Package Insert:patient information

Xagrid 0.5mg hard capsules

Anagrelida

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone,and you should not give it to others even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Xagrid contains the active ingredient, anagrelida. Xagrid is a medication that interferes with platelet development. It reduces the number of platelets produced by the bone marrow, resulting in a decrease in the platelet count in the blood that approaches a more normal level. For this reason, it is used to treat patients with essential thrombocytosis.

Essential thrombocytosis 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 severe circulation and blood coagulation problems.

Do not take Xagrid

• if you are allergic to anagrelide or any of the other components of this medication (listed in section6). Allergic reactions may manifest as a 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

Consult your doctor before starting to take Xagrid:

• if you have or may have a heart problem;
• if you were born with a prolonged QT interval or have a family history of a prolonged QT interval (observed on an ECG, heart electrical recording) or if you are taking other medications 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 Xagrid withother medications”);
• if you have liver or kidney problems.
• In combination with acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as aspirin), there is a greater risk of presenting major bleeding (hemorrhage) (see section “Taking Xagrid with other medications”).

Children and adolescents

• The information on the use of Xagrid in children and adolescents is limited, and therefore,this medication should be used with caution.

Other medicationsand Xagrid

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.

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

• Fluvoxamine, usedto treat depression;
• Certain types of antibiotics, such as enoxacine, used to treat infections;
• Theophylline, used to treat asthma and severe respiratory problems;
• Medications to treat heart conditions such as, for example, milrinone, enoximone, amrinone, olprinone, and cilostazol;
• Acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting, also known as aspirin);
• Other medications to treat conditions that affect platelets in the blood such as, for example, clopidogrel;
• Omeprazole, used to reduce the amount of acid produced in the stomach;
• Oral contraceptives. If you experience intense diarrhea while taking this medication, it may reduce the effectiveness of the oral contraceptive and it is recommended to use an additional contraceptive method (e.g., condom). Consult the instructions that appear in the prospectus of the oral contraceptive you are taking.

If used together, either Xagrid or these medications may not work correctly.

Consult your doctor or pharmacist if you have doubts.

Pregnancy and breastfeeding

Consult your doctor if you are pregnant or plan to become pregnant. If you are pregnant, do not take Xagrid. Women with the possibility of becoming pregnant should ensure they take effective contraceptive measures while taking Xagrid. Consult your doctor if you need advice on contraceptives.

Consult your doctor if you are breastfeeding or plan to breastfeed. You cannot take Xagrid while breastfeeding. If you are taking Xagrid, you should stop breastfeeding.

Driving and operating machinery

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

Xagrid contains lactose

Lactose is a component of this medication. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Xagrid as indicated by your doctor.If in doubt, consult your doctor or pharmacist again..

The amount of Xagrid 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 usual initial dose of Xagrid is 1mg. This dose is taken with a 0.5mg 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 to find the dose that best suits your case and effectively treats the condition.

The capsules should be swallowed whole with a glass of water.Do not crush 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) at the same time every day.

Do not take more capsules than your doctor has recommended.

Your doctor will instruct you to undergo regular blood tests to check if the medication is effective and if your liver and kidneys are functioning properly.

If you take more Xagrid than you should

If you take more Xagrid than you should or if someone else has taken this medication, inform your doctor or pharmacist immediately. You will need to show them the Xagrid packaging.

If you forgot to take Xagrid

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 missed doses.

Like all medicines, Xagrid can cause side effects, although not everyone will experience them. If you are concerned about this, consult your doctor.

Severe side effects:

Rare: heart failure (symptoms include shortness of breath, chest pain, swelling of the legs due to fluid accumulation), severe problem with heart rate or rhythm (ventricular tachycardia, supraventricular tachycardia, or atrial fibrillation), pancreatitis that causes intense back and abdominal pain, vomiting with blood or dark or bloody stools, severe decrease in the number of red blood cells that can cause weakness, petechiae, bleeding, or infections (pancytopenia), pulmonary hypertension (symptoms include shortness of breath, leg or ankle swelling, and blue discoloration of the lips and skin).

Uncommon: kidney failure (when little or no urine is produced), heart attack.

If you observe any of these side effects, contact your doctor immediatelyimmediately.

Very common side effects: can affect more than 1 in 10 patients

Headache.

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

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

Rare side effects:can 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, petechiae, bleeding, swelling (edema), weight loss, muscle pain, joint pain, back pain, loss or decrease of sensation or numbness (especially in the skin), abnormal sensitivity or numbness, insomnia, depression, confusion, nervousness, dry mouth, memory loss, feeling of lack of air, nasal bleeding, severe lung infection with fever, shortness of breath, cough, or phlegm, hair loss, skin itching, skin color changes, impotence, chest pain, decrease in the number of platelets in the blood that increases the risk of bleeding or petechiae (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:can affect up to 1 in 1,000 patients

Bleeding gums, weight gain, intense chest pain (angina pectoris), cardiomyopathy (symptoms include fatigue, chest pain, and palpitations), heart enlargement, fluid accumulation in the heart,painful spasms of the coronary arteries (while resting, usually at night or 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 (especiallywhen standing up after sitting or lying down),increased need to urinate at night, pain, "pseudogripal" symptoms, drowsiness, vasodilation, inflammation of the large intestine (symptoms include diarrhea, usually with blood or mucus, stomach pain, fever), inflammation of the stomach (symptoms include pain, nausea, vomiting), abnormal density area in the lungs, increase in creatinine levels in blood tests that may indicate kidney problems.

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

• Potentially fatal irregular heartbeat (torsade de pointes);
• Liver inflammation, symptoms include nausea, vomiting, itching, yellow discoloration of the skin and eyes, abnormal coloration of stools and urine (hepatitis);
• Pulmonary inflammation (symptoms include fever, cough, difficulty breathing, or wheezing; this causes pulmonary fibrosis) (allergic alveolitis that includes interstitial lung disease and pneumonitis);
• Kidney inflammation (tubulointerstitial nephritis).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,evenif it is apossibleside effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theApéndiceV.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label of the bottle or box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

If your doctor interrupts treatment, do not store any remaining capsules unless the doctor instructs you otherwise.Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications thatyouno longer need. This will help protect the environment.

Composition of Xagrid

The active ingredient is anagrelida. Each capsule contains 0.5 mg of anagrelida (as anagrelida hydrochloride).

The other components are:

Capule content: povidone (E1201), crospovidone, anhydrous lactose, monohydrate lactose, microcrystalline cellulose (E460) and magnesium stearate.

Capsule coating: gelatin and titanium dioxide (E171).

Printing ink: shellac, strong ammonia solution, potassium hydroxide (E525), iron oxide black (E172).

Appearance of the product and contents of the packaging

Xagrid is presented in the form of hard, opaque white capsules with the inscription 'S 063' printed on them. The capsules are presented in bottles of 100 hard capsules. The bottle also contains a small sealed container with a desiccant to keep the capsules dry. Keep this sealed container inside the bottle. Do not remove or consume the desiccant.

Last revision date of this leaflet:

The detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicines