Ticagrelor holsten

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ticagrelor Holsten is and what it is 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 package and other information

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

What Ticagrelor Holsten is
Ticagrelor Holsten contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

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

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

The medicine reduces the likelihood of having another heart attack or stroke, or death due to heart- or blood vessel-related disease.

How Ticagrelor Holsten works
Ticagrelor Holsten 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 openings at the site of cuts or damaged 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 – this may cause 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 causing chest pain of varying intensity (called unstable angina).

Ticagrelor Holsten helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before using 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 into the brain.
• If the patient has severe liver disease.
• If the patient is taking any of the following medicines:
  • ketoconazole (a medicine used to treat fungal infections),
  • clarithromycin (a medicine used to treat bacterial infections),
  • nefazodone (an antidepressant medicine),
  • ritonavir and atazanavir (medicines used to treat HIV and AIDS infections).

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

Warnings and precautions
Before starting Ticagrelor Holsten, discuss the following 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 condition affecting blood clotting,
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps).
• If the patient will undergo any surgical procedure (including dental) while taking Ticagrelor Holsten. 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, slow breathing, or apnea. The doctor will decide whether further evaluation is needed.
• If the patient has any liver disorders or has previously had a condition that could have damaged the liver.
• If blood tests have shown elevated levels of uric acid above normal.

Consult a doctor or pharmacist before using this medicine if any of the above situations apply (or if in doubt).

If the patient is taking heparin and Ticagrelor Holsten at the same time:

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

Children and adolescents
Ticagrelor Holsten is not recommended for use in children and adolescents under 18 years of age.

Ticagrelor Holsten and other medicines
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 Holsten may affect the action of other medicines, and some medicines may affect the action of Ticagrelor Holsten.

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 (medicines used to control seizures),
• digoxin (a medicine used to treat heart failure),
• cyclosporine (a medicine used to suppress the immune system),
• quinidine and diltiazem (medicines used to treat heart rhythm disorders),
• beta-blockers and verapamil (medicines used to treat high blood pressure),
• morphine and other opioids (medicines used to treat severe pain).

In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines, which may 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).

Also inform your doctor about taking Ticagrelor Holsten 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 Holsten 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.

Inform your doctor if you are breastfeeding. The doctor will discuss the benefits and risks of taking Ticagrelor Holsten during breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that Ticagrelor Holsten 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 of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".

3. How to take Ticagrelor Holsten

This medicine should always be taken exactly as your doctor has told you. If you are not sure,
contact your doctor or pharmacist.
What dose to take

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually given in hospital.
• After the initial dose, the usual dose is one 90 mg tablet taken twice daily for up to 12 months, unless your doctor tells you 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 Holsten with other medicines that prevent blood clotting
Your doctor will usually recommend that you also take acetylsalicylic acid. This is a substance
found in many medicines 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 Holsten

• Tablets may be taken with or without food.
• If you have a blister with sun/moon symbols, you can check the blister to see when you last took a tablet. The blister has printed symbols showing the sun (for morning doses) and the moon (for evening doses). These symbols help patients remember when they last took their dose.

What to do 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
• Stir and drink immediately
• To make sure you have taken all the medicine, pour another half glass of water into the container, swirl and drink. If you are being treated in hospital, the crushed tablet mixed with water may be administered through a nasogastric tube.

Taking more Ticagrelor Holsten than recommended
If you take more Ticagrelor Holsten than you should, 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 Holsten

• If you miss a dose, take your 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 Holsten
Do not stop taking Ticagrelor Holsten without talking to your doctor. You should take the medicine regularly and for as long as your doctor tells you to. Stopping Ticagrelor Holsten 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 how to use this medicine, ask 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 Holsten 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 is uncommon but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical care may be required:

• 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 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 very long time
  • urine that is pink, red or brown in colour
  • vomiting blood or material that looks like coffee grounds
  • stools that are red or black (resembling tar)
  • coughing 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 confusion.

Discuss with the doctor if the patient experiences:

• Shortness of breath (dyspnoea) – very common. It may be caused by heart disease or another condition, or may be an adverse reaction to Ticagrelor Holsten. Dyspnoea associated with Ticagrelor Holsten is usually mild and characterised by sudden, unexpected shortness of breath, usually occurring at rest. It may appear during the first few weeks of treatment and then not occur for many weeks. If shortness of breath worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or additional tests are necessary.

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 due to 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) and wounds that is heavier than usual
• bleeding from the stomach mucosa (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
• visual disturbances caused by blood in the eye
• vaginal bleeding that is heavier than usual 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 (frequency 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 adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ticagrelor Holsten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package following the abbreviation EXP. The expiry date refers to the last day of the
specified month. There are no special storage requirements.
Medicines must 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 packaging and other information

What Ticagrelor Holsten contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are:
  Tablet core: hypromellose (E464), mannitol (E421), microcrystalline cellulose (E460), sodium carboxymethyl starch, magnesium stearate (E470b).
  Tablet coating: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol 400 (E1521), yellow iron oxide (E172).

What Ticagrelor Holsten looks like and contents of the pack
Coated tablet (tablet): yellow, round, biconvex, film-coated, marked with "90" on one side and smooth on the other side.
Ticagrelor Holsten is available in:

• transparent blisters made of PVC/PVDC/Aluminum and/or transparent blisters made of PVC/PE/PVDC/Aluminum (with or without sun/moon symbols) in cardboard boxes containing 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
Email: [email protected]

Manufacturer:
Genepharm S.A.
18th Km Marathonos Avenue
15351 Pallini Attica
Greece