Minipil

Minipil Special Precautions

ethinylestradiol + levonorgestrel

Manufacturer:

Laboratorios Leon Farma

Distributor:

Embil
Full Prescribing Info
Special Precautions
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.
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