Allopurinol Sun 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alopurinol Sun 100 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Alopurinol Sun
6. Contents of the pack and other information

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

Pharmacotherapeutic class: inhibitor of uric acid production. ATC code: M04AA01

Alopurinol belongs to a group of medicines called enzyme inhibitors, which act by controlling the rate at which a specific chemical process occurs in the body. In this case, it results in a reduction of uric acid levels in plasma and urine. This medicine 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 renal or metabolic disorders.

2. What you need to know before starting to take Alopurinol Sun

Serious skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash may 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, and body aches. The rash may progress to blistering and widespread peeling of the skin. These serious skin reactions may be more common in people of Han Chinese, Thai, or Korean descent. In addition, 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 Sun

If you are allergic to allopurinol or to any of the other ingredients of Alopurinol Sun 100 mg tablets.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Alopurinol Sun:

• If you are experiencing 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 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 on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (swollen, red eyes), wheezing (whistling breathing), palpitations or chest tightness, or loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO ALOPURINOL. Stop treatment and contact your doctor immediately.

Severe, potentially life-threatening skin reactions (Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)) associated with the use of Alopurinol Sun initially appear as red spots or circular lesions, often with a central blister.

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

If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Alopurinol Sun, you must never use this medicine again.

If you are unsure, consult your doctor.

You must stop your 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.
• 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 malaise.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Increased thirst, fatigue, and weight loss.
• Appearance of boils.
• Blood in the urine.

An acute attack of gout may be triggered at the beginning of treatment with this medicine. Your doctor will recommend taking certain medications to prevent this. If a gout attack occurs, it is not necessary to stop treatment with Alopurinol Sun, provided that an appropriate anti-inflammatory medicine is used concurrently.

Children

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

Other medicines and Alopurinol Sun

• 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 your dose or monitor you more closely, as there is an increased risk of side effects when Alopurinol Sun 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.

The administration of 6-mercaptopurine or azathioprine together with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with Alopurinol Sun, 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 this case, your doctor will closely monitor your blood counts during treatment.

Seek immediate medical attention if you notice unexplained bruising, bleeding, fever, or sore throat.

• 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 frequently monitor your blood tests.

• Didanosine (used to treat HIV infection).
• ACE inhibitors (e.g., captopril) or diuretics (used to treat high blood pressure). The risk of developing skin reactions may increase, especially in patients with chronic impairment of kidney function.

If aluminum hydroxide is taken concomitantly, allopurinol may have a reduced effect; therefore, it is advisable to leave an interval of at least 3 hours 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 blood tests should be performed.

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

Pregnancy, breastfeeding, and fertility

This medicine is not recommended if you are pregnant.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

You should not perform these activities until you are reasonably certain that the medicine does not affect your capabilities.

Alopurinol Sun 100 mg tablets contain lactose

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

3. How to take Alopurinol Sun

Follow your doctor's instructions regarding when and how to take these tablets. Consult your doctor or pharmacist if you have any doubts. Your doctor will decide the most appropriate dose of this medicine for you and how long you should take it. Do not stop treatment early, even if you feel better.

This medicine is administered orally. Swallow the tablet whole with a little water. It is usually taken once daily, 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 condition. In such cases, if stomach discomfort occurs, it is advisable to divide the dose into several administrations per day and take it with food.

Children under 15 years of age:

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

Elderly:

Your doctor will recommend the lowest possible dose of this medicine 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 this medicine needed to reduce uric acid levels and control your symptoms. In case of kidney insufficiency, your doctor may advise taking less than 100 mg per day or taking single doses of 100 mg at intervals longer than one day. If you undergo 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 Sun than you should:

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

In case of accidental ingestion of a large amount of medicine, go immediately to your doctor or the nearest hospital emergency department. Bring this leaflet with you.

Signs of overdose may include nausea, vomiting, diarrhea, and dizziness.

If you forget to take Alopurinol Sun:

If you forget to take a dose, take the next dose as soon as you remember. Then continue taking it as before. DO NOT take a double dose to make up for a missed dose.

If you forget several doses, it is best to contact your doctor so that he or she can advise you on what to do from that point onward.

If you stop treatment with Alopurinol Sun:

Your doctor will indicate how long you should continue treatment with this medicine. Do not stop treatment early, even if you feel better.

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

4. Possible adverse effects

Like all medicines, Alopurinol Sun may have adverse effects, although not everyone will experience them.

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

The frequency of adverse effects is classified as follows:

Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Frequency not known (cannot be estimated from available data)

Infections and infestations

Very rare: Hair follicle infection.

Blood and lymphatic system disorders

Very rare: Decrease in the number of white blood cells: leucopenia (increases the risk of infections), red blood cells: anaemia (may cause tiredness, fatigue), platelets (cells involved in blood clotting, leading to bruising or bleeding more easily than usual).

Occasionally, allopurinol tablets may cause blood-related effects, 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 skin rash, skin peeling, blisters or sores in the lips or mouth).

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

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 in movements), altered normal sensation (neuropathy), tingling sensation (paraesthesia), somnolence, headache, taste disturbances.

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: Vertigo.

Cardiac disorders

Very rare: Chest pain or slow pulse (bradycardia).

Vascular disorders

Very rare: High blood pressure (hypertension).

Frequency not known: Vasculitis

Gastrointestinal disorders

Uncommon: Nausea, vomiting, diarrhoea.

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-induced skin eruptions that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2. Before taking Alopurinol 100 mg tablets), hair loss or discolouration, severe allergic reaction causing swelling of the face or throat.

Frequency not known: Lichenoid skin eruption (reddish-purple itchy rash or white-grey thread-like lines on mucous membranes).

Renal and urinary disorders

Very rare: Blood in urine.

Reproductive system and breast disorders

Very rare: Male infertility, impotence, breast enlargement (gynaecomastia).

General disorders and administration site conditions

Very rare: Swelling (oedema) 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 change in your skin, for example, mouth, throat, nose, genital ulcers, 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 investigations

Common: Elevated levels of thyroid-stimulating hormone in 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 adverse reactions, as it is possible that none of them will occur in your case.

Reporting of adverse effects

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

5. Storage of Alopurinol Sun

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

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

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Sun

Each tablet contains 100 mg of allopurinol as the active substance.

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

Appearance of Alopurinol Sun and contents of the pack

White or cream, biconvex tablets.

The tablets are supplied in packs of 25 and 100 tablets.

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

The Netherlands

Or

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007- Barcelona

Spain

Date of the most recent review of this leaflet: December 2024

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