ALLOPURINOL SUN 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Alopurinol Sun100 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Pharmacotherapeutic group: uric acid production inhibitor. ATC code: M04AA01

Alopurinol 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 uric acid levels in plasma and urine. This medication is used to prevent the onset of gout and other conditions 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 taking Alopurinol Sun

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 generalized 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, stop taking alopurinol and consult your doctor.

Do not take Alopurinol Sun

If you are allergic to alopurinol or any of the other components of Alopurinol Sun 100 mg tablets

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alopurinol Sun

• If you are having an acute gout attack.
• 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 disease or high blood pressure.
• If you notice that you bruise more easily than before or if you experience throat pain or other signs of infection.
• If a skin rash, peeling of the skin, blisters, or ulcers 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.

Severe skin rashes that can threaten the patient's life (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) with the use of Alopurinol Sun 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 Sun, you should not use this medication 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 Sun 100 mg tablets, 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, fatigue, and weight loss.
• Appearance of boils.
• Appearance of blood in urine.

It is possible that at the start of treatment with this medication, an acute gout attack may be triggered. Your doctor will recommend the use of certain medications to prevent this. In case of a gout attack, it is not necessary to stop treatment with Alopurinol Sun, provided that 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 medications and Alopurinol Sun

• It is especially important that you inform your doctor if you are taking any of the medications listed below. Your doctor may need to reduce the dose of your medication or monitor you more closely because there is a higher risk of side effects when Alopurinol Sun is taken at the same time as: 6-mercaptopurine (used in the treatment of blood cancer).
• Azathioprine, cyclosporine (used to suppress the immune system). Note that adverse effects to cyclosporine may occur more frequently.

Avoid taking 6-mercaptopurine or azathioprine with alopurinol. When 6-mercaptopurine or azathioprine is taken with Alopurinol Sun, 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 closely monitor your blood count during treatment.

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

• Vidarabine (used in the treatment of herpes). Note that adverse effects to vidarabine may occur more frequently. Be especially cautious if this happens to you.
• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).
• Probenecid (used in 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 count more frequently and, if necessary, reduce the dose of these medications.
• Phenytoin (used to treat epilepsy).
• Theophylline (used to treat asthma and other respiratory diseases). Your doctor will measure theophylline levels 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, as it is more likely that allergic reactions will appear.
• Medications for treating aggressive tumors such as:

• Cyclophosphamide
• Doxorubicin
• Bleomycin
• Procarbazine
• Mecloretamine

Your doctor will monitor your blood count 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.

If you take aluminum hydroxide concomitantly, alopurinol may have a reduced effect, so it is advisable to leave an interval of at least 3 hours between taking both medications.

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

Therefore, periodic blood counts should be performed.

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

Pregnancy, breastfeeding, and fertility

This medication 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 medication.

Driving and using machines

Due to its side effects (drowsiness, dizziness, and impaired coordination), this medication may impair your ability to drive vehicles or operate hazardous machinery.

You should not perform these activities until you are reasonably sure that the medication does not limit your abilities.

Alopurinol Sun 100 mg tablets contain 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.

3. How to take Alopurinol Sun

Follow your doctor's recommendations on when and how to take these tablets. Consult your doctor or pharmacist if you have any doubts. Your doctor will decide what dose of this medication is most suitable for you and the duration of treatment. Do not stop treatment before, even if you feel better.

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

The recommended dose is:

Adults:

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

Elderly:

Your doctor will recommend the lowest possible dose of this medication 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 this medication 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 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 Sun 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 medication, go to your doctor without delay or to the emergency department of the nearest hospital. Bring this package leaflet with you.

The signs of an overdose may include nausea, vomiting, diarrhea, and dizziness.

If you forget to take Alopurinol Sun

In case you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally would, DO NOTtake a double dose to make up for the forgotten doses.

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

If you stop treatment with Alopurinol Sun

Your doctor will indicate the duration of treatment with this medication. 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, Alopurinol Sun can have 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 (≥ 1/10)

Frequent (≥ 1/100 to <1>

Uncommon (≥ 1/1,000 to <1>

Rare (≥ 1/10,000 to <1>

Very rare (<1>

Frequency not known (cannot be estimated from available data)

Infections and Infestations

Very rareFollicular infection.

Blood and Lymphatic System Disorders

Very rareDecrease in the number of white blood cells: leucopenia (increases the risk of infections), red blood cells: anemia (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 hematomas 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 have any of these symptoms.

Immune System Disorders

UncommonHypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters, or sores on the lips or 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), alteration of normal sensitivity (neuropathy), tingling sensation (paresthesias), somnolence, headache, alteration in 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).

FrequencyVasculitis

Not known

Gastrointestinal Disorders

UncommonNausea, vomiting, diarrhea.

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

FrequentSkin rash.

Very rareHives, drug-induced skin eruptions that can threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. Before taking Alopurinol 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 filiform 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(affect less than 1 in 1000 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 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. Storage of Alopurinol Sun

Keep this medicine out of sight and reach of children.

Do not store above 25°C. Keep protected from moisture.

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

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 Sun

Each tablet contains 100 mg of alopurinol as the active ingredient.

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

Appearance of Alopurinol Sun and Package Contents

Biconvex tablets, white or cream in color.

The tablets are presented in packages of 25 and 100 tablets.

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Or

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007- Barcelona

Spain

Date of the last revision of this prospectus:December 2024

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/