Allupol

Package leaflet: Information for the patient

ALLUPOL, 100 mg tablets
ALLUPOL, 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 as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

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 package and other information

1. What A is and what it is used for

The active substance in A is allopurinol. Allopurinol belongs to a group of medicines known as enzyme inhibitors. These substances are effective in controlling the rate of certain processes in the body.
A is used long-term to prevent gout and may also be used in other conditions associated with excess uric acid in the body, such as kidney stones and other kidney diseases, as well as in patients receiving treatment for cancer or who have disorders in the function of certain enzymes.

2. Important information before taking medicine A

When not to use medicine A

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

If in doubt, consult a doctor before taking medicine A.
Warnings and precautions
Before starting to take medicine A, discuss 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 drugs known as ACE inhibitors,
• the patient currently has an acute attack of gout,
• if the patient is of Chinese (Han ethnic group), African, or Indian origin,
• the patient has thyroid gland disorders.

Special caution is required during treatment with medicine A:

• If the patient has kidney stones. Kidney stones may shrink and possibly move into the urinary tract.
• Skin rash has been reported during allopurinol treatment. The rash may often involve ulceration of the mouth, throat, nose, genital organs, and conjunctivitis (red, swollen eyes). These severe skin reactions are often preceded by symptoms such as fever, headache, and body aches (flu-like symptoms). The rash may lead to extensive blistering and skin peeling. The above-mentioned severe skin reactions may occur more frequently in patients of Chinese, Thai, or Korean origin. Chronic kidney disease may further increase the risk in these patients. If a rash or other skin symptoms occur, treatment with allopurinol must be discontinued immediately and medical advice must be sought without delay.
• In cancer diseases and in Lesch-Nyhan syndrome, the amount of uric acid in urine may increase. This effect can be minimized by ensuring adequate hydration of the patient to achieve optimal dilution of urine.

Children
Use of this medicine in children is rarely indicated, except in certain cancer diseases (especially leukemia) and certain enzymatic disorders such as Lesch-Nyhan syndrome.
Medicine A and other medicines
It is particularly important to inform the doctor if the patient is taking any of the following medicines. The doctor may need to reduce the dose and/or monitor the patient more closely due to an increased risk of adverse effects when medicine A is taken concomitantly with the following medicines:

• 6-mercaptopurine (used in the treatment of blood cancer)
• azathioprine and cyclosporine (used to suppress immune system function)
  Concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. If 6-mercaptopurine or azathioprine is administered together with medicine A, the dose of 6-mercaptopurine or azathioprine must 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 blood cell counts during treatment. Immediate medical attention should be sought if the patient notices any unexplained bruising, bleeding, fever, or sore throat.
• adenine arabinoside (vidarabine), used in the treatment of 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
• anticonvulsant 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 aluminium hydroxide is taken at the same time, allopurinol may have reduced effectiveness. 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 tests monitoring blood morphology should be performed.
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 the milk of breastfeeding women. Allopurinol is not recommended during breastfeeding.
Driving and operating machinery
Medicine A may cause drowsiness or impaired coordination. If such symptoms occur, the patient should not drive or operate machinery.
Medicine A contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take A

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor.
Method of administration
Medicine A should be taken orally, once daily, after a meal, with a glass of water.
The amount of medicine A that can be taken may vary significantly. The doctor will decide on the
dose of medicine A appropriate for the patient.
Recommended dose
The usual dose ranges from 100 to 300 mg per day. The dose may be increased up to
900 mg per day, depending on the severity of the disease.
Doses higher than 300 mg should be administered in divided doses, not exceeding
300 mg at one time. The doctor usually starts treatment with a low dose of allopurinol
(e.g. 100 mg per day) to reduce the risk of adverse effects. If necessary, the dose
will be increased.
In elderly patients or patients with impaired liver or kidney function, the doctor usually uses a lower dose or recommends longer intervals between doses.
For patients undergoing dialysis two or three times a week, the doctor may recommend
taking the medicine at a dose of 300 or 400 mg per day, administered immediately after dialysis.
Use in children (under 15 years of age)
The usual dose ranges from 100 to 400 mg per day.
Taking more medicine A than recommended
If more medicine A has been taken than recommended, contact a doctor immediately or go to hospital.
Show the doctor the medicine packaging.
Symptoms of overdose may include nausea, vomiting, diarrhoea and dizziness.
Missed dose of medicine A
If a dose has been missed, take the next prescribed 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 a missed dose.
Stopping medicine A
Do not stop taking this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor, nurse or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Hypersensitivity
Not common (may occur in less than 1 in 100 people):
Immediately contact a doctor if the patient experiences any of the following symptoms:

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

Rare (may occur in 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 (these may be symptoms of multi-organ hypersensitivity),
• bleeding of the lips, eyes, mouth, nose or genital organs,
• any skin changes, for example, mouth, throat, nose or genital ulceration and conjunctivitis (red and swollen eyes), widespread blisters or skin peeling.

Very rare (may occur in no more than 1 in 10,000 patients):

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

Frequency unknown (frequency cannot be determined from available data):

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

THE ABOVE SYMPTOMS MAY INDICATE THAT THE PATIENT IS ALLERGIC TO THE MEDICINE
ALLUPOL. IN SUCH CASES, TREATMENT MUST NOT BE CONTINUED, unless otherwise advised by a doctor.
Other adverse reactions
Common (may occur in less than 1 in 10 people):

• skin rash,
• increased blood concentration of thyrotropin hormone.

Not common (occur in less than 1 in 100 people):

• nausea, vomiting,
• abnormal liver function tests,
• diarrhoea.

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

• liver disorders, such as hepatitis.

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

• high fever,
• blood in urine (haematuria),
• high blood cholesterol (hyperlipidaemia),
• general malaise,
• weakness, numbness, instability in legs, feeling of muscle immobility (paralysis) or loss of consciousness,
• headache, dizziness, drowsiness or visual disturbances,
• chest pain, high blood pressure or slow heart rate,
• fluid accumulation leading to swelling, particularly of the ankles,
• abnormal glucose metabolism (diabetes). The doctor may recommend testing the patient's blood sugar level to establish a diagnosis.
• medicine A may occasionally affect the blood, causing bruises more easily than usual. Sore throat or other signs of infection may also occur. These symptoms usually occur in people with impaired liver or kidney function. The doctor should be informed as soon as possible,
• medicine A may cause enlargement of lymph nodes,
• infertility or erectile dysfunction in men,
• breast enlargement in men and women,
• intestinal dysfunction,
• taste disturbances,
• cataract,
• hair loss or discolouration,
• depression,
• lack of muscle coordination (ataxia),
• sensation of tingling or burning of the skin (paraesthesia).

Frequency unknown (frequency cannot be determined from available data):

• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever or altered consciousness. If such symptoms occur, seek immediate medical help.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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.: 22 49-21-301
Fax: 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 to provide more information on the safety of the medicine.

5. How to store A

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package.
The expiry date refers to the last day of the stated month.
A, 100 mg, tablets
Do not store above 25°C.
A, 300 mg, tablets
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures 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: monohydrate lactose, potato starch, Povidone (K-25), magnesium stearate.

What A looks like and contents of the pack
A, 100 mg, tablets
White, round, biconvex tablets with a score line.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not guarantee equal dosing.
The pack contains 50 tablets and a package leaflet.

A, 300 mg, tablets
White, round tablets, 12 mm in diameter, biconvex, with a score line imprinted on one side and the mark "300" imprinted on the other side of the tablet.
The tablet can be divided into equal doses.
The medicine is packaged in aluminium/PVC blisters placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 50 81
Poland

For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]
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