Clomifene Citrate 50mg Tablets
CLOMID® 50MG TABLETS
(clomifene citrate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine
■ 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.
In this leaflet:
1. What Clomid 50mg Tablets are and what they are used for
2. Before you take Clomid 50mg Tablets
3. How to take Clomid 50mg Tablets
4. Possible side effects
5. How to store Clomid 50mg Tablets
6. Further Information
1. What Clomid 50mg Tablets are and what they are used for
Clomid 50mg 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).
Clomid 50mg Tablets are used for some types of infertility, in women who are not ovulating properly.
2. Before you take Clomid 50mg Tablets
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 50mg Tablets. You should talk to your doctor about the possible risks before you take Clomid 50mg Tablets.
Do not take this medicine and tell your doctor if:
■ You are allergic (hypersensitive) to clomifene or any of the other ingredients of Clomid 50mg Tablets (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 50mg Tablets
Do not take this medicine if any of the above apply to you.
Take special care with Clomid 50mg Tablets 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 underweight
■ You have had fits or seizures in the past
■ You have 'fibroids' in your womb
■ You have 'polycystic' ovaries
■ Your ovaries are swollen
Your doctor should check for any other causes of fertility problems before starting treatment with Clomid 50mg Tablets.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clomid 50mg Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Clomid 50mg Tablets can affect the way some other medicines work. Also some medicines can affect the way Clomid 50mg 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. Clomid 50mg Tablets can lower the amount of milk produced
Ask your 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.
Important information about some of the ingredients of Clomid 50mg Tablets 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 50mg Tablets.
3. How to take Clomid 50mg Tablets
Always take Clomid 50mg Tablets 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 50mg Tablets than you should
If you take more Clomid 50mg Tablets 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 50mg 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 Clomid 50mg Tablets
Keep taking Clomid 50mg 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Clomid 50mg Tablets can cause side effects, although not everybody gets them.
Stop taking Clomid 50mg Tablets 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 50mg 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 Clomid 50mg 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
■ Cloudy lenses in the eye (cataracts)
■ Fits, feeling faint, dis-orientated 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
■ Speech problems
■ Skin rash or itching
■ Feeling or being sick
■ Flushing of the skin
■ Fleadaches
■ Swelling of the face, around the eyes, lips or tongue
■ Painful breasts
■ Hair loss or thinning
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.
5. How to store Clomid 50mg Tablets
■ KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of that month.
■ Do not store above 25°C. Protect from light and moisture.
■ If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
■ If the tablets become discoloured or show any signs of deterioration, you should ask your pharmacist who will advise you what to do.
■ 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 Clomid 50mg Tablets contain
Each tablet contains 50mg of the active ingredient, clomifene citrate.
Clomid 50mg Tablets also contain the following inactive ingredients: sucrose, lactose, soluble maize starch, magnesium stearate, maize starch and yellow iron oxide (E172).
What Clomid 50mg Tablets look like and contents of the pack
Clomid 50mg Tablets are beige tablets coded with 'M' logo.
They are available as blister packs of 10 tablets or 30 tablets.
Manufacturer
Manufactured by: Doppel Farmaceutici S.R.L., Stradone Farneses, 118 29100 Piacenza, Italy.
Or
DOPPEL Farmaceutici S.r.l., Via Martiri delle Foibe, 1,
29016 Cortemaggiore, Italy.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
POM
PL No: 04423/0247
Leaflet revision and issue date (Ref.) 09.10.12
Clomid® is a registered trademark of Aventis Pharma Ltd.
Other formats
To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information Product name Clomid 50mg Tablets
Reference number 04423/0247
CLOMIFENE CITRATE 50MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine
■ 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.
In this leaflet:
1. What Clomifene Citrate 50mg Tablets are and what they are used for
2. Before you take Clomifene Citrate 50mg Tablets
3. How to take Clomifene Citrate 50mg Tablets
4. Possible side effects
5. How to store Clomifene Citrate 50mg Tablets
6. Further Information
1. What Clomifene Citrate 50mg Tablets are and what they are used for
Clomifene Citrate 50mg 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 Citrate 50mg Tablets are used for some types of infertility, in women who are not ovulating properly.
2. Before you take Clomifene Citrate 50mg Tablets
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 Clomifene Citrate 50mg Tablets. You should talk to your doctor about the possible risks before you take Clomifene Citrate 50mg Tablets.
Do not take this medicine and tell your doctor if:
■ You are allergic (hypersensitive) to clomifene or any of the other ingredients of Clomifene Citrate 50mg Tablets (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 Clomifene Citrate 50mg Tablets
Do not take this medicine if any of the above apply to you.
Take special care with
Clomifene Citrate 50mg Tablets
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 underweight
■ You have had fits or seizures in the past
■ You have 'fibroids' in your womb
■ You have 'polycystic' ovaries
■ Your ovaries are swollen
Your doctor should check for any other causes of fertility problems before starting treatment with Clomifene Citrate 50mg Tablets.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clomifene Citrate 50mg Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Clomifene Citrate 50mg Tablets can affect the way some other medicines work. Also some medicines can affect the way Clomifene Citrate 50mg 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 Citrate 50mg Tablets can lower the amount of milk produced
Ask your 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.
Important information about some of the ingredients of Clomifene Citrate 50mg Tablets
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 Clomifene Citrate 50mg Tablets.
3. How to take Clomifene Citrate 50mg Tablets
Always take Clomifene Citrate 50mg Tablets 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 Clomifene Citrate 50mg Tablets than you should
If you take more Clomifene Citrate 50mg Tablets 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 Citrate 50mg 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 Citrate 50mg Tablets
Keep taking Clomifene Citrate 50mg 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Clomifene Citrate 50mg Tablets can cause side effects, although not everybody gets them.
Stop taking Clomifene Citrate 50mg Tablets 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 Clomifene Citrate 50mg 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 Citrate 50mg 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
■ Cloudy lenses in the eye (cataracts)
■ Fits, feeling faint, dis-orientated 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
■ 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
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.
5. How to store Clomifene Citrate 50mg Tablets
■ KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of that month.
■ Do not store above 25°C. Protect from light and moisture.
■ If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
■ If the tablets become discoloured or show any signs of deterioration, you should ask your pharmacist who will advise you what to do.
■ 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 Citrate 50mg Tablets contain
Each tablet contains 50mg of the active ingredient, clomifene citrate.
Clomifene Citrate 50mg Tablets also contain the following inactive ingredients: sucrose, lactose, soluble maize starch, magnesium stearate, maize starch and yellow iron oxide (E172).
What Clomifene Citrate 50mg Tablets look like and contents of the pack
Clomifene Citrate 50mg Tablets are beige tablets coded with ' M' logo.
They are available as blister packs of 10 tablets or 30 tablets.
Manufacturer
Manufactured by: Doppel Farmaceutici S.R.L., Stradone Farneses, 118 29100 Piacenza, Italy.
Or
DOPPEL Farmaceutici S.r.l., Via Martiri delle Foibe, 1,
29016 Cortemaggiore, Italy.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0247
Leaflet revision and issue date (Ref.) 09.10.12
Other formats
To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information
Product name Clomifene Citrate 50mg Tablets
Reference number 04423/0247
POM
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