Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Fermil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risk of you taking Fermil against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may want to read it again.
What Fermil is used for
The name of your medicine is Fermil. It contains the active ingredient clomiphene citrate.
Fermil is used to stimulate the development of ovarian follicles when normal ovulation does not occur in women wishing to become pregnant.
Your doctor may have prescribed Fermil for another reason. Ask your doctor if you have any questions about why Fermil was prescribed for you.
How Fermil works
Fermil appears to work by increasing the output of certain chemical messengers of the body, the hormones FSH and LH, which stimulate the ovary to cause follicle growth so that an egg may be released at mid-cycle.
There is no evidence that Fermil is addictive.
Before you take Fermil
When you must not take Fermil
Do not take Fermil if:
- You are allergic to the active ingredient, lactose or any of the inactive ingredients mentioned at the end of this leaflet under Product Description.
- It is past its expiry date or the packaging appears to have been tampered with or if the tablets do not look quite right.
- You are pregnant or breastfeeding.
- You have a liver disease or have ever had a liver disease in the past.
- You have abnormal menstruation or vaginal bleeding.
- You have visual disturbances.
- You have been diagnosed with enlarged ovaries or ovarian cysts not due to polycystic ovary disease.
- You have mental depression.
- You have thrombophlebitis (inflammation of a blood vessel due to a clot).
- You should consult your doctor if you have uncontrolled thyroid or adrenal gland function or have been diagnosed with a pituitary tumour.
Before you start to take Fermil
Tell your doctor if you have allergies to:
- Any other medicines.
- Any other substances, including foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions.
Taking other medicines
Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Fermil has not been shown to interfere with the actions of other medications.
However, many other medicines should not be taken if you become pregnant.
Discuss all medicines you may be taking with your doctor.
How to take Fermil
Fermil should only be used as directed by your doctor. It is very important that you always follow your doctor’s instructions about how many tablets you should take, how often you should take them and for how long.
The following is a guide to the usual dose:
Fermil 50 mg (1 tablet) daily for 5 days.
If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg Fermil (two 50 mg tablets) daily for five days may be started on advice of your doctor.
Do NOT take any more than prescribed by your doctor.
The duration of your treatment will be determined by your doctor.
Fermil is usually taken for 5 days. It is possible to have more than one course of treatment with Fermil, however if pregnancy is not achieved after 3 ovulatory responses to Fermil, further treatment is not generally recommended.
If you forget to take your dose
If you should miss a dose tell your doctor and he will advise you of the best thing to do given your own special case.
If you take too much
Immediately telephone your doctor, or the Poisons Information Centre (telephone 131 126) or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much Fermil.
Do this even if there are no signs of discomfort or poisoning.
While you are using Fermil
Things you must do
- Always follow your doctor’s instructions carefully.
- If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Fermil.
Things you must not do
- Do not use Fermil to treat any other complaint unless your doctor says so.
- Do not give this medication to anyone else, even if their symptoms seem similar to yours.
Things to be careful of
Fermil may cause visual disturbances such as blurring, spots or flashes and these might affect your ability to drive or operate machinery. These visual disturbances may become worse with bright light.
Make sure you know how Fermil affects you before you drive a car or operate machinery.
All medicines, including Fermil, can cause side effects. Sometimes they can be serious, most of the time they are mild and the effects cease once therapy is stopped. Intensity and frequency of side effects increase with higher doses and longer treatment courses.
Please inform your doctor or pharmacist as soon as possible if you experience any side effects or symptoms (whether or not they are mentioned in this leaflet) while undergoing treatment with Fermil.
The most common side effects of Fermil are:
- Hot flushes.
- Abdominal discomfort like distension, bloating, pain or soreness.
- Ovarian enlargement.
- Visual blurring – if visual disturbances occur, Fermil therapy should be stopped and a complete eye checkup by an ophthalmologist should be done.
Other less frequently reported symptoms are:
- Nausea, vomiting.
- Increased nervous tension.
- Fatigue, dizziness, light-headedness, insomnia, headache.
- Breast soreness, heavier menses, intermenstrual spotting, weight gain, ovarian cysts, ovarian hyperstimulation syndrome (OHSS).
- Urticaria, allergic dermatitis.
- Increased urinary frequency.
- Moderate reversible hair loss.
Multiple pregnancies often result from clomiphene therapy. As with any pregnancy complications may occur, such as miscarriage, stillbirth or birth defects.
In very rare cases a blood clot may form, this will usually be associated with severe ovarian hyperstimulation syndrome or OHSS. The ovarian hyperstimulation syndrome is a rare, but potentially serious complication of infertility therapy. It can usually be avoided by close monitoring of the ovarian response and withholding the Pofasi (human chorionic gonadotrophin) used to trigger ovulation if the response becomes excessive. Without proper hospital management, this condition may even be fatal but this is extremly rare. The initial symptoms may consist of lower abdominal pain, abdominal swelling and/or nausea and vomiting. Should one or more of these symptoms develop, you must consult your doctor immediately. The risk of producing the syndrome may be greatly reduced by adequate patient monitoring during therapy, and by correct adjustment of the dosage of Fermil.
If any of the following happen, stop taking Fermil, and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
- Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
This is a very serious side effect. You may need urgent medical attention or hospitalisation. This is a very rare side effect.
After using Fermil
Keep Fermil in the original packaging until you need to take it.
Store below 25°C in a dry place, out of the reach of children.
Return any unused or out of date medicine to your pharmacist.
What Fermil looks like
Fermil 50 mg tablets: white, round, biconvex tablets with a break mark on one side.
They are available in blister packs of 5 tablets.
As well as the active ingredient, Fermil also contains some inactive ingredients. These are lactose, starch-maize, cellulose-microcrystalline, povidone, silica-colloidal anhydrous, and magnesium stearate.
Fermil is supplied in Australia by:
Arrow Pharmaceuticals Limited
24 Rothschild Avenue
Rosebery NSW 2018
This leaflet was prepared in April 2004.
Australian Register Number
Fermil 50 mg: AUST R 98646
Published by MIMS December 2004