100 mg and 300 mg tablets 
allopurinol

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.

– 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Allopurinol Nordic Drugs is and what it is used for

Allopurinol Nordic Drugs is a remedy for gout and high uric acid levels in the blood and is used especially in connection with a disease of the renal ducts (gout nephropathy) and stones in the urinary tract (urate stones). Allopurinol inhibits the formation of uric acid in the body and therefore prevents urate precipitation in tissues and the formation of urate stones and gravel in the urine.

Allopurinol Nordic Drugs are also used in so-called secondary gout that can occur in blood cancer ( leukemia ), in increasing the number of red blood cells ( polycythemia vera ), or in bone marrow tumor ( myeloma ). The drug can also be used for the preventive purpose against elevated uric acid levels that may occur during treatment for cancer with cytotoxic drugs and radiation therapy.

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

What you need to know before you use Allopurinol Nordic Drugs

Do not use Allopurinol Nordic Drugs

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

Warnings and cautions

Talk to your doctor before taking Allopurinol Nordic Drugs if you:

  • has impaired renal function. 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.

Xanthine is a precursor to uric acid. Allopurinol may in rare cases increase the concentration of xanthine in the body and cause xanthine deposits in the urinary tract. It is therefore important to drink plenty of fluids during treatment with Allopurinol Nordic Drugs to avoid urinary xanthine precipitation.

Other medicines and Allopurinol Nordic Drugs

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

Certain penicillins (ampicillin), certain agents that affect the immune system (azathioprine, cyclosporine, cyclophosphamide, mercaptopurine), certain anti-asthma drugs (theophylline) may affect or be affected by treatment with allopurinol. Anyone who is being treated with blood thinners at the same time, such as warfarin, should have their blood coagulation ability checked regularly.

The use of, for example, probenecid or high- dose salicylates may reduce the effect of Allopurinol Nordic Drugs, which should be assessed on a case-by-case basis.

The treating physician therefore always needs to know about other concomitant medication.

Allopurinol Nordic Drugs with food and drink

Allopurinol Nordic Drugs tablets should be taken after a meal to reduce any nausea and vomiting. You should drink plenty when taking Allopurinol Nordic 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.

Experience with the use of Allopurinol Nordic Drugs during pregnancy is limited. Therefore, consult a doctor or pharmacist before starting treatment.

It is unknown whether Allopurinol Nordic Drugs passes into breast milk. Therefore, consult a doctor or pharmacist before starting treatment.

Driving and using machines

Isolated cases of drowsiness, dizziness, and inability to coordinate movements have occurred during treatment with Allopurinol Nordic Drugs. This should be taken into account, especially at the beginning of the treatment, for example when driving a car and handling machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

3. How to use Allopurinol Nordic Drugs

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

Dose one is determined by the doctor, who adjusts it individually for you.

The usual dose for adults: 1-6 tablets (100 mg each) daily, but there are also significantly higher doses.

If you forget to take Allopurinol Nordic Drugs

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor, 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 the following side effects, stop taking the tablets and tell your doctor immediately.

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

  • fever and chills, headache, muscle aches ( flu-like symptoms ), and general malaise
  • skin changes, such as sores in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes), widespread blistering or flaking of the skin
  • Severe hypersensitivity reactions include fever, rash, joint pain, and abnormal blood and liver function tests (these may be signs of a multi-organ hypersensitivity reaction ).

Stevens-Johnson syndrome:

An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals.

Allopurinol Nordic Drugs can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible to rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Other side effects:

Common (may affect up to 1 in 10 people)

  • rash

Uncommon (may affect up to 1 in 100 people)

  • nausea, vomiting, and diarrhea
  • liver dysfunction

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

  • enlarged lymph nodes, increase in white blood cell count
  • changes in the blood picture
  • vasculitis
  • hepatitis
  • kidney failure
  • joint pain
  • mucosa – and skin inflammations

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

  • severe, potentially life-threatening allergic reaction
  • the severe allergic reaction that causes swelling of the face or throat
  • cramps

Has been reported (occurs in an unknown number of users)

  • anaphylactic shock
  • acute bile duct inflammation, vomiting blood, fatty stools, altered bowel habits
  • inflammation of the oral cavity, altered taste perception
  • general malaise, headache, dizziness, inability to coordinate muscle movements, drowsiness, coma, depression, weakness, inability to move muscles, numbness and tingling in the skin, nerve damage, inflammation of peripheral nerves, muscle aches,
  • blood in the urine, inflammation in the kidney, swelling, stones in the urinary tract
  • diabetes, high blood fat levels,
  • chest pain, high blood pressure, low heart rate
  • visual disturbance, cataracts, yellow spot -sickness
  • infertility, impotence, enlarged breasts, nocturnal ejaculation
  • hair loss, discolored hair

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 Nordic Drugs

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 label/carton after “EXP. date .: ”. The expiration date is the last day of the specified month.

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. One tablet contains either 100 mg or 300 mg of allopurinol.

– The other ingredients are magnesium stearate, gelatin, sodium starch glycolate, microcrystalline cellulose, talc, corn starch, colloidal anhydrous silica.

What the medicine looks like and the contents of the pack

Allopurinol Nordic Drugs tablets 100 mg or 300 mg are supplied in blister packs of 100 x 1 tablets. The tablets are white, round, and cupped with a notch.

Marketing Authorisation Holder

Nordic Drugs AB

Box 300 35

200 61 Limhamn

Manufacturer

Merckle GmbH, Blaubeuren, Germany

Muhammad Nadeem

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