Therefore, this medication can also be used as a form of birth control by women taking it mainly to treat severe acne with seborrhea. However, this medication must not be used just for birth control because of its risks of very serious side effects such as blood clots.
Using this medication does not protect you or your partner against sexually transmitted diseases such as HIV, gonorrhea, chlamydia. Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your medication and what to do if you miss a dose.
If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your medication at the same time each day.
Each pack contains 21 tablets. If this is your first time using this medication, take your first tablet on the first day of your menstrual period, and continue to take 1 tablet once daily for 21 days in a row until the pack is finished.
Then, do not take any tablets for 7 days unless directed by your doctor. You should have your period during the 7 days without medication. After you have gone 7 days without taking this medication, start a new pack the next day whether or not you have your period. If you do not get your period, contact your doctor. According to the manufacturer, you should not use this medication long-term.
Once the acne has improved, stop this medication 3 to 4 cycles later. Ask your doctor or pharmacist for more details.
It may take up to several months before you get the full benefit of this drug. Tell your doctor if your condition persists or worsens. Vomiting and diarrhea may also make this medication work less well. Talk to your doctor if you have vomiting or diarrhea to see if you need to start using an additional form of birth control. See also Missed Dose section. Vaginal bleeding between periods called breakthrough bleeding or spotting and irregular periods may also occur as your body adjusts to the medication.
If you do not have bleeding during the 7 days when you are not taking the medication, ask your doctor for a pregnancy test. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. This medication may rarely cause serious sometimes fatal problems from blood clots such as deep vein thrombosis, heart attack, pulmonary embolism, stroke.
Get medical help right away if any of these side effects occur:. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of:. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.
Your doctor may need to adjust your diabetes medication, exercise program, or diet. Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time such as a long plane flight.
By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the first of these two options and to use extra precautions for the next 7 days as well. The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
The next pack must be started as soon as the current pack is finished, i. The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough bleeding on tablet-taking days. The woman may also be advised to discontinue tablet-taking from the current pack. She should then have a tablet-free interval of up to 7 days, including the days she missed tablets, and subsequently continue with the next pack. If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet-free interval, the possibility of a pregnancy should be considered.
Advice in case of gastro-intestinal disturbances: In case of severe gastro-intestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within hours after tablet-taking, the advice concerning missed tablets, as given in Management of missed tablets as previously mentioned, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet s needed from another pack.
Length of use: The length of use depends on the severity of the symptoms of androgenization and their response to treatment. In general, treatment should be carried out over several months.
Time to relieve of symptoms is at least three months. Acne and seborrhea usually respond sooner than hirsutism. The need to continue treatment should be evaluated periodically by the treating physician. Geriatric patients: Not applicable. See also Contraindications. Available data do not suggest a change in treatment in this patient population. There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and withdrawal bleeding.
The last may even occur in girls before their menarche, if they have accidentally taken the medicinal product. There are no antidotes and further treatment should be symptomatic. Should any of the conditions appear for the first time during their use, the product should be stopped immediately. Presence or a history of prodromi of a thrombosis e.
A high risk of venous or arterial thrombosis see Precautions. History of migraine with focal neurological symptoms. Diabetes mellitus with vascular involvement. Severe hepatic disease as long as liver function values have not returned to normal. Use of direct-acting antiviral DAA medicinal products containing ombitasvir, paritaprevir, or dasabuvir, and combinations of these see Interactions.
Presence or history of liver tumors benign or malignant. Known or suspected sex-steroid influenced malignancies e. Undiagnosed vaginal bleeding. Known or suspected pregnancy. Hypersensitivity to the active substances or to any of the excipients. Special Precautions. It has a similar composition to that of a combined oral contraceptive COC. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician.
Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents.
These events occur rarely. The risk of VTE is highest during the first year of use. This increased risk is present after initially starting a COC or restarting following a 4 week or greater pill free interval the same or a different COC. Data from a large, prospective 3-armed cohort study suggest that this increased risk is mainly present during the first 3 months. Extremely rarely, thrombosis has been reported to occur in other blood vessels, e. Symptoms of deep venous thrombosis DVT can include: unilateral swelling of the 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.
Symptoms of pulmonary embolism PE can include: 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 light headedness or dizziness; rapid or irregular heartbeat. Some of these symptoms e. An arterial thromboembolic event can include cerebrovascular accident, vascular occlusion or myocardial infarction MI. Symptoms of a cerebrovascular accident can include: 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.
Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity; acute abdomen. Symptoms of MI can include: 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.
Arterial thromboembolic events may be life-threatening or may have a fatal outcome. The potential for an increased synergistic risk of thrombosis should be considered in women who possess a combination of risk factors or exhibit a greater severity of an individual risk factor. This increased risk may be greater than a simple cumulative risk of the factors. See Contraindications. If a hereditary predisposition is known or suspected, the woman should be referred to a specialist for advice before deciding about any COC use; prolonged immobilization, major surgery, any surgery to the legs, or major trauma.
In these situations it is advisable to discontinue COC use in the case of elective surgery at least four weeks in advance and not to resume until two weeks after complete remobilization; smoking with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age ; dyslipoproteinemia; hypertension; migraine; valvular heart disease; atrial fibrillation.
There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism. Other medical conditions which have been associated with adverse circulatory events include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease Crohn's disease or ulcerative colitis and sickle cell disease. Biochemical factors that may be indicative of hereditary or acquired predisposition 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.
Tumors: The most important risk factor for cervical cancer is persistent HPV infection. Some epidemiological studies have indicated that long-term use of COCs may further contribute to this increased risk but there continues to be controversy about the extent to which this finding is attributable to confounding effects, e. The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. These studies do not provide evidence for causation. Since Diane 35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives.
Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism. The risk of thromboembolism occurring with these medicines is low and well known.
However, to minimise this risk, further measures should be implemented in addition to the updated product information. These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Because the CMDh took this position by majority, it will now be sent to the European Commission, which will adopt a legally binding decision.
This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only. Once the European Commission has adopted its decision, all EU Member States where Diane 35 and its generics are authorised must follow it and ensure that all agreed risk-minimisation measures, including changes to the information to prescribers and patients, are implemented.
These recommendations are based on a review of all available data on the risk of thromboembolism as well as the benefits of Diane 35 and its generics:. Medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved via national procedures and are available on prescription under various trade names in all EU Member States except Cyprus.
Diane 35 was first authorised in These medicines work by blocking the effects of a class of hormones called androgens. Cyproterone also supresses ovulation and therefore has a contraceptive effect. Its main responsibility is to resolve disagreements between Member States involved in mutual-recognition or decentralised procedures , to ensure that patients have the same level of protection, no matter where they are in the EU.
As the CMDh position was adopted by majority vote and not by consensus, the CMDh position will now be sent to the European Commission, which will take a legally binding decision throughout the EU. Please do not include any personal data , such as your name or contact details. Skip to main content. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.
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