Ticagrelor medical valley

Package leaflet: Information for the user

Ticagrelor Medical Valley, 60 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 called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

What Ticagrelor Medical Valley is used for
Ticagrelor Medical Valley, in combination with acetylsalicylic acid (another antiplatelet medicine), is used in adult patients who have had:

• a heart attack more than one year ago.

The medicine reduces the likelihood of having another heart attack or stroke, or of dying 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 cuts or damage in 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 the 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 that varies in intensity (called unstable angina).

Ticagrelor Medical Valley helps prevent platelets from sticking together. This reduces the risk of forming a clot that 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)

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 this 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) while taking 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 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 disease that may 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 Ticagrelor Medical Valley if any of the above situations apply to the patient (or if in doubt).

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 results of the diagnostic test.

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 greater 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), 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), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches)

You should 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 if you are 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 using machines

It is unlikely that Ticagrelor Medical Valley impairs the ability to drive or operate machinery. However, if dizziness or confusion occurs while taking this medicine, 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 the medicine is considered "sodium-free".

3. How to use Ticagrelor Medical Valley

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

• The usual dose is one 60 mg coated tablet twice daily. You should continue taking Ticagrelor Medical Valley for as long as your doctor recommends.
• 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 that you take acetylsalicylic acid at the same time. 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 daily).
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.
• Mix and drink immediately.
• To make sure that all the medicine is taken, add another half glass of water to the container, swirl gently, and drink.

If the patient is being treated in hospital, the crushed tablet mixed with water may be administered through a nasogastric tube.
Taking more Ticagrelor Medical Valley than recommended
If you take more Ticagrelor Medical Valley than prescribed, contact your doctor or go to a hospital immediately. Take the medicine pack with you. There may be an increased risk of bleeding.
If you miss a dose of Ticagrelor Medical Valley

• If you miss a dose, take the next dose at your 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 talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Medical Valley 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine:
Ticagrelor Medical Valley affects blood clotting; therefore, most adverse effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs less frequently but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

• Bleeding into the brain or intracranial haemorrhage is an uncommon adverse 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 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 (this is 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.

You should discuss with your doctor if the patient experiences:

• Shortness of breath (dyspnoea) – this is very common. It may be caused by heart disease or another condition, or it may be an adverse effect of Ticagrelor Medical Valley. Dyspnoea associated with Ticagrelor Medical Valley is usually mild and is characterised by sudden, unexpected shortness of breath, usually occurring at rest, typically during the first few weeks of treatment, and then may 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 effects
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 vertigo
• Diarrhoea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Severe 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 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 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 (cannot be estimated from available data)

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Ticagrelor Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle,
and cardboard box after: "Expiry date (EXP)". The expiry date refers to the last day
of the stated month.
No special storage instructions 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. These measures will help
protect the environment.

6. Contents of the pack and other information

What Ticagrelor Medical Valley contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The 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: Hypromellose type 2910 - 6 mPas, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide black (E 172)

What Ticagrelor Medical Valley looks like and contents of the pack
Ticagrelor Medical Valley, 60 mg: round (approximately 8 mm in diameter), biconvex, pink film-coated tablets, with the imprint “I” on one side and smooth on the other side.
Ticagrelor Medical Valley 60 mg is packed in:

• Blisters made of transparent PVC/PVDC/Aluminium foil containing 56 or 60 film-coated tablets
• HDPE bottles with PP screw cap containing a desiccant, containing:
  • 35 mL HDPE bottle: 56 or 60 film-coated tablets
  • 100 mL HDPE bottle: 168 film-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 for marketing in the European Economic Area countries under the following names:
Denmark: Ticagrelor Medical Valley
Netherlands: Ticagrelor Xiromed 60 mg filmomhulde tabletten
Iceland: Ticagrelor Medical Valley 60 mg filmuhúðaðar töflur
Germany: Ticagrelor AXiromed 60 mg filmtabletten
Norway: Ticagrelor Medical Valley
Poland: Ticagrelor Medical Valley
Sweden: Ticagrelor Medical Valley 60 mg filmdragerade tabletter