Allopurinol Doc Generici: detailed information

Patient Information Leaflet: Information for the User

ALLOPURINOL DOC Generics 100 mg tablets

Equivalent medicine
Please 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ALLOPURINOL DOC Generics is and what it is used for
What you need to know before taking ALLOPURINOL DOC Generics
How to take ALLOPURINOL DOC Generics
Possible side effects
How to store ALLOPURINOL DOC Generics
Contents of the pack and other information

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

Allopurinol belongs to a group of medicines called enzyme inhibitors, which act by controlling the rate at which specific chemical changes occur in the body.
Allopurinol tablets are used for the long-term preventive treatment of gout and may also be used in other conditions associated with excess uric acid in the body, including kidney stones and other types of kidney disorders.
Allopurinol is rarely indicated in children and adolescents except in severe conditions (particularly in leukaemia and certain enzymatic disorders, such as Lesch-Nyhan syndrome).

2. What you should 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 currently experiencing a gout attack or have recently had one, as allopurinol may trigger further attacks.

ALLOPURINOLO DOC Generici must 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 suffer from diseases that may cause kidney damage (e.g. hypertension or diabetes mellitus);
if you have liver problems.

Your doctor may want to carry out regular checks of your liver and kidney function and blood tests.
Gout attacks may occur at the beginning of treatment; therefore, during the first weeks of treatment with
ALLOPURINOLO DOC Generici, your doctor may prescribe anti-inflammatory medicines or colchicine.
These attacks usually become shorter and less severe after several months of therapy.
Serious skin reactions (drug hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash may include ulcers in 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, and generalized aches. The rash may progress to widespread blistering and skin peeling. These serious skin reactions may be more common in people of Han Chinese, Thai, or Korean descent. 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 blood tests to check for possible muscle damage and may consider stopping treatment 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.
Inform your doctor before starting this medicine if you are taking:

6-mercaptopurine (used to treat blood cancer).
Azathioprine, cyclosporine (used to suppress the immune system). Note that side effects of cyclosporine may occur more frequently. Concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is given together with ALLOPURINOLO DOC Generici, the dose of 6-mercaptopurine or azathioprine must be reduced because their activity is prolonged. This may increase the risk of severe blood disorders. In such cases, your doctor will closely monitor your blood count during treatment. Contact your doctor immediately if you notice any unexplained bruising, bleeding, fever, or sore throat.
Vidarabine (used to treat herpes). Note that side effects of vidarabine may occur more frequently. Pay particular attention if these occur.
Salicylates (used to reduce pain, fever, or inflammation, e.g. acetylsalicylic acid).
Probenecid (used to treat gout) or other medicines used to promote uric acid excretion.
Chlorpropamide (used to treat diabetes). A dose reduction of chlorpropamide may be necessary, especially in patients with reduced kidney function.
Warfarin, phenprocoumon, acenocoumarol (used to thin the blood). Your doctor will monitor your blood clotting values more frequently and may reduce the dose of these medicines if necessary.
Phenytoin (used to treat epilepsy).
Theophylline (used to treat asthma and other respiratory diseases). Your doctor will measure theophylline blood levels, especially at the beginning of allopurinol treatment or after any dose adjustment.
Ampicillin or amoxicillin (used to treat bacterial infections). Where possible, patients should take other antibiotics, as allergic reactions may be more likely.
When allopurinol is administered together with cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are given alone. Therefore, blood count monitoring should be performed at regular intervals.
Didanosine (used to treat HIV infections).
ACE inhibitors (used to treat heart problems or high blood pressure). The risk of skin reactions may increase, especially if your kidney function is chronically reduced.
Thiazide diuretics (used to treat high blood pressure).
Tolbutamide (used to treat diabetes).
Aluminium hydroxide. If aluminium hydroxide is taken concomitantly, allopurinol may have a reduced effect. There should be an interval of at least 3 hours between taking the two medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 harmless during pregnancy or for 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 motor coordination. If you experience these symptoms, DO NOT drive, DO NOT use machinery, and DO NOT engage in hazardous activities.
ALLOPURINOLO DOC Generici contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her 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 exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will usually start you on a low dose of allopurinol (e.g. 100 mg/day) to reduce the
risk of possible side effects. The dose may 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 required; in
this case, your doctor may increase your dose up to a maximum of 800 mg, divided into 2–3
daily doses after meals.
At the beginning of treatment, your doctor may also prescribe an anti-inflammatory drug or colchicine for one month
or longer to prevent acute gout attacks.
The allopurinol dose may be adjusted according to the severity of your condition.
Your doctor may adjust the dose if you have reduced kidney or liver function.
If your daily dose exceeds 300 mg per day and you experience gastrointestinal side effects such as nausea or vomiting (see section 4),
your doctor may prescribe allopurinol in divided doses to reduce these effects.
Elderly patients
Your doctor will prescribe the lowest necessary dose to treat your condition.
Use in patients with kidney or liver problems
If you have kidney or liver problems, your dose will be determined by your doctor.
If you undergo 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 in three divided 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 preferably be taken at the same time each day, with a glass of water.
To reduce gastrointestinal side effects, it is recommended to take the tablet after a meal.
The tablet may be divided into equal parts.
During treatment with this medicine, you should drink plenty of fluids (2–3 litres per day).
If you take more ALLOPURINOLO DOC Generici than you should
If you (or someone else) swallow many tablets at once, or if you suspect that a child has swallowed one or more tablets,
contact the nearest emergency department or your doctor immediately.
Overdose is likely to cause effects such as nausea, vomiting, diarrhoea or dizziness.
Take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that it is clear exactly which tablets have been taken.
If you forget to take ALLOPURINOLO DOC Generici
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose.
DO NOT take a double dose to make up for a 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 length of time prescribed by your doctor. DO NOT stop taking
the medicine without first talking to your doctor.
If you have any doubts about how to use this medicine, consult 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 the following symptoms, stop taking the tablets immediately and inform your doctor without delay:

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

fever and chills, headache, muscle pain (flu-like symptoms), and general feeling of malaise;
any skin changes, for example mouth, throat, nose, genital ulcers, conjunctivitis (red and swollen eyes), widespread blisters and skin peeling. These may be symptoms of serious 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 blood abnormalities or liver function test changes. These may indicate a multi-organ hypersensitivity disorder (see section 2 “Warnings and precautions”);
- potentially life-threatening serious allergic reaction (anaphylactic reaction);
- serious allergic reaction causing swelling of the face or throat (angioedema);
hypersensitivity syndrome or DRESS, angioimmunoblastic lymphadenopathy, swelling of the lymph glands.

Severe hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely with the use of this medicine.

The following side effects have been reported with 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 may decrease if the medicine is taken after meals), diarrhoea;
symptoms of hypersensitivity reaction;
increased liver function test values.

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

hepatitis (liver inflammation) and/or altered liver function;
skin reaction recurring at the same sites each time the drug is administered (fixed drug eruption).

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

boils;
blood abnormalities: decreased number of white blood cells, red blood cells and/or platelets in the blood, increased number of white blood cells; occasionally allopurinol tablets may affect the blood, which may present as increased tendency to bruising, or you may develop 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;
elevated levels of fats in the blood;
diabetes mellitus;
inability to move muscles (paralysis) or problems with coordination of movement (ataxia), numbness and pain (neuropathy), tingling (paraesthesia), drowsiness, headache, altered taste, coma;
cataract (clouding of the lens), visual disturbances and macular changes;
dizziness;
depression;
chest pain (angina), slowed heart rate;
high blood pressure (hypertension);
vomiting blood, high levels of fatty substances in the faeces (steatorrhoea), inflammation of the mouth mucosa (stomatitis), changes in bowel habits (diarrhoea or constipation), bleeding from the stomach or intestine;
hair loss or discolouration;
blood in the urine, very high levels of uric acid in the blood due to the kidneys' inability to eliminate it (uraemia);
male infertility, inability to achieve or maintain erection, breast enlargement in men;
general feeling of malaise, fatigue, fever, fluid retention leading to swelling (oedema).

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

Lichenoid eruption (itchy red-violet skin rash and/or fine white-grey lines on mucous membranes).
Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or confusion. If this occurs, seek immediate medical advice.

In addition, the following have been reported:

peripheral vascular disorders, thrombophlebitis;
hyperlipaemia;
tongue oedema;
paralysis;
paralysis of the lower limbs;
stomach pain or burning, 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);
muscle diseases (myopathies);
kidney failure, kidney inflammation (nephritis);
nosebleeds (epistaxis), bruising, inflammation of blood vessels, sometimes associated with blood clots (thrombi), increased diameter of blood vessels;
inflammation of the pericardium (a thin membrane surrounding the heart);
pancreatitis with bleeding;
bronchial muscle contraction (bronchospasm), bronchial inflammation characterised by breathing difficulty (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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 ALLOPURINOL DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ALLOPURINOLO DOC Generici contains

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

Description of the appearance of ALLOPURINOLO DOC Generici and package contents
ALLOPURINOLO DOC Generici is available as divisible tablets.
The tablets are round, biconvex, white to off-white in colour, marked with the characters "AL" and "100" separated by a break line on one of the two sides.
ALLOPURINOLO DOC Generici is available in packs of 50 divisible tablets in PVC/PVDC/Al blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer:
PharmaS d.o.o. - Industrijska cesta 5, Potok - Popovača, 44317 – Croatia.

Package leaflet: information for the user

ALLOPURINOLO DOC Generici 300 mg tablets Adults

Generic medicinal product
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ALLOPURINOLO DOC Generici is and what it is used for
What you need to know before taking ALLOPURINOLO DOC Generici
How to take ALLOPURINOLO DOC Generici
Possible side effects
How to store ALLOPURINOLO DOC Generici
Contents of the pack and other information

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

Allopurinol belongs to a group of medicines called enzyme inhibitors, which act by controlling the rate at which specific chemical changes occur in the body.
Allopurinol tablets are used for the long-term preventive treatment of gout and may also be used in other conditions associated with excess uric acid in the body, including kidney stones and other types of kidney disorders.
ALLOPURINOLO DOC Generici 300 mg tablets are indicated only in 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 to any of the other ingredients of this medicine (listed in section 6)
if you are currently experiencing a gout attack or have recently had one, as allopurinol may trigger further attacks.

ALLOPURINOLO DOC Generici must 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 suffer from diseases that may cause kidney damage (e.g. hypertension or diabetes mellitus);
if you have liver problems. Your doctor may want to carry out regular checks of your liver and kidney function, as well as blood tests.

Gout attacks may occur at the beginning of treatment; therefore, during the first weeks of treatment with
ALLOPURINOLO DOC Generici, your doctor may prescribe anti-inflammatory drugs or colchicine.
These attacks usually become shorter and less severe after several 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, and generalized body aches. The rash may progress to widespread blistering and skin peeling. These serious skin reactions may be more common in people of Han Chinese, 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 blood tests to check for possible muscle damage and may consider discontinuing treatment 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.
Inform your doctor before starting this medicine if you are taking:

6-mercaptopurine (used to treat blood cancer).
Azathioprine, cyclosporine (used to suppress the immune system). Be aware that side effects of cyclosporine may occur more frequently. Concomitant 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 is prolonged. This may increase the risk of severe blood disorders. In such cases, your doctor will closely monitor your blood counts during treatment. Contact your doctor immediately if you notice any unexplained bruising, bleeding, fever, or sore throat.
Vidarabine (used to treat herpes). Be aware that side effects of vidarabine may occur more frequently. Pay particular attention if these occur.
Salicylates (used to reduce pain, fever, or inflammation, e.g. acetylsalicylic acid).
Probenecid (used for the treatment of gout) or other medicines used to promote uric acid excretion.
Chlorpropamide (used for the treatment of diabetes). A dose reduction of chlorpropamide may be necessary, especially in patients with reduced kidney function.
Warfarin, phenprocoumon, acenocoumarol (used to thin the blood). Your doctor will monitor your blood clotting values more frequently and may reduce the dose of these medicines if necessary.
Phenytoin (used to treat epilepsy).
Theophylline (used to treat asthma and other respiratory diseases). Your doctor will measure theophylline levels in your blood, especially at the beginning of allopurinol treatment or after any dose adjustment.
Ampicillin or amoxicillin (used to treat bacterial infections). Where possible, patients should take alternative antibiotics, as allergic reactions may be more likely.
When allopurinol is administered with cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), blood dyscrasias occur more frequently than when these active substances are given alone. Therefore, regular monitoring of blood counts should be performed.
Didanosine (used to treat HIV infections).
ACE inhibitors (used to treat heart problems or high blood pressure). The risk of skin reactions may increase, especially if you have chronically impaired kidney function.
Thiazide diuretics (used to treat high blood pressure).
Tolbutamide (used to treat diabetes).
Aluminium hydroxide. If aluminium hydroxide is taken at the same time, the effect of allopurinol may be reduced. There should be an interval of at least 3 hours between taking the two medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist 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 harmless during pregnancy or for 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 motor coordination. If you experience these symptoms, DO NOT drive, operate machinery, or engage in hazardous activities.
ALLOPURINOLO DOC Generici contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
ALLOPURINOLO DOC Generici contains the colouring agent sunset yellow FCF (E110)
This medicine contains the colouring agent 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 exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Your doctor will usually start you on a low dose of allopurinol (e.g. 100 mg/day) to reduce the
risk of possible side effects. The dose may 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 required; in
this case, your doctor may increase the dose up to a maximum of 800 mg, divided into 2–3 doses
per day taken after meals.
At the beginning of treatment, your doctor may also prescribe an anti-inflammatory drug or colchicine for one month
or longer to prevent acute gout attacks.
The allopurinol dose may be adjusted according to the severity of your condition.
Your doctor may adjust the dose if you have reduced kidney or liver function.
If your daily dose exceeds 300 mg per day and you experience stomach or intestinal side effects
such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in divided doses to
reduce such effects.
Elderly patients
Your doctor will prescribe the lowest effective dose needed to treat your condition.
Use in patients with kidney or liver problems
If you have kidney or liver problems, your dose will be determined by your doctor.
If you undergo dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg
to be taken immediately after each dialysis session.
How to take ALLOPURINOLO DOC Generici
The tablet should preferably be taken at the same time each day, with a glass of water.
To reduce stomach and intestinal side effects, it is recommended that you take the tablet
after a meal.
The tablet may be divided into equal parts.
During treatment with this medicine, you should drink plenty of fluids (2–3 litres per day).
If you take more ALLOPURINOLO DOC Generici than you should
If you (or someone else) swallow many tablets at the same time, or if you suspect that a child
has ingested one or more tablets, contact the nearest emergency department or your doctor immediately.
An overdose is likely to cause side effects such as nausea, vomiting, diarrhoea or dizziness.
Take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that
it is clear exactly which tablets have been taken.
If you forget to take ALLOPURINOLO DOC Generici
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose.
DO NOT take a double dose to make up for a missed tablet. Take the remaining doses at the correct times.
If you stop taking ALLOPURINOLO DOC Generici
You must continue taking these tablets for the entire duration prescribed by your doctor. DO NOT stop taking
the medicine without first discussing it with your doctor.
If you have any doubts about how to use this medicine, consult 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 the following symptoms, stop taking the tablets and contact your doctor immediately:

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

fever and chills, headache, muscle pain (flu-like symptoms), and general feeling of malaise
any skin changes, for example mouth, throat, nose, genital ulcers, conjunctivitis (red and swollen eyes), widespread blisters and skin peeling. These may be symptoms of serious 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 and liver function tests. These may be signs of a multi-organ hypersensitivity disorder (see section 2 “Warnings and precautions”);
- serious, potentially life-threatening allergic reaction (anaphylactic reaction);
serious allergic reaction causing swelling of the face or throat (angioedema);
hypersensitivity syndrome or DRESS, angioimmunoblastic lymphadenopathy, swelling of the lymph glands. Severe hypersensitivity reactions have been rarely reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

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 may decrease if the medicine is taken after meals), diarrhoea;
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 alteration of liver function;
skin reaction recurring in the same areas each time the drug is administered (fixed drug eruption).

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

boils;
changes in blood components: decreased number of white blood cells, red blood cells, and/or platelets in the blood, increased number of white blood cells; occasionally allopurinol tablets may affect the blood, which may present as increased tendency to bruise, or 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;
elevated levels of fats in the blood;
diabetes mellitus;
inability to move muscles (paralysis) or problems with movement coordination (ataxia), numbness and pain (neuropathy), tingling (paraesthesia), drowsiness, headache, altered taste, coma;
cataract (clouding of the lens), visual disturbances and macular changes;
dizziness;
depression;
chest pain (angina), slow heart rate;
high blood pressure (hypertension);
vomiting blood, high amount of fat in the stools (steatorrhea), inflammation of the mucous membrane of the mouth (stomatitis), changes in bowel habits (diarrhoea or constipation), bleeding from the stomach or intestine;
hair loss or discolouration;
blood in the urine, very high levels of uric acid in the blood due to the kidneys' inability to eliminate it (uraemia);
male infertility, inability to achieve or maintain an erection, breast enlargement in men;
general feeling of malaise, fatigue, fever, fluid retention leading to swelling (oedema).

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

Lichenoid skin eruption (itchy red-purple rash and/or fine white-grey lines on mucous membranes)
Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or confusion. If this occurs, seek immediate medical attention.

In addition, the following have been reported:

peripheral vascular disorders, thrombophlebitis;
hyperlipaemia;
tongue oedema;
paralysis;
paralysis of the lower limbs;
stomach pain or burning, 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);
muscle diseases (myopathies);
kidney failure, inflammation of the kidneys (nephritis);
nosebleeds (epistaxis), bruising, inflammation of blood vessels sometimes associated with blood clots (thrombi), increased diameter of blood vessels;
inflammation of the pericardium (a thin membrane surrounding the heart);
pancreatitis with bleeding;
contraction of bronchial muscles (bronchospasm), inflammation of the bronchi characterized by breathing difficulty (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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 ALLOPURINOL DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ALLOPURINOLO DOC Generici contains

The active substance is allopurinol. Each tablet contains 300 mg of allopurinol.
The other components are: monohydrate lactose, maize starch, povidone, sodium starch glycolate (type A), micronized stearic acid, sunset yellow FCF (E110) coloring agent.

Description of the appearance of ALLOPURINOLO DOC Generici and package contents
ALLOPURINOLO DOC Generici is available as divisible tablets.
The tablets are round, biconvex, peach-colored, with the inscriptions “AL” and “300” printed on one side separated by a score line.
ALLOPURINOLO DOC Generici is available in packs of 30 divisible tablets in PVC/PVDC/Al blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer:
PharmaS d.o.o. - Industrijska cesta 5, Potok - Popovača, 44317 – Croatia.