Ticagrelor Aurobindo

Italy
Brand name Ticagrelor Aurobindo
Form tablets, film-coated
Active substance / Dosage
TICAGRELOR
Prescription type Prescription only
ATC code
B01AC24
Registration number 052200
Manufacturer AUROBINDO PHARMA (ITALIA) S.R.L.

Table of Contents

Package leaflet: Information for the user

Ticagrelor Aurobindo 60 mg film-coated tablets, 90 mg film-coated tablets

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

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Ticagrelor Aurobindo is
Ticagrelor Aurobindo contains an active substance called ticagrelor, which belongs to a group of
medicines known as antiplatelet agents.
What Ticagrelor Aurobindo is used for
Ticagrelor Aurobindo, in combination with acetylsalicylic acid (another antiplatelet agent), is intended for use in adult patients only.
You have been prescribed this medicine because you have had:
For 60 mg:

  • a heart attack more than one year ago.

For 90 mg:

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

This medicine reduces the likelihood of having another heart attack or stroke, or of dying due to heart or blood vessel disease.
How Ticagrelor Aurobindo works
Ticagrelor Aurobindo acts on cells called 'platelets' (also known as thrombocytes). These are very small blood cells that help stop bleeding by clumping together to seal tiny holes in cut or damaged blood vessels.
However, platelets can also form clots inside diseased blood vessels of the heart and brain. This can be very dangerous because:

  • the clot may completely block the blood supply; this can cause a heart attack (myocardial infarction) or a stroke, or
  • the clot may partially block the blood vessels supplying the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (called 'unstable angina').

Ticagrelor Aurobindo helps prevent platelets from clumping together. This reduces the risk of forming a blood clot that could reduce blood flow.

2. What you need to know before taking Ticagrelor Aurobindo

Do not take Ticagrelor Aurobindo if:

  • you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
  • you have active bleeding.
  • you have had a stroke caused by bleeding in the brain.
  • you have severe liver problems.
  • you are 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 and AIDS).

Do not take Ticagrelor Aurobindo if any of the above situations apply to you. If you are unsure, consult your
doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ticagrelor Aurobindo if:

  • you have an increased risk of bleeding due to:
    • a serious recent injury
    • a recent surgical procedure (including dental surgery; consult your dentist)
    • a disease affecting blood clotting
    • recent bleeding from the stomach or intestines (e.g., due to gastric ulcer or colon “polyps”).
  • you are scheduled to have a surgical procedure (including dental surgery) at any time while taking Ticagrelor Aurobindo. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery.
  • your heart rate is unusually low (usually less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
  • you suffer from asthma or another lung condition or have breathing difficulties.
  • you develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
  • you have previously had liver problems or any illness that affected your liver.
  • you have previously had blood tests showing higher than normal levels of uric acid.

If any of the above situations apply to you (or if you are unsure), talk to your doctor or pharmacist before
taking this medicine.
If you are taking both Ticagrelor Aurobindo and heparin:

  • your doctor may request a blood sample for diagnostic testing if he or she suspects a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor Aurobindo and heparin, as Ticagrelor Aurobindo may affect the diagnostic test.

Children and adolescents
Ticagrelor Aurobindo is not recommended for children and adolescents under 18 years of age.
Other medicines and Ticagrelor Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Aurobindo can affect how some medicines work, and some medicines can affect Ticagrelor Aurobindo.
Tell your doctor or pharmacist if you are taking any of the following medicines:

  • rosuvastatin (a medicine used to treat high cholesterol)
  • more than 40 mg per day of simvastatin or lovastatin (medicines used to treat high cholesterol)
  • 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 abnormal heart rhythm)
  • beta-blockers and verapamil (used to treat high blood pressure)
  • morphine and other opioids (used to treat severe pain).

In particular, inform your doctor or pharmacist if you are taking any of the following medicines, which
increase the risk of bleeding:

  • ‘oral anticoagulants’, often referred to as ‘blood thinners’, including warfarin;
  • non-steroidal anti-inflammatory drugs (abbreviated as NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen;
  • selective serotonin reuptake inhibitors (abbreviated as SSRIs) taken 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 and AIDS), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, since you are taking Ticagrelor Aurobindo, you may have an
increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called ‘thrombolytics’, such as
streptokinase or alteplase.
Pregnancy and breastfeeding
The use of Ticagrelor Aurobindo is not recommended if you are pregnant or suspect you may be
pregnant. Women must use appropriate contraceptive methods to avoid pregnancy while taking this
medicine.
Talk to your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you
the benefits and risks of treatment with Ticagrelor Aurobindo during this period.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Ticagrelor Aurobindo will affect your ability to drive or operate machinery. If you
experience dizziness or confusion while taking Ticagrelor Aurobindo, exercise caution when driving or
operating machinery.
Ticagrelor Aurobindo contains lactose monohydrate
The tablets contain lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain
sugars, contact him or her before taking this medicine.
Ticagrelor Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Ticagrelor Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
How much to take
For 60 mg:

  • The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Aurobindo for the entire duration prescribed by your doctor.
  • Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

For 90 mg:

  • The initial dose is two tablets taken at once (loading dose of 180 mg). This dose is normally administered in a hospital setting.
  • After this initial dose, the usual dose is one 90 mg tablet twice daily for up to 12 months, unless your doctor tells you otherwise. Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Ticagrelor Aurobindo with other blood-thinning medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75 and 150 mg per day).
How to take Ticagrelor Aurobindo

  • You may take the tablet with or without food.
  • You can keep track of when you took your last Ticagrelor Aurobindo tablet by looking at the blister pack. There is a sun symbol (for morning) and a moon symbol (for evening) to help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

  • Crush the tablet into a fine powder.
  • Pour the powder into half a glass of water.
  • Stir and drink immediately.
  • To ensure no medicine is left behind, rinse the empty glass with another half glass of water and drink it.

If you are in hospital, the tablet may be given to you crushed and mixed with a small amount of water and administered through a tube inserted through the nose (nasogastric tube).
If you take more Ticagrelor Aurobindo than you should
If you have taken more Ticagrelor Aurobindo than you should have, contact your doctor or go to hospital immediately. Take the medicine pack with you. You may be at increased risk of bleeding.
If you forget to take Ticagrelor Aurobindo

  • If you forget to take 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 the missed dose.

If you stop taking Ticagrelor Aurobindo
Do not stop taking Ticagrelor Aurobindo without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Aurobindo may increase your risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel disease.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with this medicine:
Ticagrelor Aurobindo affects blood clotting, therefore many side effects are related to bleeding. Bleeding can occur in any part of the body. Some bleedings are common (such as bruising and nosebleeds). Serious bleeding is uncommon in frequency but can be life-threatening.
Contact a doctor immediately if you notice any of the following symptoms – you may need urgent medical treatment:

  • Bleeding in the brain or inside the skull is an uncommon side effect and may cause signs of stroke such as:
    • sudden numbness or weakness of arms, legs or face, especially on one side of the body
    • sudden confusion, difficulty speaking or understanding others
    • sudden difficulty walking or loss of balance or coordination
    • sudden dizziness or sudden and severe headache with no known cause.
  • Signs of bleeding such as:
    • severe bleeding or bleeding that cannot be controlled
    • unexpected bleeding or bleeding that lasts a long time
    • pink, red or brown urine
    • vomit that is red or looks like coffee grounds
    • red or black stools (resembling tar)
    • coughing up or vomiting blood clots.
  • Fainting (syncope)
    • temporary loss of consciousness due to a sudden drop in blood flow to the brain (common).
  • Signs of 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 tiredness or confusion.

Contact your doctor if you notice any of the following symptoms:

  • Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it may represent a side effect of Ticagrelor Aurobindo. Shortness of breath related to Ticagrelor Aurobindo is generally mild and characterized by a sudden, unexpected need for air, which usually occurs at rest and may appear during the first weeks of therapy; for many people it may disappear over time. If your shortness of breath worsens or persists, inform your doctor. Your doctor will decide whether treatment is needed or further investigations should be carried out.

Other possible side effects
Very common (may affect more than 1 in 10 people)

  • High concentration of uric acid in the blood (as shown by laboratory tests)
  • Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

  • Bruising
  • Headache
  • Feeling dizzy or as if the room is spinning
  • Diarrhoea or indigestion
  • Feeling sick (nausea)
  • Constipation
  • Rash
  • Itching
  • Severe pain and swelling in joints – these are signs of gout
  • Feeling dizzy or confused, or blurred vision – these are signs of low blood pressure
  • Nosebleed
  • Bleeding after surgery or cuts (e.g. during shaving) and wounds, more than normal
  • Bleeding from the stomach lining (ulcer)
  • Bleeding gums

Uncommon (may affect up to 1 in 100 people)

  • Allergic reaction – rash, itching, or swelling of the face or lips/tongue, which may be signs of an allergic reaction
  • Confusion
  • Visual disturbances caused by bleeding in the eyes
  • Heavier vaginal bleeding or bleeding occurring at different times than normal menstrual bleeding
  • Bleeding into joints and muscles which may cause painful swelling
  • Blood in the ears
  • Internal bleeding, which may cause dizziness or mental confusion

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ticagrelor Aurobindo contains

  • The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
  • The other components are: Tablet core: Lactose monohydrate, microcrystalline cellulose (grade 101 and grade 102), croscarmellose sodium, hypromellose 2910, anhydrous colloidal silica, magnesium stearate. Tablet coating: Hypromellose 2910, macrogol 4000, calcium carbonate, iron oxide red (for the 60 mg strength), iron oxide yellow (for the 90 mg strength).

Description of the appearance of Ticagrelor Aurobindo and package contents
Ticagrelor Aurobindo 60 mg film-coated tablets
Biconvex, round, film-coated tablets, pale pink to pink in colour, marked with "60" on one side and "TL" on the other side.
Ticagrelor Aurobindo 90 mg film-coated tablets
Biconvex, round, film-coated tablets, pale yellow to yellow in colour, marked with "90" on one side and "TL" on the other side.
Ticagrelor Aurobindo is available in blisters containing 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Ticagrelor Aurobindo
Portugal: Ticagrelor Aurobindo