Alopurinol Kern Pharma 300 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Alopurinol Kern Pharma 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; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

In this leaflet:

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

1. What Alopurinol Kern Pharma is and what it is used for

Alopurinol 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, the result is a reduction in the level of uric acid in plasma and urine.

Alopurinol 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 kidney or metabolic disorders.

2. What you need to know before starting Alopurinol Kern Pharma

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash may 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, and body pain. The rash may progress to blistering and widespread peeling of the skin. 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 allopurinol and consult your doctor immediately.

Do not take Alopurinol Kern Pharma

• if you are allergic (hypersensitive) to allopurinol or to any of the other components of Alopurinol Kern Pharma.

Take special care with Alopurinol Kern Pharma

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

If you are unsure, consult your doctor.

You must stop treatment 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 in the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Nausea or vomiting (which may include blood).
• General feeling of discomfort.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Increased thirst, fatigue, and weight loss.
• Appearance of boils.
• Blood in the urine.

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of allopurinol. These initially appear as red spots or circular lesions, often with a central blister.

Other additional signs that may occur include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

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

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

If you develop skin rashes or these skin symptoms, stop taking allopurinol, seek immediate medical attention, and inform the doctor that you are taking this medicine.

It is possible that the initiation of treatment with allopurinol may trigger an acute attack of gout. Your doctor may recommend taking certain medications to prevent this. If a gout attack does occur, it is not necessary to discontinue treatment with Alopurinol Kern Pharma, provided that an appropriate anti-inflammatory medication is used concurrently.

Taking other medicines

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

Especially the following:

• 6-mercaptopurine (for the treatment of autoimmune diseases) and azathioprine (to prevent transplant rejection and for the treatment of viral infections),
• adenine arabinoside (vidarabine, for the treatment of viral infections),
• salicylates (aspirin, for pain relief) and 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 the treatment of certain types of cancer),
• doxorubicin (for the treatment of certain types of lymphoma),
• 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),
• coumarin anticoagulants (to prevent blood clots),
• didanosine (for the treatment of HIV).

The concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with Alopurinol Kern Pharma, 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 immediate medical attention if you notice unexplained bruising, bleeding, fever, or sore throat.

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

Therefore, periodic hematological monitoring should be performed.

If aluminum hydroxide is taken concomitantly, the effect of allopurinol may be reduced; therefore, an interval of at least 3 hours should be maintained between the administration of both medications.

Pregnancy and breastfeeding

Allopurinol is not recommended if you are pregnant.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Do not drive or operate tools or machinery until you are reasonably certain that the medication does not impair your capabilities.

Important information about some of the components of Alopurinol Kern Pharma

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 Kern Pharma

Follow exactly the dosing instructions for allopurinol provided by your physician. Consult your doctor or pharmacist if you have any doubts.

For oral use only. Swallow the tablet whole with a little water. It is usually taken once daily, generally after a meal.

Your doctor will usually 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 normal dose is:

Adults:

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

Children under 15 years of age:

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

Elderly patients:

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

Use in patients with impaired liver or kidney function:

If you have liver or kidney problems, your doctor will prescribe the lowest effective dose of allopurinol capable of reducing uric acid levels and controlling your symptoms. In case of renal impairment, your doctor may advise taking less than 100 mg per day or recommend single 100 mg doses at intervals longer than 24 hours.

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 Kern Pharma than you should

In this case, contact the Toxicology Information Service at telephone number 91 562 04 20, or consult your doctor immediately.

In case of accidental ingestion of a large amount of medication, go to your doctor or the nearest hospital emergency department without delay. Bring this leaflet with you.

If you forget to take Alopurinol Kern Pharma

If you forget to take a dose, take the next dose as soon as you remember. Then continue taking it as usual. Do not take a double dose to make up for missed doses.

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 Kern Pharma

Your doctor will advise you on the duration of treatment with allopurinol. Do not discontinue treatment earlier, 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

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 changes in your skin, for example, mouth, throat, nose, genital ulcers, and conjunctivitis (inflammation and redness of the eyes), widespread blisters or peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and abnormalities in blood tests and liver function (these may be symptoms of multiorgan hypersensitivity disorder).

Like all medicines, Alopurinol Kern Pharma can have adverse effects, although not everyone will experience them.

The likelihood of these occurring is higher when there are kidney and/or liver impairments.

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 fewer than 1 in 10,000 patients)

Infections and infestations

Very rare: Infection of the hair follicle.

Disorders of the blood and lymphatic system

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

Occasionally, allopurinol tablets may cause blood-related effects, manifesting as unusually frequent 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.

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 in 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).

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

Potentially life-threatening severe allergic reaction.

Metabolism and nutrition disorders

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

Very rare: Blood in vomit, excess fat in the 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.

Very rare: Hives, drug-type skin eruptions, hair loss or discoloration. Severe allergic reaction causing swelling of the face or throat.

Skin rashes may appear that could be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Frequency not known: Lichenoid eruption (reddish-purple rash with itching or whitish-gray thread-like lines on mucous membranes).

Renal and urinary disorders

Very rare: Blood in the 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.

Investigations

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

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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 Kern Pharma

This medicine does not require any special storage conditions.

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

Do not use Alopurinol Kern Pharma after the expiry date stated on the carton, following “EXP”. The expiry date refers to the last day of the month indicated.

Do not use Alopurinol Kern Pharma if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Kern Pharma 100 mg tablets

• The active substance is allopurinol. Each tablet contains 100 mg of allopurinol.
• The other components are: monohydrate lactose, corn starch, povidone, and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Alopurinol Kern Pharma 100 mg tablets are available in packs of 25 and 100 tablets.

The tablets are white, round, and biconvex.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

FAES FARMA, S.A.

C/ Máximo Aguirre, 14,

48940 Lamaico-Leioa (Vizcaya)

FAES FARMA, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

or

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This Patient Information Leaflet has been reviewed in February 2025

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