Clomid 50 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clomiphene citrate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

G03GB; G03GB02

INN (International Name):

Clomiphene citrate

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Ovulation stimulants, synthetic; clomifene

Authorization status:

Marketed

Authorization date:

1982-12-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOMID® 50MG TABLETS
clomifene citrate
Is this leaflet hard to see or read? Phone [phone] for help
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 for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
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 YOU 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)
•
Ovarian Hyperstimulation Syndrome
•
Problems with your vision
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 AND TELL YOUR DOCTOR IF:
× You are allergic (hypersensitive) 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, thro

Summary of Product characteristics

Health Products Regulatory Authority
10 August 2023
CRN00DMC7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clomid 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Clomifene Citrate 50 mg.
Excipients: Each tablet contains 67.5mg sucrose and 67.5mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige, round, flat, bevelled tablet. A scored bisect line on one side
and the other engraved M within two circles.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications
Clomid (Clomifene Citrate) is indicated for the treatment of ovulatory
failure in women desiring pregnancy.
Good levels of endogenous oestrogen provide a favourable prognosis for
ovulatory response induced by Clomid. Clomid
therapy is ineffective in patients with primary pituitary or primary
ovarian failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration:
Oral
Adults Only:
The recommended dose for the first course of Clomid (Clomifene
Citrate) is 50mg (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
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,