Zontivity - patient leaflet, side effects, dosage

A.  MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Schering-Plough Labo N.V.

Industriepark 30

BE-2220 Heist-op-den-Berg

Belgium

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

• 1. NAME OF THE MEDICINAL PRODUCT

Zontivity 2 mg film-coated tablets

Vorapaxar

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

  Each film-coated tablet contains 2.08 mg vorapaxar (as vorapaxar sulfate).

  
  

  3. LIST OF EXCIPIENTS

  
  

Contains lactose.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

7 film-coated tablets

10 × 1 film-coated tablets

28 film-coated tablets

30 film-coated tablets

50 × 1 film-coated tablets

100 film-coated tablets

Read the package leaflet before use. Oral use

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Zontivity 2 mg tablets

Vorapaxar

Package leaflet: Information for the patient

Zontivity 2 mg film-coated tablets

vorapaxar

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.

2. 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

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 i 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 mac

Zontivity and lactose

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.

3. 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.

4. 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

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

'CT

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 By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZontivityKe

edicine 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.

6. 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:

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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Bel­gien

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+32(0)27766211)

Efc^rapufl

MepK fflapn u ÆpyM E^jirapua EOOfl

Tea.:+359 2 819 3 737

Malta

Merck Sharp & Dohme Cyprus Limited

Tel: 8007 4433 (+356 99917558)

Deutschland MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)	Nederland Merck Sharp & Dohme BV Tel: 0800 9999000 (+31 23 5153153)
Eesti Merck Sharp & Dohme OÜ Tel.: +372 6144 200	Norge MSD (Norge) AS Tlf: +47 32 20 73 00
EXÀàôa MSD A.O.B.E.E. TnX: +30 210 98 97 300	Österreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00	Polska MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00
France MSD France Tél: + 33 (0) 1 80 46 40 40	Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333	România Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 299 8700 Ísland Vistor hf. Sími: +354 535 7000	Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 201 Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010
Italia MSD Italia S.r.l. Tel: +39 06 361911	Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0) 9 804650
Kùnpoç Merck Sharp & Dohme Cyprus Limited TnX: 800 00 673 (+357 22866700)	Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
Latvija SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 .	United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272

This leaflet was last revised in {MM/YYYY }.

Detailed information on this medicine is available on the European Medicines Agency web site:.

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