ALLOPURINOLO 100 mg Coated Tablet

Зміст інструкції

1. Allopurinolo Sandoz 100 mg tablets, 300 mg tablets
   1. What is Allopurinolo Sandoz and what is it used for
   2. What you need to know before taking Allopurinolo Sandoz
   3. How to take Allopurinolo Sandoz
   4. Possible side effects
   5. How to store Allopurinolo Sandoz
   6. Contents of the pack and other information

Allopurinolo Sandoz 100 mg tablets, 300 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Allopurinolo Sandoz and what is it used for

Allopurinolo Sandoz 100 mg:
Allopurinolo Sandoz is used to reduce the levels of uric acid in the blood:
in adultswhose uric acid levels are too high and cannot be controlled with diet or who
present with symptoms, in particular the following:

• gout
• kidney damagecaused by uric acid
• dissolution and prevention of stonesof uric acid
• prevention of calcium oxalate stones, when uric acid levels are also high;

in adultsand childrenweighing 15 kg or more whose uric acid levels are too
high and have caused an increase in uric acid excretion through urination, for example due to:

• radiotherapy
• cancer treatment with drugs
• another severe form of cell breakdown;

in childrenweighing 15 kg or more suffering from:

• kidney damagecaused by uric acid during cancer treatment with a high white blood cell count or abnormalities thereof
• certain particular inherited enzymatic deficiency disorders, known as Lesch-Nyhan syndrome and adenine phosphoribosyltransferase deficiency. Allopurinolo Sandoz 300 mg: Allopurinolo Sandoz is used to reduce the levels of uric acid in the blood:

in adultswhose uric acid levels are too high and cannot be controlled with diet or who
present with symptoms, in particular the following:

• gout
• kidney damagecaused by uric acid
• dissolution and prevention of stonesof uric acid
• prevention of calcium oxalate stones, when uric acid levels are also high;

in adultsand childrenweighing 45 kg or more whose uric acid levels are too
high and have caused an increase in uric acid excretion through urination, for example due to:

• radiotherapy
• cancer treatment with drugs
• another severe form of cell breakdown;

in childrenweighing 45 kg or more suffering from:

• kidney damagecaused by uric acid during cancer treatment with a high white blood cell count or abnormalities thereof
• certain particular inherited enzymatic deficiency disorders, known as Lesch-Nyhan syndrome and adenine phosphoribosyltransferase deficiency.

2. What you need to know before taking Allopurinolo Sandoz

Do not take Allopurinolo Sandoz
Allopurinolo Sandoz 100 mg

• if you are allergicto allopurinolor to any of the other ingredients of this medicine (listed in section 6). This medicine is not indicated for children with a body weight less than 15 kg.

Allopurinolo Sandoz 300 mg

• if you are allergicto allopurinolor to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe impairment of renal function, with creatinine clearance less than 20 ml/min. This medicine is not indicated for children with a body weight less than 45 kg.

Warnings and precautions
Talk to your doctor before taking Allopurinolo Sandoz:

• You are of Han Chinese, African or Indian origin
• You have problems with your liver or kidneys. Your doctor may give you the lowest dose or ask you to take it less frequently than every day. They will also monitor you more closely.
• You have heart problems or high blood pressure and are taking diuretics and/or a medicine called ACE inhibitor.
• You are currently having a gout attack
• You have thyroid problems
• Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in patients taking allopurinol. Often the rash may include ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache, body aches (flu-like symptoms). These severe skin rashes may be more common in people of Han Chinese, Thai or Korean origin. Chronic kidney disease may further increase the risk in these patients. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.
• If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid may increase in the urine. To prevent this, make sure you drink enough to dilute your urine. If you have kidney stones, the kidney stones will become smaller and enter the urinary tract.

Children
Use in children is rarely indicated, except for some types of cancer (especially in leukemia) and
in certain enzymatic disorders, for example in Lesch-Nyhan syndrome.

Other medicines and Allopurinolo Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The following medicines can influence (or be influenced by) allopurinol:

• 6-mercaptopurine, a drug used to treat blood cancers in the presence of an excessive count of white blood cells or an abnormality of them
• medicines used to treat aggressive cancers, such as cyclophosphamideor doxorubicinor bleomycinor procarbazineor alkyl halides. Your doctor will frequently check the number of your blood cells.
• azathioprine, cyclosporine, medicines used to suppress the immune system or to treat other disorders. Note: the side effects due to cyclosporine may occur more frequently.
• vidarabine, a medicine used to treat viral diseases. Note: the side effects due to vidarabine may occur more frequently: if this happens, special attention is needed
• didanosine, a medicine used to treat HIV infection
• ampicillin, amoxicillin, medicines used to treat bacterial infections. If possible, patients should receive other antibiotics, because there is a greater likelihood of allergic reactions occurring
• salicylates, drugs used to reduce pain, fever or inflammation, for example acetylsalicylic acid
• probenecid, benzbromarone, medicines used to increase the excretion of uric acid through urination
• chlorpropamide, a drug used to treat diabetes. It may be necessary to reduce the dose of chlorpropamide, especially in patients with reduced renal function
• warfarin, phenprocoumone, acenocoumarol, medicines used to prevent normal blood clotting. Your doctor will check your blood coagulation parameters more frequently and, if necessary, reduce the doses of these medicines
• phenytoin, a medicine used to treat epilepsy or certain painful conditions
• theophylline, a drug used to treat asthma and other respiratory disorders. Your doctor will measure plasma levels of theophylline, especially at the start of treatment with allopurinol or when making any changes to the dose
• captopril, a drug used to treat hypertension and heart disorders.
• Medicines used to treat heart conditions and high blood pressure such as ACE inhibitors or diuretics. This may increase the risk of skin reactions, especially if your kidney function is chronically impaired.
• If taken simultaneously with aluminum hydroxide, allopurinol may have an attenuated effect. There must be an interval of at least 3 hours between taking the two medicines.
• With the administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasia occurs more frequently than when these active ingredients are administered alone. Blood count monitoring should therefore be performed at regular intervals.

Allopurinolo Sandoz with food, beverages and alcohol
Avoid:

• alcohol, especially beer
• foods with a high purine content, such as offal (sweetbreads, kidney, brain, heart and tongue) and meat extract.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Allopurinol is
excreted in breast milk. Allopurinol is not recommended during breastfeeding.

Driving and using machines
You may feel sleepy, dizzy or have problems with coordination. If
this happens, do not drive or use tools or machines.
Side effects such as dizziness, drowsiness and difficulty controlling
movements may occur.

3. How to take Allopurinolo Sandoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Allopurinolo Sandoz 100 mg

Adults

• Initial doseusually: 1 tabletper day. The doctor may adjust the dose based on blood uric acid levels.
• Maximum dose: 9 tabletsper day.

For individual dose adjustments, tablets containing 300 mg of
allopurinol are available.

Children and adolescents under 18 years of age,weighing 15 kg or more

• Usual dose: 10 mg per kilogram of body weight per day, divided into 3 doses.
• Maximum dose: 4 tablets per day.

Patients over 65 years of age
The doctor will prescribe the minimum dose necessary to treat your condition.

Reduced kidney function
Take Allopurinolo Sandoz only under the close supervision of a doctor, who will determine the dose.

• Maximum dose for patients with severe renal failure: 1 tablet per day. However, in case of dialysis, the doctor may prescribe 3-4 tablets immediately after each treatment session.

Reduced liver function
The dose will be determined by the doctor.

Method of administration
Take Allopurinolo Sandoz

• without chewing the tablet(s)
• with plenty of liquid
• after a meal and
• always at the same time of day.

Divide the dose and take it throughout the day in the following cases

• if you need to take more than 3 tablets per day or
• if gastric or intestinal disorders occur as side effects.

Instructions for dividing the tablet
Divide the tablet as shown in this figure:

Duration of treatment
Generally, treatment with allopurinol is necessary for prolonged periods. Take Allopurinolo Sandoz
regularly and for as long as your doctor has prescribed.
Consult your doctor regularly for a check-up.
Allopurinolo Sandoz 300 mg

Adults

• Initial doseusually: 100 mgper day. The doctor may adjust the dose based on blood uric acid levels.
• Maximum dose: 3 tabletsper day.

Children and adolescents under 18 years of age,weighing 45 kg or more

• Usual dose: 10 mg per kilogram of body weight per day, divided into 3 doses.
• Maximum dose: 400 mg of allopurinol per day.

For individual dose adjustments, tablets containing 100 mg of
allopurinol are available.

Patients over 65 years of age
The doctor will prescribe the minimum dose necessary to treat your condition.

Children and adolescents under 18 years of age,weighing less than 45 kg, patients with reduced
kidney or liver function
Due to the high active ingredient content, Allopurinolo Sandoz 300 mg is not indicated in this
patient group, for whom tablets containing 100 mg of allopurinol are available.
After dialysis, the doctor may prescribe 300-400 mg of allopurinol immediately after each treatment
session.

Method of administration
Take Allopurinolo Sandoz

• without chewing the tablet(s)
• with a glass of water
• after a meal and
• always at the same time of day.

Divide the dose and take it throughout the day in the following cases

• if you need to take more than 1 tablet per day or
• if gastric or intestinal disorders occur as side effects.

Instructions for dividing the tablet
Divide the tablet as shown in this figure:

Duration of treatment
Generally, treatment with allopurinol is necessary for prolonged periods. Take Allopurinolo Sandoz
regularly and for as long as your doctor has prescribed.
Consult your doctor regularly for check-ups.

If you take more Allopurinolo Sandoz than you should
Always consult a doctor. Signs of overdose may include nausea, vomiting, diarrhea and
dizziness.

If you forget to take Allopurinolo Sandoz
Take the forgotten dose as soon as you remember. If it is almost time to take the next dose, skip the
forgotten dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Allopurinolo Sandoz
Do not stop treatment without first consulting your doctor: this could compromise the
success of the therapy.
If you have any doubts about the use of this medicine, ask your 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 with this medicine:

Hypersensitivity
If you experience a hypersensitivity (allergic) reaction, stop taking this medicine and consult a
doctor immediately. Symptoms may include:

Uncommon(may affect less than 1 in 100 people)

• Peeling of the skin, blisters or pain to lips and mouth
• Very rarely symptoms may include sudden shortness of breath, palpitations or a feeling of tightness in the chest and collapse

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

• Fever and chills, headache, muscle aches (flu-like symptoms) and a general feeling of being unwell
• Severe hypersensitivity reactions including fever, rash, joint pain and changes in blood and liver function tests (these can be signs of a multi-organ hypersensitivity disorder)
• Bleeding of lips, eyes, mouth, nose or genitals
• any change in the skin, for example mouth, throat, nose, genital ulcers and conjunctivitis (red and swollen eyes), widespread blisters and skin exfoliation

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

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

Do not take any more tablets unless your doctor tells you to.

Other side effects:
Common(may affect up to 1 in 10 people)

• Rash
• Increased levels of thyroid-stimulating hormone in the blood

Uncommon(may affect up to 1 in 100 people)

• Feeling unwell (nausea) or being sick (vomiting)
• Abnormal liver tests

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

• Liver problems such as liver inflammation

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

• Occasionally this medicine can have an effect on the blood, and this may manifest as a greater ease of bruising, or you may experience a sore throat or other signs of infection. These effects generally occur in people with liver or kidney problems. Tell your doctor as soon as possible.
• This medicine can affect the lymph nodes
• High temperature
• Blood in the urine (hematuria)
• High levels of cholesterol in the blood (hyperlipidemia)
• A general feeling of unwellness or weakness
• Weakness, numbness, instability on the feet, inability to move muscles (paralysis) or loss of consciousness
• Headache, dizziness, drowsiness or vision disturbances
• Chest pain (angina), high blood pressure or slow pulse
• Male infertility or erectile dysfunction
• Enlargement of the breasts in men as well as in women
• Changes in normal bowel habits
• Alteration of taste
• Cataract
• Hair loss or discoloration of hair
• Depression
• Lack of voluntary coordination of muscle movements (ataxia)
• A sensation of tingling, prickling, or burning of the skin (paresthesia)
• Fluid retention resulting in swelling (edema) particularly in the ankles
• Abnormal glucose metabolism (diabetes). Your doctor may want to measure your blood sugar level to check if this is happening.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Allopurinolo Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister/container of tablets of
plastic/aluminium and on the carton, after “EXP”. The expiry date refers to the last day of that
month.
The storage of this medicine does not require any particular precautions.
Tablet container
Validity after first opening of the tablet container: 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Allopurinol Sandoz contains
Allopurinol Sandoz 100 mg

• The active ingredientis allopurinol. Each tablet contains 100 mg of allopurinol.
• The other ingredients are: microcrystalline cellulose, powdered cellulose, crospovidone, macrogol 4000, magnesium stearate, povidone K25 and talc.

Allopurinol Sandoz 300 mg

• The active ingredientis allopurinol. Each tablet contains 300 mg of allopurinol.
• The other ingredients are: microcrystalline cellulose, powdered cellulose, crospovidone, macrogol 4000, magnesium stearate, povidone K25 and talc.

Description of the appearance of Allopurinol Sandoz and contents of the pack
Allopurinol Sandoz 100 mg
White tablets, rounded on the upper and lower sides, with a single fracture line. The tablets
can be divided into two equal doses.
The following packs of the medicinal product are available:

• blisters containing 1, 7, 10, 25, 28, 30, 50, 90 and 100 tablets
• containers containing 50, 100, 250, 500 and 1000 tablets.

Allopurinol Sandoz 300 mg
Tablets ranging in colour from white to off-white, oblong, rounded on the upper and lower sides, with a
fracture line on both sides. The tablets can be divided into two equal doses.
The following packs of the medicinal product are available:

• blisters containing 1, 7, 10, 20, 28, 30, 50, 90, 100 and 105 tablets
• containers containing 20, 30, 50, 100, 105, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Spa – Largo U. Boccioni 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke Allee 1, 39179 Barleben, Germany;
Lek SA Ul. Podlipie 16 C, 95010 Strykow, Poland;
Lek Pharmaceuticals d.d Verovskova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d Trimlini 2 D, 9220 Lendava Slovenia

This medicinal product is authorised in the member states of the EEA under the following denominations:
Allopurinol Sandoz 100 mg tablets
Belgium Allopurisand 100 mg tabletten
Finland Apurin
Italy Allopurinolo Sandoz 100 mg compresse
Allopurinol Sandoz 300 mg tablets
Belgium Allopurisand 300 mg tabletten
Finland Apurin
Italy Allopurinolo Sandoz 300 mg compresse