Because it includes essential information for you, please read this whole leaflet very carefully before beginning to use this medication. Thank you.
Please keep this pamphlet. It is recommended that you reread it.
If you have any more inquiries, you should see your physician, pharmacist, or nurse.
Your doctor has specifically recommended that you take this medication. Would you be unable to share it with others? Even though their disease symptoms are identical to yours, they might still be harmful to them.
If you have any adverse effects, you should see your physician, pharmacist, or nurse. This includes any potential adverse effects not explicitly mentioned in this leaflet. See the discussion in section 4.
Within this pamphlet
1. What exactly is Combipack of Mifepristone & Misoprostol, as well as the purposes it serves.
2. Information that is necessary before the usage of Combipack of Mifepristone & Misoprostol.
3. Instructions on how to utilize Combipack of Mifepristone & Misoprostol.
4. Possible adverse effects
5. Instructions for storing Combipack of Mifepristone & Misoprostol.
6. The items included in the package, in addition to additional information
1. What Combipack of Mifepristone & Misoprostol is and the many applications it has
Mifepristone and misoprostol are two of the medications that are used in the combination treatment known as Combipack of Mifepristone & Misoprostol.
Combipack is advised for the medical termination of pregnancy no later than 63 days following the first day of your most recent menstrual cycle. This time window begins on the first day of your last menstrual period.
Mifepristone is an anti-hormone that works by preventing the effects of progesterone from taking place. Progesterone is a hormone that must be present for a pregnancy to continue. Prostaglandin is a chemical that promotes the contraction of the womb, which will assist evacuate the pregnancy if misoprostol is taken. Misoprostol is a kind of prostaglandin. Because of this, the two medications have the potential to end the pregnancy, but they must be given one after the other in order to provide the patient with the highest probability that the therapy will be successful.
2. Information that is necessary before the usage of Combipack of Mifepristone & Misoprostol
Do not use Combipack of Mifepristone & Misoprostol:
- If a gynecological exam, an ultrasound scan, or biological testing has not yet verified your pregnancy, you should consider having one of these procedures done.
- if the starting day of your most recent menstruation was more than 63 days ago, you are not pregnant (if there is any doubt, the doctor can check the age of your pregnancy with a scanner)
- If your doctor has reason to suspect a pregnancy outside of the uterus (the egg is implanted outside the womb)
- If you have ever had an adverse reaction to mifepristone, misoprostol, or any other prostaglandins, or if you are allergic to any of the other components of this drug, you should not take it (listed in section6)
- If you have severe asthma that cannot be adequately controlled with medicines, you may have severe asthma.
- If you have inherited porphyria (an inherited disorder of the blood)
- If you have a condition known as a chronic adrenal failure.
Caution and safety measures are required
It is the responsibility of those working in health care to ensure that patients are informed about the possibility of teratogenicity and that a follow-up appointment is scheduled to verify that the fetus has been expelled completely. This is necessary because there is a possibility that the method will fail, and ongoing pregnancies have been found to have congenital disabilities.
The use of mifepristone has been linked to severe skin responses, such as toxic epidermal necrolysis and acute widespread exanthematous pustulosis. These events have been documented in conjunction with the drug. If you experience any of the symptoms outlined in Section 4, you must seek urgent medical assistance. If you have a severe response to your skin when using mifepristone, you should not retake it in the future.
In some situations, the therapy may not be appropriate for you, or you could need more care; thus, if any of these apply to you, be sure to let your doctor know:
- If you have had genital cutting or circumcision
- If within two weeks of using Combipack of Mifepristone & Misoprostol, you are unable to seek prompt medical assistance during an emergency, you should not use it again.
- You have a complaint related to your heart.
- The natural valves in your heart have been replaced with artificial ones.
- You have risk factors for cardiovascular disorders, such as high blood pressure and high cholesterol levels in your blood (increased fat content in your blood)
- You have a condition known as asthma.
- You have a medical condition that might interfere with the normal clotting of your blood.
- Either your liver or kidneys are failing you.
- You either have anemia or are malnourished in some other way.
Your blood will be examined for the presence of Rhesus factor before you are given the medicines. If you test negative for rhesus, your physician will go through the necessary procedures for the usual therapy with you.
After that, the physician will be in a position to talk with you about whether or not you can undergo the therapy.
Other medications, in addition to the Combipack
If you are now taking other medications, have recently taken other medications, or may take other medications in the future, you should let your doctor or pharmacist know. In particular, medicinal products that include any of the following active ingredients may prevent the Complex from performing its intended function:
- Corticosteroids, including dexamethasone, among others (used to treat asthma or inflammation);
- Ketoconazole, Itraconazole (used in the antifungal treatment);
- The medicines Erythromycin and Rifampicin (antibiotics);
- Carbamazepine, Phenytoin, and Phenobarbital are the drugs in question here (used to treat seizures or epilepsy).
When using Combipack of Mifepristone & Misoprostol in conjunction with pharmaceuticals that include any of the following active ingredients, extreme caution is advised:
- Drugs that inhibit the immune system include Cyclosporine, Tacrolimus, Sirolimus, and Everolimus (used to prevent the body from rejecting a transplanted organ);
- Alfentanil, Fentanyl (used to relieve pain);
- Ergotamine, Diergotamine (used to treat migraines);
- Quinidine (used to help keep the heart beating usually);
- During the process of general anesthesia, several medications are used.
If you want to lower your risk of getting diarrhea, you should avoid taking any antacids that include Magnesium. If an antacid is required, one that contains Aluminum or Calcium could be the most suitable option.
Talk to your primary care physician about the appropriate painkillers for you to use.
Talk to your healthcare provider if you feel you need to take any more medications while you’re undergoing treatment.
Combipack of Mifepristone & Misoprostol with the accompaniment of food and drink
If you are being treated with the Combipack, it might be beneficial for you to avoid drinking grapefruit juice at this time.
Pregnancy, nursing a baby, and a woman’s fertility
There is a lack of knowledge on the potential dangers to the unborn child. Failure of pregnancy termination (continuing pregnancy) after using Combipack of Mifepristone & Misoprostol after the first drug (Mifepristone) has been related to a threefold greater incidence of congenital abnormalities, including facial paralysis and head and limb anomalies. A specialist clinic will need to be attended if you choose to proceed with the meticulous prenatal monitoring and ultrasound exams, paying particular attention to the stems and chair. These procedures will take place.
The medicine has been shown to enter breast milk, where the infant may then consume it. After you have started taking the medication, it will be beneficial for you to discontinue nursing.
You can get pregnant again very quickly after the pregnancy termination procedure has been finished. It is suggested that you avoid getting pregnant again before your next menstrual period after taking Combipack of Mifepristone & Misoprostol. You use a method of contraception within 3 to 9 days after using the Mifepristone pill.
Operating vehicles and making use of machinery
You should be aware that taking Mifepristone and Misoprostol together may cause you to feel lightheaded. Do not go behind the wheel of a vehicle or operate any equipment until you have determined how this drug affects you.
3. Instructions on how to utilize Combipack of Mifepristone & Misoprostol
Before administering the complex, an intrauterine contraceptive device, also known as a coil, must first be removed from the uterus in cases where pregnancy has developed despite the device’s presence.
It would be helpful if you did not go too far away from the hospital or clinic that is dispensing the medication until the follow-up (see “Third step below”); in an emergency, you will need to return to the hospital or clinic. You are free to call or go back to the hospital or clinic before your scheduled appointment time in the event of a medical emergency or for any other reason that causes you concern. You will be provided with the telephone number to contact in the event of any issues or urgent situations.
Your involvement is required in the following activities to make use of Combipack of Mifepristone & Misoprostol:
Take one Mifepristone pill containing 200 milligrams, and consume it with some water.
Please let your doctor know if you have an episode of vomiting soon after the Mifepristone has been administered.
After taking the pill, you should see a medical professional if you develop any symptoms that persist longer than four hours, including severe stomach discomfort, fainting, a rapid pulse, or fever.
In very unusual circumstances, the pregnancy might end before using the misoprostol pills. You need to attend a follow-up session to verify that a total pregnancy termination has been carried out (please refer to the section below under “Third step”).
The second stage
You will put 4 Misoprostol pills between your cheek and gum, 2 on each side of your mouth. You will leave them in place for 30 minutes. After 30 minutes, you’ll swallow what’s left of the pills with water.
If you get misoprostol at a clinic, you could be required to wait in the facility for three hours after the tablets of misoprostol have been put in or until you are free to leave because you are no longer experiencing any discomfort and can go home.
After inserting the Misoprostol, the patient should lay down for the next thirty minutes.
After receiving Misoprostol medication, the pregnancy might end naturally within a few hours or over the subsequent several days.
The third stage
To verify that you are not pregnant anymore, you will need to have a follow-up appointment 14–21 days after you have ingested the Mifepristone pill.
After about two weeks have passed, a particular sort of pregnancy test is necessary to establish that the pregnancy has concluded. It’s possible that some women may need to be scanned to confirm that they are no longer pregnant.
A follow-up consultation may occur remotely with your healthcare expert via the telephone, a video chat, text messaging, or any other contact form.
You really must maintain this appointment for a follow-up to ensure that your pregnancy has been totally evacuated and that you are in good health.
Following therapy, you need to be aware of the following:
- After taking the Mifepristone pill, uterine bleeding often begins between one and two days later. The bleeding often lasts for two to three weeks (on average, 13 days). Immediately seek medical attention if the bleeding is excessive and continues for a significant amount of time.
- There is no connection between the occurrence of these bleedings and the effectiveness of the methods. If the pregnancy continues or if the ejection of the embryo is not complete, a surgical procedure to end the pregnancy will be provided to you as an option.
- If the pregnancy persists and you decide to carry it to term, you should talk to your primary care physician about it. He or she will set up rigorous prenatal monitoring and ultrasound tests.
You can get pregnant again very quickly after the pregnancy termination procedure has been finished. It is strongly advised that you do not get pregnant for the second time in the near future after the abortion. Therefore, it would be beneficial if you began using a form of birth control within three to nine days after taking the mifepristone pill. This window of time is called the “window of opportunity.” Talk to your physician about the many methods of birth control available.
In addition to the standard procedures that are followed whenever a pregnancy is terminated, it is necessary to take precautions to avoid becoming sensitized to the Rhesus factor if you want to use the Combipack and are harmful to the Rhesus factor.
If you consume more Combipack of Mifepristone & Misoprostol than is appropriate
Because your physician will prescribe you the correct quantity of Combipack of Mifepristone & Misoprostol, it is pretty unlikely that you would take more of the medication than you should.
If you take more pills than you are supposed to, you should call your physician right away or go to the emergency room of the closest hospital or clinic.
If you accidentally consume a large amount, call your physician as soon as possible or go to the emergency room of the hospital closest to you. It is possible that you may need specialized therapy, which may include the use of Dexamethasone.
If you fail to make utilization of Combipack of Mifepristone & Misoprostol
It is possible that the treatment won’t be as successful if you neglect to utilize any of its components. This indicates that the pregnancy may not have been entirely removed from your body yet. Talk to your healthcare provider if you forget to utilize any medication element, as you may need further treatment to terminate the pregnancy successfully. Talk to your healthcare provider if you end up changing your mind and deciding to carry the pregnancy to term (see also section 2. Pregnancy, breastfeeding, and fertility; Pregnancy).
Talk to your primary care physician, the pharmacist, or the registered nurse if you have any more questions about using this medication.
4. Possible adverse effects
This medication, like other medications, has the potential to have adverse effects; however, not everyone will experience them. Serious adverse consequences may result.
You should get in touch with the local hospital or clinic if you have:
- Uterine rupture, also known as tearing of the womb: the pulling of the womb after administering prostaglandins in the second or third trimester of pregnancy, primarily in women who have already given birth to a child or who have a scar from a previous cesarean section.
- Heavy bleeding that does not stop, such as soaking two sanitary pads each hour for more than two hours.
- A fever that is not breaking for more than four hours and has a temperature of 38 degrees Celsius or higher
- Reddish spots on the trunk, the patches are target-like macules or circular. They often have core blisters, skin peeling, and ulcers of the mouth, throat, nose, and genitals, as well as the eyes. These acute rashes on the skin may be followed by fever and symptoms similar to the flu (toxic epidermal necrolysis, frequency: rare or very rare).
- A fever that is accompanied by a rash that is red, scaly, and broad, with blisters and lumps beneath the skin. In most cases, the symptoms manifest themselves when the therapy is first started (acute generalized exanthematous pustulosis, frequency: not known)
- A discharge that has an unpleasant odor
- Medication does not provide any relief for the ongoing pain.
Get in touch with your healthcare provider if any of the following unwanted effects become severe or if you have any concerns about them.
Widespread side effects (may affect more than 1 in 10 people)
- In the hours after taking Ьisoprostol, you may have uterine contractions or lower stomach cramping.
Frequent adverse consequences (may affect up to 1 in 10 people)
- Сongenital disabilities (fetal malformations);
- Ecessive blood loss;
- Сramping of the gastrointestinal tract, mild to moderate;
- Nausea, vomiting, or diarrhea might be experienced. These adverse effects are a direct result of taking Misoprostol.
Uncommon side effects (may affect up to 1 in 100 people)
- Infection resulting from the abortion;
- The rash is a symptom of hypersensitivity.
Rare side effects (may affect up to 1 in 1,000 people)
- Malaise (feeling unwell);
- Flushes of heat, lightheadedness, and chills;
- A lowering in the 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)
- Toxic shock, which may be deadly, is brought on by an infection brought on by Clostridium sordellii endometritis. This infection can manifest itself without a temperature or any other visible signs of illness.
Reporting of side effects
If you have any adverse effects, you should see your physician, pharmacist, or nurse. This includes any potential adverse effects that are not explicitly mentioned in this leaflet. You can help offer additional information on the safety of this drug by reporting any adverse effects that you experience while using it.
5. Instructions for storing Combipack of Mifepristone & Misoprostol
Keep out of children’s eyes and out of their grasp. Do not use this medication beyond the expiration date, which may be found printed on the packaging and the EXP following the blister. The term “expiration date” refers to the month’жв final day in question.
If either the packaging or the blisters seem to have been damaged in any way, do not take this medication. Keep below 25 degrees Celsius.
6. The items included in the package, in addition to additional information
What exactly does Combipack of Mifepristone & Misoprostol hold?
Mifepristone comes in tablets, and each one has 200 milligrams of active ingredient inside it.
There is 0.2 milligram 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 containing Misoprostol for use in the vaginal area; ingredients include hypromellose (E464), microcrystalline cellulose (E460), sodium starch glycolate (type A), and hydrogenated castor oil.
What Combipack of Mifepristone & Misoprostol looks like and contents of the pack
A blister of aluminum includes one tablet of Mifepristone and four tablets of Misoprostol, and the combination product is referred to as Combipack of Mifepristone & Misoprostol. Each blister is then placed in an aluminum bag and given a sachet that contains silica gel as a desiccant.
Mifepristone tablet is circular in form, light yellow in color, 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.