Package Leaflet: Information for the User

Alopurinol Kern Pharma 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally and should not be given 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.

Information in this leaflet:

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

2. What you need to know before you start taking Alopurinol Kern Pharma

3. How to take Alopurinol Kern Pharma

4. Possible side effects

5. Storage of Alopurinol Kern Pharma

6. Contents of the pack and additional information

Alopurinol 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, resulting in a decrease in the level of uric acid in plasma and urine.

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

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These severe skin reactions 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, Thai, or Korean origin. Additionally, having chronic kidney disease may increase the risk in these patients. If you develop a skin rash or these symptoms, stop taking allopurinol and consult your doctor immediately.The riskof these severe skin reactions may be increased in these patients. If you develop a skin rash or these symptoms, stop taking allopurinol and consult your doctor immediately.

Do not take Alopurinol Kern Pharma

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

Be careful with Alopurinol Kern Pharma

• 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 have a sore throat or other signs of an infection.
• if you develop a skin rash, skin peeling, blisters, or sores on your lips or in your mouth, wheezing (popping sounds), palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC to allopurinol. Stop treatment and contact your doctorimmediately.

If you are unsure, consult your doctor.

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

• High fever.
• Pain in your joints or painful swelling of your ankles, armpits, or neck.
• Ictericia (yellowing of the skin and eyes).
• Nausea or vomiting (which may be bloody).
• General feeling of illness.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, 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.

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of allopurinol. These reactions initially appear as red, circular spots or patches, often with a central blister.

Additional signs that may appear include mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and conjunctivitis (inflamed and red eyes).

These life-threatening skin reactions often accompany flu-like symptoms. The rash may progress to generalized blistering or skin peeling.

The highest risk of 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 allopurinol, do not use allopurinol again at any time.

If you develop a rash or these symptoms on your skin, stop taking allopurinol, go to your doctor immediately, and inform them that you are taking this medication.

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

Use of other medications

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

Especially the following:

• 6-mercaptopurine (for the treatment of autoimmune diseases) and azathioprine (for preventing transplant rejection and treating viral infections),
• adenine arabinoside (vidarabine, for treating viral infections),
• salicylates (aspirin, for treating pain) and 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 treating 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),
• meclorethamine (for treating certain types of cancer),
• cyclosporine (for preventing transplant rejection),
• anticoagulant coumarins (for preventing blood clots),
• didanosine (for treating HIV).

Administering 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered with Alopurinol Kern Pharma, 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.

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

When administering allopurinol in combination with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood disorders occur more frequently than when these active principles are administered alone.

Therefore, regular hematological controls should be performed.

If you are taking aluminum hydroxide concomitantly, allopurinol may have a reduced effect, so you should leave a gap of at least 3 hours between taking both medications.

Pregnancy and breastfeeding

Allopurinol is not recommended during pregnancy.

Allopurinol passes into breast milk. Allopurinol is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

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

Important information about some components of Alopurinol Kern Pharma

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

Follow exactly the administration instructions for alopurinol indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Oral administration only. Swallow the tablet whole with a little water. It is usually taken once a day, generally after a meal.

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 usual dose is:

Adults:

The starting treatment dose of alopurinol is 100 to 300 mg per day. The dose may be increased up to 900 mg per day, depending on your 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 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.

Use in patients with liver or kidney dysfunction:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol to 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 longer intervals 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 Kern Pharma than you should:

In this case, consult the Toxicological Information Service. Telephone 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 room. 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 as you normally do. Do not take a double dose to compensate for the missed doses.

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 Kern Pharma:

Your doctor will indicate the duration of treatment with alopurinol. Do not stop treatment before, even if you feel better.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

Rare (affecting fewer than 1 in 1,000 people):

• Fever and chills, headache, muscle pain (flu-like symptoms), and general discomfort.
• Any change in your skin, for example, mouth ulcers, throat, nose, genital, 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 tests (these may be symptoms of multi-organ hypersensitivity disorder).

Like all medications, Alopurinol Kern Pharma may have side effects, although not everyone will experience them.

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

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)

Infections and infestations

Very rareFolliculitis.

Blood and lymphatic system disorders

Very rareDecreased white blood cell count (increases the risk of infections), red blood cells (may cause fatigue and weakness), platelets (cells involved in blood clotting, with bruising or bleeding more easily than usual).

In some cases, Alopurinol tablets may cause blood-related effects 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 experience any of these symptoms.

Immune system disorders

UncommonHypersensitivity reactions (allergy: possible appearance of skin rash, skin peeling, blisters, or sores on the lips or mouth).

RareSevere hypersensitivity reactions, associated with exfoliation, fever, joint pain, or painful swelling of the inguinal, axillary, or cervical areas, jaundice (yellowing of the skin and eyes), and other skin and subcutaneous tissue alterations (see below).

Very rareLymphadenopathy angioimmunoblastic (inflammation in the axillary, cervical, or inguinal areas).

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

Severe potentially fatal allergic reaction.

Metabolism and nutrition disorders

Very rareDiabetes mellitus (high blood sugar levels), increased lipid levels (fats) in the blood, increased uric acid levels in the blood.

Mental and behavioral disorders

Very rareDepression.

Nervous system disorders

Very rareWeakness, numbness, or loss of consciousness, paralysis, uncoordinated movements, altered sensitivity (neuropathy), drowsiness, headache, altered taste.

Unknown frequency

Meningitis aséptica (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 rareCataracts, visual disturbances.

Ear and labyrinth disorders

Very rareVestibular disorders.

Cardiac disorders

Very rareChest pain or bradycardia.

Vascular disorders

Very rareHigh blood pressure.

Gastrointestinal disorders

UncommonNausea, vomiting, diarrhea.

Very rareBlood in vomit, excessive fat in stool, mouth infections, changes in bowel habits.

Hepatobiliary disorders

UncommonAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and subcutaneous tissue disorders

CommonSkin rash.

Very rareUrticaria, drug-induced skin eruptions, hair loss or discoloration. Severe allergic reaction causing facial or throat swelling.

Severe skin reactions that may be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Unknown frequencyAcneiform eruption (red-violet rash with itching or white-gray lines on mucous membranes)

Renal and urinary disorders

Very rareBlood in urine.

Reproductive and breast disorders

Very rareMale infertility, impotence, breast growth.

General disorders and administration site conditions

Very rareSwelling (edema) of the ankles, general discomfort, fatigue, fever.

Investigations

CommonElevated levels of thyroid-stimulating hormone in the blood.

Cases of fever with or without evident signs or symptoms of a generalized hypersensitivity reaction to alopurinol 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.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special conditions for conservation.

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

Do not use Alopurinol Kern Pharma after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the

medicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you do not need. In this way, you will help protect the environment.

Composition of Alopurinol Kern Pharma 100 mg tablets

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

- The other components are: lactose monohydrate, cornstarch, povidone and magnesium stearate.

Appearance of the product and content of the packaging

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

The tablets are white, round and biconvex.

Only some packaging sizes may be marketed.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II 08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

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 leaflet has been reviewed in February 2025

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