Febuxostat Mylan - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Febuxostat Mylan 80 mg film-coated tablets Febuxostat Mylan 120 mg film-coated tablets febuxostat

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 Febuxostat Mylan is and what it is used for

• 2. What you need to know before you take Febuxostat Mylan

• 3. How to take Febuxostat Mylan

• 4. Possible side effects

• 5. How to store Febuxostat Mylan

• 6. Contents of the pack and other information

1. What Febuxostat Mylan is and what it is used for

Febuxostat Mylan tablets contain the active substance febuxostat and 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 may form in and around joints. These tophi may cause joint and bone damage.

Febuxostat Mylan works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat Mylan 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.

Febuxostat Mylan 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.

When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented.

Febuxostat Mylan is for adults.

2. What you need to know before you take Febuxostat Mylan

Do not take Febuxostat Mylan

• If you are allergic to febuxostat or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor before taking Febuxostat Mylan:

• If you have or have had heart failure, heart problems or stroke
• If you have or have had renal disease and/or serious allergic reaction to allopurinol (a

medication used for the treatment of Gout)

• If you have or have had liver disease or liver function test abnormalities
• If you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a

rare inherited condition in which there is too much uric acid in the blood)

• If you have thyroid problems.

Should you experience allergic reactions to Febuxostat Mylan, stop taking this medicine (see also section 4). Possible symptoms of allergic reactions might be:

• – rash including severe forms (e.g. blisters, nodules, itchy, exfoliative rash), itchiness

• – swelling of limbs or face

• – difficulties in breathing

• – fever with enlarged lymph nodes

• – but also serious life threatening allergic conditions with cardiac and circulatory arrest.

Your doctor might decide to permanently stop treatment with Febuxostat Mylan.

There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of febuxostat, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk. It may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin.

If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be re-started on Febuxostat Mylan at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell them that you are taking this medicine.

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 first before starting treatment with Febuxostat Mylan.

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 Febuxostat Mylan, and especially during the first weeks or months of treatment. It is important to keep taking Febuxostat Mylan even if you have a flare, as Febuxostat Mylan is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat Mylan 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).

In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones, even though this has not been observed in patients being treated with febuxostat for Tumor Lysis Syndrome.

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

Children and adolescents

Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established.

Other medicines and Febuxostat Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 Febuxostat Mylan 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)

Pregnancy and breast-feeding

It is not known if febuxostat may harm your unborn child. Febuxostat Mylan should not be used during pregnancy. It is not known if febuxostat may pass into human breast milk. You should not use Febuxostat Mylan if you are breast-feeding, or if you are planning to breast-feed.

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

Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.

Febuxostat Mylan contains lactose and sodium

Febuxostat Mylan 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 medicine.

Febuxostat Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Febuxostat Mylan

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

• The usual dose is one tablet daily. The back of the calendar 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.

Gout

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

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

Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy Febuxostat Mylan is available as a 120 mg tablet.

Start taking Febuxostat Mylan two days before chemotherapy and continue its use according to your doctor’s advice. Usually treatment is short-term.

If you take more Febuxostat Mylan 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 Febuxostat Mylan

If you miss a dose of Febuxostat Mylan 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 Febuxostat Mylan

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

If you stop taking Febuxostat Mylan 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow:

• anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and

precautions”)

• potentially life-threatening skin rashes characterised by formation of blisters and

shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens- Johnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS) (see section 2)

• generalised skin rashes

Other side effects which are not mentioned above are listed below.

Common side effects (may affect up to 1 in 10 people) are:

• abnormal liver test results
• diarrhoea
• headache
• rash (including various types of rash, please see below under “uncommon” and “rare”

sections)

• nausea
• increase in gout symptoms
• localised swelling due to retention of fluids in tissues (oedema)

Uncommon side effects (may affect up to 1 in 100 people) are:

• decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be

excessive thirst, increased blood fat levels, weight increase

• loss of sex drive
• difficulty in sleeping, sleepiness
• dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or

paraesthesia), altered sense of taste, diminished sense of smell (hyposmia)

abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation)

hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (haemorrhage, seen only in patients taking chemotherapy for blood disorders) cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis

dry mouth, abdominal pain/discomfort or wind, heartburn/indi­gestion, constipation, more frequent passing of stools, vomiting, stomach discomfort

itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, other type of skin

conditions

muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm

blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly fatigue, chest pain, chest discomfort

stones in the gallbladder or in bile ducts (cholelithiasis)

increase in blood thyroid stimulating hormone (TSH) level

changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results)

kidney stones

erectile difficulties

Rare side effects (may affect up to 1 in 1,000 people) are:

• muscle damage, a condition which on rare occasions can be serious. It may cause muscle

problems and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness or weakness

• severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals,

hands, feet or tongue, with possible sudden difficult breathing

• high fever in combination with measles-like skin rash, enlarged lymph nodes, liver

enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (leukocytosis, with or without eosinophilia)

• reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with

blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis)

• nervousness
• feeling thirsty
• ringing in the ears
• blurred vision, change in vision
• hair loss
• mouth ulceration
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and

vomiting

• increased sweating
• weight decrease, increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and/or joint stiffness
• abnormally low blood cell counts (white or red blood cells or platelets)
• urgent need to urinate
• changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial

nephritis)

• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• liver damage
• increased level of creatine phosphokinase in blood (an indicator of muscle damage)
• sudden cardiac death

5. How to store Febuxostat Mylan

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 packaging after ‘EXP.’ The expiry date refers to the last day of that month.

For bottles, after first opening use within 180 days

This medicine does not require any special 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 Febuxostat Mylan contains

The active substance is febuxostat. Each tablet contains 80 mg or 120 mg of febuxostat.

The other ingredients are:

Tablet core : lactose (see section 2, “Febuxostat Mylan contains lactose”), microcrystalline cellulose, magnesium stearate, hydroxypropyl­cellulose, croscarmellose sodium, colloidal hydrated silica, colloidal anhydrous silica, crospovidone and talc.

Film-coating: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin and iron oxide black (E172).

What Febuxostat Mylan looks like and contents of the pack

Febuxostat Mylan film-coated tablets are yellow, capsule shaped, biconvex tablets. The 80 mg tablets are marked with M on one side of the tablet and FX3 on the other side. The 120 mg tablets are marked with M on one side of the tablet and FX4 on the other side.

Febuxostat Mylan 80 mg and 120 mg film-coated tablets are available in blister packs of 14, 28, 42 and 84 tablets, calendar blister packs of 28 and 84 tablets, and perforated unit dose blister packs of 28 × 1 tablets and in multipacks of 84 film-coated tablets comprising 2 packs, each containing 42 film-coated tablets.

Febuxostat Mylan 80 mg and 120 mg film-coated tablets are available in plastic bottles of 28 and 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN

Ireland

Manufacturer

Mylan Hungary Kft

Mylan utca 1

H-2900 Komarom

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

For any information about this medicine, please contact the local representative of the

Marketing

Authorisation Holder.

Belgie/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00 Efcarapua MaöaaH EOOfl Tea: +359 2 44 55 400 Česká republika Mylan Healthcare CZ s.r.o. Tel: +420 222 004 400 Danmark Viatris ApS Tlf: +45 28 11 69 32 Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800

Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288 Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Nederland Mylan BV Tel: +31 (0)20 426 3300

Eesti

BGP Products Switzerland GmbH Eesti filiaal

Tel: + 372 6363 052

EXXáSa

Generics Pharma Hellas EnE

Tql: +30 210 993 6410

España

Mylan Pharmaceuticals, S.L

Tel: + 34 900 102 712

France

Mylan S.A.S

Tel: +33 4 37 25 75 00

Hrvatska

Mylan Hrvatska d.o.o.

Tel: +385 1 23 50 599

Ireland

Mylan Ireland Limited

Tel: +353 1 8711600

Ísland

Icepharma hf

Símí: +354 540 8000

Italia

Mylan Italia S.r.l

Tel: + 39 02 612 46921

Kúnpog

Varnavas Hadjipanayis Ltd

Tql: +357 2220 7700

Latvija

Mylan Healthcare SIA

Tel: +371 676 055 80

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.

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