Allopurinol aurovitas

Package leaflet: Information for the user

Allopurinol Aurovitas, 100 mg, tablets
Allopurinol Aurovitas, 300 mg, tablets
Allopurinolum
Please read all of this leaflet carefully before 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 someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

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

2. Important information before using Allopurinol Aurovitas

When not to use 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, consult your doctor or
pharmacist if:

• the patient is of Han Chinese, African or Indian descent;
• the patient has liver or kidney disease. The doctor may recommend a lower dose or less frequent administration than daily. The patient will also be monitored more closely;
• the patient has heart disease or high blood pressure and is taking diuretics and/or drugs known as ACE inhibitors;
• the patient is currently experiencing a gout attack;
• the patient has a thyroid disorder.

If in doubt whether any of the above points apply, the patient should
consult a doctor or pharmacist before taking allopurinol.
Exercise particular caution when using Allopurinol Aurovitas:

• Serious skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during allopurinol treatment. Skin rashes often involve ulceration of the mouth, throat, nose, genital organs and conjunctivae (red, swollen eyes). These potentially severe skin reactions are frequently preceded by flu-like symptoms, fever, headache, and body aches. The rash may progress to widespread blistering and skin peeling. Such severe skin reactions may occur more frequently in patients of Han Chinese, Thai, or Korean descent. Chronic kidney disease may further increase the risk in these patients. If a rash or skin symptoms occur, treatment must be stopped immediately and medical advice sought urgently.
• In patients with kidney stones or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. This can be minimized by ensuring adequate hydration to achieve optimal urine dilution.
• In patients with kidney stones, the stones may shrink and possibly pass into the urinary tract.

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

Allopurinol Aurovitas and other medicines
Inform your doctor or pharmacist if the patient is taking any of the
following medicines:

• 6-mercaptopurine (used in the treatment of blood cancer);
• azathioprine, cyclosporine (used to suppress immune system function); Note that adverse effects of cyclosporine may occur more frequently;
• vidarabine (used in the treatment of viral infections); Note that adverse effects of vidarabine may occur more frequently. Exercise particular caution if such effects occur;
• salicylates (used to reduce pain, fever and inflammation, e.g. aspirin - acetylsalicylic acid);
• probenecid (used in the treatment of gout);
• chlorpropamide (used in the treatment of diabetes); Dose reduction of chlorpropamide may be necessary, especially in patients with impaired kidney function;
• warfarin, phenprocoumon, acenocoumarol (used to thin the blood); The doctor will monitor blood clotting values more frequently and may reduce the dose of these medicines if necessary;
• phenytoin (used in the treatment of epilepsy);
• theophylline (used in the treatment of asthma and other conditions causing breathing difficulties); The doctor will measure theophylline blood levels, particularly after starting allopurinol or changing the dose;
• ampicillin, amoxicillin (used in the treatment of bacterial infections); Patients should receive alternative antibiotics if possible, as allergic reactions are more likely;
• Medicines used in the treatment of malignant tumors, such as:
  • cyclophosphamide,
  • doxorubicin,
  • bleomycin,
• procarbazine,
• mechlorethamine. The doctor will frequently monitor blood cell counts;
  • didanosine (used in the treatment of HIV infection);
  • ACE inhibitors (e.g. captopril) or diuretic tablets (diuretics) (used to treat high blood pressure); The risk of skin reactions may be increased, especially if the patient has chronic kidney disease.

Concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided.
If 6-mercaptopurine or azathioprine are used concomitantly with Allopurinol Aurovitas, the dose of 6-mercaptopurine or azathioprine must be reduced, as their effects will be prolonged.
This may increase the risk of serious blood disorders. In such cases, the doctor will closely monitor the patient's blood cell counts during treatment.
Seek immediate medical help if the patient notices any unexplained bruising, bleeding, fever, or sore throat.
If the patient is also taking aluminium hydroxide, allopurinol may be less effective. An interval of at least 3 hours should be maintained between taking the two medicines.
Blood count abnormalities occur more frequently when allopurinol is taken concomitantly with cytostatic agents (e.g.
cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides) than when these
active substances are taken separately. Therefore, regular blood count monitoring is necessary.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient
plans to take. This includes over-the-counter medicines, including
herbal remedies. This is necessary because Allopurinol Aurovitas may affect the action of
other medicines. Likewise, other medicines may affect the action of Allopurinol Aurovitas.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Allopurinol is excreted in breast milk. Use of allopurinol during breastfeeding is not recommended. This medicine should not be taken if the patient is pregnant or breastfeeding unless otherwise advised by a doctor.

Driving and operating machinery

• Drowsiness, dizziness or coordination disturbances may occur. If such symptoms occur, DO NOT drive or operate machinery or engage in other hazardous activities.

Allopurinol Aurovitas contains lactose
Patients with rare hereditary galactose intolerance, Lapp-type 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, i.e. essentially "sodium-free".

3. How to use Allopurinol Aurovitas

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The tablets should be taken after a meal and swallowed with a sufficient amount of water. During treatment with this medicine, you should drink plenty of fluids (2–3 litres per day).
Your doctor usually starts with a low dose of allopurinol (e.g. 100 mg/day) to reduce the risk of possible adverse effects. The dose may be increased if necessary.
Recommended doses:

• Adults (including elderly patients) Initial dose: 100 mg to 300 mg daily. At the start of treatment, your doctor may prescribe an anti-inflammatory medicine or colchicine for one month or longer to prevent attacks of gout. The allopurinol dose may be adjusted depending on the severity of the patient's condition. Maintenance doses are:
  • mild conditions, 100–200 mg daily
  • moderate conditions, 300–600 mg daily
  • severe conditions, 700–900 mg daily. Your doctor may also adjust the dose if you have impaired kidney or liver function, particularly in elderly patients. If the daily dose exceeds 300 mg and gastrointestinal adverse effects occur, such as nausea or vomiting (see section 4), your 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 daily
• or to take a 100 mg dose at intervals longer than once daily. If the patient is dialysed two or three times a week, the doctor may recommend a dose of 300 or 400 mg to be taken immediately after dialysis.
• Children (under 15 years of age) 100 mg – 400 mg daily. Treatment may be started concomitantly with an anti-inflammatory medicine or colchicine, and the dose may be adjusted if the patient has reduced kidney or liver function, or divided to alleviate gastrointestinal adverse effects, as described above for adults.

Taking more Allopurinol Aurovitas than recommended
If the patient (or someone else) takes more than the recommended dose of this medicine, or if there is suspicion that a child has swallowed tablets, consult a doctor immediately or go to the nearest hospital emergency department. The most common symptoms of overdose include nausea, vomiting, diarrhoea and dizziness. Take this leaflet, any remaining tablets and the medicine packaging with you to hospital so that the doctor knows which tablets have been taken.
If you miss a dose of Allopurinol Aurovitas
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.
Stopping Allopurinol Aurovitas treatment
Continue taking this medicine for as long as your doctor recommends.
DO NOT stop taking Allopurinol Aurovitas without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

• If any of the following symptoms occur, stop taking the tablets immediately and contact your doctor without delay: Unexpected skin reaction (possibly associated with fever, swollen lymph nodes, joint pain, unusual blisters or bleeding, kidney problems or sudden seizures). Skin rash is the most common adverse reaction 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, for example, mouth, throat, nose, genital ulcers and conjunctivitis (red and swollen eyes), extensive blisters or peeling of the skin;
• serious hypersensitivity reactions associated with fever, skin rash, joint pain and abnormalities in blood and liver tests (these may be signs of multi-organ hypersensitivity syndrome).

Allergic reactions (may occur in up to 1 in 10,000 people)
If a patient experiences a hypersensitivity reaction (allergic reaction), they should stop taking
Allopurinol Aurovitas and contact their doctor immediately. Symptoms may include:

• skin rash, skin peeling, ulceration of lips and mouth;
• swelling of the face, hands, lips, tongue or throat;
• difficulty swallowing or breathing;
• very rare symptoms include: sudden wheezing, palpitations or chest tightness and collapse. Do not take any more tablets unless advised by a doctor.

If any of the following symptoms occur while taking allopurinol, stop taking the tablets and inform your doctor as soon as possible:
Other adverse reactions:
Common (may affect up to 1 in 10 people):

• rash,
• increased blood concentration of thyrotropin hormone.

The following uncommon adverse reactions have been reported (affecting less than 1 in 100 but more than 1 in 1,000 people):

• nausea, vomiting (very rarely, blood may be present) and diarrhoea;
• abnormal liver function tests.

The following rare adverse reactions 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 whites of the eyes);
• liver or kidney function disorders;
• formation of kidney stones; symptoms may include blood in the urine and abdominal, flank or groin pain.

The following very rare adverse reactions have been reported (affecting less than 1 in 10,000 people):

• occasionally, allopurinol may affect the blood, which could result in bruising more easily than usual, or a sore throat or other signs of infection may occur. These symptoms usually occur in people with impaired liver or kidney function. Inform your doctor as soon as possible.
• blood in the urine (haematuria);
• high blood cholesterol levels (hyperlipidaemia);
• changes in normal bowel movements or unusual foul-smelling stools;
• general malaise;
• weakness, numbness, difficulty standing, inability to move muscles (paralysis) or loss of consciousness, tingling or pricking sensations;
• seizures, convulsions or depression;
• headache, dizziness, drowsiness or visual disturbances;
• chest pain, high blood pressure or slow pulse;
• fluid retention leading to swelling, particularly around the ankles;
• male infertility and erectile dysfunction or nocturnal emission ("wet dreams");
• breast enlargement in men and also in women;
• altered taste, inflammation of the mouth;
• cataract (clouding of the eye lens), and other visual disturbances;
• boils (small, tender, red nodular skin eruptions);
• hair loss or discolouration;
• excessive thirst, fatigue and weight loss (these may be symptoms of diabetes); your doctor may wish to check your blood sugar levels to determine if this is the cause;
• depression;
• lack of muscle coordination (ataxia);
• tingling, tickling, pricking or burning sensations of the skin (paraesthesiae);
• muscle pain;
• swollen lymph nodes, usually resolving after stopping allopurinol treatment;
• severe allergic reaction causing swelling of the face or throat;
• serious, potentially 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 altered consciousness. In such cases, seek medical advice immediately.
• lichenoid skin rash (itchy reddish-purple skin rash and/or white lace-like lines on mucous membranes).

Occasionally, nausea may occur, but this can usually be avoided by taking allopurinol after a meal. If the problem persists, inform your doctor.
Sometimes allopurinol may affect the blood or lymphatic system. These symptoms usually occur in people with impaired liver or kidney function. If you notice more frequent bruising than usual, a sore throat or other signs of infection, inform your doctor without delay.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Allopurinol Aurovitas

Keep this medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date (month, year) stated on the outer 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. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Allopurinol Aurovitas contains

• The active substance is allopurinol.
  Allopurinol Aurovitas 100 mg tablets: Each tablet contains 100 mg of allopurinol.
  Allopurinol Aurovitas 300 mg tablets: Each tablet contains 300 mg of allopurinol.
• Other ingredients are: lactose monohydrate, maize starch, povidone K-30, sodium carboxymethyl starch (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), bevelled-edged, uncoated tablets, with the imprint "A" and "1" on either side of the breakline on one side and smooth on the other.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not guarantee equal dosing.
Allopurinol Aurovitas 300 mg tablets:
White or almost white, round (11.5 mm in diameter), bevelled-edged, uncoated tablets, with the imprint "A" and "3" on either side of the breakline on one side and smooth on the other.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not guarantee equal dosing.
Allopurinol Aurovitas tablets are packed in blisters or HDPE bottles, placed 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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]
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 authorised for marketing in the European Economic Area under the following names:
Belgium: Allopurinol AB 100 mg/300 mg tabletten
Germany: Allopurinol PUREN 100 mg/300 mg Tabletten
Poland: Allopurinol Aurovitas
Portugal: Alopurinol Generis
Spain: Alopurinol Aurovitas 100 mg/300 mg comprimidos EFG
Netherlands: Allopurinol Aurobindo 100 mg/300 mg, tabletten