Allopurinol Bluefish 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alopurinol Bluefish 100 mg tablets EFG

Read the entire 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 only and must not be given to other people, even if they have the same symptoms as you, since it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Alopurinol Bluefish 100 mg is and what it is used for
2. What you need to know before taking Alopurinol Bluefish 100 mg
3. How to take Alopurinol Bluefish 100 mg
4. Possible adverse effects
5. How to store Alopurinol Bluefish 100 mg
6. Contents of the pack and other information

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

Alopurinol Bluefish 100 mg belongs to a group of medicines known as enzyme inhibitors, which work by controlling the rate at which a specific chemical process occurs in the body. In this case, it results in a reduction of uric acid levels in plasma and urine.

Alopurinol Bluefish 100 mg is used to prevent the occurrence of gout and other conditions caused by excess uric acid in the body, such as kidney stones and certain types of renal or metabolic disorders.

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 to any of the other ingredients of Alopurinol Bluefish 100 mg.

Take special care with Alopurinol Bluefish 100 mg

• If you are experiencing an acute attack of gout.
• 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 conditions or high blood pressure.
• If you notice that you bruise more easily than before, or if you develop a sore throat or other signs of infection.
• If you develop a skin rash, skin peeling, blisters, or sores in the lips or mouth, wheezing (whistling breath), palpitations or chest tightness, or loss of consciousness: THESE SYMPTOMS MAY INDICATE THAT YOU ARE ALLERGIC TO Alopurinol Bluefish 100 mg. Stop treatment immediately and contact your doctor without delay.

If you are unsure, consult your doctor.

You should stop 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.
• Joint pain or painful swelling of the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Nausea or vomiting (which may contain blood).
• General feeling of being unwell.
• Weakness, numbness, or loss of consciousness.
• Headache, drowsiness, dizziness, vision disturbances.
• Chest pain, high blood pressure, or slowed pulse.
• Swelling (edema) of the ankles.
• Feeling thirsty, tiredness, and weight loss.
• Appearance of boils.
• Presence of blood in urine.

At the beginning of treatment with Alopurinol Bluefish 100 mg, an acute attack of gout may be triggered. Your doctor may recommend using certain medications to prevent this. If a gout attack occurs, it is not necessary to stop treatment with Alopurinol Bluefish 100 mg, provided that an appropriate anti-inflammatory medicine 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 includes ulcers in the mouth, throat, nose, genitals, and conjunctivitis (inflammation and redness of the eyes). These serious skin rashes are frequently preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to blistering and widespread skin peeling. These severe skin reactions may be more common in individuals of Han Chinese, Thai, or Korean descent. In addition, the risk of developing chronic kidney failure may be increased in these patients. If you develop a skin rash or these skin symptoms, stop taking allopurinol and consult your doctor immediately.

The period of highest risk for developing severe skin reactions is during the first few weeks of treatment.

If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Alopurinol Bluefish, you must never take Alopurinol Bluefish again.

Other medicines and Alopurinol Bluefish 100 mg

If aluminum hydroxide is taken concomitantly, the effect of allopurinol may be reduced. Therefore, it is advisable to leave an interval of at least 3 hours between taking the two medicines.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, especially the following: 6-mercaptopurine (for the treatment of certain types of cancer), azathioprine (to prevent transplant rejection and for the treatment of autoimmune diseases), adenine arabinoside (vidarabine, for the treatment of viral infections), salicylates (aspirin, for pain relief), 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), mechlorethamine (for the treatment of certain types of cancer), cyclosporine (to prevent transplant rejection), coumarin anticoagulants (to prevent blood clots), didanosine (for the treatment of HIV), and captopril.

The concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with Alopurinol Bluefish 100 mg, the dose of 6-mercaptopurine or azathioprine must be reduced because their activity is prolonged. This may increase the risk of serious blood disorders. In such cases, your doctor will closely monitor your blood count during treatment.

Seek medical advice immediately if you notice unexplained bruising, bleeding, fever, or sore throat.

When allopurinol is administered in combination with cytostatic agents (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), blood dyscrasias occur more frequently than when these active substances are administered alone.

Therefore, periodic hematological monitoring should be performed.

Pregnancy and breastfeeding

Allopurinol passes into breast milk. The use of allopurinol is not recommended during breastfeeding.

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

Alopurinol Bluefish 100 mg is not recommended during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Due to its side effects (drowsiness, dizziness, and impaired coordination), Alopurinol Bluefish 100 mg may impair your ability to drive or operate machinery. Do not drive or operate tools or machines until you are reasonably certain that this medicine does not affect your capabilities.

Alopurinol Bluefish contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Alopurinol Bluefish 100 mg

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist.

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

For oral use only. Swallow the tablet whole with a little water. It is usually taken once daily, generally after a meal.

The score line is intended solely for dividing the tablet if you have difficulty swallowing it whole.

The usual 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 individual case. In such cases, and if stomach discomfort occurs, it is recommended to divide the dose into several administrations throughout the day and take it with food.

Children under 15 years of age:

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

Elderly patients:

Your doctor will recommend the lowest possible dose of Alopurinol Bluefish 100 mg to effectively reduce 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 effective dose of Alopurinol Bluefish 100 mg necessary to 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 100 mg doses at intervals longer than one day. If you are on dialysis two or three 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, contact the Toxicology Information Service. Telephone 91 562 04 20, or go to your doctor.

If a large amount of medicine is accidentally ingested, go immediately to your doctor or the nearest hospital emergency department. Take this leaflet with you.

If you forget to take Alopurinol Bluefish 100 mg

If you miss a dose, take the next dose as soon as you remember. Then continue as before. Do not take a double dose to make up for forgotten doses.

If you miss several doses, it is best to contact your doctor so that he or she can decide what you should do from that point onward.

If you stop treatment with Alopurinol Bluefish 100 mg

Your doctor will advise you on the duration of treatment with Alopurinol Bluefish 100 mg. Do not stop treatment early, even if you feel better.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The likelihood of such effects occurring is higher in patients with renal and/or hepatic impairment.

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

The frequency of adverse effects is classified as follows:

Very common (affects at least 1 in 10 patients)
Common (affects at least 1 in 100 patients)
Uncommon (affects at least 1 in 1,000 patients)
Rare (affects at least 1 in 10,000 patients)
Very rare (affects fewer than 1 in 10,000 patients)
Frequency not known (cannot be estimated from available data)

Infections and infestations

Very rare: Infection of the hair follicle

Blood and lymphatic system disorders

Very rare: Decrease in the number of white blood cells (increases the risk of infections), red blood cells (may cause tiredness, fatigue), platelets (cells involved in blood clotting, leading to bruising or bleeding more easily than usual).

Immune system disorders

Uncommon: Hypersensitivity reactions
Very rare: Angioimmunoblastic lymphadenopathy (swelling in armpits, neck, or groin)
Potentially life-threatening severe allergic reaction

Metabolism and nutrition disorders

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

Psychiatric disorders

Very rare: Depression

Nervous system disorders

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

Frequency not known: 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, diarrhoea
Very rare: Presence of blood in vomit, excess fat in stools, 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-type skin rashes, hair loss or discoloration.

Skin rashes may occur that could be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).
Severe allergic reaction causing swelling of the face or throat.

Frequency not known: Lichenoid skin eruption (reddish-purple rash with itching or white-gray thread-like lines on mucous membranes)

Musculoskeletal and connective tissue disorders

Very rare: Muscle pain

Renal and urinary disorders

Rare: Urinary tract stones
Very rare: Presence of blood in urine

Reproductive system and breast disorders

Very rare: Male infertility, impotence, breast enlargement

General disorders and administration site conditions

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

Cases of fever with or without evident signs or symptoms of generalized hypersensitivity to allopurinol have been reported (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, throat, nose, or genital ulcers, conjunctivitis (inflammation and redness of the eyes), blisters, or widespread peeling.
• Severe hypersensitivity reactions, with fever, skin rash, joint pain, and abnormalities in blood tests and liver function (these may be symptoms of a multi-organ hypersensitivity disorder).

Additional investigations

Common: Elevated levels of thyroid-stimulating hormone in blood.
Very rare: Occasionally, allopurinol tablets may cause blood-related effects, manifesting as unusually frequent bruising, sore throat, or other signs of infection. These effects usually occur in patients with renal or hepatic impairment. Inform your doctor as soon as possible if you experience any of these symptoms.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alopurinol Bluefish 100 mg

Keep out of the sight and reach of children.

Do not store above 25°C.

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

Do not use Alopurinol Bluefish 100 mg after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Bluefish 100 mg

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

Nature of the product and pack sizes

Alopurinol Bluefish 100 mg is available in two pack sizes containing 25 and 100 tablets.

The tablets are white or almost white, flat, round, scored, marked on one side with “I” and “56” on each side of the score line, 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U
P.O. Box 36007
28320 Las Rozas, Madrid, Branch Office 36

Date of the most recent review of this leaflet: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/