Ticagrelor Holsten

Leaflet accompanying the packaging: patient information

Ticagrelor Holsten 90 mg film-coated tablets

Ticagrelor

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

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ticagrelor Holsten and what is it used for
• 2. Important information before taking Ticagrelor Holsten
• 3. How to take Ticagrelor Holsten
• 4. Possible side effects
• 5. How to store Ticagrelor Holsten
• 6. Contents of the packaging and other information

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

What is Ticagrelor Holsten

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

What is Ticagrelor Holsten used for

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

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

How Ticagrelor Holsten works

Ticagrelor Holsten works by affecting cells called platelets in the blood (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small holes in blood vessels when they are cut or damaged. However, platelets can also form clots in diseased blood vessels in the heart and brain. This can be very dangerous because:

• a clot can completely block the blood flow - this can cause a myocardial infarction (heart attack) or stroke or:
• a clot can cause partial blockage of the blood vessels leading to the heart - this reduces blood flow to the heart and can cause chest pain of changing intensity (called unstable angina).

Ticagrelor Holsten helps prevent platelets from clumping together, reducing the likelihood of a clot forming which could block blood flow.

2. Important information before taking Ticagrelor Holsten

When not to take Ticagrelor Holsten

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

Warnings and precautions

Before taking Ticagrelor Holsten, discuss with a doctor or pharmacist:

• If the patient has an increased risk of bleeding due to:
• a recent serious injury,
• recent surgery (including dental surgery - consult a dentist),
• a condition that affects blood clotting,
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps).
• If the patient is going to have surgery (including dental surgery) at any time while taking Ticagrelor Holsten. This is because of an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned surgery.
• If the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker.
• If the patient has asthma or other lung disease or breathing difficulties.
• If the patient develops breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. The doctor will decide if further evaluation is needed.
• If the patient has any liver problems or has had a disease in the past that may have damaged the liver.
• If the patient's blood test shows high levels of uric acid.

Consult a doctor or pharmacist before taking the medicine if any of the above applies to you (or if in doubt).

If the patient is taking heparin and Ticagrelor Holsten:

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

Children and adolescents

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

Ticagrelor Holsten and other medicines

Tell a doctor or pharmacist about all medicines you are taking now or have recently taken, and any medicines you plan to take. This is because Ticagrelor Holsten may affect the way other medicines work, and some medicines may affect the way Ticagrelor Holsten works.
Tell a 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 (medicines used to control seizures)
• digoxin (a medicine used to treat heart failure)
• cyclosporin (a medicine used to weaken the immune system)
• quinidine and diltiazem (medicines used to treat irregular heartbeat)
• beta-blockers and verapamil (medicines used to treat high blood pressure)
• morphine and other opioids (medicines used to treat severe pain).

Particularly, tell a doctor or pharmacist if you are taking any of the following medicines that increase the risk of bleeding:

• oral anticoagulants, often called 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 (a medicine used to treat fungal infections), clarithromycin (a medicine used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (medicines used to treat HIV infection and AIDS), cisapride (a medicine used to treat heartburn), and ergot alkaloids (medicines used to treat migraines and headaches).

Also, inform a doctor about taking Ticagrelor Holsten and the increased risk of bleeding if a doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Holsten should not be taken during pregnancy or if there is a possibility of becoming pregnant. While taking the medicine, women should use appropriate contraceptive methods to avoid becoming pregnant.
Before taking this medicine, inform a doctor about breastfeeding. The doctor will discuss the benefits and risks of taking Ticagrelor Holsten while breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.

Driving and using machines

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

Sodium content

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

3. How to take Ticagrelor Holsten

Always take this medicine exactly as your doctor has told you. If you are not sure, consult a doctor or pharmacist.

What dose to take

• The initial dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in a hospital.
• After the initial 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 to take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Holsten with other blood-thinning medicines

A doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many medicines that prevent blood clotting. The doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Holsten

• Tablets can be taken with or without food.
• If you have a blister pack with a sun/moon symbol, you can check the pack to see when you last took a tablet. The blister pack has prints showing a sun (for morning doses) and a moon (for evening doses). These prints indicate when you took your last dose.

What to do if you have trouble swallowing the tablet

If you have trouble swallowing the tablet, you can crush it and mix it 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 you take all the medicine, add another half a glass of water, rinse, and drink. If you are being treated in a hospital, the tablet can be mixed with water and given through a nasogastric tube.

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

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

What to do if you forget to take Ticagrelor Holsten

• 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 Holsten

Do not stop taking Ticagrelor Holsten without consulting a doctor. The medicine should be taken regularly and for as long as the doctor recommends. Stopping Ticagrelor Holsten may increase the risk of having another myocardial infarction or stroke or dying from a heart or blood vessel-related disease.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Bleeding in the brain or within 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 affects only one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking, loss of balance, or coordination
• sudden dizziness or severe headache without a known cause
• Signs of bleeding, such as:
• heavy or prolonged bleeding
• unexpected or prolonged bleeding
• urine that is pink, red, or brown
• vomiting blood or material that looks like coffee grounds
• stool that is black or looks like tar
• coughing or vomiting blood clots
• Fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (occurs frequently).
• 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.

Tell a doctor if you experience:

• Shortness of breath (dyspnea) - occurs very frequently.It may be caused by heart disease or another cause, or it may be a side effect of Ticagrelor Holsten. Dyspnea associated with Ticagrelor Holsten is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If dyspnea worsens or persists, consult a doctor. The doctor will decide if treatment or further tests are needed.

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 caused by blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or lightheadedness
• diarrhea or indigestion
• nausea (feeling sick)
• constipation
• rash
• itching
• increased pain and swelling of the joints - these are symptoms of gout
• dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts and wounds, which is more than usual
• stomach bleeding (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
• confusion (disorientation)
• vision disturbances caused by blood in the eye
• vaginal bleeding, which is heavier or occurs at a different time than regular menstrual bleeding
• bleeding into the joints and muscles, causing painful swelling
• blood in the ear
• internal bleeding, which can cause dizziness or lightheadedness.

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

• abnormally low heart rate (usually less than 60 beats per minute)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl/
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Holsten

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ticagrelor Holsten contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Core of the tablet: hypromellose (E464), mannitol (E421), microcrystalline cellulose (E460), sodium carboxymethylcellulose, magnesium stearate (E470b).

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol 400 (E1521), yellow iron oxide (E172).

What Ticagrelor Holsten looks like and contents of the pack

Tablet (film-coated tablet): yellow, round, biconvex, film-coated, with "90" engraved on one side and smooth on the other side.
Ticagrelor Holsten is available in:

• transparent blisters of PVC/PVDC/Aluminum and/or transparent blisters of PVC/PE/PVDC/Aluminum (with sun/moon symbols or without) in cartons of 14, 15, 20, 28, 30, 56, 60, 90, 98, 100, 168, 195, 196, and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
Email: info@holstenpharma.de
Manufacturer:
Genepharm S.A.
18th Km Marathonos Avenue
15351 Pallini Attica
Greece

Date of last revision of the leaflet: