ALLOPURINOLO 100 mg Tabletki

Treść ulotki

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

ALLOPURINOLO MOLTENI 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, as it could be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Allopurinolo Molteni contains the active ingredient allopurinol. Allopurinol belongs to a group of
medicines used in the treatment of gout (antigout agents) and reduces the formation of uric acid.
Allopurinolo Molteni is indicated in the following conditions associated with an excessive presence of uric acid
in the blood (hyperuricemia):

• gout, when uric acid deposits in the form of crystals in the joints and tendons;
• kidney stones or kidney disease caused by uric acid;
• hyperuricemia caused by chronic kidney problems (chronic nephropathy) or by long-term therapy with medicines that promote urine elimination (diuretics).
• in association with other medicines, during the treatment of blood cancers (myeloproliferative diseases).

2. What you need to know before taking Allopurinolo Molteni

Do not take Allopurinolo Molteni

• if you are allergic to allopurinol, or to any of the other ingredients of this medicine (listed in section 6);
• during an acute attack of gout;
• if you are pregnant or suspect you may be pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Allopurinolo Molteni.
Take this medicine with caution and tell your doctor if:

• you suffer from liver disorders;
• you have kidney problems and are taking medicines that promote urine production (thiazide diuretics) (See section “Other medicines and Allopurinolo Molteni”);
• you have a bone marrow tumor (multiple myeloma) or severe heart problems (congestive heart failure).

Before starting treatment with Allopurinolo Molteni, your doctor may suggest that you modify your
diet and drink more fluids to reduce levels of uric acid in the blood (hyperuricemia).
At the beginning of treatment and for several months afterwards, gout attacks may increase. In this
case, your doctor will prescribe appropriate therapy with other medicines used for gout (colchicine and
anti-inflammatory drugs).
During treatment, drink an adequate amount of water to ensure the elimination of at least 2
liters of urine per day.
Adequate fluid intake is also recommended in cases of severe conditions such as malignancies and
Lesch-Nyhan syndrome.
If you have liver problems, your doctor will carefully and periodically monitor its function.
During the first weeks of therapy, the medicine may cause liver damage, which can manifest
with loss of appetite, weight loss and itching.
If you have kidney problems, and especially if you suffer from high blood pressure (hypertension) or diabetes, your doctor may
consider it necessary to reduce or stop treatment with Allopurinolo Molteni.
Stop treatment with this medicine immediately and tell your doctor if you experience allergic skin reactions or other symptoms of an allergic reaction. These symptoms may be followed by
more serious conditions such as:

• skin peeling (hyper-exfoliative lesions);
• skin irritation (urticarial lesions);
• formation of red spots on the skin and bleeding (purpuric lesions);
• inflammation of blood vessels (generalized vasculitis);
• severe liver damage (irreversible hepatotoxicity);
• very serious skin diseases (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) which are more common in the first weeks of treatment. 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;
• in rare cases death (See section “Possible side effects”).

Allopurinolo Molteni may cause a reduction in bone marrow activity (bone marrow depression),
especially if taken together with other medicines that can cause bone marrow damage (See the
section “Other medicines and Allopurinolo Molteni”).

Other medicines and Allopurinolo Molteni
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
This is because Allopurinolo Molteni can affect how some medicines work, or
because other medicines can affect how Allopurinolo Molteni works.
Take this medicine with caution and tell your doctor if you are taking the following medicines:

• 6-mercaptopurine, used for blood cancers and azathioprine, used after organ transplantation: your doctor will need to adjust the dose of these medicines;
• vidarabine, used for the treatment of diseases caused by viruses: Allopurinolo Molteni may increase its toxic effects;
• salicylates, used to reduce pain, fever or inflammation and probenecid, used for the treatment of gout: these medicines may reduce the effects of allopurinol.
• chlorpropamide, used to lower blood sugar (glycemia): Allopurinolo Molteni may increase its effects;
• coumarin anticoagulants (e.g. warfarin), used to thin the blood: your doctor will prescribe specific blood tests (prothrombin time) because Allopurinolo Molteni may increase their effects;
• phenytoin, used for the treatment of epilepsy;
• theophylline, used for asthma and other respiratory diseases: allopurinol increases its effects;
• ampicillin or amoxicillin, used to treat bacterial infections, because they may increase allergic skin reactions. In this case your doctor may prescribe alternative medicines for the treatment of infections;
• cyclophosphamide and other medicines for the treatment of cancer (cytotoxic drugs) because the risk of reduced bone marrow activity (bone marrow depression) is greater;
• cyclosporine, used after transplants, because Allopurinolo Molteni may increase its toxicity;
• didanosine, used for the treatment of infection caused by the human immunodeficiency virus (HIV), because it may be necessary to reduce its dose;
• medicines that promote urine production (thiazide diuretics) because they may increase the toxic effects of allopurinol. In this case the doctor must check the function of your kidneys and, if necessary, reduce the dose of allopurinol.

If aluminum hydroxide is taken simultaneously, allopurinol may have a reduced effect. There should
be an interval of at least 3 hours between taking the two medicines.
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 count monitoring should therefore be performed at regular intervals.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Allopurinolo Molteni if you are pregnant.
Allopurinol is excreted in breast milk. Allopurinolo is not recommended during breastfeeding.
If you are breastfeeding, take this medicine only if absolutely necessary and under the
direct supervision of your doctor, because allopurinol passes into breast milk.

Driving and operating machinery
This medicine can cause drowsiness. Avoid driving vehicles or operating machinery if you experience this
symptom.

Allopurinolo Molteni 100 mg tablets contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance
to certain sugars, contact him/her before taking this medicine.

3. How to take Allopurinolo Molteni

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
ALLOPURINOLO MOLTENI 100 mg: from 2 to 8 tablets a day, as prescribed by your doctor.
ALLOPURINOLO MOLTENI 300 mg: 1-2 tablets a day, as prescribed by your doctor.
Swallow the tablets with a sip of water after a meal.
The usual recommended starting dose is 100 mg per day.
The doctor may increase the dose gradually by 100 mg every week, depending on the level of
uric acid in the blood.
The maximum dose is 800 mg per day.
For the prevention of kidney problems due to uric acid accumulation (uric nephropathies) that occur
if you suffer from cancer, your doctor will prescribe treatment with Allopurinolo Molteni 2-3 days
before starting therapy with anticancer drugs. Treatment with allopurinol may continue for
the entire duration of anticancer (antineoplastic) therapy.

Use in the elderly
If you are over 65 years of age, your doctor will prescribe the minimum dose to achieve normal levels of uric acid in
the blood and urine.

Use in patients with kidney problems (renal insufficiency)
If you suffer from kidney problems (renal insufficiency), your doctor will reduce the dose based on the function of your
kidneys, which will be checked periodically (See section “Warnings and precautions”).

Use in patients with liver problems (hepatic insufficiency)
If you suffer from liver problems (hepatic insufficiency), your doctor may decide to reduce the dose. In the
early stages of treatment, he/she will periodically check the function of your liver (See section
“Warnings and precautions”).

If you take more Allopurinolo Molteni than you should
In case of taking an excessive dose of this medicine, you may experience nausea, vomiting,
diarrhea and dizziness.
In case of accidental ingestion/taking of an excessive dose of Allopurinolo Molteni, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Allopurinolo Molteni
If you forget a dose, take only the next tablet at the usual time. Do not take a double dose
to make up for the missed dose.
If you have any doubts about the use of 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 side effects, stop taking the tablets and inform your doctor immediately:

• fever and chills, headache, muscle pain and general feeling of unwellness;
• any changes to the skin (mouth, throat, nose and genital ulcers, widespread blisters and skin exfoliation) and conjunctivitis (red and swollen eyes);
• severe hypersensitivity reactions including fever, rash, joint pain and changes in blood tests and liver function tests.

The following side effects may occur,more frequently if you suffer from liver or kidney problems.

Common(may affect up to 1 in 10 people)

• skin redness (skin rashes) (See section 2 “Warnings and precautions")
• increased levels of thyroid-stimulating hormone in the blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (including skin reactions associated with exfoliation, fever, lymphadenopathy, arthralgia, eosinophilia, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• vomiting and nausea, which can be avoided by taking this medicine with food, diarrhoea, gastritis, digestive disorders (dyspepsia), abdominal pain.

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

• bruising (ecchymosis);
• liver disorders, such as yellowing of the skin and the whites of the eyes (jaundice), enlargement of the liver (hepatomegaly), changes in liver function tests (increased alkaline phosphatase, SGOT/SGPT, gamma-glutamyl transferase, bilirubin), hepatitis, granulomatous hepatitis, liver necrosis;
• severe skin diseases (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), DRESS syndrome);
• severe kidney problems (renal failure), presence of urea in the blood (uremia);
• muscle problems (myopathies).

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

• skin inflammation (furunculosis);
• serious allergic reaction causing swelling of the face or throat (angioedema);
• decrease in the number of white blood cells (leukopenia, agranulocytosis), red blood cells (aplastic anemia) and platelets (thrombocytopenia) in the blood, especially if you have kidney and liver problems (renal and/or hepatic insufficiency);
• problems with the lymph nodes (angioimmunoblastic lymphadenopathy), serious allergic reaction potentially life-threatening (anaphylactic reaction, acute anaphylactic shock);
• diabetes (diabetes mellitus), increased fats in the blood (hyperlipidemia);
• depression;
• coma, muscle blockage (paralysis), loss of coordination of movements (ataxia), nerve disorders (neuropathy, neuritis), tingling sensation (paresthesia), drowsiness, headache, changes in taste;
• vision disorders (cataract, macular alterations);
• dizziness;
• chest pain (angina), slowed heartbeat (bradycardia);
• increased blood pressure (hypertension);
• blood in vomit, inflammation of the mouth (stomatitis), presence of fatty substances in the stool (steatorrhea), change in bowel habits;
• hair loss (alopecia), discolored hair;
• blood in urine;
• infertility and sexual problems in men (impotence, dyspermia), development of breasts in men (gynecomastia). Occasionally Allopurinolo tablets may have an effect on the blood, and this may manifest as increased ease of 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.

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

• inflammation of blood vessels (necrotizing angiitis), swelling of the face and tongue due to fluid accumulation (facial edema, tongue edema);
• confusion, inability to sleep (insomnia);
• eye disorders (iritis, conjunctivitis, amblyopia);
• perception of ringing inside the ear (tinnitus);
• inflammation of the heart (pericarditis);
• circulatory disorders (peripheral vascular disease, vasodilation), formation of blood clots in the veins (thrombophlebitis), lowering of blood pressure (hypotension);
• enlargement of the glands that produce saliva, inflammation of the throat (pharyngitis), inflammation of the pancreas (hemorrhagic pancreatitis);
• swelling of the skin due to fluid accumulation (cutaneous edema), sweating;
• involuntary loss of urine during the night (nocturnal enuresis), kidney problems (nephritis);
• presence of albumin in the urine (albuminuria);
• kidney stones.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Molteni

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
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
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Allopurinolo Molteni contains
Allopurinolo Molteni 100 mg tablets

• The active ingredient is allopurinol. Each tablet contains 100 mg of allopurinol.
• The other ingredients are: lactose, pregelatinized starch, magnesium stearate, talc.

Allopurinolo Molteni 300 mg tablets

• The active ingredient is allopurinol. Each tablet contains 300 mg of allopurinol.
• The other ingredients are: povidone, carboxymethylamide, microgranular cellulose, magnesium stearate.

Description of the appearance of Allopurinolo Molteni and contents of the pack
Allopurinolo Molteni 100 mg tablets
Pack of 50 tablets.

Allopurinolo Molteni 300 mg tablets
Pack of 30 tablets.

Marketing Authorisation Holder

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. – Strada Statale 67 Fraz. Granatieri –Scandicci (FI)– Italy

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. SpA,
Istituto de Angeli srl–Località Prulli–50066 Reggello (FI)– Italy