Norestin

Norethisterone 5 mg
Tablet

1. What Norestin® is and what it is used for?
Norestin® tablet is the preparation of Norethisterone which belongs to a group of medicines called progestogens. Norestin works by acting on receptors in the body to mimic or exaggerate the effects of the natural hormone, progesterone.
Norestin® (Norethisterone) tablets is used to treat various types of Menstrual Dysfunctions which include Spasmodic Dysmenorrhea, Management of perimenopausal symptoms, Premenstrual tension, Management of endometriosis, For Dysfunctional Uterine Bleeding, Prophylaxis against recurrent dysfunctional bleeding, For the treatment of inoperable cancer of the breast, For postponement of menstruation, Menorrhagia.

2. Before you take Norestin®
Do not take this medicine and tell your doctor if you have Known or suspected Pregnancy, Lactation, History of herpes gestationalis, cholestatic or idiopathic jaundice, Dubin-Johnson and Rotor Syndrome, Undiagnosed abnormal vaginal bleeding, Hirsutism, Desire for pregnancy during continuous treatment, Known or suspected sex hormone dependent malignancies.

Take special care with Norestin®
Check with your doctor before taking this medicine if:

If you have medical history, including any allergies (especially drug allergies), undiagnosed or abnormal vaginal bleeding, liver or heart disease, cancer of the breast or genitals, missed abortion, blood clots, seizures, migraine, asthma, depression or diabetes.

Taking other medicines
Norethisterone is known to interact with other drugs like Cyclosporin, Estrogens, Griseofulvin, Phenytoin, Rifampicin. These interactions are sometimes beneficial and sometimes may cause threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Pregnancy and breast-feeding
Norethisterone has been assigned to pregnancy category X by the FDA. Norethisterone is considered contraindicated during pregnancy. Norethisterone is excreted into human milk in small amount. It should be avoided during lactation.

3. How to take Norestin®?
Always use Norestin® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take?
Abnormal bleeding – 1 tablet three times a day for 10 days. Bleeding usually stops within 1-3 days. A period usually starts 2-4 days after stopping treatment.
Prevention of abnormal bleeding – 1 tablet twice a day from the 19th - 26th day of the cycle.
Premenstrual Syndrome - 2 to 3 tablets a day from the 19th - 26th day of the cycle. You will normally be treated for several months.
Delaying a period - 1 tablet three times a day starting three days before the expected beginning of the period. Your period should occur 2-3 days after you have stopped taking the medicine.
Dysmenorrhea (Painful periods) - 1 tablet three times a day for 20 days starting on the 5th day of the cycle. You will usually be treated for 3-4 cycles.
Menorrhagia (Heavy periods) - 1 tablet two to three times a day from the 19th - 26th day of the cycle.
Endometriosis - 2 tablets a day starting on the 5th day of your cycle. If you continue having small bleeds (“spotting”), the dosage may be increased to 4 to 5 tablets a day. Once bleeding has stopped the dosage may be reduced. You will usually be treated continuously for 4-6 months or longer.
Day one of the cycle is the first day of your period.

If you take more Norestin® than you should
If you have too much of this medicine, talk to your doctor straight away.

If you forget to take Norestin®
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Norestin®
Do not stop taking this medicine without talking to your doctor. You should not stop taking Norestin® just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Norestin® can cause side effects, although not everybody gets them.

Breakthrough bleeding, Spotting, Edema, Changes in weight (decreases, increases), Cholestatic jaundice, Rash (allergic) with and without pruritus, Headache, Nausea.

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

5. How to store Norestin®?
Store in a cool and dry place. Protect from light.
Keep out of reach of children.


Norestin Prescribing Information

Located in: Hormones & Steroid