Lydia Lacta

Lydia Lacta

levonorgestrel

Manufacturer:

DKT

Distributor:

MCE
Full Prescribing Info
Contents
Levonorgestrel.
Description
Each pack of Lydia Lacta contains 28 Hormone tablets to be given orally for the purpose of contraception.
Each uncoated tablet contains: Levonorgestrel 0.03mg.
Excipients/Inactive Ingredients: q.s.
Action
Pharmacology: Pharmacodynamics: Lydia Lacta is a progestogen-only pill, which contains the progestogen "levonorgestrel". Like other progestogen-only pill, Lydia Lacta is best suited for use during breast-feeding and for women who may not or do not want to use estrogens.
The contraceptive effect of levonorgestrel is achieved primarily by increasing the viscosity of the cervical mucus, thus reducing sperm penetration. Other effects include the decreased receptivity of the endometrium to the oocyte and the disturbed transport through the tubae. Furthermore, in about 70% of the women ovulation is inhibited.
The contraceptive efficacy of levonorgestrel approaches that of the combined Oral Contraceptive, provided the tablets are taken in accordance with the directions of use, in comparison with the combined pill, more irregular bleeding may occur with levonorgestrel whereas incidentally a period may fail to occur. Generally, after a period of adaptation, bleeding pattern with the product is acceptable.
Indications/Uses
Oral Contraceptives.
Dosage/Direction for Use
How to take Lydia Lacta: Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started immediately after finishing the previous pack.
How to start Lydia Lacta: No preceeding hormonal contraceptive use [in the past month]. Tablet taking has to start on day 1 of the menstrual bleeding. Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet taking.
Changing from a combined oral contraceptive (COC): The woman should start with levonorgestrel on the day after the last active tablet of her COC. In this case, the use of an additional contraceptive method is not necessary.
Changing from a progestogens-only-method (minipill, injection, implant) or from a progestogens-releasing intrauterine system [IUS]: The woman may switch any day from the mini pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due). In all these cases, the woman should be advised to additionally use the barrier method for the first 7 days of tablet taking.
Following first-Trimester abortion: The woman may start immediately; an additional contraceptive method is not necessary.
Following delivery or second-trimester abortion: The woman should be advised to start at day 21 to 28 after delivery or second-trimester abortion.
When starting later, she should be advised to additionally use barrier method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of levonorgestrel use or the woman has to wait for her first menstrual period.
Management of Missed tablets: Contraceptive protection may be reduced if more than 27 hours have elapsed between two tablets. If the user is less than 3 hours late in taking any tablet, the missed tablets should be taken as soon as it is remembered and the next tablet should be taken at the usual time. If she is more than 3 hours late; she should follow the same advice but also additionally use a barrier method for the next 7 days of tablet taking. If tablets were missed in the very first week of use and intercourse took place in the week before the tablets were missed, the possibility of pregnancy should be considered.
Overdosage
There have been no reports of serious deleterious effects from overdose. Since the toxicity of levonorgestrel is very low, with Lydia Lacta toxic serious symptoms are not expected to occur when several tablets are taken simultaneously. Symptoms that may occur in this case are: nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.
Contraindications
Progestogen-only contraceptives should not be used in the presence of any of the conditions listed as follows. Should any of the conditions appear for the first time during the use of Lydia Lacta, the product should be stopped immediately: Known or suspected pregnancy, Active venous thromboembolic disorder, Presence or history of severe hepatic disease as long as liver function values have not returned to normal, Progestogen-dependent tumors, Undiagnosed vaginal bleeding, Hypersensitivity to the active substance or to any of the excipients of Lydia Lacta.
Special Precautions
If any of the conditions/risk factors mentioned as follows is present, the benefits of progestogen use should be weighed against the possible risk for each individual woman and discussed with the woman before she decides to start with levonorgestrel. In the event of aggravation, exacerbation or first appearance of any of these conditions, the woman should contact her physician.
The risk of breast cancer increases in general with increasing age. During the use of oral contraceptives the risk of having breast cancer diagnosed is slightly increased. The increased risk disappears gradually within 10 years after discontinuation of oral contraceptives use and is not related to the duration of use, but to the age of the woman.
Chloasma may occasionally occur, especially in women with a history of chloasmagravidarum.
Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Lydia Lacta.
Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance; there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed while taking progestogen-only pills.
Medical examination/Consultation: Before prescription, a thorough case history should be taken and a thorough gynecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before depends on the circumstances in each individual case. Lydia Lacta does not protect against HIV (AIDS) and other sexually transmitted diseases.
Effect on Ability to Drive and Use Machines: On the basis of Pharmacodynamic profile, Lydia Lacta is expected to have no or negligible influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
Levonorgestrel should not be used during pregnancy. If a pregnancy occurs, levonorgestrel treatment should be stopped immediately.
Extensive epidemiological studies have revealed neither an increased risk of birth defects in children from women who used oral contraceptives prior to pregnancy, nor a teratogenic effect when oral contraceptives were taken inadvertently during early pregnancy. To date relevant epidemiological data with respect to use of progestogen-only contraceptives during pregnancy are not available.
Similar to other progestogen-only contraceptives, levonorgestrel does not influence the production or the quality of breast milk. However, a small amount of progestogen is excreted with the milk. The amount of levonorgestrel and metabolites excreted in the milk is about 0.14% of the daily-administered dose, but no adverse effects on infant growth and development have been reported.
Adverse Reactions
The side effects, which have been reported with levonorgestrel or with hormonal contraceptives in general, are listed as follows. The side effects most frequently reported in the clinical trials with levonorgestrel include irregular bleeding, breast tenderness, mood changes, nausea, and headache, occurring in about half of the women using levonorgestrel during the first treatment cycle, declining to approximately 30% in the 12th cycle. In lactating women, 28% experience side effects during the first cycle, declining to 5% after the 12th cycle.
Breast: Tenderness, pain, enlargement, secretion.
Central Nervous System: Headache, migraine, changes in libido, depressive mood/mood changes.
Gastro Intestinal tract: Nausea, vomiting and other gastro-intestinal complaints.
Skin: Various skin disorders (eg, rash, erythema nodosum, erythema multiforme).
Uro-genital: Irregular bleeding, changes in vaginal secretion.
Eyes: Contact lens intolerance.
Various: Fluid retention, body weight changes, hypersensitivity reaction.
Drug Interactions
Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. No specific interaction studies have been performed with Lydia Lacta.
Hepatic Metabolism: Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of sex hormones (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and products containing St. John's Wort).
Women on treatment with any of these drugs should temporarily use a barrier method in addition to levonorgestrel or choose another method of contraception. The barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation.
Storage
Store in a cool & dry place. Protect from light and moisture.
MIMS Class
ATC Classification
G03AC03 - levonorgestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
Presentation/Packing
Tab 0.03 mg (uncoated) x 28's.
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