ALLOPURINOLO 100 mg Coated Tablet

Содержание инструкции

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

Allopurinolo Mylan 100 mg tablets, 300 mg tablets

allopurinolo

Generic medicine

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 pass it on to others even if they have the same symptoms as you, as it may 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 Mylan is and what it is used for
• 2. What you need to know before you take Allopurinolo Mylan
• 3. How to take Allopurinolo Mylan
• 4. Possible side effects
• 5. How to store Allopurinolo Mylan 6 Contents of the pack and other information

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

Allopurinolo Mylan contains a medicine called allopurinol. It works by slowing down the
speed of some chemical reactions in the body in order to reduce levels of uric acid in the
blood and urine and to prevent the formation of uric acid crystals.
Allopurinolo Mylan is used in conditions where the body produces too much uric acid.
These may include gout or the presence of kidney stones or some other types of kidney problems or when it needs to receive treatment for cancer. In gout, uric acid forms in the
joints and tendons crystals that can cause inflammation, swelling and pain.

2. What you need to know before taking Allopurinolo Mylan

Do not take Allopurinolo Mylan:

• 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 Mylan if:

• you have problems with your liver or kidneys
• you are having a gout attack
• you are of Chinese Han, Thai or Korean origin
• you have problems with your thyroid.

Take special care with Allopurinolo Mylan:

• 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 peeling of the skin. These severe skin reactions may be more common in people of Chinese Han, Thai or Korean origin. Chronic kidney disease may further increase the risk in these patients. 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.
• If you have kidney stones, these may become smaller and get stuck in the urinary tract, which can cause problems.

Children
Allopurinolo Mylan should not be used in children under 6 years of age because its
safety has not been established.
300 mg tablets are not recommended for use in children because they contain a
coloring agent (aluminum yellow sunset FCF(E110) pigments) that can cause allergic
reactions.

Other medicines and Allopurinolo Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is particularly important to inform your doctor if you are taking any of the medicines
listed below. Your doctor may need to reduce the dose of the medicine and/or monitor it more
carefully due to the increased risk of side effects when allopurinol is
taken at the same time as:

• mercaptopurine (used to treat blood cancers)
• azathioprine, cyclosporine (used to suppress the immune system): the simultaneous administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered together with Allopurinolo Mylan, the dose of 6-mercaptopurine or azathioprine must be reduced because their activity will be prolonged. This can increase the risk of serious blood disorders. In such cases, the doctor will carefully monitor the blood count during treatment.
• Contact your doctor immediately if you notice any unexplained bruising, bleeding, fever or sore throat
• vidarabine (used to treat herpes)
• salicylates (used to reduce pain, fever or inflammation, e.g. salicylic acid).
• probenecid (used to treat gout)
• chlorpropamide (used to treat diabetes)
• warfarin, phenprocoumon, acenocoumarol (used to thin the blood)
• phenytoin (used to treat epilepsy)
• theophylline (used to treat asthma and other respiratory diseases)
• ampicillin or amoxicillin (used to treat bacterial infections)
• cytostatic agents (used to treat aggressive tumors): with the administration of allopurinol and cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasias occur more frequently than when these active ingredients are administered alone. Blood count monitoring should therefore be performed at regular intervals.
• didanosine (used to treat HIV infections)
• diuretics or ACE-inhibitors (medicines used to treat high blood pressure).

If aluminum hydroxide (used to neutralize acid
in the stomach) is taken at the same time, allopurinol may have a reduced effect. There must be an interval of at least
3 hours between taking the two medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine if you are pregnant unless recommended by
your doctor.
Allopurinol is excreted in breast milk. Allopurinol is not recommended during
breastfeeding.

Driving and operating machinery
Allopurinolo Mylancan cause dizziness, drowsiness and affect coordination of
movements. If you experience these symptoms do notdrive, use machinery or take part in
dangerous activities.

Allopurinolo Mylan contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23mg) per tablet, i.e. essentially
‘sodium-free’.

Allopurinolo Mylan 300 mg tablets also contains the coloring agent aluminum yellow sunset
FCF (E110)
This can cause allergic reactions.

3. How to take Allopurinolo Mylan

Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

• The score line is not for breaking the tablet. The tablets must be swallowed with a glass of water. You should always take the tablets after a meal to reduce the risk of side effects such as nausea and vomiting.
• If the daily dose exceeds 300 mg and you suffer from gastrointestinal side effects such as nausea and vomiting (see section 4), your doctor may prescribe divided doses to reduce these effects.
• The dose may be modified by your doctor if you have a reduction in kidney and liver function.
• When starting treatment, your doctor may also prescribe an anti-inflammatory drug or colchicine for one month or more, to prevent attacks of gouty arthritis.
• The doctor will generally start with a low dose of allopurinol (e.g. 100 mg/day) to reduce the risk of possible undesirable effects. The dose will be increased if necessary.

The recommended doses are:

Adults and adolescents aged 15-18 years
Initial dose: 100 mg per day
The dose of allopurinol may be adjusted according to the severity of the condition:

• mild conditions: 100-200 mg per day
• moderately severe conditions: 300-600 mg per day
• severe conditions: 700-900 mg per day.

If you have kidney problems:

• you may be asked to take 100 mg at intervals greater than one day.
• If you are undergoing dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg to be taken immediately after dialysis (this is because allopurinol is removed during dialysis).

Only for Allopurinolo Mylan 100 mg tablets

Children and adolescents between 6 and 15 years of age, weighing at least 15 kg
The recommended dose is 10 - 20 mg/kg of body weight, divided into 3 doses.
The maximum dose is 400 mg.
Do not give this medicine to children under 6 years of age because its safety is not
known.
Allopurinolo Mylan is rarely given to children, except if affected by some types of cancer (e.g.
leukemia) and some other conditions.

If you take more Allopurinolo Mylan than you should
In the event that you (or another person) ingest many tablets at the same time, or if you fear that
a child has ingested one or more tablets, contact immediately the nearest emergency room or the
doctor.
An overdose may likely cause effects such as nausea, vomiting, diarrhea
or dizziness.
Bring with you to the hospital or to the doctor this leaflet, any remaining tablets and the container
so that it is known which tablets have been consumed.

If you forget to take Allopurinolo Mylan
If you forget to take a dose, take it as soon as you remember unless it is almost
time for the next dose. Do nottake a double dose to make up for the missed
tablet. Take the remaining doses at the correct time.

If you stop taking Allopurinolo Mylan
You must continue to take these tablets for as long as indicated by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop taking Allopurinolo Mylan and contact your doctor immediately if you experience any of these side effects:
Rare (may affect up to 1 in 1,000 people)

• any change to the skin, e.g. ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters and peeling of the skin, often preceded by flu-like symptoms such as fever and chills, headache, muscle aches (flu-like symptoms) and a general feeling of being unwell
• severe hypersensitivity reactions with fever, rash, joint pain and abnormalities in blood tests and liver function (these may be signs of a condition known as DRESS).

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

• signs of a severe allergic reaction that can be life-threatening, such as swelling of the face, lips, tongue or throat which can cause difficulty breathing or swallowing, skin blistering or peeling, and sores on the lips and in the mouth, sudden wheezing, agitation or tightness in the chest, itching and collapse. Do not take the tablets again unless your doctor tells you to.
• vomiting blood.

Contact your doctor as soon as possible if you experience any of these side effects
Rare (may affect up to 1 in 1,000 people)

• inflammation of the liver (hepatitis) with symptoms that may include yellowing of the skin and the whites of the eyes, poor appetite, vomiting, abdominal pain, diarrhoea

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

• reduction in certain types of white blood cells in the blood causing frequent infections, such as sore throat or high temperature (fever) or ulcers in the mouth and throat
• reduction in red blood cells or platelets (seen in blood tests) causing symptoms such as paleness, fatigue and bleeding or bruising more easily than normal. These effects usually occur in people with liver or kidney problems.

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

• Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiff neck, headache, nausea, fever or confusion. If this occurs, seek immediate medical attention.

Other possible side effects
Common (may affect up to 1 in 10 people)

• skin rashes
• increased levels in the blood of thyroid-stimulating hormone (TSH) which can be observed with blood tests

Uncommon (may affect up to 1 in 100 people)

• nausea (feeling sick), vomiting and diarrhoea
• symptoms of allergic reactions, including itchy rash
• increased values in liver function tests
• diarrhoea.

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

• may affect the function of the liver or kidneys
• formation of stones in the urinary tract with symptoms that may include blood in the urine and pain in the abdomen, side or groin

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

• joint pain or painful swelling in the groin, armpits or neck
• fever
• blood in the urine
• changes in normal bowel habits or unusually smelly stools
• excess fat in the stools causing diarrhoea
• high levels of fats in the blood
• general feeling of being unwell
• weakness, numbness, unsteadiness on the feet, inability to move muscles (paralysis) or loss of consciousness, tingling
• convulsions or depression
• headache, dizziness, drowsiness or visual disturbances
• chest pain, high blood pressure or slow pulse
• fluid retention resulting in swelling (oedema) particularly in the ankles
• male infertility or inability to achieve or maintain an erection, breast enlargement in men
• changes in taste perception, mouth pain, mouth ulcers and herpes
• cataract (clouding of the lens of the eye) and other eye problems
• pustules (small, soft, red bumps on the skin)
• loss or discoloration of hair
• feeling thirsty, fatigue and weight loss (these may be symptoms of diabetes); your doctor may measure your blood sugar levels to decide if you have diabetes
• muscle pain, joint pain
• swelling of the glands, usually disappears at the end of treatment with allopurinol
• presence of urea in the blood (uremia) which can be observed with blood tests

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

• lichenoid rash (itchy rash of reddish-purple colour and/or white-greyish linear streaks on mucous membranes)

You may occasionally feel nauseous, but this can be avoided by taking allopurinol after meals. Tell your doctor if this problem persists.

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 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 Mylan

Keep out of 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 the month.
This medicine does not require special 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 Mylan contains

• The active ingredient is allopurinol
• Each tablet contains 100 mg of allopurinol
• Each tablet contains 300 mg of allopurinol
• The other ingredients (excipients) are: lactose monohydrate (see section 2 “Allopurinolo Mylan contains lactose”), corn starch, povidone, sodium starch glycolate, aluminum yellow sunset FCF pigment (E110) (see section 2 “Allopurinolo Mylan 300 mg also contains aluminum yellow sunset FCF pigment (E110) and stearic acid.

Description of the appearance of Allopurinolo Mylan and contents of the pack
Allopurinolo Mylan 100 mg tablets are white to off-white, round,
biconvex, uncoated, with “AL” and “100” separated by an incision line on one side and smooth
on the other side.
Allopurinolo Mylan 300 mg tablets are peach-colored, round, biconvex, uncoated, with “AL” and “300” separated by an incision line on one side and smooth on the other side.
Allopurinolo Mylan 100 mg tablets are available in blisters of 20, 50, 60 and 100 tablets.
Allopurinolo Mylan 300 mg tablets are available in blisters of 30, 60 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer:
Mylan S.p.a.
Via Vittor Pisani, 20
20124 Milan

Manufacturer Responsible for batch release
Mylan Kft, Komaron
H-2900, Komarom, Mylan utca.1,
Hungary

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations:
Italy Allopurinolo Mylan
Norway Allopurinol Viatris
Portugal Alopurinol Mylan
Sweden Allopurinol Viatris