Prohidna

Patient Information Leaflet: User Information

Prohidna, 80 mg, coated tablets

Febuxostat

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Prohidna tablets contain the active substance febuxostat and are used to treat gout, which is associated with an 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 to remain dissolved. In this case, urate crystals may form inside and around the joints and kidneys. The resulting crystals can cause sudden, severe pain, redness, warmth, and swelling of the joint (known as a gout attack). If the disease is not treated, larger deposits called tophi may form inside and around the joints. Tophi can cause joint and bone damage. Prohidna works by reducing the level of uric acid. Maintaining a low level of uric acid by taking Prohidna once a day prevents the formation of crystals and over time reduces the symptoms. Maintaining sufficiently low levels of uric acid for a long enough period may also lead to a reduction in tophi. Prohidna is intended for use in adults.

2. Important information before taking Prohidna

When not to take Prohidna:

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

Warnings and precautions

Before starting treatment with Prohidna, tell your doctor:

• if you have or have had heart failure, heart disease, or stroke;
• if you currently have or have had kidney disease and/or severe allergic reactions to allopurinol (a medicine used to treat gout);
• if you currently have or have had liver disease or abnormal liver function tests;
• if you are 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 you have thyroid function disorders.

If you experience an allergic reaction to Prohidna, stop taking this medicine immediately (see also section 4). Possible symptoms of an allergic reaction are:

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

Your doctor may decide to permanently stop treatment with Prohidna. Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with febuxostat, initially appearing as red, concentric patches or circular patches often with blisters on the trunk. Symptoms may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling around the eyes). The rash may spread and cause the skin to peel and separate. If you experience Stevens-Johnson syndrome while taking febuxostat, you should never take Prohidna again. If you experience a rash or any of these skin symptoms, contact your doctor immediately and inform them that you are taking febuxostat. If you have a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling of the joint): before starting treatment with Prohidna, wait until the attack has passed. In some people, gout attacks may worsen when starting treatment with certain medicines that control uric acid levels. Worsening may not occur in everyone, but worsening may occur, even if you are taking Prohidna, especially during the first few weeks or months of treatment. It is essential to continue taking Prohidna even if you experience worsening, as Prohidna will still reduce uric acid levels. Over time, gout attacks will become less frequent and less painful if Prohidna is taken daily. Your doctor may prescribe other medicines if necessary to help prevent or treat symptoms of worsening (such as pain and swelling of the joint). Patients who have very high levels of uric acid (e.g., those receiving chemotherapy for cancer) may experience the accumulation of xanthine in the urinary tract with the possibility of stone formation, although this has not been observed in patients treated with Prohidna for tumor lysis syndrome. Your doctor may order blood tests to check if your liver is working properly.

Children and adolescents

Do not use this medicine in children under 18 years of age, as the efficacy and safety of use have not been established.

Prohidna and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription. It is particularly important to inform your doctor or pharmacist if you are taking medicines containing any of the following substances, as they may interact with Prohidna, and your doctor may need to take necessary actions:

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

Pregnancy and breastfeeding

It is not known whether Prohidna may harm the fetus. Prohidna should not be used during pregnancy. It is not known whether Prohidna passes into breast milk. Prohidna should not be used if you are breastfeeding or plan to breastfeed. If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

However, be aware that during treatment, dizziness, drowsiness, blurred vision, and a feeling of numbness or tingling may occur. If you experience any of these symptoms, do not drive or operate machinery.

Prohidna contains lactose

Prohidna 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.

Prohidna contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Prohidna

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose is one tablet per day. The back of the blister pack has the days of the week marked to help you check if you have taken your daily dose.
• Take the tablets orally; you can take Prohidna with or without food.

Gout

Prohidna is available as 80 mg tablets. Your doctor will prescribe the most suitable dose for you. Take Prohidna every day, even if you do not have a gout attack. If you experience a gout attack, continue taking Prohidna as prescribed by your doctor.

Overdose

If you accidentally take too much Prohidna, ask your doctor for advice or contact the nearest hospital emergency department.

Missed dose

If you miss a dose, take it as soon as you remember, unless it is time to take the next dose. In this case, do not take the missed dose, just take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment

Do not stop taking Prohidna without your doctor's advice, even if you feel better. Stopping treatment with Prohidna may cause an increase in uric acid levels and worsening of the disease due to the formation of new urate crystals inside and around the joints or in the kidneys. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prohidna can cause side effects, although not everybody gets them. Stop taking Prohidna and contact your doctor immediatelyor go to the nearest emergency department if you experience any of the following rare (affecting 1 in 1000 people) side effects, as they can lead to serious conditions:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and precautions").
• potentially life-threatening skin rashes characterized by blistering and peeling of the skin and internal surfaces of the body, such as the mouth and genitals, painful ulcers in the mouth and/or genitals with fever, sore throat, and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis) or lymph node enlargement, liver enlargement, hepatitis (up to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• widespread skin rashes.

Other side effects

Common:may affect up to 1 in 10 people:

• abnormal liver function tests,
• diarrhea,
• headache,
• rash (including various types of rash, see below "uncommon" and "rare"),
• nausea,
• worsening of gout symptoms,
• local swelling due to fluid accumulation in tissues (edema),
• dizziness,
• shortness of breath,
• itching,
• limb pain, muscle pain, or joint pain,
• fatigue.

Other side effects not listed above are listed below. Uncommon:may affect up to 1 in 100 people:

• decreased appetite, changes in blood sugar levels (diabetes), which may cause excessive thirst, increased levels of fats in the blood, weight gain
• decreased sex drive,
• sleep disorders, drowsiness,
• numbness, tingling, weakness, or changes in touch sensation (hypoesthesia, paresis, or paresthesia), taste disorders, decreased sense of smell (hyposmia),
• abnormalities in the electrocardiogram (ECG), irregular or rapid heartbeat, palpitations,
• hot flashes or flushing of the skin (e.g., flushing of the face or neck),
• high blood pressure,
• bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders),

Other side effects not listed above are listed below.

• cough, shortness of breath, feeling of discomfort or pain in the chest, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis, upper respiratory tract infection,
• dry mouth, abdominal pain or discomfort, gas, upper abdominal pain, heartburn or indigestion, constipation, frequent bowel movements, vomiting, abdominal discomfort,
• itchy rash, hives, skin inflammation, skin discoloration, small, red, or purple spots on the skin, small, flat red spots on the skin, flat, red areas on the skin with small bumps, rash, localized redness and spots on the skin, excessive sweating, night sweats, hair loss, skin redness (erythema), psoriasis, eczema, other skin disorders,
• muscle spasms, muscle weakness, muscle pain, or joint pain, inflammation of the tendon sheath or joint inflammation (arthritis, which is usually accompanied by pain, swelling, and/or stiffness), back pain, muscle cramps, muscle stiffness, and/or joint stiffness,
• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), decreased kidney function, urinary tract infection,
• chest pain, feeling of discomfort in the chest,
• gallstones or bile duct stones (cholelithiasis),
• increased TSH levels in the blood,
• changes in blood chemistry or blood cell count (abnormal blood test results),
• kidney stones,
• erectile dysfunction,
• hypothyroidism,
• blurred vision, changes in vision,
• ringing in the ears,
• common cold,
• mouth ulcers,
• pancreatitis: frequent symptoms are abdominal pain, nausea, and vomiting,
• sudden urge to urinate,
• pain,
• malaise,
• increased INR,
• injury,
• lip swelling.

Rare:may affect up to 1 in 1000 people:

• muscle damage, a condition that can be severe in isolated cases. Muscle disorders may occur with poor general health or high fever, caused by muscle damage. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness.
• severe swelling of the deep layers of the skin, particularly in the area of the lips, eyes, genitals, hands, feet, or tongue, with possible sudden breathing difficulties,
• high fever with a rash, lymph node enlargement, liver enlargement, 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, pus-filled blisters, peeling skin, rash), widespread redness, necrosis, blisters on the skin and mucous membranes causing peeling and possible sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• nervousness,
• thirst,
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia),
• abnormal low blood cell count (white or red blood cells or platelets),
• changes in urine or decreased urine output related to kidney inflammation (interstitial nephritis),
• hepatitis,
• jaundice (yellowing of the skin),
• urinary tract infection,
• liver damage,
• increased creatine phosphokinase activity in the blood (a marker of muscle damage),
• sudden cardiac death,
• low red blood cell count (anemia),
• depression,
• sleep disorders,
• loss of smell,
• burning sensation,
• vertigo of labyrinthine origin,
• circulatory collapse,
• lung infection (pneumonia),
• mouth ulcers, oral inflammation,
• perforation of the digestive tract,
• rotator cuff syndrome,
• polymyalgia rheumatica syndrome,
• feeling of heat,
• sudden loss of vision due to blockage of an artery in the eye.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Prohidna

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 (as 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 hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172).

What Prohidna looks like and contents of the pack

Light yellow or yellow coated tablets in capsule shape with a single-sided embossing "80", 17.2 ± 0.2 mm in length, 6.2 ± 0.2 mm in width, 5.6 ± 0.2 mm in thickness. Prohidna is packaged in a cardboard box containing an appropriate number of transparent blisters made of PVC/PCTFE/Aluminum with a leaflet. Pack sizes: Cartons containing 28 or 84 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Synoptis Pharma Sp. z o.o., ul. Krakowiaków 65, 02-255 Warsaw. 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 Nürnberg, Germany. For further information on this medicine, contact the marketing authorization holder: Synoptis Pharma Sp. z o.o., tel. +48 22 32 16 240.

This medicine is authorized 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

Date of last revision of the leaflet: