PACKAGE LEAFLET: INFORMATION FOR THE USER
Clomiphene citrate 25mg Tablets
Clomiphene citrate 50mg Tablets
Clomiphene citrate 100mg Tablets
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 Clomiphene citrate is and
what it is used for
2. What you need to know before you take Clomiphene citrate
3. How to take Clomiphene citrate
4. Possible side effects
5. How to store Clomiphene citrate
6. Contents of the pack and other information
- What Clomiphene citrate is and what it is used for
Clomiphene citrate contains a medicine called Clomiphene citrate. This belongs to a group of medicines called ovulation stimulants. It works by stimulating the release of eggs from the ovary (ovulation). Clomiphene citrate is used for some types of infertility, in women who are not ovulating properly.
- What you need to know before you take Clomiphene citrate
Before you take the medicine to 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)
- Possible increased risk of ovarian cancer Any pregnancy could lead to birth defects or miscarriage. This can happen even if you are not taking Clomiphene citrate. You should talk to your doctor about the possible risks before you take Clomiphene citrate.
Do not take this medicine and tell your doctor if:
- You are allergic (hypersensitive) to Clomiphene or any of the other ingredients of Clomiphene citrate (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 Clomiphene citrate
Do not take this medicine if any of the above apply to you.
Take special care with Clomiphene citrate
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 Clomiphene citrate.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clomiphene citrate.
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 Clomiphene citrate can affect the way some other medicines work. Also, some medicines can affect the way Clomiphene citrate 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. Clomiphene citrate 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.
Clomiphene citrate 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 cannot tolerate some sugars, talk to your doctor before taking Clomiphene citrate.
- How to take Clomiphene citrate
Always take Clomiphene citrate 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 Clomiphene citrate than you should
If you take more Clomiphene citrate 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 Clomiphene citrate
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 Clomiphene citrate
Keep taking Clomiphene citrate 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.
- Possible side-effects
Like all medicines, Clomiphene citrate can cause side effects, although not everybody gets them.
Stop taking Clomiphene citrate 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 Clomiphene citrate 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 Clomiphene citrate
- 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
- 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 Clomiphene 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.
- How to store Clomiphene citrate
Keep out of sight and reach of children.
Store in the original container below 25?C.
Do not use Clomiphene citrate 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.
- Contents of the pack and other information
What Clomiphene citrate contains
- Each tablet contains 25mg of the active substance, Clomiphene citrate
- The other ingredients are sucrose, lactose, soluble starch, maize starch, magnesium stearate, iron oxide yellow, purified water
What Clomiphene citrate looks like and contents of the pack
Clomiphene citrate 25mg Tablets are beige and round.
They are supplied in PVC and aluminium blister packs. Pack sizes 10, 30 or 100 tablets.
7.Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)