Clomifene 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clomifene citrate

Available from:

Dowelhurst Ltd

ATC code:

G03GB02

INN (International Name):

Clomifene citrate

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06050100

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
• Removed pre-printed neutral code from pg1/2
• Reduced the title blocks to run to the margin edge
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOMIFENE 50MG TABLETS
CLOMIFENE CITRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1. What Clomifene Tablets is and what it is used for
2. What you need to know before you take Clomifene Tablets
3. How to take Clomifene Tablets
4. Possible side effects
5. How to store Clomifene Tablets
6. Contents of the pack and other information
1.
WHAT CLOMIFENE TABLETS IS AND WHAT IT IS
USED FOR
Clomifene Tablets contain 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).
Clomifene Tablets are used for some types of infertility, in
women who are not ovulating properly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CLOMIFENE TABLETS
BEFORE TAKING THIS MEDICINE TALK TO YOUR DOCTOR ABOUT
THE RISKS OF:
• Becoming pregnant with more than one child at the same
time (multiple pregnancies)
• Pregnancies where the baby grows outside of the womb
(ectopic)
• A possible increased risk of ovarian cancer
Any pregnancy could lead to birth defects or miscarriage.
This can happen even if you are not taking Clomifene
Tablets. You should talk to your doctor about the
possible risks before you take Clomifene Tablets.
DO NOT TAKE CLOMIFENE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clomifene 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contain 50mg of Clomifene Citrate
Excipient with known effect
Lactose 0.220 g
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White, round tablets with HG C50 on one side and a breakline on the
other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clomifene 50mg Tablets are indicated for the treatment of ovulatory
failure in
women desiring pregnancy. Clomifene 50mg Tablets is indicated only for
patients in whom ovulatory dysfunction is demonstrated. Other causes
of
infertility must be excluded or adequately treated before giving
Clomifene
50mg Tablets.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults Only:
The recommended dose for the first course of Clomifene 50mg Tablets is
50mg (one tablet) daily for five days. Therapy may be started at any
time in
the patient who has had no recent uterine bleeding. If
progestin-induced
bleeding is planned, or if spontaneous uterine bleeding occurs before
therapy,
the regimen of 50mg daily for 5 days should be started on or about the
fifth
day of the cycle. When ovulation occurs at this dosage, there is no
advantage
to increasing the dose in subsequent cycles of treatment.
If ovulation appears not to have occurred after the first course of
therapy, a
second course of 100mg daily (two 50mg tablets given as a single daily
dose)
for 5 days should be given. This course may be started as early as 30
days after
the previous one.
Increase of the dosage or duration of therapy beyond 100mg/day for 5
days
should not be undertaken.
The majority of patients who are going to respond will respond to the
first
course of therapy, and three courses should constitute an adequate
therapeutic
trial. If ovulatory menses have not yet occurred, the diagnosis should
be re-
evaluated. Treatment beyond this is not recommended in the patient who
does
not exhibit evidence of ovulation.
_Long-term cyclic therapy: _