Ticagrelor ranbaxy

Package leaflet: Information for the patient

Ticagrelor Ranbaxy, 90 mg, film-coated tablets
Ticagrelorum
Please read this leaflet carefully before using the medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

What Ticagrelor Ranbaxy is
Ticagrelor Ranbaxy contains the active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.
What Ticagrelor Ranbaxy is used for
Ticagrelor Ranbaxy, 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 another heart attack, stroke, or death due to heart or blood vessel disease.

How Ticagrelor Ranbaxy works
Ticagrelor Ranbaxy 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 can 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 — this may cause a heart attack (myocardial infarction) 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 Ranbaxy helps prevent platelets from sticking together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before using Ticagrelor Ranbaxy

When not to use Ticagrelor Ranbaxy

• If the patient is allergic to ticagrelor or any of the other ingredients of this medicine (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 medicine)
  • ritonavir and atazanavir (used to treat HIV and AIDS infections).

Do not take Ticagrelor Ranbaxy if any of the above situations apply. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

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

• If the patient has an increased risk of bleeding due to:
  • a recent serious injury
  • a recent surgical procedure (including dental surgery – consult a dentist regarding this)
  • a disease affecting blood clotting
  • recent gastrointestinal bleeding (such as from a stomach ulcer or intestinal polyps).
• If the patient will undergo any surgical procedure (including dental surgery) while taking Ticagrelor Ranbaxy. This is due to an increased risk of bleeding. The doctor may recommend 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, slowed breathing, or apnea. 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 high levels of uric acid in the patient. Talk to a doctor or pharmacist before taking the medicine if any of the above situations apply (or if in doubt).

If the patient is taking both Ticagrelor Ranbaxy and heparin:

• 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 Ranbaxy and heparin, as Ticagrelor Ranbaxy may affect the test result.

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

Ticagrelor Ranbaxy with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Ticagrelor Ranbaxy may affect the action of other medicines, and other medicines may affect Ticagrelor Ranbaxy.

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

• rosuvastatin (a medicine used to reduce high cholesterol levels)
• simvastatin or lovastatin in doses exceeding 40 mg daily (medicines used to reduce high cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control 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 that increase the risk of bleeding:

• oral anticoagulants, often called blood thinners, 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 infections), ciprofibrate (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticagrelor Ranbaxy and the associated increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding
Ticagrelor Ranbaxy is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women 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 of using Ticagrelor Ranbaxy during breastfeeding.

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

Driving and operating machinery
It is unlikely that Ticagrelor Ranbaxy will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs while taking the medicine, caution should be exercised when driving or operating machinery.

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

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Ticagrelor Ranbaxy

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

What dose to take

• The initial dose is two tablets taken together (a loading dose of 180 mg). This dose is usually given 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.
• The medicine should be taken at approximately the same time each day (e.g. one tablet in the morning and one in the evening).

Taking Ticagrelor Ranbaxy 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 advise you what dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Ranbaxy

• Tablets may be taken with or without food.

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 to the same container, swirl gently, and drink. If the patient is being treated in hospital, the tablet, once dispersed in water, may be administered through a nasogastric tube.

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

If you miss a dose of Ticagrelor Ranbaxy

• 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 Ranbaxy
Do not stop taking Ticagrelor Ranbaxy without consulting your doctor. You must take the medicine regularly and for as long as your doctor advises. Stopping Ticagrelor Ranbaxy may increase the risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related condition.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. The following adverse reactions may occur during treatment with this medicine:
The medicine Ticagrelor Ranbaxy affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur at any site in the body. Some bleeding events are common (such as bruises and nosebleeds). Severe bleeding occurs uncommonly, but may be life-threatening.
Contact a 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 of the arms, legs, or face, especially if affecting only 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:
• heavy bleeding or bleeding difficult to stop;
• unexpected bleeding or bleeding lasting a very long time;
• urine discolored pink, red, or brown;
• vomiting blood or material that looks like coffee grounds;
• stools colored 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 (occurs frequently).
• Symptoms related to a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
• fever and purplish spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or disorientation.

Discuss with the doctor if the patient experiences:

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

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

• High levels of uric acid in the blood (detected in laboratory tests)
• Bleeding due to blood disorders.

Common (may affect up to 1 in 10 people)

• Bruising
• Headaches
• Dizziness or vertigo
• Diarrhea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Severe 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, more severe than usual
• 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 swelling of the lips and (or) tongue may be signs of an allergic reaction
• Disorientation (confusion)
• Visual disturbances due to presence of blood in the eye
• Vaginal bleeding heavier than usual or occurring 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ticagrelor Ranbaxy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via the sewage system 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 Ranbaxy contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose (E 460), hydroxypropylcellulose, sodium croscarmellose (E 468), magnesium stearate (E 470b).

Tablet coating: hypromellose (2910, 6 mPa·s), titanium dioxide (E 171), talc (E 553b),
macrogol 400, yellow iron oxide (E 172).

What Ticagrelor Ranbaxy looks like and contents of the pack
Coated tablet: the tablets are round, biconvex, yellow, film-coated,
with the imprint “90” above “T” on one side and smooth on the other.
Ticagrelor Ranbaxy, coated tablets, are packed in transparent PVC/PVDC/Aluminium blisters
and cardboard boxes containing 20, 56, 60, 100, 168 or 200 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer/Importer:
Sun Pharmaceutical Industries (Europe) B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands