Prohidna

Prohidna, 80 mg, coated tablets
Febuxostatum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Prohidna is and what it is used for
2. Important information before taking Prohidna
3. How to take Prohidna
4. Possible side effects
5. How to store Prohidna
6. Contents of the pack and other information

1. What Prohidna is and what it is used for

Prohidna tablets contain the active substance febuxostat and are used in the treatment of
gout, a condition associated with excess of a chemical compound called uric acid (urate) in the body.
In some people, the amount of uric acid in the blood increases and may become too high for the compound to remain dissolved. In such cases, urate crystals may form inside and around joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling of a joint (known as a gout attack). If the disease remains untreated, larger deposits called tophi may form within and around joints. Tophi may lead to joint and bone damage.

Prohidna works by lowering the concentration of uric acid. Maintaining low uric acid levels through daily administration of Prohidna stops the formation of crystals and, over time, reduces symptoms. Sustaining sufficiently low uric acid levels for an adequate duration may also lead to a reduction in tophi.

Prohidna is intended for use in adults.

2. Important information before using Prohidna

When not to use Prohidna:

• if the patient is allergic to febuxostat or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Prohidna, consult a doctor:

• if the patient has or has had heart failure, heart disease, or stroke;
• if the patient currently has or has previously had kidney diseases and/or severe allergic reactions to allopurinol (a medicine used to treat gout);
• if the patient currently has or has previously had liver diseases or abnormal liver function test results;
• if the patient is being treated for high levels of uric acid due to cancer or Lesch-Nyhan syndrome (a rare inherited disorder in which there is too much uric acid in the blood);
• if the patient has thyroid dysfunction.

If an allergic reaction to Prohidna occurs, treatment must be stopped immediately
(see also section 4). Possible symptoms of an allergic reaction include:

• skin rash (including severe forms of rash with blisters, nodules, itching, peeling), itching
• swelling of limbs or face
• difficulty breathing
• fever and enlarged lymph nodes
• severe, life-threatening allergic reactions with cardiac arrest and circulatory collapse.

The doctor may decide to permanently discontinue treatment with Prohidna.
Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported during febuxostat treatment, initially presenting as reddish, concentric spots or round lesions, often with blisters, on the trunk. Symptoms may also include ulceration of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling around the eyes). The rash may spread and lead to peeling and detachment of the outer layer of skin.
If Stevens-Johnson syndrome occurs during febuxostat treatment, Prohidna must never be taken again. In case of skin rash or any of the mentioned skin symptoms, the patient must contact a doctor immediately and inform them about taking febuxostat.
If the patient experiences an acute gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint): treatment with Prohidna should not be started until the gout attack has subsided.
In some people, gout attacks may worsen when starting certain medications that control uric acid levels. Flare-ups do not occur in everyone, but they may occur even when the patient is taking Prohidna, especially during the first weeks or months of treatment. It is important to continue taking Prohidna even if a flare-up occurs, because Prohidna continues to reduce uric acid levels. Over time, gout attacks will become less frequent and less painful if Prohidna is taken daily.
The doctor often prescribes additional medicines, if necessary, to help prevent or treat flare-up symptoms (such as joint pain and swelling).
In patients with very high levels of uric acid (e.g., those receiving chemotherapy for cancer), treatment with uric acid-lowering medicines may lead to xanthine accumulation in the urinary tract, potentially causing kidney stones, although this has not been observed in patients treated with Prohidna for tumor lysis syndrome.
The doctor may order blood tests to check whether liver function is normal.

Children and adolescents
Prohidna must not be used in children under 18 years of age, as the efficacy and safety have not been established.

Prohidna and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
It is especially important to inform the doctor or pharmacist if the patient is taking medicines containing any of the following substances, as they may interact with Prohidna, and the doctor may consider taking necessary actions:

• Mercaptopurine (a medicine used to treat cancer),
• Azathioprine (a medicine used to suppress immune system responses),
• Theophylline (a medicine used to treat asthma).

Pregnancy and breastfeeding
It is not known whether Prohidna may harm the unborn baby. Prohidna must not be used during pregnancy.
It is not known whether Prohidna passes into human breast milk. Prohidna must not be used if the patient is breastfeeding or planning to breastfeed.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Be aware that dizziness, drowsiness, blurred vision, and sensations of numbness or tingling may occur during treatment. If such symptoms occur, the patient must not drive or operate machinery.

Prohidna contains lactose
Prohidna tablets contain lactose (a type of sugar). If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before using this medicine.

Prohidna contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Prohidna

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.

• The recommended dose is one tablet per day. The days of the week are printed on the back of the blister pack to help confirm that a dose has been taken each day.
• Tablets should be taken orally; Prohidna can be taken with or without food.

Gout
Prohidna is available in 80 mg tablets. The physician will prescribe the most appropriate dose for the patient.
Prohidna should be taken every day, even if there is no flare-up or acute gout attack.

Taking more Prohidna than prescribed
In case of accidental overdose, consult a doctor for advice or contact the nearest hospital emergency department immediately.

Missed dose of Prohidna
If a dose of Prohidna is missed, it should be taken as soon as the patient remembers, unless it is almost time for the next dose. In that case, the missed tablet should not be taken; only the next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Prohidna treatment
Do not stop taking Prohidna without medical advice, even if symptoms improve. Stopping treatment with Prohidna may lead to increased uric acid levels and worsening of disease symptoms due to formation of new urate crystals inside and around joints or in the kidneys.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking the medicine and contact your doctor immediately or go to
the nearest emergency department if any of the following rare (occurring in 1 in 1,000
patients) adverse reactions occur, as they may lead to serious conditions:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and precautions").
• potentially life-threatening skin rashes characterized by blister formation and peeling of the skin and internal body surfaces such as the oral cavity and genital organs, painful oral ulcers and (or) genital area accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis) or swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• generalized skin rashes.

Other adverse effects
Common: may occur in 1 in 10 patients:

• abnormal liver function tests,
• diarrhoea,
• headache,
• rash (including various types of rash, see below under "not very common" and "rare"),
• nausea,
• exacerbation of gout symptoms,
• local swelling due to fluid accumulation in tissues (oedema),
• dizziness,
• shortness of breath,
• itching,
• limb pain, muscle or joint pain,
• fatigue.

Other adverse effects not listed above are listed below.
Not very common: may occur in 1 in 100 patients:

• decreased appetite, change in blood sugar levels (diabetes), which may present as excessive thirst, increased blood lipid levels, weight gain,

• loss of libido,

• sleep disorders, drowsiness,

• numbness, tingling, weakness, or altered touch sensation (hypoesthesia, paresis or paraesthesia), taste disturbances, reduced sense of smell (hyposmia),

• abnormalities in ECG heart tracing, irregular or rapid heartbeat, palpitations,

• hot flushes or skin redness (e.g. facial or neck redness), elevated
  blood pressure, bleeding (haemorrhage, observed only in patients undergoing
  chemotherapy for blood disorders),

• cough, shortness of breath, discomfort or chest pain, inflammation of the mucous membranes of the nose and (or) throat (upper respiratory tract infection), bronchitis, upper respiratory tract infection,

• dry mouth, abdominal pain or discomfort or flatulence, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort,

• itchy rash, urticaria, skin inflammation, skin discoloration, small red or purple spots on the skin, small flat red spots on the skin, flat red areas covered with small bumps, rash, local redness and skin spots, excessive sweating, night sweats, hair loss, non-skin redness (flushing), psoriasis, eruption, other types of skin disorders,

• muscle cramps, muscle weakness, muscle or joint pain, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling and (or) stiffness), back pain, muscle cramps, muscle and (or) joint stiffness,

• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), reduced kidney function, urinary tract infection,

• chest pain, discomfort in the chest,

• gallstones in the gallbladder or bile ducts (cholelithiasis),

• increased TSH levels in blood,

• changes in blood chemical composition or blood cell or platelet count (abnormal blood test results),

• kidney stones,

• erectile dysfunction,

• hypothyroidism,

• blurred vision, change in vision,

• tinnitus,

• rhinitis,

• oral ulceration,

• pancreatitis: common symptoms include abdominal pain, nausea and vomiting,

• sudden urge to urinate,

• pain,

• malaise,

• increased INR,

• injury,

• lip swelling.

Rare: may occur in 1 in 1,000 patients:

• muscle damage, a condition which in isolated cases may be severe. Muscle disorders may occur, accompanied by malaise or high body temperature, caused by muscle injury. You should contact your doctor immediately if you experience muscle pain, tenderness or weakness.
• severe swelling of the deep layers of skin, particularly affecting lips, eyes, genitals, hands, feet or tongue, possibly with sudden breathing difficulties,
• high fever associated with vesicular rash, swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leukocytosis with or without eosinophilia),
• various types of rashes (e.g. with white spots, blisters, pustular blisters, skin peeling, vesicular rash), widespread erythema, necrosis, skin and mucosal blisters leading to tissue separation and risk of sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• nervousness,
• feeling thirsty,
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia),
• abnormally low blood cell count (white or red blood cells or platelets),
• changes in urine or reduced urine output associated with kidney inflammation (tubulointerstitial nephritis),
• hepatitis,
• yellowing of the skin (jaundice),
• urinary bladder infection,
• liver damage,
• increased blood creatine phosphokinase activity (a marker of muscle damage),
• sudden death due to cardiovascular causes,
• low red blood cell count (anaemia),
• depression,
• sleep disorders,
• loss of smell,
• burning sensation,
• vertigo of labyrinthine origin,
• circulatory collapse,
• lung infection (pneumonia),
• oral ulceration; inflammation of the oral cavity,
• gastrointestinal tract perforation,
• rotator cuff syndrome,
• polymyalgia syndrome,
• feeling of heat,
• sudden vision loss due to occlusion of an artery in the eye.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps gather more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Prohidna

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the tablet
blister foil after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Prohidna contains

• The active substance is febuxostat. One tablet contains 80 mg of febuxostat (in the form of febuxostat magnesium).
• The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose,
sodium croscarmellose, light magnesium oxide, colloidal anhydrous silica, magnesium stearate.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171),
macrogol 4000, talc, yellow iron oxide (E 172).

What Prohidna looks like and contents of the pack
Pale yellow or yellow film-coated tablets, capsule-shaped, with the symbol "80" embossed on one side, 17.2 ± 0.2 mm in length, 6.2 ± 0.2 mm in width, and 5.6 ± 0.2 mm in thickness.
Prohidna is packed in cardboard boxes containing a suitable number of transparent PVC/PCTFE/Aluminium blisters with a leaflet.
Pack sizes:
Cartons containing 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

Manufacturer:
Pharmathen S.A.
6, Dervenakion str.
15351 Pallini, Attiki
Greece
Pharmathen International S.A
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece

Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nuremberg
Germany
For further information about this medicinal product, please contact the marketing authorization
holder:
Synoptis Pharma Sp. z o.o.
tel. +48 22 32 16 240
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark ELSTABYA
Germany Febuxostat Heumann
Greece ELSTABYA
Spain Gotaric
France ELSTABYA
Hungary ELSTABYA
Ireland Febuxostat Pinewood
Italy ELSTABYA
Poland PROHIDNA
United Kingdom (Northern Ireland) ELSTABYA