Ticagrelor olpha

Package leaflet: Information for the patient

Ticagrelor Olpha, 60 mg, film-coated tablets
Ticagrelorum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, please inform your doctor or pharmacist. See section 4.

Table of contents

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

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

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

What Ticagrelor Olpha is used for
Ticagrelor Olpha, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have previously had a heart attack more than one year ago. Ticagrelor Olpha reduces the likelihood of having another heart attack or stroke, or of dying from heart- or blood vessel-related disease.

How Ticagrelor Olpha works
Ticagrelor Olpha 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 cuts or damage in blood vessels. However, platelets can 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, which can lead to a heart attack (myocardial infarction) or stroke, or
• a clot may cause partial blockage of blood vessels leading to the heart, reducing blood flow to the heart and possibly causing chest pain of varying intensity (called "unstable angina").

Ticagrelor Olpha helps prevent platelets from sticking together. This reduces the risk of clot formation, which could otherwise reduce blood flow.

2. Important information before using Ticagrelor Olpha

When not to use Ticagrelor Olpha

• if the patient is allergic to ticagrelor or any of the other ingredients of Ticagrelor Olpha (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 and AIDS infections).

Do not take Ticagrelor Olpha if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Before starting to take Ticagrelor Olpha, discuss this with a doctor or pharmacist:

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

Talk to a doctor or pharmacist before taking this medicine if any of the above situations apply to the patient (or if in doubt).
If the patient is taking both Ticagrelor Olpha and heparin:

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

Children and adolescents
Ticagrelor Olpha is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Ticagrelor Olpha
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Ticagrelor Olpha may affect the action of other medicines, and other medicines may affect Ticagrelor Olpha.
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 at doses higher than 40 mg per day (medicines used to lower cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control 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 and AIDS infections), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticagrelor Olpha and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.
Pregnancy and breastfeeding
Ticagrelor Olpha is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.
Inform the doctor if the patient is breastfeeding. The doctor will discuss the benefits and risks of using Ticagrelor Olpha during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Ticagrelor Olpha will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, caution should be exercised when driving or operating machinery.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Ticagrelor Olpha

This medicine should always be taken exactly as your doctor has instructed. If in doubt,
contact your doctor or pharmacist.
What dose to take

• The usual dose is one 60 mg tablet twice daily. You should continue taking Ticagrelor Olpha for as long as your doctor recommends.
• 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 Olpha with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance
present in many medicines and used to prevent blood clotting. Your doctor will advise you on the
dose to take (usually between 75 and 150 mg daily).
How to take Ticagrelor Olpha
Tablets may be taken with or without food.
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, pour another half glass of water into the same container, swirl and drink. If the patient is being treated in hospital, the crushed tablet mixed with water may be administered via a nasogastric tube.

Taking more Ticagrelor Olpha than prescribed
If you take more Ticagrelor Olpha than prescribed, contact your doctor immediately or go to
hospital. Take the medicine packaging with you. There may be an increased risk of bleeding.
If you miss a dose of Ticagrelor Olpha

• 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 Olpha
Do not stop taking Ticagrelor Olpha without consulting your doctor. You should take the medicine
regularly and for as long as your doctor recommends. Stopping Ticagrelor Olpha may increase the
risk of another heart attack or stroke, or 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine:
Ticagrelor Olpha affects blood clotting, therefore most adverse reactions are related to bleeding.
Bleeding can occur anywhere in the body. Some bleeding events are common (e.g. bruises and nosebleeds). Severe bleeding occurs uncommonly, but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical care may be needed:

• 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 arms, legs, 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;
  • 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 disorientation.

Discuss with the doctor if the patient experiences:

• Shortness of breath (dyspnoea) – very common. This may be caused by heart disease or another condition, or it may be an adverse reaction to Ticagrelor Olpha. Dyspnoea associated with Ticagrelor Olpha treatment is usually mild and is characterised by sudden, unexpected breathlessness, usually occurring at rest. It may occur during the first few weeks of treatment and then not recur for many weeks. If breathlessness worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or further investigations 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 spinning sensation
• diarrhoea or indigestion
• nausea
• constipation
• rash
• itching
• increased 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. during shaving) 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
• disorientation (confusion)
• visual disturbances caused by blood in the eye
• vaginal bleeding that is heavier 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 not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ticagrelor Olpha

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the stated month.
There are no special requirements for storage of this medicinal product. Store in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system 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 Olpha contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet core: hypromellose 2910, mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E171), polyethylene glycol 400, talc, iron oxide red (E172).

What Ticagrelor Olpha looks like and contents of the pack
Film-coated tablet (tablet): pink, round, biconvex film-coated tablets
with the imprint “60” on one side and smooth on the other side.
Blister packs of 14 or 15 film-coated tablets. Cartons containing 56 tablets (4 blisters),
60 tablets (4 blisters), 168 tablets (12 blisters), and 196 tablets (14 blisters).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
JSC “Olpha”,
Rupnicu street 5,
Olaine, Olaines district, LV-2114,
Latvia
E-mail: [email protected]

Manufacturer:
JSC “Olpha”,
Rupnicu street 5,
Olaine, Olaines district, LV-2114,
Latvia
Genepharm S.A,
18th km Marathonos Avenue,
153 51 Pallini Attiki,
Greece