Ticagrelor ranbaxy

Package leaflet: Information for the patient

Ticagrelor Ranbaxy, 60 mg, film-coated tablets
Ticagrelorum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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

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 an 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 more than one year ago. The medicine reduces the likelihood of a subsequent heart attack, stroke, or death due to heart- or blood vessel-related 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 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 partially block blood vessels leading to the heart – reducing blood flow to the heart and possibly causing chest pain that varies in intensity (known as 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 currently has 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 take Ticagrelor Ranbaxy 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 taking Ticagrelor Ranbaxy, consult a doctor or pharmacist:

• If the patient has an increased risk of bleeding due to:
• recent serious injury
• 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 advise stopping the medicine 5 days before the 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 show the patient has high levels of uric acid. 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 diagnostic test result.

Children and adolescents
Ticagrelor Ranbaxy is not recommended for use in children and adolescents under 18 years of age.
Ticagrelor Ranbaxy and other medicines
Tell your 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 per day (medicines used to reduce high 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 that increase the risk of bleeding:

• oral anticoagulants, often called blood thinners, 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), cisapride (used to treat heartburn), and 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 the patient may become pregnant. Women should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.
Inform the doctor if the patient is breastfeeding. The doctor will discuss the benefits and risks of using Ticagrelor Ranbaxy while 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 impairs 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 the medicine 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 your doctor has told you. If you are not sure,
contact your doctor or pharmacist.
How much medicine to take

• The usual dose is one 60 mg tablet twice daily. You should continue taking Ticagrelor Ranbaxy for as long as your doctor recommends.
• Take the medicine 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 that you take acetylsalicylic acid at the same time. This is
an ingredient found in many medicines that prevent blood clotting. Your doctor will tell you
what dose to take (usually between 75 and 150 mg daily).
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, 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 the entire dose is taken, add another half glass of water to the container, swirl and drink. If the patient is being treated in hospital, the tablet, once crushed and mixed with water, may be administered through a nasogastric tube.

Taking more Ticagrelor Ranbaxy than prescribed
If you take more Ticagrelor Ranbaxy than you should, 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 Ranbaxy

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

Stopping Ticagrelor Ranbaxy
Do not stop taking Ticagrelor Ranbaxy without consulting your doctor. You should take the
medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Ranbaxy
may increase the risk of another heart attack or stroke, or of death due to heart or blood vessel disease.
If you have any further questions about how to use this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur during treatment with this medicine:
Ticagrelor Ranbaxy affects blood clotting; therefore, most side effects are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (such as bruises and nosebleeds). Severe bleeding occurs less frequently but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical care may be required:

• Intracranial bleeding or bleeding into the brain is an uncommon side effect 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 without 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 (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 disorientation.

You should 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 it may be a side effect of 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 occur for several 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 necessary.

Other possible side effects
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 spinning sensation
• Diarrhea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Intensified 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 bleed more 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)
• Vision disturbances caused by blood in the eye
• Vaginal bleeding that is heavier than usual or occurs at a different time than regular menstrual periods
• 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 side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, additional information on the safety of the medicine can be collected.

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 carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply.
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 Ranbaxy contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• Other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose (E 460), hydroxypropyl cellulose, sodium croscarmellose (E 468), magnesium stearate (E 470b).

Coating of the tablet: hypromellose (2910, 6 mPa·s), titanium dioxide (E 171), macrogol 400,
iron oxide black (E 172), iron oxide red (E 172).

What Ticagrelor Ranbaxy looks like and contents of the pack
Coated tablet (tablet): The tablets are round, biconvex, pink, film-coated,
with the imprint “60” 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, 168 or 200 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Phone: +48 22 642 07 75

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