Cyclafem 1/35 is a combination hormone contraceptive which contains 2 female hormones: ethinyl estradiol and norethindrone. The drug is used to prevent ovulation.
Indications for use
- Hormonal contraception.
Mechanism of action
The drug prevents the release of an egg during your menstrual cycle, makes vaginal fluid thicker which does not allow spermatozoa reaching an egg.
Dosage and mode of application
Each pack of Cyclafem 1/35 contains 28 tablets:
- 21 active tablets each containing 0.5 mg norethindrone/35 mcg of ethinyl estradiol;
- 7 inert pills that serve as reminders to keep you on your regular cycle.
Take one tablet tablets every day at about the same time, for 28 successive days.
You can start the pack on Day 1 of your period or on the first Sunday after your period begins. If you are a Sunday Starter, you must use a back-up method of preventing pregnancy for the first 7 days of use (during the first cycle only.)
It’s important that you do not miss active tablets since missing a tablet increases the risk of pregnancy.
After you’ve finished the pack, start a new course of Cyclafem 1/35 the following day.
After delivery, you can start using combination oral contraceptives 4 weeks postpartum (provided that you are not breastfeeding).
Serious negative effects have not been reported following the administration of excessive doses of the drug. Overdosage symptoms may include spotting (in females) and nausea.
Cyclafem 1/35 tablets are usually tolerated well but some women reported the following side effects:
- change in menstrual flow
- pulmonary embolism
- myocardial infarction
- thrombophlebitis and venous thrombosis
- arterial thromboembolism
- cerebral hemorrhage
- cerebral thrombosis
- gallbladder disease
- hepatic adenomas or benign liver tumors
- mesenteric thrombosis
- retinal thrombosis
- gastrointestinal symptoms (abdominal cramps and bloating)
- breakthrough bleeding
- temporary infertility after discontinuation of treatment
- mental depression
- reduced tolerance to carbohydrates
- melasma which may persist
- breast changes: tenderness, enlargement, secretion
- change in weight
- change in cervical erosion and secretion
- allergic reaction, including rash, urticaria, angioedema
- vaginal candidiasis
- change in corneal curvature
- intolerance to contact lenses
- pre-menstrual syndrome
- impaired renal function
- erythema multiforme
- visual impairment,
- erythema nodosum
- vaginal infection,
- changes in appetite
- cystitis-like syndrome
- urinary tract infection;
- hemorrhagic eruption
- hemolytic uremic syndrome
- changes in libido
- Budd-Chiari Syndrome
- mood changes,
- muscle spasms,
- loss of scalp hair
- diminution in lactation when given immediately postpartum
- cholestatic jaundice
- ovarian cyst,
- vulvovaginal dryness;
- hot flush;
- back pain;
- benign breast neoplasm,
- fibroadenoma of breast, breast cyst;
- night sweats,
- dry eye;
- pain in extremity,
- chest pain,
- photosensitivity reaction,
- asthenic conditions.
If you have any severe health problems after taking COCs, consult your doctor in the nearest possible time. Typically, side effects are most likely to occur during the first three months of hormonal contraception.
Cyclafem 1/35 is contraindicated in the presence of any of the listed conditions:
- estrogen- or progestin-dependent cancer;
- breast cancer;
- systemic lupus erythematosus;
- smokers over the age of 35 or heavy smokers;
- major surgery, prolonged immobilization;
- thrombogenic valvular;
- active hepatic disease;
- migraine headaches with or without aura;
- jaundice caused by the previous pregnancy or use of sex hormones;
- hypersensitivity to the drug components;
- endometrial cancer;
- benign or malignant hepatic tumors;
- coronary artery disease;
- thrombophilias, acquired or hereditary;
- persistent high blood pressure;
- undiagnosed vaginal bleeding ;
- rhythm heart disease;
- cerebrovascular disease;
- diabetes mellitus with vascular disease.
Caution is required:
- gallbladder disease;
- vomiting or diarrhea;
- diabetes mellitus;
- hepatic impairment;
- renal disease;
- sensitive to fluid retention;
- hereditary angioedema;
- depression in the anamnesis;
- inflammatory bowel disease.
Some medications can reduce the effects of COCs. They may increase the risk for side effects or reduce the contraceptive effect. Inform your doctor about all the medications, vitamins and herbal supplements you are currently using. Avoid taking the following drugs:
- Estrogens conjugated;
- Cyclosporine A;
Pregnancy and breastfeeding
Cyclafem 1/35 is not indicated for use in pregnancy and breastfeeding period. If you become pregnant when on the pills, discontinue hormonal contraception and consult your health care provider immediately.
Breastfeeding women should consider another, non-hormonal methods of birth control. Sex hormones may get into breast milk, reduce its production, change its composition and also affect the newborn.
What if I miss a pill?
If the woman misses one “active” pill in Weeks 1, 2, or 3, the pill should be taken as soon as possible. If the woman misses two “active” pills in Week 1 or Week 2, the woman should take two pills the day she remembers and two pills the following day; and then keep taking one pill a day until the pack is empty. The women should use an additional, non-hormonal method of birth control if she has sex in the seven days after missing pills. If the woman misses two “active” pills in Week 3 or misses three or more “active” pills in a row, the woman should keep taking one pill every day until Sunday, then throw out the remaining pills and start a new pack that same day. The woman should use an additional, non-hormonal method of birth control if she has sex in the seven days after missing pills.
Do not use COCs if you have not started your periods yet.
Before starting a pack of Cyclafem 1/35, it is necessary to undergo a general medical examination (including cytological examination of cervical mucus), exclude pregnancy and disorders of the blood coagulation system. With prolonged use of the drug, it’s recommended to undergo control examinations at least 1 time per year.
A woman should be informed that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Women with risk factors should discuss the potential risk and expected benefits of hormonal contraceptive with their doctors before they decide to start taking the tablets.
Epidemiological studies have revealed a slightly increased risk of venous and arterial thrombosis and thromboembolism in women when taking COCs.
COCs may cause venous thromboembolism (including deep vein thrombosis and pulmonary thromboembolism).
In extremely rare cases, COCs caused thrombosis of other blood vessels. The relationship of these cases with the intake of sex hormones has not been proven.
The patient should be informed that she should immediately consult a doctor if symptoms of venous or arterial thrombosis develop: unilateral pain in the leg and / or swelling, sudden severe chest pain, sudden shortness of breath, sudden coughing, any unusual/severe/prolonged headache or migraine, sudden partial or complete loss of vision, diplopia, slurred speech or aphasia, dizziness, fainting, weakness, motor violations, “acute” belly.
The risk of venous or arterial thrombosis and thromboembolism increases:
- with age;
- in smoking women (especially over the age of 35);
- if there is a family history of venous or arterial thromboembolism;
- if a woman has a genetic predisposition;
- valvular heart disease;
- atrial fibrillation;
- prolonged immobilization;
- major surgery (if you are planning to undergo a major surgery, you should stop using birth control pills at least 4 weeks before it).
You should consider the increased risk of thromboembolism in the postpartum period.
The risk of thrombosis during pregnancy is higher than when taking COCs.
Circulatory disorders can also be observed in women with diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn’s disease, UC, sickle cell anemia.
COCs slightly increase the risk of cervical cancer (with prolonged use). However, the relationship with the use of COCs is not proven.
There is a slightly increased risk of developing breast cancer diagnosed in women who used COCs. The connection with the COCs has not been proven.
In rare cases, birth control pills caused liver tumors, which in some cases led to life-threatening intra-abdominal bleeding. In the event of severe abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding, you should consult a doctor immediately.
The drug can affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal glands, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the normal range.
Although the drug may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using Cyclafem 1/35. However, women with diabetes should be carefully monitored while taking COCs.
Women with hypertriglyceridemia (or a predisposition to this condition) have an increased risk of developing pancreatitis while taking COCs.
Some women taking birth control pills experienced a small increase in blood pressure but clinically significant increases are rare. However, if you have a persistent, clinically significant increase in blood pressure while taking Cyclafem 1/35, this drug should be canceled. Use of COCs can be continued if the patient achieves normal blood pressure values with the help of antihypertensive therapy.
The following conditions have been observed in women taking combined oral contraceptives, but their relationship with COCs has not been proven: jaundice/itching associated with cholestasis; gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes pregnant; hearing loss associated with otosclerosis, Crohn’s disease and ulcerative colitis.
Acute or chronic liver dysfunction may require discontinuation of the contraceptive until liver function returns to normal. Recurrent cholestatic jaundice requires the discontinuation of the drug.
In some cases, birth control pills caused chloasma, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and ultraviolet radiation while taking COCs.
Some women may have irregular vaginal bleeding (spotting or breakthrough bleeding) when using COCs, especially during the first three months of use. If this bleeding recurs or occurs after regular cycles, you need to consult a doctor in order to exclude tumors or pregnancy.
Some women may not have withdrawal bleeding during a break in taking active tablets. If the drug was taken as directed, it is unlikely that the woman is pregnant. However, if she missed tablets or if she missed two withdrawal bleedings in a row, she needs to exclude pregnancy.
The drug does not affect the ability to drive motor transport and control mechanisms.
Store at room temperature in a dry place, away from direct sunlight.
Keep out of reach of children and pets.