Allopurinol Accord

Package leaflet: Information for the patient

Allopurinol Accord 100 mg tablets, 300 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ALLOPURINOLO ACCORD is and what it is used for

ALLOPURINOLO ACCORD contains the active substance allopurinol. This medicine belongs to
a group of medicines called enzyme inhibitors, which regulate the rate at which
certain chemical changes occur in the body.
ALLOPURINOLO ACCORD is used in conditions where the body produces too much uric
acid: such as gout, presence of kidney stones, or certain other types of kidney diseases; cancer and some enzymatic disorders leading to excessive accumulation of uric acid.

2. What you should know before taking ALLOPURINOLO ACCORD

Do not take ALLOPURINOLO ACCORD

• if you are allergic to allopurinol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking ALLOPURINOLO ACCORD

• if you are suffering or have suffered from liver or kidney diseases
• if you are taking medicines (diuretics and/or medicines called ACE inhibitors) for heart conditions or high blood pressure
• if you are experiencing an acute attack of gout
• if you are of Han Chinese, African, or Indian origin
• if you have thyroid problems

Take special care with ALLOPURINOLO ACCORD:

• If you have kidney stones, they may become smaller and could have a low chance of moving and blocking the urinary tract.
• Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Often, skin rash may include mouth, throat, nose, genital or conjunctival ulcers (red and swollen eyes). These serious skin reactions are often preceded by flu-like symptoms such as fever, headache, and widespread body aches. The rash may progress to widespread blistering and skin peeling. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.
• If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To help prevent this, it is important to drink enough fluids to dilute the urine.

Children and adolescents
Use in children is rarely indicated, except in certain types of cancer (especially leukemia) and in certain enzyme disorders such as Lesch-Nyhan syndrome.
Other medicines and ALLOPURINOLO ACCORD
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• medicines used to reduce the immune response (immunosuppressants), e.g. 6-mercaptopurine, azathioprine, and cyclosporine
• adenine arabinoside (vidarabine), used to treat herpes or chickenpox
• other medicines for the treatment of gout, such as probenecid
• acetylsalicylic acid (or related drugs called salicylates)
• chlorpropamide, used to treat diabetes
• medicines that thin the blood (anticoagulants), such as warfarin
• medicines used for seizures (epilepsy), phenytoin
• theophylline, used for respiratory problems
• antibiotics (ampicillin or amoxicillin)
• medicines used to treat cancer
• didanosine, used to treat HIV infection
• medicines for heart problems or high blood pressure such as ACE inhibitors and diuretics
• aluminium hydroxide, as it may reduce the effect of allopurinol. There should be an interval of at least 3 hours between taking both medicines
• cytotoxic medicines (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), as blood dyscrasias occur more frequently when cytotoxic medicines and allopurinol are taken together. Blood monitoring should therefore be performed at regular intervals

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Allopurinol is excreted in human breast milk. Allopurinol is not recommended during breastfeeding.
Driving and using machines
ALLOPURINOLO ACCORD may cause drowsiness or problems with movement coordination. Do not drive or operate machinery until you know how this medicine affects you.
ALLOPURINOLO ACCORD contains lactose
This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ALLOPURINOLO ACCORD

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor.
The amount of ALLOPURINOLO ACCORD that people can take may vary widely. Your doctor will decide the dose of ALLOPURINOLO ACCORD that is right for you.
The usual starting dose ranges between 100 and 300 mg per day, which may be taken as a single dose.
The dose may be increased up to 900 mg per day, depending on the severity of your condition.
If you are taking a daily dose higher than 300 mg, your doctor may ask you to divide the total dose into smaller doses taken at evenly spaced times throughout the day to reduce the risk of gastrointestinal side effects.
If you are elderly or have reduced liver or kidney function, your doctor may prescribe a lower dose or advise you to take it at longer intervals. If you are on 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
Children and adolescents under 15 years of age: the recommended dose is 10 to 20 mg/kg/day body weight, up to a maximum of 400 mg per day in three divided doses. Use in children is rarely indicated, except in cases of malignant diseases (particularly leukaemia) and certain enzymatic disorders such as Lesch-Nyhan syndrome.

Method of administration
ALLOPURINOLO ACCORD is for oral use.
The tablets should be taken with a glass of water to aid swallowing.
You should take the tablets after a meal to reduce the risk of side effects such as nausea (feeling unwell) and vomiting.

If you take more ALLOPURINOLO ACCORD than you should
If you take too many tablets or if someone else takes the medicine by mistake, contact your doctor immediately or go to the nearest hospital straight away. Take the medicine pack with you. Signs of an overdose may include nausea, vomiting, diarrhoea and dizziness.

If you forget to take ALLOPURINOLO ACCORD
If you forget to take 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 the forgotten tablet.

If you stop taking ALLOPURINOLO ACCORD
Do not stop taking ALLOPURINOLO ACCORD unless your doctor tells you to do so.
If you have any doubts about how to use 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.
Hypersensitivity
Uncommon (may affect up to 1 in 100 people)
Contact your doctor immediately if you experience any of the following:

• an allergic reaction of any type such as skin peeling, blisters, or painful lips and mouth
• or very rarely, sudden shortness of breath, palpitations or tightness in the chest; collapse

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

• fever and chills, headache, painful muscles (flu-like symptoms), and general malaise
• severe hypersensitivity reactions involving fever, skin rash, joint pain, blood abnormalities, and liver function tests (these may be signs of a multi-organ sensitivity disorder)
• bleeding in the lips, eyes, mouth, nose, or genitals
• any skin changes, for example; mouth, throat, nose, genital ulcers, and conjunctivitis (red and swollen eyes), widespread blisters or peeling

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

• severe allergic reaction causing swelling of the face or throat
• life-threatening severe allergic reaction

These symptoms may indicate that you are allergic to ALLOPURINOLO ACCORD. Do not take any more tablets unless your doctor tells you to do so.
Other side effects
Common (may affect up to 1 in 10 people)

• skin rash
• increased level of thyroid-stimulating hormone in the blood

Uncommon (may affect up to 1 in 100 people)

• feeling unwell (nausea) or sickness (vomiting)
• abnormal liver function test results

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

• liver problems such as liver inflammation

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

• high temperature
• blood in the urine (haematuria)
• high levels of cholesterol in the blood (hyperlipidaemia)
• general feeling of being unwell or feeling weak
• weakness, numbness, unsteadiness when walking, feeling unable to move muscles (paralysis), or loss of consciousness
• headache, dizziness, drowsiness, or vision disturbances
• chest pain (angina), high blood pressure, or slow pulse rate
• fluid retention leading to swelling (oedema), particularly of the ankles
• abnormal glucose metabolism (diabetes). Your doctor may wish to measure your blood sugar level to determine if this is occurring
• occasionally ALLOPURINOLO ACCORD tablets may affect the blood. Inform your doctor as soon as possible if you notice unusual bruising or if you develop a sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible.
• ALLOPURINOLO ACCORD may affect the lymph nodes
• male infertility, impotence
• breast enlargement in both men and women
• change in normal bowel habits
• change in taste perception
• cataract
• hair loss or discolouration
• depression
• lack of voluntary coordination of muscle movements (ataxia)
• sensation of tingling, itching, pricking, or burning of the skin (paraesthesia)

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ALLOPURINOL ACCORD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the . The expiry date refers to the last day of that month.
Store below 30°C.
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. Pack contents and other information

What ALLOPURINOL ACCORD contains

• The active substance is allopurinol.
• Allopurinol Accord 100 mg: each tablet contains 100 mg of allopurinol.
• Allopurinol Accord 300 mg: each tablet contains 300 mg of allopurinol.
• The other excipients are: monohydrate lactose, crospovidone Type B, maize starch, povidone K30 and magnesium stearate.

Description of the appearance of ALLOPURINOL ACCORD and pack contents
ALLOPURINOL ACCORD 100 mg is white to off-white, round, biconvex, uncoated tablet, with "AW" engraved on one side and smooth on the other side, with a diameter of approximately 8.0 mm.
ALLOPURINOL ACCORD 300 mg is white to off-white, round, biconvex, uncoated tablet with bevelled edges, with "AX" engraved on one side and smooth on the other side, with a diameter of approximately 11.2 mm.
PVC-ALU blisters containing 25, 28, 30, 50, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Accord Healthcare S.L.U.,
World Trade Center, Moll de Barcelona,
s/n, Edifici Est, 6th floor, Barcelona
08039, Spain
Accord Healthcare Limited
Sage house, 319 Pinner road
HA1 4HF Harrow, Middlesex,
United Kingdom
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona,
Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,
96-200 Pabianice
Poland