Prospecto:Information for the Patient

Anagrelida Teva 0.5 mg Hard Capsules EFG

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctoror pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Anagrelida Teva

3.How to take Anagrelida Teva

4.Possible adverse effects

5.Storage of Anagrelida Teva

6.Contents of the package and additional information

Anagrelida Teva contains the active ingredient, anagrelida. Anagrelida Teva 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 Anagrelida Teva

• 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 Teva:

• 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 Teva with other medicines”),
• if you have liver or kidney problems.

There is a greater risk of major bleeding (bleeding) when taking Anagrelida Teva with acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting) (see section “Taking Anagrelida Teva with other medicines”).

While taking Anagrelida Teva, 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 known cause. Please consult your doctor immediately.

Children and adolescents

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

Taking Anagrelida Teva 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 found 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). See the indications in the prospectus of the oral contraceptive you are taking.

If used together, either Anagrelida Teva 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 Teva. Women who may become pregnant should ensure they take effective contraceptive measures while taking Anagrelida Teva. Consult your doctor if you need advice on contraceptives.

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

Driving and operating machines

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

Anagrelida Teva 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 Teva 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 Teva 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 until finding the dose that best suits your case and effectively treats the condition.

Do not crush the capsules or dissolve the content in a liquid. You can take the capsules with food, after meals, or with 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 Teva than you should

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

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 Teva

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

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

Feeling weak or unwell, high blood pressure, 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 sensation like tingling and 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 platelet count in the blood that increases the risk of bleeding or petechiae (thrombocytopenia), fluid accumulation in the lungs, or 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), 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, 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 the stool and urine (hepatitis),
• Lung inflammation (signs include fever, cough, difficulty breathing, or wheezing; this causes pulmonary fibrosis) (allergic alveolitis that includes 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 down the drain or in the trash. Dispose of the containers and

medicines you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacisthow to disposeofthecontainers and of themedicines that you no longerneed. This way, you will help protect the environment.

Composition of Anagrelida Teva

• 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 Teva contains lactose and sodium”).

Capsule coating: gelatin and titanium dioxide (E171).

Appearance of the product and contents of the package

Anagrelida Teva 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 package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Local representative:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

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

or

Actavis Italy S.p.A.

Via Pasteur 10

Nerviano

20014 Milan

Italy

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

AustriaAnagrelid ratiopharm 0.5 mg capsules

Czech RepublicAnagrelide Teva

DenmarkAnagrelid Teva

GreeceAnagrelide/Teva 0.5 mghardcapsules

SpainAnagrelida Teva 0.5 mg hard capsules EFG

FinlandAnagrelide ratiopharm 0.5 mg capsule, hard

FranceAnagrelide Teva 0.5 mggeltab

ItalyAnagrelide Teva

LithuaniaAnagrelide Teva 0.5 mg hard capsules

LatviaAnagrelide Teva 0.5 mg hard capsules

NetherlandsAnagrelide Teva 0.5 mg, hard capsules

PortugalAnagrelida Teva

RomaniaANAGRELIDA TEVA 0.5 mg capsule

SloveniaAnagrelid Teva 0.5 mg hard capsules

Last review date of thisleaflet: November 2022

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