Allopurinol Medreg

Package Leaflet: Information for the Patient

Allopurinol Medreg, 300 mg, Tablets

Allopurinol

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Allopurinol Medreg and what is it used for
• 2. Important information before taking Allopurinol Medreg
• 3. How to take Allopurinol Medreg
• 4. Possible side effects
• 5. How to store Allopurinol Medreg
• 6. Contents of the pack and other information

1. What is Allopurinol Medreg and what is it used for

Allopurinol Medreg contains the active substance allopurinol. This medication belongs to a group of medications called enzyme inhibitors, which control the rate of certain chemical changes in the body.
Allopurinol Medreg is used to treat conditions where the body produces too much uric acid, such as gout, certain types of kidney disease and kidney stones, cancer, and certain enzymatic disorders that lead to excessive accumulation of uric acid.

2. Important information before taking Allopurinol Medreg

When not to take Allopurinol Medreg

• If the patient is allergic to allopurinol or any of the other ingredients of this medication (listed in section 6). This may be a rash, itching, or shortness of breath.

In case of doubts before taking the medication, consult a doctor.

Warnings and precautions

Before starting to take Allopurinol Medreg, discuss it with your doctor if:

• the patient has or has had liver or kidney disease
• the patient is taking medications (diuretics and/or ACE inhibitors) used to treat heart disease or high blood pressure
• the patient is experiencing an acute gout attack
• the patient is of Chinese (Han ethnic group), African, or Indian origin
• the patient has thyroid function disorders.

Be particularly careful when taking Allopurinol Medreg:

• if the patient has kidney stones. Kidney stones will decrease in size and may have a small chance of passing through and blocking the urinary tract.
• in patients taking allopurinol, skin rashes have been reported. The rash often involves ulcers of 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, body aches (symptoms similar to the flu). The rash can lead to the formation of extensive blisters and skin peeling. These serious skin reactions may occur more frequently in people of Chinese origin, belonging to the Han ethnic group, Thai, or Korean. Chronic kidney disease may also increase the risk in these patients. If the patient experiences a rash or skin symptoms, they should stop taking allopurinol and contact their doctor immediately.
• if the patient has cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, the patient should be properly hydrated to dilute the urine.

Children and adolescents

Use in children and adolescents is rarely indicated, except for certain types of cancer (especially leukemia) and certain enzymatic disorders, such as Lesch-Nyhan syndrome.

Allopurinol Medreg and other medications

Tell your doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
It is essential to inform the doctor if the patient is taking any of the following medications (in case of doubts, consult a doctor):

• medications used to reduce the immune system response (immunosuppressants), such as 6-mercaptopurine, azathioprine, and cyclosporine
• vidarabine, used to treat herpes or chickenpox
• other medications used to treat gout, such as probenecid
• aspirin (or similar medications called salicylates)
• chlorpropamide, used to treat diabetes
• blood thinners (anticoagulants), such as warfarin
• medications used to treat seizures (epilepsy), phenytoin
• theophylline, used for breathing problems
• antibiotics (ampicillin or amoxicillin)
• medications used to treat cancer
• didanosine, used to treat HIV infections
• medications used to treat heart disease or high blood pressure, such as ACE inhibitors or diuretics.

In case of concurrent administration of aluminum hydroxide, the effect of allopurinol may be reduced. There should be an interval of at least 3 hours between taking both medications.
In case of administration of allopurinol and cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides), blood morphology disorders occur more frequently than when these active substances are administered separately. Blood morphology disorders occur when allopurinol is taken concurrently with cytostatics.
Therefore, blood morphology should be regularly monitored.
Avoid concurrent administration of 6-mercaptopurine or azathioprine with allopurinol. During concurrent administration of 6-mercaptopurine or azathioprine with Allopurinol Medreg, the dose of 6-mercaptopurine or azathioprine should be reduced, as their effect will be prolonged.
This may increase the risk of serious blood disorders. In such cases, the doctor will closely monitor the patient's blood cell count during treatment.
Seek medical attention immediately if the patient notices any unexplained bruising, bleeding, fever, or sore throat.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.
Allopurinol passes into breast milk. It is not recommended to take allopurinol during breastfeeding.

Driving and using machines

Allopurinol Medreg may cause drowsiness or coordination problems in some people. Do not drive or operate machinery until the patient knows how the medication affects them.

Allopurinol Medreg contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

Allopurinol Medreg contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Allopurinol Medreg

Take this medication always exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The dose of Allopurinol Medreg that can be taken by different people may vary greatly. The doctor will decide what dose of Allopurinol Medreg is suitable for the patient.
Usually, the initial dose is 100 to 300 mg per day and can be taken as a single dose after a meal. The tablets should be swallowed with a glass of water to facilitate swallowing.
The dose can be increased to 900 mg per day, depending on the severity of the patient's condition.
Doses greater than 300 mg should be divided into doses not exceeding 300 mg at any given time.
In the case of elderly patients or patients with liver or kidney function disorders, the doctor may prescribe a lower dose or recommend taking the medication at longer intervals. If the patient is dialyzed two or three times a week, the doctor may prescribe a dose of 300 or 400 mg, which should be taken immediately after dialysis.
The doctor usually starts treatment with a low dose of allopurinol (e.g., 100 mg/day) to reduce the risk of side effects. If necessary, the dose will be increased.

Use in children and adolescents (under 15 years of age)

Usually, the dose is 100 to 400 mg per day.

Taking a higher dose of Allopurinol Medreg than recommended

In case of taking too many tablets or accidental ingestion by another person, seek medical attention immediately or go to the hospital. Bring the medication packaging with you. Symptoms of overdose may include nausea, vomiting, diarrhea, and dizziness.

Missing a dose of Allopurinol Medreg

If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Allopurinol Medreg

Do not stop taking Allopurinol Medreg without consulting your doctor first.
In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Allopurinol Medreg can cause side effects, although not everybody gets them.

Hypersensitivity

Uncommon(may affect less than 1 in 100 people):

• any type of reactions, such as skin peeling, boils, or pain in the lips and mouth
• or very rarely, sudden wheezing, fluttering, or pressure in the chest, collapse

Rare(may affect less than 1 in 1,000 people):

• fever and chills, headache, muscle aches (flu-like symptoms) and general malaise
• severe hypersensitivity reactions, such as fever, skin rash, joint pain, and abnormal blood test results and liver function tests (may be symptoms of multi-organ hypersensitivity syndrome)
• bleeding from the lips, eyes, mouth, nose, or genitals
• any skin changes, such as ulcers of the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes), widespread blisters, or skin peeling

Very rare(may affect less than 1 in 10,000 people):

• severe allergic reaction causing facial or throat swelling
• severe, potentially life-threatening allergic reaction

THESE SYMPTOMS MAY INDICATE THAT THE PATIENT IS ALLERGIC TO ALLOPURINOL MEDREG. DO NOT TAKE ANY MORE TABLETS WITHOUT CONSULTING A DOCTOR FIRST.
Other side effects:

• Common(may affect less than 1 in 10 people):
• skin rash
• increased thyroid-stimulating hormone levels in the blood

Uncommon(may affect less than 1 in 100 people):

• nausea or vomiting
• abnormal liver function test results
• diarrhea

Rare(may affect less than 1 in 1,000 people):

• liver function disorders, such as hepatitis

Very rare(may affect less than 1 in 10,000 people):

• high body temperature
• blood in the urine (hematuria)
• high cholesterol levels in the blood (hyperlipidemia)
• general malaise or weakness
• weakness, numbness, trembling, inability to move muscles (paralysis), or loss of consciousness
• headache, dizziness, drowsiness, or vision disturbances
• chest pain (angina pectoris), high blood pressure, or slow heart rate
• fluid retention leading to swelling (edema), especially of the ankles
• abnormal glucose metabolism (diabetes). The doctor may want to measure blood sugar levels to help decide if this is the case.
• Allopurinol Medreg can affect the blood, which may cause easier bruising than usual or may cause the patient to experience sore throat or other infection symptoms. These symptoms usually occur in people with liver or kidney function disorders. Inform your doctor as soon as possible.
• this medication may affect the lymph nodes
• infertility in men, erectile dysfunction
• breast enlargement, both in men and women
• change in normal bowel movements
• taste disorders
• cataract
• hair loss or discoloration
• depression
• lack of voluntary coordination of muscle movements (ataxia)
• tingling, itching, prickling, or burning sensation of the skin (paresthesia)

Frequency not known(cannot be estimated from the available data):

• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord); symptoms include stiffness of the neck, headache, nausea, fever, or changes in consciousness. Seek medical attention immediately if these symptoms occur.
• skin rash (itchy reddish-purple rash and/or white-gray thread-like lines on the mucous membranes).

Reporting side effects

If side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Allopurinol Medreg

Keep this medication out of the sight and reach of children.
There are no special storage instructions for this medication.
Do not use this medication after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Allopurinol Medreg contains

• The active substance is allopurinol. Each tablet contains 300 mg of allopurinol.
• The other ingredients are: lactose monohydrate, cornstarch, povidone K30, sodium carboxymethylcellulose (Type A), dried cornstarch, stearyl acid.

What Allopurinol Medreg looks like and contents of the pack

White or almost white, round, biconvex, uncoated tablets with a diameter of about 11 mm, with the markings "AL" and "300" separated by a dividing line on one side and smooth on the other. The dividing line on the tablet is only to facilitate breaking the tablet, if the patient has difficulty swallowing it whole.
The tablets are provided in PVDC/PVC/Aluminum blisters, in a cardboard box.
Package sizes: 30, 50, 60, 90, 100, or 120 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medication is authorized in the Member States of the European Economic Area under the following names:

Countries:

Slovakia:
Allopurinol Medreg 300 mg
Czech Republic:
Allopurinol Medreg
Poland:
Allopurinol Medreg
Romania:
Alopurinol Gemax Pharma 300 mg tablets

Date of last revision of the leaflet: 04/2025