Ticagrelor aurovitas

Package leaflet: Information for the user

Ticagrelor Aurovitas, 90 mg, film-coated tablets
Ticagrelor
Please 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Ticagrelor Aurovitas is and what it is used for
2. What you need to know before you take Ticagrelor Aurovitas
3. How to take Ticagrelor Aurovitas
4. Possible side effects
5. How to store Ticagrelor Aurovitas
6. Contents of the pack and other information

1. What Ticagrelor Aurovitas is and what it is used for

What Ticagrelor Aurovitas is
Ticagrelor Aurovitas contains the active substance ticagrelor. It belongs to a group of medicines
called antiplatelet agents.

What Ticagrelor Aurovitas is used for
Ticagrelor Aurovitas, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have had:

• a heart attack or
• unstable angina (chest pain or discomfort that is not adequately controlled).

Ticagrelor Aurovitas reduces the likelihood of having another heart attack or stroke, or of dying due to heart or blood vessel disease.

How Ticagrelor Aurovitas works
Ticagrelor Aurovitas affects blood cells called platelets (also known as thrombocytes).
Platelets are very small blood cells that help stop bleeding by clumping together and sealing small holes at the site of a cut or blood vessel injury.
However, platelets may also form clots inside diseased blood vessels in the heart and brain. This can be very dangerous because:

• a clot may completely block blood flow; this can cause a heart attack (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart; this reduces blood flow to the heart and may cause chest pain that varies in intensity (called unstable angina).

Ticagrelor Aurovitas helps prevent platelets from clumping together, reducing the risk of clot formation that could reduce blood flow.

2. Important information before using Ticagrelor Aurovitas

When not to use Ticagrelor Aurovitas:

• If the patient is allergic to ticagrelor or any of the other ingredients of Ticagrelor Aurovitas (listed in section 6).
• If the patient is currently experiencing bleeding.
• If the patient has had a stroke caused by bleeding into the brain.
• If the patient has severe liver disease.
• If the patient is taking any of the following medicines:
  • ketoconazole (used to treat fungal infections)
  • clarithromycin (used to treat bacterial infections)
  • nefazodone (an antidepressant)
  • ritonavir and atazanavir (used to treat HIV infection and AIDS)

Ticagrelor Aurovitas must not be used if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions

Talk to a doctor or pharmacist before starting Ticagrelor Aurovitas if:

• The patient has an increased risk of bleeding due to:
  • recent serious injury
  • recent surgical procedures (including dental procedures – advice should be sought from a dentist)
  • a medical condition affecting blood clotting
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps)
• The patient will undergo any surgical procedure (including dental) during treatment with Ticagrelor Aurovitas. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned procedure.
• The patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted.
• The patient has asthma or other lung diseases or breathing difficulties.
• The patient develops breathing problems such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is needed.
• The patient has any liver disorders or has previously had a condition that could have damaged the liver.
• Blood tests have shown that the patient has high levels of uric acid.

Talk to a doctor or pharmacist before using this medicine if any of the above situations apply to the patient (or if in doubt).

If the patient is taking both Ticagrelor Aurovitas and heparin:

• The doctor may need to take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform the doctor that the patient is taking both Ticagrelor Aurovitas and heparin, as Ticagrelor Aurovitas may affect the results of the diagnostic test.

Children and adolescents

Ticagrelor Aurovitas is not recommended for use in children and adolescents under 18 years of age.

Ticagrelor Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is necessary because Ticagrelor Aurovitas may affect the action of other medicines, and other medicines may affect Ticagrelor Aurovitas.

Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels)
• simvastatin or lovastatin in doses higher than 40 mg per day (medicines used to lower cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• cyclosporine (used to suppress the immune system)
• quinidine and diltiazem (used to treat heart rhythm disorders)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

Especially inform the doctor or pharmacist if the patient is taking any of the following medicines, which increase the risk of bleeding:

• "oral anticoagulants", often called "blood thinners", including warfarin.
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
• selective serotonin reuptake inhibitors (SSRIs), used as antidepressants, such as paroxetine, sertraline, and citalopram.
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticagrelor Aurovitas and the associated increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called "clot-busting medicines", such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Aurovitas is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women of childbearing potential should use an appropriate method of contraception during treatment with this medicine to avoid pregnancy.

Inform the doctor if the patient is breastfeeding. The doctor will discuss the benefits and risks of using Ticagrelor Aurovitas during breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

It is unlikely that Ticagrelor Aurovitas will affect the ability to drive or operate machinery. However, if dizziness or confusion (disorientation) occurs during treatment, caution should be exercised when driving or operating machinery.

Ticagrelor Aurovitas contains lactose monohydrate

The tablets contain lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Ticagrelor Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ticagrelor Aurovitas

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
What dose to take

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually administered in hospital.
• After the initial dose, the usual dose is one 90 mg tablet taken twice daily for up to 12 months, unless your doctor advises otherwise.
• It is recommended to take the medicine at the same time each day (e.g. one tablet in the morning and one in the evening).

Taking Ticagrelor Aurovitas with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many medicines that prevent blood clotting. Your doctor will advise you on the dose to take (usually between 75 and 150 mg per day).
How to take Ticagrelor Aurovitas

• Tablets may be taken with or without food.
• You can check when you last took a tablet by looking at the blister pack. The blister contains printed symbols showing the sun (for morning doses) and the moon (for evening doses). These symbols help patients remember when they last took their dose.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, it may be crushed and mixed with water as follows:

• Crush the tablet into a fine powder.
• Pour the powder into half a glass of water.
• Mix and drink immediately.
• To ensure the entire dose is taken, add another half glass of water, swirl and drink.

If you are being treated in hospital, the crushed tablet mixed with water may be administered via a nasogastric tube.
Taking more Ticagrelor Aurovitas than prescribed
If you take more Ticagrelor Aurovitas than prescribed, contact your doctor immediately or go to hospital. Bring the medicine packaging with you. There may be an increased risk of bleeding.
If you miss a dose of Ticagrelor Aurovitas

• If you miss a dose, take the next dose at your usual time.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Ticagrelor Aurovitas
Do not stop taking Ticagrelor Aurovitas without first talking to your doctor. Take the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Aurovitas may increase the risk of having another heart attack or stroke, or of death due to heart or blood vessel disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur during treatment with this medicine:
Ticagrelor Aurovitas affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs uncommonly, but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

• Intracranial haemorrhage (bleeding into the brain) is an uncommon adverse reaction and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arm, leg or face, especially on one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking, loss of balance or coordination
  • sudden dizziness or sudden severe headache with no known cause
• Signs of bleeding such as:
  • heavy bleeding or bleeding that is difficult to stop
  • unexpected bleeding or bleeding that lasts a long time
  • urine that is pink, red or brown in colour
  • vomiting blood or material that looks like "coffee grounds"
  • red or black, tarry stools
  • coughing up or vomiting blood clots
• Fainting
  • temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common)
• Symptoms related to a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
  • fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion

You should discuss with your doctor if the patient experiences:

• Shortness of breath (dyspnoea) – very common. This may be caused by heart disease or another condition, or may be an adverse reaction to ticagrelor. Dyspnoea associated with ticagrelor treatment is usually mild and characterised by sudden, unexpected shortness of breath, usually occurring at rest. It may appear during the first few weeks of treatment and then not occur for many weeks. If shortness of breath worsens or persists for a long time, contact your doctor. Your doctor will decide whether treatment or additional tests are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

• Increased blood uric acid levels (detected in laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or vertigo
• Diarrhoea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – symptoms of gout
• Dizziness, lightheadedness or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts (e.g. while shaving) and wounds that is heavier than usual
• Bleeding from the stomach lining (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, swelling of the face or lips/tongue may be signs of an allergic reaction
• Confusion (disorientation)
• Visual disturbances due to presence of blood in the eye
• Vaginal bleeding that is heavier than usual or occurs at a different time than regular menstrual bleeding
• Bleeding into joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which may cause dizziness or lightheadedness

Frequency not known (cannot be estimated from available data)

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ticagrelor Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
bottle, or blister pack after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must 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 Ticagrelor Aurovitas contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are:
  Tablet core: lactose monohydrate, microcrystalline cellulose (Type 101 and 102), sodium croscarmellose, hypromellose 2910, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose 2910, macrogol 4000, calcium carbonate, yellow iron oxide (E 172).

What Ticagrelor Aurovitas looks like and contents of the pack
Light yellow to yellow, round, biconvex film-coated tablets, with the imprint "90" on one side and "TL" on the other side.
Ticagrelor Aurovitas is available in blisters and HDPE bottles, packed in a cardboard carton.
Pack sizes:
Blisters: 14, 30, 56, 60, 90, 100, 168, 180, 200 film-coated tablets.
Calendar blisters: 14, 56 and 168 film-coated tablets.
HDPE bottles: 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmaceutica S.A.
Rua Joao De Deus N 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Ticagrelor AB 90 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
France: TICAGRELOR ARROW 90 mg, comprimé pelliculé
Germany: Ticagrelor PUREN 90 mg Filmtabletten
Netherlands: Ticagrelor Aurobindo 90 mg, filmomhulde tabletten
Poland: Ticagrelor Aurovitas
Portugal: Ticagrelor Generis Phar
Spain: Ticagrelor Aurovitas 90 mg comprimidos recubiertos con película EFG