100 mg, 300 mg tablets
allopurinol
1. What Allopurinol Sandoz is and what it is used for
- Allopurinol Sandoz belongs to a group of medicines called enzyme inhibitors. They work by regulating the speed of certain chemical processes in the body.
- Allopurinol Sandoz is used for the long-term treatment of gout and can 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 Sandoz 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.
What you need to know before you take Allopurinol Sandoz
Do not take Allopurinol Sandoz
- 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 Sandoz if:
- have Han Chinese, African or Indian descent
- you have liver and kidney problems. Your doctor may give you a lower dose or ask you to take it less often than every day. You will also be more closely monitored.
- you have heart problems or high blood pressure and are taking diuretics and/or medicines called ACE inhibitors.
- you have an ongoing gout attack
- you have thyroid problems.
If you are not sure if any of the following applies to you, talk to your doctor or pharmacist before taking allopurinol.
Severe skin rash (hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis ) have been reported with the use of allopurinol. The rash often includes sores in the mouth, throat, nose, and genitals as well as eye inflammation (red and swollen eyes). Before these severe skin rashes, you often get flu-like symptoms, fever, headaches, and body aches. The rash can develop into widespread blistering and scaly skin.
These severe skin rashes 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 these skin symptoms, stop taking Allopurinol immediately, and contact your doctor.
If you have cancer or Lesch-Nyhan’s syndrome, the amount of uric acid in your urine may increase. To prevent this, you need to drink enough to dilute the urine.
If you have kidney stones, they can become smaller and enter the urinary tract.
Children
Use in children is rarely indicated, except in certain types of cancer (especially leukemia ) and certain enzyme disorders, including Lesch-Nyhan syndrome.
Other medicines and Allopurinol Sandoz
Before you start taking this medicine, tell your doctor if you are taking:
- 6-mercaptopurine (for the treatment of blood cancer)
- azathioprine, cyclosporine (to inhibit the immune system). Note that side effects of ciclosporin may occur more frequently.
- didanosine, a drug for the treatment of HIV – infection
- vidarabine (for the treatment of herpes )Note that side effects of vidarabine may occur more frequently. Pay special attention if this happens.
- salicylates (to relieve pain, fever, and inflammation, eg acetylsalicylic acid )
- probenecid (for the treatment of gout )
- chloropropamide (for the treatment of diabetes )The chloropropamide dose may need to be reduced, especially in patients with renal impairment.
- warfarin, phenprocoumon, acenocoumarol (to thin the blood). Your doctor will monitor your blood coagulation values more often and, if necessary, lower the dose of one of them.
- phenytoin (for the treatment of epilepsy ).
- theophylline (for the treatment of asthma and other respiratory diseases)Your doctor will measure the level of theophylline in your blood, especially when you start treatment with allopurinol or when your dose changes.
- ampicillin or amoxicillin (for the treatment of bacterial infections)Patients should be given other antibiotics if possible as the risk of allergic reactions is greater.
- medicines for heart problems or high blood pressure, including ACE inhibitors and diuretics ( diuretics )
- drugs for the treatment of aggressive tumors, among others- cyclophosphamide- doxorubicin- bleomycin- procarbazinealkyl halidesYour doctor will check your blood levels frequently.
- didanosine (for treatment of HIV – infection )
- captopril (for the treatment of high blood pressure )
- 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.
The risk of skin reactions can increase, especially if you have chronic renal impairment.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Allopurinol is excreted in human milk. Allopurinol is not recommended during breast-feeding. 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.
Driving and using machines
Allopurinol Sandoz tablets can cause dizziness, drowsiness, and affect coordination. If you feel affected, DO NOT drive, use machines, or engage in activities that could be dangerous.
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 Sandoz 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.
3. How to take Allopurinol Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The tablets should be swallowed, preferably with a glass of water. The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole. 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 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 more, to prevent gout attacks.
Your allopurinol dose can be adjusted depending on the severity of the condition. The maintenance dose is:
- mild symptoms: 100–200 mg/day
- moderate: 300-600 mg / day
- severe symptoms: 700-900 mg / day
Your doctor may also adjust your dose if you have impaired kidney and liver function, especially if you are older.
If the daily dose is higher than 300 mg/day and you experience side effects from the stomach and intestines, such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in divided doses to reduce the side effects.
If you have severe kidney problems
- you may be instructed to take less than 100 mg per day
- or you may be instructed 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 Sandoz 100 mg tablets: children (under 15 years) weighing at least 15 kg.
Allopurinol Sandoz 300 mg tablets: children (under 15 years) weighing at least 45 kg.
Usual dose: 10 to 20 mg per kg body weight daily, divided into 3 doses.
Maximum dose: 400 mg allopurinol daily.
Treatment can be started with an anti-inflammatory drug or colchicine and the dose can be adjusted if you have impaired kidney and liver function, or divided to relieve gastrointestinal side effects, as for adults as above.
An overdose is likely to cause effects such as nausea, vomiting, diarrhea, or dizziness.
Bring this leaflet, any remaining tablets, and the packaging to the hospital or reception so that healthcare professionals know which tablets they are.
If you forget to take Allopurinol Sandoz
If you forget to take one tablet, take it as soon as you remember unless it is time for the next one.
DO NOT take a double dose to make up for a forgotten tablet. Take the remaining tablets at the right time.
If you stop taking Allopurinol Sandoz
You should continue to take the tablets for as long as your doctor tells you to. DO NOT stop taking this 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. This medicine may cause the following side effects:
If you experience any of the following, stop taking the tablets and contact a doctor immediately:
Hypersensitivity
Symptoms may include:
Uncommon (may affect up to 1 in 100 people)
Stop taking Allopurinol Sandoz and see a doctor immediately if you have an allergic reaction. The symptoms can be:
- scaly skin, boils, or sores on the lips and mouth
- very rare symptoms are sudden wheezing, fluttering heart or pressure over the chest, and collapse.
Do not take more tablets unless your doctor tells you to.
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 the mouth, throat, nose, and genitals as well as conjunctivitis (red and swollen eyes), widespread rash with blisters, and scaling
- severe hypersensitivity reactions with fever, rash, joint pain, and abnormal blood and liver function values (these may be signs of intolerance involving several organs)
- bleeding from lips, eyes, mouth, nose, or genitals.
Other side effects:
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 and vomiting
- abnormal liver samples.
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)
- Allopurinol Sandoz tablets can sometimes affect the blood, which can turn out to get bruises more easily than usual or get a sore throat or other signs of infection. These effects usually affect people with liver or kidney problems. Contact your doctor as soon as possible.
- Allopurinol Sandoz can affect the lymph nodes
- high body temperature
- blood in the urine ( hematuria )
- high blood cholesterol levels ( hyperlipidemia )
- 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
- male infertility or impotence
- breast augmentation, in both men and women
- altered bowel function
- taste changes
- cataract
- hair loss or discoloration of the hair
- Depression
- disturbance of the ability for will-controlled coordination of muscle movements ( ataxia )
- tingling, tingling or stinging sensation or burning in the skin ( paresthesia )
- 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.
If any of the side effects are becoming serious, or if you get side effects that are not listed in the leaflet, contact your doctor or pharmacist.
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 Sandoz
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 after EXP. date. or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
HDPE cans: to be used within 6 months after first opening.
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 Sandoz 100 mg tablets : each tablet contains 100 mg of allopurinol.
Allopurinol Sandoz 300 mg tablets : each tablet contains 300 mg of allopurinol.
The other ingredients are lactose monohydrate, corn starch, povidone, magnesium stearate.
What the medicine looks like and the contents of the pack
Allopurinol Sandoz 100 mg tablets:
White to off-white, scored, flat cylindrical tablets marked with “I” and “56” on each side of the breaker notch on one side of the tablet and smooth on the other. Diameter: about 8 mm.
Allopurinol Sandoz, 100 mg tablets are available in PVC / Alu-blister packs of 20, 30, 50, 60, 100 tablets and 30 x 1 tablet in single-dose blisters or HDPE cans with child-resistant PP caps or non-child-resistant PP-caps with a seal of 50, 100, 105, 125, 250, 500 tablets.
Not all pack sizes may be marketed.
Allopurinol Sandoz 300 mg tablets
White to off-white, scored, flat cylindrical tablets marked with “I” and “57” on each side of the scoreline on one side of the tablet and smooth on the other. Diameter: about 11 mm.
Allopurinol Sandoz 300 mg tablets are available in PVC / Alu blister packs of 30, 60, 100 tablets, and 30 x 1 tablet in single-dose blisters or HDPE cans with child-resistant PP caps containing 100, 105, 125 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova ulica 57, 1526 Ljubljana, Slovenia