Anagrelide Glenmark

Package Leaflet: Information for the Patient

Anagrelide Glenmark, 0.5 mg, Hard Capsules

Anagrelidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Anagrelide Glenmark and what is it used for
• 2. Important information before taking Anagrelide Glenmark
• 3. How to take Anagrelide Glenmark
• 4. Possible side effects
• 5. How to store 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
inhibits the development of blood platelets. This medicine reduces the number of platelets produced by the bone marrow, which leads to a decrease in the number of platelets in the blood to a more normal value. Therefore, it is used to treat patients with essential thrombocythemia.
Essential thrombocythemia is a disease that occurs when the bone marrow produces too many blood cells known as platelets. A high number of platelets in the blood can lead to severe blood circulation and clotting disorders.

2. Important information before taking Anagrelide Glenmark

When not to take Anagrelide Glenmark

• If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can cause a rash, itching, swelling of the face or lips, and difficulty breathing;
• If you have moderate or severe liver function disorders;
• If you have moderate or severe kidney function disorders.

Warnings and precautions

Before starting treatment with Anagrelide Glenmark, discuss with your doctor:

• If you have or suspect you have heart problems;
• If you have a congenital or family history of prolonged QT interval (visible on an ECG, a record of the heart's electrical activity) or if you are taking other medicines that can change the ECG or if you have decreased electrolyte levels, such as potassium, magnesium, or calcium (see "Anagrelide Glenmark and other medicines");
• If you have liver or kidney problems;

In case of concomitant administration with acetylsalicylic acid (a substance also known as aspirin, present in many medicines used to relieve pain and reduce fever, as well as in medicines that prevent blood clotting), there is an increased risk of serious bleeding (bleeding) (see "Anagrelide Glenmark and other medicines").
Anagrelide Glenmark should be taken exactly as prescribed by your doctor. Do not stop taking the medicine without consulting your doctor first. Do not suddenly stop taking this medicine without consulting your doctor. Sudden discontinuation of the medicine may lead to an increased risk of stroke.
Stroke symptoms may include sudden numbness or weakness of the face, arm, or leg, especially on one side of the body, sudden confusion, difficulty speaking or understanding speech, sudden vision problems in one or both eyes, sudden difficulty walking, dizziness, loss of balance or coordination, and sudden severe headache without a known cause. Seek medical help immediately.

Children and adolescents

Experience with the use of Anagrelide Glenmark in children and adolescents is limited, so caution should be exercised when using this medicine in this group of patients.

Anagrelide Glenmark and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor if you are taking any of the following medicines:

• medicines that can change the heart rhythm, such as sotalol, amiodarone;
• fluvoxamine used to treat depression;
• certain types of antibiotics used to treat infections, such as enoxacin;
• theophylline used to treat severe asthma and breathing problems;
• medicines used to treat heart diseases, 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 in medicines that prevent blood clotting, also known as aspirin);
• other medicines used to treat diseases that affect the number of platelets, such as clopidogrel;
• omeprazole, used to reduce the amount of acid produced in the stomach;
• oral contraceptives: the occurrence of severe diarrhea while taking this medicine may reduce the effectiveness of the oral contraceptive and therefore it is recommended to use an additional contraceptive method (e.g., condom). You should read the instructions in the patient leaflet accompanying the oral contraceptive pill.

The effect of Anagrelide Glenmark or the mentioned medicines may be impaired if they are taken at the same time.
In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or plan to have a child, inform your doctor. Women who are pregnant should not take Anagrelide Glenmark. Women of childbearing age should use effective contraceptive methods during treatment with Anagrelide Glenmark.
Your doctor can advise on contraceptive methods.
If you are breastfeeding or plan to breastfeed, inform your doctor. You should not take Anagrelide Glenmark during breastfeeding. You should stop breastfeeding if you take Anagrelide Glenmark.

Driving and using machines

Some patients taking Anagrelide Glenmark have experienced dizziness. If you experience dizziness, do not drive or operate machinery.

Anagrelide Glenmark contains lactose

Lactose is a component of this medicine. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Anagrelide Glenmark

Anagrelide Glenmark should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
The dose of Anagrelide Glenmark taken by individual patients may vary and depends on the patient's condition. Your doctor will prescribe the appropriate dose for each patient.
Usually, the initial dose of Anagrelide Glenmark is 1 mg. You take this dose as one capsule (0.5 mg) twice a day for at least one week. After this period, your doctor may increase or decrease the number of capsules taken to determine the most suitable dose for you, which will provide the most effective treatment.
Swallow the capsules whole with a glass of water. Do not crush the capsules or dissolve their contents in a liquid. You can take the capsules with food, after food, or on an empty stomach. It is best to take the capsule (capsules) at the same time every day.
Do nottake more or fewer capsules than prescribed by your doctor. Do notstop taking the medicine without consulting your doctor first. Do not suddenly stop taking this medicine without consulting your doctor.
Your doctor will order regular blood tests to determine if the medicine is effective and if your liver and kidneys are working properly.

What to do if you take more Anagrelide Glenmark than you should

If you have taken more Anagrelide Glenmark than prescribed or if someone else has taken this medicine, tell your doctor or pharmacist immediately. Show them the package leaflet.

What to do 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 the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects:
Uncommon: heart failure (symptoms include shortness of breath, chest pain, swelling of the lower limbs due to fluid accumulation), severe heart rhythm disorders (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis causing severe abdominal and back pain, bloody vomiting, or black, tarry stools, severe decrease in blood cell count, which can cause weakness, bruising, bleeding, or infections (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, swelling of the legs or ankles, possible blue discoloration of the lips and skin).
Rare: kidney failure (passing very little urine or urinary retention), heart attack.

If you experience any of the above side effects, contact your doctor immediately. Very common side effects: may occur in more than 1 in 10 people

Headache.
Common side effects: may occur in up to 1 in 10 people
Dizziness, fatigue, rapid heart rate, irregular or strong heartbeats (palpitations), nausea, diarrhea, stomach pain, bloating, vomiting, decreased red blood cell count (anemia), fluid retention or rash.
Uncommon side effects: may occur in up to 1 in 100 people
Weakness or malaise, high blood pressure, irregular heart rhythm, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling, weight loss, muscle pain, joint pain, back pain, limited sensation or loss of sensation or feeling of numbness, especially in the skin, abnormal sensation or feeling of numbness or tingling, insomnia, depression, disorientation, nervousness, dry mouth, memory loss, shortness of breath, nosebleeds, severe lung infection with fever, shortness of breath, cough, and expectoration of sputum, hair loss, itching or skin discoloration, impotence, chest pain, decreased platelet count, which can increase the risk of bleeding or bruising (thrombocytopenia), fluid accumulation around the lungs, and increased liver enzyme activity. Your doctor may order a blood test, which may show increased liver enzyme activity.
Rare side effects: may occur in up to 1 in 1,000 people
Gum bleeding, weight gain, severe chest pain (angina pectoris), heart muscle disease (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation around the heart, painful coronary artery spasm (at rest, usually at night or early in the morning) (Prinzmetal's angina), coordination disorders, speech difficulties, dry skin, migraine, vision disorders or double vision, tinnitus, dizziness when standing up (especially from a sitting or lying position), increased need to urinate at night, pain, flu-like symptoms, drowsiness, vasodilation, colitis (symptoms include diarrhea, usually containing blood and mucus, stomach pain, fever), gastritis (symptoms include pain, nausea, vomiting), lung changes, increased creatinine levels in blood tests, which may indicate kidney function disorders.
Side effects with unknown frequency:

• Potentially life-threatening heart rhythm disorders ( torsade de pointes);
• Hepatitis, which may cause nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine color (jaundice);
• Pneumonitis (symptoms include fever, cough, difficulty breathing, wheezing; the disease can lead to scarring of lung tissue) (allergic pneumonitis, including interstitial lung disease, pneumonitis);
• Nephritis (tubulointerstitial nephritis);
• Stroke (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anagrelide Glenmark

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP or on the label after: EXP. The expiry date refers to the last day of the month.
Do not store above 30°C. Store in the original package to protect from moisture.
After first opening, use within 100 days, keep the bottle tightly closed and in a dry place.
If your doctor advises you to stop treatment, do not keep any unused capsules unless your 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. This will help protect the environment.

6. Contents of the pack and other information

What Anagrelide Glenmark contains

The active substance is anagrelide (Anagrelidum).One capsule contains 0.5 mg of anagrelide (as anagrelide hydrochloride).
The other ingredients are:
Capsule contents: povidone (K30), crospovidone type A, anhydrous lactose, lactose monohydrate, microcrystalline cellulose, and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E 171).

What Anagrelide Glenmark looks like and contents of the pack

Anagrelide Glenmark is a matte, white, hard gelatin capsule, size 4 (14.4 mm), containing a white or almost white fine powder.
The medicine is available in bottles containing 100 capsules.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer

NOUCOR HEALTH, S.A.
Avda. Camí Reial, 51-57, Palau-Solità i Plegamans
08184 Barcelona
Spain
Galenicum Health S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For more information, contact your local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: poland.receptionist@glenmarkpharma.com

Date of last revision of the leaflet: