Zurampic - patient leaflet, side effects, dosage

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Grünenthal GmbH

Zieglerstr. 6

52078 Aachen

Germany

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

Periodic safety update reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

D. CONDITIONS OR RESTRICTIONS WITH R

Risk Management Plan (RMP)

ilance activities and interventions detailed in the

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be su

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being

conduct post-authorisation measures

all complete, within the stated timeframe, the below measures:

^DeSCription	Due date
Non-interventional post-authorisation safety study (PASS): In order to investigate the cardiovascular risk in association with lesinurad exposure, mainly in patients with a history of cardiovascular disorders, the MAH shall conduct and submit the results of an observational prospective study according to an agreed protocol.	2Q 2019

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

• 1. NAME OF THE MEDICINAL PRODUCT

Zurampic 200 mg film-coated tablets lesinurad

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg lesinurad

10 film-coated tablets

28 film-coated tablets

30 film-coated tablets

98 film-coated tablets

100 × 1 film-coated tablets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION X?

Read the package leaflet before use.

Oral use _

• 6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

THER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

  Lot

  Medicinal product subject to medical prescripti

  zurampic 200 mg

  17.

  <2D b

  Grünenthal GmbH Zieglerstr. 6 52078 Aachen Germany

  15. INSTRUCTIONS ON US

  12. MARKETING AUTHORISATION NUMBER(S)

  13. BATCH NUMBER

  16. INFORMATI

  14. GENERAL CLASSIFICATION FOR S

  EU/1/15/1080/001 10 film-coated tablets

  EU/1/15/1080/002 28 film-coated tablets

  EU/1/15/1080/003 30 film-coated tablets

  EU/1/15/1080/004 98 film-coated tablets

  EU/1/15/1080/­005 100×1 film-coated tablets (unit dose)

  ILLE

  DENTIFIER – 2D BARCODE

  UNIQUE IDENTIFIER – HUMAN READABLE DATA

  
  

  carrying the unique identifier included>

  
  

< PC: {number} SN: {number} NN: {number}>

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER NON-PERFORATED (10 TABLETS)

BLISTER PERFORATED UNIT DOSE

CALENDAR BLISTER (14 TABLETS)

1. NAME OF THE MEDICINAL PRODUCT

Zurampic 200 mg tablets

Package leaflet: Information for the Patient

Zurampic 200 mg film-coated tablets lesinurad

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 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. See section 4.

What is in this leaflet

• 1. What Zurampic is and what it is used for

• 2. What you need to know before you take Zurampic

• 3. How to take Zurampic

• 4. Possible side effects

• 5. How to store Zurampic

• 6. Contents of the pack and other information \°

1. What Zurampic is and what it is used for

Zurampic contains the active ingredient lesinurad and is used to treat gout in adult patients by lowering the levels of uric acid in the blood. Zurampic must be taken together with allopurinol or febuxostat, which are medicines called ‘xanthine oxidase inhibitors’ and are also used to treat gout by lowering the amount of uric acid in your blood.

Your doctor will prescribe Zurampic if your current medicine is not controlling your gout. You must use Zurampic together with either allopurinol or febuxostat.

How Zurampic works:

Gout is a type of arthritis caused by an accumulation of urate crystals around the joints. By lowering the amount of uric acid in the blood, Zurampic stops this accumulation and may prevent further joint damage.

2. What you need to know before you take Zurampic

Do not take Zurampic:

• – if you are allergic to lesinurad or any of the other ingredients of this medicine (listed in section

6)

• – if you have ‘tumour lysis syndrome’ – a fast breakdown of cancer cells which can cause high

uric acid levels

if you have ‘Lesch-Nyhan syndrome’ – a rare inherited illness that starts in childhood where there is too much uric acid in the blood

if your kidneys work very poorly or you have ‘End-Stage Kidney Disease’

if you have received a kidney transplant

if you are on kidney dialysis.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Zurampic.

Look out for side effects

Zurampic may cause serious kidney problems (see section 4), which occur more frequently if Zurampic is taken alone (see section 3). Your doctor may ask you to have tests to check how your kidneys are working.

Tell your doctor before taking Zurampic if you have or have had heart failure or other heart proble

If your gout gets worse

Some people may have more gout attacks (gout flares) when they start using Zurampic and during the first weeks or months of treatment. If this happens, keep taking Zurampic and talk to your doctor or pharmacist. The medicine is still working to lower uric acid. Over time, your gout attacks will happen less often if you keep taking Zurampic as advised by your doctor.

Your doctor may give you other medicines such as ‘colchicine’ and ‘nonsteroidal anti-inflammatory drugs (NSAIDs)’. These are to help prevent or treat the symptoms of gout attacks (a sudden or severe pain and swelling in a joint). Your doctor will tell you how long to take these other medicines for.

Tests and checks

Your doctor will check how well your kidneys are working befo ing and during treatment with

Zurampic. Your doctor may consider stopping Zurampic if your blood tests indicate changes in how your kidneys are working (blood creatinine levels increase) or if you experience symptoms of kidney problems. Your doctor may tell you to restart treatment with Zurampic when your kidney function improves.

Children and adolescents

Zurampic is not recommended for use in children and adolescents below 18 years of age.

taking, have recently taken or might take any other can affect the way some other medicines work. Also some other pic works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines as they may interact with pic and your doctor will need to know:

Jic acid – to relieve fever and pain – at doses above 325 mg per day o treat high blood pressure, e.g. amlodipine ines to treat high cholesterol levels, e.g. simvastatin nazole – to treat fungal infections amiodarone – to treat heart rhythm problems valproic acid, valpromide or carbamazepine – to treat fits (seizures), mood disorders and prevent migraines sildenafil – to treat erectile dysfunction contraceptives – used to prevent pregnancy, including oral contraception (such as ‘the pill’), injections, patches and implants rifampin – to treat tuberculosis warfarin – to prevent and treat blood clots forming in the legs, lungs, brain and heart.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Zurampic.

Pregnancy and breast-feeding

You should avoid taking Zurampic during pregnancy or if you are breast-feeding.

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

Driving and using machines

Zurampic is not expected to affect you being able to drive a car or use any tools or machines.

Zurampic contains lactose

Zurampic tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Zurampic

Always take this medicine exactly as your doctor or pharmacist has told you. Check w or pharmacist if you are not sure.

Zurampic must always be taken together with your morning dose of either allopurinol or febuxostat. Failure to follow these instructions may increase the risk of kidney side effects (see section 4).

How much to take

The recommended dose is 1 tablet of 200 mg once a day in the tablet of Zurampic per day.

Taking this medicine

• – take in the morning with food and water

• – take Zurampic at the same time as your morningjdose of ‘xanthine oxidase inhibitor’ medicine –

allopurinol or febuxostat. If you take Zurampic on its own you may be more likely to get kidney problems

g the day. Two litres is a good amount to drink.

If you stop taking your xanthine oxidase inhibitor medicine, you must also stop taking Zurampic. Zurampic must never be taken without a ‘xanthine oxidase inhibitor’ medicine. Failure to follow these instructions may increase the risk of kidney side effects.

If you take more Zurampic than you should

If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital.

If you forget to take Zurampic

If you missse of Zurampic, do not take a double dose to make up for a forgotten dose. Wait and take your nose of Zurampic with your next morning dose of allopurinol or febuxostat. Ask your doctor or pharmacist if you are not sure about how to take your next dose.

If you stop taking Zurampic

Do not stop taking Zurampic without the advice of your doctor even if you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects – Uncommon - may affect up to 1 in 100 people

Stop taking Zurampic and see a doctor straight away if you notice any of the following side effects, as these may be signs of a problem with your kidneys – you may need urgent medical treatment:

• – pain in your side (below your ribs and above your hipbone),

• – feeling sick (nausea), being sick (vomiting),

• – changes in urination or difficulty urinating,

• – feeling tired or unwell or loss of appetite.

Other side effects include:

Common – may affect up to 1 in 10 people

• – flu (influenza),

• – headache,

• – increase in the amount of creatinine in your blood – shown in tests,

• – heartburn (acid reflux).

Uncommon – may affect up to 1 in 100 people

• – kidney stones,

• – dehydration (loss of too much fluid from your body).

Rare – may affect up to 1 in 1000 people

• – skin reactions, including redness, itchy skin, lumpy rash (hives) and skin rash on exposure to

sunshine.

.......

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacistj’his 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 yo^Aanhelp provide more information on the safety of this medicine.

5. How to store Zurampic

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 or blister foil after “EXP”.

The expiry date refers to the last day of that month.

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 Zurampic contains

• – the active substance is lesinurad.

• – each Zurampic 200 mg film-coated tablet (tablet) contains 200 mg of lesinurad.

• – the other ingredients are:

• – tablet core: hypromellose, microcrystalline cellulose, lactose monohydrate (see section 2),

crospovidone, magnesium stearate

• – film-coating: hypromellose, titanium dioxide, triacetin, indigo carmine, brilliant blue FCF.

What Zurampic looks like and contents of the pack

Zurampic 200 mg: a blue, oval, dimensions 5.7 × 12.9 mm, film-coated tablet, engraved with “LES200” on one side.

Zurampic 200 mg tablets are available in clear blisters in pack sizes of 10, 28, 30 or 98 non-perforated blisters and 100 × 1 perforated unit dose blisters.

Not all pack sizes may be marketed.

Norge

Grünenthal Norway AS

C.J. Hambros Plass 2C 0164 Oslo

Tlf: +47 22996054

Österreich

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