ALOPURINOL BLUEFISH 300 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alopurinol Bluefish 300 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Alopurinol Bluefish 300 mg and what is it used for
2. What you need to know before taking Alopurinol Bluefish 300 mg
3. How to take Alopurinol Bluefish 300 mg
4. Possible side effects
5. Storage of Alopurinol Bluefish 300 mg
6. Contents of the pack and further information

1. What is Alopurinol Bluefish 300 mg and what is it used for

Alopurinol Bluefish 300 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 300 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 300 mg

Do not take Alopurinol Bluefish 300 mg:

• If you are allergic to allopurinol or any of the other ingredients of Alopurinol Bluefish 300 mg.

Be cautious with Alopurinol Bluefish 300 mg

• 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 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, palpitations, or chest tightness, loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO Alopurinol Bluefish 300 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 300 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, tiredness, and weight loss.
• Appearance of boils.
• Appearance of blood in urine.

It is possible that at the start of treatment with Alopurinol Bluefish 300 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 300 mg, as long as an appropriate anti-inflammatory medication is used at the same time.

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 aches. The rash can progress to blistering and generalized peeling of the skin. These serious 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 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 medicines and Alopurinol Bluefish 300 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, 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 treat autoimmune diseases), adenine arabinoside (vidarabine, for the treatment of viral infections), salicylates (aspirin, for pain treatment), 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 certain types of cancer), doxorubicin (for treatment of certain types of lymphoma), bleomycin (for treatment of certain types of cancer), procarbazine (for treatment of certain types of cancer), mecloretamine (for treatment of certain types of cancer), cyclosporin (to prevent rejection in transplants), coumarin anticoagulants (to prevent clot formation), and didanosine (for HIV treatment) 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.

Alopurinol Bluefish 300 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 coordination impairment), Alopurinol Bluefish 300 mg may affect 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.

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 300 mg

Follow the instructions for administration of Alopurinol Bluefish 300 mg indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 normal dose is:

Adults:

The usual starting dose of Alopurinol Bluefish 300 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 appears, 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 300 mg to achieve reduced 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 Bluefish 300 mg that achieves reduced uric acid levels and controls your symptoms. In 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 Bluefish 300 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 leaflet with you.

If you forget to take Alopurinol Bluefish 300 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 you should do from that point on.

If you stop taking Alopurinol Bluefish 300 mg

Your doctor will indicate the duration of treatment with Alopurinol Bluefish 300 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 medicines, Alopurinol Bluefish 300 mg can cause side effects, although not everybody gets them.

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

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:Folliculitis (infection of the hair follicle)

Blood and lymphatic system disorders

Very rare:Decreased white blood cell count (increases the risk of infections), red blood cell count (can cause fatigue, weakness), platelet count (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.

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.

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 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: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 may occur (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Severe allergic reaction that causes 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:Kidney 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 1000 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 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 produce 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 side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Alopurinol Bluefish 300 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 300 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 300 mg if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Alopurinol Bluefish 300 mg

• The active ingredient is alopurinol, 300 mg.
• The other components are: lactose monohydrate, corn starch, povidone, and magnesium stearate.

Appearance of the Product and Packaging Content

Alopurinol Bluefish 300 mg is presented in a format of 30 tablets.

The tablets are white or almost white, flat, round, scored, marked on one side with "I" and "57" 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/