Package leaflet: Information for the patient

Anagrelide Glenmark, 0.5 mg, hard capsules
Anagrelidum
Please read all of this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Anagrelide Glenmark is and what it is used for
What you need to know before taking Anagrelide Glenmark
How to take Anagrelide Glenmark
Possible side effects
How to store Anagrelide Glenmark
Contents of the pack and other information

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

Anagrelide Glenmark contains the active substance anagrelide. Anagrelide Glenmark is a medicine
that inhibits the production of blood platelets. This medicine reduces the number of platelets produced by the bone marrow, thereby lowering the platelet count in the blood to a more normal level.
For this reason, it is used in the treatment of patients with essential thrombocythemia.
Essential thrombocythemia is a condition that occurs when the bone marrow produces too many blood cells known as platelets. A high number of platelets in the blood may lead to serious circulation and blood clotting disorders.

2. Important information before using Anagrelide Glenmark

When not to use Anagrelide Glenmark

If the patient is allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). Allergic reaction may manifest as rash, itching, swelling of the face or lips, and shortness of breath;
If the patient has moderate or severe liver function impairment;
If the patient has moderate or severe kidney function impairment.

Warnings and precautions
Before starting Anagrelide Glenmark, discuss with your doctor:

If the patient has or suspects having heart problems;
If the patient has congenital or family history of prolonged QT interval (seen on ECG, the recording of the heart's electrical activity), or if the patient is taking other medicines that may cause ECG changes, or if the patient has low levels of electrolytes such as potassium, magnesium, or calcium (see section "Anagrelide Glenmark with other medicines");
If the patient has liver or kidney problems.

There is an increased risk of serious bleeding (haemorrhage) when Anagrelide Glenmark is taken together 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 preventing blood clotting) (see section "Anagrelide Glenmark with other medicines").
Anagrelide Glenmark must be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting your doctor. Do not suddenly stop taking this medicine without consulting your doctor. Abrupt discontinuation of the medicine may increase the risk of stroke.
Symptoms of stroke may include sudden numbness or weakness of the face, arm, or leg, especially on one side of the body; sudden confusion, trouble 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 with no known cause. Seek immediate medical help.
Children and adolescents
Experience with the use of Anagrelide Glenmark in children and adolescents is limited, therefore caution should be exercised when using this medicine in this patient group.
Anagrelide Glenmark with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

Medicines that may affect heart rhythm, e.g. 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 conditions, e.g. 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 preventing blood clotting, also known as aspirin);
Other medicines used to treat conditions affecting platelet count, e.g. clopidogrel;
Omeprazole, used to reduce stomach acid production;
Oral contraceptives: severe diarrhoea during treatment with this medicine may reduce the effectiveness of the oral contraceptive, therefore an additional method of contraception (e.g. condom) is recommended. Please refer to the instructions provided in the patient leaflet included in the packaging of the oral contraceptive pill.

The effect of Anagrelide Glenmark or the listed medicines may be altered if taken at the same time.
If in doubt, consult your doctor or pharmacist.
Pregnancy and breastfeeding
If the patient is pregnant or planning to become pregnant, she should inform her doctor. Women who are pregnant should not take Anagrelide Glenmark. Women of childbearing potential should use effective contraception during treatment with Anagrelide Glenmark. Advice on contraceptive methods can be provided by a doctor.
If the patient is breastfeeding or planning to breastfeed, she should inform her doctor. Anagrelide Glenmark should not be used during breastfeeding. The patient should stop breastfeeding if taking Anagrelide Glenmark.
Driving and operating machinery
Dizziness has been reported in some patients taking Anagrelide Glenmark. If dizziness occurs, do not drive or operate machinery.
Anagrelide Glenmark contains lactose
Lactose is an ingredient of this medicine. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Anagrelide Glenmark

Anagrelide Glenmark must always be taken exactly as directed by the physician. In case of
doubt, consult the physician or pharmacist.
The dose of Anagrelide Glenmark prescribed for individual patients may vary and depends on the
patient's condition. The physician will prescribe the appropriate dose for each patient.
The usual starting dose of Anagrelide Glenmark is 1 mg. The patient should take this dose as one capsule (0.5 mg) twice daily for at least one week. After this period, the physician may increase or decrease the number of capsules taken in order to determine the most appropriate dose for the patient, allowing for the most effective treatment.
The capsules must be swallowed whole with a glass of water. Do not crush the capsules or dissolve their contents in liquid. The patient may take the capsules with food, after food, or on an empty stomach. It is best to take the capsule(s) at the same time each day.
Do not take more or fewer capsules than prescribed by the physician. Do not stop taking
the medication without first consulting the physician. Do not abruptly discontinue this medication on your own.
The physician will order regular blood tests to monitor whether the medication is effective and to ensure that the liver and kidneys are functioning properly.
Taking more Anagrelide Glenmark than prescribed
If the patient has taken more Anagrelide Glenmark than prescribed, or if someone else has taken this medication, contact a physician or pharmacist immediately. Show the Anagrelide Glenmark packaging.
Missing a dose of Anagrelide Glenmark
If the patient misses a dose, they should take it as soon as they remember. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Serious adverse effects:
Not common: heart failure (symptoms include breathlessness, chest pain, swelling of the lower limbs due to fluid accumulation), severe disturbances in heart rate or heart rhythm (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), pancreatitis causing severe abdominal and back pain, vomiting blood or passing bloody or tarry stools, serious drop in blood cell count which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (symptoms include breathlessness, swelling of legs or ankles, possible bluish discoloration of lips and skin).
Rare: kidney failure (passing very little or no urine), heart attack.
If any of the above-mentioned adverse effects occur, contact your doctor immediately.
Very common adverse effects: may occur in more than 1 in 10 people
Headache.
Common adverse effects: may occur in up to 1 in 10 people
Dizziness, fatigue, rapid heartbeat, irregular or forceful heartbeats (palpitations), nausea, diarrhoea, stomach pain, bloating, vomiting, reduction in red blood cells (anaemia), fluid retention or rash.
Uncommon adverse effects: may occur in up to 1 in 100 people
Weakness or general 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, reduced or lost sensation or feeling of numbness, especially in the skin, abnormal sensation or feeling of numbness or tingling, insomnia, depression, disorientation, nervousness, dry mouth, memory impairment, shortness of breath, nosebleeds, severe lung infection with fever, breathlessness, cough and coughing up phlegm, hair loss, itching or discolouration of the skin, impotence, chest pain, reduced platelet count increasing 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 adverse effects: may occur in up to 1 in 1,000 people
Bleeding gums, weight gain, severe chest pain (angina), heart muscle disease (symptoms include fatigue, chest pain and palpitations), enlarged heart, fluid accumulation around the heart, painful spasm of the heart's blood vessels (at rest, usually at night or early morning) (Prinzmetal's angina), movement coordination problems, difficulty speaking, dry skin, migraine, visual disturbances or double vision, tinnitus, dizziness upon standing (especially from sitting or lying down), increased need to urinate at night, pain, flu-like symptoms, somnolence, vasodilation, inflammation of the large intestine (symptoms include diarrhoea, usually containing blood and mucus, stomach pain, fever), inflammation of the stomach (symptoms include pain, nausea, vomiting), areas of altered density in the lungs, increased blood creatinine levels which may indicate kidney dysfunction.
The following adverse effects have also been reported, but their frequency is unknown:

Potentially life-threatening heart rhythm disturbances (torsade de pointes);
Hepatitis, presenting with nausea, vomiting, itching, yellowing of the skin and whites of the eyes, and changes in stool and urine colour (jaundice);
Lung inflammation (symptoms include fever, cough, difficulty breathing, wheezing; the disease may lead to lung tissue scarring) (allergic alveolitis, including interstitial lung disease, pneumonitis);
Kidney inflammation (tubulointerstitial nephritis);
Stroke (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Anagrelide Glenmark

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton following:
Expiry date (EXP) or on the bottle label following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
After first opening, use within 100 days; keep the bottle tightly closed and store in a dry place.
If the doctor advises the patient to discontinue treatment with this medicine, do not keep any unused capsules unless advised otherwise by the doctor.
Medicines must not be disposed of via the sewage system 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

What Anagrelide Glenmark contains
The active substance is anagrelid (Anagrelidum). One capsule contains 0.5 mg of anagrelid (as
anagrelid hydrochloride).
The other ingredients are:
Capsule contents: povidone (K30), crospovidone type A, anhydrous lactose, monohydrate lactose,
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 white, opaque hard gelatin capsule, size 4 (14.4 mm), containing a white or almost white fine powder.
The medicine is supplied in bottles containing 100 capsules.
Marketing Authorisation 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 further information, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]