Auricid

Leaflet attached to the packaging: information for the user

Auricid, 100 mg, tablets

Auricid, 300 mg, tablets

Allopurinol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Auricid and what is it used for
• 2. Important information before taking Auricid
• 3. How to take Auricid
• 4. Possible side effects
• 5. How to store Auricid
• 6. Contents of the packaging and other information

1. What is Auricid and what is it used for

Auricid contains the active substance allopurinol. Its action is based on slowing down the rate of certain chemical reactions in the body to reduce the level of uric acid in the blood and urine.
High levels of uric acid can cause:

• Gout
• Formation of kidney stones or other types of kidney function disorders.

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. The patient may also experience severe pain when moving the joint.
This medicine is used in adults:

• to reduce uric acid levels 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 may be used in children and adolescents under 15 years of age:

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

2. Important information before taking Auricid

When not to take Auricid

Warnings and precautions

Before starting to take Auricid, you should discuss it with your doctor or pharmacist:

Special caution is required when taking Auricid:

• During allopurinol treatment, cases of severe skin rash (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. The rash can often involve ulcers of the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe rashes are often preceded by flu-like symptoms, such as fever, headache, body aches (resembling flu symptoms). The rash can spread, leading to blistering and peeling of the skin. These serious skin reactions can occur more frequently in people of Chinese (Han ethnic group), Thai, or Korean origin. Chronic kidney disease may also increase the risk in these patients. If a rash or the above-mentioned skin symptoms are observed, allopurinol should be discontinued and medical help should be sought immediately.
• If the patient has cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, the patient should drink enough fluids to dilute the urine.
• If the patient has kidney stones, the stones in the kidneys will decrease and may move into the urinary tract.

Children

The use of the medicine in children is rare, except for certain cancers (especially leukemia) and certain enzymatic disorders, such as Lesch-Nyhan syndrome.
Auricid 300 mg tablets contain orange yellow FCF (azo dye) and should not be given to children.

Auricid and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This includes medicines available without a prescription, including herbal medicines. This is because Auricid may affect the way some medicines work. Also, some other medicines may affect the way Auricid works.
You should inform your doctor or pharmacist about taking any of the following medicines:

• aspirin (or related medicines called salicylates)
• theophylline, used in breathing problems
• antiepileptic 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
• medicines used to weaken the immune system (immunosuppressants) such as 6-mercaptopurine, azathioprine, and cyclosporine
• chlorpropamide, a medicine used to treat diabetes
• medicines used to treat heart disorders or high blood pressure, such as ACE inhibitors or diuretics
• medicines used to thin the blood (anticoagulants), such as warfarin
• other medicines used to treat gout, such as probenecid.

You should avoid taking 6-mercaptopurine or azathioprine with allopurinol. When taking 6-mercaptopurine or azathioprine with Auricid, the dose of 6-mercaptopurine or azathioprine should be reduced, as their action will be prolonged. This may increase the risk of serious blood disorders. In this case, the doctor will closely monitor the patient's blood count.
You should seek medical help immediately if you notice any unexplained bruising, bleeding, fever, or sore throat.
If aluminum hydroxideis taken at the same time as Auricid, allopurinol may have a weaker effect. You should wait at least 3 hours between taking both medicines.
In the case of taking allopurinol and cytostatics(such as cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood disorders (dyscrasias) occur more frequently than when these medicines are taken alone.
Therefore, regular monitoring of blood morphology is necessary.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Allopurinol passes into breast milk. It is not recommended to take this medicine during breastfeeding.

Driving and using machines

You may feel drowsy, dizzy, or have problems with coordination. In this case, you should not drive or use tools or machines.

Auricid contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Auricid 300 mg contains orange yellow FCF (E 110)

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

3. How to take Auricid

This medicine should always be taken according to the doctor's recommendations. In case of doubt, consult a doctor or pharmacist.
The dose of Auricid that patients can take may vary greatly. The doctor will decide on the dose of the medicine suitable for the patient.
The tablet should be taken after a meal and swallowed with a glass of water.
The dividing line on the tablet is only for easier breaking of the tablet if the patient has difficulty swallowing it whole.
Recommended doseis from 100 to 900 mg per day. Usually, the patient starts treatment with a small dose, which can be increased if necessary.
The initial dose is usually 100 mg to 300 mg per day and can be taken as a single dose after a meal.
Depending on the severity of the disease, the dose may be increased to 900 mg per day.
Doses greater than 300 mg should be taken in divided doses, not exceeding 300 mg at a time.
In the case of elderly patients and patients with reduced liver or kidney function, the doctor may prescribe a lower dose or recommend taking the medicine at longer intervals. If the patient is dialyzed two or three times a week, the doctor may prescribe a dose of 300 mg or 400 mg, which should be taken immediately after dialysis.
The doctor usually starts treatment with a low dose of allopurinol (e.g., 100 mg per day) to reduce 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.

Taking a higher dose of Auricid than recommended

In case of taking a larger number of tablets than recommended, you should immediately consult a doctor or go to the hospital. You should take the medicine packaging with you. Symptoms of overdose may include nausea, vomiting, diarrhea, and dizziness.

Missing a dose of Auricid

In case of missing a dose, you should take it as soon as you remember. However, if it is close to the time of taking the next dose, you should skip the missed dose.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Auricid

You should not stop treatment without consulting your doctor.
In case of any further doubts about taking this medicine, you should consult a 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 when taking this medicine:

Allergic reactions (hypersensitivity)

You should inform your doctor immediatelyif you experience:
Uncommon(may affect up to 1 in 100 people)
If you experience an allergic reaction, you should stop taking the medicine and seek medical help immediately. Symptoms may include:

• peeling of the skin, boils, or pain in the lips and mouth;
• very rarely, sudden wheezing, palpitations, 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 malaise;
• severe allergic reactions with simultaneous occurrence of fever, skin rash, joint pain, and abnormal blood test results and liver function tests (may be symptoms of multi-organ hypersensitivity);
• bleeding from the lips, eyes, mouth, nose, or genitals;
• any skin changes, such as ulcers of the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes), widespread blisters, or peeling of the skin.

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 recommended, unless your doctor advises you to do so.

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 (nausea) or vomiting;
• abnormal liver function test results;
• diarrhea.

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

• liver disorders, such as hepatitis.

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

• this medicine can occasionally affect the blood, which may manifest as easier bruising than usual or may cause sore throat or other infection symptoms. These symptoms usually occur in people who have liver or kidney problems. You should tell your doctor about this as soon as possible;
• effect on lymph nodes;
• high fever;
• blood in the urine (hematuria);
• high cholesterol levels in the blood (hyperlipidemia);
• general malaise or weakness;
• weakness, numbness, unsteadiness, feeling of inability to move muscles (paralysis), or loss of consciousness;
• headache, dizziness, drowsiness, or vision disturbances;
• chest pain (angina pectoris), high blood pressure, or slow heart rate;
• infertility or erectile dysfunction in men;
• breast enlargement, both in men and women;
• gastrointestinal disorders;
• taste disorders;
• cataract;
• hair loss or discoloration;
• depression;
• lack of coordination (ataxia);
• feeling of tingling, itching, prickling, or burning 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 determine if this is the case.

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 disturbances of consciousness. If such symptoms occur, you should seek medical help immediately;
• lichenoid skin rash (itchy reddish-purple rash and/or thread-like white-gray lines on the mucous membranes)

In case of worsening of any side effects or occurrence of any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Auricid

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Tablets should be stored in the original packaging.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste.
Unused or unnecessary 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 packaging and other information

What Auricid contains

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

What Auricid looks like and contents of the packaging

Auricid 100 mg tablets: white or almost white, about 7.5 mm in diameter, round, biconvex, uncoated tablets with the inscription "AL" and "100" separated by a dividing line on one side and smooth on the other.
Auricid 300 mg tablets: peach-colored, about 11 mm in diameter, round, biconvex, uncoated tablets with the inscription "AL" and "300" separated by a dividing 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