Allospes

Leaflet attached to the packaging: patient information

Allospes, 100 mg, tablets

Allospes, 300 mg, tablets

allopurinol

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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 Allospes and what is it used for
• 2. Important information before taking Allospes
• 3. How to take Allospes
• 4. Possible side effects
• 5. How to store Allospes
• 6. Contents of the packaging and other information

1. What is Allospes and what is it used for

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

2. Important information before taking Allospes

When not to take Allospes

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

In case of doubts before taking the medicine, you should consult a doctor.

Warnings and precautions

Before starting to take Allospes, you should discuss it 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 (takes diuretics and/or ACE inhibitors);
• the patient is experiencing an acute gout attack;
• if the patient is of Chinese (Han ethnic group), Thai or Korean origin;
• the patient has thyroid function disorders.

Particular caution should be exercised when taking Allospes if:

• The patient has kidney stones. Kidney stones, during treatment, will decrease in size and may move into the urinary tract and block it.
• During allopurinol treatment, cases of severe skin rashes (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 the formation of blisters and peeling of the skin. These severe skin reactions may 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 immediately and a doctor should be consulted.
• In cancer and Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, the patient should be properly hydrated to dilute the urine.

Children and adolescents

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

Allospes and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• medicines used to weaken the immune system (immunosuppressive) such as 6-mercaptopurine, azathioprine, and cyclosporine;
• vidarabine, used to treat herpes or chickenpox,
• other medicines used to treat gout, such as probenecid;
• acetylsalicylic acid (or similar medicines, called salicylates);
• chlorpropamide, used to treat diabetes;
• medicines used to thin the blood (anticoagulants), such as warfarin;
• antiepileptic drugs (used to treat epilepsy), phenytoin;
• theophylline - a medicine used for breathing problems;
• antibiotics (ampicillin or amoxicillin);
• medicines used to treat cancer;
• didanosine, used to treat HIV infections;
• medicines used to treat heart disorders or high blood pressure, such as ACE inhibitors or diuretics;
• aluminum hydroxide, as it may reduce the effect of allopurinol. You should maintain an interval of at least 3 hours between taking both medicines;
• when taking Allospes with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood disorders occur more frequently than when these active substances are taken separately. Therefore, the patient should undergo regular blood morphology tests.

Pregnancy, breastfeeding, and fertility

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 breast milk. It is not recommended to take allopurinol during breastfeeding.

Driving and using machines

Allospes may cause drowsiness or impaired coordination in some people. You should not drive or operate machinery until you know how the medicine affects you.

Allospes contains lactose

This medicine contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Allospes

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor.
Allospes can be taken by people in very different doses. The doctor decides what dose of Allospes is suitable for the patient.
The doctor usually starts treatment with a small dose of allopurinol (e.g., 100 mg/day) to reduce the risk of side effects. If necessary, the dose will be increased.
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.
If the daily dose of the medicine is more than 300 mg, the doctor may recommend dividing the total dose into smaller doses evenly distributed throughout the day to reduce the risk of gastrointestinal side effects.
In the case of elderly patients and patients with liver or kidney function disorders, the doctor may prescribe a smaller 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 to be taken immediately after dialysis.

Use in children and adolescents

In children and adolescents under 15 years of age: from 10 to 20 mg/kg body weight per day, up to a maximum dose of 400 mg per day in three divided doses. The use of Allospes in children is rarely indicated, except for certain cancers (especially leukemia) and certain enzymatic disorders, such as Lesch-Nyhan syndrome.

Method of administration

Allospes is taken orally.
The tablets should be swallowed with a glass of water to facilitate swallowing.
The tablets should be taken after a meal to reduce the risk of side effects such as nausea and vomiting.

Taking a higher dose of Allospes than recommended

In case of taking a higher dose of Allospes than recommended or accidentally taking this medicine by another person, you should immediately consult a doctor or go to the hospital. You should bring the packaging with the tablets. Symptoms of overdose may include nausea, vomiting, diarrhea, and dizziness.

Missing a dose of Allospes

If a dose is missed, you should take the next prescribed dose as soon as possible.
If it is close to the time of the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose.

Stopping Allospes treatment

You should not stop Allospes treatment without prior consultation with a doctor.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

Hypersensitivity

Uncommon(may affect up to 1 in 100 people)
You should contact your doctor immediatelyif you experience any of the following:

• any of the reactions, such as skin peeling, boils, 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 (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 reaction causing facial or throat swelling;
• severe, potentially life-threatening allergic reaction.

These symptoms may indicate that you are allergic to Allospes. In such cases, you should not continue treatment with this medicine, unless your doctor advises otherwise.

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 or vomiting;
• abnormal liver function test results.
• diarrhea

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 (hematuria);
• high cholesterol levels in the blood (hyperlipidemia);
• general malaise or weakness;
• weakness, numbness, or trembling of the legs, feeling unable to move the muscles (paralysis) or loss of consciousness;
• headache, dizziness, drowsiness, or vision disturbances;
• chest pain (angina pectoris), high blood pressure, or slow heart rate;
• fluid accumulation leading to swelling, especially in the ankles;
• abnormal glucose metabolism (diabetes). Your doctor may recommend checking your blood sugar levels to make a proper diagnosis;
• occasionally, Allospes tablets may affect the patient's blood, making it easier to bruise than usual or causing throat pain or other infection symptoms. These symptoms usually occur in people with liver or kidney function disorders. You should tell your doctor as soon as possible;
• the use of Allospes may affect the lymph nodes;
• infertility or erectile dysfunction in men;
• breast enlargement in men and women;
• gastrointestinal disorders;
• taste disturbances;
• cataracts;
• hair loss or discoloration;
• depression;
• lack of coordination (ataxia);
• tingling or itching and burning 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, you should seek medical help immediately.

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 of 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
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 Allospes

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Allospes contains

The active substance of Allospes 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, cornstarch, 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 inscription "AW" on one side and smooth on the other, with a diameter of approximately 8.0 mm.
Allospes, 300 mg are white or almost white, round, biconvex with beveled edges, uncoated tablets with the inscription "AX" on one side and smooth on the other, with a diameter of approximately 11.2 mm.
PVC/Aluminum blister pack containing 25, 28, 30, 50, 60, 90, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: October 2024