Ticagrelor Reddi

Leaflet accompanying the packaging: information for the user

Ticagrelor Reddy, 60 mg, coated tablets

Ticagrelor

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

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ticagrelor Reddy and what is it used for
• 2. Important information before taking Ticagrelor Reddy
• 3. How to take Ticagrelor Reddy
• 4. Possible side effects
• 5. How to store Ticagrelor Reddy
• 6. Contents of the packaging and other information

1. What is Ticagrelor Reddy and what is it used for

What is Ticagrelor Reddy

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

What is Ticagrelor Reddy used for

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

• a heart attack, more than a year ago. The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel disease.

How Ticagrelor Reddy works

Ticagrelor Reddy works by affecting cells called platelets in the blood (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in injured blood vessels.

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

Ticagrelor Reddy helps prevent platelets from clumping together, reducing the likelihood of a blood clot forming, which can reduce blood flow.

2. Important information before taking Ticagrelor Reddy

When not to take Ticagrelor Reddy

• if the patient is allergic to ticagrelor or any of the other ingredients of Ticagrelor Reddy (listed in section 6);
• if the patient is currently bleeding;
• if the patient has had a stroke caused by bleeding in the brain;
• if the patient has severe liver disease;
• if the patient is 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 infections)

Do not take Ticagrelor Reddy if any of the above applies to you. If in doubt, consult a doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking Ticagrelor Reddy, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• a recent serious injury;
• recent surgery (including dental surgery - consult a dentist);
• a condition that affects blood clotting;
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps);
• if the patient will be undergoing surgery (including dental surgery) while taking Ticagrelor Reddy. This is because there is an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned surgery;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient develops breathing difficulties such as rapid breathing, slow breathing, or shortness of breath. The doctor will decide whether further evaluation is needed;
• if the patient has any liver problems or has had a disease that may have damaged the liver;
• if the patient's blood test shows high levels of uric acid.
• Tell the doctor or pharmacist if any of the above applies to you (or if in doubt).

If the patient is taking Ticagrelor Reddy and heparin:

• the doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform the doctor that you are taking both ticagrelor and heparin, as ticagrelor may affect the test result.

Children and adolescents

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

Other medicines and Ticagrelor Reddy

Tell the doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is necessary because ticagrelor may affect the action of other medicines, and other medicines may affect ticagrelor.

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

• oral anticoagulants, often called 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 infections), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, inform the doctor about taking Ticagrelor Reddy and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Reddy should not be used during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods to avoid becoming pregnant while taking the medicine.

Before taking this medicine, inform the doctor about breastfeeding. The doctor will discuss the benefits and risks of taking ticagrelor while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.

Driving and using machines

It is unlikely that ticagrelor will affect the ability to drive or use machines. If you experience dizziness or disorientation while taking the medicine, be cautious when driving or using machines.

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free".

3. How to take Ticagrelor Reddy

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

What dose to take

• 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).
• The usual dose of the medicine is one 60 mg tablet twice a day. Continue taking ticagrelor for as long as your doctor recommends.

Taking Ticagrelor Reddy with other blood-thinning medicines

Your doctor will usually recommend taking acetylsalicylic acid at the same time. 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 Reddy

• Tablets can be taken with or without food.
• The patient can check when they last took a tablet of Ticagrelor Reddy by looking at the blister pack. The blister pack has prints showing a sun (for morning doses) and a moon (for evening doses). These prints indicate to the patient when they took the last dose.

What to do if you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:

• crush the tablet into a fine powder;
• add the powder to half a glass of water;
• mix and drink immediately;
• to ensure that all the medicine is taken, add another half glass of water, rinse, and drink. If the patient is being treated in a hospital, the tablet can be dissolved in water and given through a nasogastric tube.

What to do if you take more Ticagrelor Reddy than you should

If you take more Ticagrelor Reddy than you should, contact a doctor or go to a hospital immediately. Take the medicine packaging with you. There may be an increased risk of bleeding.

What to do if you forget to take Ticagrelor Reddy

• 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 want to stop taking Ticagrelor Reddy

Do not stop taking ticagrelor without talking to your doctor. The medicine should be taken regularly and for as long as your doctor recommends. Stopping ticagrelor may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel disease.

4. Possible side effects

Like all medicines, Ticagrelor Reddy can cause side effects, although not everybody gets them.

What to do if you experience any of the following symptoms - you may need urgent medical attention:

• 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 without a known cause;
• symptoms of bleeding, such as:
• heavy or prolonged bleeding;
• unexpected or prolonged bleeding;
• urine that is pink, red, or brown;
• vomiting blood or coffee-ground-like material;
• stool that is red or black (like coal tar);
• coughing or vomiting blood clots;
• fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (occurs frequently).
• 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.

Tell your doctor if you experience:

• 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. Dyspnea associated with ticagrelor 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 shortness of breath worsens or persists, consult a doctor. The doctor will decide whether 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 caused by blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or lightheadedness
• diarrhea or indigestion
• nausea (vomiting)
• 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 (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
• vaginal bleeding that is heavier or occurs at a different time than regular menstrual bleeding
• bleeding into the joints and muscles, causing painful swelling
• blood in the ear
• internal bleeding that may cause dizziness or lightheadedness

Frequency not known (cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Reddy

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ticagrelor Reddy contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: tablet core: mannitol, calcium hydrogen phosphate, carmellose sodium (type A), hypromellose (type 2910) - 5 mPas, magnesium stearate.

tablet coating: hypromellose (HPMC 2910) – 6 mPas, titanium dioxide (E 171), macrogol (PEG 400), talc.

• talc.

What Ticagrelor Reddy looks like and contents of the pack

Coated tablet (tablet): the tablets are round, biconvex, white to off-white, coated, with the inscription "T" on one side. The tablets are approximately 8 mm in diameter.

Ticagrelor Reddy is available in packs containing 56 x 1, 56, 60, 168, or 180 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reddy Holding GmbH

Kobelweg 95

86156 Augsburg

Germany

Tel.: +49 821 74881 0

Importer/Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Rual Laboratories SRL

Splaiul Unirii nr 313, Building H, 1st floor, sector 3

030138 Bucharest

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria

Ticagrelor Reddy 60 mg, 90 mg Filmtabletten

Germany

Ticagrelor beta 60 mg, 90 mg Filmtabletten

Denmark

Ticagrelor Reddy

Spain

Ticagrelor Dr. Reddys 60 mg, 90 mg comprimidos recubiertos con película EFG

France

TICAGRELOR REDDY PHARMA 60 mg, 90 mg comprimé pelliculé

Italy

Ticagrelor Dr. Reddy’s

Netherlands

Ticagrelor Reddy 60 mg, 90 mg filmomhulde tabletten

Poland

Ticagrelor Reddy

Sweden

Ticagrelor Reddy

Date of last revision of the leaflet: