Package Leaflet: Information for the User

Alopurinol Normon 300 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this package 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet.

Alopurinol Normon belongs to a group of medications 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.

Alopurinol Normon is used to prevent the onset of gout and other situations caused by excessive 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, stop taking allopurinol and consult your doctor.

Do not take Alopurinol Normon

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

Warnings and precautions

Be especially careful with this medication:

• if you have an acute gout attack.
• 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 infection.
• if a skin rash, skin peeling, blisters, or sores on the lips or in the mouth, wheezing (popping sounds), palpitations, or chest tightness appear: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO ALOPURINOL. Suspend your treatment and contact your doctor immediately.

If you are unsure, consult your doctor.

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

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

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of allopurinol, do not use allopurinol again at any time.

If you develop a rash or these symptoms on your skin, stop taking allopurinol, go to your doctor immediately, and inform them that you are taking this medication.

You should suspend 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 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, 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 gout attack may occur at the beginning of treatment with allopurinol. 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 allopurinol as long as an appropriate anti-inflammatory medication is used concurrently.

Other medications and Alopurinol Normon

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription, especially the following:

6-mercaptopurine (for the treatment of certain types of cancer), azathioprine (to prevent rejection in transplants and the treatment of autoimmune diseases), arabinoside of adenine (vidarabine, for the treatment of viral infections), salicylates (aspirin for pain relief), uricosuric agents (probenecid, for the treatment of gout), chlorpropamide (for diabetes), theophylline (for asthma), phenytoin (for epilepsy), ampicillin (antibiotic), amoxicillin (antibiotic), cyclophosphamide (for rheumatoid arthritis and the treatment of certain types of cancer), doxorubicin (for the treatment of certain types of lymphoma), bleomycin (for the treatment of certain types of cancer), procarbazine (for the treatment of certain types of cancer), mechlorethamine (for the treatment of certain types of cancer), cyclosporine (to prevent rejection in transplants), anticoagulant coumarins (to prevent blood clotting), and didanosine (for the treatment of HIV).

The administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered with Alopurinol Normon, 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 blood count during treatment.

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

If you take aluminum hydroxide concomitantly, allopurinol may be attenuated, so 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), blood disorders occur more frequently than when these active principles are administered alone.

Therefore, periodic hematological controls should be performed.

Pregnancy and lactation:

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Allopurinol is not recommended for use during pregnancy.

Allopurinol passes into breast milk. Allopurinol is not recommended for use during lactation.

Driving and operating machinery:

Due to its side effects (drowsiness, dizziness, and coordination impairment), this medication 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.

Alopurinol Normon contains lactose

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

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

Oral administration 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 alopurinol at a low dose (e.g., 100 mg/day), to reduce the risk of possible adverse effects. Your dose will be increased if necessary.

The recommended dose is:

Adults:

The usual starting dose of alopurinol for treatment 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 daily doses and take them with food.

Children under 15 years old:

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

Geriatric patients

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 dysfunction:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol that can reduce uric acid levels and control your symptoms. In cases 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 longer intervals. 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 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 forgot to take Alopurinol Normon

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

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

If you interrupt treatment with Alopurinol Normon

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

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

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

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

The frequency of side effects are classified as:

Very common (in at least 1 in 10 patients)

Common (in at least 1 in 100 patients)

Uncommon (in at least 1 in 1,000 patients)

Rare (in at least 1 in 10,000 patients)

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

Infections and infestations

Very rare: Follicular hair infection.

Blood and lymphatic system disorders

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

In some cases, allopurinol tablets can cause blood-related effects that manifest with the appearance of more 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 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 in the mouth).

Rare:Severe hypersensitivity reactions, associated with exfoliation, fever, joint pain, or painful swelling of the inguinal, axillary, or cervical areas, jaundice (yellowing of the skin and eyes), and other skin and subcutaneous tissue alterations (see below).

Very rare:Lymphadenopathy angioimmunoblastic (inflammation in the axillary, cervical, or inguinal areas), potentially life-threatening allergic reaction.

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

Metabolism and nutrition disorders

Very rare:Diabetes mellitus (high blood sugar levels), increased levels of lipids (fats) in the blood, increased uric acid levels in the blood.

Mental and behavioural disorders

Very rare:Depression.

Nervous system disorders

Very rare:Weakness, numbness, or loss of consciousness, paralysis, uncoordinated movements, altered sensitivity (neuropathy), drowsiness, headache, altered taste.

Unknown frequency (cannot be estimated from available data):Asymptomatic 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:Vestibular disorders.

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, excessive fat in stool, oral infections, changes in bowel habits.

Hepatobiliary disorders

Uncommon:Asymptomatic increases in liver function tests.

Rare:Hepatitis (liver inflammation).

Skin and subcutaneous tissue disorders

Common:Skin rash.

Very rare:Rashes, drug-induced skin eruptions that can be life-threatening to the patient (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-violet skin rash with itching or white-grayish lines on mucous membranes).

Renal and urinary disorders

Very rare:Blood in urine.

Reproductive 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 (affects fewer 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, or 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 can be symptoms of multi-organ hypersensitivity syndrome).

Complementary investigations

Common:Elevated levels of thyroid-stimulating hormone in the blood.

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 side effects, as it is possible that your case may not appear on it.

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 Vigilance of Medicines for Human Use:https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alopurinol Normon

The active ingredient is alopurinol. Each tablet contains 300 mg of alopurinol.

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

Appearance of Alopurinol Normon and contents of the packaging

The tablets are white or slightly cream-colored, round, biconvex, scored, and printed with A/L on one face.

It is presented in a packaging containing 30 tablets in PVC-Aluminum blisters and a leaflet.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos- Madrid (SPAIN)

Date of the last review of this leaflet:December 2024

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

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

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