100 mg and 300 mg tablets
allopurinol
What Allopurinol Accord is and what it is used for
Allopurinol Accord contains the active substance allopurinol. This medicine belongs to a group of medicines called enzyme inhibitors. They work by regulating the speed of certain chemical processes in the body.
Allopurinol Accord is used to treat conditions associated with an excess of uric acid in the body, including gout, certain types of kidney disease and kidney stones, cancer, and certain enzyme disorders that lead to the accumulation of too much uric acid.
Allopurinol contained in the Allopurinol Accord 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 taking Allopurinol Accord
Do not take Allopurinol Accord
- 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 or pharmacist before taking Allopurinol Accord
- if you have or have had liver or kidney disease
- if you are taking medicines for heart disease or high blood pressure ( diuretics and/or medicines called ACE inhibitors )
- if you have an ongoing gout attack
- if you are of Han Chinese, Thai or Korean descent
- if you have thyroid problems.
Take special care with Allopurinol Accord:
- if you have kidney stones. The kidney stones can become smaller and can risk entering and blocking the urinary tract, which can cause problems.
- Severe skin rash (hypersensitivity syndrome and Stevens-Johnson syndrome, also known as toxic epidermal necrolysis ) have been reported with the use of allopurinol. The rash can often include sores in the mouth, throat, nose, and genitals as well as conjunctivitis (red and swollen eyes). Before these severe skin rashes, you often get flu-like symptoms such as fever, headache, and body aches. The rash can develop into widespread blistering and scaly skin. If you get a rash or these skin symptoms, stop taking allopurinol, and contact a doctor immediately.
- if you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in your urine may increase. To avoid this, it is therefore important to drink enough so that the urine is diluted.
Children and young people
Use in children is rarely justified, except in certain types of cancer (especially leukemia ) and certain enzyme diseases such as Lesch-Nyhan syndrome.
Other medicines and Allopurinol Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- drugs used to inhibit the immune system (immunosuppressive agents), e.g. 6 ‑ mercaptopurine, azathioprine, and cyclosporine
- adenine arabinoside (vidarabine), which is used to treat herpes or chickenpox
- other drugs to treat gout, such as probenecid
- acetylsalicylic acid (or related medicines called salicylates)
- chloropropamide, for the treatment of diabetes
- blood-thinning drugs ( anticoagulants ), e.g. warfarin
- drugs for the treatment of epilepsy, e.g. phenytoin
- theophylline, which is used for breathing problems
- antibiotics (ampicillin or amoxicillin)
- drugs used to treat cancer
- didanosine used to treat HIV – infection
- medicines for heart problems or high blood pressure, such as ACE inhibitors or diuretics ( diuretics )
- aluminum hydroxide, as it may reduce the effect of allopurinol. There should be an interval of at least 3 hours between taking these two drugs.
- cytotoxic drugs (eg cyclophosphamide, doxorubicin, bleomycin, procarbazine, and alkyl halides), as blood dyscrasias (imbalance in blood composition), are more common when these drugs are taken at the same time as allopurinol. Blood cell counts should therefore be performed at regular intervals.
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 Accord can make you drowsy and affect coordination. Do not drive or use any tools or machines until you know how the medicine affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Accord contains lactose
This medicine contains lactose (a type of sugar). 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 Accord
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The appropriate amount of Allopurinol Accord can vary greatly from individual to individual. Your doctor will decide which dose of Allopurinol Accord is best for you.
The usual starting dose is 100-300 mg daily, which can be taken as a single dose. Dose one can be increased to 900 mg daily, depending on the severity of your condition.
If the daily dose is higher than 300 mg, your doctor may prescribe the medicine in evenly divided doses during the day to avoid any side effects from the stomach and intestines.
If you are older or if you have impaired liver or kidney function, your doctor may prescribe a lower dose or decide that there should be a long time between doses. If you receive dialysis two or three times a week, your doctor may prescribe a dose of 300 mg or 400 mg to be taken immediately after dialysis.
Use for children and adolescents
Children and adolescents under 15 years of age: 10 to 20 mg/kg body weight/day up to a maximum of 400 mg daily, divided into three doses. Use in children is rarely justified, except in malignant conditions (especially leukemia ) and certain enzyme diseases, e.g. Lesch-Nyhan syndrome.
Method of administration
Allopurinol Accord should be taken by mouth.
The tablets should be taken together with a glass of water to make them easier to swallow.
You should take the tablets after a meal to reduce the risk of side effects such as nausea and vomiting.
If you forget to take Allopurinol Accord
If you forget to take a dose, take it as soon as you remember. However, skip the missed dose one if it is soon time to take the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Allopurinol Accord
Do not stop taking Allopurinol Accord unless your doctor tells you to.
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.
Hypersensitivity
Uncommon (may affect up to 1 in 100 people)
Tell your doctor immediately if you get any of the following symptoms:
- a reaction with e.g. scaly skin, boils or sores on the lips and mouth
- or very rare symptoms such as sudden wheezing, heart palpitations, or pressure over the chest and collapse.
Rare (may affect up to 1 in 1,000 people)
- fever and chills, headache, muscle aches ( flu-like symptoms ), and general malaise
- severe hypersensitivity reactions with fever, rash, joint pain, abnormal blood values , and liver function values (these may be signs of intolerance involving several organs)
- bleeding on the lips, eyes, mouth, nose, or genitals
- skin changes, e.g. sores on the mouth, throat, nose, and genitals as well as conjunctivitis (red and swollen eyes), scattered blisters, or scaling.
Very rare (may affect up to 1 in 10,000 people)
- Severe allergic reaction with swelling of the face or throat
- Severe, possibly life-threatening allergic reaction.
These symptoms may mean that you are allergic to Allopurinol Accord. Do not take more tablets unless your doctor tells you to.
Other side effects are
Common (may affect up to 1 in 10 people)
- rash
- elevated levels of thyroid-stimulating hormone in the blood.
Uncommon (may affect up to 1 in 100 people)
- nausea or vomiting
- abnormal liver function values.
Rare (may affect up to 1 in 1,000 people)
- liver problems, such as hepatitis.
Very rare (may affect up to 1 in 10,000 people)
- high body temperature
- blood in the urine ( hematuria )
- high blood cholesterol levels ( hyperlipidemia )
- a general feeling of illness or weakness.
- weakness, numbness, unstable legs, feeling unable to move the muscles (paralysis), or loss of consciousness
- headache, dizziness, drowsiness, or blurred vision
- chest pain (angina), high blood pressure, or slow heart rate
- accumulation of fluid leading to swelling ( edema ), especially of the ankles
- abnormal glucose metabolism ( diabetes ). Your doctor may want to measure your blood sugar to see if this happens.
- Allopurinol Accord can sometimes affect the blood. Contact your doctor as soon as possible if you notice that you get bruises more easily than usual or if you get a sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems.
- Allopurinol Accord may affect the lymph nodes
- infertility in men, impotence
- breast augmentation, in both men and women
- altered bowel movements/bowel habits
- taste changes
- cataract
- hair loss or discoloration of the hair
- Depression
- disorders of muscle coordination ( ataxia )
- creeping, tickling, stinging, burning sensation in the skin ( paresthesia ).
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 Accord
Keep this medicine out of sight – and the sight of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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.
Allopurinol Accord 100 mg: Each tablet contains 100 mg of allopurinol.
Allopurinol Accord 300 mg: Each tablet contains 300 mg of allopurinol.
Other ingredients are:
lactose monohydrate; crospovidone, type B; corn starch; povidone K30 and magnesium stearate.
What the medicine looks like and the contents of the pack
Allopurinol Accord 100 mg are white to off-white, round, biconvex, uncoated tablets, labeled “AW” on one side and no label on the other. Diameter: about 8 mm.
Allopurinol Accord 300 mg are white to off-white, round, biconvex, uncoated tablets with a beveled edge, marked with “AX” on one side and no marking on the other side. Diameter: about 11.2 mm.
PVC / aluminum blisters containing 25, 28, 30, 50, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
UK
LABORATORI FUNDACIÓ DAU
C / C, 12-14 Pol. Ind. Zona Franca
Barcelona, 08040
Spain
Accord Healthcare Polska Sp. z oo
ul. Taśmowa 7
Warszawa 02-677
Poland
Accord Healthcare Polska Sp. z oo
ul. Lutomierska 50
Pabianice 95-200
Poland