Clomid 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clomifene citrate

Available from:

Sanofi

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; GTIN: 5015265200015

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
CLOMID® 50MG TABLETS
clomifene citrate
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READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• 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 to 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET:
1. What Clomid is and what it is used for
2. What you need to know before you take Clomid
3. How to take Clomid
4. Possible side effects
5. How to store Clomid
6. Contents of the pack and other information 1. WHAT CLOMID IS AND WHAT 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CLOMID
BEFORE YOU TAKE THE 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).
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.
DO NOT TAKE THIS MEDICINE IF:
× You are allergic (hypersensitive) to clomifene or
any of the other ingredients of Clomid (listed in
Section 6).
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.
× You have unusual men

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Clomid™ 50mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clomifene Citrate 50mg_ _
3.
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clomid (Clomifene Citrate BP) is indicated for the treatment of
ovulatory failure in women desiring
pregnancy. Clomid is indicated only for patients in whom ovulatory
dysfunction is demonstrated.
Other causes of infertility must be excluded or adequately treated
before giving Clomid.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The recommended dose for the first course of Clomid (Clomifene Citrate
BP) is 50 mg (1 tablet)
daily for 5 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 50 mg 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 100 mg
daily (two 50 mg 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 100 mg/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 3
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. _
Not recommended.
Efficacy and safety of clomifene for more than 6 treatment cycles have
not been demonstrated.
Special Populations
Special care with lower dosage or duration of treatment is
particularly recommended if unusual
sensitivity to pituitary gona