1. Name of the medicinal product
a) Norethisterone Tablets USP 0.35mg TajPharma
b) Norethisterone Tablets USP 5mg TajPharma

2. Qualitative and quantitative composition
a) Each tablet contains:
Norethisterone USP 0.35mg,
Excipients q.s.

b) Each tablet contains:
Norethisterone USP 5mg,
Excipients   q.s.

3. Pharmaceutical form
Tablet White, flat, circular, bevel-edged tablet.

4. Clinical particulars

4.1 Therapeutic indications
Norethisterone 0.35mg is a progestogen-only oral contraceptive. It is particularly useful for women for whom oestrogens may not be appropriate.

4.2 Posology and method of administration
Posology
Starting on the first day of menstruation, one pill every day without a break in medication for as long as contraception is required. Additional contraceptive precautions (such as a condom) should be taken for the first 7 days of the first pack. Pills should be taken at the same time each day.

Missed pills
If a pill is missed within 3 hours of the correct dosage time then the missed pill should be taken as soon as possible; this will ensure that contraceptive protection is maintained. If a pill is taken 3 or more hours late it is recommended that the woman takes the last missed pill as soon as possible and then continues to take the rest of the pills in the normal manner. However, to provide continued contraceptive protection it is recommended that an alternative method of contraception, such as a condom, is used for the next 7 days.

Changing from another oral contraceptive
In order to ensure that contraception is maintained it is advised that the first pill is taken on the day immediately after the patient has finished the previous pack.

Use after childbirth, miscarriage or abortion
The first pill should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first pill, contraception may not be established until 7 days after the first pill has been taken. In these circumstances women should be advised that extra contraceptive methods will be necessary.

After a miscarriage or abortion patients can take the first pill on the next day; in this way they will be protected immediately.

Vomiting and diarrhoea
Gastrointestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the pill leading to a reduction in contraceptive efficacy. Women should continue to take Norethisterone, but they should also be advised to use another contraceptive method during the period of gastrointestinal upset and for the next 7 days.

Method of administration
For oral use.

4.3 Contraindications
The contraindications for progestogen-only oral contraceptives are:
(i) known, suspected, or a past history of breast, genital or hormone dependent cancer
(ii) acute or severe chronic liver diseases including past or present liver tumours, Dubin-Johnson or Rotor syndrome
(iii) active liver disease
(iv) history during pregnancy of idiopathic jaundice or severe pruritus;
(v) disorders of lipid metabolism
(vi) undiagnosed abnormal vaginal bleeding
(vii) known or suspected pregnancy
(viii) hypersensitivity to the active substance or to any of the excipients

Combined oestrogen/progestogen preparations have been associated with an increase in the risk of thromboembolic and thrombotic disease. Risk has been reported to be related to both oestrogenic and progestogenic activity. In the absence of long term epidemiological studies with progestogen-only oral contraceptives, it is required that the existence, or history of thrombophlebitis, thromboembolic disorders, cerebral vascular disease, myocardial infarction, angina, or coronary artery disease be described as a contraindication to Norethisterone  as it is to oestrogen containing oral contraceptives.

4.4 Special warnings and precautions for use
Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications and warnings for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.

Malignant hepatic tumours have been reported on rare occasions in long-term users of contraceptives. Benign hepatic tumours have also been associated with oral contraceptive usage. A hepatic tumour should be considered in the differential diagnosis when upper abdominal pain, enlarged liver or signs of intra-abdominal haemorrhage occur.

Hepatic adenoma – In very rare cases, hepatic adenomas may be associated with progesterone-only pill (POP) use. In some cases the hepatic adenoma may decrease in size or become undetectable after discontinuation of norethisterone. Rupture of hepatic adenomas may cause death through intra-abdominal haemorrhage. In extremely rare cases, hepatocellular carcinoma may be associated with combined oral contraceptives use.

A statistical association between the use of oral contraceptives and the occurrence of thrombosis, embolism or haemorrhage has been reported. Patients receiving oral contraceptives should be kept under regular surveillance, in view of the possibility of development of conditions such as thrombo-embolism.

The risk of coronary artery disease in women taking oral contraceptives is increased by the presence of other predisposing factors such as cigarette smoking, hypercholesterolemia, obesity, diabetes, history of pre-eclamptic toxaemia and increasing age. After the age of thirty-five years, the patient and physician should carefully re-assess the risk/benefit ratio of using oral contraceptives as opposed to alternative methods of contraception.

Norethisterone should be discontinued at least 4 weeks before elective surgery or during periods of prolonged immobilisation. It would be reasonable to resume Norethisterone 2 weeks after surgery provided the woman is ambulant. However, every woman should be considered individually with regard to the nature of the operation, the extent of immobilisation, the presence of additional risk factors and the chance of unwanted conception.

Norethisterone should be discontinued if there is a gradual or sudden, partial or complete loss of vision or any evidence of ocular changes, onset or aggravation of migraine or development of headache of a new kind which is recurrent, persistent or severe, suspicion of thrombosis or infarction, significant rise in blood pressure or if jaundice occurs.

Caution should be exercised where there is the possibility of an interaction between a pre-existing disorder and a known or suspected side effect. The use of Norethisterone in women suffering from epilepsy, or with a history of migraine or cardiac or renal dysfunction may result in exacerbation of these disorders because of fluid retention. Caution should also be observed in women who wear contact lenses, women with impaired carbohydrate tolerance, depression, gallstones, a past history of liver disease, varicose veins, hypertension, asthma or any disease that is prone to worsen during pregnancy (e.g. multiple sclerosis, porphyria, tetany and otosclerosis).

An increased risk of congenital abnormalities, including heart defects and limb defects, has been reported following the use of sex hormones, including oral contraceptives, in pregnancy. If the patient does not adhere to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and further use of oral contraceptives should be withheld until pregnancy has been ruled out. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. If pregnancy is confirmed the patient should be advised of the potential risks to the foetus and the advisability of continuing the pregnancy should be discussed in the light of these risks. It is advisable to discontinue Norethisterone three months before a planned pregnancy.

Progestogen-only oral contraceptives may offer less protection against ectopic pregnancy, than against intrauterine pregnancy.

A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk of having breast cancer diagnosed in women who are currently using oral contraceptives (OC). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The additional breast cancers diagnosed in current users of OCs or in women who have used OCs in the last ten years are more likely to be localised to the breast than those in women who never used OCs.

Breast cancer is rare among women under 40 years of age whether or not they take OCs. Whilst the background risk increases with age, the excess number of breast cancer diagnoses in current and recent progesterone-only pill (POP) users is small in relation to the overall risk of breast cancer, possibly of similar magnitude to that associated with combined OCs. However, for POPs, the evidence is based on much smaller populations of users and so is less conclusive than that for combined OCs.

The most important risk factor for breast cancer in POP users is the age women discontinue the POP; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping POP use, such that by 10 years there appears to be no excess.

The evidence suggests that compared with never-users, among 10,000 women who use POPs for up to 5 years but stop by age 20, there would be much less than 1 extra case of breast cancer diagnosed up to 10 years afterwards. For those stopping by age 30 after 5 years use of the POP, there would be an estimated 2-3 extra cases (additional to the 44 cases of breast cancer per 10,000 women in this age group never exposed to oral contraceptives). For those stopping by age 40 after 5 years use, there would be an estimated 10 extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of breast cancer per 10,000 never-exposed women in this age group).

It is important to inform patients that users of all contraceptive pills appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of oral contraceptives, but this has to be weighed against the known benefits.

Norethisterone contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction
The herbal remedy St John’s wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.

Some drugs may modify the metabolism of Norethisterone reducing its effectiveness; these include certain sedatives, antibiotics, and antiepileptics. During the time such agents are used concurrently, it is advised that an alternative method of contraception, such as a condom, is also used.

The serum levels of prednisone, prednisolone, cloprednol and possibly other corticosteroids are considerably increased in those taking oral contraceptives. Both the therapeutic and toxic effects may be expected to increase accordingly.

4.6 Fertility, pregnancy and lactation
Pregnancy
Norethisterone is contraindicated in women with suspected pregnancy. Several reports suggest an association between foetal exposure to female sex hormones, including oral contraceptives, and congenital anomalies.

Breast-feeding
There is no evidence that Norethisterone tablets diminish the yield of breast milk. Small amounts of steroid materials appear in the milk; their effect on the breast-fed child has not been determined.

4.7 Effects on ability to drive and use machines
Not relevant.

4.8 Undesirable effects
The incidence of side effects in clinical trials was lower than that experienced with oestrogen-containing oral contraceptives. Side effects which did occur included some cycle irregularity during the first few months of therapy, spotting or breakthrough bleeding, amenorrhoea, breast discomfort, gastrointestinal symptoms, rash, headaches, migraine, depression, fatigue, nervousness, disturbance of appetite and changes in weight, hepatic adenoma and libido.

Hypertension, which is usually reversible on discontinuing treatment, has occurred in a small percentage of women taking oral contraceptives.

Menstrual pattern: Women taking Norethisterone for the first time should be informed that they may initially experience menstrual irregularity. This may include amenorrhoea, prolonged bleeding and/or spotting but such irregularity tends to decrease with time. If a woman misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).

5. Pharmacological properties

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: sex hormones and modulators of the genital system, progestogens.

Norethisterone administration increases the protein and sialic acid content of cervical mucus which prevents penetration of the mucus by spermatozoa. It causes changes in the structure of the endometrium such that implantation of blastocysts is impaired. It also reduces numbers and height of cilia on cells lining the fallopian tube, which could delay tubal transport of ova.

5.2 Pharmacokinetic properties
Norethisterone is rapidly and completely absorbed after oral administration, peak plasma concentrations occurring in the majority of subjects between 1 and 3 hours. Due to first-pass metabolism, blood levels after oral administration are 60% of those after i.v. administration. The half life of elimination varies from 5 to 12 hours, with a mean of 7.6 hours. Norethisterone is metabolised mainly in the liver. Approximately 60% of the administered dose is excreted as metabolites in urine and faeces.

5.3 Preclinical safety data
The toxicity of norethisterone is very low. Reports of teratogenic effects in animals are uncommon. No carcinogenic effects have been found even in long-term studies. In subacute and chronic studies only minimal differences between treated and control animals are observed.

6. Pharmaceutical particulars

 6.1 List of excipients
Lactose
Maize starch
Magnesium stearate
Polyvidone

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
5 years.

6.4 Special precautions for storage
Do not store above 25°C.
Store in original packaging in order to protect from light.

6.5 Nature and contents of container
Norethisterone tablets are supplied in pvc/foil blister packs of 28 and 84 tablets.
Blister packaging consists of 250 micron PVC and 20 micron aluminium foil.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
No special requirements.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Norethisterone Tablets USP 5mg TajPharma

Package leaflet: Information for the patient

a) Norethisterone Tablets USP 0.35mg TajPharma
b) Norethisterone Tablets USP 5mg TajPharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet
1. What Norethisterone Tablets are and what they are used for
2. What you need to know before you take Norethisterone Tablets
3. How to take Norethisterone Tablets
4. Possible side effects
5. How to store Norethisterone Tablets
6. Contents of the pack and other information

1. WHAT NORETHISTERONE TABLETS ARE AND WHAT THEY ARE USED FOR
Norethisterone tablets belong to a group of medicines called progestogens. These work by acting on receptors in the body to mimic or exaggerate the effects of the natural hormone, progesterone.

Norethisterone tablets may be used to treat:

  • or prevent abnormal or unexpected bleeding from the uterus
  • the symptoms of pre-menstrual syndrome which occur before a period including breast pain, headache, migraine, water retention and mood disturbances
  • painful or heavy periods
  • endometriosis
  • certain types of breast cancer.
    The tablets can also be used to stop periods.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORETHISTERONE TABLETS
Before you take Norethisterone
Your doctor will discuss your medical and family history with you. Your doctor will also need to check your blood pressure and make sure you are not pregnant. You may also need additional checks, such as a breast examination, that will be specific to your medical needs and/or concerns.

Do not take Norethisterone tablets and tell your doctor if you have:

  • if you are allergicto norethisterone or any of the other ingredients of this medicine (listed in section 6).
  • pregnantor if you think you might be pregnant
  • or if you have:
  • ever had a problem with your blood circulation. This includes a blood clot(thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart attack), brain (stroke) or any other parts of the body
  • any symptoms of a blood clot, such as chest pain, unexplainedand often sudden shortness of breath and/or cough
  • any condition which makes you more at risk of a blood clot(thrombosis)
  • ever suffered migrainewith visual disturbance
  • (or are recovering from) a liver diseaseand the blood tests show that your liver is not yet working normally
  • (or have ever had) liver tumours.
  • diabeteswith damaged blood vessels.
  • any type of cancer which might be made worse by exposure to female sex hormones(including breast cancer).
  • problems with genital bleedingfor which the cause is not yet known.
  • a condition called endometrial hyperplasiawhich has not been treated.

In addition, do not take Norethisterone tablets if you have had any of the following conditions when you were pregnant:

  • yellowing of the skin (idiopathic jaundice of pregnancy)
  • itching of the whole body (pruritus of pregnancy)

Warnings and precautions

Talk to your doctor or pharmacist before taking Norethisterone tablets if you:

  • smoke
  • have Norethisterone tablets can produce changes in blood sugar levels. If you are diabetic, your doctor will check your blood sugar before starting treatment and regularly during treatment.
  • are overweight (BMI≥30kg/m2)
  • have high blood pressure
  • have a heart valve disorderor a certain heart rhythm disorder (heart problems)
  • have had a thrombosis/embolismor anyone in your close family has had a thrombosis, a heart attack or a stroke at a young age
  • suffer from migraine, asthma,or kidney problems
  • suffer from epilepsy(see “Other medicines and Norethisterone tablets”)
  • have an inflammation of your veins(superficial phlebitis)
  • have varicose veins
  • have anyone in your immediate family who has had breast cancer
  • have previously had a condition called chloasmawhere the skin on your face may develop brownish blotches. You may be advised to avoid exposure to the sun and to ultraviolet light while you are taking Norethisterone tablets.
  • have previously suffered from
  • or someone in your close family has ever had high blood levels of cholesterolor triglycerides (fatty substances)
  • have a disease of the liver or gall bladder
  • have certain rare medical conditions such as systemic lupus erythematosus(SLE), sickle cell disease, Crohn’s disease or ulcerative colitis
  • have haemolytic uremic syndrome(‘HUS)’
  • have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria,or Sydenham’s chorea)
  • have hereditary angioedema.Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing oestrogens may induce or worsen symptoms of angioedema
  • have an intolerance to some types of sugar (galactose intolerance, Lapp lactase deficiencyor glucose-galactose malabsorption)
  • are using other medications as mentioned in “Other Medicines & Norethisterone tablets”.

Tell your doctor before you take Norethisterone tablets if any of these applies to you. Also tell your doctor if any of these conditions develop or worsen while you are taking Norethisterone tablets, because you may need to stop taking it.

Norethisterone tablets and blood clots:
The main ingredient in Norethisterone (progestogen) is partly converted into oestrogen so you should also consider the general warnings given for combined oral contraceptive pills (“the Pill”).
Do not take Norethisterone tablets if you have a blood clot or have any medical condition which makes you more at risk of developing clots.
The risk of blood clots occurring in the veins and arteries is slightly greater in women who take the combined oral contraceptive pill than in women who don’t. People do not always fully recover from such blood clots, which can cause strokes, heart attacks and bleeding into the brain (subarachnoid haemorrhage). In very rare cases these blood clots can be fatal.

You are more at risk of having a blood clot:

  • as you get older
  • if you’re off your feet for a long timebecause of major surgery, injury or illness.
  • if you smoke
  • if you or any of your close family have had blood clots
  • if you are overweight (BMI ≥ 30kg/m2)
  • if you have a disorder of blood fat(lipid) metabolism
  • if you have a blood disorder
  • if you have high blood pressure
  • if you suffer from migraines
  • if you have a heart valve disorderor a particular type of irregular heartbeat (atrial fibrillation)
  • if you have recently had a baby
  • if you have diabetes
  • if you have certain medical conditions such as systemic lupus erythematosus(SLE), sickle cell disease, Crohn’s disease or ulcerative colitis

Tell your doctor if any of these apply to you. Taking Norethisterone tablets may add to this risk so it may not be suitable for you.

To reduce the risk of blood clots, treatment with Norethisterone tablets must be stopped:

  • six weeks before any planned major operation
  • before any surgery to the legs
  • before medical treatment for varicose veins
  • if you are going to be immobilised for a long time (e.g. if you need bed-rest after an accident or operation, or if you have a plaster cast on a broken leg)

Signs of a blood clot include:

  • migrainefor the first time or one that is worse than normal
  • unusually frequent or severe headaches
  • any sudden changes to your eyesight(such as loss of vision or blurred vision)
  • any sudden changes to your hearing, speech, sense of smell, taste or touch
  • pain or swelling in your leg
  • stabbing pain when you breathe
  • coughingfor no apparent reason
  • breathlessness
  • pain and tightness in the chest
  • sudden weaknessor numbness in one side or part of your body
  • dizzinessor

See a doctor as soon as possible if you notice any possible signs of blood clot. Do not take any more Norethisterone tablets until your doctor says you can.

Norethisterone tablets and cancer
If you have breast cancer, or have had it in the past, you should not take combined oral contraceptives (the Pill). The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on it, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent Pill users is small. For example:

  • Of 10,000 women who have never taken the Pill,about 16 will have breast cancer by the time they are 35 years old.
  • Of 10,000 women who take the Pill for 5 years in their early twenties,about 17–18 will have breast cancer by the time they are 35 years old.
  • Of 10,000 women who have never taken the Pill,about 100 will have breast cancer by the time they are 45 years old.
  • Of 10,000 women who take the Pill for 5 years in their early thirties,about 110 will have breast cancer by the time they are 45 years old.

Your risk of breast cancer is higher if:

  • you have a close relative (mother, sister or grandmother) who has had breast cancer
  • you are overweight (BMI ≥ 30kg/m2)

See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel.

Very rarely, the Pill has been linked with some forms of liver cancer in women who take it for a long time. These may lead to bleeding in the abdomen.

Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancerous liver tumours, but this is rare.

  • See a doctor as soon as possible if you get severe pain in your stomach that does not go away, or yellow skin or eyes (jaundice).You may need to stop taking Norethisterone tablets.

Tests
If you go to a different doctor than the one who has prescribed you this medicine, or go to the hospital, let them know that you are taking Norethisterone tablets as they may affect certain tests.

Children and adolescents
Not recommended.

Other medicines and Norethisterone tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:

  • other hormonal products (oestrogens or progestogens)
  • medicines used to treat epilepsy (e.g. phenobarbital, phenytoin, carbamazepine)
  • medicines used to treat infections (e.g. rifampicin, nevirapine, tetracyclines, ampicillin, oxacillin, co-trimoxazole, ritonavir, nelfinavir)
  • St John’s Wort (hypericum perforatum) (a herbal remedy)
  • aminoglutethimide
  • ciclosporin (to prevent transplant rejection)
  • other medicines which can also cause fluid retention such as anti-inflammatory medicines (e.g. ibuprofen) or vasodilators

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine as you should not take these tablets.

Driving and using machines
Norethisterone tablets may make you feel dizzy, drowsy or affect your vision. Make sure you are not affected before you drive or operate machinery.

Norethisterone tablets and lactose
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

3. HOW TO TAKE NORETHISTERONE TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

This medicine should be taken for as long as your doctor tells you to. If you finish the course of Norethisterone tablets you will usually have a menstrual bleed 2-3 days after the last tablet. If you do not have a period you must make sure you are not pregnant before taking more.

Day one of the cycle is the first day of your period.
The recommended dose is:

Adult

  • 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.
  • Stopping 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.
  • 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.
  • 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.
  • Breast cancer– 8 tablets a day, the dosage may be increased to 12 tablets a day.

Elderly – Not recommended.
Swallow the tablets with water.

If you take more Norethisterone tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include feeling or being sick, breast enlargement or vaginal bleeding.

If you forget to take Norethisterone tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Norethisterone tablets
Talk to your doctor before you stop taking the tablets and follow their advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Norethisterone tablets and contact your doctor immediately if you develop the following:

  • a rise in blood pressure
  • jaundice (yellowing of the skin or whites of the eyes)
  • migraine-type headaches
  • signs of sever hypersensitivity (anaphylaxis): e.g. swelling of the mouth, tongue, face, throat, difficulty breathing, wheezing, severe skin rash, itch, redness
  • if you become pregnant
  • unusually bad headache
  • sever itching (pruritus)
  • other liver problems and signs e.g. abdominal pain, nausea, vomiting, tiredness, dark brown urine
  • any sudden changes in eyesight, hearing or speech
  • any changes in sense of smell or touch
  • Hypersensitivity reactions:severe allergic reaction including skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing

Symptoms of blood clot formation or symptoms of inflammation of the veins combined with the formation of blood clots (thromnophlebitis):

  • unusual pains in your leg(s)
  • unusual swelling of your arms or legs
  • sharp pains in your chest or sudden shortness of breath
  • crushing pains or feelings of heaviness or tightness in your chest
  • coughing for no apparent reason
  • one side of your body suddenly becoming very weak or numb

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

  • Genital and urinary:breakthrough bleeding, spotting, absence of bleeding, abnormal bleeding (irregular, increase or decrease), alterations of cervical secretions, cervical erosions, prolonged anovulation (not producing a egg), over production of breast milk, breast pain and tenderness
  • Gastrointestinal:feeling or being sick
  • Heart:blood clotting disorders (in the lower limbs, lungs or eye), increased blood pressure, inflammation of the veins
  • Liver:changes in liver function
  • Nervous system:depression, headache, dizziness, tiredness, difficulty in sleeping, nervousness, drowsiness, loss of concentration, vision disorders and intolerance to contact lenses
  • Metabolic and nutritional:altered blood levels of cholesterol, changes in insulin and glucose control, diabetic cataract, worsening of diabetes mellitus, sugar in the urine
  • Skin:acne, hair growth (especially on the top lip or chin), hair loss, rash which may be itchy, worsening of existing skin conditions
  • Other:fluid retention, bloating, weight gain, fever, change in appetite, deepening of the voice, changes in the sex drive

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE NORETHISTERONE TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/strip after EXP. The expiry date refers to the last day of that month.
Keep the blister strips in the outer carton in order to protect from light. Do not store above 25degrees.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Further Information

What Norethisterone Soluble Tablets contain
The active substance is Norethisterone.
a) Each tablet contains: Norethisterone USP         0.35mg
b) Each tablet contains: Norethisterone USP              5mg
The other ingredients are lactose, maize starch, magnesium stearate.

What Norethisterone Tablets look like and contents of the pack
Norethisterone are white circular uncoated tablets.
Pack sizes are 30 tablets.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com