Package leaflet: Information for the patient

Zontivity 2 mg film-coated tablets

vorapaxar

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 further questions, ask your doctor, pharmacist, or nurse.
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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Zontivity is and what it is used for
2. What you need to know before you take Zontivity
3. How to take Zontivity
4. Possible side effects
5. How to store Zontivity
  Medicinal product no longer authorised
6. Contents of the pack and other information
1. What Zontivity is and what it is used for What Zontivity is
  Zontivity contains an active substance called vorapaxar, and it belongs to a group of medicines called ‘anti-platelet medicines.’
  
  Platelets are blood cells that help with normal blood clotting. Zontivity prevents platelets from sticking together. This reduces the chance of a blood clot forming and blocking the arteries, such as the arteries in the heart.
  
  What Zontivity is used for
  Zontivity is used in adults who have had a heart attack or have a condition known as "peripheral arterial disease" (also known as poor circulation in the legs).
  
  Zontivity is used to lower your chance of:
having another heart attack or stroke
dying from a heart attack
needing an urgent operation to open blocked arteries in the heart.

Your doctor will also give you instructions about acetylsalicylic acid or clopidogrel (other anti-platelet agents) that you may need to take with Zontivity.
1. What you need to know before you take Zontivity
  
  Do not take Zontivity:
if you have ever had a stroke or ‘mini stroke’ (also called a ‘transient ischemic attack’ or TIA)
if you have had bleeding in the brain
if you have unusual bleeding now, such as bleeding in your brain, stomach or gut
if you are allergic to vorapaxar sulfate or any of the other ingredients of this medicine (listed in section 6)
if you have severe liver disease

Do not take Zontivity if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zontivity.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Zontivity if you:
have had bleeding problems in the past
have had any recent serious injury or surgery
plan to have surgery including dental surgery
have ever had stomach ulcers or small growths in your gut (‘colon polyps’)
have had recent bleeding from the stomach or gut
have active peptic ulcer disease
have liver or kidney problems
have a bodyweight of less than 60 kg
are over 75 years of age

Medicinal product no longer authorised
If any of the above apply to you, or if you are not sure, talk to your doctor, pharmacist, or nurse before taking Zontivity.

Tell all of your doctors and dentists that you are taking Zontivity. They should talk to the doctor who prescribed Zontivity for you before you have any surgery or invasive procedure. Your doctor may advise stopping Zontivity before surgery.

If you have a stroke, ‘mini-stroke’, or bleeding in the brain while taking Zontivity, your doctor ought to stop your Zontivity. Follow your doctor's instructions about stopping Zontivity.

In general, use of anti-platelet medicines, older age, or a low body weight increase the risk of bleeding. Your doctor will decide if this medicine is appropriate for you.

Children and adolescents
Zontivity is not recommended for children and adolescents under 18 years of age. This is because it is not known if Zontivity is safe and works in children and adolescents.

Other medicines and Zontivity
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Zontivity may affect the way other medicines work, and other medicines may affect how Zontivity works. Do not take Zontivity if you are currently being treated with prasugrel or ticagrelor (other anti-platelet agents). If your doctor prescribes you prasugrel or ticagrelor, you should stop Zontivity and talk to your doctor.

It is especially important to tell your doctor if you take:
itraconazole, ketoconazole, posaconazole (used to treat fungal infections)
ritonavir, nelfinavir, indinavir, saquinavir (used to treat HIV-AIDS)
boceprevir, telaprevir (used to treat hepatitis C virus infections)
carbamazepine, phenytoin (anti-seizure medicines)
clarithromycin, telithromycin (used to treat infections)
rifampin (used to treat tuberculosis and some other infections)
nefazodone (used to treat depression)
antacids and pantoprazole (used to treat upset stomach)
digoxin (used to treat heart failure)
warfarin, other oral anticoagulants, heparin, or low molecular weight heparin (blood thinner medicines)

Ask your doctor or pharmacist if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.

It is not known if Zontivity will harm your unborn baby. You and your doctor will decide if you will take Zontivity.

Tell your doctor if you are breast-feeding. This is because it is not known if Zontivity passes into your breast milk. You and your doctor will decide if you will take Zontivity or breast-feed. You should not do both.

Driving and using machines
Zontivity is not likely to affect your ability to drive or use machines.

Zontivity and lactose
Medicinal product no longer authorised
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor, pharmacist, or nurse before taking Zontivity.
1. How to take Zontivity
  
  Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  
  The recommended dose is one tablet by mouth each day taken with or without food.
  
  It may take at least 7 days for Zontivity to start working. Your doctor will determine if you should take Zontivity for more than 24 months.
  
  Your doctor will determine if you should also take aspirin, clopidogrel, or both, while taking Zontivity.
  
  If you take more Zontivity than you should
  If you take more Zontivity than you are supposed to, 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 Zontivity
If you forget a dose, take it as soon as you remember. However, if it is within 12 hours of the next dose, skip the missed dose.
Do not take a double-dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Zontivity
Do not stop taking Zontivity without first talking to the doctor who prescribed it for you.
Take Zontivity on a regular basis and for as long as your doctor keeps prescribing it.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
1. Possible side effects
  
  Like all medicines, this medicine can cause side effects, although not everybody gets them.
  
  Call your doctor straight away if you have any of these symptoms of a stroke, which is uncommon:
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

Severe bleeding is uncommon, but can be life threatening. Call your doctor straight away, if you have any of these signs or symptoms of bleeding while taking Zontivity:
bleeding that is severe or that you cannot control
unexpected bleeding or bleeding that lasts a long time
pink, red, or brown urine
vomiting blood or your vomit looks like ‘coffee grounds’
red or black stools (looks like tar)
coughing up blood or blood clots

Other possible side effects

Common: may affect up to 1 in 10 people
nose bleeds
bruising

Medicinal product no longer authorised
Uncommon: may affect up to 1 in 100 people
low red blood cell count (anaemia)
bleeding gums
bleeding in your eye
bleeding from cuts or wounds that is more than normal
double vision
inflammation of the stomach

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
1. How to store Zontivity
  
  Keep this medicine out of the sight and reach of children.
  
  Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
  
  Store in the original package in order to protect from moisture.
  
  This medicinal product does not require any special temperature storage conditions.
  
  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2. Contents of the pack and other information
What Zontivity contains
The active substance is vorapaxar sulfate. Each tablet contains 2.08 mg of vorapaxar (as vorapaxar sulfate).
The other ingredients are:

Tablet core: lactose monohydrate; cellulose microcrystalline (E460); croscarmellose sodium (E468); povidone (E1201); magnesium stearate (E572).

Film-coating: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin (E1518); iron oxide yellow (E172).

What Zontivity looks like and contents of the pack

Tablets are yellow, oval-shaped, film-coated tablets, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.

Pack sizes

Packs of 7, 28, 30 and 100 tablets in aluminium blister cards. Packs of 10 and 50 tablets in aluminium unit-dose blister cards. Not all pack sizes may be marketed.