Ticagrelor Dr. Reddy's

Package leaflet: Information for the user

Ticagrelor Dr. Reddy’s 60 mg film-coated tablets

Ticagrelor Dr. Reddy’s 90 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ticagrelor Dr. Reddy’s is and what it is used for
2. What you need to know before taking Ticagrelor Dr. Reddy’s
3. How to take Ticagrelor Dr. Reddy’s
4. Possible side effects
5. How to store Ticagrelor Dr. Reddy’s
6. Contents of the pack and other information

1. What Ticagrelor Dr. Reddy’s is and what it is used for

What is Ticagrelor Dr. Reddy’s
Ticagrelor Dr. Reddy’s contains an active substance called ticagrelor, which belongs to a group of medicines known as platelet aggregation inhibitors (antiplatelet agents).

What Ticagrelor Dr. Reddy’s is used for
Ticagrelor Dr. Reddy’s, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adult patients. You have been prescribed this medicine because you have had:

Ticagrelor Dr. Reddy’s 60 mg film-coated tablets

• a heart attack more than one year ago.

Ticagrelor Dr. Reddy’s 90 mg film-coated tablets

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

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

How Ticagrelor Dr. Reddy’s works
Ticagrelor Dr. Reddy’s acts on cells called 'platelets' (also known as thrombocytes). These are very small blood cells that help stop bleeding by clumping together to seal tiny holes in cut or damaged blood vessels.

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

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

Ticagrelor Dr. Reddy’s helps prevent platelets from sticking together. This reduces the risk of forming a blood clot that could reduce blood flow.

2. What you should know before taking Ticagrelor Dr. Reddy’s

Do not take Ticagrelor Dr. Reddy’s if:

• You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
• You have active bleeding.
• You have had a stroke caused by bleeding in the brain.
• You suffer from severe liver problems.
• 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 infection)
    Do not take Ticagrelor Dr. Reddy’s if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ticagrelor Dr. Reddy’s if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • a recent surgery (including dental procedures; consult your dentist)
  • a disease affecting blood clotting
  • recent bleeding from the stomach or intestines (e.g., due to gastric ulcer or colon "polyps")
• You are scheduled for surgery (including dental procedures) at any time while taking Ticagrelor Dr. Reddy’s. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery.
• Your heart rate is unusually low (typically less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
• You suffer from asthma or another lung condition or have breathing difficulties.
• You develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
• You have previously had liver problems or any illness affecting your liver.
• You have previously had blood tests showing higher than normal levels of uric acid.
  If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking both Ticagrelor Dr. Reddy’s and heparin:

• Your doctor may request a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform your doctor that you are taking both Ticagrelor Dr. Reddy’s and heparin, as Ticagrelor Dr. Reddy’s may affect the diagnostic test.

Children and adolescents
Ticagrelor Dr. Reddy’s is not recommended for children and adolescents under 18 years of age.
Other medicines and Ticagrelor Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Dr. Reddy’s may affect how some medicines work, and some medicines may affect Ticagrelor Dr. Reddy’s.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to treat high cholesterol)
• more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• cyclosporine (used to suppress the immune system)
• quinidine and diltiazem (used to treat abnormal heart rhythm)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

In particular, inform 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 (abbreviated as NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (abbreviated as 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 infection), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, because you are taking Ticagrelor Dr. Reddy’s, you may have an increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called 'thrombolytics', such as streptokinase or alteplase.
Pregnancy and breastfeeding
The use of Ticagrelor Dr. Reddy’s is not recommended if you are pregnant or suspect you may be pregnant.
Women must 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 discuss with you the benefits and risks of treatment with Ticagrelor Dr. Reddy’s during this period.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Ticagrelor Dr. Reddy’s will affect your ability to drive or operate machinery. If you experience dizziness or confusion while taking Ticagrelor Dr. Reddy’s, exercise caution when driving or operating machinery.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Ticagrelor Dr. Reddy’s

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How much Ticagrelor Dr. Reddy’s to take

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

Ticagrelor Dr. Reddy’s 60 mg film-coated tablets

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Dr. Reddy’s for the entire duration prescribed by your doctor.

Ticagrelor Dr. Reddy’s 90 mg film-coated tablets

• The initial dose is two tablets taken at once (a loading dose of 180 mg). This dose is usually administered in a hospital setting.
• After this initial dose, the usual dose is one 90 mg tablet twice daily for up to 12 months, unless your doctor advises otherwise.

If you take Ticagrelor Dr. Reddy’s with other blood-thinning medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This is a substance found in
many medicines used to prevent blood clotting. Your doctor will advise you on the amount to take
(generally between 75 and 150 mg per day).
How to take Ticagrelor Dr. Reddy’s

• You may take the tablet with or without food.
• You can keep track of when you took your last Ticagrelor Dr. Reddy’s tablet by checking the blister pack. There is a sun (for morning) and a moon (for evening) symbol, which will help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may 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 ensure no medicine is left behind, rinse the empty glass with another half glass of water and drink it. If you are in hospital, the tablet may be given mixed with some water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Ticagrelor Dr. Reddy’s than you should
If you have taken more Ticagrelor Dr. Reddy’s than prescribed, contact your doctor or go to hospital immediately. Bring the medicine packaging with you. You may be at increased risk of bleeding.
If you forget to take Ticagrelor Dr. Reddy’s

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

If you stop taking Ticagrelor Dr. Reddy’s
Do not stop taking Ticagrelor Dr. Reddy’s without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Dr. Reddy’s may increase your risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel problems.
If you have any doubts about how to use this medicine, consult 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 with this medicine:
Ticagrelor Dr. Reddy’s affects blood clotting, therefore many side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding events are common (such as bruising and nosebleeds). Severe bleeding is uncommon in frequency, but may be life-threatening.
Contact a doctor immediately if you notice any of the following symptoms – you may need urgent medical treatment:

• Bleeding in the brain or inside the skull is an uncommon side effect and may cause signs of a stroke, such as:
  • sudden numbness or weakness in the arms, legs, or face, especially on one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking or loss of balance or coordination
  • sudden dizziness or sudden, severe headache with no known cause
• Signs of bleeding such as:
  • severe bleeding or bleeding that cannot be controlled
  • unexpected bleeding or bleeding that lasts a long time
  • pink, red, or brown urine
  • vomit that is red or looks like coffee grounds
  • red or black stools (appearing like tar)
  • coughing up or vomiting blood clots
• Fainting (syncope)
  • 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 extreme tiredness or confusion

Contact your doctor if you notice any of the following symptoms:

• Shortness of breath – this is very common . It may be due to your heart condition or another cause, or it could be a side effect of Ticagrelor Dr. Reddy’s. The shortness of breath caused by Ticagrelor Dr. Reddy’s is usually mild and characterized by a sudden, unexpected need for air, which generally occurs at rest and may appear in the first weeks of treatment; for many people it may disappear over time. If your shortness of breath worsens or persists, inform your doctor. Your doctor will decide whether treatment is needed or further investigations should be carried out.

Other possible side effects
Very common (may affect more than 1 in 10 people)

• High levels of uric acid in the blood (shown by laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or sensation of spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling of the joints – these are signs of gout
• Dizziness or confusion, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts (e.g. during shaving) and wounds, more than normal
• Bleeding from the stomach lining (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
• Confusion
• Vision problems caused by bleeding in the eyes
• Heavier vaginal bleeding or bleeding occurring at different times from normal menstrual bleeding
• Bleeding into joints and muscles, which may cause painful swelling
• Blood in the ears
• Internal bleeding, which may cause dizziness or mental confusion

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Dr. Reddy’s

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 and carton after the abbreviation "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ticagrelor Dr. Reddy’s contains
Ticagrelor Dr. Reddy’s 60 mg film-coated tablets

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

Ticagrelor Dr. Reddy’s 90 mg film-coated tablets

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• Other components are: Tablet core: mannitol, calcium hydrogen phosphate, sodium starch glycolate type A, hypromellose, magnesium stearate.

Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, talc, iron oxide yellow (E172) (only for 90mg)

Description of the appearance of Ticagrelor Dr. Reddy’s and contents of the pack

Ticagrelor Dr. Reddy’s 60 mg film-coated tablets:
White to off-white, round, biconvex, film-coated tablets, marked with "T" on one side and the other side smooth. The tablets have a diameter of approximately 8 mm.
Ticagrelor Dr. Reddy’s 60 mg film-coated tablets are available in packs of 56 x 1, 56, 60, 168 or 180 tablets.

Ticagrelor Dr. Reddy’s 90 mg film-coated tablets:

Yellow, round, biconvex, film-coated tablets, with the logo engraved on one side and "T" on the other. The tablets have a diameter of approximately 9 mm.
Ticagrelor Dr. Reddy’s is available in packs of 56 x 1, 56, 60, 100, 168 or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123 Milano
Italy

Manufacturers
betapharm Arzneimittel GmbH,
Kobelweg 95
86156 Augsburg
Germany
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta
Rual Laboratories SRL,
313, Splaiul Unirii, Building H, 1st floor, sector 3,
Bucharest 030138
Romania

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

Austria Ticagrelor Reddy 60mg Filmtabletten
Ticagrelor Reddy 90mg Filmtabletten
Germany Ticagrelor beta 60mg Filmtabletten
Ticagrelor beta 90mg Filmtabletten
Denmark Ticagrelor Reddy
Spain Ticagrelor Dr. Reddys 60 mg comprimidos recubiertos con película EFG
Ticagrelor Dr. Reddys 90 mg comprimidos recubiertos con película EFG
France TICAGRELOR REDDY PHARMA 60 mg, comprimé pelliculé
TICAGRELOR REDDY PHARMA 90 mg, comprimé pelliculé
Italy Ticagrelor Dr. Reddy’s
Netherlands Ticagrelor Reddy 60 mg, filmomhulde tabletten
Ticagrelor Reddy 90 mg, filmomhulde tabletten
Poland Ticagrelor Reddy
Sweden Ticagrelor Reddy