Minipil

Levonorgestrel, ethinylestradiol.

Each film-coated tablet contains a small amount of 2 different female hormones, namely levonorgestrel 100 mcg and ethinylestradiol 20 mcg. The other ingredients (excipients) are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572) and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, red aluminum lake (E129), lecithin (E322), iron oxide red (E172) and blue aluminum lake (E1329)].

The contraceptive effect of combined oral contraceptives is based on the interaction of various factors eg, the inhibition of ovulation and changes in the cervical mucus.

Contraceptive pill used to prevent pregnancy.

Take 1 tablet of Minipil everyday, if necessary with a small amount of water. The patient should take the tablets everyday around the same time.
The strip contains 21 tablets. Each day will line up with a row of pills. It is important to take the pills everyday. Follow the direction of the arrow indicated on the strip until the patient have taken all 21 tablets. Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week) bleeding should begin. This so called "withdrawal bleeding" usually starts on the 2nd or 3rd day of the week. On the 8th day after the last Minipil tablet (that is, after the 7-day gap week), start the following strip, even if the bleeding has not stopped. This means that the patient should start the following strip on the same day of the week and that the withdrawal bleed should occur on the same days each month. When using Minipil in this manner, the patient is also protected against pregnancy during 7 days of not taking a tablet.
When to Start With The First Strip: If the patient has not used a contraceptive with hormones in the previous month: Begin with Minipil on the 1st day of the cycle (that is the 1st day of the patient's menstruation). If the patient starts Minipil on the 1st day of the menstruation, she is immediately protected against pregnancy. The patient may also begin on day 2-5 of the cycle, but then use extra protective measures (eg, condom) for the first 7 days.
Changing From Another Combined Hormonal Contraceptive or Combined Contraceptive Vaginal Ring or Patch: The patient can start Minipil on the day after the tablet-free period of the previous pill finished (or after the last inactive tablet of the previous pill). When changing from a combined contraceptive vaginal ring or patch, follow the advice of the doctor.
Changing From Progestogen-Only-Method (Progestogen-Only Pill, Injection, Implant or Progestogen-Releasing IUD): The patient may switch any day from the progestogen only pill (from an implant or the IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases, use extra protective measures (eg, a condom) for the first 7 days of the tablet-taking.
After Miscarriage or An Abortion: Follow the doctor's advice.
After Having a Baby: After having a baby, the patient can start Minipil between 21 and 28 days later. If the patient starts later than day 28, she must use a so-called barrier method (eg, a condom) during the first 7 days of Minipil use.
If, after having a baby, the patient had an intercourse before starting Minipil (again), she must first be sure that she is not pregnant or must wait until the next menstrual bleed.
Let the doctor advise the patient in case she is not sure when to start.
If the patient is breastfeeding and wants to start Minipil (again) after having a baby: See Use in lactation under Precautions.
If The Patient Forgets To Take Minipil: If the patient is <12 hrs late taking a tablet, the protection from pregnancy is not reduced. Then still take the tablet as soon as the patient remembers and then take the following tablets again at the usual time.
If the patient is >12 hrs late taking a tablet, the protection from pregnancy may be reduced. The great the number of the tablets that the patient has forgotten, the greater is the risk that the protection from pregnancy is reduced.
The risk of incomplete protection against pregnancy is greatest if the patient forgets a tablet at the beginning or the end of the strip.
Therefore, the patient should adhere to the following rules: More than 1 tablet forgotten in the strip: Contact the doctor.
One Tablet Forgotten In Week 1: Take the forgotten tablet as soon as remembered, even if that means that patient has to take 2 tablets at the same time. Take the tablets again at the usual time and use extra precautions for the next 7 days eg, condom. If the patient has had sexual intercourse in the week before the oversight or has forgotten to start a new strip after the tablet-free period, the patient must realize that there is a risk of pregnancy. In that case, contact the doctor.
One Tablet Forgotten In Week 2: Take the forgotten tablet as soon as remembered, even if that means that the patient has to take 2 tablets at the same time. Take the tablets again at the usual time. The protection from pregnancy is not reduced and does not need to take extra precautions.
One Tablet Forgotten in Week 3: The patient can choose between 2 possibilities: 1) Take the forgotten tablet as soon as remembered, even if that means that the patient has to take 2 tablets at the same time. Take the tablets again at the usual time. Instead of the tablet-free period, go straight on to the next strip. Most likely, the patient will have a period (withdrawal bleed) at the end of the 2nd strip but may also have spotting or breakthrough bleeding during the 2nd strip.
2) The patient can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which the patient forgot the tablet). If the patient wants to start a new strip on fixed start day, make the tablet-free period <7days.
If the patient follows either of these 2 recommendations, she will remain protected against pregnancy.
If the patient has forgotten any of the tablets in a strip and does not have bleeding in the 1st tablet-free period, this may mean that the patient is pregnant. The patient must contact the doctor before using the next strip. (See figure.)

Click on icon to see table/diagram/image

What to Do In Case of Vomiting or Severe Diarrhea: If the patient vomits within 3-4 hrs of taking a tablet or has severe diarrhea, there is a risk that the active substances in the tablet are not fully absorbed into patient's body. The situation is similar if the patient forgets a tablet. After vomiting or diarrhea, the patient must take another tablet from a reserve strip as soon as possible. If possible take Minipil within 12 hrs when the patient normally take the tablet. If this is not possible or 12 hrs have passed, the patient should follow the advice given under If the Patient Forgets to Take Minipil as previously mentioned.
Delaying of Menstrual Period: Even if not recommended, delay of menstrual period (withdrawal bleed) is possible by going straight on to a new Minipil strip instead of the tablet-free period, to the end of the 2nd strip. The patient may experience spotting (drops or flecks of blood) or breakthrough bleeding while using the 2nd strip. The patient may experience spotting (drop or flecks of blood) or breakthrough bleeding while using the 2nd strip. After the usual tablet-free period of 7 days, continue with the following strip.
The patient might ask the doctor for advice before deciding to delay the menstrual period.
Change of The First Day of The Patient's Menstrual Period: If the patient takes Minipil according to the instructions, then the patient's menstrual period/withdrawal bleed will begin in the tablet-free week. If the patient has to change this day, do this by making the tablet-free period shorter (but never longer). For example, if the patient's tablet-free period begins on a friday and the patient wants to change this to tuesday (3 days earlier), start a new strip 3 days earlier than usual.
If the patient makes the tablet-free period very short (eg, ≤3 days) then it may be that the patient does not have any bleeding during this tablet-free period. The patient may then experience spotting (droplets or flecks or blood) or breakthrough bleeding.
If the patient is not sure on how to proceed, contact the doctor for advice.
If The Patient Wants to Stop Taking Minipil: The patient can stop taking Minipil whenever she wants. If the patient does not want to become pregnant, ask the doctor for advice about other reliable methods of birth control.
If the patient has any further questions on the use of Minipil, ask the doctor or pharmacist.

There are no reports of serious harmful results of taking too many Minipil tablets. If the patient take several tablets at once, then she may have symptoms of nausea and vomiting. Young girls may have bleeding from the vagina.
If the patient has taken too many Minipil tablets, or discovers that a child has taken some, ask the doctor or pharmacist for advice.

Hypersensitivity to levonorgestrel or ethinylestradiol or any of other ingredients of Minipil. This can be recognized by itching, rash or swelling.
If the patient has (or has had in the past) a blood clot (thrombosis) in a blood vessel of the legs, lungs (embolus) or other organs; heart attack or stroke; a disease that can be a predictor of a heart attack (eg, angina pectoris, which causes severe pain in the chest) or of a stroke (eg, a transient slight stroke with no residual effects); certain form of migraine (with so-called focal neurological symptoms); inflammation of the pancreas (pancreatitis); liver disease and liver function is still not normal; tumor in the liver; suspected to having a breast cancer or cancer of the genital organs.
Disease that may increase the risk of thrombosis in the arteries. This applies to the following situations: Diabetes with damaged blood vessels, very high blood pressure and a very high level of fat in the blood (cholesterol or triglycerides).
Patients with a disturbance of blood clotting (eg, protein C deficiency), unexplained bleeding from the vagina, unexplained absence of period for several months.
Use in Pregnancy: If the patient is pregnant, she must not take Minipil. If the patient becomes pregnant while taking Minipil, she must stop immediately and contact the doctor. Consult the doctor or pharmacist before taking any medicine.

Before the patient can begin taking Minipil, the doctor will ask the patient some questions about her personal and close relatives health history. The doctor will also measure the blood pressure and depending upon the personal situation, may also carry out some other tests.
Several situations are described where the patient should stop using Minipil or where the reliability of the Minipil may be decreased. In such situations, the patient should either not have intercourse or should take extra nonhormonal contraceptive precautions eg, use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Minipil alters the monthly changes of the body temperature and of the cervical mucus.
Minipil like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
In some situations, the patient needs to take special care while using Minipil or any other combined hormonal contraceptive, and it may be necessary that the patient are regularly checked by the doctor. If any of the following conditions applies to the patient, the patient must inform the doctor before starting use Minipil. Also if any of the following conditions develops or worsens during the use of Minipil, the patient must consult the doctor: If a close relative has or had breast cancer; have a liver or gallbladder disease, diabetes, depression, Crohn's disease or ulcerative colitis (inflammatory bowel disease); hemolytic uremic syndrome (HUS), a blood disorder that causes kidney damage; sickle cell anemia (an inherited disease of the red blood cells); epilepsy; systemic lupus erythematosus (SLE), a disorder of the immune system; disease that 1st appeared during pregnancy or earlier use of sex hormones [eg, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with vesicles during pregnancy), Sydenham's chorea (a disease of the nerves in which sudden movements of the body occur)]. If the patient has or ever had chloasma (golden brown pigment patches, so called "pregnancy patches" especially on the face). If this is the case, avoid direct exposure to sunlight or ultraviolet light. Hereditary angioedema, products containing estrogens may induce or worsens symptoms of angioedema. See the doctor immediately if the patient experience symptoms of angioedema eg, swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty in breathing.
Thrombosis: Venous Thrombosis: The use of any combination pill, including Minipil, increases a woman's risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not take any (contraceptive) pill.
The risk of venous thrombosis in users of combined pill increase with increasing age; if patient is overweight, one of the close relatives has had a blood clot (thrombosis) in the leg, lung or other organ at a young age; operation (surgery), any prolonged period of immobilization, or have had a serious accident. It is important to tell the doctor in advance that the patient is using Minipil as the treatment may have to be stopped. The doctor will inform the patient when to start Minipil again. This is usually about 2 weeks after the patient is back on her feet.
Arterial Thrombosis: The use of combination pills has been connected with an increase of the risk of arterial thrombosis (obstruction of an artery) eg, in the blood vessels of the heart (heart attack) or the brain (stroke).
The risks of arterial thrombosis in users of combines pills increases if the patient smokes, she is strongly advised to stop smoking when the patient uses Minipil especially if the patient is >35 years. Increased fat content in the blood (cholesterol or triglycerides), overweight, one of the close relatives has had a heart attack or stroke at a young age, high blood pressure, migraine, problem with the heart (valve disorder, disturbance of the heart rhythm).
Stop taking Minipil and contact the doctor immediately if the patient notices possible signs of thrombosis eg, severe pain and/or swelling in one of the legs; sudden severe pain in the chest which may reach the left arm, sudden breathlessness and cough without an obvious cause; any unusual, severe or long-lasting headache or worsening of migraine; partial or complete blindness or double vision; difficulty in speaking or inability to speak; giddiness or fainting; weakness, strange feeling or numbness in any part of the body.
Cancer: Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment. For example, it may be that more tumors are detected in women on combined pills because they are examined by the doctor more often. The occurrence of breast tumors becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check the breasts and should contact the doctor if the patient feels any lump.
In rare cases, benign liver tumors and in even fewer cases malignant liver tumors have been reported in pill users. Contact the doctor if the patient has unusual severe abdominal pain.
Bleeding Between Periods: During the 1st few months of taking Minipil, the patient may have unexpected bleeding (bleeding outside the gap week). If this bleeding lasts longer than a few months or if it begins after some months, the doctor must investigate the cause.
If No Bleeding Occurs In The Gap Week: If the patient has taken all tablets correctly, has not had vomiting or severe diarrhea and has not taken any other medicines, it is highly unlikely that the patient is pregnant.
If the expected bleeding does not happen twice in succession, the patient may be pregnant. Contact the doctor immediately. Do not start the next strip until the patient is sure that they are not pregnant.
Minipil contains lactose. If the patient cannot tolerate certain sugars, consult the doctor before the patient take the drug.
Effects on the Ability to Drive or Operate Machinery: There is no information suggesting that the use of Minipil affects driving use or machines.
Use in Lactation: Use of Minipil is generally not advisable when a woman is breastfeeding. If the patient wants to take the pill while breastfeeding, she must contact the doctor first, consult the doctor or pharmacist before taking any medicine.

Use in Pregnancy: If the patient is pregnant, she must not take Minipil. If the patient becomes pregnant while taking Minipil, she must stop immediately and contact the doctor. Consult the doctor or pharmacist before taking any medicine.
Use in Lactation: Use of Minipil is generally not advisable when a woman is breastfeeding. If the patient wants to take the pill while breastfeeding, she must contact the doctor first, consult the doctor or pharmacist before taking any medicine.

Like all medicines, Minipil can cause side effects, although not all patients get them.
Always inform the doctor if the patient suffers from a side effect, especially if this side effect is severe or persistent, or if the patient notices a change in health that could possibly be caused by the pill.
Severe side effects connected to the use of the pill are described in Thrombosis and Cancer under Precautions to obtain more information and immediately consult the doctor if necessary.
Common Side Effects (>1 in 100, but <1 in 10 Women): Headache, mood changes (including depression), nausea, abdominal ache, painful breasts, tender breast, increase weight, rash.
Uncommon Side Effects (>1 in 1000, but <1 in 100 Women): Vomiting, diarrhea, water retention or edema, migraine, less desire in sex, breast enlarged, urticaria.
Rare Side Effects: (>1 in 10,000, but <1 in 1000 women): Irritation of the eyes during the use of contact lenses, hypersensitivity, decreased weight, breast and vaginal discharge, increased libido, erythema nodosus (nodules on the legs), erythema multiforme (skin lesions).
If any of the side effects gets serious, or if the patient notices any side effects not listed or if the patient thinks that this may be the case, inform the doctor or pharmacist.

Always inform the prescriber which medicines or herbal products that the patient is using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that the patient uses Minipil. The healthcare providers can tell if the patient needs to take additional contraceptive precautions (eg, condoms) and if so, for how long.
Some medicines can make Minipil less effective in preventing pregnancy or can cause unexpected bleeding.
These include medicines used for the treatment of epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine) and tuberculosis (eg, rifampicin) or HIV infections (ritonavir) or other infectious disease (eg, griseofulvin, ampicillin, tetracycline) to increase intestinal motility (eg, metoclopramide) and the herbal remedy St. John's wort.
If the patient wants to use herbal products containing St. John's wort while she is already using Minipil, consult the doctor first.
Minipil may decrease efficacy of other medicines eg, medicines containing cyclosporine or the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).
Ask the doctor or pharmacist for advice before taking any medicine.
Laboratory Tests: If the patient needs blood test, inform the doctor or the laboratory staff that she is taking Minipil, because oral contraceptives can affect the results of some tests.

Store at temperatures not exceeding 30°C.

Oral Contraceptives

G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

Rx