Prohidna

PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the User

Prohidna, 80 mg, coated tablets

Prohidna, 120 mg, coated tablets

Febuxostat

Read 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 formed crystals can cause sudden, severe pain, redness, warmth, and swelling of the joint (so-called gout attack). If the disease is not treated, larger urate deposits (so-called tophi) may form inside and around the joints. Tophi can cause joint and bone damage. Prohidna works by reducing uric acid levels. Maintaining low uric acid levels by taking Prohidna once a day prevents the formation of crystals and over time reduces symptoms. Maintaining sufficiently low uric acid levels for a sufficient period may also lead to a reduction in tophi. Prohidna, 120 mg, tablets are also used to treat and prevent high uric acid levels in the blood that may occur during the initiation of cancer chemotherapy. When chemotherapy is used, cancer cells are destroyed, and uric acid levels in the blood increase accordingly, unless uric acid formation is prevented. 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 uric acid levels due to cancer or Lesch-Nyhan syndrome (a rare inherited disease in which there is too much uric acid in the blood);
• if you have thyroid function disorders.

In case of an allergic reaction to Prohidna, stop taking the medicine immediately and contact your doctor (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
• breathing difficulties
• fever and lymph node enlargement
• life-threatening allergic reactions with cardiac arrest and circulatory failure.

Your 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 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 peeling and separation of the skin. If Stevens-Johnson syndrome occurs during febuxostat treatment, you should never take Prohidna again. If a rash or the above skin symptoms occur, 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 gout attack has subsided. 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 still reduces uric acid levels. Over time, gout attacks will occur less frequently and will be less painful if Prohidna is taken daily. Your doctor may prescribe other medicines if necessary to help prevent or treat worsening symptoms (such as pain and swelling of the joint). In patients who have very high uric acid levels (e.g., those receiving chemotherapy for blood cancer), treatment with uric acid-lowering medicines may lead to 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 liver function is normal.

Children and adolescents

Do not use the 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 or have recently taken, as well as any medicines you plan to 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

During treatment, dizziness, drowsiness, blurred vision, and a feeling of numbness or tingling may occur. Do not drive or operate machinery if you experience these effects.

Prohidna contains lactose

Prohidna tablets contain lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, consult 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 that you have taken a dose each day.
• Take the tablets orally; the medicine can be taken with or without food.

Gout

Prohidna is available as 80 mg and 120 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 or worsening.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer

Prohidna is available as 120 mg tablets. Start taking Prohidna two days before chemotherapy and continue as directed by your doctor. Treatment is usually short-term.

If you take more Prohidna than you should

In case of accidental overdose, ask your doctor for advice or contact the nearest hospital emergency department.

If you forget to take Prohidna

If you miss a dose, take it as soon as you remember, unless it is time for your 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 a forgotten dose.

Stopping Prohidna

Do not stop taking Prohidna without your doctor's advice, even if you feel better. Stopping Prohidna may cause uric acid levels to increase and worsen the disease due to the formation of new urate crystals inside and around the joints or in the joints and kidneys. If you have any further questions about the use of 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 the medicine and contact your doctor immediatelyor go to the nearest emergency department if you experience the following rare (affecting 1 in 1000 people) side effects, as they can lead to serious reactions:

• allergic reactions: 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,
• local rash (more severe types of rash have been reported not very commonly and rarely - see below),
• nausea,
• worsening of gout symptoms,
• local swelling due to fluid accumulation in tissues (edema).

Uncommon:may affect up to 1 in 100 people:

• decreased appetite, changes in blood sugar levels (diabetes), which may cause excessive thirst, increased fat levels in the blood, weight gain
• decreased libido,
• sleep disorders, drowsiness,
• dizziness, numbness, tingling, weakness, or changes in touch sensation (hypoesthesia, paresis, or paresthesia),
• taste disorders, decreased sense of smell (hyposmia),
• abnormalities in the electrocardiogram (ECG) recording of heart function, irregular or rapid heartbeat, palpitations,
• hot flashes or flushing of the skin (e.g., facial flushing), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood diseases),
• cough, shortness of breath, feeling of discomfort or pain in the chest, inflammation of the nasal mucosa and/or throat (upper respiratory tract infection), bronchitis,
• dry mouth, abdominal pain or discomfort, gas, heartburn or indigestion, constipation, frequent bowel movements, 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 areas on the skin covered with small bumps, rash, local redness and spots on the skin, other types of skin changes,
• muscle cramps, muscle weakness, muscle pain or joint pain, bursitis or tendonitis (arthritis, usually accompanied by pain, swelling, and/or stiffness), limb pain, back pain, muscle spasms,
• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), kidney function disorders,
• fatigue, 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 count),
• kidney stones,
• erectile dysfunction.

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 concurrent malaise 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 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),
• skin redness (erythema), rashes of various types (e.g., itching, with white spots, with blisters, with pus-filled blisters, with peeling), widespread rash, skin necrosis, blisters on the skin and mucous membranes causing peeling and possible sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• nervousness,
• thirst,
• ringing in the ears,
• blurred vision, changes in vision,
• hair loss,
• mouth ulcers,
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting,
• excessive sweating,
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia),
• muscle stiffness and/or joint stiffness,
• abnormal low blood cell count (white or red blood cells or platelets),
• sudden urge to urinate,
• changes in urine or decreased urine output related to kidney inflammation (interstitial nephritis),
• hepatitis,
• jaundice (yellowing of the skin),
• liver damage,
• increased creatine phosphokinase activity in the blood (a marker of muscle damage),
• sudden cardiac death.

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 Monitoring of the 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 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 the month stated. 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. Prohidna, 80 mg, coated tablets One tablet contains 80 mg febuxostat (as febuxostat magnesium). Prohidna, 120 mg, coated tablets One tablet contains 120 mg febuxostat (as febuxostat magnesium).
• The other excipients are: Tablet core:lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, light magnesium oxide, colloidal silicon dioxide, 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

Prohidna, 80 mg, coated tablets Light yellow or yellow coated tablets in capsule shape with a single-sided embossing of the symbol "80", 17.2 ± 0.2 mm in length, 6.2 ± 0.2 mm in width, 5.6 ± 0.2 mm in thickness. Prohidna, 120 mg, coated tablets Light yellow or yellow coated tablets in capsule shape with a single-sided embossing of the symbol "120", 19.2 ± 0.2 mm in length, 8.2 ± 0.2 mm in width, 6.1 ± 0.2 mm in thickness. Prohidna is packaged in a cardboard box containing the appropriate number of transparent PVC/PCTFE/Aluminum blisters 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

This medicinal product is authorized in the Member States of the EEA 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 ELSTABYA

Date of last revision of the leaflet: