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Naphagestrel

Naphagestrel
 COMPOSITIONS: is a combined low - dose, oral contraceptive pill and is a 28-tablet cycle which has 21 hormone tablets for contraception and 7 iron tablets for your health. Each hormone tablet contains 30 mcg of ethinylestradiol and 150 mcg of levonorgestrel. Each hormone-free tablet contains 75 mg Ferrous Fumarate.

The inactive ingredients in hormone tablet are lactose, wheat starch, polyvinylpyrrolidone, magnesium stearate, HPMC, talc, titanium dioxide, PEG 6000, yellow tartrazine, ponceau.

The inactive ingredients in hormone-free tablet are wheat starch, Popyvinyl pyrolidon, Talc, Edragit E 100, PEG 6000, Eratab, Sodium lauryl sulfate, DST, Magnesium Stearate, Titanium Dioxide, Brown, Light green.

PHARMACEUTICAL DOSAGE FORM: tablet.

 

INDICATIONS

Oral contraception

CONTRAINDICATIONS

Combined oral contraceptives (COCs) are not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during COC use, the use of the product must be stopped immediately.

•     Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)

•     Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack)

•     Cerebrovascular accident present or in history

•     The presence of a severe or multiple risk factor(s) for arterial thrombosis:

            • Diabetes mellitus with vascular symptoms

Severe hypertension

Severe dyslipoproteinemia

•     Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC- resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)

•     History of migraine with focal neurological symptoms

•     Pancreatitis or a history of such a condition, if associated with severe hypertriglyceridemia

•     Severe hepatic disease, current orprevious, as long as liver function values have not returned to normal

•     Presence or history of liver tumours (benign or malignant)

•     Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)

•     Undiagnosed vaginal bleeding

•     Amenorrhea of unknown cause.

•     Hypersensitivity to the active substances levonorgestrel, ethinylestradiol or to any of the excipients in Naphagestrel film-coated tablets.


DOSAGE AND ADMINISTRATION:

Oral contraceptive tablet.

Starting your first Naphagestrel pack:

Take the first hormone tablet on the first day of your period (the day when your menstruation starts). Then take one pill everyday until all the pills in the package are finished. Be sure to use the 21 hormone pills first followed by using all 7 hormone-free pills. When the package is finished, begin a new cycle. You do not need to wait until your next menstruation. Be sure to use all the pills from one package before starting a new pack.

Provided you remember to take your first tablet on the first day of your period and do not forget any other tablets in the pack you do not need to take any additional contraceptive precaution.

Changing from another combined hormonal contraceptive (COC, vaginal ring, transdermal patch):

The use of  tablets is preferably started on the day after the last active tablet of the previous COC (or after removal of the ring or patch), but at the latest on the day following the usual tablet-free (ring-free, patch-free) break or the last placebo tablet of the previous hormonal contraceptive.

Changing from a progestogen-only method (oralpill, injection, implant) or intrauterine system (IUS):

The woman can switch to tablets any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but should in all of these cases be advised to use an additional barrier method for the first 7 days of tablet-taking.

After a miscarriage or abortion:

You should start taking Naphagestrel within 5 days of miscarriage or an abortion. You are then fully protected against pregnancy and no additional contraceptive precautions are required.

If you forget one or more tablets:

If you forget to take one pill, you should take it as soon as you remember, even if it means taking 2 pills on one day.

If you forget to take the pill for 2 days or more, you should take 2 pills every day until catching up. In this case you should also use a backup method (e.g condoms) or else not have intercourse within one week since you forget. Don’t worry if you have earlier menstruation.

If you have vomitting or diarrhea:

If, within 4 hours of tablet intake, you have vomitting or diarrhea, a tablet may not be absorbed properly by your body. Continue taking tablets as normal. Also in these circumstances you must use an additional method of contraception (e.g. condoms) after vomitting or diarrhea stops for 2 days. If your vomitting or diarrhea is persistent, you should consult your doctor.

UNDESIRABLE EFFECTS

Since its hormonal content is very low, side effects are not common with Naphagestrel. However, some women may experience nausea, headaches, breast tenderness or weight gain. These side effects will most likely go away during the first 2-3 months of use.

Bleeding during tablet-taking:

During the first few months, while your body is adjusting itself to the pill, you may experience slight bleeding between your periods. In this case, do not stop taking pills. The bleeding usually ceases in a day or two. It is not serious and it will not harm you. It does not mean that the pill does not suit you or that contraceptive protection is lost. It may simply mean that your body is adjusting itself to the pill.  However, if bleeding is heavy or prolonged, consult your doctor.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives: Thrombophlebitis, Arterial thromboembolism, Pulmonary embolism, Myocardial infarction, Cerebral hemorrhage, Cerebral thrombosis, Hypertension, Gallbladder disease, Hepatic adenomas, carcinomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis, Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea, Vomiting, Gastrointestinal symptoms (such as abdominal cramps and bloating), Breakthrough bleeding, Spotting, Change in menstrual flow, Amenorrhea, Temporary infertility after discontinuation of treatment, Edema, Melasma which may persist, Breast changes: tenderness, enlargement, secretion, Change in weight (increase or decrease), Change in cervical erosion and secretion, Diminution in lactation when given immediately postpartum, Cholestatic jaundice, Migraine, Rash (allergic), Mental depression, Reduced tolerance to carbohydrates, Vaginal candidiasis, Change in corneal curvature (steepening), Intolerance to contact lenses.

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Pre-menstrual syndrome, Cataracts, Changes in appetite, Cystitis-like syndrome, Headache, Nervousness, Dizziness, Hirsutism, Loss of scalp hair, Erythema multiforme, Erythema nodosum, Hemorrhagic eruption, Vaginitis, Porphyria, Impaired renal function, Hemolytic uremic syndrome, Budd-Chiari syndrome, Acne, Changes in libido, Colitis.

If the symptoms are serious, please consult doctors.

PRECAUTIONS AND WARNINGS

 

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PACKING SIZE: Each box contains 1 blister which contains 21 hormone tablets and 7 hormone free tablets.

STORAGE: store in a cool and dry place, protect from light, at 150C – 300C

SHELF-LIFE: 5 years from the date of manufacture.

SPECIFICATION: BP2010

Manufacturer:

Nam Ha Pharmaceutical Joint-Stock Company

No.415 Han Thuyen Street, Vi Xuyen ward, Nam Dinh City, Nam Dinh Province, Viet Nam.

Date of Revision of Package Insert:25-03-2012

Prodcuts

Namha Pharmaceutical joint-stock company

Trade name: Namha Pharma

Head office: 415 Han Thuyen – Nam Dinh – Vietnam

Tel:  84-0350-3649408      Fax: 84-0350-644650

Copyright © 2010 NamHa Pharmaceutical Joint Stock Company, All rights reserved.