Please read this whole leaflet carefully before taking this medicine since it contains important information. I appreciate it.
This brochure is yours to keep. You should give that passage another read.
If you have more questions, you should talk to your doctor, pharmacist, or nurse.
This drug is being prescribed to you by your doctor. Would you be unwilling to tell others about it? The fact that their symptoms mirror yours doesn’t mean they can’t do you damage.
Talk to your doctor, pharmacist, or nurse immediately if you have any unwanted side effects. This includes the possibility of side effects that aren’t included here. See the discussion in section 4.
Within this pamphlet
The Kit of Mifepristone and Misoprostol consists of two drugs, Mifepristone and Misoprostol.
Medical termination of pregnancy with the Kit is recommended no later than 77 days after the start day of your most recent menstrual cycle. Therefore, the beginning of your most recent menstrual cycle is the starting point for this timeframe.
The anti-hormone Mifepristone blocks progesterone’s actions to terminate a pregnancy. There can be no further development of a pregnancy without the hormone progesterone. By stimulating uterine contractions, Misoprostol aids in the delivery of the fetus. Prostaglandin is a molecule responsible for this effect. Misoprostol acts like a prostaglandin. Therefore, the two drugs can potentially terminate the pregnancy, but they must be administered immediately after one another to maximize the therapy’s chances of success.
Do not use Mifepristone & Misoprostol Kit if:
- You should really think about getting a gynecological examination, ultrasound, or another kind of biological testing to confirm your pregnancy if you haven’t already.
- You are not pregnant if the first day of your last menstrual cycle occurred more than 77 days ago (if there is any doubt, the doctor can check the age of your pregnancy with a scanner).
- If your doctor suspects you’re pregnant in a way other than the uterus (the egg is implanted outside the womb).
- Do not use this medication if you are allergic to Mifepristone, Misoprostol, or any prostaglandins or if you are allergic to any of the other ingredients (listed in section 6).
- Some people with asthma have such severe symptoms that they cannot get relief from medication.
If porphyria runs in your family (an inherited blood disorder).
- You have chronic adrenal insufficiency.
Caution and safety measures are required.
Healthcare providers have an ethical obligation to advise patients about teratogenicity risks and encourage them to arrange a follow-up visit after delivery to check the fetus was successfully delivered. The procedure may fail, and continued pregnancies have been shown to have congenital impairments. Therefore this is essential.
Toxic epidermal necrolysis and acute widespread exanthematous pustulosis are among the severe skin reactions associated with Mifepristone. There is evidence linking these occurrences to the medication. Seek immediate medical attention if you develop any symptoms described in Section 4. Avoid retaking Mifepristone if you have a severe skin reaction while using it.
You should inform your doctor if any of the following apply to you since it may mean that the treatment is not suitable for you or that you need more care:
- For those who have had genital mutilation or circumcisionю
- Within two weeks of using the Kit, you should not use it again if you cannot get timely medical care in the event of an emergency.
- You’ve been experiencing heart-related symptoms, we hear.
- Artificial valves have been implanted in your heart to replace the natural ones.
- Cardiovascular disease risk factors, including high blood pressure and cholesterol levels (increased fat content in your blood).
- Asthma is a condition that you suffer from.
- If your blood doesn’t clot normally, it may be because of your medical condition.
- Your organs are deteriorating; it’s either the liver or the kidneys.
- You’re either malnourished in general or have anemia.
Before you are given the medications, your blood will be tested for the presence of the Rhesus factor. If your rhesus test returns negative, your doctor will walk you through the steps of the standard treatment plan.
The doctor may then advise you on whether or not to proceed with the treatment.
Other medications, in addition to the Abortion Kit
Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any additional medicines. Specific pharmaceuticals containing the following active components may inhibit the Complex’s ability to function:
- Antifungal medications like Ketoconazole and Itraconazole;
- Corticosteroids like Dexamethasone for treating asthma and inflammation;
Antibiotics Erythromycin and Rifampin;
- Neuroleptics Carbamazepine, Phenytoin, and Phenobarbital (used to treat seizures or epilepsy).
Extreme care should be used while using the Kit of Mifepristone & Misoprostol with any of the following medications containing any of the following active ingredients:
- Drugs like Cyclosporine, Tacrolimus, Sirolimus, and Everolimus are used to prevent organ rejection after transplantation.
- Other drugs that inhibit the immune system include Alfentanil and Fentanyl for pain relief;
- Ergotamine and Diergotamine for migraines;
- Quinidine for regular heart rhythm maintenance.
- Several drugs are used to induce general anesthesia.
You should avoid any antacids, including Magnesium if you wish to lessen your chances of getting diarrhea. Nonetheless, if you feel you need to take an antacid, one with Aluminum or Calcium can do the trick.
Your primary care physician is the best person to advise you on what pain relievers are right for you.
Discuss this with your doctor if you think you may require additional medicine while receiving treatment.
Kit of Mifepristone & Misoprostol with the accompaniment of food and drink
If you are being treated with the Kit, it might be beneficial to avoid drinking grapefruit juice at this time.
Pregnancy, nursing a baby, and a woman’s fertility
Pregnant women often don’t recognize the risks they might expose their unborn child to. Congenital defects, such as facial paralysis and head and limb malformations, are three times more common in children whose mothers tried to terminate their pregnancies with the Kit of Mifepristone & Misoprostol but were unsuccessful.
If you decide to go through with the extensive stem and chair-focused ultrasound tests and prenatal monitoring, you’ll need to visit a specialized clinic. After that, these measures will be implemented.
Evidence suggests a nursing baby may absorb the drug. Therefore, it is recommended that you stop breastfeeding once you begin taking the prescription.
Once the operation to end the pregnancy is complete, you can get pregnant again relatively fast. After using the Mifepristone and Misoprostol Kit, you shouldn’t try to become pregnant again until your next menstrual cycle. After using Mifepristone, you should utilize birth control within 3-9 days.
Using machines and driving vehicles
Lightheadedness is a possible side effect of taking Mifepristone and Misoprostol combined. It would help if you didn’t drive or operate machinery until you know how this medicine affects you.
If a pregnancy develops despite the presence of an intrauterine contraceptive device, often known as a coil, the device must be removed from the uterus before the administration of the Complex.
Until the follow-up (see “Third step below”), it is preferable that you not go too far from the hospital or clinic dispensing the medicine; in the event of an emergency, you will need to return to the hospital or clinic. In case of a medical emergency or if you have any other reason for worry, you may phone or return to the hospital or clinic before your planned appointment. You will be given a phone number to call in case of problems or emergencies.
To make use of the Mifepristone and Misoprostol Kit, you must do the following steps:
A 200mg Mifepristone tablet should be taken orally with a glass of water.
Call your doctor immediately if you have nausea or vomiting after taking Mifepristone.
You should consult a doctor if you have severe stomach pain, fainting, a fast pulse, or fever more than four hours after taking the tablet.
Extremely rarely, the pregnancy might terminate without the need for the Misoprostol tablets to be used. As a result, you’ll need to schedule a follow-up appointment to be sure the pregnancy is really over (please refer to the section below under “Third stage”).
Two Misoprostol tablets will be placed under each gum on both sides of your mouth. You’re going to forget about them for half an hour. Take the remainder of the tablets with a glass of water after waiting 30 minutes.
It’s possible that after receiving Misoprostol at a clinic, you’ll have to stay there for three hours or until you’re no longer in pain and can go home, whichever comes first.
Once the Misoprostol has been administered, the patient should lie down for 30 minutes.
Misoprostol is a drug that may induce a natural abortion, which can happen quickly (within a few hours) or gradually (over many days).
After taking the Mifepristone pill, you will need to schedule a follow-up consultation between 14 and 21 days later to confirm that you are no longer pregnant.
A pregnancy test must be performed after roughly two weeks to confirm the pregnancy is over. Also, some women must be checked to ensure they’re not pregnant.
Your healthcare provider may be reached for follow-up consultations through phone, video chat, text message, or any other method you choose.
Keep this follow-up visit to ensure your pregnancy is over, and you’re well after that.
The following are essential considerations after completing therapy:
- Uterine bleeding often starts during the first and second days after using Mifepristone. About two to three weeks is the typical duration of the bleeding (on average, 13 days). If bleeding is severe or prolonged, medical help should be sought immediately.
- These bleeds have nothing to do with how well the treatments are working. If the pregnancy persists or the embryo is not fully expelled, you will be offered a surgical treatment to terminate the pregnancy.
- You should see your primary care physician if you intend to continue the pregnancy to term. They plan to do several ultrasounds and other forms of prenatal monitoring.
Once the operation to end the pregnancy is complete, you can get pregnant again relatively fast. It is recommended, however, that you wait at least a few months before trying to conceive again. Thus, it is recommended that you start using birth control between three and nine days after taking the Mifepristone tablet. We refer to this period as “the window of opportunity.” There are several forms of contraception available; discuss your options with your doctor.
Suppose you wish to utilize the Kit but are sensitive to the Rhesus factor. In that case, you’ll need to take extra measures beyond the usual methods for terminating a pregnancy to prevent being hypersensitive.
Overdosing on a Mifepristone and Misoprostol Kit may have serious consequences
You won’t accidentally overdose on Mifepristone and Misoprostol since your doctor will give you the exact dose they think you need.
If you accidentally take more medication than prescribed, you should contact your doctor or get to the nearest emergency department.
In case of overdosage, seek immediate medical attention by calling your doctor or going to the nearest hospital’s emergency department. In some instances, Dexamethasone is part of specialist treatment plans.
The medication might be wasted if you don’t use your Mifepristone and Misoprostol Kit.
Failure to use any part of the therapy may reduce its efficacy. If this persists, the pregnancy may not have been completely expelled from your system. If you miss taking any pharmaceutical components, you may require additional therapy to end the pregnancy properly and should talk to your healthcare professional about this. If you have second thoughts and decide to keep the baby, talk to your doctor about your options (see section 2. Pregnancy, breastfeeding, and fertility; Pregnancy).
If you have any more questions about the proper use of this drug, please see your primary care physician, pharmacist, or registered nurse.
As with other drugs, this one might cause unwanted side effects in some people. The fallout, though, might be devastating.
If you experience any of the following symptoms, it’s recommended that you contact your nearest hospital or clinic:
- Uterine rupture, or ripping of the womb, occurs most often in women who have previously given birth or who have a scar from prior cesarean surgery, and it is caused by the tugging of the uterus following the administration of prostaglandins in the second or third trimester of pregnancy.
- Heavier-than-usual bleeding that persists for more than two hours, such as soaking through two sanitary pads every hour.
- A temperature of 38 degrees Celsius or higher that has not dropped in more than four hours
areas of redness on the trunk, either round or shaped like a target.
- Core blisters, peeling skin, and mouth/throat/nose/genital/eye ulcers are common symptoms. Skin rashes may be severe and followed by flu-like symptoms (toxic epidermal necrolysis, frequency: rare or very rare).
- A red, scaly, and widespread rash with blisters and lumps under the skin often accompanies a fever. When treatment is initially started, symptoms often appear (acute generalized exanthematous pustulosis, frequency: not known)
The release of an odorous fluid.
- The medication does not help with the constant ache.
If any of the following side effects persist or cause concern, please contact your doctor.
Widespread negative reactions (may affect more than 1 in 10 people)
Some women have uterine contractions or lower abdominal cramps in the hours after the administration of Misoprostol.
Consequences that are often unfavorable (may affect up to 1 in 10 people)
- Physical or mental impairments present at birth (fetal malformations);
- Extreme bleeding; mild to severe stomach distress;
- It’s possible that you’ll become sick with nausea, vomiting, and diarrhea. The use of Misoprostol has caused several unwanted side effects.
Rare adverse reactions (may affect up to 1 in 100 people)
- Infection caused by the abortion itself;
- The rash shows that the body is reacting strongly.
Extremely Occasionally (may affect up to 1 in 1,000 people)
- Malaise (feeling unwell);
- Flushes of heat, lightheadedness, and chills;
- A lowering in blood pressure;
- Hives and other skin conditions, some of which might be life-threatening;
- Uterine rupture.
Infrequent side effects (may affect up to 1 in 10,000 people)
A potentially fatal infection called Clostridium sordellii endometritis causes toxic shock. This infection may show up even without fever or other outward symptoms.
Reported adverse effects
Talk to your doctor, pharmacist, or nurse immediately if you have any unwanted side effects. Any side effects not specifically addressed in this leaflet are also possible. Furthermore, you will contribute to further knowledge of its safety by reporting any unfavorable reactions to this treatment.
Do not let youngsters see or touch. Please note that the EXP after the blister card indicates when the drug has expired and should not be used. The last day of the month in question is what is meant by the phrase “expiration date.”
Do not use this medicine if the blisters or the box seem like they’ve been tampered with. Hold at or below 25 degrees C.
What exactly does Kit of Mifepristone & Misoprostol hold?
Mifepristone comes in tablets, each with 200 milligrams of the active ingredient.
There are 0.2 milligrams of Misoprostol in each tablet of the medication.
The following are the remaining components:
- Mifepristone tablet; silica, colloidal anhydrous, maize starch, microcrystalline cellulose (E460), povidone K30, and magnesium stearate (E470b).
- Tablets contain Misoprostol for use in the vaginal area; ingredients include hypromellose (E464), microcrystalline cellulose (E460), sodium starch glycolate (type A), and hydrogenated castor oil.
What does the Mifepristone & Misoprostol Kit look like, and what contents of the pack
A blister of aluminum includes one tablet of Mifepristone and four tablets of Misoprostol, and the combination product is called Mifepristone & Misoprostol Kit. Each blister is placed in Mifepristonebag and given a sachet containing silica gel as a desiccant.
The Mifepristone tablet is circular in form, light yellow, and marked with an “S” on one side of the tablet. The other side of the tablet is unmarked. Diameter: 11.0 mm.
Misoprostol tablets range in color from off-white to white and have a rectangular form. One side of the tablet is scored and marked with a square on either side of the score, while the other side of the tablet is unmarked. Diameter: 11.6 x 6.3 mm.