CLOMID 50MG TABLETS

Active substance: CLOMIFENE CITRATE

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VERSO

RECTO

A1-13/03/06

Clomid® 50mg Tablets

1

clomifene citrate

3

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

Responsable: Mr FRANC Pascal
Patheon France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93 88 37 fax.: 04 74 93 87 81

CODE LAETUS : 561

Taille mini du texte : 10 pt

DU NOIR

Reflex Blue

In this leaflet:
1. What Clomid is and what it is used for
2. Before you take Clomid
3. How to take Clomid
4. Possible side effects
5. How to store Clomid
6. Further Information
1.  hat Clomid is and what
W
it is used for
Clomid contains a medicine called
clomifene citrate. This belongs to a group
of medicines called ovulation stimulants.
It works by stimulating the release of eggs
from the ovary (ovulation).
Clomid is used for some types of
infertility, in women who are not
ovulating properly.
2. Before you take Clomid

Recto

RECTO / VERSO
EN ROULEAU / P. 1

LAIZE
135 mm

DIMENSIONS
210 x 135 mm

Great Britain

CRGB-V1-05/2012

Country version
Logo version
trames:
couleur(s) pantone
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression :

PACKAGE LEAFLET:
INFORMATION FOR THE USER

I
 s this leaflet hard to see or read?
Phone 01483 505515 for help

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057960)
NOTICE Double
(L04)
CLOMID 50 mg / comprimés / Angleterre
V3_30 SEP 2013
CODE ARTICLE
7060821

TEXTE TEXTE

Before you take the medicine
talk to your doctor about the
risks of:
  ecoming pregnant with more
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than one child at the same time
(multiple pregnancies)
  regnancies where the baby grows
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outside of the womb (ectopic)
  possible increased risk of ovarian
A
cancer

DÉFILEMENT

Any pregnancy could lead to birth
defects or miscarriage. This can happen
even if you are not taking Clomid. You
should talk to your doctor about the
possible risks before you take Clomid.
D
 o not take this medicine and
tell your doctor if:
×  ou are allergic (hypersensitive)
Y
to clomifene or any of the other
ingredients of Clomid (listed in
Section 6 below).
Signs of an allergic reaction
include: a rash, swallowing or
breathing problems, swelling of
your lips, face, throat or tongue
× You have or ever had liver disease
×  ou have unusual menstrual bleeding
Y
where the cause is not known
×  ou have a type of cancer that is
Y
made worse by hormones
× You have a cyst on your ovary
×  ou are pregnant. You should have
Y
a test to make sure you are not
pregnant before you take Clomid
Do not take this medicine if any of
the above apply to you.
Take special care with Clomid
Check with your doctor or
pharmacist before taking your
medicine if:
  ou are having an early
Y
menopause or have been told you
are infertile
  ou have stopped having periods
Y
because you are under-weight
  ou have had fits or seizures in the past
Y
 You have ‘fibroids’ in your womb
 You have ‘polycystic’ ovaries
 Your ovaries are swollen
  ou have hypertriglyceridemia
Y
(an excess of fats in the blood)
or a family history of
hypertriglyceridemia.

CODE ARTICLE
7060821

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057960)
NOTICE Double
(L04)
CLOMID 50 mg / comprimés / Angleterre
V3_30 SEP 2013
DU NOIR

trames:
couleur(s) pantone
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression :

Reflex Blue

DÉFILEMENT

Verso

Important information about some
of the ingredients of Clomid
This medicine contains lactose and
sucrose, which are types of sugar. If
you have been told by your doctor
that you can not tolerate some sugars,
talk to your doctor before taking
Clomid.

CODE LAETUS : 561

Driving and using machines
You may notice problems with your
eyesight such as blurred vision while
taking this medicine. If this happens,
do not drive or use any tools or
machines.

LAIZE
135 mm

Ask your doctor or pharmacist for
advice before taking any medicine if
you are pregnant or breast-feeding.

PLI / COLLE

Pregnancy and breast-feeding
•  o not take this medicine if you
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are pregnant or think you may be
pregnant
•  alk to your doctor before taking this
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medicine if you are breast-feeding
or planning to breast-feed. Clomid
can lower the amount of milk
produced

Responsable: Mr FRANC Pascal
Patheon France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93 88 37 fax.: 04 74 93 87 81

Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines. This
includes medicines you buy without
a prescription, including herbal
medicines. This is because Clomid can
affect the way some other medicines
work. Also some medicines can affect
the way Clomid works.

DIMENSIONS
210 x 135 mm

If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Clomid.

3. How to take Clomid
Always take Clomid exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
Taking this medicine
• Take this medicine by mouth
•  wallow the tablets whole with
S
a drink of water. Do not crush or
chew your tablets
•  o not take more than two tablets
D
in one day
•  o not take the tablets for more
D
than five days at a time
•  f you feel the effect of your
I
medicine is not working, do not
change the dose yourself, but ask
your doctor
The usual dose is:
Adult women only:
•  our doctor will tell you when
Y
in your menstrual cycle to start
taking the tablets
•  or the first course of treatment,
F
take one tablet a day for five days
•  f you do not have a period after
I
the first course of treatment your
doctor will increase your dose to
two tablets a day for five days
•  ou should start this second
Y
course at least 30 days after the
first course
•  ou will not usually take more
Y
than three courses of treatment.
If ovulation does not happen after
three courses talk to your doctor
This medicine should not be taken
by children, adolescents, men or
women who have already gone
through the menopause (postmenopausal).
If you take more Clomid than you
should
If you take more Clomid than you
should, tell a doctor or go to a
hospital casualty department straight
away. Take the medicine pack with
you. This is so the doctor knows what
you have taken. You are likely to get
over-stimulation of your ovary (see
section 4 below).

RECTO / VERSO
EN ROULEAU / P. 2

Your doctor should check for any
other causes of fertility problems
before starting treatment with Clomid.

CODE LAETUS : 561

DU NOIR

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

Recto

RECTO / VERSO
EN ROULEAU / P. 3

PLI / COLLE

Responsable: Mr FRANC Pascal
Patheon France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93 88 37 fax.: 04 74 93 87 81
DIMENSIONS
210 x 135 mm

Reflex Blue

LAIZE
135 mm

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057960)
NOTICE Double
(L04)
CLOMID 50 mg / comprimés / Angleterre
V3_30 SEP 2013
CODE ARTICLE
7060821

trames:
couleur(s) pantone
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression :

If you forget to take Clomid
If you forget a dose, talk to your doctor
as you may need to change your
treatment cycle. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking Clomid
Keep taking Clomid until your doctor
tells you to stop. If you stop, the
treatment may not work.

4. Possible side effects
Like all medicines, Clomid can cause
side effects, although not everybody
gets them.
Stop taking Clomid and see your
doctor or go to a hospital straight
away if:
•  ou have an allergic reaction.
Y
The signs may include: a rash,
swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
•  ou have numbness, weakness or
Y
paralysis on one side of your body,
slurred speech, sudden blurred
vision, confusion or unsteadiness.
These could be signs of a stroke
Stop taking Clomid and see a
doctor straight away if you notice
any of the following serious side
effects - you may need urgent
medical treatment:
•  ver-stimulation of the ovary.
O
This can lead to pain in the
pelvis, stomach or calf, swelling
or feeling bloated, passing less
urine, difficulty in breathing or an
increase in weight. If this happens,
your doctor may lower your dose
of Clomid
•  lurring of vision or spots or
B
flashes in front of the eyes . These
symptoms usually get better
but in some cases they may be
permanent. Your doctor may send
you for an eye examination.

DÉFILEMENT

•  iver problems that may cause the
L
eyes or skin to go yellow (jaundice)
• Sudden and severe headaches
• Mental illness such as ‘psychosis’
Tell your doctor or pharmacist if
any of the following side effects get
serious or lasts longer than a few
days:
•  ncreased pain with periods, heavy
I
periods or bleeding between
periods
•  ain in the lower part of the
P
stomach. This could be a sign of
endometriosis or worsening of
endometriosis, ovarian cancer or
enlarged ovaries
•  hinning of the layer covering the
T
inside of the uterus.
•  ncreased levels of fat in the blood
I
(hypertriglyceridaemia) which may
also cause inflammation of the
pancreas.
•  ain in the upper middle or upper
P
left part of the abdomen. This
could be a sign of inflammation of
the pancreas (pancreatitis).
• Cloudy lenses in the eye (cataracts)
•  its, feeling faint, disorientated
F
or more tense than normal. Also,
balance problems or feeling dizzy
(vertigo)
•  eeling tired or difficulty in
F
sleeping (insomnia), depression or
change in moods or behaviour
•  apid or irregular heartbeat
R
• Speech problems
• Skin rash or itching
• Feeling or being sick
• Flushing of the skin
• Headaches
•  welling of the face, around the
S
eyes, lips or tongue
• Painful breasts
• Hair loss or thinning
There have been rare reports of
ovarian cancer with fertility drugs.
Some studies suggest that prolonged
use of clomifene may increase this
risk. Therefore the recommended
duration of treatment should not be
exceeded.

CODE ARTICLE
7060821

LAIZE
135 mm

DIMENSIONS
210 x 135 mm

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057960)
NOTICE Double
(L04)
CLOMID 50 mg / comprimés / Angleterre
V3_30 SEP 2013
DU NOIR

trames:
couleur(s) pantone
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression :

Reflex Blue

CODE LAETUS : 561

DÉFILEMENT

7060821

Verso

6. Further information
What Clomid contains
•  ach tablet contains 50mg of the
E
active substance, clomifene citrate
•  he other ingredients are sucrose,
T
lactose, soluble starch, maize
starch, magnesium stearate, iron
oxide yellow (E172), purified water
What Clomid looks like and contents of
the pack
Clomid 50mg Tablets are beige
and round marked with M in two
circles. They are supplied in PVC and
aluminium blister packs. Pack sizes 30
or 100 tablets.

Responsable: Mr FRANC Pascal
Patheon France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93 88 37 fax.: 04 74 93 87 81

5. How to store Clomid
Keep out of the reach and sight of
children.
Store in original container below
25ºC.
Do not use Clomid after the expiry
date which is stated on the carton.
The expiry date refers to the last day
of that month.
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.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.
com
Manufacturer
Patheon France, 40 boulevard de
Champaret, 38300 Bourgoin-Jallieu,
France.
This leaflet does not contain all the
information about your medicine.
If you have any questions or are not
sure about anything, ask your doctor
or pharmacist.
This leaflet was last revised in
August 2013
© Sanofi 1966 - 2013

RECTO / VERSO
EN ROULEAU / P. 4

sens lecture
code laetus

Talk to your doctor or pharmacist if
any of the side effects gets serious or
lasts longer than a few days or if you
notice any side effects not listed in
this leaflet.
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 the 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.

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.

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