ANAGRELIDE GLENMARK 0.5 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Anagrelide Glenmark 0.5 mg hard capsules EFG

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Anagrelide Glenmark and what is it used for

Anagrelide Glenmark contains the active substance anagrelide. Anagrelide Glenmark is a medicine that interferes with the production of platelets. It reduces the number of platelets produced by the bone marrow, which leads to a reduction in the platelet count in the blood to a more normal level. For this reason, it is used to treat patients with essential thrombocythemia.

Essential thrombocythemia is a condition that occurs when the bone marrow produces too many of the blood cells known as platelets. A high number of platelets in the blood can cause serious problems with blood circulation and clotting.

2. What you need to know before you take Anagrelide Glenmark

Do not take Anagrelide Glenmark

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

Warnings and precautions

Talk to your doctor before you start taking Anagrelide Glenmark:

• if you have or think you may have a heart problem;

• if you were born with a prolonged QT interval or have a family history of prolonged QT interval (observed in the ECG, 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, e.g. potassium, magnesium or calcium (see the section "Taking Anagrelide Glenmark with other medicines");
• if you have liver or kidney problems;

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 a greater risk of major bleeding (bleeding) (see section "Taking Anagrelide Glenmark with other medicines").

While you are being treated with Anagrelide Glenmark, you should take the exact dose prescribed by your doctor. Do not stop taking the medicine without informing your doctor first. Do not stop taking this medicine suddenly without consulting your doctor. Stopping the medicine abruptly can increase the risk of a stroke.

The signs and symptoms of a stroke can 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 difficulty seeing with one or both eyes, sudden difficulty walking, dizziness, loss of balance or coordination, and sudden severe headache without known cause. Please consult your doctor immediately.

Children and adolescents

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

Taking Anagrelide Glenmark with other medicines

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 heart rhythm, such as sotalol, amiodarone;
• fluvoxamine, used to treat depression;
• certain types of antibiotics, such as enoxacin, used to treat infections,
• theophylline, used to treat asthma and severe respiratory problems;
• medicines for treating heart conditions, such as 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 for treating conditions that affect platelets in the blood, such as clopidogrel;
• omeprazole, used to reduce the amount of acid produced in the stomach;
• oral contraceptives: if you experience severe diarrhea while taking this medicine, the effect of the oral contraceptive may be reduced, and it is recommended to use an additional contraceptive method (e.g., condom). Consult the instructions in the package leaflet of the oral contraceptive you are taking.

If they are used together, either Anagrelide Glenmark or these medicines may not work properly.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breast-feeding

Consult your doctor if you are pregnant or plan to become pregnant. If you are pregnant, you should not take Anagrelide Glenmark. Women who may become pregnant should ensure they use effective contraceptive measures while taking Anagrelide Glenmark. Consult your doctor if you need advice on contraceptives.

Consult your doctor if you are breast-feeding or plan to breast-feed your child. You should not take Anagrelide Glenmark while breast-feeding. If you are taking Anagrelide Glenmark you must stopbreast-feeding.

Driving and using machines

Some patients who were taking Anagrelide Glenmark have reported symptoms of dizziness. Do notdrive or operate machinery if you feel dizzy.

Anagrelide Glenmark contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Anagrelide Glenmark

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The amount of Anagrelide Glenmark that different patients can take may vary, as this amount depends on the condition. Your doctor will prescribe the most suitable dose for your case.

The initial normal dose of Anagrelide Glenmark is 1 mg. This dose is taken with one 0.5 mg capsule twice a day for at least one week. After this period, your doctor may increase or decrease the number of capsules you should take until the dose that best suits your case and treats the condition most effectively is found.

The capsules should be swallowed whole with a glass of water. Do notcrush the capsules or dissolve the contents in a liquid. You can take the capsules with food, after meals, or on an empty stomach. It is recommended to take the capsule(s) always at the same time.

Do nottake more or fewer capsules than your doctor has recommended. Do not stop taking the medicine without informing your doctor first. Do not stop taking this medicine suddenly without consulting your doctor.

Your doctor will tell you to have regular blood tests to check if the medicine is working and if your liver and kidneys are working properly.

If you take more Anagrelide Glenmark than you should

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

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Anagrelide Glenmark

Take the capsules 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you are concerned about this, talk to your doctor.

Serious side effects:

Uncommon: Heart failure (symptoms include shortness of breath, chest pain, swelling of legs due to fluid accumulation), serious heart rhythm problems (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis (inflammation of the pancreas that causes severe back and abdominal pain), vomiting blood or black or bloody stools, severe decrease in blood cell count that can cause weakness, bruising, bleeding, or infection (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of legs or ankles, and bluish discoloration of the lips and skin).

Rare: Kidney failure (when little or no urine is produced), 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 patients

Headache.

Common side effects: may affect up to 1 in 10 patients

Dizziness, fatigue, rapid heartbeat, strong or irregular heartbeat (palpitations), nausea, diarrhea, stomach pain, gas, vomiting, decrease in red blood cell count (anemia), fluid retention or rash.

Uncommon side effects: may affect up to 1 in 100 patients

Feeling weak or unwell, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (edema), weight loss, muscle pain, joint pain, back pain, loss or decrease in sensation or feeling like numbness (especially in the skin), sensitivity or abnormal sensation like tingling and numbness, insomnia, depression, confusion, nervousness, dry mouth, memory loss, feeling short of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, or sputum, hair loss, itching of the skin, changes in skin color, impotence, chest pain, decrease in platelet count in the blood that increases the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the lungs or an increase in liver enzymes. Your doctor may perform blood tests that may indicate an increase in liver enzymes.

Rare side effects: may affect up to 1 in 1,000 patients

Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation in the heart, painful spasm of the heart's blood vessels (while resting, usually at night or early in the 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 at night, pain, "flu-like" symptoms, drowsiness, dilation of blood vessels, inflammation of the large intestine (symptoms include diarrhea accompanied by blood or mucus, stomach pain, fever), stomach inflammation (symptoms include: pain, nausea, vomiting), abnormal density area in the lungs, increased levels of creatinine in blood tests that may indicate kidney problems.

The following side effects have been reported, although the exact frequency with which they occur is unknown:

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

Reporting of side effects

If you experience 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 through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Anagrelide Glenmark

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 after EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C. Store in the original package to protect from moisture.

If your doctor stops the treatment, do not keep the remaining capsules unless the doctor tells you to. 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 protect the environment.

6. Contents of the pack and other information

Composition of Anagrelide Glenmark

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

The other ingredients are:

Capsule content: povidone K30 (E1201), anhydrous lactose, lactose anhydrous, lactose, microcrystalline cellulose (E460), and magnesium stearate.

Capsule shell: gelatin (E441) and titanium dioxide (E171).

Appearance and packaging

Anagrelide Glenmark is presented in the form of hard, opaque white capsules, size 4 (14.4 mm), containing a white or almost white powder. The capsules are presented in bottles of 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Noucor Health S.A

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona

Spain

Galenicum Health S.L.U

Sant Gabriel, 50

08950 Esplugues de Llobregat (Barcelona)

Spain

Glenmark Pharmaceuticals s.r.o.

Fibichova 143,

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medicine from the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Germany Anagrelid Glenmark 0.5 mg Hartkapseln

Czech Republic: Anagrelide Glenmark

Poland: Anagrelide Glenmark

Romania: Anagrelida Glenmark 0.5 mg capsule

Slovakia: Anagrelide Glenmark 0.5 mg

Netherlands: Anagrelide Glenmark 0.5 mg harde capsules

Sweden: Anagrelide Glenmark 0.5 mg hårda kapslar

Denmark: Anagrelide Glenmark 0.5 mg hårde kapsler

United Kingdom: Anagrelide Glenmark 0.5 mg Capsule, hard

Spain: Anagrelida Glenmark 0.5 mg cápsulas duras EFG

Date of last revision 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/)