Allopurinol Aurovitas 300 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alopurinol Aurovitas 300 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm 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.

Leaflet contents

1. What Alopurinol Aurovitas is and what it is used for
2. What you need to know before taking Alopurinol Aurovitas
3. How to take Alopurinol Aurovitas
4. Possible side effects
5. How to store Alopurinol Aurovitas

Pack contents and additional information

1. What Alopurinol Aurovitas is and what it is used for

• Alopurinol Aurovitas belongs to a group of medicines called enzyme inhibitors, which work by controlling the rate at which a specific chemical process occurs in the body.

Alopurinol tablets are used long-term to prevent the occurrence of gout and other conditions caused by excess uric acid in the body, including kidney stones and other types of kidney diseases.

2. What you need to know before taking Alopurinol Aurovitas

Do not take Alopurinol Aurovitas:

• If you are allergic to allopurinol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before taking allopurinol if:

• You are of Han Chinese, African, or Indian descent.
• You have liver or kidney problems. Your doctor may prescribe a lower dose or advise you to take it less frequently each day. They may also monitor you more closely.
• You have heart problems or high blood pressure and are taking diuretics and/or medicines called ACE inhibitors.
• You are currently experiencing a gout attack.
• You have thyroid problems.

If you are unsure whether any of the above apply to you, tell your doctor or pharmacist before taking allopurinol.

Take special care with allopurinol:

• Serious 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 rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to blistering and widespread skin peeling.

These serious skin reactions may be more common in people of Han Chinese, Thai, or Korean origin. Additionally, the risk of 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.

• If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in your urine may increase. To prevent this, make sure you drink enough fluids to dilute your urine.
• If you have kidney stones, the stones may shrink and enter your urinary tract.

Children

Use in children is rarely indicated, except in certain types of cancer (especially leukemia) and certain enzymatic disorders such as Lesch-Nyhan syndrome.

Taking Alopurinol Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• 6-mercaptopurine (used in the treatment of blood cancer).

• Azathioprine, cyclosporine (used to suppress the immune system). Note that adverse effects of cyclosporine may occur more frequently.

• Vidarabine (used in the treatment of herpes). Note that adverse effects of vidarabine may occur more frequently. Exercise special caution if this occurs.

• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).

• Probenecid (used for the treatment of gout).

• Chlorpropamide (used to treat diabetes). A dose reduction of chlorpropamide may be necessary, especially in patients with reduced kidney function.

• Warfarin, phenprocoumon, acenocoumarol (anticoagulants). Your doctor will monitor your blood test values more frequently and, if necessary, reduce the dose of these medicines.

• Phenytoin (used to treat epilepsy).

• Theophylline (used for the treatment of asthma and other respiratory diseases). Your doctor will measure theophylline blood levels, especially when starting allopurinol treatment or after any dose adjustment.

• Ampicillin or amoxicillin (used to treat bacterial infections). Whenever possible, patients should receive other antibiotics, as allergic reactions are more likely to occur.

• Medicines used to treat aggressive tumors such as:

  • Cyclophosphamide
  • Doxorubicin
  • Bleomycin
  • Procarbazine
  • Mechlorethamine

Your doctor will monitor your blood tests frequently.

• Didanosine (used to treat HIV infection).
• ACE inhibitors (e.g., captopril) or diuretics (used to treat high blood pressure). The risk of skin reactions may be increased, especially in patients with chronic impairment of kidney function.

The concomitant use of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine are administered together with Alopurinol Aurovitas, the dose of 6-mercaptopurine or azathioprine must be reduced because their 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.

Seek immediate medical attention if you notice unexplained bruising, bleeding, fever, or sore throat.

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 the administration of both medicines.

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.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal remedies, as allopurinol may affect how some medicines work. Other medicines may also affect how allopurinol works.

Pregnancy, breastfeeding, and fertility

• 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. Allopurinol passes into breast milk. The use of allopurinol during breastfeeding is not recommended. You should not take this medicine if you are pregnant or breastfeeding unless your doctor advises you to do so.

Driving and using machines

• Allopurinol may cause dizziness, drowsiness, and affect your coordination. If affected, DO NOT drive or operate machinery or engage in hazardous activities.

Alopurinol Aurovitas tablets contain lactose. Patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free."

3. How to take Alopurinol Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Swallow the tablet whole with a glass of water and after a meal. You should drink plenty of fluids (2–3 litres per day) while taking this medicine.

Generally, your doctor will 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.

The recommended dose is:

Adults (including elderly patients)

Starting dose: 100–300 mg/day.

When you begin treatment, your doctor may also prescribe an anti-inflammatory medicine or colchicine for one month or more to prevent gouty arthritis attacks.

Your allopurinol dose may be adjusted depending on the severity of the disease.

Maintenance dose is:

• 100–200 mg/day for mild disorders
• 300–600 mg/day for moderate disorders
• 700–900 mg/day for severe disorders

Your doctor may also adjust your dose if you have reduced kidney or liver function, especially if you are an elderly patient.

If your daily dose exceeds 300 mg/day and you are experiencing gastrointestinal adverse effects such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in divided doses to reduce these effects.

If you have severe kidney problems

• You may be advised to take less than 100 mg each day,
• or to take 100 mg at intervals longer 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.

Children (under 15 years of age)

• 100–400 mg/day.
• Treatment may be started together with an anti-inflammatory medicine or colchicine. The dose may be adjusted if you have reduced kidney or liver function, or may be divided to reduce gastrointestinal effects, as described above for adults.

If you take more Alopurinol Aurovitas than you should

If you (or someone else) take a large number of tablets at once, or if you suspect a child has ingested any tablets, go immediately to the nearest hospital emergency department or contact your doctor without delay. Symptoms of overdose may include nausea, vomiting, diarrhoea, or dizziness. Take this leaflet, any remaining tablets, and the packaging to the hospital or doctor so they know which tablets have been taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alopurinol Aurovitas

If you forget to take a tablet, take the next dose as soon as you remember, unless it is almost time for your next dose. DO NOT take a double dose to make up for forgotten doses. Take subsequent doses at the scheduled time.

If you stop taking Alopurinol Aurovitas

You must continue taking these tablets for as long as your doctor advises. DO NOT stop taking this medicine without first talking to your doctor.

If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

• If you experience any of the following adverse effects, stop treatment immediately and contact your doctor:

Unexpected skin reaction (possibly accompanied by fever, gland swelling, joint pain, appearance of blisters or unusual bleeding, kidney problems, or sudden onset of seizures). Skin rashes are the most common adverse effects associated with allopurinol use (affecting less than 1 in 10 but more than 1 in 100 people).

Rare (affects up to 1 in 1,000 people):

• Fever and chills, headache, muscle pain (flu-like symptoms), and general feeling of malaise.
• Any changes to your skin, for example, mouth, throat, nose, or genital ulcers, conjunctivitis (red and swollen eyes), widespread blistering or skin peeling.
• Severe hypersensitivity reactions including fever, skin rash, joint pain, and abnormalities in blood tests and liver function tests (these may be symptoms of a multi-organ hypersensitivity disorder).

Allergic reactions (affect up to 1 in 10,000 people):

If you experience allergic reactions, stop taking allopurinol and contact your doctor immediately. Symptoms may include:

• Skin rash, skin peeling, blisters or sores on the lips and mouth.
• Swelling of the face, hands, lips, tongue, or throat.
• Difficulty swallowing or breathing.
• Very rarely, symptoms that may include sudden wheezing, palpitations or chest tightness, or loss of consciousness.

Do not take any more tablets unless your doctor tells you to.

If you experience any of the following adverse effects while taking allopurinol, stop treatment and contact your doctor as soon as possible:

Other adverse effects:

Frequent (may affect up to 1 in 10 people):

• Skin rash.
• Elevated levels of thyroid-stimulating hormone in blood.

The following uncommon adverse effects have been reported (affect up to 1 in 100 people):

• Nausea, vomiting (which may rarely include blood), and diarrhoea.
• Increased results in liver function tests.

The following rare adverse effects have been reported (affect up to 1 in 1,000 people):

• Joint pain, painful swelling of the groin, armpits, or neck.
• Jaundice (yellowing of the skin and eyes).
• Impaired liver and kidney function.
• Formation of stones in the urinary tract; symptoms may include blood in the urine and abdominal, flank, or groin pain.

The following very rare adverse effects have been reported (affect up to 1 in 10,000 people):

• In some cases, allopurinol may affect the blood. This may manifest as bruising more easily than usual, or developing a sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems. Inform your doctor as soon as possible.
• High fever and blood in the urine (haematuria).
• Elevated blood cholesterol levels (hyperlipidaemia).
• Change in normal bowel habits or particularly foul-smelling stools.
• General feeling of malaise.
• Weakness, numbness, instability in the feet, inability to move muscles (paralysis), or loss of consciousness, sensation of pins and needles.
• Seizures, fits, or depression.
• Headache, dizziness, drowsiness, or altered vision.
• Chest pain, high blood pressure, or low pulse.
• Fluid retention causing swelling (oedema), especially in the ankles.
• Male infertility or inability to achieve or maintain an erection, or ejaculation during sleep ("wet dreams").
• Breast enlargement in both men and women.
• Change in taste perception, mouth inflammation.
• Cataracts (clouding of the eye's lens) and other vision problems.
• Blisters (small soft red lumps on the skin).
• Hair loss or discolouration.
• Increased thirst, fatigue, and weight loss (these may be symptoms of diabetes); your doctor may measure your blood sugar levels to determine if this is occurring.
• Depression.
• Lack of voluntary muscular coordination (ataxia).
• Tingling, prickling, stinging, or burning sensation on the skin (paraesthesia).
• Muscle pain.
• Swollen glands, which usually resolve once allopurinol treatment is stopped.
• Severe allergic reaction causing swelling of the face or throat.
• Severe, potentially life-threatening allergic reaction.

Frequency not known (cannot be estimated from available data):

• 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.
• Lichenoid skin eruption (reddish-purple rash with itching or white-grey thread-like lines on mucous membranes).

You may occasionally feel dizzy, but this can usually be avoided by taking allopurinol after meals. Inform your doctor if this problem persists.

Allopurinol may occasionally affect your blood or lymphatic system. These effects have typically occurred in people with liver or kidney problems. Inform your doctor as soon as you notice bruising more easily than usual, or if you develop a sore throat or other symptoms of infection.

Reporting of adverse effects

If you experience any adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alopurinol Aurovitas

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alopurinol Aurovitas

• The active substance is allopurinol. Each tablet contains 300 mg of allopurinol.
• The other components are: lactose monohydrate, maize starch, povidone (K-30), sodium carboxymethylstarch (type A) (derived from potato starch), and magnesium stearate.

Nature of the product and pack contents

Uncoated tablets, white to off-white, round in shape (11.5 mm diameter), bevelled edges, marked with “A” and “3” separated by a central line on one side and plain on the other. The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Alopurinol Aurovitas tablets are available in blister packs and PEAD bottles.

Pack sizes:

Blister packs: 20, 25, 28, 30, 50, 60, 90 and 100 tablets.

PEAD bottles: 250 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Allopurinol PUREN 300 mg Tabletten

Belgium: Allopurinol AB 300 mg tabletten

Spain: Alopurinol Aurovitas 300 mg comprimidos EFG

Poland: Allopurinol Aurovitas

Portugal: Alopurinol Generis

Netherlands: Allopurinol Aurobindo 300 mg tabletten

Date of the latest revision of this leaflet: 05/2025

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