Auricid

Package Leaflet: Information for the User

Auricid, 100 mg, tablets

Auricid, 300 mg, tablets

Allopurinol

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 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 and other information

• 1. What Auricid is and what it is used for
• 2. Before you take Auricid
• 3. How to take Auricid
• 4. Possible side effects
• 5. How to store Auricid
• 6. Contents of the pack and other information

1. What Auricid is and what it is used for

Auricid contains the active substance allopurinol. It works by slowing down the rate of certain chemical reactions in your body, which helps to lower the level of uric acid in your blood and urine.

A high level of uric acid can cause:

• Gout
• Kidney stones or other types of kidney problems.

Gout is characterized by the accumulation of uric acid in the joints and tendons in the form of crystals. These crystals cause an inflammatory reaction. The skin around some joints becomes swollen, sensitive, and painful to the touch. You may also experience severe pain when moving the joint.

This medicine is used in adults:

• to lower the level of uric acid when diet alone is not sufficient
• to treat and prevent complications mentioned above, when the body produces too much uric acid.

In addition, Auricid 100 mg can be used in children and adolescents under 15 years of age:

• to prevent and treat complications where the body produces too much uric acid, for example during cancer treatment (e.g. leukemia)
• in certain enzyme disorders, such as Lesch-Nyhan syndrome.

2. Before you take Auricid

Do not take Auricid

• if you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult your doctor or pharmacist.

Warnings and precautions

Before taking Auricid, discuss with your doctor or pharmacist:

if you are of Chinese, African or Indian descent.

if you have liver or kidney problems. Your doctor may prescribe a lower dose of Auricid or recommend taking the medicine less often than once a day. Your doctor will also closely monitor your condition.

if you have heart disease or high blood pressure and are taking diuretics and/or ACE inhibitors.

if you are currently having a gout attack.

if you have thyroid problems.

Special precautions

• Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during treatment with allopurinol. These reactions can be life-threatening and may cause skin peeling, blisters, and sores in the mouth, throat, nose, genitals, and eyes. They can also cause fever, headache, and body aches. If you experience any of these symptoms, stop taking Auricid and seek medical attention immediately.
• If you have cancer or Lesch-Nyhan syndrome, the level of uric acid in your urine may increase. To prevent this, drink plenty of fluids to dilute your urine.
• If you have kidney stones, the stones in your kidneys may decrease in size and move into the urinary tract.

Children

Auricid is not usually recommended for children, except for certain types of cancer (e.g. leukemia) and certain enzyme disorders, such as Lesch-Nyhan syndrome.

Auricid 300 mg tablets contain sunset yellow FCF (E 110), which may cause allergic reactions.

Auricid and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription, including herbal medicines.

Auricid may affect the way some medicines work, and some medicines may affect the way Auricid works.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• aspirin (or similar medicines called salicylates)
• theophylline, used for breathing problems
• anti-epileptic medicines (used to treat epilepsy), such as phenytoin
• vidarabine, used to treat herpes or chickenpox
• antibiotics (ampicillin or amoxicillin)
• didanosine, used to treat HIV infections
• cancer medicines
• immunosuppressants (e.g. 6-mercaptopurine, azathioprine, and cyclosporine)
• chlorpropamide, used to treat diabetes
• medicines used to treat heart problems or high blood pressure, such as ACE inhibitors or diuretics
• blood thinners (e.g. warfarin)
• other medicines used to treat gout, such as probenecid.

Do not take 6-mercaptopurine or azathioprine with Auricid. If you are taking 6-mercaptopurine or azathioprine with Auricid, your doctor may reduce the dose of 6-mercaptopurine or azathioprine, as their effects may be prolonged. This may increase the risk of serious blood disorders. Your doctor will closely monitor your blood counts during treatment.

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

If you are taking aluminum hydroxide at the same time as Auricid, allopurinol may have reduced effects. Wait at least 3 hours between taking both medicines.

When allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents) are given together, blood disorders (dyscrasias) occur more frequently than when these medicines are given alone.

Therefore, regular monitoring of blood counts is recommended.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Allopurinol passes into breast milk. It is not recommended for use in breastfeeding women.

Driving and using machines

You may feel drowsy, dizzy, or have problems with coordination. If this happens, do not drive or use any tools or machines.

Auricid contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Auricid 300 mg contains sunset yellow FCF (E 110)

Sunset yellow FCF (E 110) may cause allergic reactions.

3. How to take Auricid

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The dose of Auricid that you take may vary greatly. Your doctor will decide the right dose for you.

Take the tablet after a meal and swallow it with a glass of water.

The score line on the tablet is only to help you break the tablet if you have difficulty swallowing it whole.

Recommended doseis from 100 to 900 mg per day. You will usually start with a low dose, which may be increased if necessary.

The initial dose is usually 100 to 300 mg per day and can be taken as a single dose after a meal.

Depending on the severity of your condition, the dose may be increased to 900 mg per day.

Doses greater than 300 mg should be divided into doses not exceeding 300 mg at one time.

In elderly patients and patients with reduced liver or kidney function, your doctor may prescribe a lower dose or recommend taking the medicine at longer intervals. If you are on dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg, which should be taken immediately after dialysis.

Your doctor will usually start with a low dose of allopurinol (e.g. 100 mg per day) to minimize the risk of side effects. If necessary, the dose will be increased.

Use in children (under 15 years of age)

The usual dose is from 100 to 400 mg per day.

If you take more Auricid than you should

If you have taken more tablets than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you. Symptoms of overdose may include nausea, vomiting, diarrhea, and dizziness.

If you forget to take Auricid

If you forget to take 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 forgotten dose.

If you stop taking Auricid

Do not stop treatment without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur during treatment with Auricid:

Allergic reactions (hypersensitivity)

You should tell your doctor immediatelyif you experience:

Uncommon(may affect up to 1 in 100 people)

If you experience an allergic reaction, stop taking Auricid and seek medical attention immediately. Symptoms may include:

• skin peeling, boils, or pain in the lips and mouth;
• rarely, sudden wheezing, fluttering, or tightness in the chest and fainting.

Rare(may affect up to 1 in 1,000 people)

• fever and chills, headache, muscle pain (flu-like symptoms), and general feeling of being unwell;
• severe allergic reactions with fever, skin rash, joint pain, and abnormal blood test results and liver function tests (these may be symptoms of multi-organ hypersensitivity);
• bleeding from the lips, eyes, mouth, nose, or genitals;
• any skin changes, such as mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes), widespread blisters, or skin peeling.

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions causing swelling of the face or throat;
• severe, potentially life-threatening allergic reactions.

Do not take more tablets than you should

Other side effects:

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

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

Uncommon(may affect up to 1 in 100 people):

• nausea (feeling sick) or vomiting;
• abnormal liver function tests;
• diarrhea.

Rare(may affect up to 1 in 1,000 people):

• liver problems, such as hepatitis.

Very rare(may affect up to 1 in 10,000 people):

• allopurinol can affect the blood, which may cause bruising or bleeding more easily than usual or sore throat or other signs of infection. These symptoms usually occur in people with liver or kidney problems. Tell your doctor as soon as possible;
• effect on lymph nodes;
• high fever;
• blood in the urine (hematuria);
• high cholesterol levels in the blood (hyperlipidemia);
• general feeling of being unwell or weakness;
• weakness, numbness, trembling, feeling unable to move your muscles (paralysis), or loss of consciousness;
• headache, dizziness, drowsiness, or vision problems;
• chest pain (angina), high blood pressure, or slow heart rate;
• infertility or erectile dysfunction in men;
• breast enlargement, in both men and women;
• gastrointestinal disorders;
• taste disorders;
• cataracts;
• hair loss or discoloration;
• depression;
• lack of coordination;
• tingling, itching, prickling, or burning sensation of the skin (paresthesia);
• fluid accumulation leading to swelling (edema), especially in the ankles;
• abnormal glucose metabolism (diabetes). Your doctor may recommend a blood sugar test to check if this is happening.

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 stiffness of the neck, headache, nausea, fever, or changes in consciousness. If you experience these symptoms, seek medical attention immediately;
• lichen planus (itchy, reddish-purple skin rash and/or white-grayish lines on the mucous membranes)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Auricid

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Store the tablets in the original package.

No special precautions for storage are necessary.

Medicines should not be disposed of via wastewater or household waste.

Unused or expired tablets should be returned to the pharmacist for disposal. Tablets should only be stored on the advice of a doctor. This will help protect the environment.

6. Contents of the pack and other information

What Auricid contains

• Auricid 100 mg tablets contain:
• The active substance is allopurinol.
• The other ingredients are lactose monohydrate, maize starch, povidone, sodium carboxymethylcellulose (type A), maize starch (dried), stearic acid.
• Auricid 300 mg tablets contain:
• The active substance is allopurinol.
• The other ingredients are lactose monohydrate, maize starch, sunset yellow FCF (E 110), povidone, sodium carboxymethylcellulose (type A), maize starch (dried), stearic acid.

What Auricid looks like and contents of the pack

Auricid 100 mg tablets: white or almost white, approximately 7.5 mm in diameter, round, biconvex, uncoated tablets with the inscription “AL” and “100” separated by a score line on one side and smooth on the other.

Auricid 300 mg tablets: peach-colored, approximately 11 mm in diameter, round, biconvex, uncoated tablets with the inscription “AL” and “300” separated by a score line on one side and smooth on the other.

Auricid 100 mg and 300 mg are available in blisters of PVDC/PVC/Aluminum foil in packs of 20, 28, 30, 50, 100 tablets, in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

tel. +48 17 865 51 00

Importer

Bausch Health Poland sp. z o.o.

ul. Kosztowska 21

41-409 Mysłowice

Poland

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

Date of last revision of the leaflet: May 2025