Package Insert:Information for the Patient

Anagrelida ratiopharm 0.5 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication,because 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 only for you, and you should not give it to others even if they have the same symptoms as 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.

1.What is Anagrelida ratiopharm and what is it used for

2.What you need to know before starting to take Anagrelida ratiopharm

3.How to take Anagrelida ratiopharm

4.Possible adverse effects

5.Storage of Anagrelida ratiopharm

6.Contents of the package and additional information

Anagrelida ratiopharm contains the active ingredient, anagrelida. Anagrelida ratiopharm is a medication that interferes with the development of platelets. 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 Anagrelida ratiopharm

• if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may manifest 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

Consult your doctor before starting to take Anagrelida ratiopharm:

• 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 a prolonged QT interval (observed on an ECG, heart electrical recording) 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 Anagrelida ratiopharm 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 reduce fever, as well as to prevent blood clotting), there is a greater risk of major bleeding (bleeding) (see section “Taking Anagrelida ratiopharm with other medicines”).

While taking Anagrelida ratiopharm, you must take the exact dose prescribed by your doctor. Do not stop taking the medicine without first informing your doctor. Do not stop taking this medicine suddenly without consulting your doctor. Sudden withdrawal of the medicine may increase the risk of stroke.

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

Children and adolescents

The information on the use of Anagrelida ratiopharm in children and adolescents is limited, and therefore this medicine should be used with caution.

Taking Anagrelida ratiopharm with other medicines

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

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

• medicines that can alter 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 severe respiratory problems,
• medicines to treat heart conditions, such as, for example, milrinone, enoximone, amrinone, olprinone, and cilostazol,
• acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• other medicines 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 medicine, it may reduce the effect of the oral contraceptive and you are 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 Anagrelida ratiopharm or these medicines may not work correctly.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

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

Consult your doctor if you are breastfeeding or plan to breastfeed. You cannot take Anagrelida ratiopharm while breastfeeding. If you are taking Anagrelida ratiopharmyou must stop breastfeeding.

Driving and operating machines

Some patients taking Anagrelida ratiopharm have reported symptoms of dizziness.Do not drive or operate machines if you feel dizzy.

Anagrelida ratiopharm contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; this is essentially “sodium-free”.

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

The amount of Anagrelida ratiopharm 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 Anagrelida ratiopharm is 1 mg. This dose is taken with a 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 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 or fewer capsules than recommended by your doctor. Do not stop taking the medication without first informing your doctor. You should not stop taking this medication abruptly on your own.

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 Anagrelida ratiopharm than you should

If you take more Anagrelida ratiopharm than you should or if someone else has taken this medication, inform your doctor or pharmacist immediately. immediately You should show them the packaging of Anagrelida ratiopharm.

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

If you forgot to take Anagrelida ratiopharm

Take the capsules as soon as you remember. Take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

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

Severe side effects:

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

Rare:: Kidney failure (when little or no urine is produced), heart attack.

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

Frequent 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, decreased red blood cell count (anemia), fluid retention, or rash.

Infrequent side effects: can affect up to 1 in 100 patients

Feeling weak or unwell, hypertension, irregular heartbeat, dizziness, 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, decreased platelet count in the blood that increases the risk of bleeding or petechiae (thrombocytopenia), fluid accumulation in the lungs, or increased liver enzymes. Your doctor may perform blood tests that may indicate increased liver enzymes.

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

Bleeding gums, weight gain, intense chest pain (angina pectoris), heart muscle disease (signs 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 (especially when standing after sitting or lying down), increased need to urinate at night, pain, "pseudogripal" symptoms, drowsiness, vasodilation, inflammation of the large intestine (signs include diarrhea, usually with blood or mucus, stomach pain, fever), inflammation of the stomach (signs include pain, nausea, vomiting), abnormal density area in the lungs, increased 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 skin and eyes, abnormal color of stools and urine (hepatitis),
• Lung inflammation (signs include fever, cough, difficulty breathing, or wheezing; this causes pulmonary fibrosis) (allergic alveolitis including interstitial lung disease and pneumonitis),
• Kidney inflammation (tubulointerstitial nephritis),
• Stroke (see section 2 "Warnings and precautions").

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C)

Store in the original packaging to protect it from light and moisture.

If your doctor interrupts treatment, do not store any remaining capsules unless the doctor instructs you otherwise.Themedicines should not be thrown away through the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacisthow to disposeofthecontainers and medicines that you no longerneed. This will help protect the environment.

Composition of Anagrelida ratiopharm

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

The other componentsare:

Capule content: lactose monohydrate, croscarmellose sodium, povidone K 29/32, lactose, microcrystalline cellulose, and magnesium stearate (see section 2, “Anagrelida ratiopharm contains lactose and sodium”).

Capsule coating: gelatin and titanium dioxide (E171).

Appearance of the product and content of the container

Anagrelida ratiopharm is presented in the form of hard, opaque white capsules with an approximate length of 14.3 mm. The capsules are presented in bottles of 42 and 100 hard capsules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Synthon Hispania, S.L.

C/ Castelló, nº1, Pol. Las Salinas,

08830 Sant Boi de Llobregat, Barcelona (Spain)

or

Synthon B.V.

Microweg 22

6545CM Nijmegen

Netherlands

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

GermanyAnagrelid AbZ 0.5 mg Hard Capsules

SpainAnagrelida ratiopharm 0.5 mg hard capsules EFG

United KingdomAnagrelide 0.5 mg hard capsules

Last review date of thisleaflet:July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)