100 mg tablets and 300 mg tablets respectively 
allopurinol

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Allopurinol Teva is and what it is used for 
2. What you need to know before taking Allopurinol Teva 
3. How to take Allopurinol Teva 
4. Possible side effects 
5. How to store Allopurinol Teva 
6. Package contents and other information

1. What Allopurinol Teva is and what it is used for

Allopurinol Teva belongs to a group of medicines called enzyme inhibitors, which work by controlling the speed of various chemical processes in the body.

Allopurinol Teva tablets are used for the long-term prevention of gout and can also be used for other conditions associated with an excess of uric acid in the body, including kidney stones and other types of kidney disease.

Allopurinol contained in Allopurinol Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you take Allopurinol Teva

Do not take Allopurinol Teva:

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Allopurinol Teva:

  • if you have liver or kidney problems. Your doctor may give you a lower dose or ask you to take the medicine less often than once a day. You will also be more closely monitored.
  • if you have heart problems or high blood pressure.
  • if you have an ongoing gout attack

Severe skin reactions, which may be more common in people with chronic renal impairment, have been reported with the use of allopurinol. These severe skin rashes can include hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis. All of these have been reported with the use of allopurinol. The rash can usually include sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache, body aches. The rash can develop into blisters over large areas and skin detachment. These severe skin reactions may be more common in people of male, Chinese, Thai, or Korean descent. Chronic Kidney disease may further increase the risk in these patients.

If you get a rash or signs of these skin reactions, stop taking Allopurinol Teva immediately and contact your doctor immediately.

Other medicines and Allopurinol Teva

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 cancer)
  • azathioprine, cyclosporine (used to suppress the immune system) 
    Note that cyclosporine is more likely to cause side effects.
  • vidarabine (used to treat herpes ) 
    Note that vidarabine is more likely to cause side effects. Be extra careful if these occur.
  • salicylates (used to reduce pain, fever, or inflammation, eg acetylsalicylic acid )
  • probenecid (used to treat gout )
  • Chlorpropamide (used to treat diabetes ) 
    A reduced dose of chlorpropamide may be necessary, especially in patients with impaired renal function.
  • warfarin, phenprocoumon, acenocoumarol (used to make the blood thinner) 
    Your doctor may check your blood clotting more often and, if necessary, lower the dose of one of these medicines.
  • phenytoin (used to treat epilepsy )
  • Theophylline (used to treat asthma and other respiratory diseases) 
    Your doctor will measure the theophylline levels in your blood, especially when starting treatment with Allopurinol Teva, or after changing dose one.
  • ampicillin or amoxicillin (used to treat bacterial infections) 
    Patients should be given other antibiotics if possible, as allergic reactions can be expected.
  • chemotherapy (used to treat aggressive tumors )When allopurinol and cytostatics are used concomitantly (eg cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides) blood dyscrasias occur more frequently than when these active substances are used separately load levels should therefore be checked regularly.
  • didanosine (used to treat HIV – infection s)
  • captopril (used to treat high blood pressure )The risk of skin reactions can increase, especially if your kidney function is chronically impaired.
  • aluminum hydroxide (used to neutralize the stomach acid in the stomach)If aluminum hydroxide is taken at the same time, the effect of allopurinol may be reduced. There should be an interval of at least 3 hours between taking these two drugs.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Allopurinol is excreted in human milk. Allopurinol is not recommended during breast-feeding.

Driving and using machines

Allopurinol Teva tablets can cause dizziness, drowsiness, and may affect your coordination. If you are affected, DO NOT DRIVE, do not use machines, or participate in dangerous activities.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Allopurinol Teva contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Allopurinol Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The tablets should be swallowed whole, preferably with water. You should take the tablets after a meal. You should drink plenty of fluids (2-3 liters a day) while taking this medicine.

The recommended dose is:

Adults (including the elderly) 
Starting dose: 100-300 mg / day. 
When you start treatment, your doctor may also prescribe an anti-inflammatory drug or colchicine for a month or longer to prevent attacks of gout. 
Dose one of Allopurinol Teva can be adjusted depending on the severity of the condition. The maintenance dose is:

  • Mild ailments, 100-200 mg/day
  • Moderate discomfort, 300-600 mg / day
  • Serious problems, 700-900 mg / day

Your doctor may also change your dose if you have impaired kidney or liver function, especially if you are older. 
If the daily dose exceeds 300 mg/day and you suffer from stomach and intestinal 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 can take less than 100 mg every day
  • or you can take 100 mg with longer intervals than one day

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 (under 15 years)

The usual dose is 100‑400 mg/day divided into three doses. Allopurinol is rarely used in children, except in certain types of cancer (especially leukemia ) and certain enzyme disorders such as Lesch-Nyhan syndrome.

If you forget to use Allopurinol Teva

If you forget to take a tablet, take one as soon as you remember unless it is time to take the next tablet. Do not take a double dose to make up for a forgotten dose. Take the remaining dose at the correct time.

If you stop taking Allopurinol Teva

You should continue to take the tablets for as long as your doctor tells you to. DO NOT STOP taking the tablets without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following, stop taking this medicine and/or contact your doctor immediately:

  • an unexpected skin reaction (possibly accompanied by fever, swollen glands, joint pain, unusual blisters or bleeding, kidney problems, or sudden outbursts of cramps).

Skin rash is the most common side effect when using allopurinol (may affect up to 1 in 10 people).

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

  • fever and chills, headache, muscle aches ( flu-like symptoms ), and general malaise
  • skin changes e.g. sores in mouth, throat, nose, and genitals, eye inflammation (red and swollen eyes), diffuse blistering or skin detachment
  • severe hypersensitivity reactions such as fever, rash, joint pain, changes in the blood picture, or altered liver values ​​(these may be signs of a hypersensitivity reaction involving several organs)

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

Allergic reactions 

If you get an allergic reaction, stop taking Allopurinol Teva and contact your doctor immediately. Signs may include:

  • skin rash, flaky skin, boils or sore lips and mouth
  • swelling of the face, hands, lips, tongue, or throat
  • difficulty swallowing or breathing
  • Very unusual symptoms include sudden tingling, tremors, chest tightness, and collapse

Do not take more tablets unless your doctor tells you to.

If you experience any of the following while taking Allopurinol Teva, stop taking the tablets, and contact your doctor as soon as possible:

The following common side effects have been reported (may affect up to 1 in 10 people):

  • Elevated levels of thyroid-stimulating hormone in the blood.

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

  • nausea, vomiting (in rare cases containing blood), and diarrhea
  • symptoms of allergic reactions including itchy rash
  • higher results in liver function tests

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

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

The following very rare side effects have been reported (may affect up to 1 in 10,000 people):

  • fever
  • blood in the urine
  • altered bowel habits, or unusual foul-smelling stools
  • high levels of fat in the blood
  • a general feeling of feeling unwell
  • weakness, numbness, instability, inability to move the muscles (paralysis) or unconsciousness, tingling
  • muscle twitching, seizures, or depression
  • headache, dizziness, drowsiness, or visual disturbances
  • chest pain, high blood pressure, or low heart rate
  • retained fluid leading to swelling ( edema ) especially in the ankles
  • male infertility or inability to get or maintain an erection, or to have ejaculation in sleep
  • enlarged breasts in both men and women
  • taste changes, inflammation of the mouth
  • cataracts (cloudy contact lenses) and other vision problems
  • abscesses (small sore, red bumps on the skin)
  • hair loss or discoloration of the hair
  • thirst, fatigue, and weight loss (these may be symptoms of diabetes ); Your doctor may want to measure your blood sugar level if this happens
  • muscle pain
  • swollen glands, usually disappear when allopurinol treatment is stopped
  • Sometimes allopurinol can affect the blood, which can show up in that you get bruises more easily than usual or that you get 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.

You may sometimes feel nauseous, but this can usually be avoided by taking allopurinol after a meal. Tell your doctor if the problem persists.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Allopurinol Teva

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 carton and blister after EXP. dat./EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

HDPE cans:

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 carton and jar after EXP. dat./EXP. The expiration date is the last day of the specified month.

Store in the original package. Close the jar tightly. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is allopurinol. 
    Each 100 mg tablet contains 100 mg allopurinol 
    Each 300 mg tablet contains 300 mg allopurinol
  • The other ingredients are lactose monohydrate, colloidal anhydrous silica, maize starch, cellulose powder, sodium starch glycolate, sodium lauryl sulfate, povidone K30, and magnesium stearate (E470b).

What the medicine looks like and the contents of the pack

Allopurinol Teva 100 mg tablets are white, round, biconvex tablets, debossed with “4K1” on one side and smooth on the other. 
Allopurinol Teva 300 mg tablets are white, round, biconvex tablets, debossed with “2K1” on one side and smooth on the other.

The product is available in transparent aluminum blisters in the following pack sizes:

Allopurinol Teva 100 mg tablets: 20, 25, 28, 30, 50, 60, 90, 98, 100, 105 or 500 tablets and hospital packs of 50 tablets. 
Allopurinol Teva 300 mg tablets: 20, 28, 30, 50, 60, 90, 98, 100, 105 or 500 tablets and hospital packs of 50 tablets.

The product is also available in HDPE jars in the following pack sizes:

Allopurinol 100 mg tablets: 30 tablets in a 35 ml can or 100 tablets in a 35 ml can. 
Allopurinol 300 mg tablets: 30 tablets in a 35 ml can or 100 tablets in a 100 ml can.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer 
Teva Pharmaceutical Works Private Limited Company 
Debrecen, Hungary

Muhammad Nadeem

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