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GESTONE 100MG/2ML

Active substance(s): PROGESTERONE

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Gestone PIL V4 (Manufac's).qxp

16/6/10

16:01

Page 1

By Adeyanju Patrick at 4:34 pm, Sep 13, 2010

5. HOW TO STORE YOUR
MEDICINE
Keep out of the reach and sight of
children.
Store your medicine in the original
package to protect it from light. Store at
room temperature (15-25˚C). During
storage, solid matter may form in the
ampoule.This should be re-dissolved by
warming the ampoule before use.
On the label you will find the letters
“EXP” followed by some numbers.
These numbers are the date when the
medicine is no longer fit for use. Do not
use this medicine after this date.
Medicines should not be disposed of via
waste water or household waste. Ask
your pharmacist how to dispose of
medicines which you no longer require.
These measures will help to protect the
environment.

6. FURTHER INFORMATION
What Gestone 50mg/ml &
100mg/2ml ampoules contain
Each ampoule of Gestone 50mg/ml
contains 50mg of Progesterone in 1ml of
liquid. Each ampoule of Gestone
100mg/2ml contains 100mg of
Progesterone in 2ml of liquid.
The ampoules also contain benzyl
alcohol and ethyl oleate.
What Gestone 50mg/ml &
100mg/2ml ampoules look like and
contents of the pack
Gestone 50mg/ml & 100mg/2ml is a
sterile, pale yellow oily liquid. It is
supplied in clear glass ampoules in packs
containing 10 ampoules.
Marketing Authorisation Holder
Nordic Pharma Limited, Abbey House,
1650 Arlington Business Park,Theale,
Reading, RG7 4SA, United Kingdom
Manufacturers
Recipharm Limited,
Vale of Bardsley, Ashton-under-Lyne,
0L7 9RR, United Kingdom
and
SCM Pharma Limited,
Unit 6, Regents Drive,
Low Prudhoe Industrial Estate,
Prudhoe, Northumberland, NE42 6PX,
United Kingdom
This leaflet was prepared in June 2010

GESTONE® 50mg/ml and 100mg/2ml
Package leaflet:
INFORMATION FOR THE USER
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, 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 YOUR MEDICINE IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE YOUR MEDICINE
3. HOW TO USE YOUR MEDICINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE YOUR MEDICINE
6. FURTHER INFORMATION

This leaflet has been prepared for patients by:
Nordic Pharma Ltd., Abbey House, 1650 Arlington Business Park,Theale,Reading RG7 4SA United Kingdom
GESTONE is a registered trade mark.
GESTONE 50mg/ml PL 05827/0012 100mg/2ml PL 05827/0013

ml

Gestone PIL V4 (Manufac's).qxp

1. WHAT YOUR MEDICINE IS AND
WHAT IT IS USED FOR
The name of your medicine is Gestone
50mg/ml & 100mg/2ml.The active
ingredient of Gestone 50mg/ml &
100mg/2ml is Progesterone (a hormone
which acts on the lining of the uterus
and is produced naturally by the body).
Each ampoule of Gestone 50mg/ml
contains 50mg of Progesterone in 1ml of
liquid. Each ampoule of Gestone
100mg/2ml contains 100mg of
Progesterone in 2ml of liquid.
It may be prescribed in women for the
following conditions:• To help early pregnancy to continue
in cases where the body is not
producing enough progesterone and
where there have been 3 or more
unexplained miscarriages
• In selected cases, to assist infertility
treatment techniques such as in-vitro
fertilisation (IVF) or gamete intrafallopian transfer (GIFT)
• Bleeding disorders of the uterus

2. BEFORE YOU USE YOUR
MEDICINE
Do not use Gestone 50mg/ml &
100mg/2ml if
• you are allergic to progestins, or any
of the ingredients of this medicine
• you are suffering from vaginal
bleeding other than during periods
• you have ever had a missed or
incomplete abortion
• you have, or have ever had, breast
cancer or cancer of the reproductive
tract
• you have redness, swelling or pain of
the veins or any other related problem
• you have ever had a stroke, or
bleeding in the brain
• you have liver disease
Tell your doctor if any of the above
conditions apply to you, before you use
Gestone 50mg/ml & 100mg/2ml.

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Take Special Care (check with your
doctor) with Gestone 50mg/ml &
100mg/2ml if
• you have high blood pressure,
heart disease or kidney disease
• you have epilepsy
• you suffer, or have ever suffered,
from mental depression
• you are diabetic
• you suffer from porphyria
• you are breast feeding a child
• you have a sensitivity to light
• you suffer from migraine attacks
• you are having regular blood tests
to check your liver or hormones
(Gestone 50mg/ml or 100mg/2ml
may interfere with these tests)
Taking other medicines
Please inform your doctor or pharmacist
if you are taking, or have recently taken,
any other medicine – even those which
your doctor has not prescribed for you,
but which you may have bought yourself
without a prescription.
Before using Gestone 50mg/ml &
100mg/2ml please check with your
doctor if you are taking any of the
following :• bromocryptine
• ciclosporin
Driving and using machines
It is not known whether Gestone
50mg/ml & 100mg/2ml affects your
ability to drive or operate machinery. Do
not drive or operate machinery if you
feel sleepy after using Gestone 50mg/ml
& 100mg/2ml.

3. HOW TO USE YOUR
MEDICINE
Gestone 50mg/ml & 100mg/2ml will be
given to you by a doctor or nurse.The
number of injections given to you per
day or per week is called the ‘dose’.
Depending on which condition you are
being treated for, the doctor will give
the appropriate dose by injection into a
muscle (this should be deep into the
buttock).
The most common dose for bleeding of
the uterus is 5-10mg daily for 5-10 days
until 2 days before the anticipated start
of a menstrual period.
The most common dose for maintaining
pregnancy is twice weekly (or more
frequent) injections of 25-100mg
starting from about day 15, or day of
transfer of embryo or gametes, usually
until 6-8 weeks of pregnancy when
secretion of progesterone from the
placenta should be established.The
maximum frequency of injections should
be once a day.
Daily dosage can be increased to 200mg
at the discretion of your doctor.The
correct dose will have been decided by
your doctor. If you are not sure ask your
doctor.
The use of Gestone 50mg/ml &
100mg/2ml is only for women of child
bearing age.There are no appropriate
dosage recommendations for children or
the elderly.
If you think that you have missed a
dose or have been given too much
Gestone 50mg/ml & 100mg/2ml,
please tell a nurse or doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gestone 50mg/ml &
100mg/2ml can cause side effects,
although not everybody gets them.
If any of the following side effects occur
suddenly, or gradually, without explanation,
contact the doctor or your nearest hospital
casualty department at once:• problems with vision (such as blurred
vision, partial vision, sudden shortsightedness or complete loss of vision)
• any swelling of the eye
• migraine type headache
If you experience one or more of the
following side effects, or any other
undesirable effects, please tell a nurse or
doctor:• breakthrough bleeding, changes in
period flow, missed periods, changes
in vaginal secretions
• breast changes
• fluid retention with swelling
• weight gain
• weight loss
• jaundice
(yellowing of the skin or eyes)
• allergic reactions (skin rash, or sudden
pain, swelling, shortness of breath or
fever)
• acne
• dark colouration of the skin on the
face
• mental depression
• fever
• sleep disturbance (difficulty with
sleeping at night, or falling asleep
during the day)
• nausea
• hair loss from the scalp
• excessive hair growth on the face or
body
• local irritation (reactions) at the site
of injection.
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

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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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