ALOPURINOL KERN PHARMA 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alopurinol Kern Pharma 100 mg tablets EFG

Read the entire package leaflet carefully before starting to take the medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

In this package 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. Storage of Alopurinol Kern Pharma
6. Contents of the pack and further information

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

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 conditions caused 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 taking Alopurinol Kern Pharma

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 severe skin rashes are often preceded by flu-like symptoms such as fever, headache, body aches. The rash can progress to the formation of blisters and generalized peeling of the skin. These serious 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 symptoms on the skin, stop taking alopurinol and consult your doctor immediately.

Do not take Alopurinol Kern Pharma

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

Be careful with Alopurinol Kern Pharma

• if you are having an acute gout attack.
• 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 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 infection.
• if a skin rash, peeling of the skin, blisters, or sores on the lips or in the mouth, wheezing, palpitations, or chest tightness, loss of consciousness appear: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC to alopurinol. Stop treatment and contact your doctor immediately.

If you are not sure, consult your doctor.

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, fatigue, and weight loss.
• Appearance of boils.
• Appearance of blood in urine.

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

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

These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to the formation of generalized blisters or peeling of the skin.

The period of greatest 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 alopurinol, you should not use alopurinol again at any time.

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

It is possible that at the start of treatment with alopurinol, an acute gout attack may be triggered. Your doctor will recommend the use of certain medications to prevent this. In the event of a gout attack, it is not necessary to stop treatment with Alopurinol Kern Pharma as long as an appropriate anti-inflammatory medication is used at the same time.

Taking other medications

Tell 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 (to prevent rejection in transplants and treat viral infections),
• adenine arabinoside (vidarabine, for the treatment of viral infections),
• salicylates (aspirin, for pain treatment) and uricosuric agents (probenecid, for gout treatment),
• chlorpropamide (for diabetes treatment),
• theophylline (for asthma),
• phenytoin (for epilepsy),
• ampicillin (antibiotic),
• amoxicillin (antibiotic),
• cyclophosphamide (for rheumatoid arthritis and treatment of some types of cancer),
• doxorubicin (for treatment of some types of lymphoma),
• bleomycin (for treatment of some types of cancer),
• procarbazine (for treatment of some types of cancer),
• mecloretamine (for treatment of some types of cancer),
• cyclosporin (to prevent rejection in transplants),
• cumarin anticoagulants (to prevent clot formation),
• didanosine (for HIV treatment).

The administration of the product 6-mercaptopurine or azathioprine with alopurinol should be avoided. When 6-mercaptopurine or azathioprine is 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 serious blood disorders. In this case, your doctor will closely monitor your blood count during treatment.

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

In the administration of alopurinol in combination with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasias occur more frequently than when these active ingredients are administered alone.

Therefore, periodic hematological checks should be performed.

If aluminum hydroxide is taken concomitantly, alopurinol may have a reduced effect, so an interval of at least 3 hours should be left between taking both medications.

Pregnancy and breastfeeding

Alopurinol is not recommended if you are pregnant.

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

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

Important information about some of the 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.

3. How to take Alopurinol Kern Pharma

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

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

Normally, 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 normal dose is:

Adults:

The usual starting dose of alopurinol is 100 to 300 mg daily. The dose may be increased up to 900 mg per day, depending on your case. In this case, and if stomach upset occurs, it is recommended to divide the dose into several intakes per day and take them with food.

Children under 15 years:

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

Elderly 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 function impairment:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of alopurinol that reduces uric acid levels and controls your symptoms. In the 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 Kern Pharma 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 package leaflet with you.

If you forget to take Alopurinol Kern Pharma

In case you forget to take a dose, take the next dose as soon as you remember. Then, continue as you normally would. Do not take a double dose to make up for forgotten doses.

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

If you stop treatment with Alopurinol Kern Pharma

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

If you have any other doubts 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 medication and inform your doctor immediately:

Rare (affect less than 1 in 1000 people):

• Fever and chills, headache, muscle pain (flu-like symptoms) and general malaise.
• Any change in your skin, such as ulcers in the mouth, throat, nose, genitals, 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 can have adverse effects, although not all people suffer from them.

The likelihood of their occurrence is higher when there are kidney and/or liver disorders.

The frequency of adverse effects is classified as:

Very frequent (at least 1 in 10 patients)

Frequent (at least 1 in 100 patients)

Uncommon (at least 1 in 1000 patients)

Rare (at least 1 in 10,000 patients)

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

Infections and Infestations

Very rareFolliculitis (infection of the hair follicle).

Blood and Lymphatic System Disorders

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

Sometimes, alopurinol tablets can cause 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.

Immune System Disorders

UncommonHypersensitivity reactions (allergy: possible appearance of skin rash, peeling, blisters, or ulcers 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 disorders (see below).

Very rareAngioimmunoblastic lymphadenopathy (inflammation in the armpits, neck, or groin).

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

Severe potentially life-threatening allergic reaction.

Metabolic and Nutritional Disorders

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

Psychiatric Disorders

Very rareDepression.

Nervous System Disorders

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

Frequency not knownAseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiff neck, headache, nausea, fever, or altered consciousness. If you experience any of these symptoms, seek urgent medical attention.

Eye Disorders

Very rareCataracts, visual disturbances.

Ear and Labyrinth Disorders

Very rareVertigo.

Cardiac Disorders

Very rareChest pain or slowed heart rate.

Vascular Disorders

Very rareHigh blood pressure.

Gastrointestinal Disorders

UncommonNausea, vomiting, diarrhea.

Very rareAppearance of blood in vomit, excess fat in stools, mouth infections, changes in bowel habits.

Hepatobiliary Disorders

UncommonAsymptomatic increases in liver function tests.

RareHepatitis.

Skin and Subcutaneous Tissue Disorders

FrequentSkin rash.

Very rareHives, drug-related skin eruptions, hair loss or discoloration. Severe allergic reaction that causes facial or throat swelling.

Life-threatening skin eruptions may appear (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Frequency not knownLichenoid skin eruption (red-purple skin rash with itching or grayish-white lines on the mucous membranes)

Renal and Urinary Disorders

Very rareAppearance of blood in the urine.

Reproductive System and Breast Disorders

Very rareMale infertility, impotence, breast growth.

General Disorders and Administration Site Conditions

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

Investigations

FrequentElevated thyroid-stimulating hormone levels in the blood.

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.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that is 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 adverse reactions, you can contribute to providing more information on the safety of this medication.

5. Storage of Alopurinol Kern Pharma

This medication does not require special storage conditions.

Keep this medication out of sight and reach of children.

Do not use Alopurinol Kern Pharma after the expiration date shown on the carton, after "CAD". The expiration date is the last day of the month indicated.

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

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Alopurinol Kern Pharma 100 mg tablets

• The active ingredient is alopurinol. Each tablet contains 100 mg of alopurinol.
• The other ingredients are: lactose monohydrate, cornstarch, povidone, and magnesium stearate.

Appearance of the Product and Package Contents

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

The tablets are white, round, and biconvex.

Only some package 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 leaflet was revised in February 2025

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