Tikata

Italy
Brand name Tikata
Form tablets, film-coated
Active substance / Dosage
TICAGRELOR
Prescription type Prescription only
ATC code
B01AC24
Registration number 051248
Manufacturer ADAMED S.R.L.

Table of Contents

Package leaflet: Information for the user

Tikata 60 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 they have the same symptoms as you, because 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 Tikata is and what it is used for
  2. What you need to know before taking Tikata
  3. How to take Tikata
  4. Possible side effects
  5. How to store Tikata
  6. Contents of the pack and other information

1. What Tikata is and what it is used for

What Tikata is
Tikata contains the active substance ticagrelor, which belongs to a group of medicines called
antiplatelet agents.
What Tikata is used for
This medicine should be used in combination with acetylsalicylic acid (another antiplatelet agent) only in adults. You have been prescribed this medicine because you have had:

  • a heart attack more than one year ago. This medicine reduces the risk of having another heart attack or stroke, or of dying due to heart or vascular disease.

How Tikata works
This medicine affects blood cells called 'platelets' (also known as thrombocytes). These very small blood cells help stop bleeding by clumping together and sealing small holes in cut or damaged 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 can completely block the blood supply, causing a heart attack (myocardial infarction) or a stroke, or
  • the clot can partially block blood vessels leading to the heart, reducing blood flow to the heart and causing intermittent chest pain (a condition known as 'unstable angina'). Tikata helps prevent platelets from clumping together, thereby reducing the risk of forming a blood clot that could impair blood flow.

2. What you need to know before taking Tikata

Do not take Tikata if:

  • you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6);
  • you are currently experiencing 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 this medicine 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 Tikata if:

  • you have an increased risk of bleeding due to:
    • a recent serious injury
    • recent surgery (including dental procedures; in this case, consult your dentist)
    • a condition affecting blood clotting
    • recent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon 'polyps');
  • you are scheduled to undergo surgery (including dental surgery) at any time during treatment with this medicine, as the risk of bleeding is higher. Your doctor may stop treatment with this medicine 5 days before surgery.
  • your heart rate is abnormally low (usually less than 60 beats per minute) and you have not yet had a pacemaker implanted;
  • you suffer from asthma or other lung disorders or breathing difficulties;
  • you develop an irregular breathing pattern, such as rapid, slow, or intermittent breathing. Your doctor will decide whether further evaluation is needed.
  • you have previously had liver problems or diseases that may have damaged your liver;
  • a blood test has shown higher than normal levels of uric acid. If any of the conditions listed above apply to you (or if you are unsure), talk to your doctor or pharmacist before taking this medicine. If you are taking both Tikata and heparin:
  • your doctor may perform blood tests if there is suspicion of a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking this medicine together with heparin, as Tikata may affect the diagnostic test.

Children and adolescents
The use of this medicine is not recommended in children and adolescents under 18 years of age.
Other medicines and Tikata
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tikata may affect the effectiveness of certain medicines, and some medicines may affect the effectiveness of Tikata.
Inform your doctor or pharmacist if you are taking any of the following medicines:

  • rosuvastatin (a medicine used to treat high cholesterol levels)
  • more than 40 mg daily of simvastatin or lovastatin (medicines used to treat 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 abnormalities)
  • beta-blockers and verapamil (used to treat hypertension)
  • 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), often taken 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), ergot alkaloids (used to treat migraine and headache).

Also inform your doctor that, due to treatment with Tikata, you may be at increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called 'clot dissolvers', such as streptokinase or alteplase.
Pregnancy and breastfeeding
The use of this medicine is not recommended if you are pregnant or planning to become pregnant. Women should use appropriate contraceptive measures during treatment with this medicine to avoid pregnancy.
Talk to your doctor before taking this medicine while breastfeeding. Your doctor will evaluate with you the benefits and risks associated with taking Tikata during this period.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery. However, if you experience dizziness or confusion during treatment with this medicine, exercise caution when driving or operating machinery.

3. How to take Tikata

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose

  • The recommended dose is one 60 mg tablet twice daily. Continue taking this medicine for as long as your doctor prescribes it.
  • Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

Taking Tikata together with other anticoagulant medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This substance is contained in many medicines used to prevent blood clotting. Your doctor will prescribe the dose to take (usually between 75 and 150 mg daily).

How to take Tikata

  • You may take the tablet with or without food.
  • You can check the last dose taken by looking at the blister pack. It shows the symbol of the sun (for morning) and the moon (for evening). This will indicate whether you have taken your dose.

If you have difficulty swallowing a tablet
If you have trouble 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 have taken the full amount of medicine, rinse the empty glass with half a glass of water and drink it as well. If you are in hospital, you may receive this tablet mixed with water through a nasal tube (nasogastric tube).

If you take more Tikata than you should
If you take more Tikata than prescribed, contact your doctor or go to hospital immediately. Bring the medicine package with you. You may be at increased risk of bleeding.

If you forget to take Tikata

  • If you forget to take 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.

If you stop taking Tikata
Do not stop taking this medicine without consulting your doctor. Take this medicine regularly for as long as your doctor prescribes it. If you stop treatment with this medicine, your risk of having another heart attack or stroke, or of dying from heart or vascular disease, may increase.

If you have any questions 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 gets them. The following side effects may occur with this medicine:
Tikata affects blood clotting; therefore, most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding events are common (such as bruising and nosebleeds). Severe bleeding is uncommon in frequency but can be life-threatening.
Seek immediate medical advice if you experience any of the following side effects – you may require urgent medical treatment:

  • Cases of intracranial or cerebral haemorrhage are uncommon side effects and may cause signs of stroke, such as:
    • sudden numbness or weakness of 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 with no known cause
  • Signs of bleeding, such as:
    • severe or uncontrollable bleeding
    • unexpected or prolonged bleeding
    • pink, red, or brown urine
    • vomiting blood or material that looks like "coffee grounds"
    • red or black (tarry) stools
    • coughing up or vomiting blood clots
  • Fainting (syncope)
    • temporary loss of consciousness due to a sudden reduction in blood flow to the brain (common side effect)
  • Signs of blood clotting problems, known as thrombotic thrombocytopenic purpura (TTP), for example:
    • fever and purple-coloured spots (a condition called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion

Consult your doctor if you experience any of the following symptoms:

  • Shortness of breath – this is a very common effect. It may be due to your heart condition or another cause, or it may be a side effect of this medicine. Breathlessness associated with Tikata is generally mild and typically involves sudden, unexpected shortness of breath occurring at rest, usually within the first few weeks of treatment, and resolves in most cases. Inform your doctor if breathlessness worsens or persists. Your doctor will assess whether further investigation or treatment is needed.

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

  • increased levels of uric acid in the blood (shown in laboratory tests)
  • bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

  • bruising
  • headache
  • dizziness or sensation of spinning
  • diarrhoea or indigestion
  • feeling unwell (nausea)
  • constipation
  • skin rash
  • itching
  • severe joint pain and swelling – signs of gout
  • dizziness or lightheadedness, blurred vision – signs of low blood pressure
  • nosebleeds
  • excessive bleeding after surgery or injury (e.g. after shaving) and wounds
  • bleeding from the stomach lining (ulcer)
  • bleeding gums

Uncommon (may affect up to 1 in 100 people)

  • allergic reaction – skin rash, itching, or swelling of the face, lips/tongue which may indicate an allergic reaction
  • confusion
  • vision problems caused by presence of blood in the eyes
  • heavier vaginal bleeding or bleeding occurring at times other than during menstruation
  • bleeding into joints and muscles causing painful swelling
  • blood in the eyes
  • internal bleeding which may cause dizziness or feeling faint

Not known (frequency cannot be estimated from available data)

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

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

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 carton after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tikata contains
The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
The other components are:
Tablet core: mannitol, calcium hydrogen phosphate dihydrate, crospovidone (type A), hypromellose,
magnesium stearate.
Tablet film coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172).

Description of the appearance of Tikata and contents of the pack
Film-coated tablet (tablet): pink, round, biconvex, film-coated tablets with "EL 1" printed on one side and a diameter of approximately 8.1 mm.
This medicine is available in:

  • cardboard pack containing 56 or 60 tablets in PVC/PVDC//aluminum blisters,
  • cardboard pack containing 56 or 60 tablets in OPA/aluminum/PVC//aluminum blisters.
    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milano
(Italy)
Manufacturer
ELPEN PHARMACEUTICAL Co. Inc.
Marathonos Avenue 95
190 09 Pikermi (Attiki)
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Tikata
Spain: Tikata 60 mg comprimidos recubiertos con película EFG

Package leaflet: information for the user

Tikata 90 mg film-coated tablets

Ticagrelor
Generic medicine
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 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, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tikata is and what it is used for

What Tikata is
Tikata contains the active substance ticagrelor, which belongs to a group of medicines called
antiplatelet agents.
What Tikata is used for
This medicine should be used in combination with acetylsalicylic acid (another antiplatelet agent) only in adults. You have been prescribed this medicine because you have had:

  • a heart attack more than one year ago, or
  • unstable angina (angina or chest pain that is not well controlled).

This medicine reduces the risk of having another heart attack or stroke, or the risk of death due to heart or vascular disease.

How Tikata works
This medicine affects blood cells called 'platelets' (also known as thrombocytes). These tiny blood cells help stop bleeding by clumping together and plugging small holes in cut or damaged 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, causing a heart attack (myocardial infarction) or a stroke, or
  • the clot may partially block blood vessels leading to the heart, reducing blood flow to the heart and causing intermittent chest pain (a condition known as 'unstable angina').

Tikata helps prevent platelets from clumping together, thereby reducing the likelihood of blood clot formation that could impair blood flow.

2. What you need to know before taking Tikata

Do not take Tikata if:

  • you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6);
  • you are currently experiencing 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 and AIDS infection). Do not take this medicine 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 Tikata if:

  • you have an increased risk of bleeding due to:
    • a recent serious injury
    • recent surgery (including dental procedures; in this case, consult your dentist)
    • a condition affecting blood clotting
    • recent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon 'polyps');
  • you are scheduled to undergo surgery (including dental surgery) at any time during treatment with this medicine, as the risk of bleeding is higher. Your doctor may stop treatment with this medicine 5 days before surgery.
  • your heart rate is abnormally low (usually less than 60 beats per minute) and you have not yet had a pacemaker implanted;
  • you suffer from asthma or other lung disorders or breathing difficulties;
  • you develop an irregular breathing pattern, such as fast, slow, or intermittent breathing. Your doctor will decide whether further evaluation is needed.
  • you have previously had liver problems or diseases that may have damaged your liver;
  • a blood test has shown higher than normal levels of uric acid. If any of the conditions listed above apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine. If you are taking both Tikata and heparin:
  • your doctor may perform blood tests if a rare platelet disorder caused by heparin is suspected. It is important to inform your doctor that you are taking this medicine together with heparin, as Tikata may affect the diagnostic test.

Children and adolescents
The use of this medicine is not recommended in children and adolescents under 18 years of age.
Other medicines and Tikata
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Tikata may affect the effectiveness of certain medicines, and some medicines may affect the effectiveness of Tikata.
Inform your doctor or pharmacist if you are taking any of the following medicines:

  • rosuvastatin (a medicine used to treat high cholesterol levels)
  • more than 40 mg daily of simvastatin or lovastatin (medicines used to treat 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 abnormalities)
  • 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 called 'blood thinners', including warfarin;
  • non-steroidal anti-inflammatory drugs (NSAIDs), often taken 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 and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraine and headache).

Also inform your doctor that, due to treatment with Tikata, you may be at increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called 'clot busters', such as streptokinase or alteplase.
Pregnancy and breastfeeding
The use of this medicine is not recommended during pregnancy or if you are planning a pregnancy. Women must use appropriate contraceptive measures during treatment with this medicine to avoid pregnancy.
Consult your doctor before taking this medicine while breastfeeding. Your doctor will evaluate with you the benefits and risks associated with taking Tikata 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
This medicine does not affect the ability to drive or operate machinery. However, if you experience dizziness or confusion during treatment with this medicine, exercise caution when driving or operating machinery.

3. How to take Tikata

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

Recommended dose

  • The initial dose is two tablets at once (a loading dose of 180 mg). This dose is normally 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 approximately the same time each day (for example, one tablet in the morning and one in the evening).

Taking Tikata together with other anticoagulant medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This substance is contained in many medicines used to prevent blood clotting. Your doctor will prescribe the dose you should take (usually between 75 and 150 mg per day).

How to take Tikata

  • You may take the tablet with or without food.
  • You can check the last time you took a Tikata tablet by looking at the blister. It shows the symbol of the sun (for morning) and the moon (for evening). This will help you remember whether you have taken your dose.

If you have difficulty swallowing a tablet
If you have problems swallowing the tablet, you may crush it and mix it with water as described below:

  • Crush the tablet into a fine powder;
  • Pour the powder into half a glass of water;
  • Stir and drink immediately.
  • To ensure you have taken the full dose, rinse the empty glass with half a glass of water and drink it. If you are in hospital, you may receive this tablet mixed with water through a nasogastric tube (nasal gastric tube).

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

If you forget to take Tikata

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

If you stop taking Tikata
Do not stop taking this medicine without first consulting your doctor. Take this medicine regularly for as long as your doctor prescribes it. If you stop taking this medicine, your risk of having another heart attack or stroke, or of dying from heart or vascular disease, may increase.

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 experiences them. The following side effects may occur with this medicine:
Tikata affects blood clotting; therefore, most 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 can be life-threatening.
Seek immediate medical advice if you experience any of the following side effects – you may require urgent medical treatment:

  • Cases of intracranial or cerebral haemorrhage are uncommon side effects 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 or prolonged bleeding
  • pink, red, or brown urine
  • vomiting blood or material that looks like "coffee grounds"
  • red or black (tarry) stools
  • coughing up or vomiting blood clots
    • Fainting (syncope)
  • temporary loss of consciousness due to a sudden reduction in blood flow to the brain (a common side effect)
    • Signs of blood clotting problems, known as thrombotic thrombocytopenic purpura (TTP), for example:
  • fever and purple-coloured spots (a condition 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 experience any of the following symptoms:

  • Shortness of breath – this is a very common side effect. It may be due to your heart condition or another cause, or it may be a side effect of this medicine. Breathlessness associated with Tikata is generally mild and characterised by sudden, unexpected shortness of breath at rest, typically occurring during the first weeks of treatment, and resolves in most cases. Inform your doctor if breathlessness worsens or persists. Your doctor will assess whether further investigation or treatment is needed.

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

  • elevated levels of uric acid in the blood (shown in laboratory tests)
  • bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

  • bruising
  • headache
  • dizziness or sensation of spinning
  • diarrhoea or indigestion
  • feeling unwell (nausea)
  • constipation
  • skin rash
  • itching
  • severe joint pain and swelling – signs of gout
  • dizziness or lightheadedness, blurred vision – signs of hypotension
  • nosebleeds
  • excessive bleeding after surgery or after a cut (e.g. while shaving) and wounds
  • bleeding from the stomach lining (ulcer)
  • bleeding gums

Uncommon (may affect up to 1 in 100 people)

  • allergic reaction – skin rash, itching, or swelling of the face, lips, or tongue, which may be signs of an allergic reaction
  • confusion
  • vision problems caused by blood in the eyes
  • heavier vaginal bleeding or bleeding occurring outside the menstrual cycle
  • bleeding inside joints and muscles causing painful swelling
  • blood in the eyes
  • internal bleeding that may cause dizziness or feeling faint

Not known (frequency cannot be estimated from available data)

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

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

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 carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tikata contains
The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
The other components are:
Tablet core: mannitol, calcium hydrogen phosphate dihydrate, crospovidone (type A), hypromellose,
magnesium stearate.
Film coating of the tablet: hypromellose, titanium dioxide (E171), talc, macrogol 400, yellow iron oxide (E172).
Description of the appearance of Tikata and contents of the pack
Film-coated tablet (tablet): yellow, round, biconvex, film-coated tablets with a diameter of approximately 9.1 mm.
This medicine is available in:

  • cardboard pack containing 56 tablets in PVC/PVDC//aluminum blisters,
  • cardboard pack containing 56 tablets in OPA/aluminum/PVC//aluminum blisters. It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milano
(Italy)
Manufacturer
ELPEN PHARMACEUTICAL Co. Inc.
Marathonos Avenue 95
190 09 Pikermi (Attiki)
Greece
This medicine is authorized in the Member States of the European Economic Area under the
following names:
Italy: Tikata
Spain: Tikata 90 mg comprimidos recubiertos con película EFG