Allopurinol Mylan

Package leaflet: Information for the patient

Allopurinolo Mylan 100 mg tablets, 300 mg tablets

allopurinol
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Allopurinolo Mylan is and what it is used for
2. What you need to know before taking Allopurinolo Mylan
3. How to take Allopurinolo Mylan
4. Possible side effects
5. How to store Allopurinolo Mylan
6. Contents of the pack and other information

1. What Allopurinolo Mylan is and what it is used for

Allopurinolo Mylan contains a medicine called allopurinol. It works by slowing down certain chemical reactions in the body in order to reduce levels of uric acid in the blood and urine, and to prevent the formation of uric acid crystals.
Allopurinolo Mylan is used in conditions where the body produces too much uric acid.
These may include gout, kidney stones, or certain other types of kidney problems, or when you are receiving treatment for cancer. In gout, uric acid forms crystals in the joints and tendons, which can cause inflammation, swelling, and pain.

2. What you should know before taking Allopurinol Mylan

Do not take Allopurinol Mylan:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Allopurinol Mylan if:

• you have liver or kidney problems
• you are currently experiencing a gout attack
• you are of Han Chinese, Thai, or Korean descent
• you have thyroid problems.

Exercise particular caution with Allopurinol Mylan:

• severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Often, the skin rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These serious skin reactions are often preceded by flu-like symptoms such as fever, headache, and generalised aches. The rash may progress with the appearance of widespread blisters and skin peeling. These severe skin reactions may be more common in individuals of Han 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 immediately and contact your doctor without delay.
• If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To help prevent this, it is important to drink enough fluids to dilute the urine.
• If you have kidney stones, they may become smaller and pass into the urinary tract, which could cause problems.

Children
Allopurinol Mylan must not be used in children under 6 years of age, as its safety has not been established.
The 300 mg tablets are not recommended for use in children because they contain a colouring agent (aluminium lake of sunset yellow FCF (E110)) which may cause allergic reactions.

Other medicines and Allopurinol Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor if you are taking any of the following medicines. Your doctor may need to reduce the dose of the medicine and/or monitor you more closely due to an increased risk of side effects when allopurinol is taken at the same time as:

• mercaptopurine (used to treat blood cancers)
• azathioprine, cyclosporine (used to suppress the immune system): concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is administered together with Allopurinol Mylan, the dose of 6-mercaptopurine or azathioprine must be reduced because their activity is prolonged. This may increase the risk of severe blood disorders. In such cases, your doctor will closely monitor your blood count during treatment.
• Seek immediate medical advice if you notice any unexplained bruising, bleeding, fever, or sore throat
• vidarabine (used to treat herpes)
• salicylates (used to reduce pain, fever, or inflammation, e.g. salicylic acid)
• probenecid (used to treat gout)
• chlorpropamide (used to treat diabetes)
• warfarin, phenprocoumon, acenocoumarol (used to thin the blood)
• phenytoin (used to treat epilepsy)
• theophylline (used to treat asthma and other respiratory diseases)
• ampicillin or amoxicillin (used to treat bacterial infections)
• cytostatics (used to treat aggressive tumours): when allopurinol is administered together with cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone. Therefore, blood count monitoring should be performed at regular intervals.
• didanosine (used to treat HIV infections)
• diuretics or ACE inhibitors (medicines used to treat high blood pressure).

If aluminium hydroxide (used to neutralise stomach acid) 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 the two medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take this medicine during pregnancy unless specifically recommended by your doctor.
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding.

Driving and using machines
Allopurinol Mylan may cause dizziness, drowsiness, and affect motor coordination. If you experience these symptoms, you must not drive, operate machinery, or engage in hazardous activities.

Allopurinol Mylan contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

Allopurinol Mylan 300 mg tablets also contain the yellow colouring agent sunset yellow FCF (E110) based on aluminium
This may cause allergic reactions.

3. How to take Allopurinol Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

• The breakline is not intended for dividing the tablet. The tablets must be swallowed with a glass of water. Always take the tablets after a meal to reduce the risk of side effects such as nausea and vomiting.
• If your daily dose exceeds 300 mg and you experience gastrointestinal side effects such as nausea and vomiting (see section 4), your doctor may prescribe divided doses to reduce these effects.
• Your doctor may adjust your dose if you have reduced kidney or liver function.
• When starting treatment, your doctor may also prescribe an anti-inflammatory medicine or colchicine for one month or longer to prevent gouty arthritis attacks.
• Your doctor will usually start you on a low dose of allopurinol (e.g. 100 mg/day) to reduce the risk of possible adverse effects. The dose may be increased if necessary.

Recommended doses are:
Adults and adolescents aged 15–18 years
Initial dose: 100 mg daily
The allopurinol dose may be adjusted according to the severity of the condition:

• Mild conditions: 100–200 mg daily
• Moderately severe conditions: 300–600 mg daily
• Severe conditions: 700–900 mg daily

If you have kidney problems:

• You may be advised to take 100 mg at intervals longer than one day.
• If you undergo dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg to be taken immediately after dialysis (since allopurinol is removed during dialysis).

Only for Allopurinol Mylan 100 mg tablets
Children and adolescents aged 6 to 15 years, weighing at least 15 kg
The recommended dose is 10–20 mg/kg body weight, divided into 3 daily doses.
The maximum dose is 400 mg.
Do not administer this medicine to children under 6 years of age, as its safety has not been established.
Allopurinol Mylan is rarely given to children, except in cases of certain types of cancer (e.g. leukaemia) and some other conditions.

If you take more Allopurinol Mylan than you should
If you (or someone else) swallow many tablets at the same time, or if you suspect that a child has swallowed one or more tablets, contact the nearest emergency department or your doctor immediately.
An overdose is likely to cause effects such as nausea, vomiting, diarrhoea, or dizziness.
Take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that it can be determined which tablets have been taken.

If you forget to take Allopurinol Mylan
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet. Take the remaining doses at the correct times.

If you stop taking Allopurinol Mylan
You must continue taking these tablets for the entire duration prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Allopurinol Mylan and contact a doctor immediately if you experience
any of the following side effects:
Rare (may affect up to 1 in 1,000 people)

• any skin changes, for example, mouth, throat, nose, genital ulcers, conjunctivitis (red and swollen eyes), widespread blisters and skin peeling, often preceded by flu-like symptoms such as fever and chills, headache, muscle pain (flu-like symptoms), and general feeling of illness
• severe hypersensitivity reactions with fever, skin rash, joint pain, and abnormalities in blood tests and liver function (these may be signs of a condition known as DRESS).

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

• signs of a severe allergic reaction which may be life-threatening, such as swelling of the face, lips, tongue or throat causing difficulty in breathing or swallowing, skin peeling or itching, blisters and pain in the lips and mouth, sudden shortness of breath, restlessness or chest tightness, itching and collapse. Do not take the tablets again unless your doctor tells you to.
• vomiting blood.

Contact your doctor as soon as possible if you experience any of the following side effects
Rare (may affect up to 1 in 1,000 people)

• inflammation of the liver (hepatitis) with symptoms that may include yellowing of the skin and whites of the eyes, loss of appetite, vomiting, abdominal pain, diarrhoea

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

• reduction in certain types of white blood cells in the blood, leading to frequent infections such as sore throat or high temperature (fever), or mouth and throat ulcers
• reduction in red blood cells or platelets (seen in blood tests) causing signs such as paleness, fatigue, and more frequent bleeding or bruising. These effects usually occur in people with liver or kidney problems.

Not known (frequency cannot be estimated from the available data):

• Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever, or confusion. If this occurs, seek immediate medical attention.

Other possible side effects
Common (may affect up to 1 in 10 people)

• skin rashes
• increased blood levels of thyroid-stimulating hormone (TSH), which may be observed in blood tests

Uncommon (may affect up to 1 in 100 people)

• nausea (feeling unwell), vomiting and diarrhoea
• symptoms of allergic reactions, including itchy rash
• increased values in liver function tests
• diarrhoea

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

• may affect liver or kidney function
• formation of stones in the urinary tract with symptoms that may include blood in the urine and abdominal, flank or groin pain

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

• joint pain or painful swelling in the groin, armpits or neck
• fever
• blood in the urine
• changes in normal bowel habits or unusually foul-smelling bowel movements
• excess fat in bowel movements causing diarrhoea
• high levels of fat in the blood
• general feeling of being unwell
• weakness, numbness, unsteadiness when walking, inability to move muscles (paralysis), or loss of consciousness, tingling
• seizures or depression
• headache, dizziness, drowsiness or vision disturbances
• chest pain, high blood pressure or slow pulse
• fluid retention leading to swelling (oedema), particularly in the ankles
• male infertility or inability to achieve or maintain an erection, breast enlargement in men
• changes in taste perception, mouth pain, mouth ulcers and herpes
• cataract (clouding of the lens) and other vision problems
• pustules (small, soft, red skin eruptions)
• hair loss or hair discolouration
• increased thirst, fatigue and weight loss (these may be symptoms of diabetes); your doctor may check your blood sugar levels to determine if you have diabetes
• muscle pain, joint pain
• swelling of glands, usually resolves after stopping allopurinol treatment
• presence of urea in the blood (uraemia), which may be observed in blood tests

Not known (frequency cannot be estimated from the available data):

• lichenoid skin rash (itchy, red-purple rash and/or white-grey thread-like lines on mucous membranes)

You may occasionally feel nauseous, but this can be avoided by taking allopurinol after meals. Inform your doctor if this problem persists.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Allopurinolo Mylan

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp..
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Allopurinolo Mylan contains

• The active substance is allopurinol.
• Each tablet contains 100 mg of allopurinol.
• Each tablet contains 300 mg of allopurinol.
• The other ingredients (excipients) are: monohydrate lactose (see section 2 “Allopurinolo Mylan contains lactose”), maize starch, povidone, sodium starch glycolate, aluminium lake of sunset yellow FCF (E110) (see section 2 “Allopurinolo Mylan 300 mg also contains the colouring agent aluminium lake of sunset yellow FCF (E110) and stearic acid.”

Description of the appearance of Allopurinolo Mylan and contents of the pack
Allopurinolo Mylan 100 mg tablets are white to off-white, round, biconvex, uncoated tablets, marked with “AL” and “100” separated by a score line on one side and smooth on the other side.
Allopurinolo Mylan 300 mg tablets are peach-coloured, round, biconvex, uncoated tablets, marked with “AL” and “300” separated by a score line on one side and smooth on the other side.
Allopurinolo Mylan 100 mg tablets are available in blister packs containing 20, 50, 60 and 100 tablets.
Allopurinolo Mylan 300 mg tablets are available in blister packs containing 30, 60 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Mylan S.p.a.
Via Vittor Pisani, 20
20124 Milano, Italy

Responsible Pharmacist for Batch Release
Mylan Kft, Komaron
H-2900, Komarom, Mylan utca.1,
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Allopurinolo Mylan
Norway: Allopurinol Viatris
Portugal: Alopurinol Mylan
Sweden: Allopurinol Viatris