ALLOPURINOLO 100 mg Coated Tablet

Зміст інструкції

1. Allopurinolo Teva Italia 100 mg tablets, 300 mg tablets
   1. What is Allopurinolo Teva Italia and what it is used for
   2. What you need to know before taking Allopurinolo Teva Italia
   3. How to take Allopurinolo Teva Italia
   4. Possible side effects
   5. How to store Allopurinolo Teva Italia
   6. Package Contents and Other Information

Allopurinolo Teva Italia 100 mg tablets, 300 mg tablets

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, 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 Teva Italia is and what it is used for
• 2. What you need to know before you take Allopurinolo Teva Italia
• 3. How to take Allopurinolo Teva Italia
• 4. Possible side effects
• 5. How to store Allopurinolo Teva Italia
• 6. Contents of the pack and other information

1. What is Allopurinolo Teva Italia and what it is used for

• Allopurinolo Teva Italia belongs to a group of medicines called enzyme inhibitors, which work to control the rate at which specific chemical changes occur in the body.
• Allopurinolo Teva Italia tablets are used for the long-term preventative treatment of gout and can be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other types of kidney disorders.

2. What you need to know before taking Allopurinolo Teva Italia

Do not take Allopurinolo Teva Italia:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Allopurinolo Teva Italia if:

• you have liver or kidney problems. Your doctor may prescribe a lower dose or ask you to take it at intervals greater than one day. They will also monitor you more closely.
• you have heart problems or high blood pressure and if you are taking diuretics and/or a medicine called ACE inhibitor.
• you are currently having a gout attack.
• you are of Chinese Han, Thai or Korean origin.
• you have thyroid problems.

Serious skin reactions have been reported with the use of allopurinol, which may be more common in
patients with chronic kidney damage. These severe skin rashes can include hypersensitivity syndrome, Stevens-Johnson syndrome and toxic epidermal necrolysis. All 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 (defined as flu-like symptoms). The rash may progress with the appearance of widespread blisters and shedding of the skin.
These serious skin reactions may be more common in people of Chinese Han, Thai or
Korean origin. Chronic kidney disease may also 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 kidney stones, they will become smaller and there may be a small chance that
they enter and block your urinary tract.
If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid may increase in the urine. To
prevent this, you need to make sure you drink enough to dilute your urine.

Other medicines and Allopurinolo Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines:
Tell your doctor or pharmacist if you are taking any of the following:

• 6-mercaptopurine (used to treat blood cancers).
• azathioprine, cyclosporine (used to suppress the immune system). Be aware that the side effects of cyclosporine may occur more frequently.
• vidarabine (used to treat herpes). Be aware that the side effects of vidarabine may occur more frequently. Pay particular attention if they occur.
• salicylates (used to reduce pain, fever or inflammation, e.g. acetylsalicylic acid).
• probenecid (used to treat gout).
• chlorpropamide (used to treat diabetes). It may be necessary to reduce the dose of chlorpropamide, especially in patients with impaired kidney function.
• warfarin, phenprocoumon, acenocoumarol (used to thin the blood). Your doctor will monitor your blood clotting values more frequently and, if necessary, reduce the dose of these medicines.
• phenytoin (used to treat epilepsy).
• theophylline (used to treat asthma and other respiratory diseases). Your doctor will measure the levels of theophylline in your blood, particularly at the start of treatment with allopurinol or after any change in dose.
• ampicillin or amoxicillin (used to treat bacterial infections). If possible, patients should take other antibiotics, as allergic reactions may be more likely to occur.
• cytostatic agents (used to treat aggressive cancers) With the administration of allopurinol and cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood dyscrasia occurs more frequently than when these active ingredients are administered alone. Blood counts should therefore be monitored at regular intervals.
• didanosine (used to treat HIV infections).
• ACE inhibitors or diuretics (medicines to increase the elimination of water through the urine) (used to treat heart problems or high blood pressure). This may increase the risk of skin reactions, especially if your kidney function is chronically impaired.
• aluminium hydroxide (used to neutralize acid in the stomach). If taken at the same time as aluminium hydroxide, 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.
Do not take this medicine if you are pregnant unless your doctor has told you to.
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding with
breast milk.

Driving and using machines
Allopurinolo Teva Italia tablets can cause dizziness, drowsiness and affect coordination of
movements. If you experience these symptoms, DO NOT drive, DO NOT use machines or participate in hazardous
activities.

Allopurinolo Teva Italia contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

Allopurinolo Teva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take Allopurinolo Teva Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The tablets should be taken preferably with a glass of water. Take the tablets
after a meal. During treatment with this medicine, you should drink plenty of fluids (2-3 litres per
day). The recommended dose is:

Adults (including the elderly)
Initial dose: 100 - 300 mg per day.
At the beginning of treatment, your doctor may also prescribe an anti-inflammatory drug or colchicine, for one
month or more, to prevent attacks of gouty arthritis.
The dose of allopurinol may be adjusted according to the severity of your condition. The maintenance dose is:

• mild conditions: 100-200 mg per day
• moderately severe conditions: 300-600 mg per day
• severe conditions: 700-900 mg per day. The dose may be modified by your doctor if you have reduced kidney or liver function, especially if you are an elderly person. If the daily dose exceeds 300 mg per day and you experience gastrointestinal side effects such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in divided doses to reduce these effects.

If you have severe kidney problems

• you may be asked to take less than 100 mg per day
• or 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.

Use in children (under 15 years of age)

• 100 - 400 mg per day administered in 3 separate doses. Use in children is rarely indicated, except in some types of cancer, especially leukemia, and in some enzymatic disorders, such as Lesch-Nyhan syndrome.

The score line is only to facilitate breaking the tablet in case you have difficulty
swallowing it whole.

If you take more Allopurinolo Teva Italia than you should
If you (or another person) swallow many tablets at once, or if you fear that a
child has swallowed one or more tablets, contact the nearest emergency room or
doctor immediately.
An overdose may likely cause effects such as nausea, vomiting, diarrhea or
dizziness.
Bring with you to the hospital or doctor this leaflet, any remaining tablets and the container in
order that it is known exactly which tablets have been consumed.

If you forget to take Allopurinolo Teva Italia
If you forget 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 the forgotten tablet. Take the
remaining doses at the correct time.

If you stop taking Allopurinolo Teva Italia
You must continue to take these tablets for as long as your doctor has indicated. DO NOT stop
taking the medicine without talking to your doctor first.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effects

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

If you experience any of these disorders, stop taking the medicine and/or immediately inform your doctor:

• an unexpected skin reaction (possibly associated with fever, swollen glands, joint pain, blisters or unusual bleeding, kidney problems or a sudden onset of convulsions)
• skin rashes are the most common side effects of allopurinol (can affect up to 1 in 10 people)

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

• fever and chills, headache, muscle pain (flu-like symptoms) and a general feeling of unwellness
• any changes to the skin, for example, ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters and skin peeling
• bleeding from lips, eyes, mouth, nose and genitals
• severe hypersensitivity reactions including fever, skin rash, joint pain and changes in blood and liver function tests (these can be signs of a multi-organ hypersensitivity disorder).

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

• serious allergic reaction causing swelling of the face or throat
• serious allergic reaction potentially fatal

If you have an allergic reaction, stop taking allopurinol and seek immediate medical attention. Symptoms may include:

• skin rash, skin flaking, pustules or irritation to the lips or mouth
• swelling of the face, hands, lips, tongue or throat
• difficulty swallowing or breathing
• very rare signs are, among others, wheezing, agitation or tightness in the chest and collapse. Do not take any more tablets unless directed by your doctor.

If any of the following effects occur during treatment with Allopurinol
Teva Italia, inform your doctor as soon as possible:
The following side effects have been reported as common(may affect up to 1 in 10 people):

• increased levels of thyroid-stimulating hormone in the blood

The following side effects have been reported as uncommon(may affect up to 1 in 100 people):

• stomach pain, nausea, vomiting (very rarely with blood) and diarrhoea
• symptoms of an allergic reaction including itchy rashes
• increased results in liver function tests

The following side effects have been reported as rare(may affect up to 1 in 1,000 people):

• joint pain or painful swelling of the groin, armpits or neck
• inflammation of the liver (hepatitis), jaundice (yellowing of the skin and the whites of the eyes)
• liver or kidney function may be affected
• formation of stones in the urinary tract, symptoms include blood in the urine and pain in the abdomen, side or groin

The following side effects have been reported as very rare(may affect up to 1 in

• 10,000):
• high temperature
• blood in the urine
• change in bowel habits or unusually smelly stools
• high levels of fats in the blood
• feeling generally unwell
• weakness, numbness, instability on your feet, inability to move muscles (paralysis) or loss of consciousness
• lack of voluntary coordination of muscle movements (ataxia)
• tingling (paresthesia)
• convulsions or depression
• headache, dizziness, drowsiness or vision disturbances
• chest pain, high blood pressure or slow pulse
• fluid retention leading to swelling (edema) particularly in the ankles
• male infertility or inability to achieve or maintain an erection, or nocturnal emissions ("wet dreams")
• enlargement of the breasts, in men as well as women
• changes in taste perception, inflammation of the mouth
• 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 symptoms may be related to diabetes); your doctor may measure your blood sugar levels to determine if you have diabetes
• muscle pain
• swollen glands, usually disappears at the end of treatment with allopurinol
• occasionally allopurinol can have an effect on the blood, and this can manifest as easier bruising, or you may develop a sore throat or other signs of infection. These effects generally occur in people with liver or kidney problems. Inform your doctor as soon as possible.

You may occasionally feel nauseous, but this can be avoided by taking
allopurinol after meals. Inform 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 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 Teva Italia

Transparent aluminum blisters
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 package and on the blister after
Exp. The expiry date refers to the last day of the month.
This medicine does not require any particular 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.

HDPE bottles
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 package and on the bottle after
Exp. The expiry date refers to the last day of the month.
Store Allopurinolo Teva Italia in the original packaging.
Keep the bottle tightly closed to protect it from light.
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. Package Contents and Other Information

What Allopurinolo Teva Italia contains:

• The active ingredient is allopurinol. Each 100 mg tablet contains 100 mg of allopurinol. Each 300 mg tablet contains 300 mg of allopurinol.
• The other ingredients are lactose monohydrate, anhydrous colloidal silica, corn starch, powdered cellulose, sodium carboxymethylcellulose (type A), sodium lauryl sulfate, povidone K30 and magnesium stearate (E470b).

Description of the appearance of Allopurinolo Teva Italia and package contents:

• Allopurinolo Teva Italia 100 mg tablets are round, biconvex, white tablets, with “4K1 4K1” imprinted on one side and a notch on both sides.
• Allopurinolo Teva Italia 300 mg tablets are round, biconvex, white tablets, with “2K1 2K1” imprinted on one side and a notch on the other side.

The product is available in transparent aluminum blisters in the following formats:
Allopurinolo Teva Italia 100 mg tablets: packs of 20, 25, 28, 30, 50, 60, 90, 98, 100, 105 and 500
tablets and hospital pack of 50.
Allopurinolo Teva Italia 300 mg tablets: packs of 20, 28, 30, 50, 60, 90, 98, 100, 105 and 500
tablets and hospital pack of 50.
The medicine is also available in HDPE bottles in the following packs:
Allopurinolo Teva Italia 100 mg tablets: 30 tablets in a 35 ml bottle or 100 tablets in
a 35 ml bottle
Allopurinolo Teva Italia 300 mg tablets: 30 tablets in a 35 ml bottle or 100 tablets in
a 100 ml bottle
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan Italy

Manufacturer
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
Pharmachemie B.V. - Swensweg 5 – 2031 GA Haarlem (Netherlands)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: Allopurinol TEVA 100 and 300 mg tablets

Bulgaria: ALODAGRA 100 mg tablets

Denmark: Allopurinol “Teva”

France: Allopurinol Teva 100, 200 and 300 mg, comprimé

Ireland: Allopurinol TEVA 100 and 300 mg tablets

Italy: Allopurinolo Teva Italia 100 and 300 mg tablets

Netherlands: Allopurinol 100, 200 and 300 mg PCH, tablets

Sweden: Allopurinol Teva 100 and 300 mg tablets