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Active substance: NORETHISTERONE

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Package Leaflet: Information for the user


5 mg Tablets

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 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

What Utovlan is and what it is used for
What you need to know before you take Utovlan
How to take Utovlan
Possible side effects
How to store Utovlan
Contents of the pack and other information

1. What Utovlan is and what it is used for
Utovlan is one of a group of medicines called ‘Progestogens’.
Progestogens are similar to the natural female hormone progesterone.
Utovlan contains the progestogen called norethisterone as the active
ingredient. Utovlan has many uses.
You can take Utovlan 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
- Breast cancer.
Your doctor may also prescribe Utovlan if you want to delay your next period.

2. What you need to know before you take
Utovlan 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 Utovlan:
- if you are allergic to norethisterone or other similar hormone
medicines, or to 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 Utolvan if you have any
of the following conditions. This will help him or her decide if Utovlan 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 Utovlan. You
are more likely to get a clot whether or not you are taking Utovlan 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 Utovlan. Section 4 of this leaflet (‘Possible side
effects’) also has more information on the warning signs of blood clots.
Other medicines and Utovlan
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 Utovlan 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,
- 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 inflammatory drugs (NSAIDs) for treating pain and
- Medicines for high blood pressure.
Utovlan 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 and breast-feeding
Utovlan 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 Utovlan, as it is not a
If you are breast-feeding, speak to your doctor 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 Utovlan.
Utovlan 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 Utovlan
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The number of tablets 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 Utovlan 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
Continued over...

a period. To stop your periods causing problems again, your doctor may
tell you to take Utovlan 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 Utovlan 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 Utovlan 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.
Taking Utovlan for breast cancer - You will usually take 8 tablets
(40 mg) a day. Your doctor may increase this to 12 tablets (60 mg).
Taking Utovlan 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 Utovlan,
check with your doctor in case you are pregnant.
If you take more Utovlan than you should
If you take too many tablets, contact your doctor straight away.
If you forget to take Utovlan
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 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 Utovlan treatment immediately
Very rarely, Utovlan may cause a severe allergic reaction which can be lifethreatening in some cases. You can get some or all of the following symptoms:
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 Utovlan:
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).
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.

5. How to store Utovlan
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
and blister strip after EXP. The expiry date refers to the last day of that
Do not store your tablets above 25°C, and keep your blister strips
securely in the outer carton.
Do not throw away any medicines via waste water or household waste.
Ask your pharmacist how to throw away medicine you no longer use.
These measures will help protect the environment.

6. Contents of the pack and other information
What Utovlan contains
- The active substance is norethisterone 5 mg.
- The other ingredients are lactose monohydrate, maize starch,
polyvidone and magnesium stearate.
What Utovlan looks like and contents of the pack
Utovlan tablets are white, flat, circular tablets inscribed ‘SEARLE’ on one side
and ‘U’ on the other. They are available in packs of 30 and 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmacia Limited
Piramal Healthcare UK Limited
Ramsgate Road
Morpeth, Northumberland
Sandwich, Kent
NE61 3YA, UK
CT13 9NJ, UK
For further information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:
Pfizer Ltd. (Medical Information)
Walton Oaks, Dorking Road
Tadworth, Surrey, KT20 7NS, UK
Telephone: 01304 616161.
This leaflet was last revised in 04/2013
Ref: UT 5_0

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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.