ALOPURINOL BLUEFISH 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alopurinol Bluefish 100 mg Tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

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

Contents of the Package Leaflet

1. What is Alopurinol Bluefish 100 mg and what is it used for
2. What you need to know before 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 further information

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

Alopurinol Bluefish 100 mg 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 Bluefish 100 mg 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 Bluefish 100 mg

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 cautious 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.
• 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 experience a sore throat or other signs of infection.
• If a skin rash, skin peeling, blisters, or ulcers on the lips or mouth appear, wheezing (whistling), palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO Alopurinol Bluefish 100 mg. Stop treatment and contact your doctor immediately.

If you are unsure, consult your doctor.

You should stop 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 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.

It is possible that at the start of treatment with Alopurinol Bluefish 100 mg, an acute gout attack may be triggered. 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 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. Often, the rash can 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, body pain. The rash can progress to blistering and generalized skin peeling. These severe skin reactions can be more frequent in people of Chinese, Thai, or Korean origin. Additionally, the risk of chronic kidney failure may increase in these patients. If you develop a skin rash or these symptoms, stop taking allopurinol and consult your doctor immediately.

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

Other medications and Alopurinol Bluefish 100 mg

If you take aluminum hydroxide concomitantly, allopurinol may have a reduced effect, so it is advisable to leave an interval of at least 3 hours between taking both medications.

Tell your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription, especially the following: 6-mercaptopurine (for the treatment of certain types of cancer), azathioprine (to prevent rejection in transplants and treat autoimmune diseases), adenine arabinoside (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 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), mecloretamine (for the treatment of certain types of cancer), cyclosporine (to prevent rejection in transplants), coumarin anticoagulants (to prevent clot formation), didanosine (for the treatment of HIV), and captopril.

Administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered 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 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 allopurinol 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.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 using machines

Due to its side effects (drowsiness, dizziness, and impaired coordination), Alopurinol Bluefish 100 mg may impair your ability to drive vehicles. Do not drive, do not use 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 an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Alopurinol Bluefish 100 mg

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

Usually, your doctor will start treatment with allopurinol at a low dose (e.g., 100 mg/day) to reduce the risk of possible side effects. Your dose will be increased if necessary.

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.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

The normal dose is:

Adults:

The usual starting 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 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 to 400 mg per day.

Elderly patients:

Your doctor will recommend the lowest possible dose of Alopurinol Bluefish 100 mg to achieve reduced uric acid levels and control your symptoms.

Use in patients with hepatic or renal impairment:

If you have liver or kidney problems, your doctor will prescribe the lowest possible dose of Alopurinol Bluefish 100 mg that achieves reduced uric acid levels and controls your symptoms. In case of renal 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 Bluefish 100 mg 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 Bluefish 100 mg

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 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The likelihood of their occurrence is higher when there are renal and/or hepatic alterations.

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

The frequency of side effects 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:Follicular infection

Blood and lymphatic system disorders

Very rare:Decreased white blood cell count (increases the risk of infections), red blood cells (can 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: Angioimmunoblastic lymphadenopathy (inflammation in the armpits, neck, groin).

Potentially life-threatening allergic reaction

Metabolic and nutritional disorders

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

Psychiatric 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:Aseptic 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 rare:Cataracts, visual disturbances.

Ear and labyrinth disorders

Very rare:Vertigo

Cardiac disorders

Very rare:Chest pain or slow pulse.

Vascular disorders

Very rare:High blood pressure

Gastrointestinal disorders

Uncommon:Nausea, vomiting, diarrhea

Very rare:Appearance of blood in vomit, excess fat in feces, 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-related skin eruptions, hair loss or discoloration.

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

Severe allergic reaction causing swelling of the face or throat.

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

Musculoskeletal and connective tissue disorders

Very rare:Muscle pain

Renal and urinary disorders

Rare:Urinary tract stones

Very rare:Appearance of blood in urine

Reproductive system and breast disorders

Very rare:Male infertility, impotence, breast growth.

General disorders and administration site conditions

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

Cases of fever with or without signs or symptoms of generalized hypersensitivity to allopurinol have been reported (see "Immune system disorders").

Rare (affect less than 1 in 1,000 people)

• Fever and chills, headache, muscle pain (flu-like symptoms), and general discomfort.
• 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 skin peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and changes 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:Occasionally, allopurinol tablets may 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.

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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Alopurinol Bluefish 100 mg

Keep out of sight and reach of children.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Do not use Alopurinol Bluefish 100 mg after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Do not use Alopurinol Bluefish 100 mg if you notice visible signs of deterioration.

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

6. Packaging Content and Additional Information

Composition of Alopurinol Bluefish 100 mg

• The active ingredient is alopurinol, 100 mg.
• The other components are: lactose monohydrate, corn starch, povidone, and magnesium stearate.

Appearance of the Product and Packaging Content

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

The tablets are white or almost white, flat, round, scored, marked on one side with "I" and "56" on either side of the score and unmarked on the other side.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

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

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Branch 36

Date of the last revision of this leaflet:December 2024

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.gob.es/