people

• increased heart rate
• abnormal heart sounds
• labored breathing
• hemorrhoids
• involuntary loss or leakage of urine
• increased need to eliminate fluids
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients have experienced severe cramps or back pain that required 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 kidney impairment
• appearance of swelling, especially in the hands, feet and legs

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through
the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store FORSTEO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the pen after
Exp.. The expiry date refers to the last day of that month.
FORSTEO must always be stored in a refrigerator (from 2°C to 8°C). You can use FORSTEO for up to
28 days after the first injection, during this period the pen is stored in a refrigerator (2°C-
8°C).
Do not freeze FORSTEO. Avoid placing the pens near the ice compartment in the refrigerator
to prevent freezing. Do not use FORSTEO if it is or has been frozen.
After 28 days, each pen must be disposed of appropriately, even if it is not
completely empty.
FORSTEO contains a colourless and clear solution. Do not use FORSTEO if you notice the presence of
solid particles or if the solution appears cloudy or discoloured.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What FORSTEO contains

• The active substance is teriparatide. Each millilitre of injectable solution contains 250 micrograms of teriparatide.
• The excipients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.

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

Marketing Authorisation 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32 (0) 2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel: + 370 (5) 2649600

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32 (0) 2 548 84 84

България
ТП "Ели Лили Недерланд" Б.В. - България
Тел: + 359 2 491 41 40

Česká republika
Eli Lilly R, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S

Malta
Charles de Giorgio Ltd.
Tlf: + 45 45 26 60 00 Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel: + 49 (0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31(0) 30 6025800

Eesti
Eli Lilly Nederland B.V.
Tel: + 372 6817 280

Norge
Eli Lilly Norge A.S
Tlf: + 47 22 88 18 00

ΕλλάδaÖsterreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: + 30 210 629 4600
Eli Lilly Ges. m.b.H.
Tel: + 43 (0) 1 711 780

España
Valquifarma, S.A.U.
Tel: + 34-91 623 1732

Polska
Eli Lilly Polska Sp. z o.o.
Tel: + 48 22 440 33 00

France
Lilly France
Tél: + 33 (0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351 21 412 66 00

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353 (0) 1 661 4377 Tel: + 386 (0) 1 580 00 10

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358 (0) 9 8545 250

Κύπρος
Phadisco Ltd
Τηλ: + 357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46 (0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000

United Kingdom
Eli Lilly and Company Limited
Tel: +44 (0) 1256 315000
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://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.

PEN USER MANUAL
Forsteo
FORSTEO 20 micrograms (mcg)/80 microlitres, solution for injection in pre-filled pen
Instructions for use
Before using the new pen, read the Instructions for useparagraph completely. Follow
the instructions carefully when you need to use the pen.
Do not share the pen or needles as there is a risk of transmitting infectious agents.
The pen contains an amount of medicine for 28 days.
FORSTEO components*
* Needles not included. Pen needles from Becton,
Dickinson and Company can be used.
Ask your doctor or
pharmacist which needle
gauge and length are
most suitable for you.
Yellow band
Injection
button
black

Red strip Blue body Cartridge with White cap
paper tab medicine

Small needle
protector

Always wash your hands before each injection. Prepare the injection site following the
instructions of your doctor or pharmacist.
1
Remove the white cap

2
Insert the
new needle

Remove the paper
tab.
Insert the needle into

straight positionon
the cartridge with
the medicine.
Screw the needle in
until it is
tight. Remove the
large needle protector and

keep it.
3
Set the
dose
Red strip
Small needle
protector

Pullout the
black injection
button

until it stops. If you
cannot pull out the
black injection button
read Troubleshooting and

solving a

problem, Problem E

Make sure
that the
red strip
is visible.

Removethe
small needle
protector and
discard it.

4
Inject the
dose

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

Pressdown fully on the
black injection button until it
stops. Hold it down and count
to 5 slow-ly.Then
withdraw the needle from the skin.

IMPORTANT
5
Confirm the
dose
After completing
the injection:
Once
the needle is
withdrawn from the
skin, make sure
that the black
injection button
is pressed down
fully. If the
yellow band is not
visible, the injection
steps have been
completed
correctly.

Do NOTsee any
portion of the yellow
band. If it is visible and
you have already
made the injection, do not repeat
the injection a
second time on the
same day. Instead

YOU MUST reset the
FORSTEO pen
(read Troubleshooting and

solving a

problem, Problem A).

6
Remove
the needle

Place the large
needle protector
on the needle.
Reattach the
white cap
to the pen.
Immediately
after use, store
FORSTEO in
the refrigerator.
Instructions regarding the handling of needles do not replace local institutional procedures or
procedures indicated by the healthcare professional.
Unscrew the needle all
the way by turning the
large needle protector 3 to 5
full turns. Remove the needle and
discard it following the
instructions of your
doctor or
pharmacist.

Forsteo
FORSTEO 20 micrograms (mcg)/80 microlitres,
solution for injection in pre-filled pen
Troubleshooting and solving a problem
ProblemSolution

• A. The yellow band isstill visible after I havepressed the black injectionbutton. How can I reset theFORSTEO pen?

• 1)If you have already made the injection, DO NOT repeatthe injection a second time on the sameday.
• 2) Remove the needle.
• 3) Insert a new needle, remove the large needle protector and keep it.
• 4) Pull out the black injection button until it stops. Make sure that the red strip is visible.
• 5) Remove the small needle protector and discard it.

via.

• 6) Point the needle downwards into an empty container. Press the black injection button until it stops. Hold it down and count to 5 slow-ly. A small stream or drop of liquid should appear. When you arefinished, the black injection button mustbe pressed down fully.
• 7) If the yellow band is still visible, contact your doctor or pharmacist.
• 8) Place the large needle protector on the needle. Unscrew the needle all the way by turning the large needle protector 3 to 5 full turns. Remove the needle and discard it following the instructions of your doctor or pharmacist. Reattach the white cap to the pen and store FORSTEO in the refrigerator.

You can avoid this problem by always using a
NEW needle for each injection, pressing the
black injection button down fully and counting
to 5 slow-ly.

• B. How can I tellif FORSTEO is working?The FORSTEO pen is designed to inject the entire dose each time it is used according to the instructions described in the Instructions for useparagraph. The black injection button will appear pressed down fully showing that the entire dose of FORSTEO has been injected. Remember to use a new needle each time you make the injection to ensure that FORSTEO works properly.
• C. Air bubbles arevisible in FORSTEO.

A small air bubble will not change the dose, nor
will it be dangerous. You can continue to take the dose
as usual.

• D. I cannot removethe needle.

• 1) Place the large needle protector on the needle.
• 2) Use the large needle protector to unscrew it.
• 3) Unscrew the needle all the way by turning the large needle protector 3 to 5 full turns.
• 4) If you still cannot remove the needle, ask someone to help you.
• E. What should I do if I cannot pull out theblack injection button?

Use a new FORSTEO pen to administer
the dose according to your doctor's or
pharmacist's instructions.
This means you have used all of the medicine that can
be delivered accurately, even if you can still see some
medicine remaining inside the cartridge.

Cleaning and storage
Cleaning FORSTEO

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

Storing FORSTEO

• Store FORSTEO in the refrigerator immediately after use. Read and follow the instructions provided.
• Do not store FORSTEO with the needle attached, as this may cause air bubbles to form in the cartridge.
• Store FORSTEO with the white cap in place.
• Never store FORSTEO in the freezer.
• If the medicine has been frozen, discard the FORSTEO pen and use a new one.
• If FORSTEO has been kept outside the refrigerator, do not discard the pen. Return the pen to the refrigerator and contact your doctor or pharmacist.

Disposal of needles and the pen
Disposal of needles and the FORSTEO pen

• Before disposing of the FORSTEO pen, make sure you have removed the needle from the pen.
• Place used needles in a closable container specifically for sharp or hard plastic waste with a secure lid. Do not dispose of needles directly into household waste containers.
• Do not recycle the container once it is filled with needles.
• Ask healthcare professionals about available options for appropriate disposal of this container.
• Instructions regarding needle handling should not replace local institutional or healthcare professional regulations.
• Dispose of the FORSTEO pen 28 days after the first use.

Other important notes

• The FORSTEO pen contains 28 days of medicine.
• Do not transfer the medicine into a syringe.
• Write the date of the first injection on a calendar.

to use the product.

• Check the FORSTEO 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:
• FORSTEO appears damaged.
• The solution does NOT appear clear, colorless, and free of particles.
• Use a new needle with each injection.
• During the injection, you may hear one or more clicks - this is part of the normal operation of the FORSTEO pen.
• The FORSTEO pen is not recommended for use by people who are blind or have impaired vision without the assistance of someone trained in the proper use of the pen.
• Keep FORSTEO out of the sight and reach of children.

Manufactured by: Lilly France, F-67640 Fegersheim, France
for Eli Lilly and Company.
This user manual was last revised MM/YYYY