Dosage of Petibelle in details
Take 1 tablet once daily, may be taken with food or without food, if necessary with a small amount of water. Petibelle should be taken approximately the same time everyday. Always take Petibelle exactly as the physician has recommended. Check and ask with the physician or pharmacist if unsure.
Each blister contains 24 active pink tablets and 4 white placebo tablets. The 2 different colored tablets are arranged in order. A strip contains 28 tablets. Do not get confused with the tablet, take a pink tablet for the first 24 days, and then a white tablet for the last 4 days. Then start a new strip straightaway (24 pink and then 4 white tablets). There is therefore, no gap between 2 strips. Because of the different composition of the tablets, it is necessary to begin with the 1st tablet on the upperleft and that tablets may be taken every day. For the correct order, the direction of the arrows on the strip must be followed. Preparation of the Strip:
During the 4 days when taking the white placebo tablets (the placebo days), bleeding should start (also called withdrawal bleeding). Normally, the period will begin on the 2nd or 3rd day after the last pink active tablet Petibelle was taken. Once the last white tablet have been taken, the next strip should be started even if bleeding have not stopped. This means that the patient should start every strip on the same day of the week, and menstruation should occur during the same days of every month.
If Petibelle was taken as indicated, there is protection against pregnancy for the 4 days the placebo tablets are taken.
Disposal: Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose medicines when no longer required. These measures will help to protect the environment.
Starting the 1st Strip: If the Patient Has Not Taken Any Hormonal Contraceptive in the Previous Month: Start taking Petibelle on the 1st day of the cycle (the 1st day of menstruation). If the patient started taking on the 1st day of menstruation, there will be immediate protection against pregnancy. The patient can also start from the 2nd-5th day of the cycle, but an additional contraceptives (eg, a condom) should be used for the first 7 days.
Changing from a Combined Hormonal Contraceptive, Combined Contraceptive Vaginal Ring or Patch: Start taking Petibelle preferably on the day after the last active tablet (the last tablet containing the active substances) of the previous pill, but at the latest on the day after the tablet-free days of the previous pill finish (or after taking the last inactive tablet of the previous pill). When changing from a combined contraceptive vaginal ring or patch, follow the physician's recommendations.
Changing from a Progestogen-Only-Method (Progestogen Only Tablet, Injection, Progestogen-Releasing IUD or Implant): The patient can change from the progestogen-only tablet whenever they like (if had an implant or an intrauterine device, use the new tablet the day it was removed; if an injection is used, use the new tablet on the day when the patient would have injected again), but it is recommended, in all cases, to use an additional protection (eg, a condom) for the first 7 days of taking Petibelle.
After Miscarriage: Follow the physician's recommendations.
After Having a Baby: Start taking Petibelle between 21 and 28 days after having a baby. If to start later than day 28, a barrier contraceptive (eg, a condom) must be used for the first 7 days of taking Petibelle.
If, after having a baby and have had sex already before starting Petibelle (again), be sure that the patient is not pregnant or wait for the next menstrual period.
If the patient is breastfeeding and wanted to start taking Petibelle (again) after having a baby, see Use in pregnancy & lactation.
Vomiting or Severe Diarrhea: If vomiting occurs 3-4 hrs after taking an active pink tablet or severe diarrhea is present, there is a risk that the active ingredients in the pill have not been totally absorbed by the body. This is similar to what happens when forgotten to take a tablet. After vomiting or having diarrhea, another pink tablet from a reserve strip should be taken as soon as possible. If possible, take it within 12 hrs of the usual time, the tablet must be taken. If not possible or >12 hrs have passed, see Missed Dose as follows.
Delay of Menstrual Period: Although it is not recommended, period may be delayed (withdrawal bleeding) until the end of a new strip, if the white placebo tablets in the 4th row are not taken and a 2nd strip of Petibelle is immediately started and finished. Specks (drops of blood or stains) or bleeding may be experienced when taking the 2nd strip. Finish the 2nd strip by taking the 4 white tablets from the 4th row. Then start the next strip.
Ask the physician for advice before deciding to delay menstrual period.
Changing the 1st Day of Period: If the tablets are taken according to the instructions, period (withdrawal bleeding) will start during the placebo days. If the patient have to change that day, it can be done by shortening (but never increasing - 4 is the maximum) the length of the placebo days. For example, if the placebo interval begins on Friday and if the patient wanted to start on Tuesday (3 days before), the patient should begin a new strip 3 days before as normally would. Withdrawal bleeding (a period) may not be experienced during this interval. But then, a light or menstruation-like bleeding may be experienced.
If unsure of what to do, consult a physician for advice.
Discontinuation of Petibelle: Petibelle may be discontinued whenever wanted. If the patient do not want to get pregnant, consult the physician about the other efficient birth control methods. If the patient wanted to become pregnant, discontinue Petibelle and wait for the menstrual period before trying to become pregnant. The patient will be able to calculate the expected delivery date more easily.
Missed Dose: The last 4 tablets in the 4th row of the strip are placebo tablets. If forgotten to take 1 of these tablets, there will have no effect on the reliability of Petibelle. Throw away the forgotten placebo.
If forgotten to take a pink, active tablet (tablets 1-24 of the blister-strip), follow these instructions: If <12 hrs late in taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as realized and the following tablets at the usual time.
If >12 hours late in taking a tablet, protection from pregnancy may be reduced. The more tablets have forgotten to take, the greater the risk of becoming pregnant.
The risk of reduced protection against pregnancy is highest if forgotten to take a pink tablet at the beginning or at the end of the strip.
Consequently, the following measures should be adopted : Forgot to Take >1 Tablet in a Strip: Consult a physician.
Forgot to Take 1 Tablet Between Days 1–7 (1st Row): Take the forgotten tablet as soon as realized, even if this means that the 2 tablets must be taken at the same time. Continue taking the tablets at the usual time and additional precautions eg, a condom should be used for the next 7 days. If have had sex in the week before the tablet is forgotten, there is a risk for being pregnant. In this case, consult a physician.
Forgot to Take 1 Tablet Between Days 8–14 (2nd Row): Take the forgotten tablet as soon as realized, even if this means that the 2 tablets must be taken at the same time. Continue taking the tablets at the usual time. The contraceptive effect will not be reduced and should not be taken with additional precautions.
Forgot to Take 1 Tablet Between Days 15–24 (3rd or 4th Row): May choose 1 of the 2 following possibilities:
1. The tablet forgotten should be taken as soon as realized, even if this means that 2 tablets should be taken at the same time. Continue taking the following tablets at the usual time. Instead of having the white placebo tablets on this strip, throw away and start taking the next strip (the starting day will be different).
The patient will probably have period (withdrawal bleeding) at the end of the 2nd strip (while taking the white placebo tablets), but some specks or bleeding may occur when taking the active tablets of the 2nd strip.
2. The active pink tablets may also be discontinued and may directly take the 4 white placebo tablets, (before taking the placebo tablets, record the day the tablet was forgotten to be taken). If a new strip is to be started on a fixed start date, take the placebo white tablets for <4 days.
If 1 of these 2 recommendations are to be followed, the patient will be protected against pregnancy.
If forgotten to take a tablet in a strip, and there is no period during the placebo days, this could mean that the patient may be pregnant. In this case, consult the physician before continuing with the next strip.
Administration: Ask the physician for advice if not sure when to start. For any further questions on the use of Petibelle, ask a physician or pharmacist.
Petibelle interactions
Always inform the prescriber about the medications or herbal preparations the patient are taking. Also inform any other health professional that has prescribed other medication (or the pharmacist) that the patient is taking Petibelle. The healthcare professional may inform the patient the need to use additional contraceptives (eg, condom) and inform the patient the duration.
Some medicine can cause Petibelle to lose its contraceptive effect or can cause unexpected bleeding. This applies to medicines used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (eg, rifampicin), HIV (ritonavir), other infectious disease (griseofulvin, ampicillin, tetracyclines) and the medicinal herb St. John's wort.
If the patient wants to use herbal preparations which contain St. John's wort while taking Petibelle, she should consult the doctor beforehand. Petibelle can affect other medicines eg, those which contain ciclosporin or the anticonvulsant drug lamotrigine (this can increase the frequency of convulsions).
Consult the doctor or pharmacist before taking any medicine. Inform the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Petibelle with Food and Drink: Take Petibelle tablet everyday with some water if needed. The patient can take the tablets with or without food, but should take Petibelle approximately at the same time everyday.
Laboratory Tests: If the patient need a blood analysis, inform the doctor or laboratory staff that the patient is taking a contraceptive, as oral contraceptives can affect the results of some test.
References
- DailyMed. "DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "N295J34A25: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Mineralocorticoid Receptor Antagonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
