ADENURIC 120 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Adenuric®

80 mg film-coated tablets febuxostat

120 mg film-coated tablets febuxostat

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

• 2. Before you take ADENURIC

• 3. How to take ADENURIC

• 4. Possible side effects

• 5 How to store ADENURIC

• 6. Further information

1. what adenuric is and what it is used for

ADENURIC tablets are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble. When this happens, urate crystals may form in and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi (TOE-FI) may form in and around joints. These tophi may cause joint and bone damage.

ADENURIC works by reducing uric acid levels. Keeping uric acid levels low by taking ADENURIC once every day stops crystals building up, and over time it reduces symptoms. Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi.

• 2. BEFORE YOU TAKE ADENURIC

Do not take ADENURIC if you are:

• If you are allergic (hypersensitive) to febuxostat, the active ingredient of ADENURIC, or any of the other ingredients in these tablets.

Take special care with ADENURIC

Tell your doctor before you start to take this medicine:

• If you have or have had heart failure or heart problems
• If you are being treated for high uric acid levels as a result of cancer disease or Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
• If you have thyroid problems

If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with ADENURIC.

For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. Not everyone gets flares, but you could get a flare-up even if you are taking ADENURIC, and especially during the first weeks or months of treatment. It is important to keep taking ADENURIC even if you have a flare, as ADENURIC is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if you keep taking ADENURIC every day.

Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint).

Your doctor may ask you to have blood tests to check that your liver is working normally.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with ADENURIC and your doctor may wish to consider necessary measures:

• Mercaptopurine (used to treat cancer)
• Azathioprine (used to reduce immune response)
• Theophylline (used to treat asthma)
• Warfarin (used to thin your blood if you have a heart condition)

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CODE ARTICLE 7049050	DESCRIPTIF TECHNIQUE DE L’ARTICLE NOTICE DOUBLE ADENURIC 80 mg / 120 mg / UK – IE		COULEUR(S) PANTONE DANS L’ORDRE PREVU D’IMPRESSION :		TRAMES : LINEATURE : 150 LPI INCLINAISON :
LAIZE 157,5 mm			H8H		DU NOIR
			151		DU NOIR
DIMENSIONS 250 X 157,5 mm	z Patheon Performance the Woritl Over
RECTO P. 1
			CODE LEATUS : 162

Taking ADENURIC with food and drink

The tablets should be taken by mouth and can be taken with or without food.

Pregnancy and breast-feeding

It is not known if ADENURIC may harm your unborn child. Tell your doctor if you think you are pregnant or if you are planning to become pregnant as ADENURIC should not be used during pregnancy. It is not known if ADENURIC may pass into human breast milk. You should not use ADENURIC if you are breast feeding, or if you are planning to breastfeed.

Driving and using machines

No studies on the effects of ADENURIC on the ability to drive and use machines have been performed. However, you should be aware that you may experience dizziness, sleepiness and numbness or tingling sensation during treatment and should not drive or operate machines if affected.

Important information about some of the ingredients of ADENURIC

ADENURIC tablets contain lactose (a type of sugar). If you have been told that you have an intolerance to some sugars contact your doctor before taking this medicine.

3. HOW TO TAKE ADENURIC

Always take ADENURIC exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

ADENURIC is available as either an 80 mg tablet or a 120 mg tablet. Your doctor will have prescribed the strength most suitable for you.

• The usual dose is one tablet daily. The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day.
• The tablets should be taken by mouth and can be taken with or without food.

It is important that you do not stop taking ADENURIC unless your doctor tells you to.

Continue to take ADENURIC every day even when you are not experiencing gout flare or attack.

If you take more ADENURIC than you should

In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.

If you forget to take ADENURIC

If you miss a dose of ADENURIC take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

If you stop taking ADENURIC

Do not stop taking ADENURIC without the advice of your doctor even if you feel better. If you stop taking ADENURIC your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys.

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

4. POSSIBLE SIDE EFFECTS

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

Common side effects (more than 1 in 100 patients but less than 1 in 10 patients) are:

• abnormal liver test results
• diarrhoea
• headache
• rashes
• feeling sick

Uncommon side effects (more than 1 in

1,000 patients but less than 1 in 100 patients) are:

• weight gain, increased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels
• erectile difficulties and/or loss of sex drive
• difficulty in sleeping
• dizziness, numbness or tingling sensation, sleepiness, impaired sense of taste, reduction in sensation of touch
• abnormal ECG heart tracing
• hot flushes or blushing (e.g. redness of the face or neck), increased blood pressure
• cough, shortness of breath, flu-like symptoms
• dry mouth, abdominal pain/discomfort or wind, heartburn/indi­gestion, constipation, more frequent passing of stools
• vomiting
• itching, hives, skin inflammation or discolouration, other type of skin conditions

2

DEFILEMENT

Dimensions:	157.5 × 250 mm	Component code: 1004648	RE-PROOF	□
Profile ref: n/a Specification: Notice double en rouleau		Presentation: Adenuric Territory: UK/IE Language: English	Preliminary PDF Approved	□
ICN: Draft No.: Artwork Amend Date:	00608D FOUR 21/09/09		Final SET A artwork Approved^
		Print supplier: Patheon	Release ready	□
Colours:	PMS 281	S IP5EIM	TICK RELEVANT BOX AND SIGN
Barcode type:	Pharma 162	lnnovtrtfo<Tfor patient care Global Packaging Development Ipsen Ltd., 190 Bath Road,	Signature:
Patheon profile:	n/a
Back	(Page 2)	Slough, Berkshire, SL1 3XE, UK Tel: +44 (0) 1753 627700
Perforation:	n/a	Fax: +44 (0) 1753 627886	Date:

CODE ARTICLE 7049050	DESCRIPTIF TECHNIQUE DE L’ARTICLE NOTICE DOUBLE ADENURIC 80 mg / 120 mg / UK – IE		COULEUR(S) PANTONE DANS L’ORDRE PREVU D’IMPRESSION :		TRAMES : LINEATURE : 150 LPI INCLINAISON :
LAIZE 157,5 mm			H8H		DU NOIR
DIMENSIONS 250 X 157,5 mm	z Patheon Performance the Woritl Over
VERSO P. 2
			CODE LEATUS : 162

• muscle cramp, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness)
• blood in the urine, abnormal frequent urination, kidney stones, abnormal urine tests (increased level of proteins in urine), a reduction in the ability of the kidneys to function properly
• fatigue, localised swelling due to the retention of fluids in the tissues (oedema)
• changes in blood chemistry or amount of blood cells (abnormal blood test results)

Rare side effects (more than 1 in 10,000 patients but less than 1 in 1,000 patients) a­re:

• weakness
• nervousness
• feeling thirsty
• feeling your heartbeat

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ADENURIC

• Keep out of the reach and sight of children.
• Do not use after the expiry date which is stated on the carton and the tablet blister foil after ‘EXP.’ The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.

What ADENURIC looks like and contents of the pack

ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule shaped.

The 80 mg film-coated tablets are marked on one side with ‘80’. The 120 mg film-coated tablets are marked on one side with ‘120’.

ADENURIC is supplied in 2 blisters of 14 tablets (28 tablet pack), or 6 blisters of 14 tablets (84 tablet pack). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg Luxembourg

Manufacturer

Patheon France

40 boulevard de Champaret

38300 Bourgoin Jallieu

France

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency (EMEA) website

6. FURTHER INFORMATION

What ADENURIC contains

The active substance is febuxostat.

Each tablet contains 80 mg or 120 mg of febuxostat.

The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropyl­cellulose, croscarmellose sodium, colloidal hydrated silica.

Film-coating: Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide yellow (E172)

3

Dimensions:	157.5 × 250 mm	Component code: 1004648	RE-PROOF	□
Profile ref: n/a Specification: Notice double en rouleau		Presentation: Adenuric Territory: UK/IE Language: English	Preliminary PDF Approved	□
ICN: Draft No.: Artwork Amend	00608D FOUR Date: 21/09/09		Final SET A artwork Approved^
		Print supplier: Patheon	Release ready	□
Colours:	Black, PMS 281, 185	S IP5EIM	TICK RELEVANT BOX AND SIGN
Barcode type:	Pharma 162	Innovation-far patient care Global Packaging Development Ipsen Ltd., 190 Bath Road,	Signature:
Patheon profile:	n/a
Front	(Page 3)	Slough, Berkshire, SL1 3XE, UK Tel: +44 (0) 1753 627700
Perforation:	n/a	Fax: +44 (0) 1753 627886	Date:

CODE ARTICLE 7049050	DESCRIPTIF TECHNIQUE DE L’ARTICLE NOTICE DOUBLE ADENURIC 80 mg / 120 mg / UK – IE		COULEUR(S) PANTONE DANS L’ORDRE PREVU D’IMPRESSION :		TRAMES : LINEATURE : 150 LPI INCLINAISON :
LAIZE 157,5 mm			281		DU NOIR
			Noir		DU NOIR
DIMENSIONS 250 X 157,5 mm	z Patheon Performance the Woritl Over				DU NOIR
RECTO P. 3
			CODE LEATUS : 162