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JENCYCLA is a brand name for Norethindrone (also known as Norethisterone), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
JENCYCLA 28-Tablet Regimen:
The dosage of JENCYCLA tablets is one tablet daily without interruption for 28 days. 28- Day Package Starting Progestin-Only Pills 1. For the initial cycle of therapy, patients should start treatment from day 1H up to and including day 5 of their menstrual period.
Then they should continue taking one tablet every day until their package is empty. Without missing a day, they should start taking JENCYCLA from a new package. H If the first progestin-only pill is taken on another day, it is recommended that an additional method of birth control (such as latex or polyurethane condoms and spermicidal foam or gel) be used every time the patient has sex during the next 48 hours.
2. If the patient has had a miscarriage or an abortion, she can start progestin-only pills the next day. 3. Patients should take one pill at the same time every day for 28 days. After finishing a pack, they should begin a new pack the next day, NOT MISSING ANY DAYS ON THE PILLS.
Their period should occur during the last seven days of using the pill pack. JENCYCLA tablets are taken every day, even when patients are having some menstrual bleeding. Breast-feeding 1. For women who are fully breast-feeding (not giving their babies any food or formula), they may start taking JENCYCLA tablets 6 weeks after delivery.
2. For women who are partially breast-feeding (giving their babies some food or formula), they should start taking JENCYCLA tablets 3 weeks after delivery. JENCYCLA Page 12 of 32 Switching Pills 1. To switch from 21-Day combined oral contraceptive pills to progestin-only pills, patients should start taking their first JENCYCLA tablet (progestin-only pill) the day after they finish the last active combined pill.
To switch from a 28-Day combined oral contraceptive regimen, patients should not take any of the 7 inactive pills from the combined pill pack. Many women have irregular periods after switching to progestin-only pills, but this is normal and to be expected.
2. For women who switch from progestin-only pills to combined pills, the first active combined pill is taken on the first day of their period, even if their progestin-only pill pack is not finished. 3. If the patient is breast-feeding, she can switch to another method of birth control at any time, except she should not switch to the combined pills until she has stopped breast- feeding or at least until 6 months after delivery.
Administration It is recommended that JENCYCLA tablets be taken at the same time every day until the pack is empty. Progestin-only pills must be taken at the same time every day since their action is time dependent. When the pack is finished after 28 days, the next pack is started ON THE NEXT DAY.
Women are not to wait any days between packs. Vomiting and/or diarrhea may reduce absorption of oral contraceptives resulting in decreased serum concentrations and therefore may reduce contraceptive efficacy. Physicians should advise patients of the need for a backup contraceptive method in the case of such gastrointestinal symptoms.
Adverse reactions reported with the use of progestin-only pills include: Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding is common, while long duration of bleeding episodes and amenorrhea are less likely.
Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely. Decreased lactation has been reported very rarely.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of norethindrone was evaluated in 3,099 subjects in two clinical trials. 35 mg/day administered on 21 days per cycle.
Adverse drug reactions (ADRs) reported for ≥1% of norethindrone -treated subjects are shown in Table 2. 0 ADRs reported by <1% of norethindrone -treated subjects (N=3099) in the above clinical trials are shown in Table 3. JENCYCLA Page 10 of 32 Table 3 - Adverse Drug Reactions Reported by <1% of norethindrone - treated Subjects in Two Clinical Trials of norethindrone System/Organ Class Adverse Reaction Psychiatric Disorders Depression Nervousness Gastrointestinal Disorders Gastrointestinal disorder Skin and Subcutaneous Tissue Disorders Acne Hirsutism Musculoskeletal and Connective Tissue Disorders Pain in extremity Reproductive System and Breast Disorders Genital discharge General Disorders and Administration Site Conditions Edema Post-Market Adverse Drug Reactions Adverse drug reactions first identified during post-marketing experience with norethindrone are included in Table 4.
Progestin-only pills should not be used by women who currently have the following conditions: 1. when pregnancy is suspected or diagnosed; 2. active liver disease or history of/or actual benign or malignant liver tumours; 3. known or suspected carcinoma of the breast; 4.
undiagnosed abnormal vaginal bleeding; 5. hypersensitivity to any component of this product. THE COMBINED BIRTH CONTROL PILL (OR “THE PILL”) CONTAINS BOTH AN ESTROGEN AND A PROGESTIN. THEREFORE, THIS PRODUCT MONOGRAPH DOES NOT DISCUSS THE SERIOUS HEALTH RISKS THAT HAVE BEEN ASSOCIATED WITH THE ESTROGEN COMPONENT OF COMBINED ORAL CONTRACEPTIVES.
g. smoking, hyperlipidemia, hypertension or obesity Migraine with focal aura Past ectopic pregnancy Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in oral contraceptive users over 35 years of age.
Women should be counselled not to smoke. Ectopic Pregnancy The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin- only oral contraceptive users are extrauterine.
Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives. Delayed Follicular Atresia/Ovarian Cysts If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle.
Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some JENCYCLA Page 4 of 32 cases they are associated with mild abdominal pain. Rarely, they may twist or rupture, requiring surgical intervention.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Norethindrone in Canada.
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For women who take other drugs or herbal products concurrently, the pill may not work as well. See the Drug Interactions section, for a list of drugs that may decrease the effectiveness of JENCYCLA or increase breakthrough bleeding.
They should be advised to use a backup method, until they can check for possible drug interactions with their doctor or clinic. Missed Dose If a patient is more than 3 hours late taking her progestin-only pill, she should take the missed pill as soon as she remembers then go back to taking progestin-only pills at her regular time.
Inform patients to use a backup method, every time they have sex, for 48 hours after missing a pill. If patients forget more than one pill two months in a row, talk to them about ways to make pill taking easier or about using another method of birth control.
JENCYCLA Page 13 of 32 Counselling Issues The following points should be discussed with prospective users before prescribing progestin- only oral contraceptives: the necessity of taking pills at the same time every day, including throughout all bleeding episodes; the need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late; the potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities; the need to inform the clinician of prolonged episodes of bleeding, amenorrhea or severe abdominal pain; the importance of using an effective barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STIs/HIV.
42 g/mol Structural formula: DESCRIPTION Norethindrone is a white to creamy-white, odourless, crystalline powder with a melting range of 202°C - 208°C. It is practically insoluble in water, soluble in chloroform and in dioxan, sparingly soluble in alcohol and slightly soluble in ether.
35 mg norethindrone. 1 Aluminium Lake, lactose anhydrous, magnesium stearate, povidone K30 and sodium starch glycolate. STORAGE RECOMMENDATIONS Store between 15°C - 30°C. Leave contents in protective packaging until time of use. 35 mg norethindrone JENCYCLA Page 15 […]
Table 4 - Adverse Drug Reactions Identified During Post-Marketing Experience with Norethindrone from Spontaneous Reporting Immune System Disorders Anaphylactic/Anaphylactoid reaction, Hypersensitivity Gastrointestinal Disorders Abdominal pain Hepatobiliary Disorders Hepatitis, Jaundice cholestatic Skin and Subcutaneous Tissue Disorders Alopecia, Rash, Rash pruritic Pregnancy, Puerperium and Perinatal Conditions Ectopic pregnancy Reproductive System and Breast Disorders Breast pain, Menstruation delayed, Menstruation irregular, Ovarian cyst, Suppressed lactation, Vaginal hemorrhage, Menorrhagia, Withdrawal bleed when product is stopped TREATMENT OF OVERDOSE OR ACCIDENTAL INGESTION In case of overdose or accidental ingestion by children, the physician should observe the patient closely although generally no treatment is required.
There have been no reports of serious ill effects from overdosage. Overdosage may cause nausea and vomiting and withdrawal bleeding may occur in females. There are no antidotes and treatment should be symptomatic. For management of a suspected drug overdose, contact your regional Poison Control Centre.
JENCYCLA Page 11 of 32 DOSAGE AND ADMINISTRATION JENCYCLA 28-Tablet Regimen:
The dosage of JENCYCLA tablets is one tablet daily without interruption for 28 days. 28- Day Package Starting Progestin-Only Pills 1. For the initial cycle of therapy, patients should start treatment from day 1H up to and including day 5 of their menstrual period.
Then they should continue taking one tablet every day until their package is empty. Without missing a day, they should start taking JENCYCLA from a new package. H If the first progestin-only pill is taken on another day, it is recommended that an additional method of birth control (such as latex or polyurethane condoms and spermicidal foam or gel) be used every time the patient has sex during the next 48 hours.
2. If the patient has had a miscarriage or an abortion, she can start progestin-only pills the next day. 3. Patients should take one pill at the same time every day for 28 days. After finishing a pack, they should begin a new pack the next day, NOT MISSING ANY DAYS ON THE PILLS.
Their period should occur during the last seven days of using the pill pack. JENCYCLA tablets are taken every day, even when patients are having some menstrual bleeding. Breast-feeding 1. For women who are fully breast-feeding (not giving their babies any food or formula), they may start taking JENCYCLA tablets 6 weeks after delivery.
2. For women who are partially breast-feeding (giving their babies some food or formula), they should start taking JENCYCLA tablets 3 weeks after delivery. JENCYCLA Page 12 of 32 Switching Pills 1. To switch from 21-Day combined oral contraceptive pills to progestin-only pills, patients should start taking their first JENCYCLA tablet (progestin-only pill) the day after they finish the last active combined pill.
To switch from a 28-Day combined oral contraceptive regimen, patients should not take any of the 7 inactive pills from the combined pill pack. Many women have irregular periods after switching to progestin-only pills, but this is normal and to be expected.
2. For women who switch from progestin-only pills to combined pills, the first active combined pill is taken on the first day of their period, even if their progestin-only […]
24) of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and the hormonal contraceptives containing progesterone- only have not been widely used but there is data to determine that the use of POPs may also increase the risk.
A meta-analysis from 54 epidemiological studies reported that there is a small increase in the frequency of having breast cancer diagnosed in women who are currently using oral contraceptives (OCs) or had used them within the past 10 years compared to never-users.
Breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users. Breast cancer is rare among women under 40 years of age whether or not they take OCs. While the background risk increases with age, the excess number of breast cancer diagnoses in current and recent progesterone-only pill (POP) users is small in relation to the overall risk of breast cancer.
These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The most important risk factor for breast cancer in POP users is the age women discontinue the POP; the older the age at stopping, the more breast cancers are diagnosed.
Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping POP use. The evidence suggests that compared with never-users, among 10,000 women who use POPs for up to five years but stop by age 20, there would be less than one extra case of breast cancer diagnosed up to 10 years afterwards.
For those stopping by age 30 after 5 years use of the POP, there would be an estimated 2-3 extra cases (additional to the 44 cases of breast cancer per 10,000 women in this age group never exposed to oral contraceptives). For those stopping by age 40 after 5 years of use, there would be an estimated 10 extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of breast cancer per 10,000 never-exposed women in this age group).
Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, nulliparity, and late age for first full-term pregnancy. Women receiving OCs should be instructed in self-examination of their breasts.
They should notify their physicians whenever any masses are detected. A yearly clinical breast examination is also recommended. JENCYCLA Page 5 of 32 It is important to inform patients that users of all contraceptive pills appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of oral contraceptives.
Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of developing cervical intraepithelial neoplasia in some populations of women.
However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behaviour and other factors. There is insufficient data to determine whether the use of progestin-only pills increases the risk of developing cervical intraepithelial neoplasia.
Vaginal Bleeding Irregular menstrual patterns are common among women […]