ALOPURINOL TEVA 300 mg TABLETS

2. What you need to know before you take Alopurinol Teva

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 widespread peeling of the skin. These severe skin reactions can be more frequent in people of Chinese, Thai, or Korean origin. Additionally, the risk of chronic kidney failure may increase in these patients. If you develop a skin rash or these symptoms on the skin, stop taking alopurinol and consult your doctor immediately.

Do not take Alopurinol Teva

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take alopurinol

• if you are having an acute attack of gout.
• if you are pregnant, think you may be pregnant, or are breast-feeding.
• 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 on the lips or in the mouth, wheezing (whistling), palpitations, or chest tightness, loss of consciousness appear: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC to alopurinol. Stop treatment and contact your doctor immediately.

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) with the use of alopurinol initially appear as red, circular spots or patches, often with a central blister.

The period of highest risk for the onset 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, 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 this medicine, 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).
• Feeling of general discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slow pulse.
• Swelling (edema) of the ankles.
• Feeling of thirst, tiredness, and weight loss.
• Appearance of boils.
• Appearance of blood in the 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 an attack of gout occurs, it is not necessary to stop treatment with this medicine as long as an appropriate anti-inflammatory medicine is used at the same time.

Children

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

Taking Alopurinol Teva with other medicines

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

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 is taken at the same time as:

• 6-mercaptopurine (used to treat blood cancer),
• Azathioprine, cyclosporin (used to inhibit the immune system). Note that adverse effects to cyclosporin may occur more frequently.
• Vidarabine (used to treat herpes). Note that adverse effects to vidarabine may occur more frequently. Be especially cautious if this happens.
• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).
• Probenecid and uricosuric medicines (used to treat 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 test values more frequently and, if necessary, reduce the dose of these medicines.
• Phenytoin (used to treat epilepsy),
• Theophylline (used to treat 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 since it is more likely that allergic reactions will appear.
• Medicines for treating aggressive tumors such as:
• • Cyclophosphamide
  • Doxorubicin
  • Bleomycin
  • Procarbazine
  • Mecloretamine

Your doctor will monitor your blood tests 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.

Administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered with alopurinol, 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 monitor your blood count closely during treatment.

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

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 medicines.

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 substances are administered alone.

Therefore, periodic blood tests should be performed.

Pregnancy, breast-feeding, 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 impaired coordination), this medicine may affect your ability to drive or operate machinery.

Do not drive, do not use tools or machines until you are reasonably sure that the medicine does not limit your abilities.

Alopurinol Teva contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Alopurinol Teva

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Oral use only.

The tablet can be divided into equal doses.

The tablets can be taken directly or broken in half with the help of a little water. It is usually taken once a day, generally after a meal.

Normally, your doctor will start treatment with alopurinol at a low dose (e.g., 100 mg/day) to reduce the risk of possible side effects. Your dose will be increased if necessary.

The recommended dose is:

Adults:

The recommended starting dose is 100 to 300 mg. The dose can 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 recommended dose of this medicine in children is 100 to 400 mg per day.

Elderly:

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 function impairment:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol 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 Teva than you should

In this case, consult the Toxicology Information Service. Phone 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.

If you forget to take Alopurinol Teva

In case you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally would. Do not take a double dose to make up for forgotten doses.

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

If you stop taking Alopurinol Teva

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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The probability of their occurrence is higher when there are renal and/or liver disorders.

The frequency of adverse effects is classified into:

Very frequent (affects less than 1 in 10 patients)

Frequent (affects less than 1 in 100 patients)

Infrequent (affects less than 1 in 1,000 patients)

Rare (affects less than 1 in 10,000 patients)

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

Frequency not known (cannot be estimated from available data)

Infections and Infestations

Very rare:Follicular infection

Blood and Lymphatic System Disorders

Very rare:Decreased white blood cell count: 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 occasions, 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

Infrequent:Hypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters, or ulcers 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 rare:Angioimmunoblastic 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 rare:Diabetes mellitus (elevated blood glucose levels), increased blood lipid levels, increased uric acid levels in the blood.

Psychiatric Disorders

Very rare:Depression

Nervous System Disorders

Very rare:Weakness, numbness, or loss of consciousness, paralysis, motor incoordination (lack of movement coordination), altered sensitivity (neuropathy), tingling sensation (paresthesia), somnolence, headache, altered taste.

Unknown: 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.

Unknown:Maculopathy

Ear and Labyrinth Disorders

Very rare:Vertigo

Cardiac Disorders

Very rare:Chest pain or slowed heart rate (bradycardia).

Vascular Disorders

Very rare:High blood pressure (arterial hypertension)

Gastrointestinal Disorders

Infrequent:Nausea, vomiting, diarrhea

Very rare:Appearance of blood in vomit, excess fat in feces, mouth infections, changes in bowel habits.

Hepatobiliary Disorders

Infrequent:Asymptomatic increases in liver function tests.

Rare:Hepatitis

Unknown:Liver necrosis, granulomatous hepatitis

Skin and Subcutaneous Tissue Disorders

Frequent:Skin rash

Very rare:Hives, drug-induced skin eruptions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2), hair loss or discoloration, severe allergic reaction causing facial or throat swelling.

Frequency not known:Lichenoid skin eruption (red-purple skin rash with itching or white-grayish filiform lines on the mucous membranes), alopecia, Hypersensitivity syndrome (some cases with fatal outcome)

Renal and Urinary Disorders

Rare:Urinary tract stones

Very rare:Appearance of blood in urine

Unknown:Azotemia (increased nitrogenous compounds such as urea and creatinine)

Reproductive System and Breast Disorders

Very rare:Male infertility, impotence, breast growth (gynecomastia).

General Disorders and Administration Site Conditions

Very rare:Swelling (edema) of the ankles, general malaise, fatigue, fever.

Musculoskeletal and Connective Tissue Disorders

Very rare:Muscle pain

Investigations

FrequentElevated thyroid-stimulating hormone levels in blood.

UnknownAbnormal liver function test

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 changes 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 changes in blood and liver tests (these may be symptoms of multi-organ hypersensitivity disorder).

Very rare (may affect up to 1 in 10,000 patients)

• On occasions, alopurinol tablets may produce effects on the blood that manifest with the appearance of more frequent hematomas than normal, sore throat, and 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.
• Severe allergic reaction causing facial or throat swelling.
• Potentially life-threatening severe allergic reaction.

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 of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction 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 reactions, you can contribute to providing more information on the safety of this medicine.

5. Storage of Alopurinol Teva

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

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

Do not use this medicine if you notice visible signs of deterioration.

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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Alopurinol Teva

• The active ingredient is alopurinol. Each tablet contains 300 mg of alopurinol.
• The other components are: lactose monohydrate, corn starch without gluten, sodium carboxymethylcellulose (type A) (derived from potato), anhydrous colloidal silica, cellulose powder (E-460), povidone (K-30), sodium lauryl sulfate, and magnesium stearate.

Appearance of Alopurinol Teva and Package Contents

White, round, biconvex tablets, with the inscription "2K1 2K1" and scored on one side and smooth on the other. The tablet can be divided into equal doses.

They are presented in packages of 30 tablets, containing 3 blisters of 10 tablets and a prospectus.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta, Alcobendas

28108 Madrid

Spain

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi Street 13, H-4042 Debrecen

Hungary

Date of the Last Revision of this Prospectus:August 2025

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69155/P_69155.html