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NOVIMP 3.6 MG IMPLANT

Active substance(s): GOSERELIN

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PATIENT INFORMATION LEAFLET

2


BEFORE YOU USE NOVIMP

If you think that the symptoms have changed or worsened, please ask your doctor. He will be able to decide if
any changes are needed to your treatment.

Do not use Novimp
• if you are allergic to goserelin or any of the other
ingredients of Novimp.

Novimp 3.6 mg Implant

• in children.

If you use more Novimp than you should
If you receive an injection too early (less than four weeks
after the previous injection) please inform your doctor.

Goserelin
Take special care with Novimp

Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor.

• if you have or have had problems passing urine or if
you have or have had problems with your back. Please,
tell your doctor if so.

In this leaflet:
1. What Novimp is and what it is used for
2. Before you use Novimp
3. How to use Novimp
4. Possible side effects
5. How to store Novimp

• if you had a previous treatment with another medicine in this group because they can cause a small
loss of calcium from the bones (thinning of bones).
Some recovery of this loss can occur when treatment
is stopped. If you are suffering from any disease which
affects the strength of your bones please make sure
that your doctor is aware of this.

If you stop using Novimp

Children

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

Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without prescription.
Driving and using machines

6. Further information

1

3

Novimp is a medicine that acts like a hormone. It belongs
to a group of medicines called LHRH agonists. It reduces
the production of the male sexual hormone (testosterone) or the female sexual hormone (oestrogen) in the
body.
Novimp is used in men to treat prostate cancer.


Generally the treatment with Novimp is a long-term
treatment.
It is important that you keep on receiving your treatment,
even if you are feeling well, unless your doctor decides
that it is time to stop the treatment.

Using other medicines

We do not know whether Novimp could affect your
ability to drive a car or operate machines.

WHAT NOVIMP IS
AND WHAT IT IS USED FOR

Please talk to your doctor if you think the 4-weekly use
of Novimp has been forgotten.

Previous treatment

Novimp must not be used in children.



If you forget to use Novimp


HOW TO USE NOVIMP

The implant is given as an injection under the skin on
your stomach by your doctor.
Novimp should be given every month (four weeks).
Always remind your doctor or nurse to set up an
appointment for your next injection.
This dosage is the same for patients with impaired
kidney or liver function and for elderly patients.

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POSSIBLE SIDE EFFECTS

Like all medicines, Novimp can cause side effects,
although not everybody gets them.
Frequencies of side effects are defined as:
Very common: more than 1 in 10 treated patients
Common: more than 1 in 100 treated patients
less than 1 in 10 treated patients
Uncommon: more than 1 in 1000 treated patients
less than 1 in 100 treated patients
Rare: more than 1 in 10,000 treated patients
less than 1 in 1000 treated patients
Very rare: 1 or less in 10,000 treated patients
including isolated reports

General
Cardiac disorders:
Uncommon: too low or too high blood pressure

Nervous system disorders:
Very common: tingling in fingers or toes
Very rare: severe headaches, sickness, loss of
eyesight or unconsciousness caused if
there is tumour in the pituitary gland
that bleeds or collapses
Skin and subcutaneous tissue disorders:
Common:
mild skin rash

5

Marketing Authorisation Holder and Manufacturer


HOW TO STORE NOVIMP

Keep out of reach and sight of children.
Novimp should not be used after {abbreviation used
for expiry date} which is stated on the pouches and the
carton.

Acino AG
Am Windfeld 35
83714 Miesbach
Germany
Tel.: 0049 8025 2867 0
Fax: 0049 8025 2867 28

Do not store above 25° C. Store in the original package.

Musculoskeletal and connective tissue disorders:
Very rare:
pain in the joints

Do not use the implant or applicator if you notice that
the packaging is damaged.

This medicinal product is authorised in the Member
States of the EEA under the following names

General disorders and administration site conditions:
Rare:
local reactions at the injection site

After opening the pouch the product should be used
immediately.

Immune system disorders:
Rare: allergic reactions, including the
symptoms of an immediate allergy

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.

Germany:
Austria:
Italy:
Spain:
United Kingdom:

This leaflet was last approved in: June 2009.

At the beginning of the treatment
certain symptoms may occur:
Nervous system disorders:
Very rare:
lower back pain
Renal and urinary disorders:
Very rare:
problems with passing urine
Musculoskeletal and connective tissue disorders:
Common:
bone pain

During treatment the following
symptoms may occur:
Nervous system disorders:
Very rare:
benign tumors of the pituitary gland

Novimp 3.6 Implant
Novimp 3.6 Implant
Novimp 3.6 Implant
Novimp 3.6 Implant
Novimp 3.6 Implant

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Notes for the doctor:

FURTHER INFORMATION

1. Novimp consists of two pouches, the sterile
injection needle and the sterile applicator. Note
that the implant is visibly fixed in the injection
needle. Open both pouches and connect the injection needle to the applicator via the Luer lock.
Make sure that the connection is tight and that
the plunger remains unchanged in its position.

What Novimp contains
The active substance is Goserelin.
1 Implant contains 3.6 mg goserelin
(as goserelin acetate).
The other ingredient is Poly(D,L-lactide-co-glycolide).

What Novimp looks like and contents of the pack

2. Check that the implant is visible in the control
window in the needle.

The package contains:

3. Remove the locking device from the plunger.
Insert the cannula into the anterior abdominal
wall and insert the implant by depressing the
plunger completely.

Reproductive system and breast disorders:
Very common: reduced sex drive, reduction in the size
of the testicles
Common:
breast swelling
Very rare:
breast tenderness

One pouch including one sterile injection needle and a
desiccant.

In addition please pay attention to the detailed
application advice on the outer pack.

Treatment with Novimp may affect the strength of your
bones. Therefore you may have a higher risk of suffering
from bone fractures than usual.

Not all pack sizes may be marketed.

Endocrine disorders:
Very common: hot flushes and sweating

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

Novimp is a sterile, cylindrical, white to cream coloured
implant placed in a sterile injection needle.

One pouch including one sterile applicator.
Novimp is available in packs of 1, 3 and 6 implants.



By bikkinav at 3:40 pm, Aug 15, 2011
POM
PL 21806/0007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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