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ACNOCIN is a brand name for Ethinyl Estradiol (also known as Ethinylestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Co-cyprindiol is indicated for use in women only for the treatment of: - severe androgen-dependent acne, refractory to prolonged oral antibiotic therapy, or - moderately severe hirsutism In women requiring treatment for these conditions, Co-cyprindiol also provides contraception (see Section 4.4 Warnings and…
Verbatim from this product's MHRA label. Tap a section to expand.
Co-cyprindiol inhibits ovulation and thereby prevents conception. Withdrawal bleeding usually occurs by 2-4 days after the last tablet. If this does not occur, it may be necessary to exclude pregnancy. Posology Starting tablets No previous hormonal contraception (during the preceding month): First treatment course: Tablets should be started on day 1 of the natural menstrual cycle (first day of bleeding), one tablet daily for 21 days.
Tablet- taking may also be started during bleeding days 2-5, but in that case an additional non-hormonal contraceptive method is recommended for the first seven days of the first cycle.
Subsequent courses:
Each subsequent course is started after 7 tablet-free days have followed the preceding course.
Switch from another combined oral contraceptive, patch or vaginal ring:
Tablet should preferably be started on the day following the intake of the last active tablet of the previous combined oral contraceptive, but at the latest following the usual tablet-free or placebo-tablet interval of the previous combined oral contraceptive, or after removal of the patch or the vaginal ring.
Switch from progestagen-only contraceptives (minipills, injections, implants or IUS): The switch from minipills can be made at all times (the switch from implants or IUS on the day of its removal and from injections on the next scheduled day of injection), but the user should be advised to use a non-hormonal contraceptive method for the first seven days of tablet-taking.
After abortion during the first trimester:
Tablet-taking can be started immediately. In this case no other contraceptive method is needed. 6. The use of the tablets should be started 21 to 28 days after childbirth or abortion during the second trimester. If tablet-taking is started later than this, an additional non-hormonal contraceptive method should be used for the first seven days of tablet-taking.
However, if intercourse has already occurred, pregnancy should be excluded or the woman should wait for her first natural menstrual period before starting the first tablet.
Missing tablets:
Summary of the safety profile The most commonly reported adverse reactions with Co-cyprindiol are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥ 1 % of the users.
4). System Organ Class Common (≥ 1/100) Uncommon (≥ 1/1000, <1/100) Rare (≥ 1/10,000 to < 1/1000) Not known (cannot be estimated from the available data) Immune system disorders hypersensitivity Exacerbation of hereditary angioedema and acquired angioedema Metabolism and nutrition disorders fluid retention hypertriglyceridemia Psychiatric disorders depressed mood, mood altered libido decreased libido increased Nervous system disorders headache migraine exacerbation of chorea Eye disorders contact lens intolerance Vascular Disorders Thromboembolism Increased blood pressure Gastrointestinal disorders nausea, abdominal pain vomiting, diarrhea Crohn's disease, ulcerative colitis Hepatobiliary disorders liver function disturbances Skin and subcutaneous tissue disorders rash, urticaria erythema nodosum, erythema multiforme Chloasma Reproductive system and breast disorders breast pain, breast tenderness breast hypertrophy vaginal discharge, breast discharge reduced menstrual flow, spotting, breakthrough bleeding and missed withdrawal bleeding, post pill amenorrhoea Investigations weight increased weight decreased Description of selected adverse reactions Post-marketing reports of severe depression (including very rare reports of suicidal ideation or behaviour) in patients using cyproterone acetate/ethinylestradiol have been received.
However, a causal relationship between clinical depression and cyproterone acetate/ethinylestradiol has not been established. 4. 4: • Venous thromboembolic disorders • Arterial thromboembolic disorders • Hypertension • Liver tumours (benign and malignant) • Occurrence or deterioration of conditions for which association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; systemic lupus erythematosus; herpes gestationis; otosclerosis-related hearing loss; sickle cell anaemia; renal dysfunction; hereditary angioedema; porphyria; cervical cancer; haemolytic uremic syndrome; Sydenham's chorea; epilepsy • Chloasma • Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal • In women with hereditary angioedema exogenous oestrogens may induce or exacerbate symptoms of angioedema The frequency of diagnosis of breast cancer is very slightly increased among OC users.
4 Warnings and Precautions for use). It should not be used in women solely for contraception, but should be reserved for those women requiring treatment for the androgen-dependent conditions described. 2 Posology and method of administration Co-cyprindiol inhibits ovulation and thereby prevents conception.
Withdrawal bleeding usually occurs by 2-4 days after the last tablet. If this does not occur, it may be necessary to exclude pregnancy. Posology Starting tablets No previous hormonal contraception (during the preceding month): First treatment course: Tablets should be started on day 1 of the natural menstrual cycle (first day of bleeding), one tablet daily for 21 days.
Tablet- taking may also be started during bleeding days 2-5, but in that case an additional non-hormonal contraceptive method is recommended for the first seven days of the first cycle.
Subsequent courses:
Each subsequent course is started after 7 tablet-free days have followed the preceding course.
Switch from another combined oral contraceptive, patch or vaginal ring:
Tablet should preferably be started on the day following the intake of the last active tablet of the previous combined oral contraceptive, but at the latest following the usual tablet-free or placebo-tablet interval of the previous combined oral contraceptive, or after removal of the patch or the vaginal ring.
Switch from progestagen-only contraceptives (minipills, injections, implants or IUS): The switch from minipills can be made at all times (the switch from implants or IUS on the day of its removal and from injections on the next scheduled day of injection), but the user should be advised to use a non-hormonal contraceptive method for the first seven days of tablet-taking.
After abortion during the first trimester:
3. Renal impairment Co-cyprindiol has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population. Method of administration Oral. 3 Contraindications Preparations containing oestrogen/progestogen combinations should not be used in the presence of any of the conditions listed below.
Should any of the conditions appear for the first time during their use, the product should be stopped immediately. g. g. 6). 6). g. 5). • Presence or history of liver tumours (benign or malignant). g. of the genital organs or the breasts) • Meningioma or history of meningioma Co-cyprindiol is not for use in men.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the patient forgets a single tablet, it should be taken within 12 hours of the correct time to maintain contraceptive protection. With larger errors, additional contraception (barrier method, such as a condom) is needed. Handling of missed tablets may be managed by the following two basic rules: 1.
Tablet-taking must never be discontinued for longer than 7 days. 2. Adequate suppression of the hypothalamic-pituitary-ovarian axis requires 7 days of uninterrupted tablet-taking.
Accordingly, the following advice can be given for daily practice:
Week 1 The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take the next tablets at her usual time. In addition, a barrier method such as a condom should be used for the next 7 days.
If the woman has had sexual intercourse in the 7 days before missing the tablet, the possibility of a pregnancy must be considered. The more tablets have been missed and the closer they are to the regular tablet-free break, the higher the risk of pregnancy.
Week 2 The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take the next tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions.
If she has not taken the tablets correctly or has missed more than one tablet, she should be advised to use extra contraceptive precautions for the next 7 days. Week 3 The risk of reduced contraceptive reliability is imminent because of the forthcoming tablet-free break of 7 days.
However, reduced contraceptive protection can still be prevented by adjusting the dose. By adhering to the following advice, there is no need to use extra contraceptive precautions, provided that all the tablets have been taken correctly in the 7 days preceding the first missed tablet.
If this is not the case, the woman should follow the first of these two options and use extra contraceptive precautions for the next 7 days as well. 1. The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
She then continues to take the next tablets at her usual time. e. there is no tablet-free break. There will probably be no withdrawal bleed until the end of the second pack, but the woman may experience spotting or breakthrough bleeding on tablet-taking days.
2. It is also possible to stop taking tablets from the current pack. The woman must then have a tablet-free break of 7 days, including the days she missed tablets, and then continue with the next pack. If the woman misses several tablets and has no withdrawal bleed during the first normal tablet-free break, the possibility of a pregnancy must be considered.
Vomiting or diarrhoea:
If vomiting or diarrhoea occurs tablets should be taken at the usual time. In addition, a supplemental non-hormonal contraceptive method should be used for the next 7 days. Duration of use Time to relieve of symptoms is at least three months.
The need to continue treatment should be evaluated periodically by the treating physician. The length of use depends on the severity of the clinical picture. Complete remission of acne is expected within a few months of commencing treatment, but in particularly severe cases treatment for longer may be necessary before the full benefit is seen.
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As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC or cyproterone acetate/ethinylestradiol use is unknown. 4. 4). 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store.
Tablet-taking can be started immediately. In this case no other contraceptive method is needed.
After childbirth or abortion during the second trimester:
Breast-feeding mothers: see paragraph