Anagrelide Glenmark 0.5 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Anagrelide Glenmark 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 must not pass it on 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 these adverse effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Anagrelide Glenmark is and what it is used for
2. What you need to know 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 Anagrelide Glenmark is and what it is used for

Anagrelide Glenmark contains the active substance anagrelide. Anagrelide Glenmark 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 that occurs when 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 Glenmark

Do not take Anagrelide Glenmark

• if you are allergic to anagrelide or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may present as 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 starting to take Anagrelide Glenmark:

• if you have or think you may 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, e.g., potassium, magnesium, or calcium (see section “Taking Anagrelide Glenmark with other medicines”);

• if you have liver or kidney problems.

When used in combination with acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as aspirin), there is an increased risk of major bleeding (see section “Taking Anagrelide Glenmark with other medicines”).

While being treated with Anagrelide Glenmark, you must take the exact 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 difficulty walking, dizziness, loss of balance, or lack of coordination; or sudden severe headache with no 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

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

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

• medicines that may affect 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 found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as aspirin);
• other medicines used to treat conditions affecting blood platelets, such as clopidogrel;
• omeprazole, used to reduce stomach acid production;
• oral contraceptives: if you experience severe diarrhea while taking this medicine, the effectiveness of the oral contraceptive may decrease, and you are advised to use an additional contraceptive method (e.g., condom). Please refer to the instructions in the leaflet of the oral contraceptive you are taking.

If taken together, either Anagrelide Glenmark or these other 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 Glenmark. Women of childbearing potential should ensure they use effective contraception while taking Anagrelide Glenmark. Consult your doctor for advice on contraception.

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

Driving and use of machines

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

Anagrelide Glenmark contains lactose

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

3. How to take Anagrelide Glenmark

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 Glenmark taken by different patients may vary, as it depends on the condition being treated. Your doctor will prescribe the most appropriate dose for your case.

The usual starting dose of Anagrelide Glenmark is 1 mg. This dose consists of one 0.5 mg capsule taken 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 the dose best suited to your condition and most effective for treating your illness is established.

The capsules should be swallowed whole with a glass of water. Do not crush the capsules or dissolve the contents in 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 first informing your doctor. You should not stop taking this medicine suddenly on your own.

Your doctor will advise you to have regular blood tests to monitor whether the medicine is effective and to check that your liver and kidneys are functioning properly.

If you take more Anagrelide Glenmark than you should

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

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

If you forget to take Anagrelide Glenmark

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

4. Possible adverse effects

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

Serious adverse effects:

Uncommon: Heart failure (signs include shortness of breath, chest pain, swelling of 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 which may cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (signs include shortness of breath, swelling of legs or ankles, and bluish discoloration of lips and skin).

Rare: Kidney failure (when urinating little or not at all), heart attack.

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

Very common adverse effects: may affect more than 1 in 10 patients

Headache.

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

Dizziness, tiredness, fast 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 adverse 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 (oedema), weight loss, muscle pain, joint pain, back pain, loss or reduced sensation or sensation of numbness (especially in the skin), sensitivity or abnormal sensation such as 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 phlegm, hair loss, skin itching, changes in skin colour, impotence, chest pain, decreased platelet count in the blood which increases the risk of bleeding or bruising (thrombocytopenia), fluid accumulation in the lungs or increased liver enzymes. Your doctor may carry out blood tests which could indicate increased liver enzymes.

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

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 (usually at rest, typically 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 getting 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 (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 creatinine levels in blood tests which may indicate kidney problems.

The following adverse effects have been reported, although the exact frequency is unknown:

• potentially life-threatening irregular heartbeat (torsade de pointes)
• liver inflammation, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, abnormal colouration 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)
• kidney inflammation (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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagrelide Glenmark

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

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

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

If your doctor discontinues treatment, do not keep any leftover capsules unless your doctor instructs you otherwise. Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, 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 Glenmark

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

The other components are:

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

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

Nature of the product and contents of the container

Anagrelide Glenmark is presented as opaque white hard capsules, size No. 4 (14.4 mm), containing white or almost white powder. The capsules are supplied in bottles of 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturers:

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) 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 the latest revision of this product information: September 2022.

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