Norethisterone 5mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Norethisterone
Available from:
DE Pharmaceuticals
ATC code:
G03AC01
INN (International Name):
Norethisterone
Dosage:
5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 06040102
Authorization number:
; PL 00057/1054

CHANGE CONTROL : Version changes due to change in:

Size/Layout Regulatory Non-Regulatory

Changes in detail:

New regulatory text

PACKAGE LEAFLET: INFORMATION FOR

THE USER

Norethisterone 5mg Tablets

Norethisterone

Read all of this leaflet carefully before

you start using 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. See section 4.

The name of your medicine is

Norethisterone 5mg Tablets. In the rest of

this leaflet it is called Norethisterone Tablets.

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 is one of a group of

medicines called ‘Progestogens’.

Progestogens are similar to the natural

female hormone progesterone.

Norethisterone Tablets contains the

progestogen called norethisterone as the

active ingredient. Norethisterone Tablets

has many uses.

You can take Norethisterone Tablets to

treat or manage:

Heavy periods

Painful periods

Irregular periods or periods that are

more frequent than normal

Premenstrual tension (PMT)

Endometriosis (where tissue from your

womb is found outside your womb)

Breast cancer.

Your doctor may also prescribe

Norethisterone Tablets if you want to delay

your next period.

2. What you need to know before you

take Norethisterone Tablets

Norethisterone Tablets may not be suitable

for all women. Please read the following

list carefully to see if any of these apply to

you. Consult your doctor if you are not sure.

Do not take Norethisterone Tablets:

if you are allergic to norethisterone, or

other similar hormone medicines, or any

of the other ingredients of this medicine

(listed in section 6)

if you are pregnant or think you might

be pregnant. Your doctor may give you a

pregnancy test before starting treatment

or if you miss a period during treatment

if you have now or have ever had any

vaginal bleeding (not a period) for which

your doctor could not find a cause.

if you or a member of your family have

ever had a problem with blood clots,

including deep vein thrombosis (DVT).

if you have now or have had in the past,

a heart attack or angina.

if you have liver problems.

if you have ever had a pregnancy where

you had jaundice, or an itchy rash

known as pemphigoid gestationis. This

rash appears as small blisters on your

abdomen.

if you have severe generalised itching

all over your body (pruritis)

if you have a condition known as

porphyria (a rare inherited blood disease).

Warnings and precautions

Talk to your doctor or pharmacist before

taking Norethisterone Tablets if you have

any of the following conditions. This will

help them decide if Norethisterone Tablets

is suitable for you:

Epilepsy

Migraine headaches

Asthma

Heart problems

Kidney problems.

Risk of Venous Thromboembolism (VTE)

All women have a small chance of having

a blood clot in the veins of the leg, in the

lung or other part of the body. The

chances of getting a clot are very slightly

higher if you are taking a hormone

medicine like Norethisterone Tablets. You

are more likely to get a clot whether or not

you are taking Norethisterone Tablets if you:

are very overweight

have systemic lupus erythematosus.

(This is a condition where the immune

system attacks healthy tissues, typically

causing symptoms such as painful joints

and muscles, tiredness, fever and rashes).

have had a blood clot in the veins or

lungs before

have relatives who have had blood clots

are unable to move for long periods of

time (for example after an operation)

have a serious injury or have major surgery

have a history of repeated miscarriage.

Tell your doctor if you have just had an

operation or if you are going to have an

operation while taking Norethisterone

Tablets. Section 4 of this leaflet (‘Possible

side effects’) also has more information on

the warning signs of blood clots

Other medicines and Norethisterone

Tablets

Tell your doctor or pharmacist if you are

taking, have recently taken or might take

any other medicines

This includes the following medicines, as

the effect of Norethisterone Tablets may

be altered when they are taken at the

same time:

Medicines to treat epilepsy (e.g.

phenytoin, carbamazepine)

Antibiotic medicines to treat an infection

(e.g. tetracyclines, rifampicin,

co-trimoxazole)

Antiviral medicines to treat HIV (e.g.

ritonavir, nelfinavir)

Anticancer medicines

Herbal preparations containing St John’s

wort (Hypericum perforatum)

Aminoglutethimide, sometimes used in

Cushing’s Syndrome.

Ciclosporin (for suppressing the immune

system)

Non-steroidal anti-inflammatory drugs

(NSAIDs) for treating pain and inflammation

Medicines for high blood pressure.

Norethisterone Tablets can also interfere

with some laboratory tests, so tell your

doctor if you are having any blood tests or

hospital investigations.

Tell your doctor or pharmacist if you are

taking any other medicines not listed above,

including those bought without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding,

think you may be pregnant or are planning

to have a baby, ask your doctor for advice

before taking this medicine.

Pregnancy

Norethisterone Tablets must not be taken if

you are pregnant as hormonal medicines can

affect the developing baby. It is important

you use some form of contraception (e.g. a

condom) while taking Norethisterone

Tablets, as it is not a contraceptive.

Breast-feeding

If you are breast-feeding, ask your doctor

for advice before taking this medicine, so

they can advise whether you should use an

alternative method of feeding your baby.

Driving and using machines

No effect on the ability to drive or use

machinery has been seen with

Norethisterone Tablets.

Norethisterone Tablets contains lactose

Lactose is a type of sugar. If you have

been told by your doctor that you have an

intolerance to some sugars, contact your

doctor before taking this medicine.

3. How to take Norethisterone Tablets

Always take this medicine exactly as your

doctor has told you. Check with your

doctor if you are not sure.

The recommended dose will depend on

the condition you are being treated for.

This information can also be found on the

label on the box the tablets come in. The

following information will help you see

what the usual dose is for a particular

problem.

Taking Norethisterone Tablets for heavy

bleeding and other period problems -

You will usually take 1 tablet 3 times a day

(15 mg) for 10 days. A few days after you

stop taking the tablets you will usually

have bleeding like a period. To stop your

periods causing problems again, your

doctor may tell you to take Norethisterone

Tablets for a few days after your next two

periods. You will probably take 1 tablet

twice a day (10 mg) for 8 days. You will

need to start taking these tablets 19 days

after your last period began.

Taking Norethisterone Tablets for

premenstrual tension - You will usually

take one 5 mg tablet a day for 10 days,

starting 16 days after your last period

began.

Taking Norethisterone Tablets for

endometriosis - You will usually take 1

tablet 3 times (15 mg) a day for at least 6

months. If you have any irregular bleeding

or spotting, your doctor may increase the

dose to 4 or 5 tablets (20-25 mg) a day

until this bleeding stops.

pg1/2

ART WORK CHECK BOX

PRODUCT :

Norethisterone 5mg - 30 tablets

CUSTOMER :

Wockhardt UK

FP CODE:

FP2060 / FP4410

PLANT LOCATION :

Daman (Kadiaya)

DIMENSIONS :

(w)148 x (h)260mm

PHARMACODE No. :

2729

SAP CODE No. :

226093

TEXT FONT SIZE :

8 pt.

FILE NAME :

Norethisterone 5mg_Leaflet_104373-7.ai

SOFTWARE :

Adobe Illustrator CS5

TYPEFACES :

Helvetica 57 Medium Condensed / 77 Bold Condensed

ARTWORK (DETAILS)

24th February & 3rd March, 2020

RECEIVED ON :

PROOF REVISION :

R 1st PDF sent on

- 3RD MAR. 2020

R 2nd PDF sent on - 9TH MAR. 2020

Process

Black

Neutral code not required on the leaflet artworks.

Taking Norethisterone Tablets for

breast cancer - You will usually take 8

tablets (40 mg) a day. Your doctor may

increase this to 12 tablets (60 mg).

Taking Norethisterone Tablets to delay

your periods - You will usually take 1

tablet 3 times (15 mg) a day. You need to

start taking the tablets 3 days before your

period is due to start. Your period will usually

start within 3 days of finishing the tablets.

If you do not have a period after you finish

a course of Norethisterone Tablets, check

with your doctor in case you are pregnant.

If you take more Norethisterone Tablets

than you should:

If you take more Norethisterone Tablets

than you should, contact your doctor

straight away.

If you forget to take Norethisterone

Tablets

Take the tablet as soon as you remember,

and carry on taking the tablets at the

normal times. Do not take a double dose

to make up for a forgotten dose.

If you stop taking Norethisterone Tablets

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.

Reasons for stopping Norethisterone

Tablets treatment immediately

Very rarely, Norethisterone Tablets may

cause a severe allergic reaction which can

be life-threatening in some cases. You can

get some or all of the following symptoms:

wheezing

difficulty breathing

feeling faint

swelling of the face or tongue

swelling of the hands and feet

intense itchy skin rash.

If you think you are reacting badly to the

medicine, get emergency medical help

immediately.

The following symptoms could be warning

signs of thrombosis (a blood clot) which

will need urgent treatment:

Symptoms of a blood clot in the lungs:

Sudden, severe, sharp pain in your chest

Coughing up blood

You suddenly become short of breath

Your heart beats more rapidly

Symptoms of a blood clot in the brain

(‘a stroke’):

You have an unusually severe or long

headache

Your sight is affected in any way

You find it difficult to speak

You collapse or faint

Any part of your body feels weak or numb

Symptoms of a deep-vein thrombosis

(DVT):

You have severe pain, tenderness or

swelling in your calf, ankle or foot

You have purple discolouration of the

skin of the leg or the skin becomes red

and warm to touch

If you get any of these symptoms, you

should stop taking the tablets and see

your doctor immediately.

Reasons for seeking medical advice

during treatment

It is important to see your doctor

straightaway if you get:

Yellowing of the skin or whites of the

eyes (jaundice)

Migraine headache for the very first time

Your doctor may also decide to stop

treatment if your blood pressure gets too high.

Other side effects

You can also get the following side effects

with medicines like Norethisterone Tablets:

Effects on the reproductive system and

breasts: bleeding and spotting between

periods, lack of periods (amenorrhoea),

unexpected or unusual vaginal bleeding,

changes in discharge from the cervix,

cervical erosions (this may be seen when

you have a smear test), cycles where you

don’t ovulate (anovulation), breast pain

and tenderness, a milky discharge from

the breast when not pregnant or

breastfeeding (galactorrhoea).

Effects on the nervous system:

headache, depression, dizziness, fatigue,

difficulty sleeping, confusion, nervousness,

a feeling of intense happiness (euphoria),

feeling sleepy, loss of concentration, vision

problems.

Effects on the stomach and intestines:

feeling or being sick, constipation,

diarrhoea, dry mouth.

Effects on the liver: disturbed liver function,

yellowing of the skin or whites of the eyes.

Effects on your metabolism: altered fat

levels in the blood, alteration of blood

sugar levels, increased levels of insulin

between meals and existing diabetes

getting worse, decreased tolerance to

some sugars like glucose, adrenergic-like

effects (e.g. fine hand tremors, sweating,

cramps in the calves at night), effects on

the adrenal glands (e.g. Cushingoid

syndrome), cloudy vision, sugar in your urine.

Effects on your heart and circulation:

blood clots, including clots in the lung, and

swelling in the veins due to blood clots,

stroke, heart attacks, congestive heart

failure, increased blood pressure, feeling

your heartbeat, clots in the blood vessels

of the retina (this causes visual problems),

heart beating faster (tachycardia).

Effects on your skin and hair: acne,

increase in body or facial hair, hair loss,

itching, rash, hives.

Miscellaneous: fluid retention and

swelling of hands and ankles, bloating,

weight gain, raised temperature, change

in appetite, changes in sex drive, fatigue,

increase in calcium (seen in blood tests).

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.

You can also report side effects directly via

the national reporting systems listed below:

United Kingdom

Yellow Card Scheme

www.mhra.gov.uk/yellowcard. or search

for MHRA Yellow Card in the Google Play

or Apple App Store.

Malta

ADR Reporting

Website:

www.medicinesauthority.gov.mt/adrportal

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. The

expiry date refers to the last day of that

month.

Do not use this medicine if you notice

any signs of deterioration such as

discolouration (they should be white).

Norethisterone Tablets should not be

stored above 25°C. The tablets should

be kept in their original container, in

order to protect from light.

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. Contents of the pack and other

information

What Norethisterone Tablets contain

The active substance is norethisterone.

Each tablet contains 5mg.

The other ingredients are lactose, maize

starch and magnesium stearate.

What Norethisterone Tablets look like

and contents of the pack

Norethisterone Tablets are round, white,

uncoated tablets with “NE 5” on one side

and a break line on the other.

Norethisterone Tablets are available in blister

packs of 30, 72 and 180 tablets in aluminium

foil. Not all pack sizes may be marketed.

Other formats

To listen to or request a copy of this leaflet

in Braille, large print or audio please call,

free of charge 0800 198 5000 (UK Only)

Please be ready to give the following

information:

Product Name

Reference

Number

Norethisterone 5mg

Tablets

29831/0152

This is a service provided by the Royal

National Institute of Blind People.

For Malta please call +44 1978 661261.

Marketing Authorisation Holder and

Manufacturer

Marketing Authorisation Holder in UK:

Wockhardt UK Ltd, Ash Road North,

Wrexham, LL13 9UF, UK.

Marketing Authorisation Holder in Malta:

Pinewood Laboratories Ltd.,

Ballymacarbry, Clonmel, Co. Tipperary,

Ireland.

Manufacturer: CP Pharmaceuticals Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

This leaflet was revised in 02/2020.

This medicinal product is authorised in

the Member States of the EEA under the

following names:

UK: Norethisterone 5mg Tablets

Malta: Norethisterone 5mg Tablets

pg2/2

104373/7

226093

Object 1

Norethisterone 5mg Tablets

Summary of Product Characteristics Updated 21-Feb-2017 | Wockhardt UK Ltd

1. Name of the medicinal product

2. Qualitative and quantitative composition

3. Pharmaceutical form

4. Clinical particulars

4.1 Therapeutic indications

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

5. Pharmacological properties

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6. Pharmaceutical particulars

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text

1. Name of the medicinal product

Norethisterone 5mg Tablets

2. Qualitative and quantitative composition

Norethisterone 5.0mg.

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Tablet.

Norethisterone 5mg Tablets are 6.5mm, round, white, uncoated tablets with “NE 5” on one side and a

break line on the other.

4. Clinical particulars

4.1 Therapeutic indications

At low dose:

Dysfuntional uterine bleeding

Polymenorrhoea

Menorrhagia

Metropathia

Haemorrhagia

Pre-menstrual syndrome

Postponement of menstruation

At high dose:

Disseminated carcinoma of the breast.

4.2 Posology and method of administration

Posology

Low dose

Dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea and metropathia

haemorrhagia: 1 tablet three times daily for 10 days; bleeding usually stops within 48 hours. Withdrawal

bleeding resembling true menstruation occurs a few days after the end of treatment. One tablet twice

daily, from days 19 to 26 of the two subsequent cycles, should be given to prevent recurrence of the

condition.

Endometriosis: 1 tablet three times daily for a minimum treatment period of six months. The dosage

should be increased to 4 or 5 tablets a day if spotting occurs. The initial dosage should be resumed when

bleeding or spotting stops.

Postponement of menstruation: 1 tablet three times daily, starting three days before the expected onset

of menstruation. Menstruation usually follows within three days of finishing the treatment.

Pre-menstrual syndrome: 1 tablet daily from days 16 to 25 of the menstrual cycle.

High dose

For disseminated breast carcinoma the starting dose is 8 tablets (40mg) per day increasing to 12 tablets

(60mg) if no regression is noted.

Method of administration

Oral Administration

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1

Pregnancy

Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism)

Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

Disturbance of liver function

History during pregnancy of idiopathic jaundice

Severe pruritus or pemphigoid gestationis

Undiagnosed irregular vaginal bleeding

Porphyria

4.4 Special warnings and precautions for use

If menstrual bleeding should fail to follow a course of Utovlan, 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 which 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 aetiology 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 papilloedema or retinal vascular lesions before

continuing medication.

Generally recognised risk factors for VTE include a personal history or family history, severe obesity

(BMI >30 kg/m

) 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

thrombophillic predisposition. Until a thorough evaluation of thrombophillic 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 pre-operatively. Treatment should not be restarted until the patient is fully

remobilised.

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).

4.5 Interaction with other medicinal products and other forms of interaction

Interaction with other medicines

The metabolism of progestogens may be increased by concomitant administration of compounds known

to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. These compounds include

anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin,

rifabutin, nevirapine, efavirenz, tetracyclines, ampicillin, oxacillin and cotrimoxazole)

Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties

when used concomitantly with steroid hormones. Herbal preparations containing St John's wort

(Hypericum perforatum) may induce the metabolism of progestogens. Progestogen levels may therefore

be reduced.

Aminoglutethimide has been reported to decrease plasma levels of some progestogens.

Concurrent administration of cyclosporin and norethisterone has been reported to lead to increased

plasma cyclosporin levels and/or decreased plasma norethisterone levels.

When used in combination with cytotoxic drugs, it is possible that progestogens may reduce the

haematological toxicity of chemotherapy.

Special care should be taken when progestogens are administered with other drugs which also cause fluid

retention, such as NSAIDs and vasodilators.

Other forms of interaction

Progestogens can influence certain laboratory tests (e.g., tests for hepatic function, thyroid function and

coagulation).

4.6 Fertility, pregnancy and lactation

Norethisterone is contraindicated in pregnancy

4.7 Effects on ability to drive and use machines

Norethisterone has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Progestogens given alone at low doses have been associated with the following undesirable effects:

Genitourinary

breakthrough bleeding, spotting, amenorrhoea, abnormal uterine

bleeding, (irregular, increase, decrease), alterations of cervical

secretions, cervical erosions, prolonged anovulation

Breast

galactorrhoea, mastodynia, tenderness

Central Nervous System

depression, headache, dizziness, fatigue, insomnia, nervousness,

somnolence, confusion, euphoria, loss of concentration, vision

disorders

Gastrointestinal/Hepatobiliary

nausea, vomiting, cholestatic icterus/jaundice, constipation, diarrhoea,

dry mouth, disturbed liver function

Metabolic & Nutritional

altered serum lipid and lipoprotein profiles, increased fasting glucose

levels, increased fasting insulin levels, decreased glucose tolerance,

adrenergic-like effects (e.g., fine hand tremors, sweating, cramps in

calves at night), corticoid-like effects (e.g., Cushingoid syndrome),

diabetic cataract, exacerbation of diabetes mellitus, glycosuria

Cardiovascular

thrombo-embolic disorders, cerebral and myocardial infarction,

congestive heart failure, increased blood pressure, palpitations,

pulmonary embolism, retinal thrombosis, tachycardia,

thrombophlebitis

Skin & Mucous Membranes

acne, hirsutism, alopecia, pruritis, rash, urticaria

Allergy

hypersensitivity reactions (e.g., anaphylaxis & anaphylactoid

reactions, angioedema)

Miscellaneous

oedema/fluid retention, bloating, weight gain, pyrexia, change in

appetite, change in libido, hypercalcaemia, malaise

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. Healthcare professionals are

asked to report any suspected adverse reactions via the Yellow Card Scheme at

www.mhra.gov.uk/yellowcard.

4.9 Overdose

Overdosage may be manifested by nausea, vomiting, breast enlargement and later vaginal bleeding. There

is no specific antidote and treatment should be symptomatic.

Gastric lavage may be employed if the overdosage is large and the patient is seen sufficiently early

(within four hours).

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmotherapeutic group (ATC code) L02A B.

Norethisterone given at intermediate doses (5-10mg) suppresses ovulation via its effect on the pituitary.

The endogenous production of oestrogens and progesterones are also suppressed, and the ectopic

endometrium is converted to a decidua resembling that of pregnancy. In carcinoma norethisterone may

act by pituitary inhibition or by direct action on tumour deposits.

5.2 Pharmacokinetic properties

Norethisterone is rapidly and completely absorbed after oral administration, peak plasma concentration

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.

6. Pharmaceutical particulars

6.1 List of excipients

Lactose

Maize starch

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Five years.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5 Nature and contents of container

Opaque plastic tablet containers with press-on tamper evident lid containing 100 and 500 tablets.

Blister pack of PVC and aluminium foil containing 30, 72 and 180 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

8. Marketing authorisation number(s)

PL 29831/0152

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 04 August 1999

Date of latest renewal: 02 March 2009

10. Date of revision of the text

13 February 2017

Company Contact Details

Wockhardt UK Ltd

Address

Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF

Telephone

+44 (0)1978 661 261

Medical Information e-mail

[email

protected]

www.wockhardt.co.uk

+44 (0)1978 661 702

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