Allopurinol Pensa 300 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Alopurinol Pensa 300 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given 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 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 side 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 reduces the levels of uric acid 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 taking Alopurinol Pensa

Do not take Alopurinol Pensa:

• 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

Exercise special caution with this medicine:

• If you are experiencing an acute attack of gout.
• If you are pregnant, think you might 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 in the lips or mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes), wheezing (whistling breath), palpitations or chest tightness, or loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO ALLOPURINOL. Stop treatment immediately and contact your doctor immediately.

You must stop taking this medicine and contact your doctor as soon as possible if, while taking allopurinol, 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 include blood).
• General feeling of being unwell.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Feeling thirsty, tiredness, and weight loss.
• Appearance of boils.
• Blood in the urine.

It is possible that at the beginning of treatment with allopurinol, an acute attack of gout may be triggered. Your doctor will recommend using certain medications to prevent this. If a gout attack occurs, it is not necessary to stop treatment with allopurinol, provided that 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 allopurinol. Often, the rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These potentially life-threatening skin reactions 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 origin. Additionally, 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 immediately.

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

If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis with allopurinol, you must never use allopurinol again.

Other medicines and Alopurinol Pensa

Inform 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 the dose of your medication 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), vidarabine (adenosine arabinoside, for viral infections), salicylates (aspirin, for pain relief), uricosuric agents (probenecid, for treating gout), chlorpropamide (for diabetes), theophylline (for asthma), phenytoin (for epilepsy), ampicillin (antibiotic), amoxicillin (antibiotic), cyclophosphamide (for rheumatoid arthritis and certain cancers), doxorubicin (for certain types of lymphoma), bleomycin (for certain cancers), procarbazine (for certain cancers), mechlorethamine (for certain cancers), cyclosporine (to prevent transplant rejection), coumarin anticoagulants (to prevent blood clots), and didanosine (for HIV) and captopril.

The concomitant administration of 6-mercaptopurine or azathioprine with allopurinol 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 this case, your doctor will closely monitor your blood count during treatment.

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

If aluminum hydroxide is taken concomitantly, the effect of allopurinol may be reduced. Therefore, an interval of at least 3 hours should be left between the administration of both medicines.

When allopurinol is administered in combination with cytostatic agents (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), blood disorders 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of allopurinol is not recommended during pregnancy.

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

Driving and using machines

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 impair your abilities.

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 Pensa

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, please 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 score line is intended solely for dividing the tablet if you find it difficult to swallow whole.

The recommended dose is:

Adults:

The recommended starting dose is 100 mg to 300 mg of allopurinol daily. 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 it 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 that achieves reduction of uric acid levels and control of your symptoms. In 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 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 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.

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 it as soon as you remember. Then continue taking the medicine as before.

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

If you stop taking Alopurinol Pensa:

Your doctor will advise you on the duration of treatment with this medicine. Do not stop treatment prematurely, 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 people).
Common (affects at least 1 in 100 people).
Uncommon (affects at least 1 in 1,000 people).
Rare (affects at least 1 in 10,000 people).
Very rare (affects fewer than 1 in 10,000 people).
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 blood-related effects, such as increased bruising, 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 thyroid-stimulating hormone (TSH) levels in blood.

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, 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 (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 slow pulse.

Vascular disorders:

• Very rare: High blood pressure.

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.
• Skin eruptions resembling drug reactions, 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-gray thread-like lines on mucous membranes).

Musculoskeletal and connective tissue disorders:

• Very rare: Muscle pain.

Renal and urinary disorders:

• Very rare: Blood in urine.

Reproductive system and breast disorders:

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

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 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).

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 may 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 Allopurinol 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 container 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 empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. 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 300 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 circular white tablets, unmarked on one side and scored on the other, with a diameter of approximately 12 mm. Each pack contains 30 or 500 tablets (hospital pack) in PVC/aluminum blister packs.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 latest revision of this leaflet: November 2024

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