|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Asubtela||coated tablets; 1 tabl contains: 0.03 mg ethinylestradiol, 3 mg drospirenone; 21 tabl.||Exeltis Poland||26.90||Check|
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
Oral hormonal contraceptive.
The preparation belongs to the group of two-component hormonal contraceptives for oral use. It contains synthetic steroid hormones: ethinylestradiol (a hormone from the estrogen group) and drospirenone (a hormone from the progestagen group). This is called a single-phase preparation, which means that each tablet contains a constant amount of ethinylestradiol and drospirenone (in contrast to multi-phase tablets with variable hormone content in consecutively used tablets).
The effects of all two-component oral contraceptives include several mechanisms:
• stop Graaf's follicle maturation and inhibit ovulation
• change the endometrium (mucous membrane) properties of the uterus, which in the case when the egg is fertilized despite using the preparation, hinders the implantation of the embryo in the endometrium (so-called implantation) and causes the human embryo to die within a few days
• change the properties of the cervical mucus, which makes sperm MIG ration difficult
• reduce the peristalsis of the fallopian tubes.
Drospirenone is quickly and almost completely absorbed. After multiple administrations, the maximum steady-state concentration occurs approximately 8 days after the start of use. Subject to rapid metabolism, the major metabolites are formed without the cytochrome P450 enzymatic system. Excreted with faeces and urine, primarily in the form of metabolites. Ethinylestradiol is rapidly absorbed from the gastrointestinal tract. Fully metabolized, excreted in the faeces and urine, exclusively in the form of metabolites.
Indications: prevention of pregnancy.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients.
Do not use in the following states:
• occurrence of venous thromboembolism or risk of its occurrence:
- active venous thromboembolism (treated with anticoagulants) or history of venous thromboembolism (eg deep vein thrombosis, pulmonary embolism)
- known hereditary or acquired predisposition to venous thromboembolism (eg resistance to active C protein [including Le Leiden factor], antithrombin III deficiency, protein C deficiency, protein S deficiency)
- extensive surgery associated with long-term immobilization
- high risk of venous thromboembolism due to multiple risk factors
• occurrence of arterial thromboembolic events or the risk of their occurrence:
- active arterial thromboembolic events (eg myocardial infarction) or conditions that may be the first symptom of such disorders (eg angina pectoris)
- cerebrovascular disease (active or previous history of stroke or prodromal signs, e.g. transient ischemic attack)
- an inherited or acquired inclination to arterial thromboembolic events, e.g.hyperhomocysteinemia and the presence of anti-phospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
- migraine with focal neurological symptoms in an interview
- high risk of arterial thromboembolic events due to the presence of multiple risk factors or the presence of one of the major risk factors, such as: vascular diabetes, severe hypertension, severe dyslipoproteinaemia
• severe or acute renal failure
• severe or current liver disease (until normalization of liver function parameters)
• present or past liver cancer (benign or malignant)
• recognized or suspected tumors of reproductive organs or breasts dependent on the influence of sex hormones
• bleeding from the genital tract with an unexplained cause
• pregnancy or suspicion.
If any of the above-mentioned conditions occur for the first time while using the preparation, stop using it immediately and consult a physician.
The use of the preparation is contraindicated in parallel with the following drugs: ombitasvir, paritaprevir, ritonavir and dasabuvir.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Before starting the use of the preparation, it is necessary to perform tests to exclude contraindications and identify conditions requiring special care (the doctor will recommend the necessary tests).
If any of the following conditions are present, the physician will assess the benefit-risk balance of the preparation in each individual case. If any of the following conditions occur for the first time, get worse or worsen, you should immediately consult a doctor, because it may be necessary to stop taking the preparation.
1. Circulatory disorders
The use of any combined hormonal contraceptives is associated with an increased risk of arterial (eg myocardial infarction, stroke, transient ischemic attack) and venous (e.g., deep vein thrombosis, pulmonary embolism) thromboembolic disorders. Cases of arterial thromboembolism can be life-threatening and can end in death. The increase in risk varies and depends on several factors, including the hormonal composition of the preparation. In comparison to the preparations with the lowest risk of venous thromboembolism, the risk associated with the use of this preparation is twice as high. The risk of venous thromboembolism is the highest in the first year of oral hormonal contraceptives. The risk is also increased if these agents are re-used after an interval of 4 weeks or longer. Venous thromboembolism may be life-threatening (in 1-2% of cases it may be fatal). Thrombosis of other blood vessels (eg, hepatic, mesenteric, cerebral or retinal arteries) is extremely rare.
If you experience any of the following symptoms, you should immediately consult a doctor, because these symptoms may indicate the occurrence of venous or arterial thrombotic and / or thromboembolic disorders:
• one-sided swelling of the lower limb (swelling of the foot, swelling of the leg, swelling along the vein)
• pain or tenderness in the leg that can only be felt when standing or walking
• increased temperature in the affected leg, red or discolored skin of the lower limb
• a sudden fit of shallow or faster breathing
• sudden, severe chest pain that may (but does not have to) radiate to the left arm, jaw, throat, stomach or back
• sudden cough, sometimes connected to haemoptysis
• sudden pain, tightness or fullness in the chest
• feeling of fullness, indigestion or choking
• sweating, weakness, anxiety, nausea, vomiting or dizziness
• cardiac arrhythmias or increased frequency
• any unusual, severe, long-lasting headache
• sudden blurred vision, sudden partial loss or complete loss of vision
• blurred speech or aphasia
• lightheadedness or dizziness
• loss of consciousness that may be accompanied by seizures
• sudden weakness or semi-numbness or involving part of the body (eg face, arms and legs)
• movement disorders, loss of balance or motor coordination
• sudden trouble walking
• acute abdomen (a characteristic set of clinical symptoms).
Factors that increase the risk of venous thromboembolism in women taking combined oral contraceptives include:
• age (especially after the age of 35)
• obesity (BMI body mass index greater than 30 kg / m2); the risk increases significantly with the increase in BMI
• immobilization for a long time, major surgery, any surgical operation in the lower limbs or pelvis, neurosurgery, serious injury (in these situations, it is required to discontinue use - at least 4 weeks before planned surgery - and not to use it at least for 2 weeks from the moment of returning full mobility, it may also be necessary to use anticoagulant therapy - the decision is made by the physician)
• temporary immobilization (eg travel by plane lasting longer than 4 hours), especially in women with co-existing other risk factors
• occurrence of thromboembolic disorders in siblings or parents (if genetic predisposition is suspected, consult a specialist before using the preparation)
• other diseases associated with venous thromboembolism, including: cancer, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel diseases (eg Crohn's disease, ulcerative colitis) and sickle cell disease
• the presence of varicose veins and thrombophlebitis of superficial veins (the role of this factor has not been fully established)
• postpartum period.
Factors that increase the risk of arterial thromboembolic events or cerebrovascular events in women taking combined oral contraceptives include:
• age (especially after the age of 35)
• obesity (body mass index greater than 30 kg / m2); the risk increases significantly with the increase in BMI
• smoking (women using combined oral contraceptives are strongly advised not to smoke, and after the age of 35 in women smoking tobacco use contraindicated)
• migraine; an increase in the incidence or severity of migraine may indicate a cerebrovascular event, including ischemic stroke , and may require immediate discontinuation of the
• the occurrence of thromboembolic events in siblings or parents (if genetic predisposition is suspected, consult a specialist before using the preparation)
• other diseases associated with adverse events within the vessels, including: diabetes, hyperhomocysteinemia, dyslipoproteinemia, valvular heart disease, atrial fibrillation and systemic lupus erythematosus.
The presence of one serious or several risk factors for venous or arterial thromboembolic disorders is a contraindication to the use of the preparation. Consult a physician.
Long-term use of combined oral contraceptives may increase the risk of certain types of cancer.
However, there are discussions about the importance of additional factors (such as HPV human papillomavirus infection in cervical cancer) and the existence of a cause-and-effect relationship between the use of preparations and the development of cancer in breast cancer.
In women taking combined oral contraceptives, mild hepatic tumors, and even more rarely liver malignancies, are rarely possible. These tumors can in rare cases lead to abdominal haemorrhage, which is a direct threat to life. Epigastric pain, enlarged liver or bleeding into the abdomen in women using hormonal contraceptives may be a sign of liver cancer.
3. Other states
In patients treated for hepatitis C virus (HCV) infection, elevation of liver transaminases was significantly more common in women taking hormonal contraceptives.
Drospirenone contained in the preparation can rarely contribute to an increase in potassium in the blood.It is recommended to check the concentration of potassium before the start of the preparation, as well as during the first cycle of the use of the preparation in women with impaired renal function and the concentration of potassium near the upper limit of normal, especially if other potassium sparing agents are used in parallel.
In women with increased levels of triglycerides in the blood (hypertriglyceridaemia) or with a genetic predisposition in this direction (family members have increased triglyceride levels), the use of oral combined oral contraceptives may increase the risk of pancreatitis.
The use of oral contraceptives may be associated with increased blood pressure, but this is rarely clinically relevant. However, in these rare cases, it may be necessary to stop taking oral contraceptives. If an increase in blood pressure occurs during the use period, please consult your doctor immediately.
The use of oral combined oral contraceptives may be associated (although the cause and effect relationship has not been clearly confirmed) with the occurrence or worsening of jaundice, bile related cholelithiasis, cholelithiasis, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome, Sydenhama chorea, herpes simplex pregnant and hearing loss associated with otosclerosis.
In women with hereditary angioedema, estrogen intake may worsen symptoms or cause angioedema.
If hepatic disorders occur, it may be necessary to discontinue use of the preparation; please consult your doctor. Recurrence of cholestatic jaundice and / or pruritus associated with cholestasis , which occurred for the first time during pregnancy or during the use of sex hormones, require discontinuation of the preparation.
Women with diabetes during the use of oral contraceptives should be cautious and under medical supervision, following regularly recommended tests (possible impact of contraceptives on insulin resistance and Glucose tolerance).
Oral combined contraceptives may cause worsening of the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis.
The use of the preparation may cause chloasma (pigmentation spots on the face). Women prone to pigmentation on the face should avoid exposure to the sun or UV radiation during the use of oral contraceptives.
The product does not protect against HIV infection or other sexually transmitted diseases.
The effectiveness of contraception depends on the regularity of use, as well as on proper absorption (gastrointestinal disorders, such as diarrhea and vomiting, may affect the bioavailability of active substances in the preparation) and potential interactions with other drugs taken in parallel. Skipping the dose, gastrointestinal disturbances and using other medicines may reduce the effectiveness of contraception.
Preparations containing St. John's wort may reduce the contraceptive effectiveness of the preparation.
Irregular bleeding (spotting or intracranial bleeding) may occur during the use of oral contraceptives, especially in the first months of use. If irregular bleeding occurs or persists after the adaptation period, please consult your doctor; your doctor will recommend appropriate tests to rule out malignant tumors or pregnancy.
In some cases, there is no withdrawal bleeding (during a recommended break in taking the product). If the preparation was not taken in accordance with the instructions and there was no withdrawal bleed or if there were no 2 consecutive bleeding, it may indicate pregnancy and therefore consult a physician before continuing.
Additional information about the other ingredients of the preparation:
• the product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
There was no effect of oral combined contraceptives on the ability to drive vehicles and operate equipment / machines.
The preparation is in the form of coated tablets for oral use. Do not exceed the recommended doses, because it will not increase the effectiveness of action, and may harm your health and life. If you have any doubts about the use of the preparation, consult your doctor.
The tablets are used daily at the same time, one tablet a day for the next 21 days, and the next 7 days are not taken, and during the interruption the withdrawal bleeding begins. Bleeding usually starts on day 2-3 after taking the last tablet. Taking the tablets from the next pack begins after 7 days of break, even if the withdrawal bleed is still ongoing. Detailed information on administration and dosage modification can be found in the manufacturer's materials (leaflet for the patient).
The effectiveness of contraception depends on the regularity of use, as well as on proper absorption (gastrointestinal disorders, such as diarrhea or vomiting, may affect the bioavailability of active substances in the preparation) and potential interactions with other preparations taken in parallel. Skipping the dose, gastrointestinal disturbances and using other medicines may reduce the effectiveness of contraception. If in doubt, consult a physician.
Do not use any preparation during your pregnancy without consulting your doctor!
It is very important that before using any preparation during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with its use. If you are pregnant or planning to become pregnant, inform the doctor prescribing the prescription for this preparation.
The use of the preparation in pregnant women is contraindicated.
If a woman becomes pregnant while taking the preparation, her use should be discontinued immediately (based on current clinical experience, no teratogenic effects of the combined oral contraceptives used in early pregnancy have been found, the data on the preparation are limited).
You should not breastfeed when using combined hormonal contraceptives.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Using other medicines may reduce the effectiveness of contraception.
The use of other drugs may cause intracycular bleeding.
The use of the preparation is contraindicated in parallel with the following drugs: ombitasvir, paritaprevir, ritonavir and dasabuvir.
Parallel administration of the preparation with ritonavir, ombitasvir, paritaprevir or dasabuvir drugs may increase liver transaminase levels and reduce the contraceptive effectiveness of the preparation, and this may persist for several weeks after discontinuation of the above-mentioned drugs. Getting effective contraception during this period requires the use of other methods of contraception; please consult your doctor.
Drugs increasing the activity of microsomal enzymes and hepatic metabolism, such as carbamazepine, barbiturates, phenytoin, primidone, rifampicin, bosentan, medicines used to treat HIV infection (eg ritonavir, nevirapine, efavirenz), as well as oxcarbazepine, topiramate, felbamate, Griseofulvin and herbal preparations containing St. John's wort (Hypericum perforatum) may reduce the contraceptive effectiveness of the preparation. The effect of the above-mentioned drugs is maintained for about 4 weeks after they have been taken.
HIV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, including those in combination with HCV inhibitors, may increase or decrease (variable effect) the concentration of oestrogens or progestogens in the plasma, which may have clinical significance and affect the efficacy of contraception. Always read the information contained in the leaflets for patients taking medications.
The use of any of the above-mentioned groups may reduce the effectiveness of contraception, not only during the use of the drug, but also after its use. Decreased contraceptive effectiveness may persist for some time, which depends on the type of drug used.In these situations, other (non-hormonal) methods of contraception are required for effective contraception and a physician should be consulted.
Drugs that reduce the activity of the cytochrome P450 3A4 isoenzyme, such as azole antifungals (ketoconazole), cimetidine, Verapamil , macrolides (eg Erythromycin ), diltiazem, antidepressants and grapefruit juice, may increase the concentration of estrogens or progestogens in the plasma. However, the major metabolites of drospirenone are formed without the participation of cytochrome P450, so it is unlikely that drugs that inhibit the activity of this enzyme system affect the metabolism of drospirenone.
The preparation may influence the metabolism of other medicines and cause an increase (eg cyclosporin) or a decrease (eg lamotrigine) of their concentration.
The preparation may cause minor (eg theophylline) or moderate (eg, tizanidine) increase in plasma concentrations of drugs that are substrates for the cytochrome P450 1A2 isoenzyme.
Hormonal contraceptives may potentiate the antihypertensive effect of tizanidine; be careful.
The use of potassium-sparing or potassium-sparing diuretics or aldosterone antagonists requires the control of potassium levels during the first cycle of application.
The use of hormonal contraceptives may influence the results of some diagnostic tests (eg blood clotting parameters, carbohydrate metabolism parameters, liver, thyroid, adrenal and kidney function parameters, plasma protein concentration and others).
Like all preparations, Asubtela can cause side effects, although they will not occur in all people using this product. Remember that the expected benefits of the preparation are usually greater than the damage resulting from the occurrence of side effects.
The use of combined hormonal contraceptives may be associated with the occurrence of numerous side effects, including life-threatening ones:
• venous and / or arterial thromboembolic events (including myocardial infarction, stroke, transient ischemic attack, venous thrombosis, pulmonary embolism)
• hormone-dependent tumors (liver, breast cancer)
• occurrence or worsening of the clinical course of Crohn's disease, ulcerative colitis, epilepsy, migraine, uterine fibroids, porphyria, systemic lupus erythematosus, Sydenham chorea, haemolytic-uremic syndrome, cholestatic jaundice (cholestatic)
• acute or chronic liver problems that may require discontinuation of the medicine until the liver function has normalized
• in women with hereditary angioedema, estrogens may induce angioneurotic edema or exacerbate its symptoms.
In women using oral contraceptives breast cancer is diagnosed slightly more frequently, however, a cause and effect relationship has not yet been confirmed.
In addition, the following side effects may occur. Common: headaches, mood disorders and discomfort, abdominal pain, menstrual disorders (including amenorrhea, heavy menstrual bleeding), bleeding not related to the menstrual cycle, pain and / or breast tenderness, candidiasis (candidiasis) of the vagina, discharge from the vagina, nausea . Uncommon: decreased libido, dizziness, paresthesia, migraine, vomiting, diarrhea, hypertension or hypotension, acne, alopecia, eczema, pruritus, breast enlargement, vaginitis, fluid retention, weight gain or loss. Rarely: hypersensitivity reactions, asthma, hearing loss, venous thromboembolism, arterial thromboembolism, erythema nodosum, erythema multiforme, breast discharge. Increases in potassium in the blood (hyperkalemia) and increase in triglycerides may occur.
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