Ticagrelor medical valley

Package leaflet: Information for the user

Ticagrelor Medical Valley, 90 mg, film-coated tablets
Ticagrelorum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Ticagrelor Medical Valley is and what it is used for

What Ticagrelor Medical Valley is
Ticagrelor Medical Valley contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet agents.
What Ticagrelor Medical Valley is used for
Ticagrelor Medical Valley, used in combination with acetylsalicylic acid (another antiplatelet medicine), is indicated in adult patients who have had:

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

The medicine reduces the likelihood of another heart attack or stroke, or death due to heart or blood vessel disease.
How Ticagrelor Medical Valley works
Ticagrelor Medical Valley 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 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 – this may cause a heart attack (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart, reducing blood flow to the heart and possibly causing chest pain that varies in intensity (called unstable angina).

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

2. Important information before using Ticagrelor Medical Valley

When NOT TO USE Ticagrelor Medical Valley

• If the patient is allergic to ticagrelor or any of the other ingredients of this medicine (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 Medical Valley 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 Medical Valley, discuss 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 regarding this)
  • a disease 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 Medical Valley. 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 abnormally slow heart rate (usually less than 60 beats per minute) and does not have a cardiac 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 disease that could have damaged the liver.
• If blood tests have shown elevated levels of uric acid in the patient.

Talk to a doctor or pharmacist before using 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 Medical Valley 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 Medical Valley and heparin, as Ticagrelor Medical Valley may affect the diagnostic test result.

Children and adolescents

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

Ticagrelor Medical Valley 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 Medical Valley may affect the action of other medicines, and other medicines may affect Ticagrelor Medical Valley.

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 epileptic 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-thinning medicines, 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), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticagrelor Medical Valley 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 Medical Valley 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 the doctor before using this medicine if breastfeeding. The doctor will discuss the benefits and risks of using Ticagrelor Medical Valley 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 Medical Valley 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

The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Ticagrelor Medical Valley

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

• The initial dose is two tablets taken together (loading dose of 180 mg). This dose is usually administered in a hospital setting.
• 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 Medical Valley with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid concomitantly. This is a substance
present in many medicines used to prevent blood clotting. Your doctor will advise you on the dose to take
(typically between 75 and 150 mg per day).
How to take Ticagrelor Medical Valley
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.
• Stir and drink immediately.
• To ensure the entire dose is taken, add another half glass of water, 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 than the recommended dose of Ticagrelor Medical Valley
If more than the recommended dose of Ticagrelor Medical Valley has been taken, contact your doctor immediately or go to hospital. Bring the medicine packaging with you. There may be an increased risk of bleeding.
If a dose of Ticagrelor Medical Valley is missed

• If a dose is missed, 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 Medical Valley
Do not stop taking Ticagrelor Medical Valley without first talking to your doctor. The medicine should be taken regularly and for as long as your doctor recommends. Stopping Ticagrelor Medical Valley 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 everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Ticagrelor Medical Valley affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur at any site in the body. Some bleeding events are common (e.g. bruising 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 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 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 very long time, pink, red or brown discoloration of urine
  • vomiting blood or vomiting material that looks like coffee grounds
  • red or black stools (resembling tar)
  • coughing or vomiting with 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 a doctor if the patient experiences:

• Shortness of breath – very common. It may be caused by heart disease or another condition, or may be an adverse reaction to Ticagrelor Medical Valley. Shortness of breath associated with treatment with Ticagrelor Medical Valley is usually mild and characterized by sudden, unexpected breathlessness, usually occurring at rest. It may appear during the first few weeks of treatment and then not occur again for several 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 blood uric acid levels (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
• Intense 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
• Disorientation (confusion)
• Vision disturbances caused by blood in the eye
• Bleeding from the reproductive tract 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

Unknown frequency (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 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
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 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 Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle,
and cardboard packaging following “Expiry date (EXP)”. The expiry date refers to the last day
of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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 packaging and other information

What Ticagrelor Medical Valley contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• Other ingredients are:
  Tablet core: Microcrystalline cellulose, mannitol, crospovidone (type A), povidone K30, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate
  Tablet coating (90 mg): Hypromellose 2910 - 6 mPas, titanium dioxide (E 171), macrogol 400, talc, iron oxide yellow (E 172)

What Ticagrelor Medical Valley looks like and contents of the pack
Ticagrelor Medical Valley 90 mg, coated tablets: round (diameter approximately 9 mm), biconvex, yellow coated tablets, embossed with the mark “T” on one side and smooth on the other side.
Ticagrelor Medical Valley 90 mg is packaged in:

• Blisters made of transparent PVC/PVDC/Aluminium foil containing 14 or 56 coated tablets
• HDPE bottles with a PP screw cap containing a desiccant, containing:
  • 50 mL HDPE bottle: 56 coated tablets
  • 100 mL HDPE bottle: 100, 105 or 106 coated tablets
  • 250 mL HDPE bottle: 168 coated tablets

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]
Manufacturer/Importer
Laboratorios Liconsa S.A
Avda. Miralcampo 7
Polígono Industrial Miralcampo
Azuqueca de Henares
19200 Guadalajara
Spain
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park,
Paola, PLA 3000,
Malta
This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Ticagrelor Medical Valley
Netherlands: Ticagrelor Xiromed 90 mg filmomhulde tabletten
Iceland: Ticagrelor Medical Valley 90 mg filmuhúðaðar töflur
Germany: Ticagrelor AXiromed 90 mg filmtabletten
Norway: Ticagrelor Medical Valley
Poland: Ticagrelor Medical Valley
Sweden: Ticagrelor Medical Valley 90 mg filmdragerade tabletter