ZYLORIC 100 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Contents of the pack:

1. What Zyloric 100 mg tablets are and what they are used for
2. What you need to know before you take Zyloric 100 mg tablets
3. How to take Zyloric 100 mg tablets
4. Possible side effects
5. Storing Zyloric 100 mg tablets
6. Contents of the pack and other information

1. What Zyloric 100 mg tablets are and what they are used for

Zyloric 100 mg tablets belong 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 resulting in a decrease in the level of uric acid in plasma and urine.

Zyloric 100 mg tablets are used to prevent the occurrence of gout and other conditions caused by excess uric acid in the body, such as kidney stones and certain types of kidney or metabolic disorders.

2. What you need to know before you start taking Zyloric 100 mg tablets

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Often, the rash can include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These severe skin rashes are often preceded by flu-like symptoms such as fever, headache, body aches. The rash can progress to blistering and widespread peeling of the skin. These serious skin reactions can be more frequent in people of Chinese, Thai, or Korean origin. Additionally, having chronic kidney failure can 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 100 mg tablets

• if you are allergic to allopurinol or any of the other ingredients of Zyloric 100 mg tablets.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zyloric

• if you are having an acute attack of gout.
• if you are pregnant, think you may be pregnant, or are breastfeeding.
• if you have or have had any kidney or liver disease.
• if you are taking or are going to start taking any medicine for heart disease or high blood pressure.
• if you notice that you bruise more easily than before or if you get a sore throat or other signs of infection.
• if a skin rash, peeling of the skin, blisters, or ulcers on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (puffy and red eyes), wheezing (whistling), palpitations, or chest tightness, loss of consciousness occur: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO ZYLORIC. Stop treatment and contact your doctor immediately.

Life-threatening skin rashes (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 few weeks of treatment.

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

If you are not sure, consult your doctor.

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

• High fever.
• Pain in the joints or painful swelling of the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Nausea or vomiting (which may be bloody).
• Feeling of general discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slow pulse.
• Swelling (edema) of the ankles.
• Feeling of thirst, tiredness, and weight loss.
• Appearance of boils.
• Appearance of blood in urine.

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

Children

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

Other medicines and Zyloric 100 mg tablets

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

It is especially important that you inform your doctor if you are taking any of the medicines listed below. Your doctor may need to reduce the dose of your medicine or monitor you more closely because there is a higher risk of side effects when Zyloric is taken at the same time as:

• 6-mercaptopurine (used in the treatment of blood cancer).
• Azathioprine, cyclosporin (used to inhibit the immune system). Note that adverse effects to cyclosporin may occur more frequently.
• Vidarabine (used in the treatment of herpes). Note that adverse effects to vidarabine may occur more frequently. Be especially cautious if this happens.
• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).
• Probenecid (used for the treatment of gout).
• Chlorpropamide (used to treat diabetes). It may be necessary to reduce the dose of chlorpropamide, especially in patients with reduced kidney function.
• Warfarin, phenprocoumon, acenocoumarol (anticoagulants). Your doctor will monitor your blood test results more closely and, if necessary, reduce the dose of these medicines.
• Phenytoin (used to treat epilepsy).
• Theophylline (used to treat asthma and other respiratory diseases). Your doctor will measure the levels of theophylline in your blood, especially when starting treatment with allopurinol, or following any change in dose.
• Ampicillin or amoxicillin (used to treat bacterial infections). When possible, patients should receive other antibiotics since it is more likely that allergic reactions will appear.
• Medicines for treating aggressive tumors such as:
• • Cyclophosphamide
  • Doxorubicin
  • Bleomycin
  • Procarbazine
  • Mecloretamine

Your doctor will monitor your blood test results frequently.

• Didanosine (used to treat HIV infection).

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

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

Go to the doctor immediately if you notice that you have any unexplained bruising, bleeding, fever, or sore throat.

If you take aluminum hydroxide concomitantly, allopurinol may have a reduced effect, so there should be an interval of at least 3 hours between taking both medicines.

In the administration of allopurinol in combination with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood disorders occur more frequently than when these active substances are administered alone.

Therefore, regular blood tests should be performed.

Pregnancy, breastfeeding, and fertility

Zyloric is not recommended if you are pregnant.

Allopurinol passes into breast milk. The use of allopurinol is not recommended during the breastfeeding period.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Due to its side effects (drowsiness, dizziness, and impaired coordination), Zyloric may affect your ability to drive or operate machinery.

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

Zyloric 100 mg tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Zyloric 100 mg tablets

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

Oral use only. Swallow the tablet whole with the help of 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 side effects. Your dose will be increased if necessary.

The recommended dose is:

Adults:

The recommended starting 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 upset occurs, it is recommended to divide the dose into several intakes per day and take them with food.

Children under 15 years:

The recommended dose of this medicine 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 function impairment

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of Zyloric that reduces uric acid levels and controls your symptoms. In case of kidney failure, your doctor may advise you to take less than 100 mg per day or tell you 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 100 mg tablets than you should

In this case, consult the Toxicology Information Service. Telephone 91 562 04 20 or go to your doctor.

In case of accidental ingestion of too much medicine, go to your doctor without delay or to the emergency department of the nearest hospital. Bring this leaflet with you.

If you forget to take Zyloric 100 mg tablets

In case you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally would. Do not take a double dose to make up for forgotten doses.

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

If you stop treatment with Zyloric 100 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

The likelihood of their occurrence is higher when there are kidney and/or liver disorders.

The frequency of adverse 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 RareHair follicle infection.

Blood and Lymphatic System Disorders

Very RareDecreased white blood cell count: leukopenia (increases the risk of infections), red blood cells: anemia (can cause fatigue, tiredness), platelets (cells involved in blood clotting, with the appearance of bruises or bleeding, more easily than usual).

On occasion, Zylorictablets may cause effects on the blood that manifest with the appearance of more frequent bruising than usual, 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

UncommonHypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters, or ulcers on the lips or in the mouth).

RareSevere hypersensitivity reactions, 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 disorders (see below).

Very RareAngioimmunoblastic lymphadenopathy (characterized by weight loss, fever, inflammation in the axillary, neck, or groin lymph nodes), potentially life-threatening severe allergic reaction.

Very rarely, seizures, wheezing, palpitations, chest tightness, or loss of consciousness may occur.

Metabolic and Nutrition Disorders

Very RareDiabetes mellitus (elevated blood glucose levels), increased blood lipid levels, increased uric acid levels in the blood.

Psychiatric Disorders

Very RareDepression.

Nervous System Disorders

Very RareWeakness, numbness, or loss of consciousness, paralysis, motor incoordination (lack of movement coordination), altered normal sensitivity (neuropathy), tingling sensation (paresthesia), somnolence, headache, altered taste.

Frequency Not KnownAseptic 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 slowed heart rate (bradycardia).

Vascular Disorders

Very RareHigh blood pressure (arterial hypertension).

Gastrointestinal Disorders

UncommonNausea, vomiting.

Very RareAppearance of blood in vomit, excess fat in stools, mouth infections, changes in bowel habits.

Hepatobiliary Disorders

UncommonAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and Subcutaneous Tissue Disorders

CommonSkin rash.

Very RareHives, drug-induced skin eruptions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. Before taking Zyloric 100 mg tablets), hair loss or discoloration, severe allergic reaction causing facial or throat swelling.

Frequency Not KnownLichenoid skin eruption (red-purple skin rash with itching or grayish-white lines on the mucous membranes)

Renal and Urinary Disorders

Very RareAppearance of blood in urine.

Reproductive System and Breast Disorders

Very RareMale infertility, impotence, breast growth (gynecomastia).

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, such as ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes), blisters, or generalized peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and alterations in blood and liver tests (these may be symptoms of a multi-organ hypersensitivity disorder).

Additional Tests

CommonElevated thyroid-stimulating hormone levels in blood.

There have been reports of fever with or without signs or symptoms of generalized hypersensitivity to allopurinol (see Immune System Disorders).

Do not be alarmed by this list of adverse reactions, as it is possible that none of them will appear in your case.

Reporting of Adverse Effects

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

5. Storage of Zyloric 100 mg Tablets

This medicine does not require special storage conditions.

Keep this medicine out of sight and reach of children.

Do not use Zyloric 100 mg tablets after the expiration date shown on the carton, after "EXP". The expiration date is the last day of the month indicated.

Do not use Zyloric 100 mg tablets if you notice visible signs of deterioration.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Zyloric 100 mg Tablets

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

Appearance of the Product and Package Contents

Zyloric 100 mg tablets are available in packages of 25 and 100 tablets.

The tablets are white, round, and biconvex.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

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

Date of the Last Revision of this Leaflet: November 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/