400 microgram tablets
misoprostol
What Topogyne is and what it is used for
Topogyne tablets contain misoprostol, which is similar to a substance called prostaglandin that the body naturally produces. Misoprostol triggers contractions in the uterus and softens the cervix. For medical abortion: Topogyne is used after taking another medicine called mifepristone. It should be taken no later than 49 days after the first day of the last menstrual cycle.
For surgical abortion: Topogyne is taken as the only medicine before surgical abortion in the first trimester of pregnancy (within 12 weeks after the first day of your menstrual cycle).
The misoprostol contained in Topogyne may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Topogyne
Do not take Topogyne
- if you are allergic to misoprostol, any other prostaglandin, or any of the other ingredients of this medicine (listed in section 6)
- if the pregnancy has not been confirmed by ultrasound or biological tests
- if your doctor suspects an ectopic pregnancy (the egg attaches itself outside the uterus)
- if you cannot take mifepristone (when mifepristone is used in combination with Topogyne)
- for medical abortion if the first day of your last menstrual cycle was more than 49 days (7 weeks) ago.
Warnings and precautions
Talk to your doctor before taking Topogyne
- if you have liver or kidney disease
- if you suffer from anemia or malnutrition
- if you have cardiovascular disease (cardiovascular disease)
- if you have an increased risk of cardiovascular disease. The risk factors include age over 35 and smoking or high blood pressure, high cholesterol, or diabetes.
- if you have a disease that affects blood clotting
- if you have previously undergone cesarean section or surgery on the uterus
Healthcare professionals must ensure that patients, due to the risk of failure of the method and possible fetal damage in the event of continued pregnancy, are informed of the risk of malformations and that a return visit is booked to check that the pregnancy has been terminated (see section Pregnancy, breastfeeding, and fertility ).
Before taking mifepristone and Topogyne, you will have blood tests to determine the Rh factor. If you are Rh negative, your doctor will advise you on the routine treatment required.
For medical abortion:
If you are using an IUD, it must be removed before you take the first drug, mifepristone.
For surgical abortion:
– no data are available for the preparation of the cervix with misoprostol for surgical abortion after the first trimester. Therefore, Topogyne should not be taken later than 12 weeks after the first day of your menstrual cycle.
– Due to the possible occurrence of vaginal bleeding after taking this medicine, you should preferably take Topogyne at the treatment clinic before the surgical procedure.
Other medicines and Topogyne
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
In particular, talk to your doctor if you are taking any of the following:
- Non-steroidal anti-inflammatory drugs ( NSAIDs ), eg acetylsalicylic acid or diclofenac
- Antacids and antacids containing magnesium (used in the treatment of heartburn and indigestion).
Pregnancy, breastfeeding, and fertility
Pregnancy
Failed abortion (continued pregnancy) after taking Topogyne has been associated with a 3-fold increased risk of congenital malformations, especially facial paralysis and malformations of the head, arms, and legs. Malformations in newborns have also been seen when this medicine is taken alone. For medical abortion, you must take the second medicine, mifepristone, 36-48 hours before taking Topogyne.
The risk of Topogyne not working increases
- unless taken orally
- with the duration of pregnancy
- with number of previous pregnancies
- for medical abortion if taken later than 49 days after the first day of your last menstrual cycle.
If the abortion fails after taking this medicine, there is an unknown risk to the fetus. If you decide to continue the pregnancy, the pregnancy must be carefully monitored and repeated ultrasound examinations, with special control of the arms, legs, and head, carried out in a specialist clinic. The doctor will give you further advice.
If you decide to proceed with the termination of pregnancy, another method will be used. The doctor will inform you about the options.
You should avoid becoming pregnant again before your next period after taking this medicine. You should start a contraceptive immediately after the termination of the pregnancy has been confirmed by the doctor.
Breast-feeding
If you are breastfeeding, consult a doctor before using this medicine. You should not breastfeed as this medicine passes into breast milk.
Fertility
This medicine does not affect fertility. You can get pregnant again after the abortion is complete. You should start a contraceptive immediately after the termination of pregnancy is confirmed.
Driving ability and use of machinery
This medicine may cause dizziness. You should be careful when driving or using machines after taking this medicine until you know how Topogyne affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to take Topogyne
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage for adults
- A tablet is taken by mouth.
How to take the tablet
- In all cases:
- Swallow the tablet whole with a glass of water
- If you vomit within 30 minutes of taking the tablet, consult a doctor immediately. You need to take a new tablet.
Immediately contact the prescribing clinic after the abortion (medical or surgical):
- If you have vaginal bleeding for longer than 12 days and/or if it is very heavy (eg if you need more than 2 pads per hour for 2 hours)
- If you have severe stomach pain
- If you have a fever or if you feel cold and shiver.
For medical abortion
The schedule for taking Topogyne for medical abortion is as follows.
- At the clinic, you will be given the first medicine, mifepristone, which must be taken by mouth.
- 36-48 hours after this, you take Topogyne by mouth. You must rest for at least 3 hours after taking this medicine.
- The embryo may be expelled within a few hours or in the next few days after you take Topogyne. You will have vaginal bleeding lasting an average of 12 days after taking the first medicine, mifepristone, and the bleeding will decrease over time.
- You must visit the clinic within 14-21 days of taking the first drug, mifepristone, for a return visit to ensure the abortion is complete.
Important things to remember when taking this medicine:
| This tablet must be taken by mouth for medical abortion, Topogyne must be taken 36–48 hours after 600 mg mifepristone is taken Failure to follow these instructions will increase the risks associated with this medication |
- For surgical abortion
The tablet should be taken 3 to 4 hours before the surgical abortion procedure.
The schedule for taking Topogyne for surgical abortion is as follows.
- Take Topogyne by mouth
- The surgical procedure will be performed 3 to 4 hours after you take Topogyne.
You will have vaginal bleeding that lasts an average of 12 days after the surgical procedure and the bleeding will decrease over time.
3. You must visit the clinic within 14-21 days after the surgical procedure for a return visit.
Other important points to consider:
- In all cases
- Do not take this medicine if the blister foil is damaged or if the tablet has not been kept in the package.
In urgent cases or if you have any questions, call or visit the prescribing clinic. You don’t have to wait for your return visit.
- For medical abortion
- Vaginal bleeding does not mean that expulsion has been completed after an abortion.
- The risk of side effects increases if you take this medicine later than 49 days after the first day of your last menstrual cycle, or if you do not take it by mouth.
If the pregnancy continues or the abortion is incomplete, the doctor will inform you of the options available to terminate the pregnancy.
It is recommended that you do not travel too far away from the clinic until after your return visit.
- For surgical abortion
- After you take Topogyne, there is a risk of miscarriage before the surgical procedure has started, although the risk is low.
- The risk of side effects increases if you take Topogyne later than 12 weeks after the first day of your last menstrual cycle (first trimester of pregnancy).
Use in children and adolescents
There are only limited data regarding the use of misoprostol in adolescents.
If you have taken too much Topogyne
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
The doctor will give you the exact amount of Topogyne and it is, therefore, unlikely that you will take too many tablets. Taking too many tablets can cause symptoms such as drowsiness, tremors, convulsions, breathing difficulties, abdominal pain, diarrhea, fever, chest pain, low blood pressure, and slow pulse which can be fatal.
If you forget to take Topogyne
If you forget to take mifepristone or Topogyne, discontinuation is unlikely to be complete. Talk to your doctor or the clinic if you forget to take Topogyne.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information.
The following side effects may occur:
Serious side effects are
The risk of serious side effects increases if this medicine is taken:
– later than 49 days after the first day of the last menstrual cycle for medical abortion.
Or
– 12 weeks after the first day of the last menstrual cycle for surgical abortion
Serious side effects include:
- allergic reaction. Severe skin rashes, eg itchy red dots, blisters, or sores.
Other serious side effects include:
- cardiovascular – side effect ar. Chest pain, difficulty breathing, confusion, or irregular pulse.
- severe or fatal cases of toxic or septic shock (severe drop in blood pressure due to severe blood poisoning). Fever with muscle aches, fast pulse, dizziness, diarrhea, vomiting, or feeling weak.
These side effects may occur if you do not take this medicine by mouth, or if you take it later than 49 days after the first day of your last menstrual cycle for a medical abortion.
If you experience any of these side effects, contact a doctor IMMEDIATELY or go to the nearest emergency department.
Other side effects are
Very common (may affect more than 1 in 10 users):
- contractions or cramping of the uterus
- diarrhea
- nausea or vomiting
- bleeding in the uterus
Common (may affect up to 1 in 10 users):
- profuse vaginal bleeding
- abdominal pain
- mild to the moderate stomach or intestinal cramps
- infection of the uterus (endometritis or pelvic inflammatory disease)
- congenital malformations (fetal malformations)
Rare (may affect up to 1 in 1,000 users):
- fever
- fetal death
- headache, dizziness, general malaise or tiredness
- hives and skin diseases that can be serious
- ruptured uterus (uterine rupture): rupture of the uterus after the administration of prostaglandin er during the second or third trimester of pregnancy, mainly in women who have previously undergone childbirth or have a scar after a cesarean section
Very rare (may affect up to 1 in 10,000 users)
- local swelling of the face and/or throat, possibly with hives
Other side effects include
- frostbite, chills
- back pain
How Topogyne should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 25°C.
Do not use this medicine if there is visible damage to the packaging or blister.
Do not use this medicine if the tablet has not been stored in the blister pack.
Medicines should not be thrown down the drain. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is misoprostol.
One tablet of Topogyne contains 400 micrograms of misoprostol.
Other ingredients are microcrystalline cellulose, hypromellose, sodium starch glycolate (type A), and hydrogenated castor oil.
Appearance and package sizes of the medicine
White, round, flat tablets, 11 mm in diameter and 4.5 mm thick, with a score on each side and a double “M” debossed on one side. The tablet can be divided into two equal doses.
Topogyne is available in pack sizes of 1, 4, 16, or 40 tablets in perforated single-dose blisters of PVC-PCTFE/Al or Al/Al.
Marketing Authorisation Holder
EXEL GYM
216 boulevard Saint-Germain
75007 Paris
France
Manufacturer
Nordic Pharma BV
Siriusdreef 41
2132 WT Hoofddorp
Netherlands
Delpharm Lille SAS
ZI de Roubaix Est
Rue de Toufflers
59452 Lys -le-Lannoy
France
Laboratoires MACROS
Rue des Caillottes
ZI Plaine des Isles
89000 Auxerre
France