Package Leaflet: Information for the User

Alopurinol Bluefish 100 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine.

−Keep this leaflet, as you may need to read it again.

−If you have any questions, ask your doctor or pharmacist.

−This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

−If you experience any side effects, talk to your doctor or pharmacist. See section 4

1. What Alopurinol Bluefish 100 mg is and what it is used for

2. What you need to know before you start taking Alopurinol Bluefish 100 mg

3. How to take Alopurinol Bluefish 100 mg

4. Possible side effects

5. Storage of Alopurinol Bluefish 100 mg

6. Contents of the pack and additional information

Alopurinol Bluefish 100 mg 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, resulting in a decrease in the level of uric acid in plasma and urine.

Alopurinol Bluefish 100 mg 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.

Do not take Alopurinol Bluefish 100 mg:

-If you are allergic to allopurinol or any of the other components of Alopurinol Bluefish 100 mg.

Be especially careful with Alopurinol Bluefish 100 mg

•If you are experiencing an acute gout attack.

•If you are pregnant, think you may be pregnant, or are breastfeeding your child.

•If you have or have had 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 experience throat pain or other signs of an infection.

•If you experience a skin rash, skin peeling, blisters, or sores on your lips or in your mouth, wheezing (pitos), palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO Alopurinol Bluefish 100 mg. Suspend your treatment and contact your doctor immediately.

If you are unsure, consult your doctor.

You should suspend your treatment and contact your doctor as soon as possible if, while taking Alopurinol Bluefish 100 mg, you experience any of the following symptoms:

-High fever.

-Pain in your joints or painful swelling of your ankles, armpits, or neck.

-Ictericia (yellowing of your 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 (edemas) of your ankles.

-Feeling thirsty, tired, and weight loss.

-Appearance of boils.

-Blood in your urine.

It is possible that an acute gout attack may occur at the beginning of treatment with Alopurinol Bluefish 100 mg. Your doctor will recommend the use of certain medications to prevent it. If a gout attack occurs, it is not necessary to suspend treatment with Alopurinol Bluefish 100 mg as long as an appropriate anti-inflammatory medication is used concurrently.

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. The rash often includes 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, 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 Han, Thai, or Korean origin.Additionally, the risk of developing chronic kidney disease may increase in these patients.If you develop a skin rash or these symptoms on your skin, stop taking allopurinol and consult your doctor immediately.

The 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 Alopurinol Bluefish, you should not use Alopurinol Bluefish again at any time.

Other medications and Alopurinol Bluefish 100 mg

If you are taking aluminum hydroxide, allopurinol may be reduced, so it is recommended to leave a gap of at least 3 hours between taking both medications.

Inform your doctor or pharmacist if you are using or have used recently other medications, even those purchased without a prescription, especially the following: 6-mercaptopurine (for the treatment of certain types of cancer), azathioprine (to prevent rejection in transplants and the treatment of autoimmune diseases), arabinoside of adenine (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 the treatment of certain types of cancer), doxorubicin (for the treatment of certain types of lymphomas), 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 rejection in transplants), anticoagulant coumarins (to prevent the formation of blood clots), didanosine (for the treatment of HIV) and captopril.

6-mercaptopurine or azathioprine should not be administered together with allopurinol. When 6-mercaptopurine or azathioprine are administered together with Alopurinol Bluefish 100 mg, 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 throat pain.

In the administration of allopurinol in combination with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, halogenated aliphatic compounds), hematological disorders occur more frequently than when these active principles are administered alone.

Therefore, periodic hematological controls should be performed.

Pregnancy and breastfeeding

Allopurinol passes into breast milk. It is not recommended to use allopurinol during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Alopurinol Bluefish 100 mg is not recommended if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Due to its side effects (drowsiness, dizziness, and coordination impairment), Alopurinol Bluefish 100 mg 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.

Alopurinol Bluefish contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

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.

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

The groove is only for breaking the tablet if it is difficult to swallow it whole.

The usual dose is:

Adults:

The starting treatment dose of Alopurinol Bluefish 100 mg is 100 to 300 mg. 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 to 400 mg per day.

Geriatric patients:

Your doctor will recommend the lowest possible dose of Alopurinol Bluefish 100 mg 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 Bluefish 100 mg that can reduce uric acid levels and control your symptoms. In 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. 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 Bluefish 100 mg than you should:

In this case, consult the Toxicology 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 forget to take Alopurinol Bluefish 100 mg:

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 Bluefish 100 mg:

Your doctor will indicate the duration of treatment with Alopurinol Bluefish 100 mg. 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

Side effect frequency 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 available data).

Infections and infestations

Very rare:Carbuncle

Blood and lymphatic system disorders

Very rare:Decreased 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).

Immune system disorders

Uncommon:Hypersensitivity reactions

Very rare:Lymphadenopathy angioimmunoblastic (inflammation in the armpits, neck, and groin).

Severe potentially fatal allergic reaction

Metabolism and nutrition disorders

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

Mental and behavioural disorders

Very rare:Depression

Nervous system disorders

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

Unknown:Asymptomatic 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:Dizziness

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, excessive fat in stool, 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:Maculopapular rash, drug-induced skin eruptions, hair loss or discoloration.

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

Severe allergic reaction causing facial or throat swelling.

Unknown::Lichenoid skin eruption (red-violet rash with itching or white-grayish lines on mucous membranes)

Musculoskeletal and connective tissue disorders

Very rare:Muscle pain

Renal and urinary disorders

Rare:Urinary tract stones

Very rare:Blood in urine

Reproductive and breast disorders

Very rare:Male infertility, impotence, breast growth.

General disorders and administration site conditions

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

There have been reports of fever with or without evident signs or symptoms of a generalized hypersensitivity reaction to allopurinol (see "Immune system disorders").

Rare (affects fewer than 1 in 1,000 people)

-Fever and chills, headache, muscle pain (flu-like symptoms) and general malaise.

-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, rash, joint pain, and alterations in blood and liver tests (these may be symptoms of multi-organ hypersensitivity disorder).

Investigations

Common:Elevated thyroid-stimulating hormone levels in blood.

Very rare:In some cases, allopurinol tablets may cause effects on the blood that manifest as more 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.

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at a temperature above 25°C..

Store in the original packaging to protect it from light and moisture.

Do not use Alopurinol this medication 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 Bluefish 100 mg if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Alopurinol Bluefish 100 mg

-The active ingredient is alopurinol, 100 mg.

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

Appearance of the product and contents of the packaging

Alopurinol Bluefish 100 mg is presented in two formats of 25 and 100 tablets.

The tablets are white or off-white, flat, round, scored, marked on one face with “I” and “56” on either side of the score and unmarked on the other face.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Responsible for manufacturing

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

You can requestmore information about this medication by contacting the local representative of the holder of the marketing authorization:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Branch 36

Date of the last review of this leaflet:December 2024

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