CLOMIFENE 50MG TABLETS

Active substance: CLOMIFENE CITRATE

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PACKAGE LEAFLET INFORMATION FOR
THE USER

Clomifene 50mg Tablets
Clomifene Citrate

• do not want to risk having a multiple pregnancy.
The chance of having multiple pregnancies
(mainly twins, sometimes triplets, but very
occasionally even more babies) is increased by
clomifene therapy.
Before you take Clomifene Tablets, other possible
causes of infertility, in you or your partner, should
first be ruled out.
Clomifene is not suitable for children or elderly
patients.

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 further questions, please ask your
doctor or nurse.
- This medicine has been prescribed for you
personally and you should not pass it on to
others. It may harm them, even if their
symptoms are the same as yours

Speak to your doctor before taking Clomifene
Tablets if you:
• have polycystic ovaries (enlarged ovaries
resulting from many small cysts on the ovarian
follicles)
• suffer from fibroids (growths on the uterus)
• are suffering from depression
• have, or have a tendency to, thrombosis (blood
clots).
Pregnancy and breast-feeding
You should not take Clomifene Tablets if you are
pregnant or think you might be pregnant (this
should be carefully ruled out) unless you have
discussed this with your doctor first.

In this leaflet:
1. What clomifene is and what it is used for
2. Before you take Clomifene Tablets
3. How to take Clomifene Tablets
4. Possible side effects
5. How to store Clomifene Tablets
6. Further information

Clomifene can make breast-feeding difficult. If you
wish to breast-feed whilst taking Clomifene
Tablets, discuss this with your doctor first.

1. WHAT CLOMIFENE IS AND WHAT IT
IS USED FOR

Important information for patients with an
intolerance to some sugars
If you have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.

Clomifene is a type of hormone, known as an
anti-oestrogen.
Clomifene Tablets are used to treat anovulatory
infertility. This is when your infertility may be
caused by failure of your ovaries to ovulate
(release eggs). Clomifene triggers ovulation (egg
production) by releasing certain hormones in
cases where the monthly cycle does not stimulate
release of the egg.

2. BEFORE YOU TAKE CLOMIFENE
TABLETS
Before taking this medicine talk to your doctor
about a possible increased risk of ovarian cancer.
Do not take Clomifene Tablets if you:
• are allergic to clomifene or to any of the other
ingredients in the tablets (see ‘What Clomifene
Tablets contain’ in section 6)
• suffer from galactose intolerance
• have or have had liver problems
• suffer from abnormal bleeding from the womb
for which a cause has not yet been found
• have an ovarian cyst or a hormone dependent
tumour (e.g. ovary or pituitary) (but clomifene
can be taken if you have what are called
polycystic ovaries)

Driving and using machines
Clomifene can cause blurring of vision. If you are
affected by this or any other problems with vision,
you should not drive or operate machinery.

3. HOW TO TAKE CLOMIFENE TABLETS
Always take Clomifene Tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual starting dose is one Clomifene Tablet
each day for five consecutive days, starting during
the first five days of your period if you are having
periods.
What you should do whilst you are taking
Clomifene Tablets
You should take your temperature every day, as
instructed by your doctor. From this record your
doctor will be able to tell if ovulation has occurred,
and if you do not then start a period, you should
have a pregnancy test. If you are pregnant, you
should not take another course of Clomifene
Tablets.
If ovulation occurs but is not followed by
pregnancy, and if your doctor agrees, you may
take another course at the same dosage (one
tablet each day for five days), up to a maximum of
three courses.

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Your doctor should check your ovaries before
each course of treatment.
If ovulation does not occur after three courses,
then you are not likely to benefit from any further
courses of clomifene.
If you take more clomifene than you should
If you take too much clomifene, or if someone else
has accidentally taken the tablets, you should tell
your doctor or go to the nearest hospital casualty
department, taking this leaflet and any remaining
tablets with you.
If you forget to take Clomifene Tablets
If you forget to take a dose, you should take it on
the following day and then continue with your
course of therapy. Do not take a double dose to
make up for a forgotten tablet.

4. POSSIBLE SIDE EFFECTS
Like many other medicines, clomifene may cause
side effects in some patients, particularly when
treatment is first started.
Clomifene may cause visual disturbances
including blurring of vision, spots, or flashes
before the eyes. If any of these occur, stop taking
Clomifene Tablets and tell your doctor
immediately, so that an eye test can be arranged.

are implanted outside the womb, leading to
complications) multiple pregnancy (only rarely
more than twins).
If you experience any side effects or feel that the
medicine is affecting you badly, speak to your
doctor or pharmacist.

5. HOW TO
STORE
CLOMIFENE
TABLETS
Keep out of the
sight and reach of
children
Do not use after expiry date which is stated on the
carton. The expiry date refers to the last day of
that month.
Do not store above 25°C. Store in the original
package.
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.

6. FURTHER INFORMATION

Do not drive or operate machinery until your sight
is normal again, which should be within a few
days or weeks of stopping treatment with
Clomifene Tablets.

What Clomifene Tablets contain
The active ingredient in Clomifene Tablets is
clomifene citrate. Each tablet contains 50mg of
clomifene citrate.

Ovarian Hyperstimulation Syndrome (OHSS) can
occur. If you experience abdominal pain,
swelling of any part of the body, shortness of
breath, or pain in a calf muscle, tell your doctor
immediately.

The other ingredients are lactose, maize starch
and magnesium stearate.

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.
Other side effects include:
• nausea
• vomiting
• breast tenderness or discomfort
• drying-up of milk when breast-feeding
• hot flushes
• bleeding between periods, heavy or painful
periods
• rashes, and/or itchy skin
• hair loss
• headache
• fits (more likely in patients with epilepsy)
• jaundice (with yellowing of the skin and the
whites of the eyes), abnormalities in liver
function tests may occur
• weight gain
• tiredness, difficulty sleeping
• depression, nervousness, acute paranoia
• feeling light headed or dizzy
• vertigo
• ectopic pregnancy (where one or more embryos

What Clomifene Tablets look like and contents
of the pack
Clomifene tablets are white, round tablets with HG
C50 on one side and a breakline on the other side.
They are available in packs of 30 tablets.
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

Reference number

Clomifene 50mg Tablets

PL 29831/0037

This is a service provided by the Royal National
Institute of Blind People.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder: Wockhardt UK
Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Date of leaflet preparation: September 2011
103768/4
214478
DD/DRUGS/207

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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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