Allopurinol Molteni

Package leaflet: Information for the patient

ALLOPURINOL MOLTENI 100 mg tablets, 300 mg tablets

Equivalent medicine
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, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Allopurinol Molteni is and what it is used for
2. What you need to know before taking Allopurinol Molteni
3. How to take Allopurinol Molteni
4. Possible side effects
5. How to store Allopurinol 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 substance allopurinol. Allopurinol belongs to a group of
medicines used in the treatment of gout (antigout agents) and reduces the production of uric acid.
Allopurinolo Molteni is indicated in the following conditions associated with excessive levels of uric acid
in the blood (hyperuricemia):

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

2. What you need to know before taking Allopurinol Molteni

Do not take Allopurinol 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 Allopurinol Molteni.
Take this medicine with caution and inform your doctor if:

• you have liver problems;
• you have kidney problems and are taking medicines that promote urine elimination (thiazide diuretics) (see section “Other medicines and Allopurinol Molteni”);
• you have a bone marrow tumour (multiple myeloma) or severe heart problems (congestive heart failure).

Before starting treatment with Allopurinol Molteni, your doctor may recommend that you modify your diet and increase your fluid intake to reduce blood uric acid levels (uricaemia).
At the beginning of treatment and for several months thereafter, gout attacks may increase. In such cases, 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 litres of urine per day.
Adequate fluid intake is also recommended in serious conditions such as malignancies and Lesch-Nyhan syndrome.
If you have liver problems, your doctor will carefully and periodically monitor liver function.
During the first weeks of treatment, the medicine may cause liver damage, which may manifest as loss of appetite, weight loss, and itching.
If you have kidney problems, especially if you also have high blood pressure (hypertension) or diabetes, your doctor may consider it necessary to reduce or discontinue treatment with Allopurinol Molteni.
Stop taking this medicine immediately and inform your doctor if you develop skin allergic reactions or other symptoms of an allergic reaction. These symptoms may progress to more serious conditions such as:

• skin peeling (exfoliative lesions);
• skin irritation (urticarial-like lesions);
• development 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 frequent during the first weeks of treatment. These serious skin reactions may be more common in individuals of Han Chinese, Thai, or Korean origin. Chronic kidney disease may also increase the risk in these patients;
• in rare cases, death (see section “Possible side effects”).

Allopurinol Molteni may cause reduced bone marrow activity (bone marrow depression), especially when taken together with other medicines that may damage the bone marrow (see section “Other medicines and Allopurinol Molteni”).
Other medicines and Allopurinol Molteni
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription.
This is because Allopurinol Molteni may affect how some medicines work, or because other medicines may affect how Allopurinol Molteni works.
Take this medicine with caution and inform 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 to treat viral diseases: Allopurinol Molteni may increase its toxic effects;
• salicylates, used to reduce pain, fever, or inflammation, and probenecid, used to treat gout: these medicines may reduce the effects of allopurinol;
• chlorpropamide, used to lower blood sugar (glycaemia): Allopurinol Molteni may enhance its effects;
• coumarin anticoagulants (e.g. warfarin), used to make blood less likely to clot: your doctor will prescribe periodic specific blood tests (prothrombin time) because Allopurinol Molteni may enhance their effects;
• phenytoin, used to treat 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 the risk of skin allergic reactions. In such cases, your doctor may prescribe alternative medicines for treating infections;
• cyclophosphamide and other cancer-treatment medicines (cytotoxic agents), because the risk of reduced bone marrow activity (bone marrow depression) is higher;
• cyclosporine, used after transplants, because Allopurinol Molteni may increase its toxicity;
• didanosine, used to treat HIV infection, because its dose may need to be reduced;
• medicines that promote urine elimination (thiazide diuretics), because they may increase the toxic effects of allopurinol. In such cases, your doctor must monitor kidney function and, if necessary, reduce the allopurinol dose.

If aluminium hydroxide is taken at the same time, allopurinol may have a reduced effect. There should be an interval of at least 3 hours between taking the two medicines.
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 administered alone.
Therefore, regular monitoring of blood counts should be performed.
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.
Do not take Allopurinol Molteni if you are pregnant.
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding.
If you are breastfeeding, take this medicine only when strictly necessary and under direct medical supervision, as allopurinol passes into breast milk.
Driving and using machines
This medicine may cause drowsiness. Avoid driving or operating machinery if you experience this symptom.
Allopurinol Molteni 100 mg tablets contain lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Allopurinolo Molteni

Take this medicine exactly as prescribed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
ALLOPURINOLO MOLTENI 100 mg: 2 to 8 tablets per day, according to medical prescription.
ALLOPURINOLO MOLTENI 300 mg: 1-2 tablets per day, according to medical prescription.
Swallow the tablets with a glass of water after a meal.
The usual recommended starting dose is 100 mg per day.
Your doctor may gradually increase the dose by 100 mg each week, depending on your blood
uric acid levels.
The maximum dose is 800 mg per day.
For prevention of kidney problems due to accumulation of uric acid (uric acid nephropathy)
occurring in patients with tumours, your doctor will prescribe treatment with Allopurinolo Molteni 2-3 days
before starting anticancer therapy. Treatment with allopurinol may continue throughout the duration of anticancer therapy.
Use in elderly patients
If you are over 65 years old, your doctor will prescribe the lowest effective dose to achieve normal
uric acid levels in blood and urine.
Use in patients with kidney problems (renal impairment)
If you have kidney problems (renal impairment), your doctor will adjust the dose according to your
kidney function, which will be monitored periodically (see section “Warnings and precautions”).
Use in patients with liver problems (hepatic impairment)
If you have liver problems (hepatic impairment), your doctor may decide to reduce the dose. During the
initial phase of treatment, your liver function will be monitored periodically (see section “Warnings and precautions”).
If you take more Allopurinolo Molteni than you should
If you take too much of this medicine, you may experience nausea, vomiting,
diarrhoea and dizziness.
In case of accidental ingestion/overdose of Allopurinolo Molteni, contact your doctor immediately
or go to the nearest hospital.
If you forget to take Allopurinolo Molteni
If you forget a dose, take the next tablet at your usual time. Do not take a double
dose to make up for the missed dose.
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 side effects, stop taking the tablets and inform your doctor
immediately:

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

The following side effects may occur, more frequently if you have liver or kidney problems.
Common (may affect up to 1 in 10 people)

• skin redness (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 (ecchymoses);
• liver disorders such as yellowing of the skin and whites of the eyes (jaundice), liver enlargement (hepatomegaly), changes in liver function tests (increased alkaline phosphatase, SGOT/SGPT, gamma-glutamyltransferase, 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 (uraemia);
• muscle problems (myopathies).

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

• skin inflammation (folliculitis);
• serious allergic reaction causing swelling of the face or throat (angioedema);
• decreased number of white blood cells (leucopenia, agranulocytosis), red blood cells (aplastic anaemia) and platelets (thrombocytopenia) in the blood, especially if you have kidney or liver problems (renal and/or hepatic impairment);
• lymph node problems (angioimmunoblastic lymphadenopathy), serious potentially life-threatening allergic reaction (anaphylactic reaction, acute anaphylactic shock);
• diabetes (diabetes mellitus), increased blood fats (hyperlipidaemia);
• depression;
• coma, muscle paralysis, loss of coordination of movements (ataxia), nerve disorders (neuropathy, neuritis), tingling sensation (paraesthesia), drowsiness, headache (cephalalgia), taste disturbances;
• vision problems (cataract, macular alterations);
• dizziness;
• chest pain (angina), reduced heart rate (bradycardia);
• increased blood pressure (hypertension);
• presence of blood in vomit, mouth inflammation (stomatitis), presence of fatty substances in faeces (steatorrhoea), changes in bowel habits;
• hair loss (alopecia), discoloured hair;
• presence of blood in urine;
• infertility and sexual problems in men (impotence, dispermia), breast development in men (gynaecomastia). Occasionally Allopurinol tablets may affect the blood, which may manifest as increased tendency to bruising, or you may develop sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems. Inform your doctor as soon as possible.

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

• inflammation of blood vessels (necrotizing vasculitis), facial and tongue swelling due to fluid accumulation (facial oedema, tongue oedema);
• confusion, inability to fall asleep (insomnia);
• eye disorders (iritis, conjunctivitis, amblyopia);
• perception of ringing in the ear (tinnitus);
• heart inflammation (pericarditis);
• circulatory disorders (peripheral vascular disease, vasodilation), formation of blood clots in veins (thrombophlebitis), low blood pressure (hypotension);
• enlargement of the salivary glands, throat inflammation (pharyngitis), pancreas inflammation (haemorrhagic pancreatitis);
• skin swelling due to fluid accumulation (cutaneous oedema), sweating;
• involuntary loss of urine during the night (nocturnal enuresis), kidney problems (nephritis);
• presence of albumin in urine (albuminuria);
• renal colic.

Reporting of side effects
If you experience any side effects, 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 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 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 Molteni contains
Allopurinolo Molteni 100 mg tablets

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

Allopurinolo Molteni 300 mg tablets

• The active substance is allopurinol. Each tablet contains 300 mg of allopurinol.
• The other components are: povidone, carboxymethylamide, microcrystalline cellulose, magnesium stearate.

Description of the appearance of Allopurinolo Molteni and contents of the pack
Allopurinolo Molteni 100 mg tablets
Box containing 50 tablets.
Allopurinolo Molteni 300 mg tablets
Box containing 30 tablets.
Marketing Authorization 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