Ticagrelor Medical Vallei

Package Leaflet: Information for the User

Ticagrelor Medical Valley, 90 mg, Coated Tablets

Ticagrelor

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

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

What is Ticagrelor Medical Valley

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

What is Ticagrelor Medical Valley used for

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

• myocardial infarction (heart attack) or
• unstable angina (chest pain or discomfort which is a sign of decreased blood flow to the heart muscle).

The medicine reduces the risk of having another heart attack or stroke, or dying from a heart condition or blood vessel disease.

How Ticagrelor Medical Valley works

Ticagrelor Medical Valley works by affecting cells in the blood called platelets (also known as thrombocytes). Platelets are very small blood cells which help to stop bleeding by clumping together and blocking the damaged blood vessel. However, platelets can also form clots in narrowed blood vessels in the heart and brain, which can lead to a heart attack or stroke.

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

Ticagrelor Medical Valley helps to 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 Medical Valley

When NOT to take Ticagrelor Medical Valley

• If you are allergic to ticagrelor or any of the other ingredients of this medicine (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 Medical Valley 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 Medical Valley, tell your doctor or pharmacist:

• If you have an increased risk of bleeding due to:
• recent serious injury
• recent surgery (including dental surgery - consult your dentist)
• a condition 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) while taking Ticagrelor Medical Valley. 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 rate or pauses in breathing. Your doctor will decide whether further evaluation is needed.
• If you have any liver problems or have had a liver condition in the past which may have damaged your liver.
• If you have high levels of uric acid in your blood.

Tell your doctor or pharmacist if any of the above apply to you (or if you are unsure). If you are taking Ticagrelor Medical Valley and heparin:

• Your doctor may take a blood sample to perform 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 Medical Valley and heparin, as Ticagrelor Medical Valley may affect the result of the diagnostic test.

Children and adolescents

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

Ticagrelor Medical Valley with other medicines

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 Medical Valley may affect the way other medicines work, and other medicines may affect the way Ticagrelor Medical Valley works. In particular, tell your doctor or pharmacist if you are taking:

• rosuvastatin (used to lower cholesterol levels)
• simvastatin or lovastatin in doses greater than 40 mg per day (used to lower cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine and phenobarbital (used to control epilepsy)
• digoxin (used to treat heart failure)
• cyclosporin (used to suppress the immune system)
• quinidine and diltiazem (used to treat irregular heart rhythms)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

In particular, tell your doctor or pharmacist if you are taking any of the following medicines which may increase the risk of bleeding:

• oral anticoagulants (often referred to as blood thinners), such as 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 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)

Also, inform your doctor about taking Ticagrelor Medical Valley and the increased risk of bleeding if your doctor prescribes you fibrinolytic medicines (also known as clot-dissolving medicines), such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Medical Valley should not be used during pregnancy or if you are planning to become pregnant. Women of childbearing potential should use appropriate contraceptive methods to prevent pregnancy while taking the medicine. If you are breastfeeding, consult your doctor before taking the medicine. Your doctor will discuss the benefits and risks of taking Ticagrelor Medical Valley during breastfeeding. If you are pregnant or breastfeeding, 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

Ticagrelor Medical Valley is unlikely to 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 Medical Valley

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

How much 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 a hospital.
• After the starting dose, the usual dose is one 90 mg tablet taken 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 Medical Valley with other anti-clotting medicines

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 Medical Valley

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.
• Put the powder into half a glass of water.
• Mix and drink immediately.
• To make sure that you take all of the medicine, add another half a glass of water to the glass, stir and drink.

If you are in hospital, the crushed tablet can be given to you through a nasogastric tube.

What to do if you take more Ticagrelor Medical Valley than you should

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

What to do if you forget to take Ticagrelor Medical Valley

• 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 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 tells you. Stopping Ticagrelor Medical Valley may increase the risk of another heart attack or stroke, or death from a heart condition or blood vessel 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 Medical Valley can cause side effects, although not everybody gets them. The most common side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g. bruising and nosebleeds). Serious bleeding is less common but can be life-threatening.

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

• 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 others
• sudden difficulty walking, loss of balance or coordination
• sudden dizziness or severe headache with no known cause.
• Signs of bleeding such as:
• heavy or prolonged bleeding
• unexpected or prolonged bleeding, pink, red or brown urine
• bloody vomit or vomit which looks like coffee grounds
• red or black stools (like tar)
• coughing or vomiting blood clots.
• Fainting
• temporary loss of consciousness due to a sudden drop in blood flow to the brain (common).
• Signs of a condition called thrombotic thrombocytopenic purpura (TTP), such as:
• fever and purple spots 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 a heart condition or another cause, or it may be a side effect of Ticagrelor Medical Valley. Dyspnoea associated with Ticagrelor Medical Valley 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 levels of uric acid 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 feeling of spinning
• Diarrhoea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Dizziness or fainting or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds which is more than usual
• Bleeding from the stomach lining (stomach ulcer)
• Bleeding gums

Uncommon(may affect up to 1 in 100 people):

• Allergic reactions - rash, itching, swelling of the face or lips/tongue may be signs of an allergic reaction
• Confusion (disorientation)
• Visual disturbances due to bleeding in the eye
• Bleeding from the reproductive organs which is heavier or occurs at an unusual time (e.g. heavy or irregular periods)
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding which may cause dizziness or fainting.

Not known

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system listed in the website of your country. By reporting side effects you can help 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 which is stated on the blister, bottle and carton after EXP. The expiry date refers to the last day of that month. There are no special storage conditions. 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 Medical Valley contains

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

What Ticagrelor Medical Valley looks like and contents of the pack

Ticagrelor Medical Valley, 90 mg, coated tablets: round (about 9 mm in diameter), biconvex, yellow coated tablets, with the inscription "T" on one side and smooth on the other. Ticagrelor Medical Valley 90 mg is packaged in:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: safety@medicalvalley.se

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 medicine is authorised in the Member States of the European Economic Area 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
Date of last revision of the package leaflet:03/2025