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ANAGRELIDE 0.5 MG HARD CAPSULES

Active substance(s): ANAGRELIDE HYDROCHLORIDE MONOHYDRATE / ANAGRELIDE HYDROCHLORIDE MONOHYDRATE

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Anagrelide 0.5 mg
Hard Capsules
Package leaflet: Information for the patient

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. See section 4.
What is in this leaflet

1. What Anagrelide Hard Capsules are and what they are
used for
2. What you need to know before you take Anagrelide Hard
Capsules
3. How to take Anagrelide Hard Capsules
4. Possible side effects
5. How to store Anagrelide Hard Capsules
6. Contents of the pack and other information

1

What Anagrelide Hard Capsules are and what
they are used for

Anagrelide Hard Capsules contains the active substance,
anagrelide. Anagrelide is a medicine which interferes with
the development of platelets. It reduces the number of
platelets produced by the bone marrow, which results in a
decrease in the platelet count in the blood towards a more
normal level. For this reason it is used to treat patients with
essential thrombocythaemia.
Essential thrombocythaemia is a condition which occurs
when the bone marrow produces too many of the blood cells
known as platelets. Large numbers of platelets in the blood
can cause serious problems with blood circulation and
clotting.

2

What you need to know before you take
Anagrelide

Do not take Anagrelide Hard Capsules:
• if you are allergic to anagrelide or any of the other
ingredients of this medicine (listed in section 6). An allergic
reaction may be recognised as a rash, itching, swollen face
or lips, or shortness of breath.
• if you have moderate or severe liver problems
• if you have moderate or severe kidney problems.
Warnings and precautions
Talk to your doctor before taking Anagrelide:
• if you have or think you might have a problem with your
heart
• if you were born with or have family history of prolonged
QT interval (seen on ECG, electrical recording of the heart),
or you are taking other medicines that result in abnormal
ECG changes or if you have low levels of electrolytes e.g.
potassium, magnesium or calcium (see section “Other
medicines and Anagrelide Hard Capsules”)
• if you have any problems with your liver or kidneys.
In combination with acetylsalicylic acid (a substance present
in many medicines used to relieve pain and lower fever, as
well as to prevent blood clotting, also known as aspirin),
there is an increased risk of major haemorrhages (bleeding)
(see section “Other medicines and Anagrelide Hard
Capsules”).
Children and adolescents
There is limited information on the use of Anagrelide in
children and adolescents and therefore this medicine should
be used with caution.
Other medicines and Anagrelide Hard Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following
medicines:
• medicines that can alter your heart rhythm e.g. sotalol,
amiodarone
• fluvoxamine, used to treat depression
• certain types of antibiotic, such as enoxacin, used to treat
infections
• theophylline, used to treat severe asthma and breathing
problems
• medicines used to treat heart disorders, for example,
milrinone, enoximone, amrinone, olprinone and cilostazol
• acetylsalicylic acid (a substance present in many medicines
used to relieve pain and lower fever, as well as to prevent
blood clotting, also known as aspirin)
• other medicines used to treat conditions affecting the
platelets in your blood, e.g. clopidogrel
• omeprazole, used to reduce the amount of acid produced
in the stomach
• oral contraceptives: if you experience bad diarrhoea whilst
taking this medicine, it may reduce how well the oral
contraceptive works and use of an extra method of
contraception is recommended (e.g. condom). See the
instructions in the patient leaflet of the contraceptive pill
you are taking.
Anagrelide or these medicines may not work properly if
taken together.
If you are not sure, speak to your doctor or pharmacist for
advice.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or are planning to
become pregnant. Anagrelide should not be taken by
pregnant women. Women who are at risk of becoming
pregnant should make sure that they are using effective
contraception when taking Anagrelide. Speak to your doctor
if you need advice with contraception.
Tell your doctor if you are breast-feeding or if you are
planning to breast-feed your baby. Anagrelide should not be
taken while breast-feeding. You must stop breast-feeding if
you are taking Anagrelide.
Driving and using machines
Dizziness has been reported by some patients taking
Anagrelide. Do not drive or use machines if you feel dizzy.
Anagrelide Hard Capsules contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3

How to take Anagrelide Hard Capsules

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The amount of Anagrelide that people take can be different,
and this depends on your condition. Your doctor will
prescribe the best dose for you.
The usual starting dose of Anagrelide is 1 mg. You take this
dose as one capsule of 0.5 mg twice a day, for at least a week.
After this time, your doctor may either increase or decrease
the number of capsules that you take to find the dose best
suited to you and which treats your condition most effectively.
Your capsules should be swallowed whole with a glass of
water. Do not crush the capsules or dilute the contents in a
liquid. You can take the capsules with food or after a meal or
on an empty stomach. It is best to take the capsule(s) at the
same time every day.
Do not take more capsules than your doctor has recommended.
Your doctor will ask you to have blood tests at regular
intervals to check that your medicine is working effectively
and that your liver and kidneys are working well.
If you take more Anagrelide Hard Capsules than you should
If you take more Anagrelide than you should or if someone
else has taken your medicine, tell a doctor or pharmacist
immediately. Show them the pack of Anagrelide.

If you forget to take Anagrelide Hard Capsules
Take your capsules as soon as you remember. Take your next
dose at the usual time. Do not take a double dose to make
up for a forgotten dose.

4

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them. If you are worried, speak
to your doctor.
Serious side effects:
Uncommon: Heart failure (signs include shortness of breath,
chest pain, swelling of the legs due to fluid build-up), severe
problem with the rate or rhythm of the heart beat (ventricular
tachycardia, supraventricular tachycardia or atrial
fibrillation), inflammation of the pancreas which causes
severe abdominal and back pain (pancreatitis), vomiting
blood or passing bloody or black stools, severe reduction in
blood cells which can cause weakness, bruising, bleeding or
infections (pancytopenia), pulmonary hypertension (signs
include shortness of breath, swelling in legs or ankles, and
lips and skin can turn bluish colour).
Rare: Kidney failure (when you pass little or no urine), heart
attack.
If you notice any of these side effects, contact your doctor
immediately.
Very common side effects: may affect more than 1 in 10
people
Headache.
Common side effects: may affect up to 1 in 10 people
Dizziness, tiredness, rapid heart beat, irregular or strong
heartbeat (palpitations), feeling sick (nausea), diarrhoea,
stomach pain, wind, being sick (vomiting), reduction in red
blood cell count (anaemia), fluid retention or rash.
Uncommon side effects: may affect up to 1 in 100 people
A feeling of weakness or feeling unwell, high blood pressure,
irregular heart beat, fainting, chills or fever, indigestion, loss
of appetite, constipation, bruising, bleeding, swelling
(oedema), weight loss, muscle aches, painful joints, back
pain, decreased or loss of feeling or sensation such as
numbness, especially in the skin, abnormal feeling or
sensation such as tingling and ‘pins and needles’,
sleeplessness, depression, confusion, nervousness, dry
mouth, loss of memory, breathlessness, nosebleed, serious
lung infection with fever, shortness of breath, cough,
phlegm, hair loss, skin itching or discolouration, impotence,
chest pain, reduction in blood platelets, which increases the
risk of bleeding or bruising (thrombocytopenia),
accumulation of fluid around the lungs or an increase in liver
enzymes. Your doctor may do a blood test which may show
an increase in your liver enzymes.
Rare side effects: may affect up to 1 in 1,000 people
Bleeding gums, weight gain, severe chest pain (angina
pectoris), heart muscle disease (signs include fatigue, chest
pain and palpitations), enlarged heart, accumulation of fluid
around the heart, loss of coordination, difficulty in speaking,
dry skin, migraine, visual disturbances or double vision,
ringing in the ears, dizziness on standing up (especially when
getting up from a sitting or lying position), increased need to
pass water at night, pain, ‘flu-like’ symptoms, sleepiness,
widening of blood vessels, inflammation of the large bowel
(signs include: diarrhoea, usually with blood and mucus,
stomach pain, fever), inflammation of the stomach (signs
include: pain, nausea, vomiting), area of abnormal density in
the lung, increased creatinine level in blood tests, which may
be a sign of kidney problems.
The following side effects have been reported but it is not
known exactly how often they occur:
• potentially life-threatening, irregular heart beat (torsade de
pointes)
• inflammation of the liver, symptoms include nausea,
vomiting, itching, yellowing of the skin and eyes,
discolouration of stool and urine (hepatitis)
• lung inflammation (signs include fever, coughing, difficulty
breathing, wheezing; which causes scarring of the lungs)
(allergic alveolitis, including interstitial lung disease,
pneumonitis)
• inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5

How to store Anagrelide Hard Capsules

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 bottle after EXP. The expiry date refers to
the last day of that month.
Do not store above 30ºC.
Store in the original package in order to protect from light
and moisture.
If your doctor stops your medicine, do not keep any leftover
capsules unless your doctor tells you to. 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 Anagrelide Hard Capsules contains
The active substance is anagrelide. Each capsule contains
0.5 mg of anagrelide (as anagrelide hydrochloride
monohydrate).
The other ingredients are:
Capsule contents: lactose monohydrate; croscarmellose
sodium; povidone K 29/32; lactose; cellulose,
microcrystalline and magnesium stearate (see section 2,
“Anagrelide Hard Capsules contains lactose”).
Capsule shell: gelatin and titanium dioxide (E171).
What Anagrelide Hard Capsules looks like and contents of
the pack
Anagrelide is supplied as opaque white hard capsules which
are approximately 14.3 mm in length. The capsules are
provided in bottles containing 42 and 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Synthon Hispania, S.L., C/ Castelló, nº1, Pol. Las Salinas,
Sant Boi de Llobregat, Barcelona 08830, Spain
This leaflet was last revised in 07/2017
PL 00289/2091
The reference medicinal product on which this generic
medicinal product is based has been authorised under
“exceptional circumstances”. This means that because of the
rarity of this disease it has been impossible to get complete
information on this medicine.
The European Medicines Agency will review any new
information on this medicine every year and this leaflet will
be updated as necessary.

EAS5b

284590.01-GB

Expand Transcript

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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