Patient Medication Information: uses, side effects, how to take - Clomid
ABOUT THIS MEDICATION
What the medication is used for:
CLOMID is an ovulation stimulant used for some types of infertility, in women who desire pregnancy but who are not ovulating properly.
What it does:
CLOMID belongs to a group of medications called ovulation stimulants. CLOMID works by stimulating the release of eggs from the ovary (ovulation) to increase the chances of conception.
When it should not be used:
You should not take CLOMID if you have any of the following conditions:
- You are allergic (hypersensitive) to clomiphene or any of the other ingredients of CLOMID (listed below).
- 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
What the medicinal ingredient is:
clomiphene citrate
What the non-medicinal ingredients are:
Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sucrose.
What dosage forms it comes in:
CLOMID tablets are available as a 50 mg white and round tablet scored on one side with debossed “CLOMID” above score and debossed “50” below score. The other side is plain.
WARNINGS AND PRECAUTIONS
BEFORE you use CLOMID talk to your doctor or pharmacist if:
- 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.
- You are pregnant or plan to become pregnant
- You are breastfeeding or plan to breastfeed
Your doctor should check for any other causes of fertility problems before starting treatment with CLOMID.
The chances of multiple pregnancies are higher when you use CLOMID. You should be aware of the potential complications of multiple pregnancies before taking CLOMID.
Do not drive or use any tools or machines if you have a blurry vision from treatment with CLOMID.
INTERACTIONS WITH THIS MEDICATION
Please tell your doctor or pharmacist if you are taking or have recently taken any other medications. This includes medications you buy without 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.
PROPER USE OF THIS MEDICATION
Always take CLOMID exactly as your doctor has told you. You should check with your doctor.
Taking this medication
- Take this medication by mouth
- Swallow the tablets whole with a drink of water.
- 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 medication is not working, do not change the dose yourself, but ask your doctor
Usual dose: (for adult women only), treatment should begin with a low dose, 50 mg daily (1 tablet) for 5 days; dose changes will be made by your doctor. The first dose should be taken on the 5th day of your ovulatory cycle and the subsequent doses at about the same time of day for a total of 5 days. The tablet should be swallowed with a glass of water.
Overdose:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, CLOMID can cause side effects, although not everybody gets them.
The more common side effects include hot flashes, abdominal-pelvic discomfort (distention, bloating, pain, or soreness), ovarian enlargement, and visual blurring. The symptoms resembling menopausal “hot flashes” are not usually severe and disappear promptly after treatment is discontinued. Abdominal symptoms may be most often related to ovulatory or premenstrual phenomena, or to swollen ovaries.
Other less frequently reported symptoms during CLOMID (clomiphene citrate) therapy have included nausea or vomiting, appetite increase, constipation, diarrhea, increased nervous tension, depression, fatigue, dizziness or lightheadedness, insomnia, headache, breast soreness, abnormal uterine bleeding, heavier menses, intermenstrual spotting, vaginal dryness, urticaria or allergic dermatitis, vertigo, weight gain, and increased urinary frequency or volume. Moderate, reversible hair loss has been reported in a few patients, primarily on prolonged continuous therapy. Birth defects have been reported.
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
- Pain in the upper middle or upper left part of the abdomen. This could be a sign of hypertriglyceridemia (excess of fats in the blood)-induced pancreatitis (inflammation of the pancreas).
- Cloudy lenses in the eye (cataracts)
- Feeling tired or difficulty in sleeping (insomnia), depression or change in moods or behaviour
- Skin rash or itching
- Flushing of the skin
- Swelling of the face, around the eyes, lips or tongue
- Painful breasts
- Heart palpitations (sensation of rapid, pounding, or irregular heartbeat)
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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Allergic reactions, such as rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue | ✓ | ||
| Blurring of vision or spots or flashes in front of the eyes. | ✓ | ||
| Stroke with symptoms such as numbness, weakness or paralysis on one side of your body, slurred speech, sudden blurred vision, confusion or unsteadiness. | ✓ | ||
| 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. | ✓ | ||
| Liver problems that may cause the eyes or skin to go yellow (jaundice) | ✓ | ||
| Sudden and severe headaches | ✓ | ||
| Mental illness such as “psychosis” | ✓ | ||
| Symptoms of pancreatitis may include: Upper abdominal pain that radiates into the back; swollen and tender abdomen, nausea and vomiting, fever, increased heart rate | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking CLOMID, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of the reach and sight of children.
Store in original container between 15 to 30ºC.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: --------------------------------------------------------------------------
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
www.sanofi.ca or by contacting the sponsor, sanofi-aventis Canada Inc. at: 1-800-265-7927