Anagrelide Stada 0.5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Anagrelide Stada 0.5 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Anagrelide Stada is and what it is used for
2. What you need to know before taking Anagrelide Stada
3. How to take Anagrelide Stada
4. Possible side effects
5. How to store Anagrelide Stada
6. Contents of the pack and other information

1. What Anagrelida Stada is and what it is used for

Anagrelida Stada contains the active substance anagrelide.

Anagrelide is a medicine that interferes with platelet development. It reduces the number of platelets produced by the bone marrow, resulting in a decrease in platelet count in the blood towards a more normal level. For this reason, it is used to treat patients with essential thrombocythemia.

Essential thrombocythemia is a condition in which the bone marrow produces an excessive number of blood cells known as platelets. A high number of platelets in the blood can cause serious circulation and blood clotting problems.

2. What you need to know before taking Anagrelide Stada

Do NOT take Anagrelide Stada

• if you are allergic to anagrelide or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include rash, itching, swelling of the face and lips, or difficulty breathing (dyspnea);
• if you have moderate or severe liver problems;
• if you have moderate or severe kidney problems.

Warnings and precautions

Talk to your doctor before starting anagrelide:

• if you have or think you might have a heart condition;
• if you were born with prolonged QT interval or have a family history of prolonged QT interval (seen on ECG, the electrical recording of the heart), or if you are taking other medicines that cause abnormal changes in the ECG, or if you have low levels of electrolytes, such as potassium, magnesium, or calcium (see section “Other medicines and Anagrelide Stada”);
• if you have liver or kidney problems.

When taken together with acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting), there is an increased risk of major bleeding (haemorrhage) (see section “Other medicines and Anagrelide Stada”).

While being treated with anagrelide, you must take exactly the dose prescribed by your doctor. Do not stop taking the medicine without informing your doctor first. You should not stop taking this medicine suddenly without consulting your doctor. Abrupt discontinuation of the medicine may increase the risk of stroke.

Signs and symptoms of stroke may include sudden numbness or weakness in the face, arm, or leg, especially on one side of the body; sudden confusion; difficulty speaking or understanding speech; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; and sudden severe headache with no known cause. Please consult your doctor immediately.

Children and adolescents

Information on the use of anagrelide in children and adolescents is limited, and therefore this medicine should be used with caution.

Other medicines and Anagrelide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking any of the following medicines:

• medicines that may affect your heart rhythm, for example: sotalol, amiodarone;
• fluvoxamine, used to treat depression;
• certain types of antibiotics, such as enoxacin, used to treat infections;
• theophylline, used to treat asthma and serious breathing problems;
• medicines used to treat heart conditions such as milrinone, enoximone, amrinone, olprinone, and cilostazol;
• acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting);
• other medicines to treat conditions affecting blood platelets, such as clopidogrel;
• omeprazole, used to reduce the amount of acid produced in the stomach;
• oral contraceptives. If you experience severe diarrhoea while taking this medicine, the effectiveness of the oral contraceptive may be reduced and it is recommended to use an additional contraceptive method (e.g., condom). Please refer to the instructions in the leaflet of the oral contraceptive you are taking.

When used together, either anagrelide or these medicines may not work properly.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

Consult your doctor if you are pregnant or planning to become pregnant. If you are pregnant, you must not take anagrelide. Women who could become pregnant should ensure they use effective contraception while taking anagrelide. Consult your doctor if you need advice on contraception.

Consult your doctor if you are breastfeeding or planning to breastfeed. You must not take anagrelide while breastfeeding. If you are taking anagrelide, you must stop breastfeeding.

Driving and using machines

Some patients taking anagrelide have reported dizziness. Do not drive or operate machinery if you feel dizzy.

Anagrelide Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take Anagrelide Stada

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The amount of anagrelide that different patients can take may vary, as this amount depends on the condition being treated. Your doctor will prescribe the most appropriate dose for your case.

The usual starting dose of anagrelide is 1 mg. This dose is taken as one 0.5 mg capsule twice daily for at least one week. After this period, your doctor may increase or decrease the number of capsules you need to take until finding the dose best suited to your condition and that treats it most effectively.

The capsules must be swallowed whole with a glass of water. Do not crush the capsules or dissolve the contents in a liquid. You may take the capsules with food, after meals, or on an empty stomach. It is recommended to take the capsule(s) at the same time each day.

Do not take more or fewer capsules than your doctor has recommended. Do not stop taking the medicine without informing your doctor first. You must not stop taking this medicine suddenly on your own.

Your doctor will instruct you to have regular blood tests to check whether the medicine is working and to ensure your liver and kidneys are functioning properly.

If you take more Anagrelide Stada than you should

If you take more anagrelide than you should, or if someone else has taken this medicine, inform your doctor or pharmacist immediately. You should show them the anagrelide packaging.

If you forget to take Anagrelide Stada

Take the missed dose as soon as you remember. Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Empty section

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. If you are concerned about this, please consult your doctor.

Serious adverse effects:

Uncommon (may affect up to 1 in 100 people)

• heart failure (signs include shortness of breath, chest pain, swelling of the legs due to fluid accumulation)
• serious problem with heart rate or heart rhythm (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation)
• inflammation of the pancreas causing severe back and abdominal pain (pancreatitis)
• vomiting blood or dark or bloody stools
• severe decrease in blood cell count that may cause weakness
• bruising
• bleeding or infections (pancytopenia)
• pulmonary hypertension (signs include shortness of breath, swelling of legs or ankles, and bluish color of lips and skin)

Rare (may affect up to 1 in 1,000 people)

• kidney failure (when passing little or no urine)
• heart attack

If you notice any of these adverse effects, contact your doctor immediately.

Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• dizziness
• tiredness
• rapid heartbeat
• strong or irregular heartbeat (palpitations)
• feeling sick (nausea)
• diarrhoea
• stomach pain
• gas
• vomiting
• decrease in red blood cell count (anaemia)
• fluid retention or rash

Uncommon (may affect up to 1 in 100 people)

• feeling of weakness or discomfort
• high blood pressure
• irregular heartbeat
• fainting, chills, or fever
• indigestion
• loss of appetite
• constipation
• bruising
• bleeding
• swelling (oedema)
• weight loss
• muscle pain
• joint pain
• back pain, loss or decrease in sensation or tingling sensation (especially in the skin)
• skin sensitivity or abnormal sensation such as tingling or numbness
• insomnia
• depression
• confusion
• nervousness
• dry mouth
• memory loss
• feeling short of breath
• nosebleeds
• severe lung infection with fever
• shortness of breath
• cough or phlegm
• hair loss
• itching of the skin
• changes in skin colour
• impotence
• chest pain
• decrease in platelet count in the blood, increasing the risk of bleeding or bruising (thrombocytopenia)
• fluid accumulation in the lungs or an increase in liver enzymes

Your doctor may carry out blood tests which could indicate an increase in liver enzymes.

Rare (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)
• enlargement of the heart
• fluid accumulation around the heart
• painful spasm of the blood vessels of the heart (at rest, usually at night or early morning) (Prinzmetal's angina)
• loss of coordination
• difficulty speaking
• dry skin
• migraine
• visual disturbances or double vision
• ringing in the ears
• dizziness when standing up (especially when standing up after sitting or lying down)
• increased need to urinate during the night
• pain
• "flu-like" symptoms
• drowsiness
• dilation of blood vessels
• inflammation of the large intestine (signs include diarrhoea usually accompanied by blood or mucus, stomach pain, fever)
• inflammation of the stomach (signs include pain, nausea, vomiting)
• area of abnormal density in the lungs
• increased levels of creatinine in blood tests, which may indicate kidney problems

The following adverse effects have been reported, although the exact frequency is unknown (frequency cannot be estimated from the available data)

• potentially life-threatening irregular heartbeat (torsade de pointes);
• liver inflammation, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, abnormal colour of stools and urine (hepatitis);
• lung inflammation (signs include fever, cough, difficulty breathing or wheezing; this leads to lung scarring) (allergic alveolitis including interstitial lung disease and pneumonitis);
• inflammation of the kidneys (tubulointerstitial nephritis).
• stroke (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagrelide Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the bottle or the box after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

If your doctor discontinues treatment, do not keep any leftover capsules unless otherwise instructed by your doctor.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to a SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anagrelide Stada

The active substance is anagrelide. Each capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate).

The other components are:

Capsule contents: lactose monohydrate, sodium croscarmellose, povidone (K29/32), lactose, microcrystalline cellulose, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171).

Appearance of the product and contents of the pack

Anagrelide 0.5 mg is available as hard capsules (size 4), opaque white in colour. The capsules contain white or almost white powder.

The capsules are supplied in bottles with child-resistant closures and desiccant, containing 42 or 100 hard capsules.

Only some pack sizes may be marketed.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: September 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.