ALOPURINOL AUROVITAS 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alopurinol Aurovitas 100 mg Tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

• Alopurinol Aurovitas 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.
• Alopurinol tablets are used in the long term to prevent the occurrence of gout and other situations produced by excess uric acid in the body, including kidney stones and other types of kidney disease.

2. What you need to know before you take Alopurinol Aurovitas

Do not take Alopurinol Aurovitas:

• If you are allergic to allopurinol or 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 have Han Chinese, African or Indian ancestry.
• You have liver and kidney problems. Your doctor may give you a lower dose or ask 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 medications called ACE inhibitors.
• You are currently having a gout attack.
• You have thyroid problems.

If you are not sure if you are affected by any of the following situations, tell your doctor or pharmacist before taking allopurinol.

Be particularly careful with allopurinol:

• 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 rashes are often preceded by flu-like symptoms such as fever, headache, body aches. The rash can progress to blistering and widespread 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 on the skin, stop taking allopurinol and consult your doctor immediately.

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

Children

Use in children is rarely indicated, except in some types of cancer (especially leukemia) and some enzymatic pathologies 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 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 to cyclosporine may occur more frequently.
• Vidarabine (used in the treatment of herpes). Note that adverse effects to vidarabine may occur more frequently. Be especially cautious if this happens to you.
• Salicylates (used to reduce pain, fever, or inflammation; e.g., aspirin).
• Probenecid (used for the treatment of gout).
• Chlorpropamide (used to treat diabetes). It may be necessary to reduce the dose of chlorpropamide, especially in patients with reduced renal function.
• Warfarin, phenprocoumon, acenocoumarol (anticoagulants). Your doctor will monitor your blood test results more frequently and, if necessary, reduce the dose of these medicines.
• Phenytoin (used to treat epilepsy).
• Theophylline (used to treat asthma and other respiratory diseases). Your doctor will measure the levels of theophylline in your blood, especially when you start treatment with allopurinol, or following any change in dose.
• Ampicillin or amoxicillin (used to treat bacterial infections). When possible, patients should receive other antibiotics since it is more likely that allergic reactions will appear.
• Medicines for treating aggressive tumors such as:

• Cyclophosphamide
• Doxorubicin
• Bleomycin
• Procarbazine
• Mechlorethamine

Your doctor will monitor your blood test results 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 increase, especially in patients with chronic kidney function limitations.

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

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

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 blood tests should be performed.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other type of medicine, including those obtained without a prescription, herbal medicines, as allopurinol may affect how some medicines work. Other medicines may also affect the functioning of allopurinol.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Alopurinol passes into breast milk. The use of alopurinol is not recommended during breastfeeding. You should not take this medicine if you are pregnant or breastfeeding unless your doctor recommends it.

Driving and using machines

• Alopurinol may cause dizziness, drowsiness, and affect your coordination. If it affects you, DO NOT drive or operate machinery or participate 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; i.e., it is essentially “sodium-free”.

3. How to take Alopurinol Aurovitas

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 liquid (2-3 liters per day) while taking this medicine.

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.

The recommended dose is:

Adults (including elderly patients)

Initial dose: 100 - 300 mg/day.

When you start your treatment, your doctor may also prescribe an anti-inflammatory medication or colchicine for a month or more to prevent gout attacks.

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

The maintenance dose is:

1. 100 - 200 mg/day in mild conditions
2. 300 - 600 mg/day in moderate conditions
3. 700 - 900 mg/day in severe conditions

Your doctor may also modify your dose if you have reduced renal and hepatic function, especially if you are an elderly patient.

If the daily dose exceeds 300 mg/day and you are suffering from gastrointestinal side 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 asked to take less than 100 mg per day,
• or to take 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.

Children (under 15 years)

• 100-400 mg/day.
• Treatment may be started together with an anti-inflammatory medication or colchicine. The dose may be adjusted if you have reduced renal or hepatic function, or divided to reduce gastrointestinal side effects, as in the case of adults.

If you take more Alopurinol Aurovitas than you should

If you (or someone else) swallow many tablets at the same time or if you think a child has swallowed some tablets, go to the emergency department of the nearest hospital or contact your doctor immediately. The symptoms of an overdose are likely to include nausea, vomiting, diarrhea, or dizziness. Bring this leaflet, remaining tablets, and packaging to the hospital or doctor so they know which tablets have been taken.

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

If you forget to take Alopurinol Aurovitas

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

If you stop taking Alopurinol Aurovitas

You should continue taking these tablets for the time your doctor indicates. DO NOT stop taking your medicine without talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Unexpected skin reaction (probably along with fever, inflammation of the glands, joint pain, appearance of blisters or unusual bleeding, kidney problems, or sudden onset of seizures). Skin rashes are the most frequent side effects associated with the use of allopurinol (affecting less than 1 in 10 but more than 1 in 100 people).

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

• Fever and chills, headache, muscle pain (flu-like symptoms), and general feeling of discomfort.
• Any change in your skin, for example, ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes), generalized blisters, or peeling.
• Severe hypersensitivity reactions that include fever, skin rash, joint pain, and changes in blood and liver function tests (these may be symptoms of multi-organ hypersensitivity disorder).

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

If you suffer from allergic reactions, stop treatment with allopurinol and go to your doctor immediately. The symptoms may include:

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

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

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

Other side effects:

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

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

The following side effects have been reported infrequently(affecting up to 1 in 100 people):

• Nausea, vomiting (which may be with blood in very rare cases), and diarrhea.
• Increased results of liver function tests.

The following side effects have been reported rarely(affecting up to 1 in 1,000 people):

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

The following side effects have been reported very rarely(affecting up to 1 in 10,000 people):

• In some cases, allopurinol may affect the blood. This can be seen through the appearance of bruises more easily than normal or the development of 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 (hematuria).
• High levels of cholesterol in the blood (hyperlipemia).
• Change in your normal bowel habit or special bad smell in your stools.
• General feeling of discomfort.
• Weakness, numbness, instability in your feet, inability to move your muscles (paralysis), or loss of consciousness, sensation of having pins and needles.
• Seizures, attacks, or depression.
• Headache, dizziness, drowsiness, or altered vision.
• Chest pain, high blood pressure, or low pulse.
• Fluid retention leading to swelling (edema), especially in the ankles.
• Male infertility or inability to have and maintain an erection or ejaculate during sleep (“wet dreams”).
• Enlargement of the breasts, both in men and women.
• Change in the perception of taste, inflammation of the mouth.
• Cataracts (clouding of the eye lenses) and other vision problems.
• Blisters (small soft red bumps on the skin).
• Hair loss or discoloration.
• Feeling thirsty, feeling tired, and losing weight (these may be symptoms of diabetes); it is possible that your doctor will measure your blood sugar level to determine if this is happening to you.
• Depression.
• Lack of voluntary coordination of muscle movements (ataxia).
• Sensation of tingling, pricking, piercing, or burning of the skin (paresthesia).
• Muscle pain.
• Inflamed glands, which usually disappear once treatment with allopurinol is finished.
• Severe allergic reaction that causes swelling of the face or throat.
• Potentially life-threatening severe allergic reaction.

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

• Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiff neck, headache, nausea, fever, or altered consciousness. If you present any of these symptoms, seek urgent medical attention.
• Lichenoid skin rash (red-purple skin rash with itching or white-grayish lines on the mucous membranes).

You may feel dizzy from time to time, but this can usually be avoided if you take allopurinol after meals. Inform your doctor if this problem persists.

Alopurinol may occasionally affect your blood or lymphatic system. These effects have usually occurred in people with liver or kidney problems. Inform your doctor as soon as you notice that you bruise more easily than normal or if you have a sore throat or other signs of infection.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Alopurinol Aurovitas

• The active ingredient is alopurinol. Each tablet contains 100 mg of alopurinol.
• The other ingredients are: lactose monohydrate, corn starch, povidone (K-30), sodium carboxymethyl starch (type A) (derived from potato starch), and magnesium stearate.

Appearance of the Product and Package Contents

Uncoated tablets, white to off-white in color, round in shape (diameter 8 mm), with a beveled edge, marked with "A" and "1" separated by a middle line on one side and smooth on the other. The score line is only to facilitate breaking for swallowing, not for dividing into equal doses.

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

Package Sizes:

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

PEAD bottles: 250 tablets.

Not all package 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

Phone: 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Allopurinol PUREN 100 mg Tabletten

Belgium: Allopurinol AB 100 mg tabletten

Spain: Alopurinol Aurovitas 100 mg comprimidos EFG

Poland: Allopurinol Aurovitas

Portugal: Alopurinol Generis

Netherlands: Allopurinol Aurobindo 100 mg tabletten

Date of the Last Revision of this Leaflet:05/2025

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