PATIENT INFORMATION LEAFLET

Zyloric 300 mg tablets belongs to a group of medicines called enzyme inhibitors, which act by controlling the speed at which a certain chemical process occurs in the body, in this case, a decrease in the level of uric acid in plasma and urine.

Zyloric 300 mg tablets is used to prevent the occurrence of gout and other situations caused by excess uric acid in the body, such as for example kidney stones and certain types of kidney or metabolic diseases.

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to the formation of blisters and generalized skin peeling. These severe skin reactions may be more common in people of Chinese, Thai, or Korean origin. Additionally, having chronic kidney disease may increase the risk in these patients. If you develop a skin rash or these symptoms on the skin, stop taking allopurinol and consult your doctor.

Do not take Zyloric 300 mg tablets

• if you are allergic to allopurinol or any of the other components of Zyloric 300 mg tablets.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zyloric

• if you have an acute attack of gout.
• if you are pregnant, think you may be pregnant, or are breastfeeding your child.
• if you have or have had any kidney or liver disease.
• if you are taking or will start taking any medication for heart disease or high blood pressure.
• if you notice that you bruise more easily than before or if you have a sore throat or other signs of an infection.
• if a skin rash, skin peeling, blisters, or sores on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes), wheezing (popping sounds), palpitations, or chest tightness appear: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO ZYLORIC. Suspend your treatment and contact your doctor immediately.

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) with the use of Zyloric initially appear as red, circular spots or patches, often with a central blister.

The period of highest risk of severe skin reactions is during the first weeks of treatment.

If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Zyloric, you should not use this medication again at any time.

If you are unsure, consult your doctor.

You should stop your treatment and contact your doctor as soon as possible if, while you are taking Zyloric, you experience any of the following symptoms:

• High fever.
• Joint pain or painful swelling of the ankles, armpits, or neck.
• Ictericia (yellowing of the skin and eyes).
• Nausea or vomiting (which may be bloody).
• General feeling of discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, or vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Feeling thirsty, tired, and weight loss.
• Appearance of boils.
• Blood in the urine.

It is possible that an acute attack of gout may precipitate at the beginning of treatment with Zyloric. Your doctor will recommend the use of certain medications to prevent it. If a gout attack occurs, it is not necessary to stop treatment with Zyloric as long as an appropriate anti-inflammatory medication is used concurrently.

Children

The use in children is rarely indicated, except for some types of cancer (especially leukemia) and certain enzymatic disorders such as Lesch-Nyhan syndrome.

Other medications and Zyloric 300 mg tablets

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

It is especially important to inform your doctor if you are taking any of the medications listed below. Your doctor may need to reduce your medication dose or monitor you more closely due to an increased risk of side effects when Zyloric is taken at the same time as:

• 6-mercaptopurine (used in the treatment of blood cancer).
• Azathioprine, cyclosporine (used to inhibit the immune system). Note that cyclosporine side effects may occur more frequently.
• Vidarabine (used in the treatment of herpes). Note that vidarabine side effects may occur more frequently. Be especially cautious if this occurs.
• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).
• Probenecid (used to treat gout).
• Chlorpropamide (used to treat diabetes). You may need to reduce your chlorpropamide dose, especially in patients with reduced renal function.
• Warfarin, phenprocoumon, acenocoumarol (anticoagulants). Your doctor will monitor your hematological controls more closely and, if necessary, reduce your dose of these medications.
• Phenytoin (used to treat epilepsy).
• Theophylline (used to treat asthma and other respiratory diseases). Your doctor will measure your theophylline blood levels, especially when starting treatment with allopurinol, or following any dose change.
• Ampicillin or amoxicillin (used to treat bacterial infections). When possible, patients should receive other antibiotics as they are more likely to experience allergic reactions.
• Medications to treat aggressive tumors such as:
• • Cyclophosphamide
  • Doxorubicin
  • Bleomycin
  • Procarbazine
  • Mecloretamine

Your doctor will monitor your hematological controls frequently.

• Didanosine (used to treat HIV infection).
• ACE inhibitors (e.g., captopril) or diuretics (used to treat high blood pressure). The risk of experiencing skin reactions may increase, especially in patients with chronic kidney function limitations.

Administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered with Zyloric, the dose of 6-mercaptopurine or azathioprine should be reduced because its activity will be prolonged. This may increase the risk of severe blood disorders. In this case, your doctor will closely monitor your hemogram during treatment.

Seek medical attention immediately if you notice any unexplained bruising, bleeding, fever, or sore throat.

If you take aluminum hydroxide concomitantly, allopurinol may be attenuated, so you should leave a gap of at least 3 hours between taking both medications.

In the administration of allopurinol in combination with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), hematological disorders occur more frequently than when these active principles are administered alone.

Therefore, periodic hematological controls should be performed.

Pregnancy, breastfeeding, and fertility

Zyloric is not recommended if you are pregnant.

Allopurinol passes into breast milk. Zyloric is not recommended during lactation.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Due to its side effects (drowsiness, dizziness, and coordination impairment), Zyloric may impair your ability to drive vehicles.

Do not drive, do not operate tools or machines until you are reasonably sure that the medication does not limit your abilities.

Zyloric 300 mg tablets contain lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Zyloric indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Oral use only. Swallow the tablet whole with a little water. It is usually taken once a day, generally after a meal.

Generally, your doctor will start treatment with allopurinol at a low dose (e.g., 100 mg/day), to reduce the risk of possible adverse effects. Your dose will be increased if necessary..

Dosage recommended is:

Adults:

The initial recommended dose is 100 to 300 mg. The dose may be increased up to 900 mg per day, depending on your case. In this case, and if stomach discomfort appears, it is recommended to divide the dose into several doses per day and take them with food.

Children under 15 years:

The recommended dose of this medication in children is 100 to 400 mg per day.

Advanced age:

Your doctor will recommend the lowest possible dose of Zyloric to reduce uric acid levels and control your symptoms.

Use in patients with liver or kidney dysfunction:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of Zyloric that can reduce uric acid levels and control your symptoms. In the case of kidney insufficiency, your doctor may advise you to take less than 100 mg per day or to take single doses of 100 mg at intervals greater than one day. If you are on dialysis 2 or 3 times a week, your doctor may prescribe a dose of 300-400 mg immediately after each dialysis session.

If you take more Zyloric 300 mg tablets than you should:

In this case, consult the Toxicological Information Service. Phone 91 562 04 20 or visit your doctor.

In case of accidental ingestion of a large amount of medication, go to your doctor immediately or to the nearest hospital emergency room. Bring this leaflet with you.

If you forget to take Zyloric 300 mg tablets:

If you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally do. Do not take a double dose to compensate for the missed doses.

If you forget several doses, it is best to contact your doctor to decide what you should do from then on.

If you interrupt treatment with Zyloric 300 mg tablets:

Your doctor will indicate the duration of treatment with Zyloric. Do not stop treatment before, even if you feel better.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Zyloric may cause side effects, although not everyone will experience them.

The likelihood of them occurring is higher when there are kidney and/or liver abnormalities.

The frequency of side effects is classified as:

Very common(affects less than 1 in 10 patients)

Common(affects less than 1 in 100 patients)

Uncommon(affects less than 1 in 1,000 patients)

Rare(affects less than 1 in 10,000 patients)

Very rare(affects less than 1 in 10,000 patients)

Frequency not known(cannot be estimated from available data)

Infections and infestations

Very rareFollicular hair infection.

Haematological and lymphatic system disorders

Very rareLeucopenia (decreased white blood cell count): increases the risk of infections, anaemia (may cause fatigue, tiredness), thrombocytopenia (decreased platelet count): may cause bruising or bleeding more easily than usual.

In some cases, allopurinol tablets may cause blood-related effects that manifest as frequent bruising, sore throat, or other signs of infection. These effects usually occur in people with kidney or liver problems. Inform your doctor as soon as possible if you experience any of these symptoms.

Immune system disorders

UncommonReactions of hypersensitivity (allergy: possible appearance of skin rash, skin peeling, blisters or sores on the lips or in the mouth).

RareSevere reactions of hypersensitivity, associated with exfoliation, fever, joint pain or painful swelling of the groin, armpits, or neck, jaundice (yellowing of the skin and eyes), and other skin and subcutaneous tissue alterations (see below).

Very rareLymphadenopathy angioimmunoblastic (occurs with weight loss, fever, inflammation of the lymph nodes in the armpits, neck, or groin), potentially life-threatening allergic reaction.

Very rarely, convulsions, wheezing (pitos), palpitations, chest tightness, or loss of consciousness may occur.

Metabolic and nutritional disorders

Very rareDiabetes mellitus (elevated blood glucose levels), increased levels of lipids in the blood, increased uric acid in the blood.

Mental disorders

Very rareDepression.

Nervous system disorders

Very rareWeakness, numbness, or loss of consciousness, paralysis, motor incoordination (lack of coordination of movements), alteration of normal sensitivity (neuropathy), paresthesia (tingling sensation), drowsiness, headache, alteration in taste.

Frequency not knownAsymptomatic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or altered consciousness. If you experience any of these symptoms, seek urgent medical attention.

Eye disorders

Very rareCataracts, visual disturbances.

Ear and labyrinth disorders

Very rareVertigo.

Cardiac disorders

Very rareChest pain or bradycardia (slow heart rate).

Vascular disorders

Very rareHigh blood pressure (hypertension).

Gastrointestinal disorders

UncommonNausea, vomiting, diarrhoea.

Very rareBlood in vomit, excessive fat in stools, infections of the mouth, changes in bowel habits.

Hepatobiliary disorders

UncommonAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and subcutaneous tissue disorders

CommonSkin rash.

Very rareUrticaria, drug-induced skin eruptions that may threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. Before taking Zyloric 300 mg tablets), hair loss or discoloration, severe allergic reaction causing facial or throat swelling.

Frequency not knownLichenoid skin eruption (red-violet rash with itching or white-grayish lines on mucous membranes)

Renal and urinary disorders

Very rareBlood in urine.

Reproductive and breast disorders

Very rareMale infertility, impotence, gynaecomastia (breast growth).

General disorders and administration site conditions

Very rareSwelling (edema) of the ankles, general malaise, fatigue, fever.

If you experience any of the following symptoms, stop taking the medicine and inform your doctor immediately:

Rare(affects less than 1 in 1,000 people)

• Fever and chills, headache, muscle pain (flu-like symptoms) and general malaise.
• Any change in your skin, for example, ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes), blisters or widespread peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and alterations in blood and liver function tests (these may be symptoms of multi-organ hypersensitivity disorder).

Complementary examinations

CommonElevated levels of thyroid-stimulating hormone in the blood.

Cases of fever with or without evident signs or symptoms of a generalized hypersensitivity reaction to allopurinol have been reported (see Immune system disorders).

Do not be alarmed by this list of side effects, as it is possible that none of them will occur in your case.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special conditions for conservation.

Keep this medication out of the sight and reach of children.

Do not use Zyloric 300 mg tablets after the expiration date that appears on the carton, after “CAD”. The expiration date is the last day of the month indicated.

Do not use Zyloric 300 mg tablets if you observe visible signs of deterioration.

Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Zyloric 300 mg tablets

• The active ingredient is alopurinol.
• The other components are: lactose monohydrate, cornstarch, povidone and magnesium stearate.

Appearance of the product and content of the packaging

Zyloric 300 mg tablets are presented in packs of 30 tablets.

The tablets are white, round and biconvex.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa(Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet: November 2021

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/