100 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 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 side effects that are not mentioned in this information. See section 4.

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

What Allopurinol Takeda is and what it is used for

Allopurinol Takeda inhibits the formation of uric acid and thus lowers the level of urate (uric acid salt) in the body. In this way, the formation of urate stones and gravel in the urine, as well as urate crystallization in joints and tissues, are prevented.

Allopurinol Takeda is used for gout and conditions with elevated uric acid levels in the blood.

Allopurinol contained in Allopurinol Takeda 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 use Allopurinol Takeda

Do not use Allopurinol Takeda

-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 using Allopurinol Takeda

  • if you have impaired liver or kidney function
  • if you have an ongoing gout attack
  • if you are of Chinese or Korean descent
  • if you have thyroid problems.

During treatment with Allopurinol Takeda:

– Severe skin rash (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis ) has been reported with the use of allopurinol. The rash can often include sores in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash can develop into extensive blistering and flaking of the skin.

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 develop a rash or these skin symptoms, stop taking allopurinol, and contact a doctor immediately.

– If you have a serious illness such as cancer or Lesch-Nyhan syndrome, xanthine, a precursor to uric acid, can accumulate in the body. To avoid the accumulation of xanthine in the urinary tract, it is therefore important to drink enough.

– If you have kidney stones, the kidney stones can become smaller and get into the urinary tract, which can cause problems.

Other medicines and Allopurinol Takeda

The effect of the treatment can be affected if Allopurinol Takeda is taken at the same time as other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

  • azathioprine (used to suppress the immune system)
  • chemotherapy (used to treat cancer). 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.
  • mercaptopurine (used to treat blood cancer ( leukemia )
  • cyclosporine (used to suppress the immune system, for example after organ transplantation and in rheumatism)
  • didanosine (used to treat HIV – infection s)
  • theophylline (used to treat asthma )
  • vidarabine (used to treat viral infections)
  • phenytoin (used in epilepsy )
  • blood thinners such as warfarin
  • antacids (for heartburn and acid reflux)
  • probenecid (used to treat gout )
  • chloropropamide (used to treat diabetes )
  • diuretics, ACE inhibitors (medicines used to treat heart problems or high blood pressure )
  • salicylates in high doses (used for pain relief, to reduce swelling, and to lower body temperature).
  • ampicillin or amoxicillin (medicines used to treat infections ). The risk of allergic rash may increase with concomitant treatment with Allopurinol Takeda.
  • aluminum hydroxide (used to neutralize stomach acid). 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 for advice before using this medicine. Limited experience of use during pregnancy.

Allopurinol and oxypurinol (substance allopurinol is converted to in the body) are excreted in breast milk. Allopurinol is not recommended during breast-feeding.

Driving and using machines

Drowsiness, dizziness, and inability to coordinate movements have occurred during treatment with Allopurinol Takeda. This should be taken into account when sharpened attention is required, e.g. when driving and handling machines. 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 Takeda contains lactose and glucose

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 use Allopurinol Takeda

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. Dosage one should be adjusted by the doctor during treatment after measuring the level of uric acid salts and uric acid in blood and urine.

Adults

You usually start with a low dose, for example, 100 mg daily. If necessary, the dose can be gradually increased to 900 mg daily. Doses above 300 mg should be divided over the day.

To avoid possible nausea and vomiting, you should take the tablets with a glass of water with a meal.

Older

You will receive the lowest dose of Allopurinol Takeda that has sufficient effect for you.

Impaired kidney or liver function

Your doctor may reduce your dose or decide that it will take longer between doses if you have impaired liver or kidney function.

Use for children

The recommended dose for children aged 6-10 years is 100 mg 3 times daily.

The recommended dose for children under 6 years is 50 mg 3 times daily.

Allopurinol Takeda tablet 100 mg

The tablet can be divided into two equal doses.

Signs of overdose may include nausea, vomiting, diarrhea, and dizziness.

If you forget to use Allopurinol Takeda

If you forget to take a tablet, take one as soon as you can. However, skip the missed dose if it is soon time to take the next tablet. Do not take a double dose to make up for a forgotten dose.

If you stop using Allopurinol Takeda

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.

Stop taking Allopurinol Takeda and contact a doctor immediately or see a hospital if you get  any of the following symptoms:

  • Allergic reactions ( hypersensitivity reactions ). Symptoms of an allergic reaction may include swelling of the eyelids, face, or lips, low blood pressure, palpitations, sudden itchy rash (hives), sudden wheezing, chest tightness, shortness of breath, and dizziness. (Uncommon side effects may affect up to 1 in 100 people).
  • Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing. Maybe a sign of angioedema. (Very rare side effect – may affect up to 1 in 10,000 people).
  • Sometimes allopurinol can affect the blood, which can manifest itself in the fact that you get bruises more easily than usual or that 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 severe to pee. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible so that blood tests can rule out a deficiency in certain blood cells( thrombocytopenia, agranulocytosis, or aplastic anemia ). It is important that you then information about your medication. (Very rare side effect – may affect up to 1 in 10,000 people).
  • Skin changes or 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. Or severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes). Maybe a sign of erythema multiforme, Stevens-Johnson syndrome, or Lyell´s syndrome ( toxic epidermal necrolysis ) (Rare side effects – may affect up to 1 in 1,000 people).

Other side effects that may occur:

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, vomiting, and diarrhea
  • impact on liver function

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

  • liver inflammation ( hepatitis )
  • changes in skin or mucous membranes, such as red or lumpy rash, widespread blisters or flaking, itching, redness, sores in mouth, throat, nose, genitals, or conjunctivitis (red and swollen eyes)

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

  • a severe allergic reaction that causes swelling of the face or throat
  • severe, potentially life-threatening allergic reaction
  • blood in the urine
  • vomiting (hematemesis)
  • elevated blood cholesterol levels
  • a general feeling of illness or weakness
  • drowsiness, headache, taste changes
  • dizziness
  • unconsciousness, difficulty moving (paralysis)
  • seizures ( spasms, attacks)
  • muscle pain
  • chest tightness, slow heart rate, high blood pressure, vascular inflammation
  • swelling of the mouth and lips ( stomatitis )
  • swelling, usually in legs, feet, or hands ( edema )
  • thirst, fatigue, and weight loss (these may be symptoms of diabetes ); Your doctor may want to measure your blood sugar level if this happens
  • kidney inflammation
  • kidney failure
  • impact on the lymph nodes
  • male infertility or erectile dysfunction ( impotence )
  • tenderness and swelling in the breasts, both in men and women
  • altered bowel movements/bowel habits
  • visual disturbances
  • hair loss, discolored hair
  • Depression
  • disorders of muscle coordination
  • stinging and burning sensation and numbness in the skin ( paresthesia )
  • urinary tract stones
  • varbölder ( furunculous )
  • fat in the stool ( steatorrhea )
  • increase in urea and creatinine in the blood (azotemia)
  • joint pain
  • elevated body temperature (fever).

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 Takeda

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. 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 100 mg and 300 mg per tablet respectively.
  • The other ingredients are lactose 6 mg and 18 mg per tablet, liquid glucose 5 mg and 15 mg per tablet, magnesium stearate, povidone, talc, corn starch, crospovidone (only in the 300 mg tablet).

What the medicine looks like and the contents of the pack

Allopurinol Takeda 100 mg is a white, round tablet with a diameter of 8 mm. It has a break notch on one side and is embossed with “Nyco” on the other side.

Allopurinol Takeda 300 mg is a white, convex tablet with a diameter of 12 mm. It is marked with “No” on one side and “300” on the other side.

Pack sizes: plastic jars with 100 or 500 tablets.

Muhammad Nadeem

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