TICAGRELOR DR. REDDYS 60 mg FILM-COATED TABLETS

1. What is Ticagrelor Dr. Reddys and what is it used for

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This medicine contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet agents.

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Ticagrelor Dr. Reddys in combination with acetylsalicylic acid (another antiplatelet agent) should only be used in adults. You have been prescribed this medicine because you have had:

Ticagrelor Dr. Reddys 60 mg film-coated tablets:

• a heart attack, more than a year ago.

Ticagrelor Dr. Reddys 90 mg film-coated tablets:

• a heart attack, or
• unstable angina (angina or chest pain that is not well controlled).

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

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Ticagrelor works on cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to block tiny holes in blood vessels that are cut or damaged.

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

• the clot can completely block the blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot can partially block the blood vessels that go to the heart; this reduces blood flow to the heart and can cause intermittent chest pain (called ‘unstable angina’).

Ticagrelor helps prevent platelets from clumping together. This reduces the chance of a blood clot forming that can reduce blood flow.

2. What you need to know before you take Ticagrelor Dr. Reddys

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• You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• You have a current bleeding condition.
• You have had a stroke caused by bleeding in the brain.
• You have severe liver disease.
• You are taking any of the following medicines:
• • ketoconazole (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 if you are in any of these situations. If you are unsure, consult your doctor or pharmacist before taking this medicine.

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Consult your doctor or pharmacist before taking Ticagrelor Dr. Reddys if:

• You have a higher risk of bleeding due to:
• • a recent severe injury
  • a recent surgical procedure (including dental procedures, ask your dentist about this)
  • you have a disorder that affects blood clotting
  • a recent stomach or intestine bleeding (such as stomach ulcer or colon ‘polyps’)
• You are going to have surgery (including dental procedures) at any time while taking ticagrelor. This is because it increases the risk of bleeding. Your doctor may want to stop your treatment with this medicine 5 days before surgery.
• Your heart rate is abnormally slow (usually less than 60 beats per minute) and you do not have a device that regulates your heart (pacemaker).
• You have asthma or other lung problems or breathing difficulties.
• You develop irregular breathing patterns, such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide if you need any further evaluation.
• You have had any liver problems or have had a disease that may have affected your liver.
• You have had a blood test that shows that the amount of uric acid is higher than normal.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking ticagrelor and heparin:

• Your doctor may require a blood sample for diagnostic tests if they suspect the presence of a rare platelet disorder caused by heparin. It is important that you inform your doctor that you are taking ticagrelor and heparin, as ticagrelor may affect the diagnostic test.

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

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Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because ticagrelor may affect the way some medicines work and some medicines may affect ticagrelor.

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

• rosuvastatin (a medicine to treat high cholesterol)
• more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• cyclosporin (used to reduce the body's defenses)
• quinidine and diltiazem (used to treat abnormal heart rhythms)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat acute pain)

In particular, 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) frequently taken as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (SSRIs) taken as antidepressants, such as paroxetine, sertraline, and citalopram.
• other medicines such as ketoconazole (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 stomach acidity), and ergot alkaloids (used to treat migraines and headaches).

Tell your doctor that, because you are taking ticagrelor, you may have a higher risk of bleeding if your doctor gives you fibrinolytics, often referred to as ‘clot dissolvers’, such as streptokinase or alteplase.

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Ticagrelor should not be used if you are pregnant or may become pregnant. Women should use appropriate contraceptive methods to prevent pregnancy while taking this medicine.

Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will explain the benefits and risks of taking ticagrelor during this period.

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

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Ticagrelor is unlikely to affect your ability to drive or use machines. If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.

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This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially ‘sodium-free’.

3. How to take Ticagrelor Dr. Reddys

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

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• Take this medicine at the same time every day (for example, one tablet in the morning and one in the evening).

Ticagrelor Dr. Reddys 60 mg film-coated tablets:

• The usual dose is one 60 mg tablet twice a day. Continue taking ticagrelor as long as your doctor tells you to.

Ticagrelor Dr. Reddys 90 mg film-coated tablets:

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

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Your doctor will also usually prescribe acetylsalicylic acid for you. This is a substance found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75-150 mg daily).

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• You can take this medicine with or without food.

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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
• Pour the powder into half a glass of water
• Stir and drink immediately
• To make sure that there is no medicine left in the glass, rinse the empty glass with another half a glass of water and drink it.

If you are in the hospital, this tablet may be given to you mixed with a little water through a tube in your nose (nasogastric tube).

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If you take more ticagrelor than you should, consult your doctor or go to the hospital immediately. Bring the medicine pack with you. You may have a higher risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

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• If you forget to take a dose, just take your next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for forgotten doses.

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Do not stop taking ticagrelor without consulting your doctor. Take this medicine regularly and for as long as your doctor tells you to. If you stop taking this medicine, you may increase the risk of having another heart attack or stroke, or dying from a heart 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, this medicine can cause side effects, although not everybody gets them. With this medicine, the following side effects may occur:

Ticagrelor affects blood clotting, so most side effects are related to bleeding. Bleeding can occur in any part of the body. Some level of bleeding is common (such as bruising and nosebleeds). Severe bleeding is rare but can be life-threatening.

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• A bleeding in the brain or inside the skull is an uncommon side effect, and can cause signs of a stroke such as:
• • sudden numbness or weakness of the arms, legs, or face, especially if it affects only one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking or loss of balance or coordination
  • sudden feeling of dizziness or severe headache of unknown cause

- signs of bleeding such as:

• severe or uncontrollable bleeding
• unexpected or prolonged bleeding
• urine that is pink, red, or brown
• vomiting blood or vomit that looks like “coffee grounds”
• stools that are black or red (like tar)
• coughing or vomiting blood

- fainting (syncope)

• temporary loss of consciousness due to a sudden drop in blood flow to the brain (frequent)

- signs of a blood clotting problem called thrombotic thrombocytopenic purpura (TTP) such as:

-

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• Difficulty breathing - this is very common.It may be due to heart disease or another cause, or it may be a side effect of ticagrelor. The breathing difficulty related to this medicine is usually mild and is characterized by a sudden, unexpected need for air that usually occurs at rest and may appear in the first weeks of treatment and in many cases may disappear. If you think your breathing difficulty has worsened or lasts a long time, tell your doctor. They will decide if you need treatment or further investigations.

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Very common (may affect more than 1 in 10 people)

• High level of uric acid in the blood (as seen in blood tests)
• Bleeding caused by blood disorders

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• Bruising
• Headache
• Feeling dizzy or like everything is spinning
• Diarrhea or indigestion
• Feeling sick (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in the joints - these are signs of gout
• Feeling dizzy or faint, or blurred vision - these are signs of low blood pressure
• Nosebleeds
• Bleeding more than usual after surgery or cuts (for example, when shaving) and wounds
• Bleeding from the stomach wall (ulcer)
• Bleeding gums

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• Allergic reaction - a skin rash, itching, swelling of the face or swelling of the lips/tongue may be signs of an allergic reaction
• Confusion
• Vision problems caused by bleeding in the eye
• Heavier or irregular vaginal bleeding, or bleeding between periods
• Bleeding in the joints and muscles that causes painful inflammation
• Bleeding in the ear
• Internal bleeding, this can cause dizziness or fainting

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• Abnormally slow heart rate (usually below 60 beats per minute)

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If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

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

5. Storage of Ticagrelor Dr. Reddys

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 carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any 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

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Ticagrelor Dr. Reddys 60 mg film-coated tablets:

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.

Ticagrelor Dr. Reddys 90 mg film-coated tablets:

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.

The other ingredients are:

Core of the tablet: mannitol, calcium hydrogen phosphate, sodium carboxymethyl starch type A (from potato), hypromellose, magnesium stearate.

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172) (only for 90 mg).

Appearance of the product and pack contents

Ticagrelor Dr. Reddys 60 mg film-coated tablets:

The tablets are round, biconvex, white to off-white, film-coated, marked with a “t” on one side and smooth on the other. The tablets are approximately 8 mm in size.

Ticagrelor Dr. Reddys is available in packs of 56 x 1, 56, 60, 168, or 180 tablets.

Ticagrelor Dr. Reddys 90 mg film-coated tablets:

The tablets are round, biconvex, yellow, film-coated, and marked with (logo) on one side and “t” on the other. The tablets are approximately 9 mm in size.

Ticagrelor Dr. Reddys is available in packs of 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 Pharma Iberia, s.a.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer

Betapharm Arzneimittel GMBH

Kobelweg 95

86156 Augsburg

Germany

or

Pharmadox healthcare LTD.

Kw20a Kordin industrial park

Paola Pla 3000

Malta

or

Rual laboratories SRL

313, Splaiul Unirii, building h 1st floor, sector 3

Bucharest, 030138

Romania

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:December 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.