100 and 300 mg tablets 
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. See section 4.

This leaflet contains information about: 
1. What Allopurinol Orion is and what it is used for 
2. What you need to know before you use Allopurinol Orion 
3. How to use Allopurinol Orion 
4. Possible side effects 
5. How to store Allopurinol Orion 
6. Contents of the pack and other information 

What Allopurinol Orion is and what it is used for

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

Allopurinol Orion 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.

Children under 15 years of age: Only Allopurinol Orion 100 mg tablets can be used in children under 15 years of age.

300 mg tablets contain a para-orange dye (E110) which is not recommended for use in children and adolescents.

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

What you need to know before you use Allopurinol Orion

Do not use Allopurinol Orion

  • if you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).
  • if you have an ongoing gout attack or have just had a gout attack.

Warnings and cautions

Talk to your doctor or pharmacist before taking Allopurinol Orion tablets 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.
  • have heart problems or high blood pressure.
  • have thyroid problems.
  • have an ongoing gout attack.

Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis ) 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 of skin detachment. These severe skin reactions may be more common in people of Han 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 immediately, and contact a doctor immediately.

Other medicines and Allopurinol Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Talk to your doctor before taking this medicine if you are taking:

  • 6-mercaptopurine (used to treat blood cancer)
  • azathioprine, cyclosporine (used to suppress the immune system). Note that cyclosporine can more often cause side effects.
  • vidarabine (used to treat herpes ). Note that vidarabine can more often 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 chloropropamide may be necessary, especially in patients with renal impairment.
  • 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.
  • furosemide, thiazides, or other diuretics (used to treat high blood pressure )
  • 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 Orion, 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.

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.

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.

Blood levels should therefore be checked regularly.

Your doctor will check your blood levels frequently if you take:

  • 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.

Pregnancy, breastfeeding, and fertility

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 Orion tablets can cause dizziness, drowsiness, and may affect your coordination. If you are affected, do not drive, use machines, or participate in risky 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 Orion 100 mg and 300 mg tablets contain lactose and Allopurinol Orion 300 mg tablets contain the dye para-orange (E110)

Allopurinol Orion 100 mg and 300 mg tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Allopurinol Orion 300 mg tablets contain the dye para-orange (E110) which may cause allergic reactions. 300 mg tablets are not recommended for children under 15 years of age.

3. How to use Allopurinol Orion

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablet can be divided into equal doses. The tablets should be swallowed with a glass of water. You should take the tablets after a meal. You should drink plenty of fluids (2-3 liters per day) while taking this medicine.

The recommended doses are:

Adults, young people (15‑18 years), older

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 more, to prevent attacks of gouty arthritis.

Your dose of allopurinol can be adjusted depending on the severity of the condition. The maintenance dose is:

  • mild conditions: 100‑200 mg / day
  • moderately severe conditions: 300‑600 mg / day
  • severe conditions: 700‑900 mg / day.Your dose may also be changed by your doctor if you have impaired kidney and liver function, especially if you are older. If your daily dose exceeds 300 mg/day and you suffer from 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 disease
  • you may be asked to take less than 100 mg per day or so
  • you may be asked to take 100 mg at longer intervals than one day.If you receive 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 for children and adolescents

Allopurinol 100 mg tablets only:

Children under 15 years

100 to 400 mg / day.

Treatment can be started with an anti-inflammatory drug or colchicine, and the dose is adjusted if you have impaired kidney and liver function, or divided to reduce the gastrointestinal side effects, as for adults above.

An overdose can cause symptoms such as nausea, vomiting, diarrhea, or dizziness.

Take this leaflet, any remaining tablets, and the package with you to the hospital or doctor so that they know which tablets have been taken.

If you forget to use Allopurinol Orion

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

If you stop using Allopurinol Orion

You should continue to take the tablets for as long as your doctor tells you to. Do not stop taking your medicine 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.

Stop taking Allopurinol Orion and contact a doctor immediately if you experience:

  • an unexpected skin reaction (possibly accompanied by fever, swollen glands, joint pain, unusual blisters or bleeding, kidney problems, or sudden outbursts of cramps).
    Common side effects are (may affect up to 1 in 10)
    • Rash
    • Elevated levels of thyroid-stimulating hormone in the blood. Rare side effects are (may affect up to 1 in 1000 users)
    • 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). Allergic reactions (may affect up to 1 in 10,000 users)If you get an allergic reaction, stop taking Allopurinol Orion 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 collapsed not take more tablets unless your doctor tells you to. If you experience any of the following while taking Allopurinol Orion, stop taking the tablets, and contact your doctor as soon as possible:
      Less common side effects are (may affect up to 1 in 100):
    • nausea, vomiting (in rare cases containing blood), and diarrhea
    • symptoms of allergic reactions including itchy rash
    • higher results in liver function tests are side effects are (may affect up to 1 in 1000 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 groinVery rare side effects are (may affect up to 1 in 10 000 users):
    • 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 ejaculate in sleep (“nocturnal ejaculation”)
    • 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 you may sometimes feel nauseous, but this can usually be avoided by taking allopurinol after a meal. Tell your doctor if the problem persists. 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.
      Reporting of side effects if you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via The Medical Products AgencyBox 26751 03 Uppsalawww.lakemedelsverket.se
      By reporting side effects, you can help increase drug safety information.

5. How to store Allopurinol Orion

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance 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, corn starch, povidone, sodium starch glycolate, and stearic acid. Allopurinol Orion 300 mg also contains the dye para-orange (E 110)

What the medicine looks like and the contents of the pack

Allopurinol Orion 100 mg tablets are white to off-white, round, biconvex uncoated tablets with “AL” and “100” separated by a score line on one side and smooth on the other.


Allopurinol Orion 300 mg tablets are peach-colored, round, biconvex uncoated tablets with “AL” and “300” separated by a score line on one side and smooth on the other. 

Allopurinol Orion 100 mg tablets are available in packs of 50 and 100. 
Allopurinol Orion 300 mg tablets are available in packs of 30 and 100. 

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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