What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

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 04425/5900R.


Clomid 50mg Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clomid® 50mg Tablets

clomifene citrate

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Phone no - 08453727101 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 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 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)
  • 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 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, throat or tongue
  • You have or ever had liver disease
  • You have unusual menstrual bleeding where the cause is not known
  • You have a type of cancer that is made worse by hormones
  • You have a cyst on your ovary
  • You are pregnant. You should have a test to make sure you are not pregnant before you take Clomid

Do not take this medicine if any of the above apply to you.

Take special care with Clomid

Check with your doctor or pharmacist before taking your medicine if:

  • You are having an early menopause or have been told you are infertile
  • You have stopped having periods because you are under-weight
  • You have had fits or seizures in the past
  • You have ‘fibroids’ in your womb
  • You have ‘polycystic’ ovaries
  • Your ovaries are swollen
  • 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 Clomid.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clomid.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy with a prescription, including herbal medicines. This is because Clomid can affect the way some other medicines work. Also some medicines can affect the way Clomid works.

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. Clomid 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.

Clomid contains lactose and sucrose

This medicine contains lactose and sucrose, which are types of sugar. If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Clomid.

3. How to take Clomid

Always take Clomid exactly as your doctor has told you. You should 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 Clomid than you should

If you take more Clomid 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 Clomid

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 Clomid

Keep taking Clomid 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 product, ask your doctor or pharmacist.

4. Possible side-effects

Like all medicines, Clomid can cause side effects, although not everybody gets them.

Stop taking Clomid and see your doctor or 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 Clomid 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 calves, 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 Clomid
  • 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
  • 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.

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days or if you notice any side effects not listed in this leaflet.

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 the 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 Clomid

Keep out of sight and reach of children.

Store in the original container below 25°C.

Do not use Clomid after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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 Clomid contains

  • Each tablet contains 50mg of the active substance, clomifene citrate
  • The other ingredients are sucrose, lactose, soluble starch, maize starch, magnesium stearate, iron oxide yellow (E172), purified water

What Clomid looks like and contents of the pack

Clomid 50mg Tablets are beige and round marked with M in two circles.

They are supplied in PVC and aluminium blister packs. Pack sizes 30 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi
410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UK
Tel: 08453727101

Manufacturer

Zentiva k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

or

Patheon France
40 Boulevard de Champeret
38300 Bourgoin-Jallieu
France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in July 2019

© Sanofi 1966 - 2019