АЛЛОПУРИНОЛО 100 mg Таблетка

Содержание инструкции

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

ALLOPURINOLO DOC Generici 100 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 their symptoms are the same as yours, as it may 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 DOC Generici is and what it is used for
• 2. What you need to know before you take ALLOPURINOLO DOC Generici
• 3. How to take ALLOPURINOLO DOC Generici
• 4. Possible side effects
• 5. How to store ALLOPURINOLO DOC Generici
• 6. Contents of the pack and other information

1. What is ALLOPURINOLO DOC Generici and what it is used for

Allopurinol belongs to a group of medicines called enzyme inhibitors, which work to control the
rate at which special chemical changes occur in the body.
Allopurinol tablets are used for the long-term preventative treatment of gout and can
be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other
types of kidney disorders.
Allopurinol is rarely indicated in children and adolescents except for serious conditions (in
particular in leukemia and certain enzymatic disorders, for example in Lesch-Nyhan syndrome).

2. What you need to know before taking ALLOPURINOLO DOC Generici

Do not take ALLOPURINOLO DOC Generici

• if you are allergic to allopurinol or to any of the other ingredients of this medicine (listed in section 6)
• if you are having an attack of gout or have just had one, as allopurinol may cause further attacks.

ALLOPURINOLO DOC Generici should not be taken by children weighing less than 15 kg.

Warnings and precautions
Talk to your doctor before taking ALLOPURINOLO DOC Generici:

• if you have kidney problems or if you suffer from diseases that can cause kidney damage (e.g. high blood pressure or diabetes mellitus);
• if you have liver problems.

The doctor will want to subject you to regular checks of liver and kidney function and blood tests.
Attacks of gout may occur at the beginning of treatment; in the first weeks of treatment with
ALLOPURINOLO DOC Generici your doctor may therefore prescribe anti-inflammatory drugs or colchicine.
These attacks usually become shorter and less severe after a few months of therapy.
Serious skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash can include ulcers
of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin reactions are often
preceded by flu-like symptoms such as fever, headache, widespread pain. The rash may progress with the
appearance of widespread blisters and exfoliation of the skin. These serious skin reactions may be more
common in people of Chinese Han, Thai or Korean origin. Chronic kidney disease may also increase
the risk in these patients.

If you develop a rash or these skin symptoms, you must stop taking allopurinol and contact
your doctor immediately.
If you experience muscle problems, after taking the medicine, your doctor may
prescribe some blood tests to check that there is no damage to your muscles and assess
subsequently the possible interruption of therapy with ALLOPURINOLO DOC Generici.

Other medicines and ALLOPURINOLO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Tell your doctor before starting to take this medicine if you are taking:

• 6-mercaptopurine (used to treat blood cancer).
• Azathioprine, cyclosporine (used to suppress the immune system). Please note that the side effects of cyclosporine may occur more frequently. The simultaneous administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered together with ALLOPURINOLO DOC Generici, the dose of 6-mercaptopurine or azathioprine must be reduced because their activity will be prolonged. This may increase the risk of serious blood disorders. In this case, the doctor will carefully monitor the blood count during treatment. Contact your doctor immediately if you notice any unexplained bruising, bleeding, fever or sore throat.
• Vidarabine (used to treat herpes). Please note that the side effects of vidarabine may occur more frequently. Pay particular attention if they occur.
• Salicylates (used to reduce pain, fever or inflammation, e.g. acetylsalicylic acid).
• Probenecid (used to treat gout) or other medicines used to facilitate the elimination of uric acid.
• Chlorpropamide (used to treat diabetes). It may be necessary to reduce the dose of chlorpropamide, especially in patients with reduced kidney function.
• Warfarin, phenprocoumon, acenocoumarol (used to thin the blood). The doctor will monitor blood coagulation values more frequently and, if necessary, reduce the dose of these medicines.
• Phenytoin (used to treat epilepsy).
• Theophylline (used to treat asthma and other respiratory diseases). The doctor will measure the levels of theophylline in the blood, especially at the beginning of treatment with allopurinol or after any change in dose.
• Ampicillin or amoxicillin (used to treat bacterial infections). If possible, patients should take other antibiotics, as allergic reactions may occur more frequently.
• With the administration of allopurinol and cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasia occurs more frequently than when these active ingredients are administered alone. The blood count should therefore be monitored at regular intervals.
• Didanosine (used to treat HIV infections).
• ACE inhibitors (used to treat heart problems or high blood pressure). May increase the risk of skin reactions, especially if your kidney function is chronically reduced.
• Thiazide diuretics (used to treat high blood pressure).
• Tolbutamide (used to treat diabetes).
• Aluminium hydroxide. If taken simultaneously, aluminium hydroxide may have a reduced effect on allopurinol. There must be an interval of at least 3 hours between taking the two medicines.

Pregnancy and breastfeeding
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.

Pregnancy
If you are pregnant, take ALLOPURINOLO DOC Generici only if your doctor considers it absolutely
necessary, as there is insufficient evidence that this medicine is not harmful to
pregnancy or your baby.

Breastfeeding
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding.

Driving and using machines
ALLOPURINOLO DOC Generici tablets may cause dizziness, drowsiness and affect coordination
of movements. If you experience these symptoms, DO NOT drive, DO NOT use machinery or take part in hazardous
activities.

ALLOPURINOLO DOC Generici contains lactose
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact
your doctor before taking this medicine.

ALLOPURINOLO DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take ALLOPURINOLO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The doctor will generally start with a low dosage of allopurinol (e.g. 100 mg/day) to reduce the
risk of possible side effects. The dose will be increased if necessary.

Use in adults
The average daily dose is 300 mg per day.
If you have high levels of uric acid in the blood and/or urine, higher doses may be necessary; in
this case your doctor may increase the dose up to a maximum of 800 mg divided into 2-3
administrations per day after meals.
At the beginning of treatment, your doctor may also prescribe an anti-inflammatory drug or colchicine for one month
or more to prevent acute gout attacks.
The dose of allopurinol may be adjusted based on the severity of your condition.
The dose may be modified by the doctor if you have reduced kidney or liver function.
If the daily dose exceeds 300 mg per day and you experience side effects to the stomach or intestines
such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in separate doses to
reduce these effects.

Elderly
The doctor will prescribe the minimum dose necessary to treat your condition.

Use in patients with kidney or liver problems
If you have kidney or liver problems, the dose will be established by the doctor.
If you are undergoing dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400
mg to be taken immediately after dialysis.

Use in children and adolescents (up to 15 years of age and weighing 15 Kg or more)
The usual daily dose is 10-20 mg per kg of body weight (up to a maximum of 400 mg per day)
administered divided into 3 doses.
The dose may be adjusted in case of reduced kidney or liver function, or may be divided
to reduce gastrointestinal side effects, as indicated above for adults.

How to take ALLOPURINOLO DOC Generici
The tablet should be taken preferably at the same time each day, with a glass of water.
In order to reduce side effects to the stomach and intestines, it is recommended to take the tablet
after a meal.
The tablet can be divided into equal parts.
During treatment with this medicine, you should drink plenty of fluids (2-3 liters per day).

If you take more ALLOPURINOLO DOC Generici than you should
In the event that you (or another person) ingest many tablets at the same time or if you fear that a child
has ingested one or more tablets, contact the nearest emergency room or doctor immediately.
An overdose is likely to cause effects such as nausea, vomiting, diarrhea or dizziness.
Bring with you to the hospital or doctor this leaflet, any remaining tablets and the container so
that it is known exactly which tablets have been consumed.

If you forget to take ALLOPURINOLO DOC Generici
If you forget a dose, take it as soon as you remember unless it is almost time for the next dose.
DO NOT take a double dose to make up for the missed tablet. Take the remaining doses
at the correct time.

If you stop taking ALLOPURINOLO DOC Generici
You must continue to take these tablets for the entire time indicated by your doctor. DO NOT stop taking
the medicine without talking to your doctor first.
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.
If you get any of these symptoms, stop taking the tablets and immediately tell your
doctor:
Rare(may affect up to 1 in 1,000 people):

• fever and chills, headache, muscle pain (flu-like symptoms) and a general feeling of being unwell;
• any changes to the skin, for example mouth, throat, nose, genital sores and conjunctivitis (red and swollen eyes), widespread blisters and skin peeling. These may be symptoms of severe skin reactions called “Stevens-Johnson Syndrome” and “toxic epidermal necrolysis” (see section 2 “Warnings and precautions”).

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

• severe hypersensitivity reactions including fever, skin rash, joint pain and changes in blood tests and liver function tests. These may be signs of a multi-organ hypersensitivity disorder (see section 2 “Warnings and precautions”);
• serious allergic reaction potentially fatal (anaphylactic reaction);
• serious allergic reaction causing swelling of the face or throat (angioedema);
• hypersensitivity syndrome or DRESS, angioimmunoblastic lymphadenopathy, swelling of the

lymph nodes. Serious hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely.
The following side effects have been reported with the use of this medicine:

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

• skin rashes;
• increased levels of thyroid stimulating hormone in the blood.

Uncommon(may affect up to 1 in 100 people):

• nausea, vomiting (these side effects decrease when taking the medicine after meals), diarrhoea;
• symptoms of a hypersensitivity reaction;
• increased values in liver function tests.

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

• hepatitis (inflammation of the liver) and/or altered liver function;
• skin reaction that always appears in the same places each time the drug is taken (drug fixed eruption).

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

• boils;
• changes in blood components: decrease in the number of white blood cells, red blood cells and/or platelets in the blood, increase in the number of white blood cells; occasionally Allopurinol tablets can have an effect on the blood and this can manifest as easier bruising, or you may develop 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;
• high levels of fats in the blood;
• diabetes mellitus;
• inability to move muscles (paralysis) or problems with coordination of movements (ataxia), numbness and pain (neuropathy), tingling (paresthesia), drowsiness, headache, altered taste, coma;
• cataract (clouding of the lens of the eye), visual disturbances and macular changes;
• dizziness;
• depression;
• chest pain (angina), slowed heartbeat;
• high blood pressure (hypertension);
• bleeding with vomit, high amount of fat in the stool (steatorrhea), inflammation of the mouth lining (stomatitis), changes in bowel habits (diarrhoea or constipation), bleeding from the stomach or intestines;
• hair loss or discoloration;
• blood in the urine, very high levels of uric acid in the blood due to the kidneys’ inability to eliminate it (uremia);
• male infertility, inability to achieve or maintain an erection, breast enlargement in men;
• feeling generally unwell, fatigue, fever, fluid retention leading to swelling (edema).

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

• Lichenoid eruption (itchy reddish-purple rash and/or whitish-grey fine lines on mucous membranes).
• Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiff neck, headache, nausea, fever or confusion. If this happens, seek medical attention immediately.

In addition, the following have been reported:

• peripheral vascular disorders, thrombophlebitis;
• hyperlipemia;
• tongue edema;
• paralysis;
• paralysis of the lower limbs;
• pain or burning in the stomach, indigestion (dyspepsia), abdominal pain, loss of appetite (anorexia);
• enlarged liver, yellowing of the skin or whites of the eyes (jaundice);
• increased bilirubin in the blood, increased calcium in the blood;
• inflammation of nerves including those of the eyes (neuritis and optic neuritis);
• diseases affecting the muscles (myopathies);
• kidney failure, inflammation of the kidneys (nephritis);
• nosebleeds (epistaxis), bruising, inflammation of blood vessels also associated with the formation of thrombi (blood clots), increased diameter of blood vessels;
• inflammation of the pericardium (a thin membrane surrounding the heart);
• inflammation of the pancreas with bleeding;
• constriction of the bronchial muscles (bronchospasm), inflammation of the bronchi characterized by difficulty breathing (asthma);
• sore throat (pharyngitis), inflammation of the nasal mucosa (rhinitis);
• inflammation of the eye (iritis or conjunctivitis), double vision;
• confusion, dizziness, insomnia, decreased libido;
• ringing in the ears (tinnitus);
• nocturnal urinary incontinence;
• enlargement of the salivary glands.

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 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 DOC Generici

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 package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALLOPURINOLO DOC Generici contains

• The active ingredient is allopurinol. Each tablet contains 100 mg of allopurinol.
• The other ingredients are: lactose monohydrate, corn starch, povidone, sodium starch glycolate (type A), stearic acid (micronized).

Description of the appearance of ALLOPURINOLO DOC Generici and contents of the pack
ALLOPURINOLO DOC Generici is available in divisible tablets.
The tablets are round biconvex, from white to off-white in colour, with the inscriptions “AL” and “100”
separated by a fracture line on one side.
ALLOPURINOLO DOC Generici is available in packs of 50 divisible tablets in PVC/PVDC/Al blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano – Italy.

Manufacturer:
PharmaS d.o.o. - Industrijska cesta 5, Potok - Popovača, 44317 – Croatia.

ALLOPURINOLO DOC Generici Adulti 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 their symptoms are the same as yours, as 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 DOC Generici is and what it is used for
• 2. What you need to know before you take ALLOPURINOLO DOC Generici
• 3. How to take ALLOPURINOLO DOC Generici
• 4. Possible side effects
• 5. How to store ALLOPURINOLO DOC Generici
• 6. Contents of the pack and other information

1. What is ALLOPURINOLO DOC Generici and what is it used for

Allopurinol belongs to a group of medicines called enzyme inhibitors, which work to control the
rate at which special chemical changes occur in the body.
Allopurinol tablets are used for the long-term preventive treatment of gout and can
be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other
types of kidney disorders.
ALLOPURINOLO DOC Generici 300 mg tablets are only indicated for adults.

2. What you need to know before taking ALLOPURINOLO DOC Generici

Do not take ALLOPURINOLO DOC Generici

• if you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6)
• if you are having an attack of gout or have recently had one, as allopurinol may cause further attacks.

ALLOPURINOLO DOC Generici should not be taken by children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor before taking ALLOPURINOLO DOC Generici:

• if you have kidney problems or if you suffer from diseases that can cause kidney damage (e.g. high blood pressure or diabetes mellitus);
• if you have liver problems. Your doctor may want to perform regular checks of your liver and kidney function and blood tests.

Gout attacks may occur at the beginning of treatment; in the first weeks of treatment with
ALLOPURINOLO DOC Generici your doctor may therefore prescribe anti-inflammatory drugs or colchicine.
These attacks usually become shorter and less severe after a few months of therapy.
Serious skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash may include ulcers
of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin reactions are often
preceded by flu-like symptoms such as fever, headache, widespread pain. The rash may progress with the
appearance of widespread blisters and skin peeling. These serious skin reactions may be more
common in people of Chinese Han, Thai or Korean origin. Chronic kidney disease may also increase
the risk in these patients.

If you develop a rash or these skin symptoms, you must stop taking allopurinol and contact
your doctor immediately.
If you experience muscle problems after taking the medicine, your doctor may
prescribe some blood tests to check that there is no damage to your muscles and assess
subsequently the possible interruption of therapy with ALLOPURINOLO DOC Generici.

Other medicines and ALLOPURINOLO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor before starting to take this medicine if you are taking:

• 6-mercaptopurine (used to treat blood cancer).
• Azathioprine, cyclosporine (used to suppress the immune system). Keep in mind that the side effects of cyclosporine may occur more frequently. The simultaneous administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered together with ALLOPURINOLO DOC Generici, the dose of 6-mercaptopurine or azathioprine must be reduced because their activity will be prolonged. This may increase the risk of serious blood disorders. In this case, the doctor will carefully monitor the blood count during treatment. Contact your doctor immediately if you notice any unexplained bruising, bleeding, fever or sore throat.
• Vidarabine (used to treat herpes). Keep in mind that the side effects of vidarabine may occur more frequently. Pay particular attention if they occur.
• Salicylates (used to reduce pain, fever or inflammation, e.g. acetylsalicylic acid).
• Probenecid (used to treat gout) or other medicines used to facilitate the elimination of uric acid.
• Chlorpropamide (used to treat diabetes). It may be necessary to reduce the dose of chlorpropamide, especially in patients with impaired kidney function.
• Warfarin, phenprocoumon, acenocoumarol (used to thin the blood). The doctor will monitor your blood coagulation values more frequently and, if necessary, reduce the dose of these medicines.
• Phenytoin (used to treat epilepsy).
• Theophylline (used to treat asthma and other respiratory diseases). The doctor will measure the levels of theophylline in the blood, especially at the beginning of treatment with allopurinol or after any change in dose.
• Ampicillin or amoxicillin (used to treat bacterial infections). If possible, patients should take other antibiotics, as allergic reactions may occur more frequently.
• With the administration of allopurinol and cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasia occurs more frequently than when these active ingredients are administered alone. Blood counts should therefore be monitored at regular intervals.
• Didanosine (used to treat HIV infections).
• ACE inhibitors (used to treat heart problems or high blood pressure). It may increase the risk of skin reactions, especially if your kidney function is chronically impaired.
• Thiazide diuretics (used to treat high blood pressure).
• Tolbutamide (used to treat diabetes).
• Aluminum hydroxide. If taken simultaneously, aluminum hydroxide may have a reduced effect on allopurinol. There must be an interval of at least 3 hours between taking the two medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, take ALLOPURINOLO DOC Generici only if your doctor considers it absolutely
necessary, as there is insufficient evidence that this medicine is not harmful to
pregnancy or your baby.

Breastfeeding
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding.

Driving and using machines
ALLOPURINOLO DOC Generici tablets may cause dizziness, drowsiness and affect coordination
of movements. If you experience these symptoms, DO NOT drive, DO NOT use machines or engage in hazardous
activities.

ALLOPURINOLO DOC Generici contains lactose
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact
them before taking this medicine.

ALLOPURINOLO DOC Generici contains the colourant sunset yellow FCF (E110)
This medicine contains the colourant sunset yellow FCF (E110) which may cause allergic reactions.

ALLOPURINOLO DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take ALLOPURINOLO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The doctor will generally start with a low dosage of allopurinol (e.g. 100 mg/day) to reduce the
risk of possible side effects. The dose will be increased if necessary.

Adults
The average daily dose is 300 mg per day.
If you have high levels of uric acid in the blood and/or urine, higher doses may be necessary; in
this case the doctor may increase the dose up to a maximum of 800 mg divided into 2-3 administrations
daily after meals.
At the beginning of treatment, the doctor may also prescribe an anti-inflammatory drug or colchicine for one month
or more to prevent acute gout attacks.
The dose of allopurinol may be adjusted according to the severity of your condition.
The dose may be modified by the doctor if you have reduced kidney or liver function.
If the daily dose exceeds 300 mg per day and you experience side effects to the stomach or intestines
such as nausea or vomiting (see section 4), the doctor may prescribe allopurinol in separate doses to
reduce these effects.

Elderly
The doctor will prescribe the minimum dose necessary to treat your condition.

Use in patients with kidney or liver problems
If you have kidney or liver problems, the dose will be established by the doctor.
If you are undergoing dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400
mg to be taken immediately after dialysis.

How to take ALLOPURINOLO DOC Generici
The tablet should be taken preferably at the same time each day, with a glass of water.
In order to reduce side effects to the stomach and intestines, it is recommended to take the tablet
after a meal.
The tablet can be divided into equal parts.
During treatment with this medicine, you should drink plenty of fluids (2-3 liters per day).

If you take more ALLOPURINOLO DOC Generici than you should
If you (or another person) ingest many tablets at the same time or if you fear that a child
has ingested one or more tablets, contact the nearest emergency room or doctor immediately.
An overdose is likely to cause effects such as nausea, vomiting, diarrhea or dizziness.
Bring with you to the hospital or doctor this leaflet, any remaining tablets and the container so
that it is known exactly which tablets have been consumed.

If you forget to take ALLOPURINOLO DOC Generici
If you forget a dose, take it as soon as you remember unless it is almost time for the next dose.
DO NOT take a double dose to compensate for the forgotten tablet. Take the remaining doses
at the correct time.

If you stop taking ALLOPURINOLO DOC Generici
You must continue to take these tablets for the entire time indicated by your doctor. DO NOT stop taking
the medicine without talking to your doctor first.
If you have any questions 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.
If you experience any of these disorders, stop taking the tablets and immediately inform your
doctor:
Rare(may affect up to 1 in 1,000 people):

• fever and chills, headache, muscle aches (flu-like symptoms) and a general feeling of being unwell
• any changes to the skin, for example mouth, throat, nose, genital sores and conjunctivitis (red and swollen eyes), widespread blisters and skin peeling. These may be symptoms of severe skin reactions called “Stevens-Johnson Syndrome” and “toxic epidermal necrolysis” (see section 2 “Warnings and precautions”).

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

• severe hypersensitivity reactions including fever, skin rash, joint pain and changes in blood tests and liver function tests. These may be signs of a multi-organ hypersensitivity disorder (see section 2 “Warnings and precautions”);
• serious allergic reaction potentially fatal (anaphylactic reaction);
• serious allergic reaction causing swelling of the face or throat (angioedema);
• hypersensitivity syndrome or DRESS, angioimmunoblastic lymphadenopathy, swelling of the lymph nodes. Severe hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely.

The following side effects have been reported with the use of this medicine:

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

• skin rashes;
• increased levels of thyroid stimulating hormone in the blood.

Uncommon(may affect up to 1 in 100 people):

• nausea, vomiting (these side effects decrease when taking the medicine after meals), diarrhea;
• symptoms of hypersensitivity reactions;
• increased values in liver function tests.

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

• hepatitis (inflammation of the liver), and/or changes in liver function;
• skin reaction that always appears in the same places each time the drug is administered (drug fixed eruption).

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

• boils;
• changes in blood components: decrease in the number of white blood cells, red blood cells and/or platelets in the blood, increase in the number of white blood cells; occasionally Allopurinol tablets may have an effect on the blood, and this may manifest as easier bruising, or you may develop a sore throat or other signs of infection. These effects generally occur in people with liver or kidney problems. Inform your doctor as soon as possible;
• high levels of fats in the blood;
• diabetes mellitus;
• inability to move muscles (paralysis) or problems with coordination of movements (ataxia), numbness and pain (neuropathy), tingling (paresthesia), drowsiness, headache, altered taste, coma;
• cataract (clouding of the lens), visual disturbances and macular changes;
• dizziness;
• depression;
• chest pain (angina), slowed heartbeat;
• high blood pressure (hypertension);
• vomiting blood, high amount of fat in the stool (steatorrhea), inflammation of the mouth lining (stomatitis), changes in bowel habits (diarrhea or constipation), bleeding from the stomach or intestines;
• hair loss or discoloration;
• blood in the urine, very high levels of uric acid in the blood due to the kidneys' inability to eliminate it (uremia);
• male infertility, inability to achieve or maintain an erection, breast enlargement in men;
• feeling generally unwell, fatigue, fever, fluid retention resulting in swelling (edema).

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

• Lichenoid eruption (itchy reddish-purple rash and/or whitish-grey thread-like lines on mucous membranes)
• Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiff neck, headache, nausea, fever or confusion. If this occurs, seek immediate medical attention.

In addition, the following have been reported:

• peripheral vascular disorders, thrombophlebitis;
• hyperlipemia;
• tongue edema;
• paralysis;
• paralysis of the lower limbs;
• pain or burning in the stomach, indigestion (dyspepsia), abdominal pain, loss of appetite (anorexia);
• liver enlargement, yellowing of the skin or whites of the eyes (jaundice);
• increased bilirubin in the blood, increased calcium in the blood;
• inflammation of the nerves including those of the eyes (neuritis and optic neuritis);
• diseases affecting the muscles (myopathies);
• kidney failure, inflammation of the kidneys (nephritis);
• nosebleeds (epistaxis), bruising, inflammation of blood vessels also associated with blood clot formation (thrombi), increased diameter of blood vessels;
• inflammation of the pericardium (a thin membrane surrounding the heart);
• inflammation of the pancreas with bleeding;
• constriction of the bronchial muscles (bronchospasm), inflammation of the bronchi characterized by difficulty breathing (asthma);
• sore throat (pharyngitis), inflammation of the nasal mucosa (rhinitis);
• eye inflammation (iritis or conjunctivitis), double vision;
• confusion, dizziness, insomnia, decreased libido;
• ringing in the ears (tinnitus);
• nocturnal urinary incontinence;
• enlargement of the salivary glands.

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
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 DOC Generici

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 package and on the blister after “Scad.”. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALLOPURINOLO DOC Generici contains

• The active ingredient is allopurinol. Each tablet contains 300 mg of allopurinol.
• The other ingredients are: lactose monohydrate, corn starch, povidone, sodium starch glycolate (type A), stearic acid (micronized), sunset yellow FCF (E110).

Description of the appearance of ALLOPURINOLO DOC Generici and contents of the pack
ALLOPURINOLO DOC Generici is available in divisible tablets.
The tablets are round biconvex, peach-colored, with the inscriptions “AL” and “300” imprinted, separated by a
break line on one side.
ALLOPURINOLO DOC Generici is available in packs of 30 divisible tablets in PVC/PVDC/Al blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano – Italy.

Manufacturer:
PharmaS d.o.o. - Industrijska cesta 5, Potok - Popovača, 44317 – Croatia.