Allopurinol medreg

Package leaflet: Information for the patient

Allopurinol Medreg, 300 mg, tablets
Allopurinolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Allopurinol Medreg contains the active substance allopurinol. This medicine belongs to a group of medicines called enzyme inhibitors, which regulate the rate of certain chemical reactions in the body.
Allopurinol Medreg is used in the treatment of conditions in which the body produces too much uric acid, such as: gout, certain types of kidney diseases and kidney stones, cancer, and certain enzymatic disorders leading to excessive accumulation of uric acid.

2. Important information before using Allopurinol Medreg

When not to use Allopurinol Medreg

• If the patient is allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6). This may include rash, itching or difficulty breathing.

If in doubt, consult a doctor before using the medicine.
Warnings and precautions
Before starting treatment with Allopurinol Medreg, discuss with your doctor if:

• the patient has or has had liver or kidney disease
• the patient is taking medicines (diuretics and/or medicines called ACE inhibitors) used in the treatment of heart conditions or high blood pressure
• the patient is experiencing an acute attack of gout
• the patient is of Han Chinese, African or Indian descent
• the patient has thyroid dysfunction.

Special caution is required when using Allopurinol Medreg:

• if the patient has kidney stones. Kidney stones may shrink and have a small chance of passing and blocking the urinary tract.
• skin rashes have been reported in patients taking allopurinol. Rashes may often involve ulceration of the mouth, throat, nose, genital organs and conjunctivitis (red, swollen eyes). These severe skin rashes are often preceded by flu-like symptoms such as fever, headache and body aches. The rash may lead to the development of extensive blisters and peeling of the skin. These serious skin reactions may occur more frequently in patients of Han Chinese, Thai or Korean descent. Chronic kidney disease may further increase the risk in these patients. If the patient develops a rash or skin symptoms, allopurinol treatment must be stopped immediately and medical advice sought without delay.
• if the patient has cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, adequate hydration of the patient should be ensured to dilute the urine.

Children and adolescents
Use in children and adolescents is rarely indicated, except in certain types of cancer (particularly leukemia) and certain enzymatic disorders such as Lesch-Nyhan syndrome.
Allopurinol Medreg with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is important to inform the doctor if the patient is taking any of the following medicines (if in doubt, consult the doctor):

• medicines used to reduce the immune system response (immunosuppressants), e.g. 6-mercaptopurine, azathioprine and cyclosporine
• adenine arabinoside (vidarabine), used in the treatment of herpes or chickenpox
• other medicines used to treat gout, such as probenecid
• aspirin (or similar medicines called salicylates)
• chlorpropamide, used in the treatment of diabetes
• anticoagulant medicines (blood thinners), such as warfarin
• medicines used for seizures (epilepsy), phenytoin
• theophylline, used for breathing problems
• antibiotics (ampicillin or amoxicillin)
• medicines used in cancer treatment
• didanosine, used in the treatment of HIV infection
• medicines used for heart disease or high blood pressure, such as ACE inhibitors or diuretic tablets (diuretics).

Concomitant use of aluminium hydroxide may reduce the effect of allopurinol. At least a 3-hour interval should be maintained between administration of the two medicines.
When allopurinol is given together with cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides), blood count abnormalities occur more frequently than when these active substances are administered separately.
Therefore, regular monitoring of blood counts is required.
Concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. If 6-mercaptopurine or azathioprine is used concomitantly with Allopurinol Medreg, the dose of 6-mercaptopurine or azathioprine should be reduced, as their effects may be prolonged.
This may increase the risk of serious blood disorders. In such cases, the doctor will closely monitor the patient's blood cell counts during treatment.
Seek immediate medical help if the patient notices any unexplained bruising, bleeding, fever or sore throat.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Allopurinol passes into breast milk. Allopurinol is not recommended during breastfeeding.
Driving and using machines
Allopurinol Medreg may cause drowsiness or coordination problems in some patients. Do not drive or operate machinery until the patient knows how the medicine affects them.
Allopurinol Medreg contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Allopurinol Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Allopurinol Medreg

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The dose of Allopurinol Medreg may vary significantly from person to person. Your doctor will determine the appropriate dose of Allopurinol Medreg for you.
The usual starting dose is 100 to 300 mg once daily, taken as a single dose after a meal. Tablets should be swallowed with a glass of water to aid swallowing.
The dose may be increased up to 900 mg daily, depending on the severity of the patient's condition.
Doses exceeding 300 mg should be administered in divided doses, not exceeding 300 mg at any one time.
For elderly patients or those with impaired liver or kidney function, the doctor may prescribe a lower dose or recommend taking the medicine at longer intervals. If the patient undergoes dialysis two or three times a week, the doctor may prescribe a dose of 300 or 400 mg to 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 adverse effects. If necessary, the dose will be increased gradually.

Use in children and adolescents (under 15 years of age)
The usual dose ranges from 100 to 400 mg daily.

Taking more Allopurinol Medreg than recommended
If too many tablets are taken or if the medicine is accidentally ingested by someone else, contact your doctor immediately or go to a hospital. Bring the medicine package with you. Symptoms of overdose may include nausea, vomiting, diarrhoea, and dizziness.

Missing a dose of Allopurinol Medreg
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

Stopping Allopurinol Medreg
Do not stop taking Allopurinol Medreg without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Hypersensitivity

Uncommon (may affect less than 1 in 100 patients):
Immediately contact a doctor if the patient experiences any of the following symptoms:

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

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

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

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

• severe allergic reaction causing swelling of the face or throat
• severe, potentially life-threatening allergic reaction

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

Other adverse reactions:

Common (may affect less than 1 in 10 patients):

• skin rash
• increased blood levels of thyroid-stimulating hormone

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

• feeling unwell (nausea) or vomiting
• abnormal liver function tests
• diarrhoea

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

• liver function disorders, such as hepatitis

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

• high body temperature
• blood in the urine (haematuria)
• high blood cholesterol levels (hyperlipidaemia)
• general malaise or weakness
• weakness, numbness, unsteadiness, inability to move muscles (paralysis), or loss of consciousness
• headache, dizziness, drowsiness, or visual disturbances
• chest pain (angina), high blood pressure, or slow heart rate
• fluid retention leading to swelling (oedema), especially of the ankles
• abnormal glucose metabolism (diabetes). The doctor may wish to measure blood sugar levels to help determine whether this is occurring.
• occasionally, the medicine Allopurinol Medreg may affect the blood, which may result in bruising more easily than usual, or the patient may experience a sore throat or other signs of infection. These symptoms usually occur in people with impaired liver or kidney function. Inform the doctor as soon as possible if any of these occur.
• this medicine may affect the lymph nodes
• infertility in men, erectile dysfunction
• breast enlargement in both men and women
• change in normal bowel habits
• taste disturbances
• cataract
• hair loss or discolouration
• depression
• lack of voluntary muscle coordination (ataxia)
• tingling, itching, pricking, or burning sensations of the skin (paraesthesia)

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

• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord); symptoms include neck stiffness, headache, nausea, fever, or altered consciousness. If these symptoms occur, seek immediate medical help.
• skin rash (itchy reddish-purple rash and/or white lace-like lines on mucous membranes).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Allopurinol Medreg

Keep this medicine out of the sight and reach of children.
No special storage instructions apply for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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, maize starch, povidone K30, sodium carboxymethyl starch (Type A), dried maize starch, stearic acid.

What Allopurinol Medreg looks like and contents of the pack
White or almost white, round, biconvex, uncoated tablets with a diameter of approx. 11 mm, marked
with "AL" and "300" separated by a score line on one side and smooth on the other. The score line is
provided only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
The tablets are supplied in blisters made of PVDC/PVC/Aluminium, packed in a cardboard box.
Pack sizes: 30, 50, 60, 90, 100 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:
Slovakia: Allopurinol Medreg 300 mg
Czech Republic: Allopurinol Medreg
Poland: Allopurinol Medreg
Romania: Alopurinol Gemax Pharma 300 mg tablets