NORETHISTERONE TABLETS BP 5MG

Active substance: NORETHISTERONE

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Norethisterone 5mg tablets
• an inherited disorder of the red blood pigment
haemoglobin (porphyria)
• severe itching
• had cancer of the breast or genital tract (unless
Norethisterone tablets are given as part of a cancer
treatment programme).

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Read all of this leaflet carefully before you start taking
this medicine.
• 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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

• not had a period before starting a new course of
norethisterone (it must be confirmed you are not pregnant)
• diabetes
• epilepsy, migraine, asthma, kidney or heart problems
(norethisterone may cause fluid retention which can
aggravate these conditions).



Taking other medicines



Please tell your doctor or pharmacist if you are taking or
have recently taken 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, cotrimoxazole, 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.

Index
1 What Norethisterone tablets are
and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further 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.







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.

Sugar intolerance



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.



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.

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

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



2 Before you take

• an allergy (hypersensitivity) to Norethisterone tablets or
any of the other ingredients (see section 6)
• any liver disease or disturbance of liver function
• suffered from jaundice or herpes during pregnancy
• Dubin-Johnson Syndrome (chronic jaundice (yellowing
of the skin or eyes)) or Rotor Syndrome (jaundice in
childhood)
• irregular vaginal bleeding of unknown cause
• had a blood clot affecting the legs (deep vein thrombosis)
or lungs (pulmonary embolism)
• had a recent heart attack (myocardial infarction) or suffer
from angina

Check with your doctor or pharmacist before taking
Norethisterone tablets if you have:



3 How to take

Always take Norethisterone tablets exactly as your doctor
has told you. If you are not sure, check with your doctor or
pharmacist.



Swallow the tablets with water.



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.



Continued over page

• Hypersensitivity reactions: severe allergic reaction
including skin rash, swelling of the face, lips, tongue or
throat, or difficulty breathing or swallowing
• Other: fluid retention, bloating, weight gain, fever, change
in appetite, deepening of the voice, changes in the sex
drive.

Day one of the cycle is the first day of your period.





Doses:
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 & Children - Not recommended.












If you notice any side
effects, they get worse,
or if you notice any not
listed, please tell your
doctor or pharmacist.

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5 How to store

Keep out of the reach and
sight of children.
Do not store the tablets
above 25°C and keep in
the original packaging.
Do not use Norethisterone
tablets after the expiry date stated on the label/carton/bottle.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6 Further information

What Norethisterone tablets contain

• The active substance (the ingredient that makes the tablet
work) is norethisterone. Each tablet contains 5mg of the
active ingredient.
• The other ingredients are lactose, maize starch, magnesium
stearate.



If you take more 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 the tablets

What Norethisterone tablets look like and contents
of the pack



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.



Norethisterone are white circular uncoated tablets.



Pack sizes are 30 tablets.



If you stop taking the tablets



Talk to your doctor before you stop taking the tablets and
follow their advice.



4 Possible side effects

Like all medicines, Norethisterone tablets can cause side
effects, although not everybody gets them.



Manufacturer
CP Pharmaceuticals Ltd, Wrexham, LL13 9UF
Date of revision: August 2009

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.



Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK

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), 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

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Actavis, Barnstaple, EX32 8NS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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