Prospect: Information for the User

Alopurinol Kern Pharma 100 mg Tablets EFG

Read this prospect carefully before starting to take the medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you personally and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

In this prospect:

1. What Alopurinol Kern Pharma is and for what it is used
2. What you need to know before starting to take Alopurinol Kern Pharma
3. How to take Alopurinol Kern Pharma
4. Possible adverse effects
5. Storage of Alopurinol Kern Pharma
6. Contents of the package 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 excessive uric acid in the body, such as 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 frequent 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 riskin 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 attack of gout.
• 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 are about to 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. Suspend the treatment and contact your doctor immediately.

If you are unsure, consult your doctor.

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

• High fever.
• Pain in the joints or painful swelling of the ankles, armpits, or neck.
• Ictericia (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, visual disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Feeling thirsty, tired, and weight loss.
• Appearance of boils.
• Blood in the urine.

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

Other additional signs that may appear are mouth, throat, nose, genital ulcers, and conjunctivitis (inflamed and red eyes).

These life-threatening skin reactions, often accompanied by flu-like symptoms, may progress to generalized blistering or skin peeling.

The period of highest risk of severe skin reactions is during the first 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 attack of gout may precipitate at the beginning of treatment with allopurinol. Your doctor will recommend the use of certain medications to prevent it. 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, even those purchased without a prescription.

Especially the following:

• 6-mercaptopurine (for the treatment of autoimmune diseases) and azathioprine (for preventing rejection in transplants and the treatment of viral infections),
• adenine arabinoside (vidarabine, for the treatment of viral infections),
• salicylates (aspirin, for pain relief) and uricosuric agents (probenecid, for gout treatment),
• chlorpropamide (for 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),
• meclorethamine (for the treatment of certain types of cancer),
• cyclosporine (for preventing rejection in transplants),
• anticoagulant coumarins (for preventing blood clots),
• didanosine (for the treatment of 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 could 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.

In the administration of 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, periodic hematological controls should be performed.

If aluminum hydroxide is taken concomitantly, allopurinol may be attenuated, so a gap of at least 3 hours should be left between the administration of 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 machines

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 machines 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 him 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 can 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.

Geriatric 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 that can 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 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 Kern Pharma than you should

In this case, consult the Toxicological Information Service. Phone 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 department. Bring this leaflet with you.

If you forgot 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 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 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, 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 them 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, tiredness), 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 groin, armpits, or neck, jaundice (yellowing of the skin and eyes), and other skin and subcutaneous tissue alterations (see below).

Very rareLymphadenopathy angioimmunoblastic (inflammation in the armpits, neck, or groin).

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

Severe potentially life-threatening 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 slowed pulse.

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 thyroid-stimulating hormone levels in blood.

Cases of fever with or without evident signs or symptoms of generalized hypersensitivity 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 effects 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 Vigilance 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 medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, 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/.