Adnamil

Package leaflet: Information for the user

Adnamil, 100 mg, tablets
Adnamil, 300 mg, tablets
Allopurinolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Adnamil is and what it is used for

Allopurinol, the active substance in Adnamil, and its main metabolite, oxypurinol, reduce serum and urinary uric acid concentrations by inhibiting xanthine oxidase, the enzyme responsible for the oxidation of hypoxanthine to xanthine and xanthine to uric acid.
Adnamil is indicated to reduce the production of urates/uric acid in diseases where deposition has already occurred (e.g. gouty arthritis, tophi, kidney stones) or in clinical conditions where such risk exists (e.g. cancer treatment potentially leading to acute uric acid nephropathy).
The main clinical conditions in which urate/uric acid deposition may occur include:

• Primary gout
• Uric acid kidney stones
• Acute uric acid nephropathy
• Malignant diseases and myeloproliferative syndromes with rapid cell turnover, in which elevated urate levels occur spontaneously or are induced by cytotoxic therapy
• Disorders of certain enzyme functions leading to overproduction of urates, e.g.:
  • Hypoxanthine-guanine phosphoribosyltransferase (e.g. Lesch-Nyhan syndrome);
  • Glucose-6-phosphatase (e.g. glycogen storage disease);
  • Phosphoribosylpyrophosphate synthetase;
  • Phosphoribosylpyrophosphate amidotransferase;
  • Adenine phosphoribosyltransferase.

Adnamil is indicated in the treatment of kidney stones composed of 2,8-dihydroxyadenine (2,8-DHA) resulting from reduced adenine phosphoribosyltransferase activity.
Adnamil is indicated in the treatment of recurrent calcium oxalate kidney stones associated with hyperuricosuria, when dietary, fluid, and other treatments have proven ineffective.

2. Important information before using Adnamil

When not to use Adnamil

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

Warnings and precautions
Before starting treatment with Adnamil, discuss this with your doctor or pharmacist if the
patient:

• is of Chinese, African or Indian origin;
• has impaired liver or kidney function. The doctor may prescribe a lower dose of the medicine or recommend taking the medicine less frequently than daily. The patient's condition will also be closely monitored;
• has heart problems or high blood pressure and is taking diuretics and/or medicines called ACE inhibitors;
• is currently experiencing a gout attack;
• has thyroid disorders.

If in doubt whether any of the above conditions apply, consult your doctor or pharmacist before starting allopurinol.

Special caution is required during treatment with Adnamil
Severe skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported during treatment with allopurinol.
The rash is often accompanied by ulceration of the mouth, throat, nose, genital organs and conjunctivitis (redness and swelling of the eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache and body aches (so-called flu-like symptoms). The rash may progress, leading to blistering and peeling of the skin. These severe skin reactions may occur more frequently in patients of Chinese (Han ethnic group), Thai or Korean origin. Chronic kidney disease may further increase the risk in these patients.
If a rash or any of the described skin symptoms occur, allopurinol must be discontinued immediately and the patient should contact a doctor.

In cancer diseases or in Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, adequate hydration should be ensured to dilute the urine.
If the patient has kidney stones, they may decrease in size and pass into the urinary tract.

Children
The use of this medicine in children is rarely indicated, except in certain types of cancer (particularly leukemias) and certain enzymatic disorders such as Lesch-Nyhan syndrome.

Adnamil with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take. This includes over-the-counter medicines, including herbal medicines. This is because Adnamil may affect the way certain medicines work. Likewise, some other medicines may affect the action of Adnamil.
Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• salicylates, including acetylsalicylic acid;
• theophylline, used for breathing problems;
• medicines used to treat seizures (epilepsy), phenytoin;
• vidarabine, used to treat viral infections;
• antibiotics (ampicillin, amoxicillin);
• didanosine, used to treat HIV infection;
• medicines used in cancer treatment;
• medicines used to suppress the immune response (immunosuppressants), such as 6-mercaptopurine, azathioprine and cyclosporine;
• chlorpropamide (a medicine used to treat diabetes);
• medicines used to treat heart conditions or high blood pressure, such as ACE inhibitors or diuretics;
• medicines used to thin the blood (anticoagulants), such as warfarin;
• other medicines used to treat gout.

If aluminium hydroxide is taken at the same time, allopurinol may be less effective.
An interval of at least 3 hours should be maintained between taking both medicines.
Blood count abnormalities occur more frequently when allopurinol is taken together with cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides) than when these active substances are taken separately. Therefore, regular blood morphology tests should be performed.

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 her doctor or pharmacist before using this medicine.
Allopurinol passes into breast milk. The use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
Drowsiness, dizziness or coordination disturbances may occur. If such symptoms occur, the patient should not drive or operate machinery.

Adnamil contains lactose monohydrate and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Adnamil 300 mg also contains sunset yellow (E 110)
This medicine may cause allergic reactions.

3. How to take Adnamil

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Administration method
Adnamil should be taken orally, once daily, after a meal, with a glass of water.
Recommended dose
The usual dose ranges from 100 to 900 mg per day. Treatment may be started with a low dose, which may then be increased if necessary.
In elderly patients or in patients with impaired kidney or liver function, the doctor will usually prescribe a lower dose or recommend longer intervals between doses.
In patients undergoing dialysis two or three times a week, the doctor may recommend taking the medicine at a dose of 300 or 400 mg per day, administered immediately after dialysis.
Use in children (under 15 years of age)
The usual dose ranges from 100 to 400 mg per day.
Taking more Adnamil than prescribed
If more Adnamil has been taken than prescribed, contact a doctor immediately or go to hospital. Show the doctor the medicine packaging.
Symptoms of overdose may include nausea, vomiting, diarrhoea, and dizziness.
Missed dose of Adnamil
If a dose has been missed, take the next prescribed dose as soon as possible.
If it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Adnamil
Do not stop treatment without consulting your doctor.
If you have any further doubts 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.
The following adverse reactions may occur during treatment with Adnamil:
Hypersensitivity
Uncommon (may occur in up to 1 in 100 patients):
If symptoms of hypersensitivity (allergic reaction) occur, treatment with Adnamil should be stopped immediately and a doctor should be consulted. Symptoms may include:

• skin peeling, ulceration or irritation of the lips and oral cavity,
• very rarely sudden wheezing, palpitations or chest tightness and collapse.

Rare (may occur in up to 1 in 1,000 patients):

• fever and chills, headache, muscle pain (flu-like symptoms) and general malaise,
• severe hypersensitivity reactions with fever, skin rash, joint pain and abnormal blood test results or liver function tests (these may be symptoms of multiorgan hypersensitivity),
• bleeding of the lips, eyes, oral cavity, nose or genital organs,
• any skin changes, for example ulceration of the mouth, throat, nose, genital organs and conjunctivitis (red and swollen eyes), widespread blisters or skin peeling.

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

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

In such cases, treatment should not be continued unless otherwise advised by a doctor.
Other adverse reactions
Common (may occur in up to 1 in 10 patients):

• skin rash,
• increased blood concentration of thyroid-stimulating hormone (TSH).

Uncommon (may occur in up to 1 in 100 patients):

• nausea, vomiting,
• abnormal liver function test results.

Rare (may occur in up to 1 in 1,000 patients):

• liver function disorders, such as hepatitis.

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

• Adnamil may occasionally affect the blood, which may manifest as easier than usual bruising. Sore throat or other signs of infection may also occur. These symptoms usually occur in patients with impaired liver or kidney function. Such symptoms should be reported to a doctor as soon as possible.
• treatment with Adnamil may lead to enlarged lymph nodes,
• high fever,
• blood in the urine (haematuria),
• high blood cholesterol levels (hyperlipidaemia),
• general malaise,
• weakness, numbness, instability in the legs, inability to move muscles (paralysis) or loss of consciousness,
• headache, dizziness, somnolence or visual disturbances,
• chest pain, high blood pressure or slow heart rate,
• infertility or erectile dysfunction in men,
• breast enlargement in men and women,
• gastrointestinal disturbances,
• taste disturbances,
• cataract,
• hair loss or depigmentation of hair,
• depression,
• lack of muscle coordination (ataxia),
• tingling or burning sensation of the skin (paraesthesia),
• fluid accumulation leading to swelling, particularly of the ankles,
• abnormal glucose metabolism (diabetes). The doctor may recommend testing the patient's blood sugar levels to establish a diagnosis.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 Adnamil

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Adnamil Contains

• The active substance is allopurinol. Each tablet contains 100 mg or 300 mg of allopurinol.
• Other ingredients in Adnamil 100 mg: lactose monohydrate, maize starch, povidone (K-30), sodium carboxymethyl starch (type A), maize starch (dried), stearic acid.
• Other ingredients in Adnamil 300 mg: lactose monohydrate, maize starch, povidone (K-30), sodium carboxymethyl starch (type A), sunset yellow FCF aluminium lake (E 110), maize starch (dried), stearic acid.

What Adnamil Looks Like and Contents of the Pack
Adnamil 100 mg, white or almost white tablets, round, biconvex, uncoated, with an embossed mark "AL" and "100" separated by a division line on one side and smooth on the other side.
The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.
PVDC/PVC/Aluminium blister pack in a cardboard box.
The package contains 50 tablets and a patient information leaflet.

Adnamil 300 mg, peach-coloured tablets, round, biconvex, uncoated, with an embossed mark "AL" and "300" separated by a division line on one side and smooth on the other side.
The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.
PVDC/PVC/Aluminium blister pack in a cardboard box.
The package contains 30 tablets and a patient information leaflet.

Marketing Authorisation Holder and Importer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]