АЛЛОПУРИНОЛО 100 mg Coated tablet

Содержание инструкции

1. Allopurinolo Accord 100 mg tablets, 300 mg tablets
   1. What is ALLOPURINOLO ACCORD and what it is used for
   2. What you need to know before taking ALLOPURINOLO ACCORD
2. ALLOPURINOL ACCORD may cause drowsiness or problems with coordination.
   1. How to take ALLOPURINOL ACCORD
   2. Possible side effects
   3. How to store ALLOPURINOLO ACCORD
   4. Contents of the pack and other information
3. ALLOPURINOL ACCORD 100 mg is white to off-white in color, round, biconvex, uncoated, with “AW” imprinted on one side and plain on the other side with a diameter of approximately 8.0 mm.

Allopurinolo Accord 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ALLOPURINOLO ACCORD contains the active ingredient allopurinol. This medicine belongs to
a group of medicines called enzyme inhibitors, which control 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 or the presence of kidney stones or some other types of kidney diseases; cancer and some
enzymatic disorders that lead to the accumulation of too much uric acid.

2. What you need to 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

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

Take special care with ALLOPURINOLO ACCORD:

• If you have kidney stones, these may become smaller and may have a low chance of entering 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 the rash may include ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These severe skin reactions are often preceded by symptoms similar to those of the flu such as fever, headache, widespread aches and pains. The rash may progress with the appearance of widespread blisters and exfoliation of the skin. 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 sufficiently to dilute the urine.

Children and adolescents
Use in children is rarely indicated, except in some types of cancer (especially leukemia) and in
some enzymatic disorders such as Lesch-Nyhan syndrome.

Other medicines and ALLOPURINOLO ACCORD
Tell 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 breathing problems
• antibiotics (ampicillin or amoxicillin)
• medicines used for the treatment of cancer
• didanosine, used to treat HIV infection
• medicines for heart problems or high blood pressure such as ACE inhibitors 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 taking cytotoxic drugs and allopurinol at the same time. Blood counts should therefore be monitored at regular intervals

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
Allopurinol is excreted in human breast milk. Allopurinol is not recommended during
breastfeeding.

Driving and using machines

ALLOPURINOL ACCORD may cause drowsiness or problems with coordination.

Do not drive or operate machinery until you know how it affects you.

ALLOPURINOL 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 ALLOPURINOL ACCORD

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor.
The amount of ALLOPURINOL ACCORD that people can take can vary greatly. Your doctor will decide the
dose of ALLOPURINOL ACCORD that is right for you.
The usual starting dose is between 100 and 300 mg per day, which can be taken as a single dose.
The dose may be increased to up to 900 mg per day, depending on the severity of your condition.
If you are taking a daily dose of more than 300 mg, your doctor may ask you to divide the
total dose into smaller doses spaced evenly throughout the day to reduce the risk of side
effects on the gastrointestinal tract.
If you are an elderly person or have reduced liver or kidney function, your doctor may prescribe a
lower dose or take it at longer intervals. If you are undergoing dialysis two or three times a week, your doctor
may prescribe a dose of 300 or 400 mg that should 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 of
body weight up to a maximum of 400 mg per day in three divided doses. Use in children is rarely
indicated, except in conditions of malignant diseases (particularly leukemia) and some enzymatic
disorders such as Lesch-Nyhan syndrome.
Route of administration
ALLOPURINOL ACCORD is for oral use.
The tablets should be taken with a glass of water to facilitate 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 ALLOPURINOL ACCORD than you should
If you take too many tablets or someone else takes the medicine by mistake, inform your
doctor immediately or go immediately to the hospital. Bring the medicine package with you. Signs of an
overdose may include nausea, vomiting, diarrhea and dizziness.

If you forget to take ALLOPURINOL ACCORD
If you forget to take a dose, take it as soon as you remember unless it is almost time for
the next dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking ALLOPURINOL ACCORD
Do not stop taking ALLOPURINOL ACCORD unless your doctor tells you to do so.
If you have any questions about using 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.
manifest.

Hypersensitivity
Uncommon(may affect up to 1 in 100 people)
See your doctor immediately if you experience any of the following problems:

• a reaction of any kind such as skin peeling, blisters or painful lips and mouth
• or very rarely, sudden shortness of breath, fluctuations or tightness in the chest; collapse

Rare(may affect up to 1 in 1000)

• fever and chills, headache, muscle pain (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 changes to the skin, for example; mouth ulcers, throat ulcers, nose ulcers, genital ulcers and conjunctivitis (red and swollen eyes), widespread blisters or peeling.

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

• Severe allergic reaction causing swelling of the face or throat
• A severely life-threatening allergic reaction

These symptoms may indicate that you are allergic to ALLOPURINOL ACCORD. Do not take any further
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 sick (nausea) or being sick (vomiting)
• abnormal liver function test results.

Rare(may affect up to 1 in 1000)

• Liver problems such as liver inflammation.

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

• high temperature
• blood in the urine (hematuria)
• high levels of cholesterol in the blood (hyperlipidemia)
• a general feeling of being unwell or feeling weak
• weakness, numbness, instability on your feet, a feeling of inability to move your 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 (edema) particularly in the ankles
• abnormal glucose metabolism (diabetes). Your doctor may want to measure your blood sugar level to decide if this is happening.
• occasionally ALLOPURINOL ACCORD tablets can affect the blood. Tell your doctor as soon as possible if you notice you bruise more easily than usual 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.
• ALLOPURINOL ACCORD can affect the lymph nodes
• male infertility, impotence
• enlargement of the breasts, in both men and women
• change to normal bowel habits
• change in the perception of taste
• cataract
• loss or discoloration of hair
• depression
• lack of voluntary coordination of muscle movements (ataxia)
• a sensation of tingling, prickling, or burning of the skin (paresthesia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system located 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 ALLOPURINOLO ACCORD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the . The expiry
date refers to the last day of that month.
Store at a temperature below 30°C
Do not dispose of any medicine in waste water 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 ACCORD contains

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

Description of the appearance of ALLOPURINOLO ACCORD and contents of the pack

ALLOPURINOL ACCORD 100 mg is white to off-white in color, round, biconvex, uncoated, with “AW” imprinted on one side and plain on the other side with a diameter of approximately 8.0 mm.

ALLOPURINOL ACCORD 300 mg is white to off-white in color, round, biconvex, uncoated with a beveled edge, with “AX” imprinted on one side and plain on the other side with a diameter of approximately 11.2 mm.
PVC-ALU blister 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