Allopurinol Normon 300 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Alopurinol Normon 300 mg tablets EFG

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 personally. Do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet.

Leaflet Contents:

1. What Alopurinol Normon is and what it is used for
2. What you need to know before taking Alopurinol Normon
3. How to take Alopurinol Normon
4. Possible side effects
5. How to store Alopurinol Normon
6. Contents of the pack and further information

1. What Alopurinol Normon is and what it is used for

Alopurinol belongs to a group of medicines called enzyme inhibitors, which work 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.

Alopurinol is 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 taking Alopurinol Normon

Severe 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 serious 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 severe skin reactions may be more common in people of Han Chinese, Thai, or Korean descent. Additionally, 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 Alopurinol Normon

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Alopurinol Normon

• if you are experiencing an acute attack of gout.
• if you are pregnant, think you might 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 breathing), palpitations, chest tightness, or loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC to allopurinol. Stop treatment immediately and contact your doctor without delay.

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) associated with allopurinol initially appear as red spots or circular patches, often with a central blister.

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

If you have experienced Stevens-Johnson syndrome or Toxic Epidermal Necrolysis with allopurinol, you must never use allopurinol again.

If you are unsure, consult your doctor.

You should stop your treatment and contact your doctor as soon as possible if, while taking allopurinol, 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 contain blood).
• General feeling of discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Feeling thirsty, tiredness, and weight loss.
• Appearance of boils.
• Blood in the urine.

An acute attack of gout may be triggered at the beginning of treatment with allopurinol. Your doctor may recommend taking certain medications to prevent this. If a gout attack occurs, it is not necessary to stop treatment with allopurinol, 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 some enzymatic disorders such as Lesch-Nyhan syndrome.

Other medicines and Alopurinol Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

It is especially important to 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 allopurinol 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 medicines.

• 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 other antibiotics, as allergic reactions are more likely to occur.

• Medicines 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 Alopurinol Normon, 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, at least a 3-hour interval should be left between taking the two medicines.

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:

The use of allopurinol is not recommended during pregnancy.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines:

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

Do not drive or operate tools or machinery until you are reasonably certain that the medicine does not affect your ability.

Alopurinol Normon contains lactose

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

3. How to take Alopurinol Normon

Follow exactly the instructions for use of this medicine as prescribed 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 condition. In such cases, and if stomach discomfort occurs, it is advisable to divide the dose into several administrations per day and take them with food.

Children under 15 years of age:

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

Elderly patients

Your doctor will recommend the lowest possible dose of allopurinol 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 allopurinol to reduce uric acid levels and control your symptoms. In case of kidney 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 Alopurinol Normon than you should

In this case, contact the Toxicology Information Service at telephone number 91 562 04 20, or consult your doctor immediately.

In case of accidental ingestion of a large amount of medicine, go to your doctor or the nearest hospital emergency department without delay. Take this leaflet with you.

If you forget to take Alopurinol Normon

If you forget to take a dose, take it as soon as you remember. Then continue taking it as before. Do not take a double dose to make up for forgotten doses.

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 taking Alopurinol Normon

Your doctor will advise you on the duration of treatment with allopurinol. Do not stop treatment earlier, even if you feel better.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The likelihood of these effects occurring is higher when there are kidney and/or liver impairments.

The frequency of adverse effects is classified as follows:

Very common (affects at least 1 in 10 patients)
Common (affects at least 1 in 100 patients)
Uncommon (affects at least 1 in 1,000 patients)
Rare (affects at least 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 rare: Infection of the hair follicle.

Blood and lymphatic system disorders

Very rare: Decrease in the number of white blood cells (leukopenia – increases the risk of infections), red blood cells (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 effects on the blood, 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 appearance of 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 armpits, groin, 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, swollen lymph nodes in the armpits, neck, or groin), severe allergic reaction potentially fatal.

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 of movements), altered sensation (neuropathy), drowsiness, 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: Dizziness.

Cardiac disorders

Very rare: Chest pain or slowed pulse.

Vascular disorders

Very rare: High blood pressure.

Gastrointestinal disorders

Uncommon: Nausea, vomiting, diarrhea.

Very rare: Blood in vomit, excess fat in 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), hair loss or discoloration, severe allergic reaction causing swelling of the face or throat.

Frequency not known (cannot be estimated from available data): Lichenoid skin eruption (reddish-purple itchy rash or white-grayish linear streaks on mucous membranes).

Renal and urinary disorders

Very rare: Blood in urine.

Reproductive system and breast disorders

Very rare: Male infertility, impotence, breast enlargement.

General disorders and administration site conditions

Very rare: Swelling (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 changes to 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 tests

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

5. Storage of Alopurinol Normon

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Normon

The active substance is allopurinol. Each tablet contains 300 mg of allopurinol.

The other components are: monohydrate lactose, corn starch, povidone, and magnesium stearate.

Appearance of Alopurinol Normon and contents of the pack

White or slightly cream-colored, round, biconvex tablets, scored and printed with "A/L" on one side.

Packaged in a pack containing 30 tablets in PVC-aluminum blisters, with a package leaflet.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760
Tres Cantos - Madrid
Spain

Date of the most recent review of this leaflet: August 2025

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/63222/P_63222.html