ANAGRELID 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Anagrelid Nordic, 0.5 mg, tablets
3. Anagrelid Nordic, 0.75 mg, tablets
4. Anagrelid Nordic, 1 mg, tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
5. What Anagrelid Nordic is and what it is used for
6. Before you take Anagrelid Nordic
   1. When not to take Anagrelid Nordic
   2. Warnings and precautions
   3. Anagrelid Nordic with other medicines
   4. Anagrelid Nordic with food and drink
   5. Pregnancy and breast-feeding
   6. Driving and using machines
   7. Anagrelid Nordic contains lactose
7. How to take Anagrelid Nordic
   1. Adults
   2. Use in children and adolescents
   3. Patients with liver or kidney problems
   4. Method of administration
   5. If you take more Anagrelid Nordic than you should
   6. If you forget to take Anagrelid Nordic
   7. If you stop taking Anagrelid Nordic
8. Possible side effects
   1. If you experience any of the above side effects, contact your doctor immediately. Other side effects:
   2. Reporting of side effects
9. How to store Anagrelid Nordic
10. Contents of the pack and other information
    1. What Anagrelid Nordic contains
    2. What Anagrelid Nordic looks like and contents of the pack
    3. Marketing Authorisation Holder
    4. Manufacturer
    5. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
    6. AT, BG, CZ, DE, IT, PL, RO, SK:

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 all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Anagrelid Nordic is and what it is used for
• 2. Before you take 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 number of platelets (thrombocytes) in the blood in patients with essential thrombocythaemia, a condition where the body produces too many platelets. A large increase in the number of platelets in the blood can cause problems with blood circulation and blood clotting. Reducing the number of platelets reduces the risk of serious complications.

2. Before you take 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 problems;
• If you have severe liver problems;
• If you have severe kidney problems.

Warnings and precautions

Before taking Anagrelid Nordic, tell your doctor:

• If you have heart disease;
• If you have been born with or have a family history of a prolonged QT interval (a heart condition that can be seen on an electrocardiogram, a recording of the electrical activity of the heart) or if you are taking other medicines that can affect the electrocardiogram or if you have low levels of electrolytes such as potassium, magnesium or calcium (see section “Anagrelid Nordic with other medicines”);
• If you have liver or kidney problems.

If you are taking aspirin (acetylsalicylic acid) at the same time, there is an increased risk of serious bleeding (haemorrhage) (see section “Anagrelid Nordic with other medicines”).

Anagrelid Nordic with other medicines

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

• Medicines that can affect the heart rhythm, such as sotalol, amiodarone;
• Medicines used to treat heart conditions, such as milrinone, enoximone, amrinone, olprinone and cilostazol;
• Aspirin (acetylsalicylic acid), which is present in many medicines used to relieve pain and reduce fever, as well as in medicines that prevent blood clotting;
• Other medicines used to treat conditions that affect the number of platelets in the blood, such as clopidogrel;
• Fluvoxamine, used to treat depression;
• Certain types of antibiotics used to treat infections, such as enoxacin;
• Omeprazole, used to reduce the production of stomach acid;
• Theophylline, used to treat severe cases of asthma and breathing problems;
• Oral contraceptives: if you experience severe diarrhoea while taking this medicine, the effectiveness of your oral contraceptive may be reduced, and you should use an additional method of contraception (e.g. a condom). You should read the instructions in the package leaflet for your oral contraceptive.

The effect of Anagrelid Nordic or the other medicines may be affected if they are taken together. If you are in doubt, consult your doctor or pharmacist.

Anagrelid Nordic with food and drink

Food delays the absorption of Anagrelid Nordic but does not affect its efficacy. You should not drink grapefruit juice as it may prolong the time it takes for the medicine to be removed from the body.

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant, tell your doctor. Women who are pregnant should not take Anagrelid Nordic. Women of childbearing age should use effective contraception while taking Anagrelid Nordic. If you are breast-feeding or planning to breast-feed, tell your doctor. You should not take Anagrelid Nordic while breast-feeding. You should stop breast-feeding 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 told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Anagrelid Nordic

Adults

Always take this medicine exactly as your doctor has told you. Your doctor will decide the most suitable dose for you. The usual starting dose of Anagrelid Nordic is between 0.5 mg and 1 mg once daily for at least one week. After this period, your doctor may increase or decrease the number of tablets to be taken to determine the most suitable dose for you, which will provide the best effect. 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 recommended.

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 problems

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

Method of administration

Take the tablets with a sufficient amount of liquid.

If you take more Anagrelid Nordic than you should

If you have taken more Anagrelid Nordic than you should, contact your doctor or pharmacist immediately. Show them the pack of Anagrelid Nordic. High doses of the medicine may cause a decrease in blood pressure, accompanied by dizziness, nausea, vomiting and disturbances in heart rhythm.

If you forget to take Anagrelid Nordic

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

If you stop taking Anagrelid Nordic

Do not stop taking Anagrelid Nordic without consulting your doctor. After stopping treatment with Anagrelid Nordic, the number of platelets will return to pre-treatment levels within 14 days. If you have any further questions on 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 leaflet, tell your doctor or pharmacist. Serious side effects:
Uncommon (may affect up to 1 in 100 people):

• Severe disturbances in heart rhythm or rate (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 little urine or urinary retention)

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

• Severe disturbances in heart rhythm or rate (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 number of red blood cells (anaemia), 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 forceful heartbeat (palpitations), high blood pressure, nosebleeds, diarrhoea, nausea, indigestion, rash, back pain, fatigue.
Uncommon (may affect up to 1 in 100 people):
Decreased number of platelets (thrombocytopenia), bleeding, bruising, weight gain, depression, nervousness, dry mouth, migraine, conjunctivitis, visual disturbances, 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, itching, joint pain, muscle pain, cystitis, 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, gastritis (symptoms include pain, nausea, vomiting), fluid accumulation around the lungs, pneumonia, asthma, increased need to urinate at night, increased activity of liver enzymes, flu-like symptoms, chills, general feeling of being unwell.
Side effects with unknown frequency:
Irregular heart rhythm (torsades de pointes), respiratory disease causing scarring of lung tissue (symptoms include shortness of breath), interstitial nephritis.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). 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 in the outer carton 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 which is stated on the bottle, carton or blister after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 anagrelide (as anagrelide hydrochloride monohydrate)
Anagrelid Nordic, 0.75 mg:Each tablet contains 0.75 mg anagrelide (as anagrelide hydrochloride monohydrate)
Anagrelid Nordic, 1 mg:Each tablet contains 1 mg anagrelide (as anagrelide hydrochloride monohydrate)
The 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 a child-resistant closure, containing 100 tablets.
PVC/PVDC/Aluminium blisters in packs containing 100 tablets.

Marketing Authorisation Holder

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

Manufacturer

QPharma AB
Agneslundsvägen 27
21215 Malmö
Sweden

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

AT, BG, CZ, DE, IT, PL, RO, SK:

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 leaflet:2020-04-08