Ticagrelor Menarini

Package leaflet: Information for the user

Ticagrelor Menarini 60 mg film-coated tablets, 90 mg film-coated tablets

ticagrelor
Generic medicine
Please read all of 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ticagrelor Menarini contains an active substance called ticagrelor. This belongs to a group of
medicines known as antiplatelet agents.
What Ticagrelor Menarini is used for
Ticagrelor Menarini, 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:

• a heart attack, more than one year ago. This medicine reduces the likelihood of you having another heart attack, stroke, or dying from heart or blood vessel disease.

You have been prescribed this medicine because you have had:

• a heart attack, or
• unstable angina (unstable chest pain or angina). This medicine reduces the likelihood of you having another heart attack, stroke, or dying from heart or blood vessel disease.

How Ticagrelor Menarini works
Ticagrelor Menarini 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 damaged or ruptured 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 blood vessels supplying the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (called 'unstable angina').

Ticagrelor Menarini helps prevent platelets from clumping together. This reduces the likelihood of forming a blood clot that could reduce blood flow.

2. What you need to know before taking Ticagrelor Menarini

Do not take Ticagrelor Menarini if:

• You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
• You are currently experiencing active bleeding.
• You have had a stroke caused by bleeding in the brain.
• You have severe liver disease.
• 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 infection and AIDS)

Do not take Ticagrelor Menarini 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 Menarini if:

• You have an increased risk of bleeding due to:
  • a severe recent injury
  • a recent surgical procedure (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 to undergo any surgical procedure (including dental procedures) while taking Ticagrelor Menarini. 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 (generally less than 60 beats per minute) and you do not already have a device regulating your heart rhythm (pacemaker) implanted.
• 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 condition 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 Menarini 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 Menarini and heparin, as Ticagrelor Menarini may affect the diagnostic test.

Children and adolescents
Ticagrelor Menarini is not recommended for children and adolescents under 18 years of age.

Other medicines and Ticagrelor Menarini
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Menarini may affect how certain medicines work, and some medicines may affect Ticagrelor Menarini. Inform 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)
• ciclosporin (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, which may increase the risk of bleeding:

• 'oral anticoagulants', often referred to as 'blood thinners', including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (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 infection and AIDS), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, since you are taking Ticagrelor Menarini, 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 Menarini is not recommended during pregnancy or if you suspect you might 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 Menarini during this period.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is unlikely that Ticagrelor Menarini will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking this medicine, exercise caution when driving or operating machinery.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to take Ticagrelor Menarini

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

How much Ticagrelor Menarini to take

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Menarini for the entire duration prescribed by your doctor.
• Take this medicine at the same time each day (for example, 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 this initial dose, the usual dose is one 90 mg tablet twice daily for up to 12 months, unless your doctor tells you otherwise.
• Take this medicine at the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Ticagrelor Menarini 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 tell you how much to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Menarini

• You may take the tablet with or without food.
• You can keep track of when you took your last dose of Ticagrelor Menarini by looking at the blister pack. There is a sun symbol (for morning) and a moon symbol (for evening) to 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 you do not leave any medicine behind, rinse the empty glass with another half glass of water and drink it.
• If you are in hospital, the tablet may be given to you mixed with water and administered through a tube inserted through the nose into the stomach (nasogastric tube).

If you take more Ticagrelor Menarini than you should
If you have taken more Ticagrelor Menarini than you should, contact your doctor or go to hospital immediately. Take the medicine pack with you. You may be at increased risk of bleeding.

If you forget to take Ticagrelor Menarini

• 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 a missed dose.

If you stop taking Ticagrelor Menarini
Do not stop taking Ticagrelor Menarini without first talking to your doctor. Take this medicine regularly for as long as your doctor prescribes it. Stopping Ticagrelor Menarini may increase your risk of having another heart attack or stroke, or of dying from a disease 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 everyone will experience them.
The following side effects may occur with this medicine:
Ticagrelor Menarini affects blood clotting, therefore many side effects are related to bleeding. Bleeding can occur in any part of the body. Some bleeding events are common (such as bruising and nosebleeds). Serious bleeding is uncommon in frequency, but may be life-threatening.
Seek immediate medical attention if you notice any of the following symptoms – you may need urgent medical treatment:

• Bleeding in the brain or within the skull is an uncommon side effect and may cause signs of 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 without known cause
• Signs of bleeding such as:
  • severe or uncontrollable bleeding
  • 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 (resembling 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 fatigue or confusion
    Contact your doctor if you notice any of the following symptoms:
• Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it could be a side effect of Ticagrelor Menarini. Dyspnea (shortness of breath) due to ticagrelor is generally mild and characterized by a sudden, unexpected need for air, usually occurring at rest, and may appear during the first weeks of treatment; for many people, it may resolve spontaneously. If your shortness of breath worsens or persists, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

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

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

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or sensation that the room is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in joints – these are signs of gout
• Dizziness or mental confusion, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Bleeding after surgery or 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 times different from the normal menstrual cycle
• Bleeding into joints and muscles, which may cause painful swelling
• Blood in the ears
• Internal bleeding, which may cause dizziness or mental confusion

Frequency not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 Menarini

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 the abbreviation "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information What Ticagrelor Menarini contains

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

Ticagrelor Menarini 90 mg film-coated tablets
Each film-coated tablet contains 90 mg of ticagrelor.

• The other components are:
  Tablet core: hypromellose, mannitol, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E171), macrogol (E1521), talc (E553b), red iron oxide (E172) (for the 60 mg film-coated tablets), yellow iron oxide (E172) (for the 90 mg film-coated tablets).

Description of the appearance of Ticagrelor Menarini and package contents
Film-coated tablet (tablet)
Ticagrelor Menarini 60 mg film-coated tablets
Pink, round, biconvex film-coated tablets with a nominal diameter of 8.1 mm, marked “60” on one side and smooth on the other.
Ticagrelor Menarini 90 mg film-coated tablets
Yellow, round, biconvex film-coated tablets with a nominal diameter of 9.1 mm, marked “90” on one side and smooth on the other.
Ticagrelor Menarini is available in:
Blister packs in boxes of 56 tablets

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite S.r.l., via Sette Santi 3, 50131 Florence, Italy
Manufacturer
Genepharm S.A., 18th km. Marathonos Ave., 15351 Pallini Attiki, Greece