Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 29831/0037.
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 Tablets:
if you are allergic to clomifene or any of the other ingredients of this medicine (listed in section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
if you have or ever had liver disease
if you have unusual menstrual bleeding where the cause is not known
if you have a type of cancer that is made worse by hormones
if you have a cyst on your ovary
if you are pregnant. You should have a test to make sure you are not pregnant before you take Clomifene Tablets
Do not take this medicine if any of the above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clomifene Tablets:
if you are having an early menopause or have been told you are infertile
if you have stopped having periods because you are under-weight
if you have had fits or seizures in the past
if you have 'fibroids' in your womb
if you have 'polycystic' ovaries
if your ovaries are swollen
if you have hypertriglyceridemia (an excess of fats in the blood) or a family history of hypertriglyceridemia.
Your doctor should check for any other causes of fertility problems before starting treatment with Clomifene Tablets.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clomifene Tablets.
Other medicines and Clomifene Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This includes medicines you buy with a prescription, including herbal medicines. This is because Clomifene Tablets can affect the way some other medicines work. Also some medicines can affect the way Clomifene Tablets work.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or think you may be pregnant
Talk to your doctor before taking this medicine if you are breast-feeding or planning to breast-feed. Clomifene Tablets can lower the amount of milk produced.
Ask you doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
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.
Clomifene Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Clomifene Tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Taking this medicine
Take this medicine by mouth
Swallow the tablets whole with a drink of water. Do not crush or chew your tablets
Do not take more than two tablets in one day
Do not take the tablets for more than five days at a time
If you feel the effect of your medicine is not working, do not change the dose yourself, but ask your doctor
The usual dose is:
Adult women only:
Your doctor will tell you when in your menstrual cycle to start taking the tablets
For the first course of treatment, take one tablet a day for five days
If you do not have a period after the first course of treatment your doctor will increase your dose to two tablets a day for five days
You should start this second course at least 30 days after the first course
You will not usually take more 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 (post-menopausal).
If you take more clomifene than you should
If you take more clomifene 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).
If you forget to take Clomifene Tablets
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 Clomifene Tablets
Keep taking Clomifene Tablets until your doctor tells you to stop. If you stop, the treatment may not work.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Clomifene Tablets and go to a hospital straight away if:
You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
You have numbness, weakness or paralysis on one side of your body, slurred speech, sudden blurred vision, confusion or unsteadiness. These could be signs of a stroke
Stop taking Clomifene Tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Over-stimulation of the ovary.
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 Clomifene Tablets
Blurring of vision or spots or 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.
Liver problems that may cause the 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:
Increased pain with periods, heavy periods or bleeding between periods
Pain in the lower part of the stomach. This could be a sign of endometriosis or worsening of endometriosis, ovarian cancer or enlarged ovaries
Thinning of the layer covering the inside of the uterus.
Increased levels of fat in the blood (hypertriglyceridaemia) which may also cause inflammation of the pancreas.
Pain in the upper middle or upper left part of the abdomen. This could be a sign of inflammation of the pancreas (pancreatitis).
Cloudy lenses in the eye (cataracts)
Fits, feeling faint, disorientated or more tense than normal. Also, balance problems or feeling dizzy (vertigo)
Feeling tired or difficulty in sleeping (insomnia), depression or change in moods or behaviour
Rapid or irregular heartbeat
Speech problems
Skin rash or itching
Raised red skin patches with blisters surrounded by rings, sores on the lips, eyes or mouth and fever (erythema multiforme), red or purple skin patches (ecchymosis)
Feeling or being sick
Flushing of the skin
Headaches
Swelling of the face, around the eyes, lips or tongue
Painful breasts
Hair loss or thinning
Increased levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
Numbness or tingling on your skin (paraesthesia)
Feeling anxious
Feeling more nervous than usual.
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.
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 this 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.
5. How to store Clomifene Tablets
Keep this medicine out of the sight and reach of children
Do not use this medicine after the 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Clomifene Tablets contain
The active substance is clomifene citrate.
Each tablet contains 50mg of clomifene citrate.
The other ingredients are lactose, maize starch and magnesium stearate.
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:
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Please be ready to give the following information:
Product name Reference number
Clomifene 50mg Tablets 29831/0037
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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