SUMMARY CMI

Mifepristone Linepharma 200 mg Tablet

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

1. Why am I using Mifepristone Linepharma?

Mifepristone Linepharma contains the active ingredient mifepristone. Mifepristone Linepharma is used to terminate a pregnancy for medical reasons beyond the first trimester. Mifepristone Linepharma is used in combination with a second medicine called a prostaglandin analogue.

For more information, see Section 1. Why am I using Mifepristone Linepharma 200mg Tablet? in the full CMI.

2. What should I know before I am given Mifepristone Linepharma?

Do not use it if you have ever had an allergic reaction to mifepristone or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I am given Mifepristone Linepharma? in the full CMI?

3. What if I am taking other medicines?

Some medicines may interfere with Mifepristone Linepharma and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Mifepristone Linepharma given?

Mifepristone Linepharma should be swallowed with water. The completion of your pregnancy termination will take place in a hospital environment. 36-48 hours after taking Mifepristone Linepharma you will be given the prostaglandin to complete the termination of pregnancy.

More instructions can be found in Section 4. How is Mifepristone Linepharma given? in the full CMI.

5. What should I know while being given Mifepristone Linepharma?

For more information, see Section 5. What should I know while being given Mifepristone Linepharma? in the full CMI.

6. Are there any side effects?

The common side effects include headache, dizziness, nausea, vomiting, diarrhoea, gastric discomfort, abdominal pain, spotting breast tenderness, cramping, breast tenderness, fatigue, fever / chills and fainting. Serious side effects include serious skin reactions, prolonged heavy vaginal bleeding, infections that can be potentially life threatening and ongoing abdominal pain.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

WARNING: This medication is for use in termination of pregnancy for medical reasons beyond the first trimester. For medical termination of pregnancy up to 63 days gestation, a different product should be used (MS -2 Step (mifepristone and misoprostol). It is very important that all patients receiving this medicine are followed up by a medical practitioner, preferably the prescriber, to ensure that the medicine has been effective. Even if no adverse events have occurred all patients must receive follow-up after taking Mifepristone Linepharma.

FULL CMI

Mifepristone Linepharma 200 mg Tablet

Active ingredient: mifepristone

Consumer Medicine Information (CMI)

This leaflet provides important information about Mifepristone Linepharma. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about being given Mifepristone Linepharma.

Where to find information in this leaflet:

1. Why am I using Mifepristone Linepharma?
2. What should I know before I am given Mifepristone Linepharma?
3. What if I am taking other medicines?
4. How is Mifepristone Linepharma given?
5. What should I know while being given Mifepristone Linepharma?
6. Are there any side effects?
7. Product details

1. Why am I using Mifepristone Linepharma?

Mifepristone Linepharma contains the active ingredient mifepristone. Mifepristone 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 beyond the first trimester (the first three months). It is used in combination with a second medicine called a prostaglandin analogue.

Ask your doctor if you have any questions about why Mifepristone Linepharma has been prescribed for you.

This medicine is available only with a doctor's prescription and will be given to you under the care of an appropriately trained doctor. The required prostaglandin analogue will be administered in a hospital setting.

2. What should I know before I am given Mifepristone Linepharma?

Warnings

Do not use Mifepristone Linepharma if:

• you are allergic to mifepristone, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include:
  - Reddish circular patches on the trunk
  - Skin peeling
  - Ulcers of mouth, throat, nose, genitals, and eyes.
• Always check the ingredients to make sure you can use this medicine.
• you are unable to access emergency medical care after taking this medicine until the medical termination is complete
• your pregnancy has not been confirmed by an ultrasound scan or biological test such as urine or serum HCG.
• you are pregnant and wish to carry your pregnancy to term
• 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.

If you are under 18 years of age, you should only take mifepristone 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.

Check with your doctor if you:

• have any other medical conditions such as:
  - kidney problems
  - liver problems
  - malnutrition
  - problems with your adrenal glands
  - heart or cardiovascular disease
  - anaemia
  - 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) in place

If you have not told your doctor about any of the above, tell him/her before you take Mifepristone Linepharma.

Serious skin reactions including toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported in association with mifepristone treatment. Stop using the Mifepristone Linepharma and seek medical attention immediately if you notice any of the symptoms described under the ‘Side Effects’ section. If you get a serious skin reaction you should not use mifepristone again in the future.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Do not use Mifepristone Linepharma if:

• your pregnancy has not been confirmed by a pregnancy test or an ultrasound scan
• you are pregnant and wish to carry your pregnancy to term

Talk to your doctor if you are breastfeeding or intend to breastfeed. Mifepristone Linepharma should not be taken if you are breast-feeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop, naturopath, herbalist or internet.

Some medicines may interfere with Mifepristone Linepharma and affect how it works. 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 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.

Grapefruit juice should not be taken when you are treated with Mifepristone Linepharma.

4. How is Mifepristone Linepharma 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). You will then receive a prostaglandin analogue to complete the termination of pregnancy.

When to take

• It is recommended that the Mifepristone Linepharma tablet should be taken on an empty stomach - 2 hours before or 2 hours after a meal.

How to take

• Mifepristone Linepharma tablet should be swallowed with water.
  It is very important that you follow any instructions your doctor has given you following administration of Mifepristone Linepharma.
  The completion of your pregnancy termination will take place in a hospital environment. 36-48 hours after taking Mifepristone Linepharma you will be given the prostaglandin analogue. You may require several doses of prostaglandin before completion of the termination occurs.

If you are given too much Mifepristone Linepharma

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.

5. What should I know while being given Mifepristone Linepharma?

Things you must do

• If you are pregnant
  In some cases treatment with Mifepristone Linepharma may not result in a complete termination of pregnancy and you may require another method, such as surgery, to complete the termination.
  If treatment with Mifepristone Linepharma does not work or you change your mind after taking it and wish to keep your pregnancy, it is not known if Mifepristone Linepharma can cause harm to your baby.
• 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.

It is very important that you have follow up with your doctor after you take Mifepristone Linepharma, to ensure that the termination was complete because incomplete termination will increase the risk of serious infection or bleeding.

In case of heavy and prolonged bleeding, you should contact your doctor or clinic immediately to get advice and care.

Using contraceptives: 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.

Tell your doctor if you are a smoker.

Call your doctor straight away:

• Very occasionally you may begin to bleed heavily or miscarry the pregnancy before the planned administration of the prostaglandin. If you are worried this may be occurring, you must follow the instructions given to you by your doctor or seek urgent medical care.
• Remind any doctor, dentist or pharmacist you visit that you are using Mifepristone Linepharma as it may interact with other medicines or anaesthetics they may use.

Things you should not do

• 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

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Mifepristone Linepharma affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Mifepristone Linepharma will be stored by your doctor or pharmacist under the recommended conditions
• Store below 30 degrees C.
• Store in the original packaging.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Any Mifepristone Linepharma which is not used will be disposed of in a safe manner by your doctor or pharmacist.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Mifepristone Linepharma contains

The tablets do not contain gluten, lactose, tartrazine or any azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What Mifepristone Linepharma looks like

The Mifepristone Linepharma tablet is a white to off white, round tablet, with MF embossed on one side of the tablet. Each tablet contains 200 mg of mifepristone. Mifepristone Linepharma is in a blister pack of one tablet.

Australian registration number: AUST R 175671

Who distributes Mifepristone Linepharma

Mifepristone Linepharma is supplied in Australia by:
MS Health Pty Ltd
Suite 60, 278 Church Street,
Richmond, VIC, Australia, 3121.
Ph: 1300 515 883

Licensed from Linepharma International Limited (UK)

This leaflet was prepared in September 2024.

Published by MIMS December 2024

1 Name of Medicine

Mifepristone.

2 Qualitative and Quantitative Composition

Each tablet contains 200 mg of mifepristone.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablet, uncoated.
Mifepristone Linepharma, white to off-white, round biconvex tablets, diameter 11 mm, with MF debossed on one side of the tablet.

4 Clinical Particulars

4.1 Therapeutic Indications

Mifepristone Linepharma 200 mg tablet is indicated in females of childbearing age for:
Preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester.

4.2 Dose and Method of Administration

Preparation for the action of prostaglandin analogues during the termination of pregnancy for medical reasons beyond the first trimester.

4.3 Contraindications

This product should not be prescribed in the following situations:
Lack of access to emergency medical care until complete expulsion is recorded.
Suspected or confirmed ectopic pregnancy.
Uncertainty about gestational age.
Chronic adrenal failure.
Concurrent long-term corticosteroid therapy.
Suspected or known haemorrhagic disorders or treatment with anti-coagulants.
Hypersensitivity to mifepristone, the prostaglandin analogue to be used, or any of the excipients.
Contraindication to the prostaglandin analogue selected.
Pregnancy not confirmed by an ultrasound or biological test such as urine or serum HCG.

4.4 Special Warnings and Precautions for Use

The prescriber must ensure that consent and treatment of the patient is in accordance with the appropriate state or territory legislation.
This medication is for use in termination of pregnancy for medical reasons beyond the first trimester. Medical termination of pregnancy up to 63 days gestation requires the use of MS-2 Step (mifepristone, misoprostol).
Mifepristone Linepharma (or the prostaglandin analogue) should be used with caution if an intrauterine device is present. If it can be removed safely first, this should be done.
During clinical trials, pregnancies occurred between fetus expulsion and the resumption of menses. To avoid the potential exposure of a subsequent pregnancy to mifepristone, it is recommended that conception be avoided during the next menstrual cycle. Reliable contraceptive precautions should therefore commence as early as possible after Mifepristone Linepharma administration.
Due to the antiglucocorticoid activity of mifepristone, take special care in case of suspected acute adrenal failure. In addition, the efficacy of long-term corticosteroid therapy, including inhaled corticosteroids in asthmatic patients, may be decreased during the 3 to 4 days following intake of mifepristone. Therapy should be adjusted. In case of suspected acute adrenal failure, dexamethasone administration is recommended (please refer to the dexamethasone Product Information).
The precautions related to the prostaglandin analogue used should be followed where relevant.
Rare serious cardiovascular accidents have been reported following administration of prostaglandins. For this reason women with risk factors for cardiovascular disease or established cardiovascular disease should be treated with caution.
Severe cutaneous adverse reactions, including toxic epidermal necrolysis and acute generalised exanthematous pustulosis, have been reported in association with mifepristone (see Section 4.8 Adverse Effects (Undesirable Effects)). In patients who experience severe cutaneous adverse reactions, treatment with mifepristone should be immediately discontinued. Re-treatment with mifepristone is not recommended.

Populations not studied.

Precautions.

Failures.

Bleeding.

Infection.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.
On the basis of mifepristone's metabolism by CYP3A4, it is possible that ketoconazole, itraconazole, erythromycin, and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, rifampicin, dexamethasone, St. John's Wort and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of mifepristone).
Based on in vitro information showing that mifepristone acts as a mechanism based inhibitor of CYP3A4, co-administration of mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates. Due to the irreversible nature of the CYP binding and the slow elimination of mifepristone from the body, such interaction may be observed for a prolonged period after its administration. Therefore, caution should be exercised when mifepristone is administered with drugs that are CYP3A4 substrates and have narrow therapeutic range, including some agents used during general anesthesia.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

There are limited safety data from experience with use of mifepristone in medical terminations beyond the first trimester. The adverse events reported with mifepristone use in first trimester terminations with the prostaglandin analogues misoprostol or gemeprost, classified according to frequency and system organ class, are summarised as shown in Table 1.
Post-marketing experience for first trimester termination of pregnancy indicates that death can occur as a result of medical termination of pregnancy (although this is a very rare outcome, < 1 in 100,000). The reported deaths were due to sepsis (fatal toxic shock syndrome) associated with Clostridium sordellii, which also occurs in association with childbirth and spontaneous termination. The symptoms of Clostridium sordellii infection are sometimes not the usual symptoms of sepsis. Therefore, the possibility of sepsis should be considered in all women who present with nausea, vomiting, or diarrhoea and weakness, with or without abdominal pain following mifepristone/ prostaglandin use. These symptoms, even without a fever, may indicate Clostridium sordellii infection. Strong consideration should be given to obtaining a complete blood count in these patients. Significant leukocytosis with a marked left shift and haemo-concentration may be indicative of sepsis. Practitioners should consider immediately initiating treatment with antibiotics that includes coverage of anaerobic bacteria such as Clostridium sordellii. No causal relationship between mifepristone and prostaglandin use and an increased risk of infection or death has been established. Clostridium sordellii and other infections such as Streptococcus and other bacteria have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynaecologic and non-gynaecologic conditions. Reviews have estimated overall serious infection rates after medical abortion at less than 1%.
Bleeding is an almost constant part of the procedure, whatever the prostaglandin analogue used. It can occur after mifepristone alone. When heavy, it usually reflects incomplete abortion: in clinical trials surgical evacuation was needed in 10-12% of women, with some studies reporting a rate as high as 20-30%. It can be prolonged for several days after prostaglandin analogue administration and sometimes leads to a decrease in haemoglobin levels. The degree of bleeding can necessitate a blood transfusion in around 0.5% of patients in the second trimester.

Reporting suspected adverse effects.

4.9 Overdose

No case of overdose has been reported. In the event of massive ingestion signs of adrenal failure might occur. Signs of acute intoxication may require specialist treatment including the administration of dexamethasone.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Mifepristone Linepharma 200 mg tablet contains the following excipients: maize starch, povidone, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.
Keep in the original carton in order to protect from light.
Keep out of reach of children.

6.5 Nature and Contents of Container

PVC/PVDC/Aluminium blister of 1 tablet.
Pack size of 1 tablet.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Mifepristone.

Chemical structure.

CAS number.

References

1. Thong KJ. Baird DT. A study of gemeprost alone, dilapan or mifepristone in combination with gemeprost for the termination of second trimester pregnancy. Contraception 1992, 46, 11-7.
2. Ho PC. Chan YF. Lau W. Misoprostol is as effective as gemeprost in termination of second trimester pregnancy when combined with mifepristone: a randomised comparative trial. Contraception 1996, 53, 281-3.
3. Ho PC. Ngai SW. Liu KL. Wong GC. Lee SW. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Obstetr Gynecol 1997, 90, 735-8.
4. Tang O.S. Thong K.J. Baird D.T. Second trimester medical abortion with mifepristone and gemeprost: A review of 956 cases. Contraception 2001, 64, 29-32.
5. Webster D. Penney GC. Templeton A. A comparison of 600 and 200 mg mifepristone prior to second trimester abortion with the prostaglandin misoprostol. Br J Obstetr Gynecol 1996, 103, 706-9.
6. Bartley J. Baird DT. A randomised study of misoprostol and gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy. Br J Obstetr Gynecol 2002, 109, 1290-4.
7. Ngai SW. Tang OS. Ho PC. Randomized comparison of vaginal (200 microg every 3 h) and oral (400 microg every 3 h) misoprostol when combined with mifepristone in termination of second trimester pregnancy. Human Reprod 2000, 15, 2205-8.
8. Tang OS. Chan CC. Kan AS. Ho PC. A prospective randomized comparison of sublingual and oral misoprostol when combined with mifepristone for medical abortion at 12-20 weeks gestation. Human Reprod 2005, 20, 3062-6.
9. Tang O.S. Thong K.J. Baird D.T. Second trimester medical abortion with mifepristone and gemeprost: A review of 956 cases. Contraception 2001, 64, 29-32.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes