- anagrelide hydrochloride monohydrate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0806 .
Anagrelide Zentiva 0.5 mg hard capsules
Package leaflet: Information for the patient
Anagrelide 0.5 mg hard capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What anagrelide is and what it is used for
2. What you need to know before you take anagrelide
3. How to take anagrelide
4. Possible side effects
5. How to store anagrelide
6. Contents of the pack and other information
1 What anagrelide is and what it is used for
The name of this medicine is Anagrelide 0.5 mg hard capsules (called anagrelide in this leaflet).
Anagrelide 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:
Warnings and precautions
Talk to your doctor before taking anagrelide:
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").
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
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines:
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 contains lactose
Lactose is an ingedient in this medicine. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 How to take anagrelide
Always take anagrelide 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 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
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)
Rare: Kidney failure (when you pass little or no urine)
If you notice any of these side effects, contact your doctor immediately.
Very common side effects: may affect more than 1 in 10 people
Common side effects: may affect up to 1 in 10 people
Uncommon side effects: may affect up to 1 in 100 people
A feeling of weakness or feeling unwell
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
The following side effects have been reported but it is not known exactly how often they occur:
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: 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
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 label and carton after 'EXP'.The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 contains
The active substance is anagrelide. Each capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride monohydrate).
The other ingredients are:
Capsule contents: Lactose monohydrate, Croscarmellose sodium, Povidone (K29/32), Lactose, Cellulose, microcrystalline, Magnesium stearate
Capsule Shell: Gelatin, Titanium dioxide (E171)
What anagrelide looks like and contents of the pack
Anagrelide 0.5 mg is supplied as a hard capsule (size 4) with an opaque white body and cap. The capsule is filled with white to off-white powder.
The capsules are provided in bottles containing 42 or 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in October 2017
381444-01 - Laetus-2535