Charlize

Charlize

Manufacturer:

DKT

Distributor:

DKT
Full Prescribing Info
Contents
Ethinylestradiol, levonorgestrel, ferrous fumarate.
Description
Each of the 21 beige tablets contain: Ethinylestradiol 30 mcg and Levonogestrel 150 mcg.
Each of the 7 pinkish-brown tablets contain: Ferrous Fumarate 75 mg (equivalent to 24.75 mg of elemental iron).
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) is a safe and easy to use contraceptive pill. It is also used in the treatment of menstrual disorders such as painful menstruation, menstrual cycle symptoms, and excessive uterine bleeding. It contains Iron that helps improve the hemoglobin level of blood during menstruation.
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) does not delay the return of fertility after discontinuing its use. Generally, the patient's bleeding pattern before taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) will return after the patient discontinue taking it. Some women, however, may have to wait a few months before their usual bleeding pattern returns.
Action
Pharmacology: Mechanism of Action: Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) works primarily by preventing the release of eggs from the ovaries. Also, Ethinylestradiol acts synergistically with Levonorgestrel to provide regular and consistent suppression of ovulation.
Pharmacokinetics: Ethinylestradiol is absorbed well and rapidly by the gastrointestinal tract. The presence of an Ethinyl group at the 17-position greatly reduces hepatic first-pass metabolism compared with Estradiol, enabling the compound to be much more active if taken orally. There is some initial conjugation at the gut wall, and the systemic bioavailability is only 40%. Ethinylestradiol is highly protein bound, unlike naturally occurring estrogens, which are mainly bound to sex hormone-binding globulin; it is principally bound to albumin. It is metabolized in the liver, and excreted in urine and feces. Metabolites undergo enterohepatic recycling.
Levonorgestrel is rapidly and almost completely absorbed after being taken orally and undergoes little first-pass hepatic metabolism. It is highly bound to plasma proteins; 42% to 68% to sex hormone-binding globulin and 30% to 50% to albumin. The proportion bound to sex hormone-binding globulin is higher when it is given with an estrogen. Levonorgestrel is metabolized in the liver to sulfate and glucuronide conjugates, which are excreted in the urine and to a lesser extent in the feces.
Indications/Uses
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) is indicated for contraception and treatment of menstrual syndrome disorders such as dysmenorrhea, premenstrual syndrome, and menorrhagia.
Dosage/Direction for Use
Talk to a healthcare provider before taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE).
Take 1 pill daily. Patient may begin within the first 5 days of menstrual bleeding. Patient may also start any day as long as patient is not pregnant and use a back-up method such as condom for the next 7 days as a precaution to avoid pregnancy. Start with the pill marked number "1". Follow the arrows indicated on the pack.
The interval between 2 pills should be 24 hours. Incorporate it to daily routine - after eating meals or before going to sleep to easily remember to take it. A pack is good for 28 days.
Start a new pack the next day after taking the last pinkish-brown pill regardless whether the menstrual bleeding has stopped or not. Patient's menstrual bleeding will return to normal 2 days after finishing the beige pills and while taking the pinkish-brown pills.
Patient may continue taking the pill as long as wanted to avoid pregnancy. Do not skip taking the pill even if there is a brief pause from sexual activity.
Patient should only stop taking the pill after finishing a pack; otherwise bleeding may start.
Vomiting and persistent diarrhea can interfere with the absorption of the pill. If vomiting occurs within two hours after taking a pill, another pill should be taken as soon as possible. If persistent vomiting and diarrhea last more than 24 hours, follow the instructions on Missed Pills.
If patient missed 1 beige pill, it must be taken within 12 hours after the 24-hour lapse to sustain its efficacy. Take the remaining pills as scheduled to avoid premature withdrawal bleeding. Follow the instructions on Missed Pills.
Missed Pills: If patient missed taking 1 or 2 beige pills, or started the pack of 1 or 2 days late, take 1 pill as soon as remembered. Take the pill due for the day at the scheduled time even if it means taking 2 pills at the same time or in 1 day. Keep taking 1 pill each day at the usual time. Patient will not need a back-up contraceptive method if missed only 1 or 2 consecutive beige pills.
If the patient missed 3 or more consecutive beige pills or started the pack 3 or more days late, take the most recently missed beige pill as soon as remembered and dispose of the remaining missed pills. Take the scheduled pill for the day even if it means taking 2 pills for that day. Then continue taking 1 pill a day at the scheduled time. Either refrain from having sex or use a condom for the next 7 days of pill taking.
If the patient missed 3 or more consecutive beige pills on the 3rd week of use (pill #15 to #21), start taking 1 pill from a new pack. Either refrain from having sex or use a condom for the next 7 days of pill taking.
Diagram as follows will help patient to better understand: see figure.

Click on icon to see table/diagram/image

What to do if patient missed taking the pinkish-brown pill: Discard the missed pinkish-brown pills. Take the remaining pinkish-brown pills as scheduled until patient finishes the pack. Start with a new pack after. The pinkish-brown pill contains Ferrous Fumarate, an Iron supplement, that helps improve the hemoglobin content of the blood during menstruation.
If patient continually forgets to take the pills, ask the healthcare provider for ways to become compliant, or for another method of contraceptive which will suit patient better.
Overdosage
No serious ill effects have been reported after ingestion of large doses of oral contraceptives, although it may cause nausea and withdrawal bleeding in females. Treatment is unnecessary because the overdose is unlikely to be life-threatening. Ask the healthcare provider for further instructions.
Contraindications
Patient should inform the healthcare provider if she has the following conditions before starting Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE): liver disorders, clotting disorders, breast and cervical cancer, sickle-cell anemia, hormone-active tumors, hyperlipidemia, severe cardiovascular diseases, previous or existing thromboembolic diseases, idiopathic jaundice.
(See Use in Pregnancy & Lactation section for further information.)
Special Precautions
Regular consultation with a healthcare provider is recommended while taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE). If patient suffers from diarrhea and/or vomiting, its efficacy may be reduced. Inform the healthcare provider if patient is suffering from the following conditions: diabetes mellitus, high blood pressure, varicose veins, multiple sclerosis, epilepsy, migraine, ophthalmological problems, tetany.
Use In Pregnancy & Lactation
Make sure the patient is not pregnant before taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE).
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) is not recommended for pregnant women.
Breastfeeding mothers should not use Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE). This may reduce the volume of the breast milk. Breastfeeding mothers can use progestin-only pills.
Adverse Reactions
The oral contraceptive pill is one of the most researched products in the history of modern medicine, and its safety has long been established. Women may experience side effects such as headache, gastric upsets, nausea, vomiting, abdominal cramps, changes in appetite, breast tenderness, change in body weight and libido, depressive moods, or interference with liver functions.
Drug Interactions
Taking drugs for infection (such as ampicillin, chloramphenicol, neomycin, penicillin V, nitrofurantoin, sulfonamides, tetracycline and isoniazid) and pain (analgesic, anti-migraine and tranquilizer) with contraceptive pill may decrease the contraceptive's efficacy. If patient is advised to take the previously mentioned drugs, consult a healthcare provider for proper intake and dosage schedule of the contraceptive pill.
Taking contraceptive pills and anti-infective drugs (such as clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or grapefruit juice may inhibit cytochrome P-450 isoenzyme 3A4. Adverse effects may be seen upon taking these drugs.
Taking oral contraceptive pills and drugs that induce hepatic enzyme production such as anti-epileptic drugs (carbamazepine, oxcarbazepine, felbamate, topiramate, phenytoin), anti-fungal (griseofulvin), anti-diabetic (troglitazone), musculoskeletal (phenylbutazone) and anti-tuberculosis (rifampicin) drugs can considerably reduce the contraceptive's efficacy.
Taking contraceptives and troleandomycin may increase the risk of cholestatic jaundice.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs / Oral Contraceptives
ATC Classification
G03CA01 - ethinylestradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Presentation/Packing
Form
Charlize tab
Packing/Price
28's
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