ALLOPURINOL SUN 300 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alopurinol Sun 300 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, pharmacist, or nurse.

• 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. See section 4.

Contents of the pack:

1. What Alopurinol Sun is and what it is used for
2. What you need to know before you take Alopurinol Sun
3. How to take Alopurinol Sun
4. Possible side effects
5. Storage of Alopurinol Sun
6. Contents of the pack and other 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 medicines 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. This medicine is used to prevent the onset of gout and other conditions produced 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 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 serious 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 Sun

If you are allergic to alopurinol or any of the other ingredients of Alopurinol Sun 300 mg tablets.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alopurinol Sun

• If you are having 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 medicine 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 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 spots or circular 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 this medicine, you should not use this medicine again at any time.

If you are not sure, consult your doctor.

You should stop treatment and contact your doctor as soon as possible if, while taking Alopurinol Sun 300 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 medicine, an acute attack of gout may be triggered. Your doctor will recommend the use of certain medicines to prevent this. If a gout attack occurs, it is not necessary to stop treatment with Alopurinol Sun as long as an appropriate anti-inflammatory medicine is used at the same time.

Children

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

Other medicines and Alopurinol Sun

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, especially the following

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 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.

Concomitant administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered 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 your doctor immediately if you notice that you have any unexplained bruising, bleeding, fever, or sore throat.

• 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 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 hematological 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 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 because it is more likely that allergic reactions will appear.
• Medicines for treating aggressive tumors such as:

• Cyclophosphamide
• Doxorubicin
• Bleomycin
• Procarbazine
• Mechlorethamine

Your doctor will monitor your blood counts 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 aluminum hydroxide is taken concomitantly, alopurinol may have a reduced effect, so it is advisable to leave an interval of at least 3 hours 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 hematological checks should be performed.

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

Pregnancy, breastfeeding, and fertility

This medicine 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 impairment), this medicine may affect your ability to drive vehicles or use dangerous machinery. You should not perform these activities until you are reasonably sure that the medicine does not limit your abilities.

Alopurinol Sun 300 mg tablets contain lactose

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

3. How to take Alopurinol Sun

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

This medicine is administered orally. Swallow the tablet whole with the help of 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 medicine 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 intakes per day and take them with food.

Children under 15 years:

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

Advanced age:

Your doctor will recommend the lowest possible dose of this medicine 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 medicine 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 Sun than you should

In this case, consult the Toxicological 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.

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 forgotten doses.

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

If you stop treatment with Alopurinol Sun

Your doctor will indicate the duration of treatment with this medicine. 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, this medicine 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>

Infrequent (≥ 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 bruises 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

InfrequentHypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters, or sores on the lips or in the 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, convulsions, wheezing, palpitations, chest tightness, or loss of consciousness may occur.

Metabolic and Nutritional Disorders

Very rareDiabetes mellitus (high 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 (paresthesia), 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 clouding of 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).

Frequency

Not knownVasculitis

Gastrointestinal Disorders

InfrequentNausea, vomiting, diarrhea.

Very rareAppearance of blood in vomit, excess fat in stool, mouth infections, changes in bowel habits.

Hepatobiliary Disorders

InfrequentAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and Subcutaneous Tissue Disorders

FrequentSkin rash.

Very rareHives, drug-induced skin rashes that can threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. Before taking Alopurinol 300 mg tablets), hair loss or discoloration, severe allergic reaction causing facial or throat swelling.

Frequency not knownLichenoid skin rash (red-purple rash with itching or white-grayish 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 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 multi-organ hypersensitivity disorder).

Complementary Tests

FrequentElevated thyroid-stimulating hormone levels in blood.

Cases of fever with or without signs or symptoms of generalized hypersensitivity to alopurinol 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 appear 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 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 Sun

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°C. Keep protected from humidity.

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 down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers 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 300 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 30 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

Tel.:+34 342 78 90

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/