Mifepristone Linepharma Tablets
Mifepristone Linepharma Tablets is a brand of medicine containing the active ingredient mifepristone.
Find out more about active ingredients.
Consumer medicine information (CMI) leaflet
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
Mifepristone Linepharma 200 mg Tablet
Each tablet contains mifepristone 200 mg
Consumer Medicine Information
It is important that all patients receiving this medication are followed up by a medical practitioner, preferably the prescriber, to ensure that the medication has been effective. Even if no adverse events have occurred all patients must receive follow-up 14 to 21 days after taking mifepristone.
What is in this leaflet
This leaflet answers some common questions about Mifepristone Linepharma 200 mg tablet. It does not contain all the available information. It does not take the place of talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given Mifepristone Linepharma 200 mg tablet against the expected benefits it will have for you.
If you have any concerns about being given this medicine, ask your doctor.
Keep this leaflet. You may need to read it again.
What Mifepristone Linepharma 200 mg tablet is used for
Mifepristone Linepharma is an anti-hormone. It acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue.
Mifepristone Linepharma can therefore be used to terminate a pregnancy.
Mifepristone Linepharma is recommended for:
1- The medical termination of pregnancy. It is recommended for use up to 49 days after your last menstrual period. It is given in combination with another medicine called misoprostol, a prostaglandin analogue.
2- The medical termination of a second trimester pregnancy in combination with a prostaglandin analogue. Second trimester means a pregnancy after the first three months.
Ask your doctor if you have any questions about why Mifepristone Linepharma 200 mg tablet has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
Before you are given Mifepristone Linepharma 200 mg tablet
When you must not be given it
You should not be given Mifepristone Linepharma 200 mg tablet if:
- you are pregnant and wish to carry your pregnancy to term
- you have any allergies to mifepristone or any of the other ingredients listed at the end of this leaflet
- you suffer from chronic adrenal failure
- you suffer from severe disease where it is necessary to take steroids (e.g. asthma uncontrolled by treatment)
- you have known or suspected hypocoagulation diseases
- you are on anticoagulant therapy
- you are allergic to prostaglandins. This is because of the need to use a prostaglandin analogue in combination with Mifepristone Linepharma.
You should not be given Mifepristone Linepharma 200 mg tablet for termination of pregnancy up to 49 days since your last period if:
- your pregnancy has not been confirmed by a pregnancy test or an ultrasound scan
- the first day of your last period was more than 49 days ago, unless tests have been done to confirm the age of the pregnancy is no more than 49 days
- your doctor suspects an ectopic pregnancy (the egg is implanted outside the womb)
You should not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If this medicine is used after the expiry date it may not work as well.
If you are under 18 years of age, you should only take Mifepristone Linepharma if advised to do so by your doctor. There is limited information on the use of Mifepristone Linepharma in adolescents under 18 years of age.
If you are not sure whether you should be given this medicine, talk to your doctor.
Your doctor will give you more information about what to expect with medical abortion, the risks and side effects, when you need to seek advice or help, and contact numbers for 24 hour assistance.
Before you take Mifepristone Linepharma
Tell your doctor if you have allergies to any other medicines, foods preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- kidney problems
- liver problems
- problems with your adrenal glands
- heart or cardiovascular disease
- blood disorders which lead to difficulty in clotting
- if you are taking anticoagulants
- if you are taking corticosteroids including inhaled corticosteroids for the treatment of asthma
- if you have an intra-uterine device (IUD), as this needs to be removed.
If you have not told your doctor about any of the above, tell him/her before you take Mifepristone Linepharma 200 mg tablet.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.
Some medicines and Mifepristone Linepharma 200 mg tablet may interfere with each other. These include:
- corticosteroids including inhaled corticosteroids for the treatment of asthma
- ketoconazole or itraconazole, medicines used to treat fungal infections
- erythromycin or rifampicin, antibiotics for treating infections
- St John’s Wort, a natural remedy used to treat mild depression
- phenytoin, phenobarbitone, carbamazepine, medicines used to treat epilepsy
These medicines may be affected by Mifepristone Linepharma 200 mg tablet, or may affect how well it works. You may need to be given different amounts of your medicines, or you may need to be given different medicines.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while being treated with Mifepristone Linepharma 200 mg tablet.
Grapefruit juice should not be taken when you are treated with Mifepristone Linepharma 200 mg tablet.
How Mifepristone Linepharma 200 mg tablet is given
How much to take
Your doctor will tell you how many tablets you need to take and when to take them.
The usual dose of Mifepristone Linepharma is 200 mg (one tablet).
Your doctor will advise you about taking misoprostol tablets or another prostaglandin, usually 36 to 48 hours later.
It is recommended that Mifepristone Linepharma 200 mg tablet should be taken on an empty stomach - 2 hours before or 2 hours after a meal.
How to take Mifepristone Linepharma 200 mg tablet for termination of pregnancy up to 49 days since your last period
Mifepristone Linepharma 200 mg tablet should be swallowed with water in the presence of your doctor or a member of his or her medical staff. You can then return home.
Vaginal bleeding usually starts 1 to 2 days after taking Mifepristone Linepharma 200 mg tablet.
36 to 48 hours after taking Mifepristone Linepharma, you need to take misoprostol tablets as directed by your doctor or given to you by medical staff. After you take misoprostol tablets, you should stay at home and rest for 3 hours. Some women may be at a clinic for this part of the treatment. Vaginal bleeding will usually occur and the pregnancy may be expelled within a few hours of taking misoprostol or during the next few days. The bleeding lasts on average for 10 to 16 days and may be heavy.
It is very important that you have follow up with your doctor 14 to 21 days after you take Mifepristone Linepharma and misoprostol, to ensure that the termination was complete because incomplete termination will increase the risk of serious infection or bleeding.
It is recommended that you do not travel away from home during the time that you are bleeding so that you can visit your doctor or clinic if necessary.
In case of heavy and prolonged bleeding, you should contact your doctor or clinic immediately to get advice and care.
In a few cases, a termination can occur after you take mifepristone but before you take misoprostol. It is essential that you are checked to confirm that a complete termination has occurred. If this occurs, you should contact your doctor immediately in order to schedule an appointment.
If you forget to take your dose of Misoprostol
Contact your doctor immediately if you forget to take the dose of misoprostol tablets and it is greater than 48 hours after you have taken Mifepristone Linepharma 200 mg tablet.
If you are given too much (overdose)
Mifepristone Linepharma 200 mg is available as a single tablet pack and it is given to you by your doctor. An overdose is not likely to occur. Ask your doctor if you have any concerns.
How to take Mifepristone Linepharma 200 mg tablet for termination of pregnancy in the second trimester
The way you take Mifepristone Linepharma may be different for second trimester termination. This will occur in a hospital setting. Your doctor will tell you what to do.
While you are being given Mifepristone Linepharma 200 mg tablet
Things you must do
If you are pregnant
In some cases treatment with Mifepristone Linepharma may not result in a termination of pregnancy. You must keep all of your clinic appointments so that your progress can be checked. This is very important.
If treatment with Mifepristone Linepharma does not work, a termination can be arranged using another method.
If treatment with Mifepristone Linepharma does not work and you wish to keep your pregnancy, it is not known if Mifepristone Linepharma can cause harm to your baby. It is believed, though, that misoprostol can cause harm to your baby. You need to tell your doctor or nurse about Mifepristone Linepharma and misoprostol so that they can carefully monitor your pregnancy.
If you are Rhesus negative, the use of Mifepristone Linepharma requires that your doctor will take measures to prevent Rhesus factor sensitization, along with the general measures taken during any pregnancy termination.
If you are breastfeeding
Mifepristone Linepharma should not be taken if you are breast-feeding.
If you are taking other medicines
If you are about to be started on any new medicines, remind your doctor or pharmacist that you have recently been given Mifepristone Linepharma 200 mg tablet. Ask your doctor or pharmacist for advice before taking any medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you have recently been given this medicine, as it may interact with other medicines or anaesthetics they may use.
Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Mifepristone Linepharma 200 mg tablet.
Do not be alarmed by the following list of side effects, you may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
- vaginal bleeding which may be heavy or prolonged
- breast tenderness
- hot flushes, skin rashes or itching
- side effects that may also be related to prostaglandin analogues such as nausea, vomiting, diarrhoea, dizziness, abdominal discomfort, abdominal pain, cramps, fatigue and chills and/or fever.
Tell your doctor if you notice anything that is making you feel generally unwell.
Vaginal bleeding usually starts a few hours after taking misoprostol tablets. Bleeding can occur for 10 to 16 days and it is usual for bleeding to be heavier than a normal period for 2 to 3 days. Contact your doctor immediately if you find you have very heavy bleeding and have soaked more than 2 pads per hour over 2 hours.
Serious infections are very rare in a medical termination of pregnancy and can be potentially life threatening. If you have symptoms more than 24 hours after taking misoprostol of ongoing abdominal pain, or feeling unwell, or feeling weak, with or without a fever, you should contact your doctor without delay.
Other side effects not listed above may also occur in some people.
After being given Mifepristone Linepharma 200 mg tablet
Mifepristone Linepharma will be stored by your doctor or pharmacist under the recommended conditions. It should be kept in a cool, dry place where the temperature stays below 30 degrees C. Store Mifepristone Linepharma in the original packaging.
Keep Mifepristone Linepharma where children cannot reach it.
Mifepristone Linepharma should not be used after the expiry date printed on the pack. If this medicine is used after the expiry date it may not work as well.
Any Mifepristone Linepharma which is not used will be disposed of in a safe manner by your doctor or pharmacist.
It is possible for you to become pregnant again immediately after the pregnancy termination is completed. As some effects of Mifepristone Linepharma may still be present, it is recommended that you avoid getting pregnant again before your next menstrual period after taking Mifepristone Linepharma.
What it looks like
Mifepristone Linepharma 200 mg tablets are white to off-white, round tablets, with MF embossed on one side of the tablet. Each tablet contains 200 mg of mifepristone. Mifepristone Linepharma 200 mg is in a blister pack of one tablet.
Mifepristone Linepharma contains the active ingredient mifepristone plus Starch - maize, Povidone, Cellulose - microcrystalline, Silica - colloidal anhydrous and Magnesium stearate.
The tablets do not contain gluten, lactose, tartrazine or any azo dyes.
Mifepristone Linepharma 200 mg tablet is supplied in Australia by:
Suite 129, 135 Cardigan Street
Carlton VIC 3053
MS Health Nurse After-care Telephone Service: 1300 515 883 (24 hours)
Licensed from Linepharma (France)
Australian registration number: AUST R 175671
This leaflet was prepared on 21 January 2013.
Copyright. All rights reserved.
CMI provided by MIMS Australia, February 2015