OVULOC®



Desogestrel and
Ethinyl Estradiol tablets

Detailed Patient Labeling:

This product like all Oral Contraceptives (OCs) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

OVULOC®
contains a combination of a progestogen and estrogen, the two kinds of female hormones. It is an unique OC as it contains 28 tablets to help you remember when to start the new strip, in line with international brands.

Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. The pink tablets do not contain any hormones and are included to help remember to start the new strip on time.


INTRODUCTION
Any woman who considers using OCs should understand the benefits and risks of using this form of birth control. This patient labeling will give you much of the information and tell you how to use the pill properly so that it will be as effective as possible. However this labeling is not a replacement for a careful discussion between you and your doctor or clinic. You should also follow your doctor’s or clinic’s advice with regard to regular check-ups while you are on the pill.


EFFECTIVENESS OF OCs
OCs or “birth control pills” or “the pill” are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1% ( 1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during the menstrual cycle.


WHO SHOULD NOT TAKE OCs
Cigarette smoking increases the risk of serious cardiovascular side effects from OC use. This risk increases with age and with heavy smoking and is quite marked in women over 35 years of age. Women who use OCs are strongly advised not to smoke.
Some women should not use the pill. For e.g., you should not use the pill if you have any of the following conditions:

  • A history of heart attack or stroke.
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), eyes, or a history of blood clots in the deep veins of your legs.
  • Chest pain (angina pectoris).
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina.
  • Unexplained vaginal bleeding (until a diagnosis is reached by your doctor).
  • Jaundice during pregnancy or during previous use of OCs.
  • Live tumor (benign or cancerous).
  • Known or suspected pregnancy.

Tell your doctor if you have ever had any of these conditions. Your doctor can recommend another method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING OCs
Tell your doctor or clinic if you have or have had :

  • Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram.
  • Diabetes, elevated cholesterol or triglycerides or High BP.
  • Migraine or epilepsy or Mental depression.
  • Gallbladder, heart or kidney disease.
  • History of scanty or irregular menstrual periods.

Women with any of these conditions should be checked often by their doctor or clinic if they choose to use OCs. Also be sure to inform your doctor or clinic if you smoke or are on any medications.

HOW TO TAKE OVULOC®
BEFORE YOU START TAKING YOUR PILLS

  1. DECIDE WHAT TIME OF DAY you want to take your pill. It is important to take it at about the same time every day. Pick a time of the day which will be easy to remember. Usually, bed-time is a good idea as it is easy to remember, though there is no relation to efficacy and time of taking tablets.
     
  2. THE RIGHT WAY to take the pill is to TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills, you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
     
  3. Look at your pill pack to see if it has 28 pills: The 28-pill pack has 21 “active” while pills (with hormones) to take for 3 weeks, followed by 1 week of “reminder” pink pills (without hormones).
     
  4. Also discuss with your doctor on :
  • where on the pack to start taking pills,
  • in what order to take the pills.

   5. BE SURE YOU HAVE READY AT ALL TIMES:

  • Another kind of birth control (such as condoms) to use as a back-up method in case you miss pills.
  • An EXTRA, full pack of OVULOC®

WHEN TO START THE FIRST PACK OF PILLS
You have a choice of which day to start taking your first pack of pills. OVULOC® tablets are available in a 28 day tablet strip pre-printed for a Monday Start. Decide with your doctor or clinic which is the best day for you. Usually, the doctor may recommend starting on the first day of your menstrual period. If so, you do not need to use a back-up method of birth control, as you are starting the pill at the beginning of your period.

INSTRUCTION FOR USE
Note: REMEMBER that the 21 white tablets contain the hormones and so ALWAYS consume ALL the white tablets BEFORE starting the pink tablets.
The blister pack comes to you pre-printed for a Monday Start and is indicated with “Start” written in RED. Depending on when your doctor has instructed you to start the tablets, follow the instructions given below:

If your doctor has instructed you to START pill-taking ON MONDAY
Step 1: Take the tablet under “START” and with MON printed on the foil
Step 2: On the next day, FOLLOW the arrow and take the tablet for TUE and so on
Step 3: Keep following the arrows till you come to the last white tablet in Week 3, for SUNDAY. After you take this tablet, there are no white tablets left.
Step 4: In Week 4, you will now start the 7 pink tablets. Take one pink tablet daily, following the arrows.
Step 5: When you finish the last tablet, remember to start a new pack the very next day, following all the steps as above.
DO NOT MISS STARTING A NEW PACK ON THE NEXT DAY as missing tablets increases the chances of pregnancy. When followed correctly, you will be starting a new pack always on a Monday, every 4 weeks.

If your doctor has instructed you to START pill-taking on ANY DAY OTHER than MONDAY
For e.g. if your doctor has instructed you to start on Day 1 of your period and it occurs on WEDNESDAY
Step 1: Take the tablet in the FIRST ROW that has WED printed on the foil
Step 2: On the next day, FOLLOW the arrow and take the tablet for THU and so on
Step 3: Keep following the arrows till you come to the last white tablet in Week 3, for SUNDAY. After you take this tablet, there are two white tablets left in the first row i.e. for MON and TUE.
Step 4: On the next day i.e. Monday, take the tablet for MON and on Tuesday (following day) take the tablet TUE. After this, there are no white tablets left.
Step 5: For the next day i.e. Wednesday, start the pink tablets for 7 days. Taking the pink tablet for WED and follow the arrows. After taking the tablet for SUN, take the pink tablets for MON and TUE left at the start of the last row.
Step 6: When you finish the last tablet, remember to start a new pack the very next day, following all the steps as above.
DO NOT MISS STARTING A NEW PACK ON THE NEXT DAY as missing tablets increases the chances of pregnancy. When followed correctly, you will be starting a new pack always on a Wednesday, every 4 weeks.

DURING THE MONTH
  • Do not skip pills even if you are spotting/bleeding between monthly periods or feel uneasy in your stomach.
  • Do not skip pills even if you do not have sex very often.
  • During the 7 days when you are taking the pink tablets, your period should begin.

WHEN YOU FINISH A PACK:
Start the next pack on the day after your last “reminder” pill. Do not wait any days between packs.

IN CASE OF MISSED PILLS…
In general, always take a pill immediately and contact your doctor as soon as you can. The recommendations below are for your guidance but should not over-ride your doctor’s advice.

If you MISS 1 white “active” pill:
1. Take it as soon as your remember. Take the next pill at your regular time. This means you may take 2 pills in a day.
2. You do not need to use a back-up birth control method if you have sex.

If you MISS 2 white “active” pills in a row in WEEK 1 or WEEK 2 of your pack:
1. Take 2 pills on the day you remember and 2 pills the next day.
2. Then take 1 pill a day until you finish the pack.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms) as a back-up method for those 7 days, without stopping the pills.

If you MISS 2 white “active” pills in a row in WEEK 3:
1. THROW OUT the rest of the pill pack and start a new pack that same day.
2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor because you might be pregnant.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills you MUST use another control method (such as condoms) as a back-up method for those 7 days.

If you MISS 3 OR MORE white “active” pills in a row (during the first 3 weeks):
1. THROW OUT the rest of the pill pack and start a new pack that same day.
2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills you MUST use another control method (such as condoms) as a back-up method for those 7 days.

If you forget any of the 7 pink pills in Week 4:
1. THROW AWAY the pills you missed.
2. Keep taking 1 pill each day until the pack is empty.
3. You do not need a back-up method.

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:

  • Use a BACK-UP METHOD anytime you have sex.
  • KEEP TAKING ONE “ACTIVE” PILL EACH DAY until you can reach your doctor or clinic.

POINTS TO NOTE

  1. Many women have spotting or light/less bleeding, or may feel uneasy in their stomach during the first 1-3 packs of pills. If you feels so, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your doctor or clinic.
  2. Missing pills can also cause spotting or light/less bleeding, even when you make up for missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little uneasiness in your stomach.
  3. If you have VOMITING OR DIARRHOEA, for any reason, or if you take some medicines, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms) until you check with your doctor.
  4. IF, YOU HAVE ANY QUESTIONS OR ARE UNSURE, call your doctor or clinic.

WARNING SIGNALS
If any of these adverse effects occur while you are taking OCs, call your doctor or clinic immediately :

  • Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung).
  • Pain in the calf (indicating a possible clot in the leg).
  • Crushing chest pain or heaviness in the chest (indicating a possible heart attack).
  • Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke).
  • Sudden partial or complete loss of vision (indicating a possible clot in the eye).
  • Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast).
  • Severe pain or tenderness in the stomach region.
  • Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (indicating severe depression).
  • Jaundice accompanied by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements.

SIDE EFFECTS OF OCs
1. Vaginal Bleeding: Irregular vaginal bleeding or spotting may occur while you are taking pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of OC use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor.
2. Contact lenses: If you wear contact lenses and notice a change in vision or an inability to wear lenses, contact your doctor.
3. Fluid retention: OCs may cause fluid retention with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor.
4. Other side effects: Other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections. If any of these side effects bother you, call your doctor.

GENERAL PRECAUTIONS
1. Missed periods and use of OC before or during early pregnancy: There may be times when you may not menstruate regularly after you have completed taking cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your doctor. If you have not taken the pills daily as instructed and missed a menstrual period, you may be pregnant. If you missed two consecutive menstrual periods, you may be pregnant. /check with your doctor or clinic immediately to determine whether you are pregnant. Do not continue to take OCs until you are sure you are not pregnant, but continue to use another method of contraception.
There is no conclusive evidence that OC use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Nevertheless, OCs or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor.

2. While breast feeding: If you are breast feeding, consult your doctor or clinic before starting OCs.

3. Laboratory tests: If you are scheduled for any laboratory tests, tell your doctor or clinic you are taking OCs. Certain blood tests may be effected by OCs.

4. Drug Interactions: Certain drugs may interact with OCs to make them less effective in preventing pregnancy or cause a increase in spotting or light bleeding. Such drugs including rifampin, drugs used for epilepsy such as barbiturates, anti-convulsants such as carbamazepine, phenytoin, phenylbutazone, and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make OCs less effective.

5. Sexually transmitted diseases: This product (like all OCs) is intended to prevent pregnancy. It does not protect against transmission of any sexually transmitted diseases.

PREGNANCY AFTER STOPPING THE PILL
There may be some delay in becoming pregnant after you stop using OC’s, especially if you had irregular menstrual cycles before you used OCs. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.
There does not appear to be any increase in birth defects in newborns when pregnancy occurs soon after stopping the pill.

OVER-DOSAGE
Serious ill effects have not been reported following ingestion of large doses of OCs, even in young children. Over-dosage may cause nausea and withdrawal bleeding in females. In case of over dosage, contact your doctor.

OTHER INFORMATION
Your doctor or clinic will take a medical and family history before prescribing OCs and will examine you. You should be re-examined at least once a year. Be sure to inform your doctor or clinic if there is a family history of any of the conditions listed previously in this leaflet.
Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills.

HEALTH BENEFITS FROMS OCs
In addition to preventing pregnancy, combination OCs may provide certain benefits like :

  • menstrual cycles may become more regular
  • blood flow during menstruation may be lighter and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur.
  • pain or other symptoms during menstruation may be encountered less frequently
  • ectopic (tubal) pregnancy may occur less frequently
  • non-cancerous cysts or lumps in the breast may occur less frequently
  • acute pelvic inflammatory disease may occur less frequently
  • OC use may provide some protection against developing cancer of the ovaries and cancer of the lining of the uterus.

Each pack contains:

  A) 21 White coloured active tablets    
    Each uncoated tablet contains:    
    Desogestrel B.P. 0.15 mg    
    Ethinyl Estradiol I.P. 0.03 mg    
         
  B) 7 pink coloured placebo tablets    
    Each uncoated tablet contains:    
    Excipients q.s.    
         
    Colour : Erythosine Lake    

Dosage : As directed by the Physician

 

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