Anagrelid Nordic

Package Leaflet: Information for the User

Anagrelid Nordic, 0.5 mg, tablets

Anagrelid Nordic, 0.75 mg, tablets

Anagrelid Nordic, 1 mg, tablets

Anagrelid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What Anagrelid Nordic is and what it is used for
• 2. Important information before taking Anagrelid Nordic
• 3. How to take Anagrelid Nordic
• 4. Possible side effects
• 5. How to store Anagrelid Nordic
• 6. Contents of the pack and other information

1. What Anagrelid Nordic is and what it is used for

Anagrelid Nordic is used to reduce the increased number of platelets (thrombocytes) in patients with essential thrombocythemia, which occurs when the body produces too many blood platelets. A large increase in the number of blood platelets can cause problems with blood circulation (circulatory disorders) and blood clotting. Reducing the number of platelets reduces the risk of serious complications.

2. Important information before taking Anagrelid Nordic

When not to take Anagrelid Nordic

• If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6);
• If you have severe heart disorders;
• If you have severe liver disorders;
• If you have severe kidney disorders.

Warnings and precautions

Before starting treatment with Anagrelid Nordic, consult your doctor:

• If you have heart disease;
• If you have a congenital or family history of QT interval prolongation (a heart disease visible on an ECG, a record of the heart's electrical activity) or if you are taking other medicines that affect the ECG or if you have low levels of electrolytes such as potassium, magnesium, or calcium (see "Anagrelid Nordic and other medicines");
• If you have liver or kidney problems.

When taking Anagrelid Nordic with acetylsalicylic acid (a substance also known as aspirin, found in many pain-relieving and fever-reducing medicines, as well as in medicines that prevent blood clotting), there is an increased risk of serious bleeding (see "Anagrelid Nordic and other medicines").

Anagrelid Nordic and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Inform your doctor if you are taking any of the following medicines:

• Medicines that can change the heart rhythm, such as sotalol, amiodarone;
• Medicines used to treat heart diseases, such as milrinone, enoximone, amrinone, olprinone, and cilostazol;
• Acetylsalicylic acid (a substance also known as aspirin, found in many pain-relieving and fever-reducing medicines, as well as in medicines that prevent blood clotting);
• Other medicines used to treat diseases that affect the number of blood platelets, such as clopidogrel;
• Fluvoxamine, used to treat depression;
• Certain types of antibiotics used to treat infections, such as enoxacin;
• Omeprazole, used to reduce stomach acid production;
• Theophylline, used to treat severe asthma and breathing problems;
• Oral contraceptives: the occurrence of severe diarrhea while taking this medicine may reduce the effectiveness of the oral contraceptive, and therefore, an additional contraceptive method (e.g., condom) is recommended. You should read the recommendations in the patient information leaflet that comes with the oral contraceptive pill.

The effect of Anagrelid Nordic or the mentioned medicines may be impaired if taken together. If in doubt, consult your doctor or pharmacist.

Anagrelid Nordic with food and drink

Food delays the absorption of Anagrelid Nordic, but does not significantly affect its potency. You should not drink grapefruit juice, as it may prolong the elimination of the medicine from the body.

Pregnancy and breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor. Pregnant women should not take Anagrelid Nordic. Women of childbearing age should use effective contraception while taking Anagrelid Nordic. If you are breastfeeding or plan to breastfeed, inform your doctor. You should not take Anagrelid Nordic while breastfeeding. You should stop breastfeeding if you take Anagrelid Nordic.

Driving and using machines

Some patients taking Anagrelid Nordic have experienced dizziness. If you experience dizziness, do not drive or operate machinery.

Anagrelid Nordic contains lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Anagrelid Nordic

Adults

This medicine should always be taken exactly as your doctor has instructed. Your doctor will determine the most suitable dose for you. The usual initial dose of Anagrelid Nordic is 0.5 mg to 1 mg once daily for at least one week. After this period, your doctor may increase or decrease the number of tablets to determine the most suitable dose for you, which will provide the most effective treatment. The maximum dose is 5 mg per day. The tablet can be divided into equal doses. Do not take more tablets than your doctor has prescribed.

Use in children and adolescents

Since experience with Anagrelid Nordic in children and adolescents is limited, this medicine should not be used in children and adolescents under 18 years of age.

Patients with liver or kidney disorders

If you have liver or kidney disease, your doctor will decide whether you can be treated with Anagrelid Nordic.

Method of administration

Anagrelid Nordic tablets should be taken with a sufficient amount of liquid.

Overdose of Anagrelid Nordic

If you have taken more Anagrelid Nordic than prescribed or if someone else has taken your medicine, immediately inform your doctor or pharmacist. You should show the packaging of Anagrelid Nordic. High doses of the medicine can lead to a decrease in blood pressure, accompanied by dizziness, nausea, and heart rhythm disorders.

Missed dose of Anagrelid Nordic

You should take the tablet as soon as you remember. The next dose should be taken at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Anagrelid Nordic

Do not stop taking Anagrelid Nordic without consulting your doctor. After stopping treatment with Anagrelid Nordic, the platelet count will return to pre-treatment values within 14 days. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Anagrelid Nordic can cause side effects, although not everybody gets them. If you experience any serious side effects or any side effects not listed in this package leaflet, inform your doctor or pharmacist. Serious side effects:
Uncommon (may affect up to 1 in 100 people):

• Severe heart rhythm disorders (ventricular tachycardia, supraventricular tachycardia)
• Heart failure (symptoms include shortness of breath, chest pain, swelling of the lower limbs due to fluid accumulation)
• Kidney failure (passing very small amounts of urine or urinary retention)

Rare (may affect up to 1 in 1,000 people):

• Severe heart rhythm disorders (atrial fibrillation)
• Myocardial infarction (symptoms include severe chest pain and shortness of breath).

If you experience any of the above side effects, contact your doctor immediately. Other side effects:

Very common (may affect more than 1 in 10 people):
Headache.
Common (may affect up to 1 in 10 people):
Decreased red blood cell count (anemia), bleeding under the skin, swelling, dizziness of inner ear origin, insomnia, abnormal sensations or feelings, such as tingling or "pins and needles", rapid heartbeat, irregular or strong heartbeats (palpitations), high blood pressure, nosebleeds, diarrhea, nausea, indigestion, rash, back pain, fatigue.
Uncommon (may affect up to 1 in 100 people):
Decreased platelet count (thrombocytopenia), bleeding, bruising, weight gain, depression, nervousness, dry mouth, migraine, conjunctivitis, vision disorders, ringing in the ears (tinnitus), fainting, shortness of breath or difficulty breathing, pneumonia, increased blood pressure in the lungs, causing symptoms such as shortness of breath, fatigue, chest pain, or swelling, vomiting, flatulence, stomach pain, constipation, hair loss, skin itching, joint pain, muscle pain, urinary tract infection, pain, weakness.
Rare (may affect up to 1 in 1,000 people):
Severe chest pain (angina pectoris), dizziness when standing up (especially from a sitting or lying position), loss of appetite, stomach inflammation (symptoms include pain, nausea, vomiting), fluid accumulation around the lungs, pneumonia, asthma, increased need to urinate at night, increased liver enzyme activity, flu-like symptoms, chills, general feeling of being unwell.
Side effects with unknown frequency:
Irregular heartbeat (torsades de pointes), respiratory disease causing scarring in lung tissue (symptoms include shortness of breath), kidney inflammation (interstitial nephritis).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. You can also report side effects directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anagrelid Nordic

Store the blister pack in the outer packaging to protect from light. Store the bottle tightly closed to protect from light. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the bottle, carton, or blister after "EXP". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Anagrelid Nordic contains

The active substance is anagrelide.
Anagrelid Nordic, 0.5 mg:Each tablet contains 0.5 mg of anagrelide (as anagrelide hydrochloride monohydrate)
Anagrelid Nordic, 0.75 mg:Each tablet contains 0.75 mg of anagrelide (as anagrelide hydrochloride monohydrate)
Anagrelid Nordic, 1 mg:Each tablet contains 1 mg of anagrelide (as anagrelide hydrochloride monohydrate)
Other ingredients are: lactose anhydrous, povidone (K30), crospovidone (type B), microcrystalline cellulose, and magnesium stearate.

What Anagrelid Nordic looks like and contents of the pack

Anagrelid Nordic, 0.5 mg, are white to almost white, round tablets, approximately 6.5 mm in diameter, with "0.5" engraved on one side and a score line on the other side.
Anagrelid Nordic, 0.75 mg, are white to almost white, round tablets, approximately 8 mm in diameter, with "0.75" engraved on one side and a score line on the other side.
Anagrelid Nordic, 1 mg, are white to almost white, round tablets, approximately 9 mm in diameter, with "1.0" engraved on one side and a score line on the other side.
The tablets can be divided into equal doses.
Polyethylene bottles with child-resistant closures, containing 100 tablets.
PVC/PVDC/Aluminum blisters in packs containing 100 tablets.

Marketing authorization holder

Nordic Group B.V.
Siriusdreef 41
2132 WT Hoofddorp
Netherlands

Manufacturer:

QPharma AB
Agneslundsvägen 27
21215 Malmö
Sweden

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:
Anagrelid Nordic 0.5 mg Tabletten
Anagrelid Nordic 0.75 mg Tabletten
Anagrelid Nordic 1 mg Tabletten
Bulgaria:
Anagrelid Nordic 0.5 mg tablets
Анагрелид Нордик 0.5 mg, таблетки
Anagrelid Nordic 0.75 mg tablets
Анагрелид Нордик 0.75 mg, таблетки
Anagrelid Nordic 1 mg tablets
Анагрелид Нордик 1 mg, таблетки
Italy:
REDESK
Czech Republic:
Anagrelid Nordic
Poland:
Anagrelid Nordic
Romania:
Anagrelidă Nordic 0.5 mg, comprimate
Anagrelidă Nordic 0.75 mg, comprimate
Anagrelidă Nordic 1.0 mg, comprimate
Slovakia:
Anagrelid Nordic 0.5 mg tablets
Anagrelid Nordic 0.75 mg tablets
Anagrelid Nordic 1.0 mg tablets
Date of last revision of the package leaflet:2020-04-08