Patient leaflet - Elstabya 80 mg film-coated tablets
1. What ELSTABYA is and what it is used for
ELSTABYA 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.
ELSTABYA works by reducing uric acid levels. Keeping uric acid levels low by taking ELSTABYA 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.
ELSTABYA 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.
ELSTABYA is for adults.
2. What you need to know before you take ELSTABYA
Do not take ELSTABYA:
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 ELSTABYA: · if you have or have had heart failure, heart problems
or stroke
if you have or have had kidney disease and/or serious
allergic reaction to Allopurinol (a medicine 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 ELSTABYA, 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 ELSTABYA.
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 ELSTABYA at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him/her 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 before first starting treatment with ELSTABYA.
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 ELSTABYA, and especially during the first weeks or months of treatment. It is important to keep taking ELSTABYA even if you have a flare, as ELSTABYA is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if you keep taking ELSTABYA 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 ELSTABYA
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 ELSTABYA 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 ELSTABYA may harm your unborn child. ELSTABYA should not be taken during pregnancy. It is not known if ELSTABYA may pass into human breast milk. You should not take ELSTABYA 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.
ELSTABYA contains lactose
ELSTABYA 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.
ELSTABYA contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
3. How to take ELSTABYA
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended 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.
Gout
ELSTABYA 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 ELSTABYA 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
ELSTABYA is available as a 120 mg tablet. Start taking ELSTABYA two days before chemotherapy and continue its use according to your doctor's advice. Usually treatment is short-term.
If you take more ELSTABYA 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 ELSTABYA
If you miss a dose of ELSTABYA, 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 ELSTABYA
Do not stop taking ELSTABYA without the advice of your doctor even if you feel better. If you stop taking ELSTABYA, 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
Common: may affect up to 1 in 10 people: · 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)
- dizziness
- shortness of breath
- itching
- pain in extremity, pain/ache in muscles/joints · fatigue
Other side effects which are not mentioned above are listed below.
Uncommon: may affect up to 1 in 100 people: · 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
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 (hemorrhage, seen only in patients taking chemotherapy for blood disorders)
cough, chest discomfort or pain, inflammation of nasal
passage and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection · dry mouth, abdominal pain/discomfort or wind,
abdominal pain upper, heartburn/indigestion, constipation, more
frequent passing of stools, vomiting, stomach
discomfort
itching rash, 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, increased sweating, night sweating, alopecia, reddening of the skin (erythema), psoriasis, eczema, other types of skin conditions muscle cramp, muscle weakness, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), back pain, muscle spasm, muscle and/or joint stiffness
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, urinary tract infection · 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
decreased activity of thyroid gland, blurred vision,
change in vision
- ringing in the ears
- runny nose
- mouth ulceration
inflammation of the pancreas: common symptoms are
abdominal pain, nausea and vomiting
- urgent need to urinate
- pain
- malaise
- INR increased
- contusion
- lip swelling
Rare: may affect up to 1 in 1,000 people:
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 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) · rash in various types (e.g. 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 skin and mucous membranes, resulting in peeling and possible serious infection (Stevens-Johnson Syndrome/Toxic epidermal necrolysis)
- nervousness
feeling thirsty
- weight decrease, increased appetite, uncontrolled loss of appetite (anorexia)
- abnormally low blood cell counts (white or red blood cells or platelets)
- changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis)
- inflammation of the liver (hepatitis)
- yellowing of the skin (jaundice)
- infection of the bladder
- liver damage
- increased level of creatine phosphokinase in blood (an indicator of muscle damage)
- sudden cardiac death
- low red blood cell counts (anaemia)
- depression
- sleep disturbance
- loss of sense of taste
- burning sensation
- vertigo
- circulatory failure
- lung infection (pneumonia)
- mouth sores; inflammation of the mouth · gastrointestinal perforation
- rotator cuff syndrome
- polymyalgia rheumatic
- feeling hot
- sudden vision loss due to blockage of an artery in the eye
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to United Kingdom' s
Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ELSTABYA
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 the tablet blister foil after “EXP”. The expiry date refers to the last day of that month.
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 ELSTABYA contains
The active substance is febuxostat.
Each tablet contains 80 mg of febuxostat (as magnesium salts).
Each tablet contains 120 mg of febuxostat (as magnesium salts).
The other ingredients are
Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium oxide, silica colloidal anhydrous, magnesium stearate
Tablet coating: Coating medium (yellow) containing:
polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172)
What ELSTABYA looks like and contents of the pack
ELSTABYA 80 mg film-coated tablets
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “80” on one side, 17.2 ± 0.2 mm in length, 6.2 ± 0.2 mm in width, 5.6 ± 0.2 mm in thickness.
ELSTABYA 120 mg film-coated tablets
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side, 19.2 ± 0.2 mm in length, 8.2 ± 0.2 mm in width, 6.1 ± 0.2 mm in thickness.
ELSTABYA is packed in a cardboard box containing the appropriate number of transparent PVC/PCTFE-Aluminium foil blisters (Aclar) with an instruction leaflet.
Pack sizes:
Cartons containing 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Amarox Limited
Congress House
14 Lyon Road
Harrow, Middlesex
HA1 2EN
United Kingdom
Manufacturers
Pharmathen S.A.
Dervenakion 6, Pallini 15351, Attiki Greece
Or
Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
Or
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
MALTA.
This leaflet was last revised in 03/2022
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