Package Leaflet: Information for the User

Alopurinol pensa 300 mg tablets EFG

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

Alopurinol Pensa 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, it results in a decrease in the level of uric acid in plasma and in urine.

This medication is used to prevent the onset of gout and other situations caused by excessive uric acid in the body, such as, for example, kidney stones and certain types of renal or metabolic diseases.

Do not take Alopurinol Pensa:

• If you are allergic to the active ingredient in any of the other components of this medication (listed in section 6).

Warnings and Precautions

Be especially careful with this medication:

• 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 experience sore throat or other signs of infection.
• If you experience a skin rash, skin peeling, blisters, or sores on your lips, mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes), wheezing (whistling), palpitations, or chest tightness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO ALOPURINOL. Discontinue your treatment and contact your doctor immediately.

You should discontinue your treatment and contact your doctor as soon as possible if, while taking alopurinol, you experience any of the following symptoms:

• High fever.
• Pain in your joints or painful swelling of your ankles, armpits, or neck.
• Ictericia (yellowing of your skin and eyes).
• Nausea or vomiting (which may be bloody).
• General feeling of discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, or vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of your ankles.
• Feeling thirsty, tired, and weight loss.
• Appearance of boils.
• Blood in your urine.

It is possible that an acute gout attack may occur at the beginning of treatment with alopurinol. Your doctor will recommend the use of certain medications to prevent this. If a gout attack occurs, it is not necessary to discontinue treatment with alopurinol as long as an appropriate anti-inflammatory medication is used concurrently.

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of alopurinol. Often, the rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These life-threatening skin eruptions 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 Han, Thai, or Korean origin. Additionally, having chronic renal insufficiency may increase the risk in these patients. If you develop a skin rash or these skin symptoms, stop taking alopurinol and consult your doctor immediately.

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

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of alopurinol, you should not use alopurinol again at any time.

Other Medications and Alopurinol Pensa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, especially the following. 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 Pensa is taken at the same time as: 6-mercaptopurine (used to treat blood cancer), azathioprine (used to inhibit the immune system), arabinoside of adenine (vidarabine, for the treatment of viral infections), salicylates (aspirin, for pain relief), uricosuric agents (probenecid, for gout treatment), chlorpropamide (for diabetes), theophylline (for asthma), phenytoin (for epilepsy), ampicillin (antibiotic), amoxicillin (antibiotic), cyclophosphamide (for rheumatoid arthritis and certain types of cancer), doxorubicin (for the treatment of certain types of lymphomas), bleomycin (for the treatment of certain types of cancer), procarbazine (for the treatment of certain types of cancer), mechlorethamine (for the treatment of certain types of cancer), cyclosporine (to prevent transplant rejection), anticoagulant coumarins to prevent blood clotting) and didanosine (for HIV treatment) and captopril.

Administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered with Alopurinol Pensa, 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 count during treatment.

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

If you are taking aluminum hydroxide concurrently, alopurinol may be reduced in effect, so leave a gap of at least 3 hours between taking both medications.

Administration of alopurinol in combination with cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents) results in more frequent blood disorders than when these active ingredients are administered alone.

Therefore, regular hematological controls should be performed.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, think you may be pregnant, or are breastfeeding your child, consult your doctor or pharmacist before using this medication.

Alopurinol is not recommended for use during pregnancy.

Alopurinol passes into breast milk. Alopurinol is not recommended for use during breastfeeding.

Driving and Operating Machines

Due to its side effects (drowsiness, dizziness, and coordination impairment), this medication may impair your ability to drive vehicles.

Do not drive, operate tools, or machines until you are reasonably sure that the medication does not limit your abilities.

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

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

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

The groove is only for breaking the tablet if it is difficult to swallow it whole.

The recommended dose is:

Adults:

The recommended starting dose is 100 mg to 300 mg of alopurinol per day. The dose can be increased up to 900 mg per day, depending on the 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 and adolescents under 15 years

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

Older patients

Your doctor will recommend the lowest possible dose of alopurinol to reduce uric acid levels and control your symptoms.

Patients with liver or kidney dysfunction

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol that can reduce uric acid levels and control your symptoms. In the case of renal insufficiency, 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 Pensa than you should

In this case, consult the Toxicological Information Service, Teléfono 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 department. Bring this leaflet with you.

If you forgot to take Alopurinol Pensa

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose, take the next dose as soon as you remember. Then, continue taking it as you normally do.

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 Pensa:

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.

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

The frequency of side effects is classified as:

Very common (in at least 1 in 10 patients).

Common (in at least 1 in 100 patients).

Uncommon (in at least 1 in 1,000 patients).

Rare (in at least 1 in 10,000 patients).

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

Frequency unknown (cannot be estimated from available data).

Infections and infestations:

• Very rare: Folliculitis.

Blood and lymphatic system disorders:

• Very rare: Decreased white blood cell count (increases the risk of infections), red blood cell count (may cause fatigue, tiredness), platelet count (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.

Diagnostic procedures:

• Common: Elevated levels of thyroid-stimulating hormone in the blood.

Immune system disorders:

• Uncommon: Hypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters, or sores on the lips or in the mouth).
• Rare: Severe 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 alterations (see below).
• Very rare: Angioimmunoblastic lymphadenopathy (inflammation in the armpits, neck, groin), potentially life-threatening allergic reaction.

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

Metabolism and nutrition disorders:

• Very rare: Diabetes mellitus (high blood sugar levels), increased levels of lipids (fats) in the blood, increased uric acid levels in the blood.

Mental and behavioral disorders:

• Very rare: Depression.

Nervous system disorders:

• Very rare: Weakness, numbness, or loss of consciousness, paralysis, uncoordinated movements, altered sensitivity (neuropathy), drowsiness, headache, altered taste.
• Frequency unknown: Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or loss of 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 slowed pulse.

Vascular disorders:

• Very rare: High blood pressure.

Gastrointestinal disorders:

• Uncommon: Nausea, vomiting, diarrhea.
• Very rare: Vomiting blood, excessive fat in the stool, 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.
• Blistering, skin rashes of a drug-like type that may threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2), hair loss or discoloration.
• Very rare: Severe allergic reaction causing facial or throat swelling.
• Frequency unknown: Lichenoid skin eruption (red-violet skin rash with itching or white-gray lines on the mucous membranes).

Musculoskeletal and connective tissue disorders:

• Very rare: Muscle pain

Renal and urinary disorders:

• Very rare: Hematuria.

Reproductive and breast disorders:

• Very rare: Male infertility, impotence, breast growth.

General disorders and administration site conditions:

• Very rare: Swelling (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 fewer 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, 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 function tests (these may be symptoms of multi-organ hypersensitivity disorder).

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 adverse reactions:

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

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

No special storage conditions are required. Store in the original packaging.

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

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

Composition of Alopurinol Pensa:

The active ingredient is alopurinol. Each tablet contains 300 mg of alopurinol.

The other components (excipients) are: lactose, sodium croscarmellose, povidone K-30, and magnesium stearate.

Appearance of the product and content of the packaging:

Alopurinol Pensa are white, round, uncoated tablets on one side and scored on the other, approximately 12 mm in diameter. Each package contains 30 or 500 (clinical package) tablets conditioned in PVC/aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet:November 2024

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