Ticagrelor Sandoz: detailed information

Patient Information Leaflet

Ticagrelor Sandoz 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, as 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 they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ticagrelor Sandoz is and what it is used for
What you need to know before taking Ticagrelor Sandoz
How to take Ticagrelor Sandoz
Possible side effects
How to store Ticagrelor Sandoz
Contents of the pack and other information

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

What Ticagrelor Sandoz is
Ticagrelor Sandoz contains an active substance called ticagrelor, which belongs to a group of
medicines known as platelet aggregation inhibitors.
What Ticagrelor Sandoz is used for
Ticagrelor Sandoz 60 mg film-coated tablets
Ticagrelor Sandoz, in combination with acetylsalicylic acid (another platelet aggregation inhibitor), is intended for use only in adult patients. You have been prescribed this medicine because you have had:

a heart attack more than one year ago. This medicine reduces the likelihood that you will suffer another heart attack or stroke, or die from heart disease or blood vessel-related conditions.

Ticagrelor Sandoz 90 mg film-coated tablets
Ticagrelor Sandoz, in combination with acetylsalicylic acid (another platelet aggregation inhibitor), is intended for use only in adult patients. You have been prescribed this medicine because you have had:

a heart attack, or
unstable angina (angina or chest pain that is not well controlled). This medicine reduces the likelihood that you will suffer another heart attack or stroke, or die from heart disease or blood vessel-related conditions.

How Ticagrelor Sandoz works
Ticagrelor Sandoz 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 blood vessels supplying the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (known as 'unstable angina').

Ticagrelor Sandoz helps prevent platelet aggregation. This reduces the likelihood of blood clot formation, which could impair blood flow.

2. What you need to know before taking Ticagrelor Sandoz

Do not take Ticagrelor Sandoz:

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

you have an increased risk of bleeding due to:
- a serious recent injury
- recent surgery (including dental procedures; please consult your dentist)
- a blood clotting disorder
- recent bleeding from the stomach or intestines (e.g., due to gastric ulcer or colon "polyps")
you are scheduled to undergo surgery (including dental procedures) at any time while taking Ticagrelor Sandoz. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before the surgery.
your heart rate is unusually slow (typically less than 60 beats per minute) and you do not already have a heart rhythm-regulating device implanted (pacemaker).
you suffer from asthma or another lung condition or have breathing difficulties.
you develop irregular breathing patterns such as periods of rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
you have previously had liver problems or any illness affecting 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), consult your doctor or pharmacist before taking this medicine.
If you are taking both Ticagrelor Sandoz and heparin:

Your doctor may request a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform your doctor that you are taking both Ticagrelor Sandoz and heparin, as Ticagrelor Sandoz may affect the diagnostic test.

Children and adolescents
Ticagrelor Sandoz is not recommended for children and adolescents under 18 years of age.
Other medicines and Ticagrelor Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Sandoz may affect how some medicines work, and some medicines may affect Ticagrelor Sandoz.
Inform 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 that 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, because you are taking Ticagrelor Sandoz, 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 Sandoz is not recommended if you are pregnant or suspect you may be pregnant. Women should use appropriate contraceptive methods to avoid pregnancy while taking this medicine.
Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you the benefits and risks of treatment with Ticagrelor Sandoz during this period.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Ticagrelor Sandoz will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Ticagrelor Sandoz, exercise caution when driving or operating machinery.
Ticagrelor Sandoz 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 Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
To open the bottle: unscrew the cap; the container can only be opened if the child-resistant cap
is pressed downward and turned in the direction of the arrow.
How much Ticagrelor Sandoz to take
Ticagrelor Sandoz 60 mg film-coated tablets

The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Sandoz for the entire period indicated 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).

Ticagrelor Sandoz 90 mg film-coated tablets

The initial dose is two tablets taken at once (a loading dose of 180 mg). This dose is normally administered in hospital.
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 take Ticagrelor Sandoz 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 advise you how
much to take (usually between 75 and 150 mg per day).
How to take Ticagrelor Sandoz

You may take the tablet with or without food.
You can keep track of when you took your last Ticagrelor Sandoz tablet by looking at the blister pack. There is a sun (for morning) and a moon (for evening) symbol. These will 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.
Mix 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 mixed with a small amount of water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Ticagrelor Sandoz than you should
If you have taken more Ticagrelor Sandoz than you should have, contact your doctor or go
to hospital immediately. Take the medicine package with you. You may be at increased
risk of bleeding.
If you forget to take Ticagrelor Sandoz

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 a missed dose.

If you stop taking Ticagrelor Sandoz
Do not stop taking Ticagrelor Sandoz without first talking to your doctor. Take this
medicine regularly and for as long as prescribed by your doctor. If you stop taking
Ticagrelor Sandoz, this may increase your risk of having another heart attack or stroke,
or of dying from a disease related to heart or blood vessel problems.
If you have any questions about how to use this medicine, ask 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 affects blood clotting, therefore many side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (such as bruising and nosebleeds). Severe 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 within the skull is an uncommon side effect and may cause signs of stroke, such as:
- sudden numbness or weakness in the 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, 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 (which look like 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 could represent a side effect of Ticagrelor Sandoz. Dyspnea (shortness of breath) due to ticagrelor 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 resolve 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 (shown by laboratory tests)
Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

Bruising
Headache
Dizziness or sensation of spinning
Diarrhea or indigestion
Feeling unwell (nausea)
Constipation
Rash
Itching
Severe joint pain and swelling – these are signs of gout
Dizziness or mental confusion, or blurred vision – these are signs of low blood pressure
Nosebleeds
Bleeding after surgery or cuts (e.g., during shaving) and wounds, more than usual
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 may be signs of an allergic reaction
Confusion
Vision problems 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 available data)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton, 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 medicines 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 Sandoz contains

The active substance is ticagrelor.

Ticagrelor Sandoz 60 mg film-coated tablets
Each film-coated tablet contains 60 mg of ticagrelor.
Ticagrelor Sandoz 90 mg film-coated tablets
Each film-coated tablet contains 90 mg of ticagrelor.

The other components are:
Tablet core: Mannitol (E421), calcium hydrogen phosphate dihydrate, maize starch,
pregelatinized maize starch, talc (E553b), sodium stearyl fumarate.

Ticagrelor Sandoz 60 mg film-coated tablets
Coating of the tablet: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171),
glycerol monocaprylocaprate, sodium lauryl sulfate, red iron oxide (E172), black iron oxide (E172).

Ticagrelor Sandoz 90 mg film-coated tablets
Coating of the tablet: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171),
glycerol monocaprylocaprate, sodium lauryl sulfate, yellow iron oxide (E172).

Description of the appearance of Ticagrelor Sandoz and pack contents
Ticagrelor Sandoz 60 mg film-coated tablets
Round, biconvex, pink in colour, with "60" engraved on one side and smooth on the other, with a diameter of approximately 8.6 mm ± 5%.

Ticagrelor Sandoz 90 mg film-coated tablets
Round, biconvex, yellow in colour, with "90" engraved on one side and smooth on the other, with a diameter of approximately 9.6 mm ± 5%.

Ticagrelor Sandoz 60 mg is available in:

Standard blisters (with or without sun/moon symbols) in packs of 10, 14, 20, 56, 60, 100 and 168 tablets
Calendar blisters (with or without sun/moon symbols) in packs of 14, 56 and 168 tablets
Multipacks containing 168 (3 packs of 56), 180 (3 packs of 60) and 200 (4 packs of 50) tablets in standard blisters (with or without sun/moon symbols)
Multipacks containing 168 (3 packs of 56) in calendar blisters (with or without sun/moon symbols)
High-density polyethylene (HDPE) bottles closed with a child-resistant polypropylene (PP) cap with an LDPE lining, containing 30, 60 or 250 tablets

Ticagrelor Sandoz 90 mg is available in:

Standard blisters (with or without sun/moon symbols) in packs of 10, 14, 20, 56, 60, 100 and 168 tablets
Calendar blisters (with or without sun/moon symbols) in packs of 14, 56 and 168 tablets
Multipacks containing 168 (3 packs of 56), 180 (3 packs of 60) and 200 (4 packs of 50) tablets in standard blisters (with or without sun/moon symbols)
Multipacks containing 168 (3 packs of 56) in calendar blisters (with or without sun/moon symbols)
Unit dose divisible blister in a pack of 100 x 1 tablets
High-density polyethylene (HDPE) bottles closed with a child-resistant polypropylene (PP) cap with an LDPE lining, containing 30, 60 or 250 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta

This medicinal product is authorized in the European Economic Area Member States under the
following names:
Austria Ticagrelor Sandoz 60 mg – Filmtabletten
Ticagrelor Sandoz 90 mg – Filmtabletten
Belgium Ticagrelor Sandoz 60 mg, filmomhulde tabletten
Ticagrelor Sandoz 90 mg, filmomhulde tabletten
Denmark Ticagrelor Sandoz
Finland Ticagrelor Sandoz 60 mg kalvopäällysteinen tabletti
Ticagrelor Sandoz 90 mg kalvopäällysteinen tabletti
France TICAGRELOR SANDOZ 60 mg, comprimé pelliculé
TICAGRELOR SANDOZ 90 mg, comprimé pelliculé
Germany Ticagrelor HEXAL 60 mg Filmtabletten
Ticagrelor HEXAL 90 mg Filmtabletten
Ireland Ticagrelor Rowex 90 mg Film-coated tablets
Italy Ticagrelor Sandoz
Malta Ticagrelor PharOS 60 mg film-coated tablets
Ticagrelor PharOS 90 mg film-coated tablets
Norway Ticagrelor Sandoz
Netherlands Ticagrelor Sandoz 60 mg, filmomhulde tabletten
Ticagrelor Sandoz 90 mg, filmomhulde tabletten
Portugal Ticagrelor Sandoz
Sweden Ticagrelor Sandoz 60 mg filmdragerade tabletter
Ticagrelor Sandoz 90 mg filmdragerade tabletter