Ticagrelor Olpha

Package Leaflet: Information for the Patient

Ticagrelor Olpha, 90 mg, Film-Coated Tablets

Ticagrelor

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Ticagrelor Olpha and what is it used for
• 2. Important information 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 is Ticagrelor Olpha and what is it used for

What is Ticagrelor Olpha

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

What is Ticagrelor Olpha used for

Ticagrelor Olpha is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults who have had:

• myocardial infarction (heart attack)
• unstable angina (chest pain or discomfort which is not well controlled). The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel condition.

How Ticagrelor Olpha works

Ticagrelor Olpha works by affecting cells in the blood called platelets (also known as thrombocytes). Platelets are very small blood cells which help stop bleeding by clumping together and blocking the damaged blood vessel. However, platelets can also form clots in narrowed blood vessels in the heart or brain, which can be dangerous because:

• a clot can completely block the blood flow, causing a heart attack (myocardial infarction) or stroke, or
• a clot can partially block the blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain (unstable angina).

Ticagrelor Olpha helps prevent platelets from clumping together and forming clots. This reduces the risk of a clot forming and so reduces the risk of a heart attack or stroke.

2. Important information before taking Ticagrelor Olpha

When not to take Ticagrelor Olpha

• if you are allergic to ticagrelor or any of the other ingredients of Ticagrelor Olpha (listed in section 6)
• if you have active bleeding
• if you have had a stroke caused by bleeding in the brain
• if you have severe liver disease
• if you are taking any of the following medicines:
• ketokonazole (used to treat fungal infections)
• clarithromycin (used to treat bacterial infections)
• nefazodone (an antidepressant)
• ritonavir and atazanavir (used to treat HIV infection and AIDS). Do not take Ticagrelor Olpha if any of the above apply to you. If you are in doubt, consult your doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking Ticagrelor Olpha, discuss the following with your doctor or pharmacist:

• if you have an increased risk of bleeding due to:
• a recent serious injury
• recent surgery (including dental surgery; you should consult your dentist)
• a disease which affects blood clotting
• recent bleeding from the stomach or gut (such as a stomach ulcer or colon polyps)
• if you are going to have surgery (including dental surgery) at any time during treatment with Ticagrelor Olpha. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the planned surgery
• if you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker
• if you have asthma or other lung conditions or breathing difficulties
• if you develop breathing difficulties such as rapid or slow breathing or pauses in breathing. Your doctor will decide if further evaluation is needed
• if you have any liver problems or have had a disease in the past which may have damaged your liver
• if your blood test results show that you have more uric acid than normal in your blood

Discuss the following with your doctor or pharmacist before taking the medicine if any of the above apply to you (or if you are unsure). If you are taking Ticagrelor Olpha and heparin:

• your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor Olpha and heparin, as Ticagrelor Olpha may affect the result of the diagnostic test.

Children and adolescents

Ticagrelor Olpha should not be used in children and adolescents under 18 years of age.

Other medicines and Ticagrelor Olpha

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take. This is because Ticagrelor Olpha may affect the action of other medicines, and other medicines may affect Ticagrelor Olpha. You should inform your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels)
• simvastatin or lovastatin in doses greater 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)
• cyclosporin (used to suppress the immune system)
• quinidine and diltiazem (used to treat irregular heartbeat)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

Particularly, 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 medicines (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 ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraine and headache).

You should also inform your doctor about taking Ticagrelor Olpha and the increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, often referred to as clot-busting medicines, such as streptokinase or alteplase.

Pregnancy and breast-feeding

Ticagrelor Olpha should not be used during pregnancy or if you are planning to become pregnant. If you are able to become pregnant, you should use appropriate contraceptive methods to prevent pregnancy while taking the medicine. Before taking this medicine, inform your doctor if you are breast-feeding. Your doctor will discuss the benefits and risks of taking Ticagrelor Olpha while breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that Ticagrelor Olpha will affect your ability to drive or use machines. However, if you experience dizziness or confusion while taking the medicine, be careful when driving or using machines.

Sodium content

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

3. How to take Ticagrelor Olpha

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

What dose to take

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

Taking Ticagrelor Olpha with other medicines that prevent blood clotting

Your doctor will usually also prescribe acetylsalicylic acid. This is a substance found in many medicines and is used to prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Olpha

The tablets can be taken with or without food.

What to do if you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, it can be crushed and mixed with water as follows:

• crush the tablet into a fine powder
• add the powder to half a glass of water
• mix and drink immediately
• to make sure that you have taken all the medicine, add another half glass of water, swirl, and drink. If you are being treated in hospital, the tablet can be mixed with water and given through a nasogastric tube.

What to do if you take more Ticagrelor Olpha than you should

If you take more Ticagrelor Olpha than you should, contact your doctor or go to hospital immediately. Take the medicine pack with you. You may be at risk of bleeding.

What to do if you forget to take Ticagrelor Olpha

• If you forget to take 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 forgotten dose.

What to do if you stop taking Ticagrelor Olpha

Do not stop taking Ticagrelor Olpha without discussing it with your doctor. You should take the medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Olpha may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel condition. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ticagrelor Olpha can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine: Ticagrelor Olpha affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g. bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

Seek medical help immediately if you experience any of the following – you may need urgent medical attention:

• Bleeding in the brain or inside the skull is an uncommon side effect and may cause stroke-like symptoms such as:
• sudden numbness or weakness of the arms, legs or face, especially if it occurs on one side of the body
• sudden confusion, difficulty speaking or understanding speech
• sudden difficulty walking, loss of balance or coordination
• sudden dizziness or severe headache with no known cause
• Bleeding symptoms such as:
• heavy or prolonged bleeding
• unexpected bleeding or bleeding that is difficult to stop
• urine that is pink, red or brown
• vomiting blood or coffee ground-like material
• stools that are black or tarry
• coughing or vomiting blood clots
• Fainting
• temporary loss of consciousness due to a sudden drop in blood flow to the brain (common).
• Symptoms of a condition 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.

Tell your doctor if you experience:

• Shortness of breath (dyspnoea) - very common.This may be due to heart disease or another cause, or it may be a side effect of Ticagrelor Olpha. Dyspnoea associated with Ticagrelor Olpha is usually mild and characterised by sudden, unexpected shortness of breath at rest, which may occur in the first few weeks of treatment and then resolve over several weeks. If your dyspnoea worsens or persists, contact your doctor. Your doctor will decide whether you need treatment or further investigations.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• increased uric acid levels in the blood (found in laboratory tests)
• bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or feeling of spinning
• diarrhoea or indigestion
• nausea (feeling sick)
• constipation
• rash
• itching
• increased pain and swelling of the joints - symptoms of gout
• dizziness or fainting or blurred vision - symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts and wounds (e.g. after shaving) which is more than usual
• bleeding from the stomach (stomach ulcer)
• bleeding gums

Uncommon (may affect up to 1 in 100 people)

• allergic reaction - rash, itching, swelling of the face or lips or tongue may be signs of an allergic reaction
• confusion (disorientation)
• vision disturbances due to bleeding in the eye
• vaginal bleeding which is heavier or occurs at an unusual time (e.g. heavy or irregular periods)
• bleeding into the joints and muscles, causing painful swelling
• bleeding in the ear
• internal bleeding which may cause dizziness or fainting.

Frequency not known (frequency cannot be estimated from the available data)

• abnormally low 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, please inform your doctor or pharmacist. Side effects can be reported to the national reporting system listed in the contact details. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Olpha

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Store in the original package 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. 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 film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Core of the tablet:hypromellose 2910, mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate Coating of the tablet:hypromellose 2910, titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172).

What Ticagrelor Olpha looks like and contents of the pack

Film-coated tablet (tablet): yellow, round, biconvex film-coated tablets with the marking “90” on one side and smooth on the other side. Blister pack of 10, 14 or 15 film-coated tablets. Carton containing 56 tablets (4 blisters), 60 tablets (4 blisters), 100 tablets (10 blisters), 100 x 1 tablet (10 perforated unit dose 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
Email: [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

Date of last revision of the package leaflet: