Ticagrelor reddy

Package leaflet: Information for the user

Ticagrelor Reddy, 90 mg, film-coated tablets
Ticagrelorum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else 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.

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

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

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 cuts or damage in blood vessels.

However, platelets can also form clots inside blood vessels that are already diseased. This can be very dangerous because:

• a clot may completely block blood flow – this can cause a heart attack (of the heart muscle) or stroke, or
• a clot may partially block blood vessels leading to the heart,
  • reducing blood flow to the heart and possibly causing chest pain that varies in intensity (called unstable angina).

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

2. 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 infections).
  Do not use Ticagrelor Reddy if any of the above situations apply to the patient. In case of doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions
Before taking Ticagrelor Reddy, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• recent serious injury;
• recent surgical procedures (including dental procedures – consult a dentist regarding this);
• a medical condition affecting blood clotting;
• recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedures (including dental procedures) during treatment with Ticagrelor Reddy. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the scheduled 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 disorders such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is necessary;
• if the patient has any liver disorders or has previously had a disease that may have damaged the liver;
• if blood tests have shown elevated levels of uric acid in the patient.

Talk to a doctor or pharmacist before using this medicine 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 you are currently taking, have recently taken, or plan to take. This is necessary because ticagrelor may affect the action of other medicines, and other medicines may affect ticagrelor.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin at doses higher than 40 mg per day (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 your doctor or pharmacist if you are taking any of the following medicines, which increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly 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 infections), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform your doctor about taking Ticagrelor Reddy and the 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 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 your doctor if you are breastfeeding. The doctor will discuss the benefits and risks of using ticagrelor during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 sodium (23 mg) per dose, meaning the medicine is considered essentially "sodium-free".

3. How to take Ticagrelor Reddy

This medicine should always be taken as prescribed by your doctor. If in doubt, contact your doctor or pharmacist.

How much medicine to take

• It is recommended to take this medicine at the same time each day (e.g. one tablet in the morning and one in the evening).
• The initial dose is two tablets taken together (a loading dose of 180 mg). This dose is usually administered in hospital.
• After the initial dose, the usual maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless your doctor advises otherwise.

Taking Ticagrelor Reddy with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid (aspirin) at the same time. This is a substance found in many medicines used to prevent blood clotting. Your doctor will advise you on the 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 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 their 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 the nearest hospital. Take 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 advises. 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine:
Ticagrelor affects blood clotting, therefore most adverse effects are related to bleeding. Bleeding may occur at any site in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding is uncommon, but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical care may be required:

• Bleeding into the brain or intracranial bleeding is an uncommon adverse effect and may cause stroke-like symptoms such as:
• sudden numbness or weakness in arms, legs, or face, especially if affecting only 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 the doctor if the patient experiences:

• shortness of breath – very common. It may be caused by heart disease or another condition, or may be an adverse effect of ticagrelor. Shortness of breath associated with ticagrelor is usually mild and characterized by sudden, unexpected breathlessness, usually at rest, which may occur during the first few weeks of treatment and then may not recur for several weeks. If shortness of breath worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or further investigations are necessary.

Other possible adverse effects
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
• headaches
• dizziness or vertigo
• diarrhoea or indigestion
• nausea
• 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
• 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 (frequency cannot be estimated from available data)

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 .
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the 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 pack and the cardboard
box following the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 90 mg of ticagrelor.
• 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 (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, film-coated, marked with " " (logo) on one side and "T" on the other. 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 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