Possia
ticagrelor
ticagrelor
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 them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What Possia is and what it is used for
What you need to know before you take Possia
How to take Possia
Possible side effects
How to store Possia
Contents of the pack and other information
Medicinal product no longer authorised
Possia contains the active substance called ticagrelor. This belongs to a group of medicines called
anti-platelet medicines.
Possia affects cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged.
However, platelets can also form clots inside diseased blood vessels in the heart and brain. This can be very dangerous because:
the clot can cut off the blood supply completely - this can cause a heart attack (myocardial
infarction) or stroke, or
the clot can partly block the blood vessels to the heart - this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina’).
Possia helps stop the clumping of platelets. This reduces the chance of a blood clot forming that can reduce blood flow.
Possia is to be used in adults only. You have been given Possia because you have had:
a heart attack, or
unstable angina (angina or chest pain that is not well controlled).
Possia reduces the chances of you having another heart attack or a stroke or of dying from a disease related to your heart or blood vessels.
You are allergic (hypersensitive) to ticagrelor or any of the other ingredients of Possia (listed in section 6).
You are bleeding now or have bled recently inside your body, such as bleeding in your stomach or gut from an ulcer.
You have moderate to 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).
You have had a stroke caused by bleeding in the brain.
Do not take Possia if any of the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Possia.
Check with your doctor, pharmacist or dentist before taking Possia if:
You have an increased risk of bleeding because of:
a recent serious injury
recent surgery (including dental work)
you have a condition that affects blood clotting
recent bleeding from your stomach or gut (such as a stomach ulcer or colon ‘polyps’)
You are due to have surgery (including dental work) at any time while taking Possia. This is
because of the increased risk of bleeding. Your doctor may want you to stop taking Possia 7 days prior to surgery.
Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not
already have in place a device that paces your heart (pacemaker).
You have asthma or other lung problem or breathing difficulties.
Medicinal product no longer authorised
You have had a blood test that showed more than the usual amount of uric acid
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or dentist before taking Possia.
Children
Possia is not recommended for children and adolescents under 18 years.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines that you buy without a prescription, dietary supplements and herbal remedies. This is because Possia can affect the way some medicines work and some medicines
can have an effect on Possia.
Tell your doctor or pharmacist if you are taking any of the following medicines:
more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high cholesterol)
rifampicin (an antibiotic), phenytoin, carbamazepine and phenobarbital (used to control seizures), dexamethasone (used to treat inflammatory and auto immune conditions), digoxin
(used to treat heart failure), cyclosporin (used to lessen your body’s defenses), quinidine and
diltiazem (used to treat abnormal heart rhythms), beta blockers and verapamil (used to treat high blood pressure).
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that increase your risk of bleeding:
‘oral anticoagulants’ often referred to as ’blood thinners’ which include warfarin.
non-steroidal anti-inflammatory drugs (abbreviated as NSAIDs) often taken as pain killers such as ibuprofen and naproxen.
selective serotonin reuptake inhibitors (abbreviated as 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 migraines and headaches).
Also tell your doctor that because you are taking Possia, you may have an increased risk of bleeding if your doctor gives you fibrinolytics, often called ‘clot dissolvers’, such as streptokinase or alteplase.
You can take Possia with or without food.
It is not recommended to use Possia if you are pregnant or may become pregnant. Women should use
appropriate contraceptive measures to avoid pregnancy while taking this medicine.
Talk to your doctor before taking Possia if you are breast-feeding. Your doctor will discuss with you the benefits and risks of taking Possia during this time.
Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast- feeding.
Possia is not likely to affect your ability to drive or use machines.
Medicinal product no longer authorised
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The starting dose is two tablets at the same time (loading dose of 180 mg). This dose will usually be given to you in the hospital.
After this starting dose, the usual dose is one tablet of 90 mg twice a day for up to 12 months unless your doctor tells you differently. Take Possia around the same time everyday (for example, one tablet in the morning and one in the evening).
Your doctor will usually also tell you to take acetylsalicylic acid. This is a substance present in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75-150 mg daily).
You can take the tablet with or without food.
You can check when you last took a tablet of Possia by looking on the blister. There is a sun (for the morning) and a moon (for the evening). This will tell you whether you have taken the
dose.
If you take more Possia than you should, talk to a doctor or go to hospital straight away. Take the
medicine pack with you. You may be at increased risk of bleeding.
If you forget to take a dose, just take your next dose as normal.
Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
Do not stop taking Possia without talking to your doctor. Take Possia on a regular basis and for as long as your doctor keeps prescribing it. If you stop taking Possia, it may increase your chances of having another heart attack or stroke or dying from a disease related to your heart or blood vessels.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
The frequency of possible side effects listed below is defined using the following convention: common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10
users in 10,000).
sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body
sudden confusion, difficulty speaking or understanding others
sudden difficulty in walking or loss of balance or co-ordination
suddenly feeling dizzy or sudden severe headache with no known cause
These are signs of a kind of stroke caused by bleeding into the brain. This is uncommon.
Medicinal product no longer authorised
nosebleed (common)
blood in your urine (uncommon)
black stools or blood in your stools (common)
blood in your eye (uncommon)
coughing up or bringing up blood (uncommon)
vaginal bleeding that is heavier, or happens at different times, to your normal period
(menstrual) bleeding (uncommon)
bleeding after surgery or from cuts and wounds that is more than normal (common)
bleeding from your stomach lining (ulcer) (uncommon).
bleeding gums (uncommon)
blood in your ear (rare)
internal bleeding (rare)
bleeding into joints causing painful swelling (rare)
lasts a long time, tell your doctor. Your doctor will decide if it needs treatment or further investigations.
Bruising
Allergic reaction – a rash, itching, or a swollen face or swollen lips/tongue may be signs of an allergic reaction (see section 2: What you need to know before you take Possia).
Headache
Feeling dizzy or like the room is spinning
Abdominal pain
Diarrhoea or indigestion
Feeling or being sick
Rash
Itching
Inflamed stomach (gastritis)
Constipation
A tingling feeling
Confusion
If you get any side effects, talk to your doctor or pharmacist, but do not stop taking Possia until you have spoken to them. This includes any possible side effects not listed in this leaflet.
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicinesvia wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use . These measures will help to protect the environment.
Medicinal product no longer authorised
The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
The other ingredients are:
Tablet core: mannitol (E421), dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl-cellulose (E463), magnesium stearate (E470b)
Tablet film coating: hypromellose (E464), titanium dioxide (E171), talc, polyethylene-glycol 400, and ferric oxide yellow (E172).
Film-coated tablet (tablet): The tablets are round, biconvex, yellow, film-coated marked with a “90”
above “T” on one side.
Possia is available in:
standard blisters (with sun/moon symbols) in cartons of 60 and 180 tablets
calendar blisters (with sun/moon symbols) in cartons of 14, 56 and 168 tablets
perforated blisters in a carton of 100x1 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder: AstraZeneca AB
S-151 85
Södertälje Sweden
Manufacturer: AstraZeneca AB Gärtunavägen SE-151 85
Södertälje Sweden
Manufacturer: AstraZeneca UK Limited Silk Road Business Park
Macclesfield, Cheshire, SK10 2NA United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AstraZeneca България ЕООД Teл.: +359 2 971 25 33
AstraZeneca kft
Tel.: + 36 1 883 6500
Medicinal product no longer authorised
AstraZeneca Czech Republic s.r.o Tel: +420 222 807 111
Associated Drug Co. Ltd Tel: + 356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca
Tel: +372 6549 600
AstraZeneca AS
Tlf: + 47 21 00 64 00
AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
AstraZeneca A.E.
Τηλ: + 30 2 106871500
AstraZeneca Pharma Poland Sp. z o.o. Tel.: + 48 22 874 35 00
Laboratorios Almirall, S.A. Tel: + 34 93 31 28 748
Medinfar Produtos Farmacêuticos, S.A. Tel: + 351 21 499 74 00
AstraZeneca
Tél: + 33 1 41 29 40 00
AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: + 353 1609 7100
AstraZeneca Pharma SRL Tel: + 40 21 317 60 41
AstraZeneca UK Limited Tel: + 386 1 51 35 600
Vistor hf
Sími: + 354 535 7000
AstraZeneca S.p.A. Tel: + 39 02 98011
AstraZeneca Oy
Puh/Tel: + 358 10 23 010
Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305
AstraZeneca AB
Tel: +46 8 553 26 000
SIA AstraZeneca Latvija Tel: + 371 67377100
UAB AstraZeneca Tel: +370 5 2660550
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