Brilinta (Ticagrelor) 56 Film Tablets

• Active substance: Each tablet contains 90 mg of ticagrelor.

• Excipients: Mannitol (E421), dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose (E463), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), talc, polyethylene glycol 400, iron oxide yellow ( E172).

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When you go to a doctor or hospital during the use of this medicine, tell your doctor that you are taking this medicine.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is BRILINTA and what is it used for?

2. What should be considered before using BRILINTA

3. How is BRILINTA used?

4. What are the possible side effects?

5. BRILINTA storage

heads are included.

1. What is BRILINTA and what is it used for?

BRILINTA is a drug that contains the active substance ticagrelor. This is included in the group of drugs called antiplatelet agents (which prevent blood clotting).

BRILINTA, round, biconvex (convex on both sides), yellow, film-coated, "90" on one side and "T" on the other face is a flat tablet. Available in blister packs with 56 (4x14 tablets) and 168 (12x14 tablets) tablets.

BRILINTA is used in adults only in combination with acetylsalicylic acid (other antithrombotic drug).

The reason you are given BRILINA is;

- having a heart attack or

- having unstable angina (chest pain or angina that cannot be controlled well).

BRILINTA reduces your risk of another heart attack or stroke or death from a disease related to your heart or blood vessels.

BRILINTA affects cells called platelets (coagulation cells). These very small blood cells help to stop the bleeding by clustering together to fill the small holes in the cut or damaged blood vessels.

However, platelets may form clots in the diseased blood vessels in the heart and brain. This can be very dangerous; because:

• Clot can completely cut off blood flow; this may cause heart attack (myocardial infarction) or stroke.

• The clot may partially block blood vessels leading to the heart; this reduces blood flow to the heart, which may cause chest pain (called geçen unstable angina “).

BRILINTA helps stop the clustering of platelets. This reduces the likelihood of blood clots, which can prevent blood flow.

2. Things to consider before using BRILINTA If you do

not use BRILINTA in the following cases

:

• If you have allergies to your Ticagrelor or other auxiliaries of BRILINTA,If you

•have an active bleeding,

•have stroke due to cerebral hemorrhage,have

If you• If you severe liver disease,If you

•are using any of the following drugs:

- Ketoconazole (in the treatment of fungal infections)

-- Clarithromycin (used in the treatment of bacterial infections),

- Nefazodone (used in the treatment of depression),

- Ritonavir and atazanavir (used in the treatment of HIV infections and AIDS)

If you see any of the above mentioned, do not use BRILINTA. If you are unsure, consult your doctor or pharmacist before taking the medicine.

USE BRILINTA CAREFULLY in the following cases

;

• If you have a high risk of bleeding due to one of the following conditions:If you

-havea major injury,have

recently undergone- If you recently had surgery (including dental treatment, consult your dentist about this)

- If you have a disease that affects blood clotting,,

- Recently Stomach or intestinal bleeding (such as stomach ulcers or intestine ”polyps ().

• If you need to undergo surgery at any time while using BRILINA (including dental treatment). This is because the risk of bleeding is increased. Your doctor may ask you to stop taking this medicine 7 days before the surgery. If your heart rate is abnormally

slow inways (usually less than 60 beats per minute) and you do not have a pacemaker,

• If you have asthma or other lung problems or have difficulty breathing,

• have experienced any problems with your liver, or before you had an illness that affected your liver.

• If your blood test shows that your blood contains more than normal uric acid.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

The use of BRILINTA with food and drink can be used with

combination BRILINTA food and beverages.

Do not drink grapefruit juice when receiving BRILINTA. May change the way the drug acts.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

BRILINTA is not recommended if you are pregnant or if you are pregnant. When using BRILINTA, use appropriate methods of contraception not to become pregnant.

If you are pregnant, if you are pregnant or are planning to become pregnant, consult your doctor or pharmacist before using BRILINTA.

BRILINTA should not be used during pregnancy unless necessary.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

BRILINTA 's products in the body passes into milk.

Before using BRILINTA, tell your doctor that you are breastfeeding. Your doctor will explain to you the benefits and risks of using BRILINTA during this time. It should be decided to stop breastfeeding or to discontinue treatment / treatment of BRILINTA.

Vehicle and machine use

BRILINTA is not expected to affect your ability to drive or use machines. If you are confused or confused while using BRILINTA, you must be careful when using the vehicle or machine.

Use with

other medicines Tell your doctor or pharmacist if you have recently taken or are taking any other medicines. Because BRILINTA can affect the working mechanism of some drugs and some drugs may have an effect on BRILINTA.

Tell your doctor or pharmacist if you are using any of the following medications:

• More than 40 mg / day simvastatin or lovastatin (drugs used to treat high cholesterol),

• Rifampicin (one antibiotic),

• Phenytoin, carbamazepine, and phenobarbital (epileptic seizures) is used to control)

• Digoxin (used in the treatment of heart failure),

• cyclosporine (used to weaken the body's defenses),

• quinidine and diltiazem (used in the treatment of abnormal heart rhythm),

• beta blockers and verapamil (used to treat high blood pressure).

Please report to your doctor or pharmacist if you are using any of the following medicines, especially those that increase your risk of bleeding:

• "oral anticoagulants", which include warfarin and are often referred to as "blood thinners"; s abbreviated)

• paroxetine, antidepressants such as sertraline, and citalopram (effective against depression) received as selective serotonin reuptake inhibitors (abbreviated as SSRIs),

• ketoconazole (used to treat fungal infections), clarithromycin (used in the treatment of bacterial infections) nefazodone (an antidepressant drug), ritonavir and atazanavir (used in the treatment of HIV infection and AIDS), cisapride (used in the treatment of heartburn), ergot alkaloids (used in the treatment of migraine and headache) Drugs.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How is BRİLİNTA used?

Always use your medicine exactly as your doctor told you. If you are unsure, you should talk to your doctor or pharmacist.

Instructions for proper use and dose / frequency of administration:

• The initial dose is 2 tablets (loading dose 180 mg) taken at the same time. This dose is usually given to you in the hospital.

• Following this initial dose, the general use dose for a period of 12 months is 90 mg twice a day, unless your doctor has informed you of a different time period.

• Take your medication at approximately the same time every day (eg 1 tablet in the morning, 1 tablet in the evening).

Your doctor will usually tell you to take low-dose acetylsalicylic acid (aspirin). This substance is found in many drugs used to prevent blood clotting. Your doctor will tell you how much you should receive (usually 75-150 mg per day).

Method and method of:

administration• You may take the medication with or without food.

• You can check the day of the BRILINTA tablet that you recently received by looking at the blist. In the morning you need to take your medicine for the sun; The moon icon is available for your medicine that you need to take in the evening. These symbols may indicate whether you received your medicine.

If you have a problem If you have a problem

swallowing the tablet swallowing the tablet, you can break the tablet and mix it with water by following the instructions below:

• Break the tablet into a fine powder.

• Throw the powdered tablet into half a glass of water.

• Drink and mix without waiting.

• Rinse the empty glass with half a glass of water to ensure there are no more drugs left at the bottom.

Different age groups::

Use in children The use of

BRILINTA in children and young people under 18 years of age is not recommended.

Use in the elderly: No

dosage adjustment is required in the elderly.

Special Use Cases:

Renal insufficiency:

There is no need for dose adjustment in renal failure.

It is recommended that patients entering the dialysis should not use BRILINTA.

Hepatic impairment:

No dosage adjustment is required in mild or moderate hepatic impairment. BRILINTA should not be used in patients with severe hepatic impairment. Care should be taken in patients with moderate hepatic impairment.

If you have an impression that the effect of BRILINTA is too strong or too weak, talk to your doctor or pharmacist.

If you have used more BRILING than you should: You

may have a high risk of bleeding.

If you have used more than you should use BRILINTA, talk to a doctor or pharmacist or go to the nearest hospital urgently. Do not forget to take the medicine with you on your way to the hospital.

If Forget to use BRILINTA:

youIf you forget to take a dose, take another dose at the time you need to take it.

Do not take double doses to compensate for the forgotten dose.

The effects that may occur when treatment is discontinued with BRILINTA:

Do not stop taking BRILINA without talking to your doctor. As long as your doctor prescribes, continue to use this medicine regularly. If you stop taking BRILINTA, you may be at increased risk of another heart attack or stroke, or you may be at increased risk of death from an illness related to your heart or blood vessels.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. What are the possible side effects?

As with all medicines, people who are sensitive to the substances in the content of BRILINTA may have side effects. The following side effects may occur during the use of this medication:

Most of the side effects are associated with bleeding as BRILINTA affects blood clotting. Bleeding can occur in any part of your body. Some bleedings (such as bruising and nasal bleeding) are common. Serious bleedings are not common but can be life-threatening.

The frequency of side effects is listed in the following categories:

Very common: It can be seen in at least 1 of 10 patients.

Common: Less than one in 10 patients, but can be seen in one or more of 100 patients.

Uncommon: Less than one in 100 patients, but may be seen in one or more of 1,000 patients.

Rare: Less than one in 1,000 patients, but can be seen in one or more of 10,000 patients.

Very rare: less than one in 10,000 patients.

Frequency unknown: Can not be estimated with available data.

If you have any of the following, stop using BRILINTA and IMMEDIATELY tell your doctor or contact the emergency department of your nearest hospital:

• Bleeding within the brain or skull is an uncommon side effect and may cause the following stroke symptoms:

- Sudden numbness on your arm, leg or face or inactivity (especially if it is only on one side of your body)

- Sudden sudden difficulty in understanding drowsiness, speech, or others

- Sudden loss of walking difficulty, balance or coordination (non-widespread)

- Suddenly felt dizziness or sudden onset headache

• The following signs of bleeding:

- Severe or uncontrolled bleeding

- Unexpected bleeding or prolonged bleeding

- Pink, red or brown urine

- Red blood vomiting or vomit appearing as ed coffee grains belirtil

- Red or black stool ( that looks like tar)

- Cough or vomiting blood clot arrive

• Fainting (syncope)

Beyne Temporary loss of consciousness due to a sudden drop in blood flow (common)

These are all very serious side effects. If you have one of these, you may need emergency medical care or hospitalization.

If you notice any of the following, tell your doctor:

• Feeling short of breath - is very common. This may be caused by your heart condition or by any other reason, or it may be a side effect of BRILINTA. BRILINTA-associated breathlessness is usually mild and characterized by sudden, unexpected air starvation, most of which occur at rest and occur in the first weeks of treatment, many of which are lost. Tell your doctor if your shortness of breath gradually deteriorates or persists. Your doctor will decide whether you need treatment or more comprehensive examination.

Possible other side effects:

Very common

• High uric acid level in your blood (as seen in tests)

• Bleeding caused by blood diseases

• Shortness of breath

Common

• Low blood pressure (hypotension)

• Respiratory bleeding (bloody sputum haemoptysis)

• Bruising

• Headache

• Drowsiness Feeling or feeling like returning to the room

• Diarrhea or indigestion

• Feeling sick (nausea)

• Constipation

• Skin or skin bleeding

• Itching

• Rash

• Severe pain and swelling in your joints - these are symptoms of gout.

• Feel dizziness or dizziness or blurred vision - these are symptoms of low blood pressure.

• Nasal bleeding

• Post-operative or cut-off (eg, when shaving) and post-traumatic bleeding in the wound - bleeding after trauma

• Stomach bleeding (ulcers)

• Bleeding in gums Bleeding in the

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