Allupol

Package Leaflet: Information for the Patient

ALLUPOL, 100 mg tablets

ALLUPOL, 300 mg tablets

Allopurinol

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What A is and what it is used for

The active substance of A is allopurinol. Allopurinol belongs to a group of medicines called enzyme inhibitors. These substances are effective in controlling the rate of certain changes in the body.
A is used long-term to prevent gout and may be used in other conditions related to an excess of uric acid in the body, such as kidney stones and other kidney diseases, as well as when the patient is receiving treatment for cancer or has enzyme function disorders.

2. Important information before taking A

When not to take A

• If the patient is allergic (rash, itching, shortness of breath) to A, allopurinol, or any of the other ingredients of this medicine (listed in section 6).

In case of doubts before taking A, consult a doctor.

Warnings and precautions

Before starting to take A, discuss it with your doctor if:

• the patient has or has had liver or kidney function disorders.
• the patient has heart disease or high blood pressure and is taking diuretics and/or ACE inhibitors,
• the patient is currently experiencing an acute gout attack,
• if the patient is of Chinese (Han ethnic group), African, or Indian origin,
• the patient has thyroid function disorders.

Particular caution should be exercised when taking A:

• If the patient has kidney stones. Kidney stones will decrease and may move into the urinary tract.
• During allopurinol treatment, cases of skin rash 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 symptoms such as fever, headache, body aches (flu-like symptoms). The rash can lead to widespread blisters and skin peeling. The above severe skin reactions may occur more frequently in people of Chinese, Thai, or Korean origin. Chronic kidney disease may also increase the risk in these patients. If a rash or other skin symptoms are observed, stop taking allopurinol and contact a doctor immediately.
• In cancer and Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. This effect can be minimized by ensuring proper hydration of the patient to achieve optimal urine dilution.

Children

The use of A in children is rarely indicated, except for certain cancers (especially leukemia) and certain enzyme disorders, such as Lesch-Nyhan syndrome.

A and other medicines

It is especially important to tell your doctor if you are taking any of the following medicines. Your doctor may need to reduce the dose of A and/or monitor you more closely due to the increased risk of side effects when A is taken with the following medicines:

• 6-mercaptopurine (used to treat blood cancer)
• azathioprine and cyclosporine (used to suppress the immune system) Avoid taking 6-mercaptopurine or azathioprine with allopurinol. When 6-mercaptopurine or azathioprine is taken with A, 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 help immediately if you notice any unexplained bruising, bleeding, fever, or sore throat.
• vidarabine (used to treat herpes or chickenpox)
• other medicines used to treat gout, such as probenecid
• aspirin (or similar medicines called salicylates)
• chlorpropamide used to treat diabetes
• medicines used to thin the blood (anticoagulants), such as warfarin
• antiepileptic medicines (medicines used to treat epilepsy), phenytoin,
• theophylline, a medicine used for breathing problems
• antibiotics (ampicillin or amoxicillin)
• medicines used to treat cancer
• didanosine (a medicine used to treat HIV infection)
• medicines used to treat heart disorders or high blood pressure, such as ACE inhibitors or diuretics

If aluminum hydroxide is taken at the same time, allopurinol may have a weaker effect. A gap of at least 3 hours should be maintained between taking both medicines.
Blood disorders occur more frequently when allopurinol is taken with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides) than when these active substances are taken alone.
Therefore, regular blood morphology tests should be performed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. Allopurinol is excreted in the breast milk of nursing mothers. The use of allopurinol is not recommended during breastfeeding.

Driving and using machines

A tablets may cause drowsiness or coordination disorders. If such symptoms occur, do not drive or operate machinery.

A contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take A

This medicine should always be taken as directed by your doctor. In case of doubts, consult a doctor.
Method of administration
A should be taken orally, once a day, after a meal, with a glass of water.
The amount of A that can be taken may vary greatly. The doctor will decide on the dose of A that is suitable for the patient.
Recommended dose
Usual doses range from 100 to 300 mg per day. The dose may be increased to 900 mg per day, depending on the severity of the disease.
Doses greater than 300 mg should be given in divided doses, not exceeding 300 mg at a time. 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.
In elderly patients or patients with liver or kidney function disorders, the doctor usually uses a lower dose or recommends longer intervals between doses.
In the case of patients undergoing dialysis two or three times a week, the doctor may recommend taking the medicine in a dose of 300 or 400 mg per day, which is taken immediately after dialysis.

Use in children (under 15 years of age)

Usual doses range from 100 to 400 mg per day.

Taking a higher dose of A than recommended

In case of taking a higher dose of A than recommended, contact a doctor or go to the hospital immediately. Show the doctor the package with the tablets.
Symptoms of overdose may include nausea, vomiting, diarrhea, and dizziness.

Missing a dose of A

If a dose is missed, take the next scheduled dose as soon as possible.
If it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping treatment with A

Do not stop treatment without consulting a doctor.
In case of any further doubts about the use of this medicine, consult a doctor, nurse, or pharmacist.

4. Possible side effects

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

Hypersensitivity

Uncommon(may affect less than 1 in 100 people):
Immediatelycontact a doctor if the patient experiences any of the following symptoms:

• any reactions, such as skin peeling, ulcers, or irritation of the lips and mouth,
• or very rarely, sudden wheezing, palpitations, or chest tightness; collapse.

Rare(may affect less than 1 in 1,000 people):

• fever and chills, headache, muscle pain (flu-like symptoms), and general malaise,
• severe hypersensitivity reactions with 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 skin peeling.

Very rare(may affect less than 1 in 10,000 people):

• severe allergic reaction causing facial or throat swelling,
• severe, life-threatening allergic reaction.

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

• lichenoid skin rash (itchy reddish-purple rash and/or white thread-like lines on the mucous membranes).

THE ABOVE SYMPTOMS MAY INDICATE THAT THE PATIENT IS ALLERGIC TO ALLUPOL. In such cases, DO NOTcontinue treatment, unless the doctor advises otherwise.

Other side effects

Common(may affect less than 1 in 10 people):

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

Uncommon(may affect less than 1 in 100 people):

• nausea, vomiting
• abnormal liver function test results,
• diarrhea.

Rare(may affect less than 1 in 1,000 people):

• liver disorders, such as hepatitis,

Very rare(may affect less than 1 in 10,000 people):

• high fever,
• blood in the urine (hematuria),
• high cholesterol levels in the blood (hyperlipidemia),
• general malaise,
• weakness, numbness, instability in the legs, feeling of inability to move muscles (paralysis), or loss of consciousness,
• headache, dizziness, drowsiness, or vision disorders,
• chest pain, high blood pressure, or slow heart rate,
• fluid accumulation leading to swelling, especially of the ankles,
• abnormal glucose metabolism (diabetes). The doctor may recommend checking the patient's blood sugar levels to diagnose.
• occasionally, A may affect the blood, making it easier to bruise than usual. It may also cause sore throat or other infection symptoms. These symptoms usually occur in people with liver or kidney function disorders. Tell your doctor as soon as possible,
• taking A may affect lymph node enlargement,
• infertility or erectile dysfunction in men,
• breast enlargement in men and women,
• gastrointestinal disorders,
• taste disorders,
• cataracts,
• hair loss or discoloration,
• depression,
• lack of muscle coordination (ataxia),
• tingling or burning sensation of the skin (paresthesia).

Frequency not known(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 such symptoms occur, seek medical help immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 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, you can help provide more information on the safety of this medicine.

5. How to store A

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.

A, 100 mg, tablets

Do not store above 25°C

A, 300 mg, tablets

No special precautions for storage.
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 A contains

• The active substance is allopurinol.
• The other ingredients are: lactose monohydrate, potato starch, Povidone (K-25), magnesium stearate.

What A looks like and contents of the pack

A, 100 mg, tablets

White, round, flat tablets with a dividing line.
The dividing 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.
The pack contains 50 tablets and an information leaflet.

A, 300 mg, tablets

White, round, 12 mm in diameter, convex tablets with a dividing line embossed on one side and "300" embossed on the other side.
The tablet can be divided into equal doses.
The medicine is packaged in aluminum/PVC blisters placed in a cardboard box.
The box contains 30 tablets and a patient information leaflet.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 (22) 755 50 81
Poland
To obtain more detailed information, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet:

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