Ticagrelor Medical Vallei

Package Leaflet: Information for the User

Ticagrelor Medical Valley, 60 mg, Film-Coated Tablets

Ticagrelor

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

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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:

• a heart attack, more than a year ago.

The medicine reduces the risk of having another heart attack or stroke, or of dying from a disease related to the heart or blood vessels.

How Ticagrelor Medical Valley works

Ticagrelor Medical Valley works by affecting platelets in the blood. Platelets are very small blood cells that help to stop bleeding by clumping together to block the bleeding site. However, platelets can also form clots in narrowed blood vessels in the heart or brain, which can lead to a heart attack or stroke.

• a clot can completely block the blood flow, which can cause a heart attack (of the heart muscle) 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 (called unstable angina).

Ticagrelor Medical Valley helps to prevent platelets from clumping together and forming clots. This reduces the risk of a clot forming, which can reduce blood flow.

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 are currently 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 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:
• a recent serious injury
• recent surgery (including dental surgery - consult your dentist)
• a disease that affects blood clotting
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal 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 diseases or breathing difficulties.
• If you develop breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. Your doctor will decide if further evaluation is needed.
• If you have any liver problems or have had a disease that may have damaged your liver.
• If your blood test shows high levels of uric acid.

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 for 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 test result.

Children and adolescents

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

Ticagrelor Medical Valley with other medicines

Tell your doctor or pharmacist about all 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. Tell your doctor or pharmacist if you are taking:

• 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 (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporin (used to weaken 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)

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

• oral anticoagulants, often referred to as blood thinners, 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 ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches)

Also, tell your doctor if you are taking Ticagrelor Medical Valley and are at increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, often referred to 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. While taking the medicine, women should use appropriate contraceptive methods to prevent pregnancy. Before taking this medicine, tell your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Ticagrelor Medical Valley while 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

It is unlikely that Ticagrelor Medical Valley will 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.

What dose to take

• The usual dose is one 60 mg film-coated tablet twice a day. Continue taking Ticagrelor Medical Valley for as long as your doctor recommends.
• 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 Medical Valley with other medicines that prevent blood clotting

Your doctor will usually recommend taking acetylsalicylic acid as well. This is a substance found in many medicines that 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

• 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 you take all the medicine, refill the glass with half a glass of water, swirl, 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 package 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 recommends. Stopping Ticagrelor Medical Valley may increase the risk of another heart attack or stroke, or death due to a disease related to the heart or blood vessels. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Ticagrelor Medical Valley affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

Seek medical help immediately if you get 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 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
• vomiting blood or coffee ground-like vomit
• black or tar-like stools
• 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 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 severe tiredness or confusion.

Tell your doctor if you get any of the following symptoms:

• Shortness of breath (dyspnea) - very common.It may be caused by heart disease or another cause, or it may be a side effect of Ticagrelor Medical Valley. Dyspnea related to Ticagrelor Medical Valley 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, contact your doctor. Your 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 due to 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 that is more than usual
• Bleeding from the stomach lining (stomach 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 problems due to bleeding in the eye
• Bleeding from the reproductive tract, which is heavier or occurs at a different time than your regular periods (menstrual bleeding)
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which can cause dizziness or lightheadedness.

Not known

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

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below. 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 instructions for this medicine. 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 film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Core:Microcrystalline cellulose, mannitol, crospovidone (type A), povidone K30, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, magnesium stearate 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 (about 8 mm in diameter), biconvex, pink film-coated tablets, with "I" engraved on one side and smooth on the other side. Ticagrelor Medical Valley 60 mg is packaged in:

• Blisters of transparent PVC/PVDC/Aluminum foil containing 56 or 60 film-coated tablets
• HDPE bottles with PP caps 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 authorization 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 medicine is authorized in the Member States of the European Economic Area 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
Date of last revision of the package leaflet:03/2025