Allopurinol Pensa 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alopurinol Pensa 100 mg tablets EFG

Read the entire leaflet carefully before you start using 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, and you should not give it to others, 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 Pensa is and what it is used for
2. What you need to know before taking Alopurinol Pensa
3. How to take Alopurinol Pensa
4. Possible adverse effects
5. How to store Alopurinol Pensa
6. Contents of the pack and other information

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

Alopurinol Pensa belongs to a group of medicines called enzyme inhibitors, which work 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 Alopurinol Pensa

Do not take Alopurinol Pensa:

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

Warnings and precautions

Take special care with this medicine:

• 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 and red eyes), wheezing (whistling breathing), palpitations or chest tightness, or loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC to alopurinol. Stop your treatment and contact your doctor immediately.

You must stop taking this medicine and contact your doctor as soon as possible if, while taking alopurinol, you experience any of the following symptoms:

• High fever.
• Joint pain or painful swelling in the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Nausea or vomiting (which may contain blood).
• General feeling of being unwell.
• 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 thirsty, tired, and weight loss.
• Appearance of boils.
• Blood in the urine.

An acute attack of gout may be triggered at the beginning of treatment with alopurinol. Your doctor may recommend using certain medications to prevent this. If a gout attack occurs, it is not necessary to stop alopurinol treatment as long as an appropriate anti-inflammatory medicine is used at the same time.

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of alopurinol. Frequently, the rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These potentially life-threatening skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to blistering and widespread skin peeling. These serious skin reactions may be more common in individuals 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 alopurinol and consult your doctor immediately.

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

If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking alopurinol, you must never use alopurinol again.

Other medicines and Alopurinol Pensa

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, especially the following. Your doctor may need to reduce your dose or monitor you more closely, as there is an increased risk of side effects when Alopurinol Pensa is taken together with: 6-mercaptopurine (used to treat blood cancer), azathioprine (used to suppress the immune system), adenine arabinoside (vidarabine, for treating viral infections), salicylates (aspirin, for pain relief), uricosuric agents (probenecid, for treating gout), chlorpropamide (for treating diabetes), theophylline (for asthma), phenytoin (for epilepsy), ampicillin (antibiotic), amoxicillin (antibiotic), cyclophosphamide (for rheumatoid arthritis and certain types of cancer), doxorubicin (for treating certain types of lymphoma), bleomycin (for treating certain types of cancer), procarbazine (for treating certain types of cancer), mechlorethamine (for treating certain types of cancer), cyclosporine (to prevent transplant rejection), coumarin anticoagulants (to prevent blood clots), and didanosine (for treating HIV) and captopril.

The concomitant administration of 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with Alopurinol Pensa, 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 such cases, your doctor will closely monitor your blood count during treatment.

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

If aluminum hydroxide is taken concomitantly, alopurinol may have a reduced effect; therefore, at least a 3-hour interval should be left between taking the two medicines.

When alopurinol is administered in combination with cytostatic agents (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasias occur more frequently than when these active substances are administered alone.

Therefore, periodic hematological monitoring should be performed.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of alopurinol is not recommended during pregnancy.

Alopurinol passes into breast milk. The use of alopurinol is not recommended during breastfeeding.

Driving and operating machinery

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

Do not drive or operate tools or machinery until you are reasonably certain that this medicine does not affect your ability to do so.

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

3. How to take Alopurinol Pensa

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

Adults:

The recommended starting dose is 100 mg to 300 mg daily of allopurinol. The dose may be increased up to 900 mg per day, depending on the individual case. In such cases, and if stomach discomfort occurs, it is advisable to divide the dose into several administrations per day and take them with food.

Children and adolescents under 15 years of age

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

Elderly patients

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

Patients with impaired liver or kidney function

If you have liver or kidney problems, your doctor will prescribe the lowest effective dose of allopurinol to reduce uric acid levels and control your symptoms. In case of renal insufficiency, your doctor may advise you to take less than 100 mg per day or to take single 100 mg doses at intervals longer than one day.

If you are on 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 Pensa than you should

In this case, contact the Toxicology Information Service, Telephone 91 562 04 20, or go to your doctor.

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

If you forget to take Alopurinol Pensa

Do not take a double dose to make up for missed doses.

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

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

If you stop treatment with Alopurinol Pensa:

Your doctor will advise you on the duration of 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, this medicine can cause adverse effects, although not everyone will experience them.

The frequency of adverse effects is classified as follows:

Very common (affects at least 1 in 10 patients).
Common (affects at least 1 in 100 patients).
Uncommon (affects at least 1 in 1,000 patients).
Rare (affects at least 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: Hair follicle infection.

Blood and lymphatic system disorders:

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

Occasionally, allopurinol tablets may cause effects on the blood, 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.

Investigations:

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

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 groin, armpits, or neck, jaundice (yellowing of the skin and eyes), and other skin and subcutaneous tissue disorders (see below).
• Very rare: Angioimmunoblastic lymphadenopathy (swelling in armpits, neck, groin), potentially life-threatening severe 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 (high blood sugar levels), increased levels of lipids (fats) in blood, increased uric acid levels in blood.

Psychiatric disorders:

• Very rare: Depression.

Nervous system disorders:

• Very rare: Weakness, numbness, or loss of consciousness, paralysis, uncoordinated movements, altered normal sensation (neuropathy), drowsiness, 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 slowed pulse.

Vascular disorders:

• Very rare: High blood pressure.

Gastrointestinal disorders:

• Uncommon: Nausea, vomiting, diarrhoea.
• Very rare: Presence of 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.
• Skin rashes of drug origin, which may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2), hair loss or discoloration.
• Very rare: Severe allergic reaction causing swelling of the face or throat.
• Frequency not known: Lichenoid skin eruption (reddish-purple rash with itching or white-grey thread-like lines on mucous membranes).

Musculoskeletal and connective tissue disorders:

• Very rare: Muscle pain.

Renal and urinary disorders:

• Very rare: Presence of blood in urine.

Reproductive system and breast disorders:

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

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 changes to 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 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 adverse reactions, as it is possible that none of them will occur in your case.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Pensa

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

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

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 containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Pensa:

The active substance is allopurinol. Each tablet contains 100 mg of allopurinol.

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

Appearance of the product and contents of the pack:

Alopurinol Pensa are white, circular tablets, approximately 8 mm in diameter. Each pack contains 25 or 100 tablets in PVC/aluminum blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer:

Towa Pharmaceutical Europe, S.L.
C/ de Sant Martí 75-97
08107 Martorelles (Barcelona)
Spain

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

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