Ticagrelor olpha

Package leaflet: Information for the patient

Ticagrelor Olpha, 90 mg, film-coated tablets
Ticagrelorum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, 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 called ticagrelor. It belongs to a group of medicines known as 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 had:

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

This medicine reduces the likelihood of another heart attack or stroke, or death due to 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 holes at the site of a cut or damaged blood vessel.

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, leading to a heart attack (of the heart muscle) or stroke, or
• a clot may partially block blood vessels leading to the heart, reducing blood flow to the heart and 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 use 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 your 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 regarding this);
  • 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 the 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, slowed breathing, or apnoea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a disease that could have damaged the liver;
• if blood tests have shown elevated uric acid levels in the patient.

Talk to your doctor or pharmacist before taking this medicine if any of the above situations apply to the patient (or if you have any doubts).
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 your 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 your 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 your doctor or pharmacist if the patient is taking any of the following medicines, which increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), often 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).

You should also inform the doctor about taking Ticagrelor Olpha and the associated 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 of childbearing potential should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Before using this medicine, inform the doctor if you are 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 baby, she should consult her doctor or pharmacist before using this medicine.
Driving and using machines
It is unlikely that Ticagrelor Olpha impairs the ability to drive or operate machinery. However, if dizziness or disorientation 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 use Ticagrelor Olpha

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
contact your doctor or pharmacist.
What dose should be taken

• 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 maintenance 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 Olpha with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid concomitantly. This is a substance
found 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 has been taken, add another half glass of water, swirl the glass, and drink. If the patient is being treated in hospital, the tablet dissolved in 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 pack 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 the 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. The medicine should be taken regularly and for as long as your doctor recommends. Stopping Ticagrelor Olpha may increase the risk of recurrent 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 everybody will experience 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 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.

Seek immediate medical advice 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 symptoms of stroke such as:
  • sudden numbness or weakness of the arms, legs, or face, especially if affecting only 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;
  • stools that are red or black (resembling tar);
  • coughing up or vomiting blood clots;
• Fainting
  • temporary loss of consciousness due to 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.

Talk to your doctor if the patient experiences:

• Shortness of breath – very common. This may be caused by heart disease or another cause, or may be an adverse reaction to Ticagrelor Olpha. Shortness of breath 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 shortness of breath worsens or persists for a long time, contact your doctor. Your 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 uric acid levels in blood (detected in laboratory tests)
• bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headaches
• feeling dizzy or lightheaded
• diarrhoea or indigestion
• nausea
• constipation
• rash
• itching
• increased joint pain and swelling – symptoms of gout
• feeling dizzy, lightheaded or blurred vision – symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts (e.g. during shaving) and wounds, which 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 presence of blood in the eye
• vaginal bleeding that is heavier than normal 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 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 outer carton following the abbreviation EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicinal product.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 90 mg of ticagrelor.
• Other ingredients are:
  Tablet core: hypromellose 2910, mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate
  Tablet coating: hypromellose 2910, titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172)

What Ticagrelor Olpha looks like and contents of the pack
Coated tablet (tablet): yellow, round, biconvex coated tablets
with the imprint “90” on one side and smooth on the other.
Blister packs containing 10, 14 or 15 coated tablets.
Cardboard box containing 56 tablets (4 blisters),
60 tablets (4 blisters), 100 tablets (10 blisters), 100 x 1 tablet (10 perforated blisters
divisible into single doses), 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