Herz Special Precautions

In some situations the patient needs to take special care while taking HERZ or any other combined pill, and the doctor may need to examine her regularly. Consult the doctor before starting to use HERZ if any of the following conditions apply or if any of them develop or worsen while taking HERZ: if the patient smokes.
If the patient has diabetes.
If the patient is overweight.
If the patient has high blood pressure.
If the patient has a heart valve disorder or a certain heart rhythm disorder.
If the patient has an inflammation of the veins (superficial phlebitis).
If the patient has varicose veins.
If anyone in the immediate family has ever had a blood clot (thrombosis in the leg, lung 'pulmonary embolism', or elsewhere), a heart attack or a stroke at a young age.
If the patient suffers from migraine.
If the patient has epilepsy.
If the patient has an increased potassium blood level (e.g. due to problems with the kidneys) and also use diuretics that may increase the potassium in the blood (ask the doctor if not sure).
If the patient or someone in the immediate family has ever had high blood levels of cholesterol or triglycerides (fatty substances).
If a close relative has or has ever had breast cancer.
If the patient has a disease of the liver or gall bladder.
If the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
If the patient has systemic lupus erythematosus (or SLE, a disease of the immune system).
If the patient has hemolytic uremic syndrome (or 'HUS', a disorder of blood coagulation causing failure of the kidneys).
If the patient has sickle cell disease.
If the patient has a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, or a neurological disease called Sydenham's chorea).
If the patient has (or has ever had) golden brown pigment patches so-called 'pregnancy patches' especially on the face (chloasma). If this is the case, avoid direct exposure to sunlight or ultraviolet light.
If the patient has hereditary angioedema. Consult the doctor immediately if the patient experiences symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing estrogens may induce or worsen symptoms of angioedema.
If any of the previously mentioned conditions appear for the first time, recur or worsen while using the Pill, contact the doctor.
The Pill and blood clots: A thrombosis is the formation of a blood clot which may block a blood vessel.
A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). Venous thromboembolism (VTE) can develop whether or not the patient is taking the pill. It can also happen if the patient becomes pregnant. If a blood clot breaks away from the vein where it has formed; it may reach and block the arteries of the lungs, causing a so-called 'pulmonary embolism'. Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack). Blood clots or a ruptured blood vessel in the brain may cause a stroke.
From the Long-term studies, they have suggested that there may be a link between the use of the pill and an increased risk of venous and arterial blood clots, embolism, heart attack or stroke. The occurrence of these events is rare.
The risk of venous thromboembolism is highest during the first year of use. This increased risk is present after initially starting the combined pill or restarting (following a 4 week or greater pill free interval) the same or a different combined pill. Data from a large study suggest that this increased risk is mainly present during the first 3 months.
Overall the risk for venous thromboembolism in users of low estrogen dose (< 50 µg ethinylestradiol) pills is two to threefold higher than for non-users of combined oral contraceptives who are not pregnant and remains lower than the risk associated with pregnancy and delivery.
Very occasionally venous or arterial thromboembolic events may cause serious permanent disabilities, may be life-threatening, or may even be fatal.
Venous thromboembolism, manifesting as deep venous thrombosis and/or pulmonary embolism, may occur during the use of all combined pills.
Extremely rarely blood clots can occur in other parts of the body including the liver, gut, kidney, brain or eye.
Stop taking the pill and contact a doctor immediately if the patient notices signs of: deep venous thrombosis, such as: swelling of one leg or along a vein in the leg; pain or tenderness in the leg which may be felt only when standing or walking, increased warmth in the affected leg; red or discolored skin on the leg.
Pulmonary embolism, such as: sudden onset of unexplained shortness of breath or rapid breathing; sudden coughing which may bring up blood; sharp chest pain which may increase with deep breathing; sense of anxiety; severe lightheadedness or dizziness; rapid or irregular heartbeat. Some of these symptoms (e.g. "shortness of breath", "coughing") are non-specific and might be misinterpreted as more common or less severe event (e.g. respiratory tract infection).
Arterial thromboembolism (arterial blood vessels blocked by blood clots and such blood clots which have broken away): stroke such as: sudden numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden, severe or prolonged headache with no known cause; loss of consciousness or fainting with or without seizure.
Blood clots blocking other arterial blood vessels, such as: sudden pain, swelling and slight blue discoloration of an extremity; "acute" abdomen.
Heart attack such as: pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach; fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeats.
The doctor will check, e.g. whether the patient has a higher risk of getting a thrombosis due to a combination of risk factors or perhaps one very strong risk factor. In the case of a combination of factors the risk may be higher than simply adding two individual risks. If the risk is too high, the doctor will not prescribe the Pill.
The risk of venous or arterial blood clots (e.g. deep venous thrombosis, pulmonary embolism, heart attack) or stroke increases: with age.
If the patient is overweight.
If anyone in the immediate family has ever had a blood clot (thrombosis in the leg, lung 'pulmonary embolism', or elsewhere), a heart attack or a stroke at a young age, or if the patient or any of the relatives are known or suspected of having a hereditary blood clotting disorder increasing the risk for developing blood clots. In this case the patient should see a specialist before deciding about using any combined oral contraceptive. Certain blood factors that may suggest the patient has tendency for venous or arterial thrombosis include activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
With prolonged immobilization (for example, when the patient has her leg or legs in plaster or splints), major surgery, any surgery to the legs; or major trauma. In these situations it is better to stop taking the pill (if the surgery is planned the patient should stop at least four weeks beforehand) and not to start again until two weeks after the patient is fully on her feet again.
If the patient smokes (the risk increases the more the patient smokes and the older she gets, especially in women over 35 years of age). When using the pill the patient should stop smoking, especially if she is older than about 35 years of age.
If the patient or someone in the immediate family has or has ever had high blood levels of cholesterol or triglycerides (fatty substances).
If the patient has high blood pressure. If she develops high blood pressure while using the pill, she may be told to stop using it.
If the patient suffers from migraine.
If the patient has a heart valve disorder or a certain heart rhythm disorder.
Directly after giving birth, women are at an increased risk of blood clots so the patient should ask the doctor how soon after delivery she can start taking a combined pill.
The Pill and 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 itself. For example, it may be that more tumors are detected in women on combined pills because they are examined by their doctor more often. The risk of breast tumors becomes gradually less after stopping the combined hormonal contraceptive. It is important to regularly check the breasts and the patient should contact the doctor if she feels any lump.
In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors have been reported in contraceptive pill users. In isolated cases, these tumors have led to life-threatening internal bleeding. Contact the doctor if the patient has unusually severe abdominal pain.
The most important risk factor for cervical cancer is persistent Human Papilloma Virus (HPV) infection. Some studies suggest that long-term use of the pill increases a woman's risk of developing cervical cancer. However, it is not clear to what extent sexual behavior or other factors such as Human Papilloma Virus increases this risk.
The previously mentioned tumors may be life-threatening or may have a fatal outcome.
Bleeding between periods: With all Pills, for the first few months, the patient can have irregular vaginal bleeding (spotting or breakthrough bleeding) between the periods. The patient may need to use sanitary protection, but continue to take the tablets as normal. Irregular vaginal bleeding usually stops once the body has adjusted to the Pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell the doctor.
What to do if no bleeding occurs: If the patient has taken all the tablets correctly, has not had any vomiting or severe diarrhea and she has not taken any other medicines, it is highly unlikely that she is pregnant. Continue to take HERZ as usual.
If the patient has taken the tablets incorrectly, or, if she has taken the tablets correctly but the expected bleeding does not happen twice in a row, she may be pregnant. Contact the doctor immediately. Do not start the next pack until the patient is sure that she is not pregnant. In the meantime, use non-hormonal contraceptive measures.
EFFECT ON ABILITY TO DRIVE AND USE MACHINE: Referring the studies of originator product, no studies on the effects of the ability to drive and use machines have been performed.