Package Insert: Information for the User

Alopurinol Aurovitas 300 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

• Alopurinol Aurovitas 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.

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

Do not take Alopurinol Aurovitas:

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

Warnings and precautions

Inform your doctor or pharmacist before taking allopurinol if:

• You are of Chinese Han, African, or Indian descent.
• 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 currently have a gout attack.
• You have thyroid problems.

If you are unsure whether any of the following situations affect you, inform your doctor or pharmacist before taking allopurinol.

Be especially careful with allopurinol:

• Severe 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 reactions are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to the formation of blisters and generalized peeling of the skin.

These severe skin reactions may be more common in people of Chinese Han, Thai, or Korean origin. Additionally, the risk of developing chronic kidney disease may increase in these patients.

If you develop a skin rash or these symptoms on your skin, 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 to drink enough to dilute your urine.
• In the case of kidney stones, the stones will become smaller and may enter your urinary tract.

Children

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

Taking Alopurinol Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication:

• 6-mercaptopurine (used in the treatment of blood cancer).
• Azathioprine, cyclosporine (used to suppress the immune system). Note that the adverse effects of cyclosporine may occur more frequently.
• Vidarabine (used in the treatment of herpes). Note that the adverse effects of vidarabine may occur more frequently. Be especially cautious if this happens.
• Salicylates (used to reduce pain, fever, or inflammation; e.g. Aspirin).
• Probenecid (used to treat gout).
• Chlorpropamide (used to treat diabetes). You may need to reduce the dose of chlorpropamide, especially in patients with reduced renal function.
• Warfarin, phenprocoumon, acenocoumarol (anticoagulants). Your doctor will monitor your hematological controls more frequently, and if necessary, reduce the dose of these medications.
• 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 after any dose change.
• Ampicillin or amoxicillin (used to treat bacterial infections). When possible, patients should receive other antibiotics as it is more likely that allergic reactions will occur.
• Medications to treat aggressive tumors such as:

• Cyclophosphamide
• Doxorubicin
• Bleomycin
• Procarbazine
• Mecloretamine

Your doctor will monitor your hematological controls 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.

If you take aluminum hydroxide concomitantly, allopurinol may be attenuated, so it is advisable to leave a gap of at least 3 hours between the two medications.

In the administration of allopurinol in combination with cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), hematological disorders occur more frequently than when these active principles are administered alone.

Therefore, periodic hematological controls should be performed.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other type of medication, including over-the-counter medications, herbal medications, as allopurinol may affect how some medications work. Other medications 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 medication. Allopurinol passes into breast milk. It is not recommended to use allopurinol during breastfeeding. Do not take this medication if you are pregnant or breastfeeding unless your doctor recommends it.

Driving and operating machinery

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

Alopurinol Aurovitas tablets contain lactose.Patients with hereditary galactose intolerance, total lactase deficiency, or problems with glucose or galactose absorption should not take this medication.

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

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

Swallow the entire tablet with a glass of water and after a meal. You should drink a lot of liquid (2-3 liters per day) while taking this medication.

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

The recommended dose is:

Adults (including elderly patients)

Starting dose: 100 - 300 mg/day.

When starting treatment, your doctor may prescribe an anti-inflammatory medication or colchicine for a month or more to prevent gouty arthritis attacks.

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

The maintenance dose is:

• 100 - 200 mg/day in mild alterations
• 300 - 600 mg/day in moderate alterations
• 700- 900 mg/day in severe alterations

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 experiencing gastrointestinal adverse effects such as nausea or vomiting (see section 4), your doctor may prescribe alopurinol in divided doses to reduce these effects.

If you have severe kidney problems

• They may ask you to take less than 100 mg per day,
• or take 100 mg at longer intervals than a 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 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 effects, as in the case of adults.

If you take more Alopurinol Aurovitas than you should

If you (or someone else) ingest many tablets at once or if you think a child has ingested some tablets, go to the nearest hospital emergency room or contact your doctor immediately. It is likely that symptoms of an overdose will include nausea, vomiting, diarrhea, or dizziness. Bring this leaflet, remaining tablets, and packaging to the hospital or doctor so they know how many tablets you have ingested.

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

If you forgot 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 to take the next one. DO NOT take a double dose to make up for the missed doses. Take the next doses at the usual time.

If you interrupt treatment with Alopurinol Aurovitas

You should continue taking these tablets for the time your doctor tells you. DO NOT stop taking your medication without first talking to your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Unexpected skin reaction (probably accompanied by fever, gland inflammation, joint pain, blister or unusual bleeding, kidney problems, or sudden seizures). Skin eruptions are the most common side effects associated with the use of allopurinol (affecting fewer 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, mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes), widespread blisters, or peeling.
• Severe hypersensitivity reactions that include fever, skin rash, joint pain, and alterations 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 experience allergic reactions, stop taking allopurinol and see 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, 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 your treatment and inform your doctor as soon as possible:

Other side effects:

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

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

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

• Joint pain, painful swelling of the groin, armpits, or neck.
• Ictericia (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 abdominal, side, or groin pain.

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

• In some cases, allopurinol may affect the blood. This may manifest as 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).
• Elevated levels of cholesterol in the blood (hyperlipemia).
• Change in normal bowel habit or special bad odor in your stools.
• General feeling of discomfort.
• Weakness, numbness, instability in your feet, inability to move muscles (paralysis), or loss of consciousness, sensation of having needles and pins.
• Seizures, attacks, or depression.
• Headache, dizziness, drowsiness, or altered vision.
• Chest pain, high blood pressure, or low pulse.
• Fluid retention that causes inflammation (edema), especially in the ankles.
• Male infertility or inability to maintain an erection, or ejaculate during sleep (“wet dreams”).
• Enlargement of the breasts, both in men and women.
• Change in taste perception, inflammation of the mouth.
• Cataracts (clouding of the eye lenses) and other vision problems.
• Blisters (small, soft, and red lumps on the skin).
• Loss or discoloration of hair.
• Thirst, feeling tired, and weight loss (these may be symptoms of diabetes); your doctor may 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, prickling, puncturing, or burning in the skin (paresthesia).
• Muscle pain.
• Inflamed glands, which usually disappear once the treatment with allopurinol is finished.
• Severe allergic reaction that causes swelling of the face or throat.
• Potentially fatal allergic reaction.

Unknown frequency (cannot be estimated from available data):

Asymptomatic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or loss of consciousness. If you experience any of these symptoms, seek urgent medical attention.

You may feel dizzy from time to time, but this can usually be prevented by taking allopurinol after meals. Inform your doctor if this problem persists.

Allopurinol may occasionally affect your blood or lymphatic system. These effects have occurred normally in people with liver or kidney problems. Inform your doctor as soon as you notice that you are getting bruises more easily than normal, or if you have a sore throat or other symptoms of infection.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Alopurinol Aurovitas

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

Appearance of the product and contents of the package

Uncoated tablets, white to off-white in color, round in shape (diameter 11.5 mm), with a beveled edge, marked with “A” and “3” separated by a median line on one side and smooth on the other. The groove is only for facilitating breakage 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.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible 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

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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 with 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:AlopurinolGeneris

Czech Republic: Allopurinol Aurovitas

Romania:Allopurinol Aurobindo 300 mg comprimate

Netherlands:Allopurinol Aurobindo 300 mg tabletten

Last review date of this leaflet:February 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)