Zyloric 300 mg tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zyloric 300 mg tablets allopurinol Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you. Keep this leaflet as you may need to read it again. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them. If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Package leaflet contents:

1. What Zyloric 300 mg tablets are and what they are used for
2. What you need to know before taking Zyloric 300 mg tablets
3. How to take Zyloric 300 mg tablets
4. Possible side effects
5. How to store Zyloric 300 mg tablets
6. Contents of the pack and other information

1. What Zyloric 300 mg tablets are and what they are used for

Zyloric 300 mg tablets belong to a group of medicines called enzyme inhibitors, which act by controlling the rate at which a specific chemical process occurs in the body. In this case, the result is a reduction in the level of uric acid in plasma and urine.

Zyloric 300 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 renal or metabolic disorders.

2. What you need to know before taking Zyloric 300 mg tablets

Serious skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Often, the rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These severe skin rashes are frequently preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to blistering and widespread peeling of the skin. These serious skin reactions may be more common in individuals of Han Chinese, Thai, or Korean descent. In addition, having chronic kidney disease may increase the risk in these patients. If you develop a skin rash or these skin symptoms, 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 ingredients of Zyloric 300 mg tablets.

Warnings and precautions

Consult your doctor or pharmacist before taking Zyloric

• if you are experiencing 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 about to start taking any medication for heart conditions or high blood pressure.
• if you notice that you bruise more easily than before, or if you develop a sore throat or other signs of infection.
• if you develop a skin rash, skin peeling, blisters, or sores in the lips or mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes), wheezing (whistling breath), palpitations, chest tightness, or loss of consciousness: 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) associated with the use of Zyloric initially appear as red or purplish circular spots, often with a central blister.

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

If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Zyloric, you must never use this medication again.

If you are unsure, consult your doctor.

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

• High fever.
• Joint pain or painful swelling of the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Nausea or vomiting (which may include blood).
• General feeling of malaise.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, visual disturbances.
• Chest pain, high blood pressure, or slow pulse.
• Swelling (edema) of the ankles.
• Increased thirst, fatigue, and weight loss.
• Appearance of boils.
• Blood in the urine.

It is possible that starting treatment with Zyloric may trigger an acute attack of gout. Your doctor may recommend taking certain medications to prevent this. If a gout attack occurs, it is not necessary to discontinue Zyloric, provided that an appropriate anti-inflammatory medication is used concurrently.

Children

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

Other medicines and Zyloric 300 mg tablets

Inform 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 following medicines. Your doctor may need to reduce the dose of your medication or monitor you more closely, as there is an increased risk of side effects when Zyloric is taken together with:

• 6-mercaptopurine (used in the treatment of blood cancer).
• Azathioprine, cyclosporine (used to suppress the immune system). Note that adverse effects of cyclosporine may occur more frequently.
• Vidarabine (used in the treatment of herpes). Note that adverse effects of vidarabine may occur more frequently. Exercise special caution if this occurs.
• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).
• Probenecid (used for the treatment of gout).
• Chlorpropamide (used to treat diabetes). A dose reduction of chlorpropamide may be necessary, especially in patients with reduced kidney function.
• Warfarin, phenprocoumon, acenocoumarol (anticoagulants). Your doctor will monitor your blood test values more frequently and, if necessary, reduce the dose of these medications.
• Phenytoin (used to treat epilepsy).
• Theophylline (used for the treatment of asthma and other respiratory diseases). Your doctor will measure theophylline blood levels, especially when starting allopurinol treatment or after any dose adjustment.
• Ampicillin or amoxicillin (used to treat bacterial infections). Whenever possible, patients should receive alternative antibiotics, as allergic reactions are more likely to occur.
• Medications used to treat aggressive tumors such as:
  • Cyclophosphamide
  • Doxorubicin
  • Bleomycin
  • Procarbazine
  • Mechlorethamine

Your doctor will monitor your blood tests 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 impairment of kidney function.

The concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with Zyloric, the dose of 6-mercaptopurine or azathioprine must be reduced because their activity will be prolonged. This could increase the risk of serious blood disorders. In such cases, your doctor will closely monitor your blood counts during treatment.

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

If aluminum hydroxide is taken concomitantly, the effect of allopurinol may be reduced; therefore, an interval of at least 3 hours should be left between the administration of both medications.

When allopurinol is administered in combination with cytostatic agents (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), blood dyscrasias occur more frequently than when these active substances are administered alone.

Therefore, periodic hematological monitoring should be performed.

Pregnancy, breastfeeding, and fertility

Zyloric is not recommended if you are pregnant.

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

Consult your doctor or pharmacist before using any medication.

Driving and use of machines

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

Do not drive or operate tools or machinery until you are reasonably certain that this medication does not limit your capabilities.

Zyloric 300 mg tablets contain lactose

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

3. How to take Zyloric 300 mg tablets

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

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

Your doctor will usually start treatment with allopurinol at a low dose (e.g., 100 mg/day) to reduce the risk of possible adverse effects. Your dose may 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 individual case. In such cases, and if stomach discomfort occurs, it is recommended to divide the dose into several administrations per day and take it with food.

Children under 15 years of age:

The recommended dose of this medicine in children is 100 to 400 mg daily.

Elderly:

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

Use in patients with impaired liver or kidney function

If you have liver or kidney problems, your doctor will prescribe the lowest effective dose of Zyloric necessary to reduce uric acid levels and control your symptoms. In case of renal impairment, your doctor may advise you to take less than 100 mg per day or to take single 100 mg doses at intervals longer than one day. If you are on dialysis two or three 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, contact the Toxicology Information Service at telephone number 91 562 04 20, or consult your doctor.

In case of accidental ingestion of a large amount of medication, go to your doctor or the nearest hospital emergency department without delay. Take 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 taking it as before. Do not take a double dose to make up for a missed dose.

If you miss several doses, it is best to contact your doctor so that he or she can decide what you should do from that point onward.

If you stop treatment with Zyloric 300 mg tablets

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

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

4. Possible adverse effects

Like all medicines, Zyloric may cause adverse effects, although not everyone experiences them.

The likelihood of such effects occurring is higher in the presence of kidney and/or liver impairment.

The frequency of adverse effects is classified as follows:

Very common (affects less than 1 in 10 people)
Common (affects less than 1 in 100 people)
Uncommon (affects less than 1 in 1,000 people)
Rare (affects less than 1 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)
Frequency not known (cannot be estimated from available data)

Infections and infestations

Very rare: Infection of the hair follicle.

Blood and lymphatic system disorders

Very rare: Decreased number of white blood cells: leucopenia (increases the risk of infections), red blood cells: anaemia (may cause tiredness, fatigue), or platelets (cells involved in blood clotting, leading to bruising or bleeding more easily than usual).

Occasionally, allopurinol tablets may cause blood-related effects, manifesting as more frequent bruising than normal, 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

Uncommon: Hypersensitivity reactions (allergy: possible skin rash, skin peeling, blisters or sores on the lips or in the mouth).

Rare: Severe hypersensitivity reactions, associated with skin exfoliation, fever, joint pain, or painful swelling of the lymph nodes in the groin, armpits, or neck, jaundice (yellowing of the skin and eyes), and other skin and subcutaneous tissue disorders (see below).

Very rare: Angioimmunoblastic lymphadenopathy (characterized by weight loss, fever, and swollen lymph nodes in the armpits, neck, or groin), severe allergic reaction potentially leading to death.

Very rarely, seizures, wheezing (whistling breathing), palpitations, chest tightness, or loss of consciousness may occur.

Metabolism and nutrition disorders

Very rare: Diabetes mellitus (elevated blood glucose levels), increased blood lipid levels, increased blood uric acid levels.

Psychiatric disorders

Very rare: Depression.

Nervous system disorders

Very rare: Weakness, numbness, or loss of consciousness, paralysis, motor incoordination (lack of coordination in movements), altered normal sensation (neuropathy), tingling sensation (paraesthesiae), somnolence, headache, altered taste.

Frequency not known: Aseptic 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 rare: Cataracts, visual disturbances.

Ear and labyrinth disorders

Very rare: Vertigo.

Cardiac disorders

Very rare: Chest pain or slow pulse (bradycardia).

Vascular disorders

Very rare: High blood pressure (hypertension).

Gastrointestinal disorders

Uncommon: Nausea, vomiting, diarrhoea.

Very rare: Presence of blood in vomit, excess fat in the stools, mouth infections, changes in bowel habits.

Hepatobiliary disorders

Uncommon: Asymptomatic increases in liver function tests.

Rare: Hepatitis.

Skin and subcutaneous tissue disorders

Common: Skin rash.

Very rare: Hives, drug-type skin rashes that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. Before taking Zyloric 300 mg tablets), hair loss or discoloration, severe allergic reaction causing swelling of the face or throat.

Frequency not known: Lichenoid skin eruption (reddish-purple rash with itching or white-grey thread-like lines on mucous membranes).

Renal and urinary disorders

Very rare: Presence of blood in the urine.

Reproductive system and breast disorders

Very rare: Male infertility, impotence, breast enlargement (gynaecomastia).

General disorders and administration site conditions

Very rare: Swelling (oedema) 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 skin peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and abnormalities in blood tests and liver function (these may be symptoms of a multi-organ hypersensitivity disorder).

Additional investigations

Common: Elevated blood levels of thyroid-stimulating hormone.

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zyloric 300 mg tablets

This medicine does not require any special storage conditions.

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

Do not use Zyloric 300 mg tablets after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zyloric 300 mg tablets

• The active substance is allopurinol.
• The other components are: monohydrate lactose, corn starch, povidone, and magnesium stearate.

Appearance of the product and contents of the pack

Zyloric 300 mg tablets are supplied in packs of 30 and 60 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 most recent review of this leaflet: November 2021

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