Package Insert: Information for the User

Alopurinol Sun 300 mg Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

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

• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isAlopurinol Sunand what is it used for

2. What you need to know before starting to takeAlopurinol Sun

3. How to takeAlopurinol Sun

4. Possible adverse effects

5. Storage ofAlopurinol Sun

6. Contents of the package and additional information

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 the level of uric acid in plasma and urine. This medication is used to prevent the onset of gout and other situations caused by excessive uric acid in the body, such as kidney stones and certain types of renal 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 Sun

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alopurinol Sun

• 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 an infection.
• If a skin rash, skin peeling, blisters, or sores on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes), 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.

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET)) 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 developing severe skin reactions is during the first weeks of treatment.

If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of this medication, you should not use this medication again at any time.

If you are unsure, consult your doctor.

You should stop your treatment and contact your doctor as soon as possible if, while you are taking Alopurinol Sun 300 mg tablets, you present 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, visual disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Feeling of thirst, fatigue, 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 this medication. 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 Alopurinol Sun as long as an appropriate anti-inflammatory medication is used concurrently.

Children

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

Other medications and Alopurinol Sun

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription, especially the following:

It is especially important to inform your doctor if you are taking any of the medications listed below.It may be necessary for your doctor 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 cyclosporine side effects may occur more frequently.

Administration of 6-mercaptopurine or azathioprine with allopurinol 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 may increase the risk of severe blood disorders. In this case, your doctor will closely monitor your blood counts during treatment.

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

• Vidarabine (used to treat herpes). Note that vidarabine side effects may occur more frequently. Be especially cautious if this occurs.
• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).
• Probenecid (used to treat gout).
• Chlorpropamide (used to treat diabetes).It may be necessary to reduce the dose of chlorpropamide, especially in patients with reduced renal function.
• Warfarin, phenprocoumon, acenocoumarol (anticoagulants). Your doctor will closely monitor your blood counts 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 the blood, especially when starting treatment with allopurinol or following any dose change.
• Ampicillin or amoxicillin (used to treat bacterial infections). When possible, patients should receive other antibiotics as it is more likely that allergic reactions will occur.
• Medications to treat aggressive tumors such as:

- Cyclophosphamide

- Doxorubicin

- Bleomycin

- Procarbazine

- Mechlorethamine

Your doctor will closely monitor your blood counts.

• 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 kidney function limitations.

If taken concomitantly with aluminum hydroxide, allopurinol may have a reduced effect, so it is recommended to leave a gap of at least 3 hours between the two 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.

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

Pregnancy, breastfeeding, and fertility

This medication is not recommendedif you are pregnant,

Alopurinol passes into breast milk. It is not recommended to use allopurinol during the lactation period.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Due to its side effects (drowsiness, dizziness, and coordination impairment), 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 300 mg tablets contain lactose

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

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 on the most suitable dose of this medication 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 initial treatment dose of this medication for adults is 100 to 300 mg. The dose may be increased 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:

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

Advanced age:

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 dysfunction:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of this medication that can reduce uric acid levels and control your symptoms. In the case of kidney insufficiency, your doctor may recommend taking less than 100 mg per day or taking 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 Sun 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.

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

If you forgot 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 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 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 doubts about the use of this product, ask your doctor or pharmacist.

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

The likelihood of these side effects occurring is higher when there are kidney and/or liver abnormalities.

The frequency of side effects is classified as:

Very common (≥ 1/10)

Common (≥ 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 rareFolliculitis.

Blood and lymphatic system disorders

Very rareLeucopenia (decreased white blood cell count): increases the risk of infections), anemia (may cause fatigue, tiredness), platelets (cells involved in blood clotting, with the appearance of bruises or bleeding, more easily than usual).

In some cases, allopurinol tablets may cause effects on the blood that manifest with the appearance of more frequent bruises, 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

UncommonReactions of hypersensitivity (allergy: possible appearance of skin rash, skin peeling, blisters, or sores on the lips or in the mouth).

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).

RareSevere hypersensitivity reactions, potentially life-threatening.

Very rareLymphadenopathy angioimmunoblastic (occurs with weight loss, fever, inflammation in the axillary, cervical, or inguinal lymph nodes), potentially life-threatening allergic reaction.

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

Metabolism and nutrition disorders

Very rareDiabetes mellitus (elevated blood glucose levels), increased blood lipid levels, increased uric acid levels in the blood.

Mental and behavioural disorders

Very rareDepression.

Nervous system disorders

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

Frequency

not knownAsymptomatic 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 rareVestibular disorders.

Cardiac disorders

Very rareChest pain or bradycardia (slow heart rate).

Vascular disorders

Very rareHypertension (high blood pressure).

Frequency

Not knownVasculitis

Gastrointestinal disorders

UncommonNausea, vomiting, diarrhea.

Very rareBleeding in the vomit, steatorrhea (excess fat in the stool), oral infections, changes in bowel habits.

Hepatobiliary disorders

UncommonAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and subcutaneous tissue disorders

CommonSkin rash.

Very rareUrticaria, drug-induced skin eruptions that may 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 eruption (red-violet skin rash with itching or white-grayish lines on mucous membranes)

Renal and urinary disorders

Very rareBlood in the urine.

Reproductive and breast disorders

Very rareMale infertility, impotence, gynecomastia (breast growth).

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(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, such as mouth ulcers, throat, nose, genital, or conjunctivitis (inflammation and redness of the eyes), blisters, or generalized peeling.
• Severe hypersensitivity reactions, with fever, rash, joint pain, and alterations in blood and liver function tests (these may be symptoms of multi-organ hypersensitivity syndrome).

Complementary examinations

CommonElevated 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 none of them will occur in your case.

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.

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

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

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

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 Sunand contents of the packaging

White or cream-colored biconvex tablets

The tablets are presented in packs of 30 tablets.

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Responsible for manufacturing:

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 medication by contacting the local representativeof the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona.

Spain

Tel.: +34 342 78 90

Last review date of this leaflet:December 2024

The detailed information about this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/