Ticagrelor reddy

Package leaflet: Information for the user

Ticagrelor Reddy, 60 mg, film-coated tablets
Ticagrelorum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• Please talk to your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

What Ticagrelor Reddy is
Ticagrelor Reddy contains the active substance called ticagrelor. It belongs to a group of medicines
known as antiplatelet agents.

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

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

How Ticagrelor Reddy works
Ticagrelor Reddy affects blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing small openings at the site of a cut or damaged blood vessel.

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

• a clot may completely block blood flow – which may lead to a heart attack (myocardial infarction) or stroke, or
• a clot may cause partial blockage of blood vessels leading to the heart,
  • reducing blood flow to the heart and possibly causing chest pain of varying intensity (called unstable angina).

Ticagrelor Reddy helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before using Ticagrelor Reddy

When not to use 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 experiencing bleeding;
• if the patient has had a stroke caused by bleeding into the brain;
• if the patient has severe liver disease;
• if the patient is 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)

Ticagrelor Reddy must not be used if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Before using Ticagrelor Reddy, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• a recent serious injury;
• recent surgical procedures (including dental procedures – advice should be sought from a dentist);
• a condition affecting blood clotting;
• recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedures (including dental) during treatment with Ticagrelor Reddy. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before a planned procedure;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient develops breathing problems such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a disease that could have damaged the liver;
• if blood tests have shown elevated uric acid levels in the patient.

Talk to a doctor or pharmacist before using Ticagrelor Reddy if any of the above situations apply (or if in doubt).

If the patient is taking Ticagrelor Reddy and heparin at the same time:

• the doctor may take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform the doctor about taking both ticagrelor and heparin, as ticagrelor may affect the diagnostic test result.

Children and adolescents

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

Other medicines and Ticagrelor Reddy

Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use. This is necessary because ticagrelor may affect the action of other medicines, and other medicines may affect ticagrelor.

Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin at doses higher than 40 mg daily (medicines used to lower cholesterol levels);
• 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 heart rhythm disorders);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe pain)

Especially inform the doctor or pharmacist if the patient is taking any of the following medicines, which may increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, 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 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 heartburn), 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 is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women of childbearing potential should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.

Inform the doctor if the patient is breastfeeding. The doctor will discuss the benefits and risks associated with using ticagrelor during breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that ticagrelor will impair the ability to drive or operate machinery. However, if dizziness or disorientation occurs during treatment, caution should be exercised when driving or operating machinery.

Sodium content

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

3. How to take Ticagrelor Reddy

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
contact 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 is one 60 mg tablet twice daily. You should continue taking ticagrelor for as long as your doctor recommends.

Taking Ticagrelor Reddy with other blood-thinning medicines
Your doctor will usually recommend that you also take acetylsalicylic acid. This is a substance
found in many medicines that help prevent blood clots. Your doctor will tell you what dose to take
(usually between 75 and 150 mg daily).
How to take Ticagrelor Reddy

• Tablets may be taken with or without food.
• You can check when you last took a Ticagrelor Reddy tablet by looking at the blister pack. The blister contains printed symbols showing a sun (for morning doses) and a moon (for evening doses). These symbols help patients remember when they last took a dose.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, it may be crushed and mixed 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 the entire dose is taken, add another half glass of water, swirl and drink. If you are being treated in hospital, the crushed tablet may be administered through a nasogastric tube after mixing with water.

Taking more Ticagrelor Reddy than prescribed
If you take more Ticagrelor Reddy than prescribed, contact your doctor immediately or go to hospital.
Bring the medicine pack with you. There may be an increased risk of bleeding.
If you miss a dose of Ticagrelor Reddy

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

Stopping 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 recommends. Stopping ticagrelor may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
The following adverse reactions may occur during treatment with this medicine:
Ticagrelor affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs uncommonly, but may be life-threatening.
Contact your doctor immediately if any of the following symptoms occur – urgent medical care may be needed:

• Bleeding into the brain or intracranial bleeding is an uncommon adverse reaction and may cause stroke-like symptoms 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, loss of balance or coordination;
• sudden dizziness or sudden severe headache without known cause;
• symptoms of bleeding such as:
• heavy bleeding or bleeding that is difficult to stop;
• unexpected bleeding or bleeding that lasts a long time;
• urine that is pink, red or brown;
• vomiting blood or material that looks like coffee grounds;
• stools that are red or black (resembling tar);
• coughing or vomiting blood clots;
• fainting
• temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common).
• 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 confusion.

Discuss with your doctor if the patient experiences:

• shortness of breath (dyspnea) – very common. This may be caused by heart disease or another condition, or may be an adverse reaction to ticagrelor. Dyspnea associated with ticagrelor is usually mild and characterized by sudden, unexpected breathlessness, typically occurring at rest. It may appear during the first few weeks of treatment and then not recur for many weeks. If shortness of breath worsens or persists for a long time, contact your doctor. Your doctor will decide whether treatment or additional tests are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

• increased uric acid levels in blood (detected in laboratory tests)
• bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or spinning sensation
• diarrhoea or indigestion
• nausea (feeling sick)
• constipation
• rash
• itching
• increased joint pain and swelling – symptoms of gout
• dizziness, lightheadedness or blurred vision – symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts (e.g. during shaving) and wounds that is heavier 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
• confusion (disorientation)
• visual disturbances caused by presence of blood in the eye
• vaginal bleeding that is heavier or occurs at a different time than regular menstrual bleeding
• bleeding into joints and muscles, causing painful swelling
• blood in the ear
• internal bleeding, which may cause dizziness or lightheadedness

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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.
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ticagrelor Reddy

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package following the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
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

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, sodium carboxymethyl starch (type A), hypromellose (type 2910) – 5 mPas, magnesium stearate.

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

What Ticagrelor Reddy looks like and contents of the pack

Coated tablet (tablet): The tablets are round, biconvex, white to off-white, film-coated, with the imprint "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 Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Austria Ticagrelor Reddy 60 mg, 90 mg Filmtabletten
Germany Ticagrelor beta 60 mg, 90 mg Filmtabletten
Italy Ticagrelor Dr. Reddy’s
Netherlands Ticagrelor Reddy 60 mg, 90 mg filmomhulde tabletten
Poland Ticagrelor Reddy
Sweden Ticagrelor Reddy