Allospes

Patient Information Leaflet

Allospes, 100 mg, tablets
Allospes, 300 mg, tablets
allopurinol
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with 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 or pharmacist. See section 4.

Table of contents:

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

1. What Allospes is and what it is used for

The active substance in Allospes is allopurinol. Allopurinol belongs to a group of medicines called enzyme inhibitors, which regulate the rate at which certain chemical processes occur in the body.
Allospes is used when too much uric acid is produced in the patient's body, in such medical conditions as: gout, certain kidney diseases and kidney stones, cancer, or disorders involving the activity of specific enzymes leading to excessive accumulation of uric acid in the body.

2. Important information before using Allospes

When not to use Allospes

• If the patient is allergic to allopurinol or to any of the other ingredients of this medicine (listed in section 6).

If in doubt, consult a doctor before taking this medicine.
Warnings and precautions
Before starting treatment with Allospes, discuss this with your doctor or pharmacist if:

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

Special caution is required during treatment with Allospes when:

• The patient has kidney stones. During treatment, kidney stones may shrink and move into the urinary tract, potentially causing blockage.
• Severe skin rashes (including drug hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during allopurinol treatment. Skin rash may often involve ulceration of the mouth, throat, nose, genital organs, and conjunctivitis (red and swollen eyes). These serious skin reactions are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may spread, leading to blistering and peeling of the skin. These severe skin reactions occur more frequently in patients of Chinese (Han ethnic group), Thai, or Korean origin. Chronic kidney disease may further increase the risk in these patients. If a rash or any of the above-mentioned skin symptoms occur, 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. To prevent this, adequate hydration of the patient should be ensured to maintain urine dilution.

Children and adolescents
Use of this medicine in children and adolescents is rarely indicated, except in certain cancer diseases (particularly leukemia) and certain enzymatic disorders such as Lesch-Nyhan syndrome.
Allospes and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take.

• medicines used to suppress the immune system (immunosuppressants), e.g. 6-mercaptopurine, azathioprine, and cyclosporine;
• adenine arabinoside (vidarabine), used in the treatment of herpes or chickenpox;
• other medicines used to treat gout, such as probenecid;
• acetylsalicylic acid (or similar medicines called salicylates);
• chlorpropamide, used in the treatment of 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 in cancer treatment;
• didanosine, used in the treatment of HIV infection;
• medicines used to treat heart disorders or high blood pressure, such as ACE inhibitors or diuretics;
• aluminium hydroxide, as it may reduce the effectiveness of allopurinol. A minimum interval of 3 hours should be maintained between administration of the two medicines;
• when Allospes is taken together with cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), blood count abnormalities occur more frequently than when these active substances are used separately. Therefore, the patient should undergo regular blood monitoring.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding.
Driving and operating machinery
Allospes may cause drowsiness or coordination problems in some patients. Do not drive or operate machinery until the patient knows how this medicine affects them.
Allospes contains lactose
This medicine contains lactose (a type of sugar). 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 use Allospes

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
Allospes can be administered at very different doses. The doctor decides which dose of Allospes is
appropriate for a given patient.
The doctor usually starts treatment with a low dose of allopurinol (e.g. 100 mg/day) to reduce the
risk of adverse effects. If necessary, the dose may be increased.
The initial dose is usually 100 mg to 300 mg per day and may be taken as a single dose after a meal.
Depending on the severity of the disease, the dose may be increased up to 900 mg per day.
If the daily dose exceeds 300 mg, the doctor may recommend dividing the total dose into smaller
doses taken evenly throughout the day to reduce the risk of gastrointestinal adverse effects.
For elderly patients and patients with impaired liver or kidney function, the doctor may prescribe a
lower dose or recommend taking the medicine at longer intervals.
If the patient undergoes dialysis two or three times a week, the doctor may prescribe a dose of 300 mg
or 400 mg to be administered immediately after dialysis.
Use in children and adolescents
In children and adolescents under 15 years of age: 10 to 20 mg/kg body weight per day, up to a
maximum dose of 400 mg per day in three divided doses. Use of this medicine in children is rarely
indicated, except in neoplastic diseases (especially leukemia) and certain enzymatic disorders, such
as Lesch-Nyhan syndrome.
Method of administration
Allospes tablets are for oral use.
The tablets should be taken with a glass of water to facilitate swallowing.
The tablets should be taken after a meal to reduce the risk of adverse effects such as nausea and
vomiting.
If you take more Allospes than prescribed
If you take more Allospes than prescribed or if someone else accidentally takes this medicine,
contact your doctor immediately or go to hospital without delay. Bring the medicine packaging with
you. Symptoms of overdose may include nausea, vomiting, diarrhoea and dizziness.
If you forget to take a dose of Allospes
If you have missed a dose, 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 one.
Stopping Allospes
Do not stop taking Allospes 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.
Hypersensitivity
Not common (may affect up to 1 in 100 people)
The patient should contact a doctor immediately if any of the following occur:

• any of the following reactions, such as skin peeling, sores, or pain in the lips and mouth;
• or very rarely, sudden wheezing, palpitations or chest tightness, fainting.

Rare (may affect up to 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 from the lips, eyes, mouth, nose, or genital organs;
• any skin changes, for example, ulceration of the mouth, throat, nose, or genital organs, and conjunctivitis (red and swollen eyes), widespread blisters or skin peeling.

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

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

These symptoms may mean that the patient is allergic to Allospes. In such cases, do not continue treatment with this medicine unless otherwise advised by a doctor.
Other adverse reactions
Common (may affect up to 1 in 10 people):

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

Not common (affect up to 1 in 100 people):

• nausea or vomiting;
• abnormal liver function test results;
• diarrhoea.

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

• liver function disorders, such as hepatitis.

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

• high body temperature;
• blood in the urine (haematuria);
• high blood cholesterol levels (hyperlipidaemia);
• general malaise or weakness;
• weakness, numbness or unsteadiness, inability to move muscles (paralysis), or loss of consciousness;
• headache, dizziness, drowsiness, or visual disturbances;
• chest pain (angina), high blood pressure, or slow heart rate;
• fluid accumulation leading to swelling, particularly in the ankles;
• impaired glucose metabolism (diabetes). The doctor may recommend checking the patient's blood sugar levels to make a correct diagnosis;
• Allospes tablets may occasionally affect the patient's blood, leading to bruising more easily than usual, or sore throat or other signs of infection. These symptoms usually occur in people with impaired liver or kidney function. Inform the doctor as soon as possible;
• use of Allospes may affect the lymph nodes;
• infertility or erectile dysfunction in men;
• breast enlargement in both men and women;
• intestinal disorders;
• taste disturbances;
• cataract;
• hair loss or discolouration;
• depression;
• lack of muscle coordination (ataxia);
• tingling, itching, or burning sensation of the skin (paraesthesia).

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Allospes

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
carton. The expiry date refers to the last day of the stated month.
Store below 30ºC.
Medicines must 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 Allospes contains
The active substance is allopurinol.
Allospes 100 mg: each tablet contains 100 mg of allopurinol.
Allospes 300 mg: each tablet contains 300 mg of allopurinol.
The other ingredients are: lactose monohydrate, crospovidone type B, maize starch, povidone K 30,
magnesium stearate.

What Allospes looks like and contents of the pack
Allospes 100 mg are white or almost white, round, biconvex, uncoated tablets with the imprint "AW" on one side and smooth on the other side, with a diameter of approximately 8.0 mm.
Allospes 300 mg are white or almost white, round, biconvex with bevelled edges, uncoated tablets with the imprint "AX" on one side and smooth on the other side, with a diameter of approximately 11.2 mm.
PVC/Aluminium blisters containing 25, 28, 30, 50, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
LABORATORI FUNDACIÓ DAU
C/C, 12-14. Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia
32009, Greece

This medicinal product is authorised for sale in the European Economic Area Member States under the following names: