Allopurinol Aurovitas

Leaflet attached to the packaging: information for the user

Allopurinol Aurovitas, 100 mg, tablets

Allopurinol Aurovitas, 300 mg, tablets

Allopurinol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Allopurinol Aurovitas and what is it used for
• 2. Important information before taking Allopurinol Aurovitas
• 3. How to take Allopurinol Aurovitas
• 4. Possible side effects
• 5. How to store Allopurinol Aurovitas
• 6. Contents of the packaging and other information

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

• Allopurinol belongs to a group of medicines called enzyme inhibitors, which work by slowing down the rate of certain chemical reactions in the body.
• Allopurinol tablets are used for long-term, preventive treatment of gout and can be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other types of kidney disease.

2. Important information before taking Allopurinol Aurovitas

When not to take Allopurinol Aurovitas

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

Warnings and precautions

Before starting treatment with Allopurinol Aurovitas, the patient should discuss it with their doctor or pharmacist if:

• the patient is Chinese of Han ethnicity, African, or Indian;
• the patient has liver or kidney disease. The doctor may recommend taking a lower dose or taking the medicine less frequently than daily. The doctor will also monitor the patient more closely;
• the patient has heart disease or high blood pressure and is taking diuretics and/or ACE inhibitors;
• the patient is currently experiencing a gout attack;
• the patient has thyroid disease.

In case of uncertainty about any of the above points, the patient should consult their doctor or pharmacist before taking allopurinol.
Particular caution should be exercised when taking Allopurinol Aurovitas:

• Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during treatment with allopurinol. Often, the rash can include ulcers of the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These potentially severe skin reactions are often preceded by flu-like symptoms, fever, headache, and body aches. The rash can progress to generalized blisters and skin peeling. Such severe skin reactions can occur more frequently in people of Chinese Han ethnicity, Thai, and Korean populations. Chronic kidney disease may also increase the risk in these patients. If a rash or skin symptoms occur, the patient should stop taking the medicine immediately and seek medical attention urgently.
• If the patient has kidney stones or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. This can be minimized by ensuring the patient is properly hydrated to optimize urine dilution.
• If the patient has kidney stones, they may decrease in size and may enter the urinary tract.

Children

Use in children is rarely indicated, except for a few types of cancer (particularly leukemia) and certain enzyme disorders, such as Lesch-Nyhan syndrome.

Allopurinol Aurovitas and other medicines

The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• 6-mercaptopurine (used to treat blood cancer);
• azathioprine, cyclosporine (used to suppress the immune system); Note that the side effects of cyclosporine may occur more frequently;
• vidarabine (used to treat viral infections); Note that the side effects of vidarabine may occur more frequently. Particular caution should be exercised if such side effects occur;
• salicylates (used to reduce pain, fever, and inflammation, e.g., aspirin - acetylsalicylic acid);
• probencid (used to treat gout);
• chlorpropamide (used to treat diabetes); The dose of chlorpropamide may need to be reduced, especially in patients with kidney function disorders;
• warfarin, phenprocoumon, acenocoumarol (used to thin the blood); The doctor will monitor the patient's blood clotting values more closely and may reduce the dose of these medicines if necessary;
• phenytoin (used to treat epilepsy);
• theophylline (used to treat asthma and other breathing difficulties); The doctor will measure the theophylline level in the blood, especially after starting treatment with allopurinol or changing the dose;
• ampicillin, amoxicillin (used to treat bacterial infections); Whenever possible, patients should receive other antibiotics, as allergic reactions are more likely;
• Medicines used to treat cancer, such as:
• cyclophosphamide,
• doxorubicin,
• bleomycin,
• procarbazine,
• mechlorethamine. The doctor will monitor the patient's blood count more closely;
• 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 if the patient has chronic kidney disease.

Avoid taking 6-mercaptopurine or azathioprine with allopurinol. When taking 6-mercaptopurine or azathioprine with Allopurinol Aurovitas, the dose of 6-mercaptopurine or azathioprine should be reduced, as their effect will be prolonged.
This may increase the risk of serious blood disorders. In such cases, the doctor will closely monitor the patient's blood count during treatment.
Seek medical attention immediately if the patient notices any unexplained bruising, bleeding, fever, or sore throat.
If the patient is taking aluminum hydroxide, allopurinol may not work as well. The patient should leave a gap of at least 3 hours between taking the two medicines.
Blood disorders occur more frequently when allopurinol is taken with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents) than when these active substances are taken alone. Therefore, regular blood count monitoring is necessary.
Tell the doctor about all medicines being taken currently or recently, as well as any medicines the patient plans to take. This includes medicines sold without a prescription, including herbal medicines. This is necessary because Allopurinol Aurovitas may affect the action of other medicines. Other medicines may also affect the action of Allopurinol Aurovitas.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Allopurinol is excreted in breast milk. Breastfeeding is not recommended during treatment with allopurinol. The patient should not take this medicine if they are pregnant or breastfeeding, unless their doctor recommends it.

Driving and using machines

• Drowsiness, dizziness, or coordination disorders may occur. If such symptoms occur, the patient should NOTdrive vehicles or operate machines and should not engage in other hazardous activities.

Allopurinol Aurovitas contains lactose

Patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Allopurinol Aurovitas

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Tablets should be taken after a meal and swallowed with a sufficient amount of water. During treatment with this medicine, the patient should drink plenty of fluids (2-3 liters per day).
The doctor usually starts with a low dose of allopurinol (e.g., 100 mg/day) to minimize the risk of possible side effects. If necessary, the dose will be increased.
Recommended doses:

• Adults (and elderly patients)Initial dose: 100 mg to 300 mg per day. After starting treatment, the doctor may prescribe an anti-inflammatory medicine or colchicine for a month or longer to prevent gout attacks. The dose of allopurinol may be adjusted depending on the severity of the patient's condition. The maintenance dose is:
• mild conditions, 100-200 mg per day
• moderate conditions, 300-600 mg per day
• severe conditions, 700-900 mg per day. The doctor may also change the dose if the patient has liver or kidney function disorders, especially in elderly patients. If the daily dose exceeds 300 mg and gastrointestinal side effects occur, such as nausea or vomiting (see section 4), the doctor may prescribe allopurinol in divided doses to reduce these symptoms.

If the patient has severe kidney disease

• the patient may be advised to take a dose lower than 100 mg per day
• or take a dose of 100 mg at intervals longer than once a day. If the patient is dialyzed 2 or 3 times a week, the doctor may recommend a dose of 300 or 400 mg to be taken immediately after dialysis.
• Children (under 15 years)100 mg - 400 mg per day. Treatment can be started simultaneously with an anti-inflammatory medicine or colchicine, and the dose can be adjusted if the patient has reduced liver or kidney function or divided to alleviate gastrointestinal side effects, as above, in the case of adults.

Taking a higher dose of Allopurinol Aurovitas than recommended

If the patient (or someone else) takes a higher dose of the medicine than recommended or suspects that a child has swallowed a tablet, they should consult a doctor or go to the hospital emergency department immediately. The most common symptoms of overdose are nausea, vomiting, diarrhea, and dizziness. The patient should take this leaflet, any remaining tablets, and the packaging of this medicine with them to the hospital, so the doctor knows which tablets were taken.

Missing a dose of Allopurinol Aurovitas

If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Allopurinol Aurovitas

The patient should continue taking the medicine for as long as the doctor recommends.
The patient should NOTstop taking Allopurinol Aurovitas without consulting their doctor first.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

• If the patient experiences any of the following symptoms, they should stop taking the tablets and contact their doctor immediately:Unexpected skin reaction (possibly related to fever, swollen lymph nodes, joint pain, unusual blisters, or bleeding, kidney problems, or sudden seizure). Skin rash is the most common side effect associated with allopurinol (affects less than 1 in 10 but more than 1 in 100 people).

Rare (affects less than 1 in 1,000 people):

• fever and chills, headache, muscle pain (flu-like symptoms), and general malaise;
• any skin changes, such as mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes), widespread blisters, or skin peeling;
• severe hypersensitivity reactions associated with fever, skin rash, joint pain, and blood and liver test abnormalities (may be symptoms of multi-organ hypersensitivity disorders).

Allergic reactions(may affect up to 1 in 10,000 people)
If the patient has experienced an allergic reaction (allergic reaction), they should stop taking Allopurinol Aurovitas and consult their doctor immediately. Symptoms may include:

• skin rash, skin peeling, mouth and lip ulcers;
• swelling of the face, hands, lips, tongue, or throat;
• difficulty swallowing or breathing;
• very rare symptoms include: sudden wheezing, rapid heartbeat, or chest tightness and collapse. The patient should not take any more tablets unless their doctor recommends it.

If the patient experiences any of the following symptoms while taking allopurinol, they should stop taking the tablets and inform their doctor as soon as possible:

Other side effects:

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

• skin rash,
• increased thyroid-stimulating hormone levels in the blood.

The following uncommonside effects have been reported (affecting less than 1 in 100 but more than 1 in 1,000 people):

• nausea, vomiting (very rarely, may be bloody) and diarrhea;
• abnormal liver test results.

The following rareside effects have been reported (affecting less than 1 in 1,000 but more than 1 in 10,000 people):

• joint pain or painful swelling in the groin, armpits, or neck;
• jaundice (yellowing of the skin and eyes);
• liver or kidney function disorders;
• formation of stones in the urinary tract, symptoms may include blood in the urine and abdominal, side, or groin pain.

The following very rareside effects have been reported (affecting less than 1 in 10,000 people):

• sometimes allopurinol may affect the blood or lymphatic system. These symptoms usually occur in people with liver or kidney function disorders. If the patient notices more frequent bruising than usual, sore throat, or other infection symptoms, they should inform their doctor immediately.
• blood in the urine (hematuria);
• high cholesterol levels in the blood (hyperlipidemia);
• changes in normal bowel movements or unusual, foul-smelling stools;
• general malaise;
• weakness, numbness, difficulty walking, inability to move muscles (paralysis), or loss of consciousness, feeling of tingling or prickling;
• seizures, convulsions, or depression;
• headache, dizziness, drowsiness, or vision disturbances;
• chest pain, high blood pressure, or slow pulse;
• fluid accumulation leading to swelling, especially in the ankles;
• male infertility and erectile dysfunction or ejaculation during sleep ("wet dreams");
• breast enlargement in men and women;
• change in taste, mouth inflammation;
• cataract (clouding of the lens of the eye), and other vision disorders;
• furuncles (small, sensitive, red, nodular rash on the skin);
• hair loss or discoloration;
• excessive thirst, fatigue, and weight loss (may be symptoms of diabetes); the doctor may want to measure the blood sugar level to decide if this is the cause.
• depression;
• lack of coordination (ataxia);
• tingling, itching, prickling, or burning sensation of the skin (paresthesia);
• muscle pain;
• enlarged lymph nodes, usually resolving after treatment with allopurinol is stopped;
• severe allergic reaction, which causes swelling of the face or throat;
• life-threatening allergic reaction.

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

• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or clouding of consciousness. In such cases, the patient should seek medical attention immediately.
• lichenoid skin rash (itchy, reddish-purple skin rash and/or white-gray, thread-like lines on the mucous membranes).

Occasionally, nausea may occur, but it can usually be avoided by taking allopurinol after a meal. If the problem persists, the patient should inform their doctor.
Sometimes allopurinol may affect the blood or lymphatic system. These symptoms usually occur in people with liver or kidney function disorders. If the patient notices more frequent bruising than usual, sore throat, or other infection symptoms, they should inform their doctor immediately.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Allopurinol Aurovitas

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
Do not use this medicine after the expiry date (month, year) stated on the carton after "expiry date". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Allopurinol Aurovitas contains

• The active substance of the medicine is allopurinol. Allopurinol Aurovitas, 100 mg, tabletsEach tablet contains 100 mg of allopurinol. Allopurinol Aurovitas, 300 mg, tabletsEach tablet contains 300 mg of allopurinol.
• The other ingredients are: lactose monohydrate, cornstarch, povidone K-30, sodium carboxymethylcellulose (Type A), magnesium stearate.

What Allopurinol Aurovitas looks like and contents of the pack

Tablet.
Allopurinol Aurovitas, 100 mg, tablets:
White or almost white, round (8 mm in diameter) with beveled edges, uncoated tablets with the inscription "A" and "1" on either side of the break line on one side and smooth on the other.
The break line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Allopurinol Aurovitas, 300 mg, tablets:
White or almost white, round (11.5 mm in diameter) with beveled edges, uncoated tablets with the inscription "A" and "3" on either side of the break line on one side and smooth on the other.
The break line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Allopurinol Aurovitas tablets are packaged in blisters or HDPE bottles, in a cardboard box.

Pack sizes:

Blisters: 20, 25, 28, 30, 50, 60, 90, and 100 tablets.
HDPE bottles: 250 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
Amadora, 2700-487
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Allopurinol AB 100 mg/300 mg tablets
Germany:
Allopurinol PUREN 100 mg/300 mg tablets
Poland:
Allopurinol Aurovitas
Portugal:
Alopurinol Generis
Spain:
Alopurinol Aurovitas 100 mg/300 mg tablets EFG
Netherlands:
Allopurinol Aurobindo 100 mg/300 mg tablets

Date of last revision of the leaflet: 12/2024