DECAPEPTYL SR 3MG POWDER FOR SUSPENSION FOR INJECTION

Active substance: TRIPTORELIN

View full screen / Print PDF » Download PDF ⇩

Transcript
Read all of this leaflet carefully before you start using this medicine.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
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 become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Decapeptyl SR is and what it is used for
2. Before you are given Decapeptyl SR
3. How Decapeptyl SR is given
4. Possible side effects
5. How to store Decapeptyl SR
6. Further Information

1.

What Decapeptyl SR is and What it is Used For

The active ingredient in Decapeptyl SR is triptorelin. Triptorelin belongs to a group of medicines called
gonadotropin releasing hormone (GnRH) agonists. Triptorelin is similar to the gonadotropin releasing
hormone which occurs naturally in your body. In men, triptorelin lowers the levels of the hormone
testosterone. In women, it reduces oestrogen levels.
Decapeptyl SR is used in men and women to treat completely different conditions. Decapeptyl SR is
available in two other strengths: Decapeptyl SR 11.25mg is used once every 3 months and Decapeptyl SR
22.5mg is used once every 6 months. Not all dose strengths are approved for all indications. Ask your doctor
if you would like to discuss changing your treatment.
This leaflet gives information for the use of Decapeptyl SR in men and women. Please read the column
that is about you and your condition.
Me
Women
In men, Decapeptyl SR is used to treat prostate
In women, Decapeptyl SR is used to treat:
cancer.
x Endometriosis - a condition in which the
tissue that normally lines the uterus
(endometrium) grows in other places.
x Uterine fibroids- abnormal (benign)
growth of cells in your uterus.

2.

Before You Are Given Decapeptyl SR

Men
You should not be given Decapeptyl SR:
x if you know that you are allergic to triptorelin or
similar types of drugs (other GnRH agonists) or
any of the other ingredients. (Go to Section 6
'What Decapeptyl contains' for a list of the other
ingredients.)

Women
You should not be given Decapeptyl SR:
x if you know that you are allergic to triptorelin or
similar types of drugs (other GnRH agonists) or
any of the other ingredients. (Go to Section 6
'What Decapeptyl contains' for a list of the other
ingredients.)
x if you are pregnant or breast-feeding.

Take special care with Decapeptyl SR:
There have been reports of depression in patients
taking Decapeptyl SR which may be severe. If you
are taking Decepeptyl SR and develop depressed
mood, inform your doctor.
If you are using medicines for preventing your blood
clotting, you may experience bruising at the site of
injection.
In adults if triptorelin or other GnRH agonists are
used for a long period of time you may increase the
risk of developing thin or weak bones, especially if
you are a heavy drinker, a smoker, have a family
history of osteoporosis (a condition that affects the
strength of your bones), have a poor diet or take
anticonvulsants (medicines for epilepsy or fits) or
corticosteroids (steroids). If you have anything
wrong with you that affects your bones, such as
osteoporosis, tell your doctor. This may affect the
way your doctor decides to treat you.

Take special care with Decapeptyl SR:
There have been reports of depression in patients
taking Decapeptyl SR which may be severe. If you
are taking Decepeptyl SR and develop depressed
mood, inform your doctor.
If you are using medicines for preventing your blood
clotting, you may experience bruising at the site of
injection.
In adults if triptorelin or other GnRH agonists are
used for a long period of time you may increase the
risk of developing thin or weak bones, especially if
you are a heavy drinker, a smoker, have a family
history of osteoporosis (a condition that affects the
strength of your bones), have a poor diet or take
anticonvulsants (medicines for epilepsy or fits) or
corticosteroids (steroids). If you have anything
wrong with you that affects your bones, such as
osteoporosis, tell your doctor. This may affect the
way your doctor decides to treat you.

When you first start treatment with Decapeptyl SR it
actually increases the level of your hormones for a
short time. This means that you may feel worse to
begin with (see Section 4. 'Possible Side Effects' for
more information). The doctor may give you some
medicine (an anti-androgen) to prevent your
symptoms from getting worse. After a short time the
amount of hormone will drop and your symptoms
will get better.
During the first weeks of treatment, Decapeptyl SR
may, as with other GnRH agonists, in isolated cases,
cause the spinal cord to compress or the urethra
(where you pass urine) to block. You will be
monitored by your doctor and given treatment for
these conditions if they occur.
If you have some problems with your heart rhythm
(irregular heartbeat), or are being treated with
medicines for this condition, inform your doctor.
The risk of heart rhythm problems may be increased
when using therapies to reduce testosterone.If you
have diabetes, or if you suffer from heart problems,
inform your doctor.
If you have an enlargement (benign tumour) of the
pituitary gland that you were unaware of, this may
be discovered during treatment with Decapeptyl SR.
Symptoms include sudden headache, problems with
eye sight and paralysis of the eye muscles.
Tell your doctor if you:
x notice blood in your urine or if you find it difficult
or painful to urinate.
x Have back pain, weakness, numbness or tingling
in your legs.
Your doctor may give you another drug to help you
feel better during this time.

You may have some vaginal bleeding in the first
month of treatment. After that your periods
normally stop.
Tell your doctor if you have bleeding after the first
month of treatment.
Your periods should start about 2 months after the
last injection. You must use some form of
contraception other than the ’pill’ while you are
having treatment and until you start your next
period. Your doctor may suggest using a barrier
method of contraception such as a condom or
diaphragm (cap).
If you have diabetes, or if you suffer from heart
problems, inform your doctor.
If you have an enlargement (benign tumour) of the
pituitary gland that you were unaware of, this may
be discovered during treatment. Symptoms include
sudden headache, problems with eye sight and
paralysis of the eye muscles.

Taking other medicines:
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicine including medicines obtained without a prescription
Drugs which increase the level of a hormone called
prolactin may react with Decapeptyl SR. Many
different kinds of drugs may increase prolactin
levels.
Since therapies reducing testosterone may influence
the heart rhythm, your doctor should carefully
evaluate your use of other medicines which can have
an effect on heart rhythm (e.g. quinidine,
procainamide, amiodarone, sotalol).

Taking other medicines:
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicine including medicines obtained without a prescription.
Drugs which increase the level of a hormone called
prolactin may react with Decapeptyl SR. Many
different kinds of drugs may increase prolactin
levels.

Pregnancy and breast feeding:
Do not take Decapeptyl SR if you are pregnant or
breast feeding.
Driving and using machines:
You may feel dizzy, tired or have problems with
your sight such as blurred vision. These are possible
side effects of treatment or from the underlying
disease. If you experience any of these side effects
you should not drive or use machines.

3.

Driving and using machines:
You may feel dizzy, tired or have problems with
your sight such as blurred vision. These are possible
side effects of treatment or from the underlying
disease. If you experience any of these side effects
you should not drive or use machines.

How Decapeptyl SR is Given

Men
Decapeptyl SR 3mg will be injected into a muscle,
usually your bottom, by a doctor or nurse.
On this leaflet there are instructions for them that
explain how to prepare the injection.

Women
Decapeptyl SR 3mg will be injected into a muscle,
usually your bottom, by a doctor or nurse.
On this leaflet there are instructions for them that
explain how to prepare the injection.

You will normally receive an injection once every 28
days.

You will normally receive one injection every 28
days. This injection should be given in the first 5
days of your menstrual cycle.
If you are being treated for uterine fibroids you
should be treated for at least 3 months.

Also read 'Taking other medicines' in section 2.

You should not need to be treated for more than 6
months.
Also read 'Taking other medicines' in section 2.
If you are given more Decapeptyl SR than you
should:
If you are given too much Decapeptyl SR you may
experience additional or more severe side effects
(see Section 4. 'Possible Side Effects').
If you forget to take a dose of Decapeptyl SR :
As soon as you realise that you have missed an
injection you should tell your doctor. You will then
be given your next injection.

If you are given more Decapeptyl SR than you
should:
If you are given too much Decapeptyl SR you may
experience additional or more severe side effects
(see Section 4. 'Possible Side Effects').
If you forget to take a dose of Decapeptyl SR :
As soon as you realise that you have missed an
injection you should tell your doctor. You will then
be given your next injection.

If you stop receiving Decapeptyl SR:
If you stop receiving your Decapeptyl SR injection
before your doctor tells you to then your symptoms
are likely to return.

If you stop receiving Decapeptyl SR:
If you stop receiving your Decapeptyl SR injection
before your doctor tells you to then your symptoms
are likely to return.

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

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

4.

Possible Side Effects

Men
Women
Like all medicines, Decapeptyl SR can have side effects although not everybody gets them. In rare
cases you may experience a severe allergic reaction. Tell your doctor immediately if you develop
symptoms such as swallowing or breathing problems, a rash, swelling of your lips, face, throat or
tongue.
Many of the side effects are expected, due to the
At the beginning of treatment the symptoms of
change in the level of testosterone in your body.
uterine fibroids and endometriosis (pelvic pain,
These effects include hot flushes, impotence and
painful periods) may be worse. These symptoms
decreased libido.
should disappear in one or two weeks.
Side effects which are very common (more than 1 in
10 patients treated) are hot flushes, weakness,
excessive sweating, back pain, pins and needles
sensation in the legs.
At the beginning of treatment, increased bone pain,
getting blood in your urine, back pain, weakness and
numbness or tingling in your legs are common (see
Section 2 “Take special care with Decapeptyl SR”).
Side effects which are common (less than 1 in 10
patients treated) are nausea, tiredness, redness,
bruising and/or pain at injection site, muscle and
bone pain, pain in arms/legs, oedema (build-up of
fluid in the body tissues), dizziness, headache,
decreased sex drive, impotence, depression and mood
changes.
Side effects that are uncommon (less than 1 in 100
patients treated) are ringing in the ears, pain in
abdomen, constipation, diarrhoea, vomiting,
drowsiness, shaking, sleepiness, pain, some blood
tests affected (including raised liver function tests),
increase in weight, weight loss, gout (severe pain and
swelling in the joints usually in the big toe),
increase in appetite, joint pain, muscle cramp, muscle
weakness, muscle pain, tingling or numbness,
inability to sleep, irritabilitydevelopment of enlarged
breasts in men, breast pain, reduction in testicular
size, pain in testicles, difficulty in breathing, acne,
hair loss, itching, rash, high blood pressure.
Side effects that are rare (less than 1 in 1000 patients
treated) are red or purple discolorations on the skin,

Many of the side effects are expected due to the
change in the level of oestrogens in your body.
Side effects which are very common (more than 1
in 10 patients treated) include headache, decreased
libido, mood changes, difficulty in sleeping, pain
during or after sexual intercourse, painful periods,
vaginal bleeding, pelvic pain, vaginal dryness,
excessive sweating and hot flushes.
Side effects which are common (less than 1 in 10
patients treated) are breast pain, muscle cramps,
painful joints, weight gain, feeling sick, depression,
stomach pain or discomfort, redness or inflamation
and/or pain at the injection site.
Other reported side effects are: vomiting, diarrhoea,
nose bleeds, general discomfort, increased blood
pressure, muscle pain and weakness, anxiety,
confusion, dizziness, absence of periods, swelling of
your lips, face, throat and /or tongue, skin rash,
difficulty in breathing, abnormal sensation in the eye
and/or changes in sight.
You may have some thinning or weakening of bone
during treatment. This is thought to be reversible.
Rarely, surgery for vaginal bleeding has been
needed in patients treated for uterine fibroids.
If you have uterine fibroids your doctor will check
your response to treatment carefully. If you do not
respond to treatment your doctor may do more tests.

diabetes, vertigo, abnormal sensation in the eye,
blurring or disturbance in vision, sensation of fullness
in the abdomen, flatulence, dry mouth, abnormal
sense of taste, chest pain, difficulty in standing, flulike symptoms, fever, allergic reaction, anaphylactic
reaction (serious allergic reaction which can cause
dizziness or difficulty in breathing), inflammation of
the nose/throat, increased body temperature, weight
loss, stiff joints, joint swelling, musculoskeletal
stiffness, osteoarthritis, memory loss,
feeling confused, decreased activity, having a feeling
of elation or well-being, inability to ejaculate ,
shortness of breath when lying flat, blisters, nose
bleeds, low blood pressure.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.

General discomfort has also been reported.
An increase in white blood cell count may be found,
as with other GnRH analogues, in patients being
treated with Decapeptyl SR.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5.

How to Store Decapeptyl SR

Keep Decapeptyl SR out of the reach and sight of children.
Do not use the vial or ampoule after the expiry date printed on the box.
This medicinal product should not be stored above 250C. The vial and ampoule should be kept in the outer
box.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help to protect the environment.

6.

Further Information

What Decapeptyl SR contains:
The active substance of Decapeptyl SR is triptorelin. Each vial contains sufficient quantity of triptorelin (as
triptorelin acetate) to ensure that the minimum triptorelin quantity injected is 3mg.
The other ingredients are d,l lactide-glycolide copolymer, mannitol, carmellose sodium, polysorbate 80.
What Decapeptyl SR looks like and contents of the pack
Each pack contains:
1 clear glass vial with a rubber stopper and an aluminium cap containing the powder.
1 glass ampoule containing the suspension vehicle.
1 syringe
2 needles
Marketing Authorisation Holder
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK.
Manufacturer
Ipsen Pharma Biotech, Signes, France.

Is this leaflet hard to see or read? Please phone 01753 627777 to ask for help.
This leaflet was last revised in December 2013.

Expand view ⇕

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.

Hide
(web2)