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MOVISSE 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.
MOVISSE® 28-Tablet Regimen:
The dosage of MOVISSE tablets is one tablet daily without interruption for 28 days. 28-Day Regimen Package Starting Progestin-Only Pills 1. For the initial cycle of therapy, patients should start treatment from day 1† 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 MOVISSE from a new package. 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.
MOVISSE 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 MOVISSE tablets 6 weeks after delivery.
2. For women who are partially breast-feeding (giving their babies some food or formula), they should start taking MOVISSE tablets 3 weeks after delivery. † 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.
___________________________________________________________________________ Page 12 of 36 Switching Pills 1. To switch from 21-Day combined oral contraceptive pills to progestin-only pills, patients should start taking their first MOVISSE 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 MOVISSE 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.
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. 35mg) was evaluated in 3099 subjects in two clinical trials. 35mg)/day administered on 21 days per cycle.
35mg)-treated subjects are shown in Table 2. 35mg) -treated subjects (N=3099) in the above clinical trials are shown in Table 3. 35mg) are included in Table 4. 35mg) 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..
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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 MOVISSE 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.
___________________________________________________________________________ Page 13 of 36 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.
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 Molecular Formula: C20H26O2 DESCRIPTION Norethindrone is a white to practically white powder with a melting range of 202oC - 208oC. It is practically insoluble in water, soluble in chloroform, dioxin and in methylene chloride, sparingly soluble in acetone, ethanol anhydrous, ethanol (95%) and in tetrahydrofuran, slightly soluble in ether.
350 mg norethindrone. Each tablet also contains inert ingredients, namely, corn starch, D&C Yellow # 10, ethyl cellulose, FD&C Blue # 1, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate and talc.
STORAGE RECOMMENDATIONS Store between 15 oC - 30 oC. Leave contents in protective packaging until time of use. AVAILABILITY OF DOSAGE FORMS MOVISSE® Tablets are available in a 28-Day […]
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.
___________________________________________________________________________ Page 11 of 36 DOSAGE AND ADMINISTRATION MOVISSE® 28-Tablet Regimen: The dosage of MOVISSE tablets is one tablet daily without interruption for 28 days. 28-Day Regimen Package Starting Progestin-Only Pills 1.
For the initial cycle of therapy, patients should start treatment from day 1† 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 MOVISSE from a new package.
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. MOVISSE 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 MOVISSE tablets 6 weeks after delivery.
2. For women who are partially breast-feeding (giving their babies some food or formula), they should start taking MOVISSE tablets 3 weeks after delivery. † 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.
___________________________________________________________________________ Page 12 of 36 Switching Pills 1. To switch from 21-Day combined oral contraceptive pills to progestin-only pills, patients should start taking their first MOVISSE tablet (progestin-only pill) the day after they finish the last active combined pill.
To switch from a 28-Day combined oral […]