ALOPURINOL NORMON 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alopurinol Normon 100 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information

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

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

Alopurinol 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, it results in a decrease in the level of uric acid in plasma and urine.

Alopurinol is used to prevent the onset of gout and other situations caused by excess uric acid in the body, such as kidney stones and certain types of kidney or metabolic diseases.

2. What you need to know before you take Alopurinol Normon

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of alopurinol. 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 severe 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 alopurinol and consult your doctor.

Do not take Alopurinol Normon

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

Warnings and precautions

Consult your doctor or pharmacist before taking Alopurinol Normon

• if you have 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 medication 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 sores appear on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes), wheezing (whistling), palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC to alopurinol. Stop treatment and contact your doctor immediately.

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) with the use of alopurinol 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 alopurinol, you should not use alopurinol again at any time.

If you are unsure, consult your doctor.

You should stop treatment and contact your doctor as soon as possible if, while taking alopurinol, 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).
• General feeling of discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision changes.
• 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 alopurinol, 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 alopurinol 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 Alopurinol Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 Alopurinol 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 adverse effects to cyclosporine 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 values more frequently 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 alopurinol 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 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 kidney function impairment.

Administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered with Alopurinol Normon, 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, alopurinol may have a reduced effect, so an interval of at least 3 hours should be left between taking both medicines.

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

Therefore, periodic blood tests should be performed.

Pregnancy, breastfeeding, and fertility

Alopurinol is not recommended if you are pregnant.

Alopurinol passes into breast milk. The use of alopurinol 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 coordination problems), this medicine may impair 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.

Alopurinol Normon contains 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 Alopurinol Normon

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

Oral use only.

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

Normally, your doctor will start treatment with alopurinol 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 can 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 alopurinol 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 alopurinol 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 Alopurinol Normon 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 Alopurinol Normon

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 moment on.

If you stop treatment with Alopurinol Normon

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

If you have any other 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 all people suffer from them.

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

The frequency of adverse effects is classified into:

Very frequent (less than 1 in 10 patients)

Frequent (less than 1 in 100 patients)

Uncommon (less than 1 in 1,000 patients)

Rare (less than 1 in 10,000 patients)

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

Unknown frequency(cannot be estimated from available data)

Infections and Infestations

Very rare: Follicular infection.

Blood and Lymphatic System Disorders

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

On occasion, alopurinol tablets may produce 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 have 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 mouth).

Rare: Severe hypersensitivity reactions, associated with exfoliation, fever, joint pain, and swelling of 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, inflammation in the armpit, neck, or groin lymph nodes), potentially life-threatening severe allergic reaction.

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

Metabolic and Nutritional Disorders

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

Psychiatric Disorders

Very rare: Depression.

Nervous System Disorders

Very rare: Weakness, numbness, or loss of consciousness, paralysis, motor incoordination (lack of movement coordination), alteration of normal sensitivity (neuropathy), tingling sensation (paresthesia), somnolence, headache, alteration in taste.

Unknown frequencyAseptic 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 slowed heart rate.

Vascular Disorders

Very rare: High blood pressure.

Gastrointestinal Disorders

Uncommon: Nausea, vomiting.

Very rare: Appearance of 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

Frequent: Skin rash.

Very rare: Hives, drug-induced skin eruptions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2), hair loss or discoloration, severe allergic reaction causing facial or throat swelling.

Unknown frequency(cannot be estimated from available data): Lichenoid skin eruption (red-purple skin rash with itching or grayish-white lines on the mucous membranes).

Renal and Urinary Disorders

Very rare: Appearance of blood in urine.

Reproductive System and Breast Disorders

Very rare: Male infertility, impotence, breast growth.

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 (affect 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

FrequentElevated thyroid-stimulating hormone levels in blood.

There have been reports of fever with or without signs or symptoms of generalized hypersensitivity to alopurinol (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 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 prospectus. 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. Conservation of Alopurinol Normon

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

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

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

6. Package Contents and Additional Information

Composition of Alopurinol Normon

The active ingredient is alopurinol. Each tablet contains 100 mg of alopurinol.

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

Appearance of Alopurinol Normon and Package Contents

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

It is presented in packages containing 25 and 100 tablets in PVC-Aluminum blisters and a prospectus.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos- Madrid

Spain

Date of the Last Revision of this Prospectus:August 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/63221/P_63221.html