ALOPURINOL PENSA 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alopurinol Pensa 100 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Alopurinol Pensa and what is it used for
2. What you need to know before you take Alopurinol Pensa
3. How to take Alopurinol Pensa
4. Possible side effects
5. Storage of Alopurinol Pensa
6. Contents of the pack and other information

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

Alopurinol Pensa belongs to a group of medicines called enzyme inhibitors, which act by controlling the speed at which a certain chemical process occurs in the body. In this case, it produces a decrease in the level of uric acid in plasma and urine.

This medicine is used to prevent the onset of gout and other situations produced by excess uric acid in the body, such as kidney stones and certain types of kidney or metabolic diseases.

2. What you need to know before you take 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

Be particularly careful with this medicine:

• If you have 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 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 have a sore throat or other signs of infection.
• If a skin rash, skin peeling, blisters, or ulcers appear on the lips or in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes), wheezing (whistling), palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC to alopurinol. Stop treatment and contact your doctor immediately.

You should stop treatment and contact your doctor as soon as possible if, while taking alopurinol, 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).
• General feeling of discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision changes.
• 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 urine.

It is possible that when starting treatment with alopurinol, an acute attack of gout may be triggered. Your doctor will recommend the use of certain medications to prevent this. In case of a gout attack, it is not necessary to stop treatment with alopurinol as long as an appropriate anti-inflammatory medication 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. Often, the rash can include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These life-threatening skin reactions are often preceded by flu-like symptoms such as fever, headache, body pain. The rash can progress to blistering and generalized skin peeling. These severe skin reactions can be more frequent in people of Chinese, Thai, or Korean origin. Additionally, having chronic kidney failure can 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 severe skin reactions is during the first few 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 medicines and Alopurinol Pensa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, especially the following. 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 Pensa is taken at the same time as: 6-mercaptopurine (used to treat blood cancer), azathioprine (used to inhibit the immune system), vidarabine (for the treatment of viral infections), salicylates (aspirin, for the treatment of pain), uricosuric agents (probenecid, for the treatment of gout), chlorpropamide (for the treatment of diabetes), theophylline (for asthma), phenytoin (for epilepsy), ampicillin (antibiotic), amoxicillin (antibiotic), cyclophosphamide (for rheumatoid arthritis and some types of cancer), doxorubicin (for the treatment of certain types of lymphomas), bleomycin (for the treatment of some types of cancer), procarbazine (for the treatment of some types of cancer), mecloretamine (for the treatment of some types of cancer), cyclosporin (to prevent transplant rejection), coumarin anticoagulants to prevent clot formation, and didanosine (for the treatment of HIV) and captopril.

The 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 could increase the risk of serious blood disorders. In this case, your doctor will closely monitor your blood count during treatment.

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

If you take aluminum hydroxide at the same time, alopurinol may have a reduced effect, so there should be 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, breastfeeding, and fertility

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

The use of alopurinol is not recommended if you are pregnant.

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

Driving and using machines

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

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

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

3. How to take Alopurinol Pensa

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

Usually, 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 dose to start treatment is 100 mg to 300 mg of alopurinol per day. The dose may be increased up to 900 mg per day, depending on each case. In this case, and if stomach upset appears, it is recommended to divide the dose into several intakes per day and take them with food.

Children and adolescents under 15 years

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

Elderly patients

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

Patient with liver or kidney function impairment

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

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

In case of accidental ingestion of too much medication, 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 Pensa

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

In case you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally would.

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

If you stop taking Alopurinol Pensa:

Your doctor will indicate the duration of treatment with this medicine. 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of side effects is classified as:

Very common (at least 1 in 10 patients).

Common (at least 1 in 100 patients).

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

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

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

Frequency not known (cannot be estimated from the available data).

Infections and infestations:

• Very rare: Folliculitis (infection of the hair follicle).

Blood and lymphatic system disorders:

• Very rare: Decreased number of white blood cells (increases the risk of infections), red blood cells (can cause fatigue, weakness), platelets (cells involved in blood clotting, with the appearance of bruises or bleeding more easily than usual).

Occasionally, alopurinol tablets can produce effects on the blood that manifest with the appearance of more frequent bruising than usual, 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.

Investigations:

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

Immune system disorders:

• Uncommon: Hypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters, or ulcers on the lips or in the mouth).
• Rare: Severe hypersensitivity reactions, associated with exfoliation, fever, joint pain, and alterations in blood and liver tests (these can be symptoms of multi-organ hypersensitivity disorder).
• Very rare: Angioimmunoblastic lymphadenopathy (inflammation in the armpits, neck, groin), potentially life-threatening severe allergic reaction.

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

Metabolism and nutrition disorders:

• Very rare: Diabetes mellitus (high blood sugar levels), increased lipid levels 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, alteration of normal sensitivity (neuropathy), drowsiness, headache, alteration in taste.
• 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, vision changes.

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, diarrhea.
• Very rare: Appearance of blood in vomit, excess fat in feces, 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.
• Rare: Medicamentous skin eruptions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2), hair loss or discoloration.
• Very rare: Severe allergic reaction that causes swelling of the face or throat.
• Frequency not known: Lichenoid skin eruption (red-purple skin rash with itching or grayish-white lines on the mucous membranes).

Musculoskeletal and connective tissue disorders:

• Very rare: Muscle pain.

Renal and urinary disorders:

• Very rare: Appearance of blood in urine.

Reproductive system and breast disorders:

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

General disorders and administration site conditions:

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

If you experience any of the following symptoms, stop taking the medicine and inform your doctor immediately:

Rare (affect less than 1 in 1000 people)

• Fever and chills, headache, muscle pain (flu-like symptoms), and general discomfort.
• 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 skin peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and alterations in blood and liver tests (these can be symptoms of multi-organ hypersensitivity disorder).

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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 expiration date that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Alopurinol Pensa:

The active ingredient is alopurinol. Each tablet contains 100 mg of alopurinol.

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

Appearance of the Product and Packaging Contents:

Alopurinol Pensa are circular white tablets, approximately 8 mm in diameter. Each package contains 25 or 100 tablets packaged 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 Last Revision of this Leaflet:November 2024

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