Norethisterone Tablet 5mg

Important precautions while taking Norethisterone Tablet 5 mg

If menstrual bleeding should fail to follow a course of Norethisterone Tablet 5mg, the possibility of pregnancy must be excluded before a further course is given.

Therapy should be discontinued if the following occur:

– Jaundice or deterioration in liver function

– Significant increase in blood pressure

– New onset of migraine-type headache

Progestogens may cause fluid retention. Special care should be taken when prescribing norethisterone in patients with conditions that might be aggravated by this factor:

– Epilepsy

– Migraine

– Asthma

– Cardiac dysfunction

– Renal dysfunction

Risk of venous thromboembolism (VTE)

Long-term use of low-dose progestogens as part of combined oral contraception or combined hormone replacement therapy has been associated with an increased risk of venous thromboembolism, although the role of progestogens in this etiology is uncertain. A patient who develops symptoms suggestive of thromboembolic complications should have her status and need for treatment carefully assessed before continuing therapy.

Any patient who develops an acute impairment of vision, proptosis, diplopia, or migraine headache should be carefully evaluated ophthalmologically to exclude papilledema or retinal vascular lesions before continuing medication.

Generally recognized risk factors for VTE include a personal history or family history, severe obesity (BMI >30 kg/m²) and systemic lupus erythematosus (SLE). There is no consensus about the possible role of varicose veins in VTE.

Treatment with steroid hormones may add to these risk factors. Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition. Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of progestogens in these patients should be viewed as contraindicated. Where a patient is already taking anticoagulants, the risks and benefits of progestogen therapy should be carefully considered.

The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery. As in all post-operative patients, scrupulous attention should be given to prophylactic measures to prevent VTE. Where prolonged immobilisation is likely to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to stopping progestogen therapy 4-6 weeks preoperatively. Treatment should not be restarted until the patient is fully remobilized.

If VTE develops after initiating therapy, the drug should be withdrawn. Patients should be advised to contact their doctor immediately if they become aware of a potential thromboembolic symptom (e.g., painful swelling in the leg, sudden pain in the chest, dyspnoea).

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 contraceptive use.

Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behavior and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.