Adnamil

Package Leaflet: Information for the User

Adnamil, 100 mg, tablets
Adnamil, 300 mg, tablets
Allopurinol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Adnamil and what is it used for
• 2. Important information 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 is Adnamil and what is it used for

Allopurinol, the active substance of Adnamil, and its main metabolite oxypurinol, reduce the concentration of uric acid in the blood and urine by inhibiting the activity of xanthine oxidase, an enzyme that catalyzes the oxidation of hypoxanthine to xanthine and xanthine to uric acid.
Taking Adnamil is indicated to reduce the production of uric acid in diseases where its deposition has already occurred (e.g., gouty arthritis, gouty tophi, kidney stones) or in clinical conditions where there is such a risk (e.g., cancer treatment potentially leading to acute uric acid nephropathy).
The main clinical conditions where uric acid deposition may occur are:

• primary gout
• uric acid stones
• acute uric acid nephropathy
• cancer diseases and myeloproliferative syndromes with rapid cell turnover, where increased uric acid levels occur spontaneously or are induced by cytotoxic treatment
• disorders of certain enzyme functions, leading to overproduction of uric acid, 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 for the treatment of kidney stones with 2,8-dihydroxyadenine (2,8-DHA) stones, resulting from reduced activity of adenine phosphoribosyltransferase.
Adnamil is indicated for the treatment of recurrent kidney stones, with kidney stones of mixed calcium oxalate composition, with accompanying hyperuricosuria, in cases where attempts at dietary treatment, fluids, and other methods have been ineffective.

2. Important information before taking Adnamil

When not to take Adnamil

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

Warnings and precautions

Before starting to take Adnamil, discuss it with your doctor or pharmacist if you:

• are of Chinese, African, or Indian origin;
• have liver or kidney problems. Your doctor may use a lower dose or recommend taking the medicine less often than once a day. They will also closely monitor your condition;
• have heart problems or high blood pressure and are taking diuretics and/or ACE inhibitors;
• are currently having a gout attack;
• have thyroid problems.

If you are unsure whether the above circumstances apply to you, consult your doctor or pharmacist before taking allopurinol.

Special caution when taking Adnamil

During treatment with allopurinol, severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported.
Often, the rash can involve ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes). Such severe skin reactions are often preceded by symptoms similar to the flu, such as fever, headache, body aches (so-called flu-like symptoms). The rash may progress, leading to the formation of blisters and peeling of the skin. Such severe skin reactions may occur more frequently in people of Chinese (Han ethnic group), Thai, or Korean origin. Chronic kidney disease may also increase the risk in these patients.
If a rash or skin symptoms occur, stop taking allopurinol immediately and contact your doctor.
In cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, ensure adequate hydration of the patient to dilute the urine.
If you have kidney stones, they may decrease in size and enter the urinary tract.

Children

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

Adnamil and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This includes medicines available without a prescription, including herbal medicines. This is because Adnamil may affect the way some medicines work. Also, some other medicines may affect the way Adnamil works.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• salicylates, including acetylsalicylic acid;
• theophylline, used in case of 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 weaken the immune response (immunosuppressive medicines), such as 6-mercaptopurine, azathioprine, and cyclosporine;
• chlorpropamide (a medicine used to treat diabetes);
• medicines used to treat heart problems 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 you are taking aluminum hydroxide, allopurinol may have a weaker effect.
Keep an interval of at least 3 hours between taking both medicines.
Blood disorders occur more frequently when allopurinol is taken with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides) than when these active substances are taken alone. Therefore, regular blood morphology tests should be performed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Allopurinol passes into breast milk. It is not recommended to take this medicine during breastfeeding.

Driving and using machines

Drowsiness, dizziness, or coordination disorders may occur. If such symptoms occur, do not drive or operate machinery.

Adnamil contains lactose monohydrate and sodium

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Adnamil 300 mg also contains orange yellow S (E 110)

The medicine may cause allergic reactions.

3. How to take Adnamil

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Method of administration
Adnamil should be taken orally, once a day, after a meal, with a glass of water.

Recommended dose

Usual doses are between 100 and 900 mg per day. Treatment can start with a small dose of the medicine, and then, if necessary, it can be increased.
In elderly patients or patients with kidney or liver problems, the doctor usually uses a lower dose or recommends taking the medicine less often than once a day.
In the case of patients undergoing dialysis two or three times a week, the doctor may recommend taking the medicine in a dose of 300 or 400 mg per day, which is taken immediately after dialysis.

Use in children (under 15 years)

Usual doses are between 100 and 400 mg per day.

Taking a higher dose of Adnamil than recommended

In case of taking a higher dose of Adnamil than recommended, contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.
Symptoms of overdose may include nausea, vomiting, diarrhea, and dizziness.

Missing a dose of Adnamil

If you miss a dose, 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 the missed dose.

Stopping treatment with Adnamil

Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Adnamil can cause side effects, although not everybody gets them.
During treatment with Adnamil, the following side effects may occur:

Hypersensitivity

Uncommon(may affect up to 1 in 100 people):
In case of an allergic reaction (hypersensitivity), stop taking Adnamil and contact your doctor immediately. Symptoms may include:

• peeling of the skin, ulcers, or irritation of the lips and mouth,
• very rarely, sudden wheezing, palpitations, or tightness in the chest and collapse.

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

• 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 and liver function tests (may be symptoms of multi-organ hypersensitivity),
• bleeding from the lips, eyes, mouth, nose, or genitals,
• any skin changes, such as mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes), widespread blisters, or peeling of the skin.

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

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

In such cases, do not continue treatment unless your doctor advises otherwise.

Other side effects

Common(may affect up to 1 in 10 people):

• skin rash,
• increased thyroid-stimulating hormone levels in the blood.

Uncommon(may affect up to 1 in 100 people):

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

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

• liver problems, such as hepatitis.

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

• Adnamil can rarely affect the blood, which may manifest as easier bruising than usual. It may also cause sore throat or other signs of infection. These symptoms usually occur in people with liver or kidney problems. Tell your doctor as soon as possible.
• Adnamil may affect the enlargement of lymph nodes,
• high fever,
• blood in the urine (hematuria),
• high cholesterol levels in the blood (hyperlipidemia),
• general malaise,
• weakness, numbness, instability in the legs, feeling of inability to move muscles (paralysis), or loss of consciousness,
• headache, dizziness, drowsiness, or vision disorders,
• chest pain, high blood pressure, or slow heart rate,
• infertility or erectile dysfunction in men,
• breast enlargement in men and women,
• gastrointestinal disorders,
• taste disorders,
• cataracts,
• hair loss or discoloration,
• depression,
• lack of coordination (ataxia),
• tingling or burning sensation of the skin (paresthesia),
• fluid accumulation leading to swelling, especially of the ankles,
• abnormal glucose metabolism (diabetes). Your doctor may recommend checking your blood sugar levels to diagnose.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 medicine.

5. How to store Adnamil

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

6. Contents of the pack and other information

What Adnamil contains

• The active substance of Adnamil is allopurinol. One tablet contains 100 mg or 300 mg of allopurinol.
• The other ingredients of Adnamil 100 mg are: lactose monohydrate, corn starch, povidone (K-30), sodium carboxymethyl starch (type A), corn starch (dried), stearic acid.
• The other ingredients of Adnamil 300 mg are: lactose monohydrate, corn starch, povidone (K-30), sodium carboxymethyl starch (type A), orange yellow S (E 110), corn 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 the inscription "AL" and "100" 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 to make it easier to swallow, and not to divide it into equal doses.
PVDC/PVC/Aluminum blister in a cardboard box.
The pack contains 50 tablets and an information leaflet.
Adnamil 300 mg, peach-colored tablets, round, biconvex, uncoated, with the inscription "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 to make it easier to swallow, and not to divide it into equal doses.
PVDC/PVC/Aluminum blister in a cardboard box.
The pack contains 30 tablets and an information leaflet.

Marketing authorization holder and importer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: