Ticagrelor Reddi

Leaflet accompanying the packaging: information for the user

Ticagrelor Reddy, 90 mg, coated tablets

Ticagrelor

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

• Keep this leaflet, you may need to read it again.
• 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 them, 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, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have had:

• myocardial infarction or
• unstable angina (chest pain or discomfort that is not adequately controlled). The medicine reduces the likelihood of having another myocardial infarction 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.

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

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

Ticagrelor Reddy helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could block 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) Do not take Ticagrelor Reddy if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ticagrelor Reddy, consult your doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• a recent serious injury;
• recent surgery (including dental surgery - consult your 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 having surgery (including dental surgery) while taking Ticagrelor Reddy. This is because of an increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the planned surgery;
• if the patient has a heart rate that is too slow (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 has high levels of uric acid in the blood.
• Tell your 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 your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take. This is because ticagrelor may affect the way other medicines work, and other medicines may affect ticagrelor.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• 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 irregular heartbeat);
• 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 called blood thinners, including warfarin;
• non-steroidal anti-inflammatory medicines (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 Reddy and have an increased risk of bleeding if your 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 effective contraception to avoid becoming pregnant while taking this medicine.

Before taking this medicine, tell your doctor if you are breastfeeding. Your 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 baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which 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.

How much 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 initial dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in the hospital.
• After the initial dose, the usual dose is one 90 mg tablet taken twice a day for up to 12 months, unless your doctor tells you otherwise.

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 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 their last dose.

What to do if you have trouble swallowing the tablet

If you have trouble swallowing the tablet, you can crush it and mix it 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 you take all the medicine, add another half glass of water, rinse, and drink. If you are being treated in the hospital, the tablet can be mixed with 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 your doctor or go to the hospital immediately. Take the medicine packaging with you. You may be at 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 stop taking Ticagrelor Reddy

Do not stop taking ticagrelor without talking to your doctor. You should take the medicine regularly and for as long as your doctor tells you. Stopping ticagrelor may increase the risk of having another myocardial infarction or stroke, or dying from a heart or blood vessel disease.

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 occur when taking this medicine:

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

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

• Bleeding into 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;
• symptoms of bleeding, such as:
• heavy or prolonged bleeding;
• unexpected or prolonged bleeding;
• urine that is pink, red, or brown;
• vomiting blood or material that looks like coffee grounds;
• stool that is red or black (like 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 severe tiredness or confusion.

Tell your doctor if you experience:

• shortness of breath (dyspnea) - occurs very commonly.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 dyspnea worsens or persists, consult your doctor. Your 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, which can 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, 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 the 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 that month.

No special storage precautions are required.

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 90 mg of ticagrelor.
• The other ingredients are: Core: mannitol, calcium hydrogen phosphate, sodium carboxymethylcellulose (type A), hypromellose (type 2910) - 5mPas, magnesium stearate. Coating: hypromellose (HPMC 2910) - 6mPas, titanium dioxide (E171), macrogol (PEG 400), talc, yellow iron oxide (E172).

What Ticagrelor Reddy looks like and contents of the pack

The tablets are round, biconvex, yellow, coated, marked (logo) on one side and "
" on the other side. The tablets are approximately 9 mm in diameter.

Ticagrelor Reddy is available in packs containing 56 x 1, 56, 60, 100, 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: