Each box contains 2 blister strips.
Mifton® strip : Each strip contains 1 tablet of Mifepristone INN 200 mg.
Misotol® strip : Each strip contains 4 tablets of Misoprostol USP 200 microgram each.

Mifton® (Mifepristone): Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
Misotol® (Misoprostol): Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

MM Kit ® is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation. 

MM Kit ® can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Day 1 (First visit): Mifepristone administration
One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.
Day 2 (Second visit) : Misoprostol administration
24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.
Day 10 to 14 (Third visit): Post-treatment examination
Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.
Patients who have an ongoing pregnancy at this visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Mifton® (Mifepristone): The treatment procedure is designed to induce the vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness and asthenia occurred rarely.
Misotol® (Misoprostol): Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.

Pregnancy:
Mifton® (Mifepristone): is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.
Lactation:
Mifton® (Mifepristone): It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
Misotol® (Misoprostol): Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.
Use in Patients with Hepatic Impairment: Misotol® (Misoprostol): Patients with hepatic disease should receive a decreased dose.
Use in Patients with Renal Impairment: Misotol® (Misoprostol): No routine dosage adjustment is recommended in older patients or patients with renal impairment but dosage may need to be reduced if the usual dose is not tolerated.

MM Kit ® : Each box contains 1 tablet of Mifton® (Mifepristone) in a blister strip & 4 tablets of Misotol® (Misoprostol) in another blister strip.

MM kit is a combination therapy for menstrual regulation/termination of pregnancy. Menstrual Regulation (MR) refers to the process of taking medications to regulate the menstruation, rather than through surgical intervention. The most effective and safest menstrual regulation regimen requires the use of two medications, MIFTON (Mifepristone) and MISOTOL (Misoprostol). MM kit is the first product to package and license these two medications together.

How MM kit works?
A woman first takes a Mifton tablet, which-when swallowed early in pregnancy-makes it difficult for the endometrial lining to sustain a growing embryo. This facilitates menstrual regulation/termination of pregnancy. 4 Misotol tablets are placed in between cheek and gum or under the tongue 24-48 hours after taking Mifton, makes the uterus contract and expel its contents, ending the pregnancy. Misotol is the preferred medication of its kind because of its efficacy, safety, low cost and wide availability. 

When can women take MM kit?
MM kit is approved for pregnancy termination up to nine weeks (through 63 days after the first day of a woman's last menstrual period). Doctors can determine the length of pregnancy by taking the woman's history and with a physical examination. If signs of pregnancy are not clearly present, a blood or urine test can be used. Ultrasound is not necessary but where available, can help to determine the length of pregnancy in cases of uncertainty.

How safe is MM kit?
Menstrual regulation (MR)/termination of pregnancy with MM kit is safe. There is less risk associated with properly used modern methods of menstrual regulation including medication. Neither Mifton nor Misotol have been associated with long term effects on women's health or on future pregnancies. 

How effective is MM kit?
The MM kit regimen has been shown to achieve menstrual regulation in about 98 percent of cases and fewer than 1 percent of women continue to have ongoing, viable pregnancies after using the regimen. A small percentage will experience nonviable pregnancies that have not been expelled or residual tissue that might require further intervention-such as vacuum aspiration or a second dose of Misotol.

How many visits to a Doctor are required?
It requires two or three visits to a health clinic, depending on where Misotol administration takes place. If a woman chooses menstrual regulation with MM kit she will take Mifton at the first clinic visit. After 24-48 hours, she will take Misotol in between cheeck and gum or under the tongue, either at home or in the clinic. 10 to 14 days after taking Mifton, she will return to her Doctor for confirmation .

How long does it take for Menstrual Regulation (MR) to occur with MM kit?
Most women will expel the products of conception within four to six hours of taking Misotol. Vaginal bleeding or spotting generally lasts about two to three weeks and other side effects tend to resolve sooner.

Who cannot use MM kit?
MM kit is safe for virtually all women. Before a woman chooses MM kit she will need to discuss her medical history with her doctor to rule out the few conditions that preclude her from using the medication. They include allergy to any of the drugs involved (Mifepristone, Misoprostol or other prostaglandin analogs), inherited porphyria, hemorrhagic disorders and known or suspected ectopic pregnancy.

What are the most common side effects of MM kit?
Vaginal bleeding and cramping are normal. These symptoms are often described as similar to a long, intense menstrual period with cramping. Side effects may include nausea, vomiting, diarrhea, headache, chills, shivering and transient fever lasting less than a day.

What happens if Menstrual Regulation (MR) / termination of pregnancy does not occurs completely?
If doctor confirms during the two week follow-up visit that a woman's pregnancy is ongoing and viable, vacuum aspiration is recommended. If there are signs that the menstrual regulation has occured but all tissue is not yet expelled and the woman feels well and is healthy, vacuum aspiration may not be needed. Additional options include waiting longer or administering the same dose of Misotol again.

What are the contraindications?
Allergy to Mifepristone or Misoprostol, adrenal insufficiency, current steroid use, coagulopathy or anticoagulant use, IUD in place, no access to follow-up.

What painkillers can you use?
You can use Ibuprofen, Naproxen or Diclofenac. You can also use Aspirin. For some women, additionally a hot water bottle on the belly brings relief.

Is it possible to do Menstrual Regulation (MR) by yourself?
The first tablet (Mifton) should be taken in front of doctor and then the 4 tablets (Misotol) can be taken in your home.

Is a Menstrual Regulation (MR) dangerous?
No, it is not dangerous. Rather it is safer than surgical procedure.

Can you use Mifton and Misotol if you are still breastfeeding? 
It is better not to breastfeed during the first 5 hours after taking Mifton and after using Misotol. It is best to throw away the milk produced in the first 5 hours.

What happens if you do not use Misotol in time?
It is advised you to use the Misotol 24 hours after swallowing the Mifton tablet. However, it can also be used earlier or later, from 12 hours to 72 hours after swallowing Mifton.

What if you don't bleed after you use the medications?
If you do not start bleeding within 4 hours of taking 4 tablets of Misotol, you should apply another 2 tablets. If you still do not bleed and you are positive that you were pregnant, then you either have an ectopic pregnancy or a continuing pregnancy. You should have an ultrasound.

How do you know if you have a continuing pregnancy?
Continuing pregnancy means termination of pregnancy has failed completely. Even if you bleed, you can still have a continuing pregnancy. Bleeding does not mean that you have had a successful menstrual regulation / termination of pregnancy. If you still have symptoms of pregnancy such as sore breasts or nausea, you may be experiencing a continuing pregnancy. You should have an ultrasound or do a pregnancy test 3 weeks later to confirm that the pregnancy has ended. Most pregnancy tests that are done 3 weeks after the termination of pregnancy are reliable.

When can a women start contraception after Menstrual Regulation (MR)/termination of pregnancy?
Women should begin contraception as soon as possible after termination of pregnancy, because it is possible to become pregnant again almost immediately. The timing will depend on what method a woman chooses. For example, she can begin taking oral contraceptives the day she takes Misotol or, if she prefers a barrier method, these can be used the next time she has sex. Each woman will need to discuss options with her doctor.

Is it safe to have a Menstrual Regulation (MR)/termination of pregnancy if you've already had one in the past?
Women are fertile for about 40 years. Some women need more than one menstrual regulation because for example contraception fails or some women cannot choose when to have sexual relations.
Having one or more menstrual regulation/termination of pregnancy, do not impact a woman's health or ability to have children in future.

Mifton® (Mifepristone): Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Misotol® (Misoprostol): Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption, blood levels and antiplatelet effects of therapeutic doses of aspirin.

Mifton® (Mifepristone): No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.
Misotol® (Misoprostol): Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.

Store in a cool and dry place, protected from light.