Lydia 1Safe Pill

Lydia 1Safe Pill

levonorgestrel

Manufacturer:

DKT

Distributor:

MCE
Full Prescribing Info
Contents
Levonorgestrel.
Description
Each Lydia 1SafePill tablet contains 1.5 mg levonorgestrel.
Lydia 1SafePill is an emergency contraceptive for women. Lydia 1SafePill should be used within 120 hours of unprotected intercourse. It should not be taken as regular birth control pill. This medicine is also known as Post Coital Pill and Morning After Pill.
The active substance in this medicine is levonorgestrel.
Excipients/Inactive Ingredients: Magnesium Stearate, Colloidal Silicon Dioxide, Polyvinyl Pyrrolidone, Maize Starch, Pre-Gelatinized Maize Starch, Lactose Monohydrate.
Action
Pharmacotherapeutic Group: Progestogen.
Indications/Uses
Lydia 1SafePill is an oral emergency contraceptive.
Emergency contraception is a rescue method, which is aimed to prevent pregnancy in case of unprotected intercourse.
This contraception must be used as soon as possible, preferably within 12 hours and no later than 120 hours (5 days) after the unprotected sexual intercourse, particularly; If the patient has had a sexual intercourse whereas either the patient or her partner did not use a contraceptive method; If the patient has forgotten to take consecutive 3 contraceptive pills; (in this case, read the information leaflet); If partner's condom has broken, slipped or been improperly removed, or if he has forgotten to use it; If the patient fears that the intrauterine device has been expelled; If vaginal diaphragm or contraceptive cap has moved or if the patient has removed it too early; If the patient is afraid that the method of coitus interruptus has failed or if the patient has had sexual intercourse during the period when the patient is to be fertile while using the rhythm method; In the non-consentual unprotected sex.
Dosage/Direction for Use
Posology: The treatment necessitates the intake of one tablet. The Lydia 1SafePill tablet must be taken as soon as possible, preferably within 12 hours, after the unprotected intercourse and no longer than within 120 hours (5 days) after the intercourse. Lydia 1SafePill can be taken at any moment during the menstrual cycle.
After using an emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, and cervical cap) until the next menstrual period resume. The use of Lydia 1SafePill does not contraindicate the continuation of regular hormonal contraception.
If the patient has used this medicine while using an oral contraception (contraceptive pill), the patient should carry on taking the usual tablets until the end of the treatment. In case no menstrual period occurs in the next pill-free period following the use of Lydia 1SafePill a pregnancy test should be performed to rule out a pregnancy.
Method and route of administration: Oral use: The tablet should be taken with a glass of water.
What should the patient do if she missed a dose: The efficacy of this medicine is not guaranteed if dose has been omitted.
Overdosage
No acute toxicity has been demonstrated with this medicine in case of intake of several doses
Contraindications
If the patient has hypersensitivity to levonorgestrel or any of the excipients (Magnesium Stearate, Colloidal Silicon Dioxide, Polyvinyl Pyrrolidone, Maize Starch, Pre-Gelatinized Maize Starch, Lactose Monohydrate) of Lydia 1SafePill.
Special Precautions
Emergency contraception must be used exceptionally, since: It does not allow to prevent a pregnancy in every instance; The associated hormonal overdosing is not advisable in case of regular intake; It cannot replace a regular contraception.
After taking Lydia 1SafePill, menstrual period usually occurs at the expected date however, it can occur earlier or later by a few days. After taking this medicine, it is therefore recommended to check the absence of pregnancy by performing a pregnancy test in case of abnormal bleeding at the date of expected menses or in case of menstrual delay of more than 5 days.
The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases and the measures to be taken in case of risk of transmission (see Advice/Sanitary Education under Patient Counselling Information).
Taking this medicine is not recommended if the patient has had an ectopic pregnancy or if the patient has a severe digestive disease, which impairs absorption of medications.
If vomiting would occur within two hours after taking this medicine, it is recommended to take immediately another Lydia 1SafePill tablet.
Simultaneous administration of certain anticonvulsant agents (phenobarbitone, phenytoin, primidone, carbamazepine), also other medications such as rifampicin, and griseofulvin can reduce or suppress the effectiveness of this emergency contraception.
In order to avoid potential interactions between several medicines, the patient must systematically notify the doctor of any other treatment she is currently taking.
Use In Pregnancy & Lactation
Pregnancy: This medicine is not indicated in case of pre-existing pregnancy and cannot interrupt it. In case of failure of this contraceptive mean with persisting pregnancy, epidemiological studies indicate no adverse effects of progestogen on malformation of a fetus.
Lactation: Lactation is possible. However, since levonorgestrel is secreted into breast milk, it is suggested that the patient breastfeeds immediately before taking each Lydia 1SafePill tablet and that she skips the nursing following each Lydia 1SafePill administration.
Adverse Reactions
Undesirable effects, which have been observed, are: Nausea and vomiting; Dizziness, fatigue, headache; Abdominal pain; A feeling of breast tenderness; Bleeding can occur after taking this medicine.
Inform the doctor of any unwanted effect which is not mentioned.
Storage
Store in cool dry conditions (below 30°C).
Keep the tablet in the outer carton.
Patient Counseling Information
Some information about the menstrual cycle and contraception. The menstrual cycle is the time elapsed between two menstrual periods. Normally, the cycle lasts for 28 days but its length can vary noticeably from one woman to another.
Menstrual periods occur when a woman is not pregnant. At the middle of the cycle, an ovum is expelled by one of the 2 ovaries (this moment is called "ovulation"). Usually ovulation takes place at the middle of the cycle, but it can occur at any moment during the cycle.
If sperms are near the ovum, fertilization (i.e. the merge between the ovum and a sperm cell in order to create an embryo) can take place. After a few days, the fertilized ovum implants in the womb and the pregnancy starts.
Contraceptive methods are aimed to prevent: Either the ovulation: this is the case for the contraceptive pill; Either the fertilization (merge of the sperm with the ovum): this is the case for condoms; Or the implantation of a fertilized ovum: this is the case for intrauterine devices.
Emergency contraception aims to block ovulation or prevent implantation if the sexual intercourse has taken place in the hours or days preceding ovulation, i.e. at a time when the likelihood of fertilization is the highest. It could also prevent implantation. It becomes inefficient as soon as implantation has started.
Without a contraceptive method, a woman cannot exclude the possibility of becoming pregnant after a sexual intercourse. If the patient has taken this medicine and that she does not use a regular contraception, it is highly recommended to visit the doctor in order to obtain advice on a method of contraception suitable to the patient.
Advice in case of risk of transmission of sexually transmitted disease. If the patient fears a pregnancy, this can mean that the patient has not used a condom (or that the patient has used it improperly) during the sexual intercourse. The patient may therefore have contracted a sexually transmitted disease or the AIDS virus, if the patient is not aware of her partner's health status, or if the patient has several partners. The patient should ask advice from the doctor as soon as possible for early detection and, if necessary, early treatment.
During the next sexual intercourses, it is recommended to take the appropriate measures in order to prevent an unwanted pregnancy and/or a sexually transmitted disease and to avoid AIDS contamination.
If the patient needs further information about Lydia 1SafePill, ask the doctor, or a family planning center.
MIMS Class
ATC Classification
G03AC03 - levonorgestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
Presentation/Packing
Tab 1.5 mg (white, round) x 1's.
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