Clomifene 50mg Tablets
PACKAGE LEAFLET INFORMATION FOR THE USER
Clomifene 50mg Tablets Clomifene Citrate
Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours
In this leaflet:
1. What clomifene is and what it is used for
2. Before you take Clomifene Tablets
3. How to take Clomifene Tablets
4. Possible side effects
5. How to store Clomifene Tablets
6. Further information
1. WHAT CLOMIFENE IS AND WHAT IT IS USED FOR
Clomifene is a type of hormone, known as an anti-oestrogen.
Clomifene Tablets are used to treat anovulatory infertility. This is when your infertility may be caused by failure of your ovaries to ovulate (release eggs). Clomifene triggers ovulation (egg production) by releasing certain hormones in cases where the monthly cycle does not stimulate release of the egg.
2. BEFORE YOU TAKE CLOMIFENE TABLETS
Before taking this medicine talk to your doctor
about a possible increased risk of ovarian cancer.
Do not take Clomifene Tablets if you:
• are allergic to clomifene or to any of the other ingredients in the tablets (see ‘What Clomifene Tablets contain’ in section 6)
• suffer from galactose intolerance
• have or have had liver problems
• suffer from abnormal bleeding from the womb for which a cause has not yet been found
• have an ovarian cyst or a hormone dependent tumour (e.g. ovary or pituitary) (but clomifene can be taken if you have what are called polycystic ovaries)
• do not want to risk having a multiple pregnancy. The chance of having multiple pregnancies (mainly twins, sometimes triplets, but very occasionally even more babies) is increased by clomifene therapy.
Before you take Clomifene Tablets, other possible causes of infertility, in you or your partner, should first be ruled out.
Clomifene is not suitable for children or elderly patients.
Speak to your doctor before taking Clomifene Tablets if you:
• have polycystic ovaries (enlarged ovaries resulting from many small cysts on the ovarian follicles)
• suffer from fibroids (growths on the uterus)
• are suffering from depression
• have, or have a tendency to, thrombosis (blood clots).
Pregnancy and breast-feeding
You should not take Clomifene Tablets if you are pregnant or think you might be pregnant (this should be carefully ruled out) unless you have discussed this with your doctor first.
Clomifene can make breast-feeding difficult. If you wish to breast-feed whilst taking Clomifene Tablets, discuss this with your doctor first.
Driving and using machines
Clomifene can cause blurring of vision. If you are affected by this or any other problems with vision, you should not drive or operate machinery.
Important information for patients with an intolerance to some sugars
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 Clomifene Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual starting dose is one Clomifene Tablet each day for five consecutive days, starting during the first five days of your period if you are having periods.
What you should do whilst you are taking Clomifene Tablets
You should take your temperature every day, as instructed by your doctor. From this record your doctor will be able to tell if ovulation has occurred, and if you do not then start a period, you should have a pregnancy test. If you are pregnant, you should not take another course of Clomifene Tablets.
If ovulation occurs but is not followed by pregnancy, and if your doctor agrees, you may take another course at the same dosage (one tablet each day for five days), up to a maximum of three courses.
Your doctor should check your ovaries before each course of treatment.
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Please be ready to give the following information:
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Product name |
Reference number |
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Clomifene 50mg Tablets |
PL 29831/0037 |
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If ovulation does not occur after three courses, then you are not likely to benefit from any further courses of clomifene.
If you take more clomifene than you should
If you take too much clomifene, or if someone else has accidentally taken the tablets, you should tell your doctor or go to the nearest hospital casualty department, taking this leaflet and any remaining tablets with you.
If you forget to take Clomifene Tablets
If you forget to take a dose, you should take it on the following day and then continue with your course of therapy. Do not take a double dose to make up for a forgotten tablet.
4. POSSIBLE SIDE EFFECTS
Like many other medicines, clomifene may cause side effects in some patients, particularly when treatment is first started.
Clomifene may cause visual disturbances including blurring of vision, spots, or flashes before the eyes. If any of these occur, stop taking Clomifene Tablets and tell your doctor immediately, so that an eye test can be arranged.
Do not drive or operate machinery until your sight is normal again, which should be within a few days or weeks of stopping treatment with Clomifene Tablets.
Ovarian Hyperstimulation Syndrome (OHSS) can occur. If you experience abdominal pain, swelling of any part of the body, shortness of breath, or pain in a calf muscle, tell your doctor immediately.
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.
Other side effects include:
• nausea
• vomiting
• breast tenderness or discomfort
• drying-up of milk when breast-feeding
• hot flushes
• bleeding between periods, heavy or painful periods
• rashes, and/or itchy skin
• hair loss
• headache
• fits (more likely in patients with epilepsy)
• jaundice (with yellowing of the skin and the whites of the eyes), abnormalities in liver function tests may occur
• weight gain
• tiredness, difficulty sleeping
• depression, nervousness, acute paranoia
• feeling light headed or dizzy
• vertigo
• ectopic pregnancy (where one or more embryos are implanted outside the womb, leading to complications) multiple pregnancy (only rarely more than twins).
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 out of the
sight and reach of children
Do not use after 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Clomifene Tablets contain
The active ingredient in Clomifene Tablets 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:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)
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.
This leaflet was last revised in 07/2015