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Cipla mtp kit

Cipla mtp kit  contains 1 tablet of mifepristone 200 mg to be given orally and 4 tablets of 200 mcg misoprostol to be given vaginally for the medical termination of pregnancy up to 63 days (9 weeks). This kit has been developed in accordance with guidelines issued by the Royal College of Obstetricians and Gynaecologists, UK.

Pharmaceutical Particulars

Incompatibilities

Not applicable

Shelf-life

18 months

Packaging Information

5 tablets in a blister pack

MTP Kit contains 1 tablet of mifepristone and 4 tablets of misoprostol.

Storage and Handing Instructions

Store below 25oC.

Patient Counselling Information

  1. What is MTP Kit and what is it used for?

MTP Kit is a combination therapy containing two medicines called mifepristone and misoprostol. MTP Kit is indicated for the medical termination of intrauterine pregnancy of up to 63 days gestation based on the first day of your last menstrual period.

Mifepristone is an anti-hormone that acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue. Misoprostol is a prostaglandin, which is a substance that increases contraction of the womb that will help expel the pregnancy. The two drugs can therefore, cause termination of pregnancy and must be used one after the other to give the best possible chance for the treatment to work.

  1. What do you need to know before you take MTP Kit?

Do not take mifepristone and misoprostol tablets if –

  • your pregnancy has not been confirmed by gynecological examination, ultrasound scan or biological tests,
  • the first day of your last period was more than 63 days ago (if there is any doubt, the doctor can check the age of your pregnancy with a scanner),
  • your doctor suspects an extra-uterine pregnancy (the egg is implanted outside the womb),
  • you have bleeding disorders or are on blood-thinning drugs,
  • you have undergone genital cutting or circumcision,
  • you cannot return for a follow up visit to assess that the pregnancy is completely terminated,
  • you cannot easily get emergency medical help in the 2 weeks after you take mifepristone and misoprostol,
  • you are allergic to mifepristone, misoprostol (or any other prostaglandins) or any of the other ingredients of this medicine,
  • you suffer from severe asthma which cannot be adequately treated with medication,
  • you have hereditary porphyria (an inherited disorder of the blood),
  • you suffer from chronic adrenal failure
  • you have an intrauterine device (this must be removed prior to administering mifepristone tablet)

Warnings and Precautions

In some circumstances the treatment may not be suitable for you, so please tell your doctor if:

  • you have a heart complaint,
  • your heart has been fitted with an artificial valve,
  • you have a risk factors for heart diseases, such as high blood pressure or high blood cholesterol levels (increased fat content in your blood),
  • you suffer from asthma,
  • you suffer from an illness that may affect the clotting of your blood,
  • you have liver or kidney disease,
  • you are anaemic or otherwise malnourished.

The doctor will then be able to discuss with you if you are able to have the treatment.

Other Medicines and MTP Kit

Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, medicines containing the following active substances may interfere with the action of mifepristone and misoprostol:

  • corticosteroids (used to treat asthma or inflammation),
  • ketoconazole, itraconazole (used in antifungal treatment),
  • erythromycin, rifampicin (antibiotics),
  • St John’s Wort (natural remedy used to treat mild depression),
  • phenytoin, phenobarbital, carbamazepine (used to treat seizures or epilepsy).

The incidence of diarrhoea may be reduced by avoiding antacids that contain magnesium. If an antacid is needed, one that contains aluminium or calcium may be a more appropriate choice.

Ask your doctor about which medicines you can take for pain.

Talk to your doctor if you need to take any other medicines during the treatment.

MTP Kit with Food and Drink

You should not drink grapefruit juice when you are treated with mifepristone and misoprostol.

Pregnancy and Breastfeeding

Mifepristone and misoprostol may pass into breast milk and be taken in by your baby. You should stop breast feeding once you have taken the treatment. There is little information on the risks to the unborn baby. If the pregnancy continues and you decide to keep it, discuss this with your doctor who will arrange careful pre-natal monitoring and ultrasound examinations. It is recommended that you avoid becoming pregnant again before your next menstrual period after taking mifepristone and misoprostol.

Driving and Using Machines

You should know that mifepristone and misoprostol may make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

  1. How to Take MTP Kit
  • For pregnancies that have occurred with an intrauterine contraceptive device (coil) in place, this must be removed prior to administering mifepristone and misoprostol.
  • It is recommended that you do not travel too far away from the prescribing hospital/clinic until the follow-up visit date. In an emergency or if you are worried for any reason, you can contact or return to the hospital/clinic before the appointment time. You will be given the telephone number to call for emergencies or any problems.

The use of mifepristone and misoprostol tablets requires your active participation as follows:

First Visit to the Hospital / Clinic

  • You will be given one tablet of mifepristone 200 mg to swallow with some water in the presence of a doctor.
  • You will be able to go home after taking the tablet of mifepristone once the doctor is sure that you will not be sick. If you experience symptoms such as severe abdominal pain, fainting, fast heartbeat, fever lasting more than 4 hours after taking the tablet, please tell your doctor.
  • In rare cases, the pregnancy may be expelled before you take the misoprostol tablets. It is essential that you return to the hospital/clinic to confirm that a complete pregnancy termination has occurred.

Follow-up Visit

  • You must return to the hospital/clinic 1-3 days after taking mifepristone, as directed by your doctor.
  • You will be given 4 vaginal tablets of misoprostol to ensure the treatment is effective. The tablets will be placed into your vagina or you may do this yourself. In this case, please make sure that you empty your bladder and clean your hands thoroughly before inserting the misoprostol vaginal tablets. Push the four vaginal tablets one at a time up into the vagina as far as you can using your finger. It is recommended that you lie down for about 30 minutes after the misoprostol vaginal tablets have been inserted.
  • You should stay in the hospital/clinic for a few hours or until you and the doctor are happy that you are well enough to go home. The pregnancy may be expelled within a few hours or during the next few days after misoprostol treatment.

Third Visit

  • You must return to the hospital/clinic for a check-up within approximately 14 days of taking the mifepristone tablet.
  • It is important that you keep this appointment to check that your pregnancy has been completely expelled and you are well, as you will not be able to judge for yourself if the treatment has been successful.

After Treatment you Should be Aware that

  • Uterine bleeding usually starts 1 to 2 days after taking the mifepristone tablet. The bleeding lasts 2 or 3 weeks (on average 13 days). If the bleeding is heavy and prolonged, contact the doctor immediately for an earlier appointment.
  • The presence of these bleedings is not related to the success of the method. If pregnancy continues or expulsion is incomplete, you will be offered a surgical method for terminating the pregnancy.
  • If the pregnancy continues and you decide to keep it, discuss this with your doctor who will arrange careful pre-natal monitoring and ultrasound examinations.
  • Important: It is possible for you to become pregnant again very soon after the pregnancy termination is complete. It is recommended that you avoid getting pregnant again soon after the termination. You should therefore start using a method of contraception within 3 to 9 days of taking the mifepristone tablet. Discuss contraceptive options with your doctor.

The use of mifepristone and misoprostol requires that measures are taken to prevent Rhesus factor sensitisation (if you are Rhesus negative) along with the general measures taken during any pregnancy termination.

If you Take More Mifepristone and Misoprostol than you Should

As you will be supervised during administration of the treatment, it is unlikely that you will take more than you should.

If you Forget to take Mifepristone and Misoprostol

If you forget to take any part of the treatment, it may not be fully effective. Talk with your doctor if you forgot to take the treatment.

If you have any further questions on the use of this medicine, ask your doctor.

  1. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious Side Effects

Contact the hospital/clinic if you have:

  • tearing of the womb after administration of prostaglandins in the second or third trimester of pregnancy, mainly in women with previous deliveries of a child or with a scar of a caesarean section.
  • persistent heavy bleeding, for example soaking two sanitary pads per hour, for more than two hours
  • persistent fever with a temperature of 38°C or higher, for more than four hours
  • an unpleasant smelling discharge
  • persistent pain unrelieved by medication.

Contact your doctor if any of the following side effects gets serious or you are worried.

Very Common Side Effects (may affect more than 1 in 10 people)

  • uterine contractions or lower abdominal cramps in the hours following misoprostol.

Common Side Effects (may affect up to 1 in 10 people)

  • heavy bleeding
  • gastrointestinal cramping, light or moderate
  • nausea, vomiting or diarrhoea.

Uncommon Side Effects (may affect up to 1 in 100 people)

  • infection following abortion
  • hypersensitivity: skin rashes.

Rare Side Effects (may affect up to 1 in 1,000 people)

  • headaches
  • malaise (feeling unwell)
  • hot flushes, dizziness, chills
  • fever
  • low blood pressure
  • hives and skin disorders, which can be serious.

Very Rare Side Effects (may affect up to 1 in 10,000 people)

  • fatal toxic shock caused by infection by Clostridium sordellii endometritispresenting without fever or other obvious symptoms of infection.

Reporting of Side Effects

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 18002677779 (Cipla Number) or you can report to PvPI on 1800 180 3024. By reporting side-effects, you can help provide more information on the safety of this product.

  1. How to store MTP Kit

Store below 25°C.

  1. Contents of the pack and other information

What does MTP Kit contain

MTP Kit contains 1 tablet of mifepristone 200 mg and 4 tablets of misoprostol 200 mcg each.

Mifepristone 200 mg tablet is a yellowish, uncoated, circular, biconvex that is plain on both sides.

Misoprostol 200 mcg tablets are white to off white, capsule shaped, biconvex, uncoated with central break-line on one side and plain on other side.

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