Prolutex contains the active ingredient Progesterone.
Progesterone is a naturally occurring female sex
hormone. The medicine works on the lining of the
womb and helps you to become pregnant and to
stay pregnant.
Prolutex is for women who need extra progesterone
while undergoing treatment in an Assisted
Reproductive Technology (ART) programme who are
unable to use or tolerate vaginal preparations.

• If you are allergic (hypersensitive) to
progesterone or any of the other
ingredients of Prolutex
• If you are suffering from vaginal bleeding
(other than normal periods) that has not
been eVBiuated by your doctor
• If you have a miscarriage and your doctor
suspects some tissue is still in the womb
If you have had a pregnancy outside of
the womb (ectopic pregnancy)
• If you currently have or have had severe
liver problems
• If you have known or suspected breast
cancer or cancer of the naproductive tract If you have or have had blood dots in the
legs, lungs, eyes or elsewhere in the
body
• If you have porphyria disorders (a group
of inherited or acquired disorders of
certain enzymes)
• If during pregnancy you have suffered
from jaundice (yellowing of eyes and skin
due to liver problems) severe itching
and/or blisters on the skin
• If you are under 18 years of age.
Taka special a;re with Prolutex
If you experience any of the following during
treatment tell your doctor immediately as your
treatment may need to be stopped. Also tell your
doctor immediately if you experience these a few
days after the last dosage:
• Heart attack (pains in the chest, or back
pain and/or deep aching and throbbing
in one or both arms a sudden shortness
of breath, sweating, dizziness, lighthea
dedness, naseau, palpitations)
Stroke (severe headache or vomiting,
dizziness, faintness, or changes in vision
or speech, weakness or numbness of an
arm or leg.)
• Blood clots in the eyes or anywhere in
the body (pain in your eyes or pain and
swelling in your ankles, feet and hands)
• Worsening of depression
• Severe headaches, changes in vision.
Before treatment with Prolutex
Tell your doctor if you have had or have any of the
following before using Prolutex:
• Liver problems (mild or moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney problems
• Diabetes
• Depression
If any of the above applies to you, your doctor will
monitor you carefully during treatment.
Other medldnu and Prolutex
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription
and herbal medicines.
• Carbamazepine (used to treat
seizures/fits)
• Rifampin (an antibiotic)
• Griseofulvin (an antifungal medicine)
Phenytoin and Phenobarbital (used to
treat epilepsy)
• St. John's Wort-containing herbal
products.
• Ciclosporine(a medicine for some types
of inflammation and after organ
transplants)
• Diabetic medicines.
• Ketoconazole (an antifungal medicines)
Do not administer Prolutex at the same time as any
other injectable medicine.

Pregnancy and bruit-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
• Prolutex can be used during the first
thnae months of pregnancy.
• This medicine should not be used during
breast-feeding.
Driving and using machinas
Do not drive or use any tools or machines if you feel
drowsy and/or dizzy whilst taking Prolutex.

Always use Prolutex exactly as your doctor has told
you. Remember Prolutex should only be used under
the supervision of a doctor experienced in tnaating
fertility problems.
H- much Prolutex should you 11M and for hlong?
The usual dose is a once daily injection of 25 mg
usually until12 weeks of confirmed pregnancy (i.e.
1 0 weeks oftreatment).
H- Prolutex should be given
Prolutex can be given either under your skin
(subcutaneous injection) for doses of 25mg or into a
muscle (intramuscular injection) for doses of 25mg.
You will be able to administer 25 mg of Prolutex
subcutaneously after suitable advice and training by
your doctor or healtkcare professional.
Before you inject Prolutex you will receive the
following training and advice:
• Practice giving subcutaneous injections
• Where to inject your medicine
• How to prepare your solution for
injection
• How to administer your medicine.
Pleue read insti\ICI:ion below on preparation and
admlnilltnltion of Prolutex.
The steps for self-administration are:
A Preparing your injection
B Checking pack
C Preparing the vial and syringe
D Riling the syringe
E Changing the injecting needle
F Removing air bubbles
G Injection by subcutaneous administration
H Disposal of used items.
These steps are explained in full below.
IMPORTANT: each vial should only be used once.
The solutions should be used immediately after
opening the vial. It should not be stored in the
syringe.
A. Preparing your Injection
It is important to keep everything as clean as
possible, so start by washing your hands thoroughly and drying on a clean towel. Choose a clean area to
prepare your medicine:
• One vial containing Prolutex solut ion for
injection
The following items are not s upplied with your
medicine. Your doctor or pharmacist will supply
these items.
• One syringe
• One large needle (typically 21 G green
needle; for intramuscular administrat ion)
• One small fine needle (typically 27G grey
needle; for subcutaneous injection)
• Two alcohol wipes
• A sharps container (for safe disposal of
needles, vials etc.)
B. Checking pack
• The Prolutex vial, syringe and needles all
have protective covers.
• Check that all the covers are on firmly
and if they are not on properly or are
damaged, do not use them
• Make sure that the expiry date is still
valid on the vial of Prolutex. Do not use
the products if outside the expiry date.
C. Preparing the vial and syringe
•
•
•
• Remove the plastic cap from
the top of a Prolutex vial by gent ly
pushing it upwards.
• Wipe tke rubber top with an alcohol
wipe and allow to dry
Unpack the syringe, hold the syringe
Take tke packaging off the large 21G
green needle, but keep the needle cover
on
Hold the syringe in your hand, attach the
large 21 G green needle to the syringe,
then remove the needle cover
D. Filling die syringe
• Push the large 21 G green needle
through the rubber middle of the
Prolutex vial top
• With the needle still inserted, tum the
vial upside down. The needle should
support the vial unaided
• Make sure the large needle tip is
underneath the level of the liquid
• Gently pull the plunger to draw all the
mixture into the syringe
• Pull the large needle out of the vial.
E. Changing the lnjectfng needle
This step is only required if you are doing a
s ubcutaneous administration; if your doctor is
performing an intramuscular injection they will move
on to set the dose and administer the injection.
• Put the cap on the large 21 G green
needle and then gent ly take the large
needle off the syringe
• Remove the smalle r 27G grey injecting
needle, from its package, keeping the
needle cover on
• Attach the small 27G grey needle onto
the syringe then namove the needle
cover.
F. Removing air bubblas
• Holding the syringe straight up with the
small 27G grey needle pointing to the
ceiling, draw back slightly on the plunger
and tap the syringe so that any air
bubbles rise to the top.
Slowly press the plunger until all the air is
out of the syringe and at least one drop
of solution comes out of the tip of the
smaii27G grey needle
G. Injection by subcutaneous administration
• Your doctor or healthcare professional
will have already shown you where to
inject Prolutex (e .g. tummy or front of
thigh)
• Open the alcohol wipe and carefully
clean the area of s kin to be injected, and
allow it to dry
• Hold the syringe in one hand. Use the
othe r hand to gently pinch the s kin in the
injection site area between your thumb
and index finger
• Using a dart -like mot ion insert the fine
grade small 27G grey needle into the skin
so the skin and needle form a right angle.
• Insert the small 27G grey needle all the
way into the skin. Do not inject directly
into a vein
• Inject the solution by pushing gently on
the plunger in a slow and steady motion
until all the solution is injected beneath
the skin. Inject all of the prescribed
solution
• Release the skin and pull tke
needle straight out
• Wipe the skin at the injection
site with an alcohol swab using
a circular motion.
H. Disposal of uled Items
• Once you have finished your injection,
put all needles, empty vials and syringes
into a sharps container.
• Any unused solution must also be thrown
away.
Injection by intnmuiiCLIIar ec:lminildnltion given by
a doctor or healthcare profvulonal
For all intramuscular injections, your doctor or
another healthcare professional will perform the
injection.
The Prolutex injection will be given into the side of
the thigh or bottom. Your doctor or kealthcare
professional will clean the area of skin to be inje cted
using an alcohol wipe, and allow it to dry. Using a dart-like motion they will insert the large needle into
the muscle. They will inject the solution by pushing
gently on the plunger in a slow and steady motion
until all the solution is injected into the muscle. They
will pull the needle straight out and wipe the skin at
the injection s ite with an alcohol wipe.
If you 11M more Prolutex then you should
Tell your doctor or pharmacist. The symptoms of an
overdose include drowsiness.
If you forget to use Prolutex
Take the dose as soon as you remember and then
canry on as before. Do not take a double dose to
make up for a forgotten dose. Tell your doctor what
you have done.
If you stop using Prolutex
Do not stop using Prolutex without speaking to your
doctor or pharmacists first. Abrupt discontinuation of
Prolutex may cause increased anxiety, moodiness,
and increase your risk of having seizures (fits).
If you have any further questions on the
use of this product, ask your doctor or pharmacist.

Like all medicines, Prolutex can cause side effects,
although not everybody gets them_
Very common s ide effects (affecting up to 1 in 1 0 of
every patient treated):
• Pain, redness, itching, irritation or
swelling at the injection s ite
• Uterine spasm
• Vaginal bleeding.
Common lide effects (affect between 1 in 1 0 and 1
in 1 00 of every patients treated):
• Overstimulation of the ovaries (symptoms
include lower stomach pain, feeling
thirsty and s ick, and sometimes being
sick, passing reduced quantit ies of
concentrated urine and weight gain)
• Headache
• Bloated stomach
• Stomach pain
• Constipation
• Being sick and feeling sick
• Breast tenderness and/or pain
• Vaginal discharge
• A tingling or uneasy irritation or itching
of the skin of the vagina and the
surrounding area
Hardening of area around injection site
• Bruising around injection site
• Fatigue (excessive tiredness, exhaustion,
lethargy).
Uncommon side effects (affecting between 1 in 1 00
and 1 in 1 000 patients treated):
• Changes in mood
• Dizziness
Insomnia
• Stomach and int estinal disturbance
(Including stomach discomfort and/or tenderness, wind, painful spasms and
retching)
• Skin rashes (including red warm skin, or
raised, itchy bumps or wheals or dry,
cracked or blistered or swollen s kin)
• Breast swelling and/or enlargement
• Feeling hot
• General feeling of discomfort or "feeling
out of sorts"
• Pain.
The following disorders, although not reported by
patients in clinical studies using Prolutex, have been
described with other progestins: depression,
jaundice, insomnia, premenstrual like syndrome and
menstrual disturbances, urticaria, acne, hirsutism,
alopecia, weight gain and anaphylactoid reactions.
If any of the side effects gets serious, or if you notice
any s ide effects not listed in this leaflet, please tell
your doctor or pharmacist.
To report any side effe~
If you get any side effects, talk to your doctor or
pkannacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the national reporting system:
S..udl Ar•bla:
The National Pharmacovigilance and Drug Safety
Centre (NPC)
Fax: +966-11-205·7662
Call NPC at +966-11-2038222, Exts:
2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC Stllt:H:
Please contact the relevant competent authority.

Keep out of the sight and neach of children.
Store below 25oc_
Do not refrigerate or freeze.
Store in the original package in order to protect from
light.
This medicinal product must be used immediately
after first opening.
Any remaining solution must be discarded_
Do not use Prolutex after the expiry date whick is
stated on the label after Exp: The expiry date refers
to the last day of that month.
Do not use Prolutex if you notice particles in tke
solution or if the solution is not clear.
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 he lp to protect t he environment-