Package leaflet: Information for the patient

Allurit 150 mg tablets

Allopurinol
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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Allurit is and what it is used for

Allurit contains allopurinol, a substance that acts against gout by reducing the amount of uric acid produced by the body.
Allurit is used for:

treating gout: a condition characterized by the accumulation of uric acid crystals in the joints and surrounding tissues, causing an inflammatory reaction. This inflammation may make the skin around the joint swollen, warm, tender, and painful. You may also experience severe pain when moving the joint;
reducing excess uric acid in the blood. This excess may be due to: kidney problems, certain skin diseases (psoriasis), some tumours, severe physical wasting, increased red blood cells in the blood (polycythaemia), during treatment with diuretics (medicines that increase urine production) or certain anticancer drugs, or during weight-loss diets;
preventing the accumulation of uric acid crystals in tissues and the formation of tissue, joint or bone damage, and kidney stones (renal calculi);
preventing the formation of calcium oxalate stones, when uric acid levels are also elevated;
treating or preventing kidney damage due to uric acid accumulation in the kidneys, in patients with tumours, especially those receiving radiotherapy or anticancer drug therapy;
dissolving uric acid crystals, in combination with other therapies.

2. What you need to know before taking Allurit

Do not use Allurit

if you are allergic to allopurinol or to any of the other ingredients of this medicine (listed in section 6);
if you have had a severe reaction after the first dose;
in children, except those affected by tumors causing high levels of uric acid in the blood;

Warnings and precautions
Talk to your doctor or pharmacist before taking Allurit:

if you have kidney problems;
if you or a family member has haemochromatosis (an inherited disorder characterized by excessive iron accumulation in the body).

Gout attacks may occur at the beginning of treatment; therefore, your doctor may prescribe colchicine or uricosuric agents (medicines used to treat gout).
Your doctor will want to carry out regular checks of liver and kidney function, as well as blood tests.
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 in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache, and generalized body aches. The rash may progress to widespread blisters and skin peeling. These serious skin reactions may be more common in individuals 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 immediately and contact your doctor immediately.
If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking allopurinol, you must not take this medicine again.

Children
This medicine must not be used in children, except in those affected by tumor forms causing high levels of uric acid in the blood.

Other medicines and Allurit
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Allurit may interfere with the action of:

6-mercaptopurine (used to treat certain tumors) and azathioprine (used to prevent organ transplant rejection or to treat autoimmune diseases). Concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered together with Allurit, the dose of 6-mercaptopurine or azathioprine must be reduced, as their activity will be 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. Your doctor will reduce the dose of these medicines;
medicines used to thin the blood (such as warfarin): your doctor will monitor your blood clotting values more frequently;
uricosuric agents, medicines used to reduce uric acid levels in the body;
iron-containing products;
aluminium hydroxide. If aluminium hydroxide is taken at the same time as allopurinol, the effect of allopurinol may be reduced. There should be an interval of at least 3 hours between taking the two medicines;
cytostatic agents. When allopurinol is administered together with cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), blood dyscrasias occur more frequently than when these active substances are administered alone. Therefore, blood counts should be monitored at regular intervals.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Take Allurit during pregnancy only if your doctor considers it absolutely necessary.
Breastfeeding
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding.

Driving and using machines
Allurit may cause drowsiness. If you experience this symptom, do NOT drive or operate machinery or engage in activities requiring special attention.

3. How to take Allurit

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will usually start with a low dose of allopurinol (e.g. 100 mg/day) to reduce the risk of possible adverse effects. The dose may be increased if necessary.
The recommended dose is 2-3 tablets daily, taken before or after meals, or 2 tablets as a single daily dose, according to your doctor's instructions.
During treatment, drink plenty of fluids, sufficient to produce at least 2 litres of urine per day.
If you have any questions 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 everyone gets them.
If you experience any of the following symptoms, stop taking the tablets and inform your
doctor immediately:

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").
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.

The following side effects have been reported with the use of this medicine:
Common (may affect up to 1 in 10 people):
Increased levels of thyroid-stimulating hormone in the blood.
Uncommon (may affect up to 1 in 100 people):
Diarrhoea
Rare (may affect up to 1 in 1,000 people):
Hepatitis (liver inflammation) and/or alteration of liver function
Very rare (may affect up to 1 in 10,000 people):
Swelling of the skin or mucous membranes (angioedema).
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Frequency not known (frequency cannot be estimated from the available data):
Lichenoid eruption (itchy red-purple rash and/or white-grey thread-like 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, muscle pain and general malaise. If this occurs, seek immediate medical attention.

Other possible side effects

nausea, vomiting;
intermittent abdominal pain (occurring and disappearing at short, more or less regular intervals);
blood in the urine;
chills;
changes in white blood cell count;
itching.
pain in one or more joints (arthralgia)
hair loss (alopecia) with or without skin inflammation (dermatitis).

Reporting of side effects
If you get any side effects, including ones 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 Allurit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no 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 Allurit contains
The active substance is allopurinol; one tablet contains 150 mg of allopurinol.
The other components are starch, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silicon dioxide.
Description of the appearance of Allurit and contents of the pack
Allurit is supplied in a box containing 40 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
Teofarma S.r.l.
Viale Certosa 8/A
Pavia