Aglan

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Aglan (Recoxa)
15 mg/1.5 ml, solution for injection
Meloxicam
Aglan and Recoxa are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Aglan is and what it is used for
2. Important information before using Aglan
3. How to use Aglan
4. Possible side effects
5. How to store Aglan
6. Contents of the pack and other information

1. What Aglan is and what it is used for

Aglan is a medicine containing the active substance meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.
Aglan is intended for short-term treatment of acute flare-ups of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis (also known as Bechterew's disease) in cases where oral or rectal administration of meloxicam is not possible.
Aglan is intended for use in adult patients.

2. Important information before using Aglan

When not to use Aglan

• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• In patients with allergy (hypersensitivity) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• If any of the following symptoms occurred after taking acetylsalicylic acid or other NSAIDs:
  • Wheezing, tightness in the chest, shortness of breath (asthma);
  • Nasal congestion due to swelling of the nasal mucosa (nasal polyps);
  • Skin rash and/or urticaria;
  • Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may possibly make breathing difficult (angioedema);
• In patients with bleeding disorders or those being treated with anticoagulant medicines;
• If there has ever been gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs;
• In patients who currently have or have previously had stomach or intestinal ulcers or gastrointestinal bleeding (ulceration or bleeding occurred at least twice);
• If the patient has recently experienced bleeding in the brain or bleeding from any other cause;
• If the patient has severe liver function impairment;
• In non-dialysed patients with severe renal failure;
• In patients with severe heart failure;
• In pregnant women during the last three months of pregnancy;
• In children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Aglan, discuss with your doctor:

• If you have previously had oesophagitis, gastritis or any other gastrointestinal disorder, e.g. Crohn's disease or ulcerative colitis.
• In case of heart disease:
  • Treatment with medicines such as Aglan may be associated with a small risk of heart attack ("myocardial infarction") or stroke ("apoplexy"). Any risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment (see section 3 "How to use Aglan").
• In case of heart disease, previous stroke or suspected risk of these conditions (e.g. the patient has high blood pressure, diabetes, high cholesterol levels or smokes), discuss the treatment approach with your doctor or pharmacist.
• If skin disorders occur:
  • Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with meloxicam. These typically begin as red spots or circular lesions on the trunk, often with central blisters. Additional symptoms may include ulcers in the mouth, throat, nose, or genital organs, and conjunctivitis (red, swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or detachment of the skin. The highest risk of severe skin reactions occurs during the first weeks of treatment.
• In patients who have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Aglan, treatment with Aglan must never be resumed.
• If a skin rash or any of the above-mentioned skin symptoms occur, discontinue Aglan immediately and seek medical advice without delay, informing the doctor about taking this medicine.
• If the patient has ever developed fixed drug eruption (persistent redness) after taking meloxicam or other oxicams (e.g. piroxicam) [circular or oval, red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria and itching].
• In case of impaired liver or kidney function.
• In case of reduced blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgery, or low fluid intake.
• If the patient has previously been diagnosed by a doctor with high blood potassium levels.
• In case of high blood pressure (hypertension).
• If the patient is elderly.
• If the patient has diabetes or is taking medicines known to increase blood potassium levels. The doctor will monitor the patient's condition during treatment.

Frail patients and those of smaller build may have poorer tolerance to potential adverse effects and should be under close medical supervision.
Aglan is not suitable for the treatment of acute pain.
Aglan may mask signs of infection (e.g. fever). If the patient suspects an infection, they should contact a doctor.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
If gastrointestinal bleeding or ulceration occurs in patients taking Aglan, treatment must be discontinued.

Aglan and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used or planned to be used.
In particular, before using Aglan, inform your doctor about all medicines currently used or recently used:

• Other non-steroidal anti-inflammatory drugs (NSAIDs);
• Medicines preventing blood clotting, such as warfarin, heparin administered by injection, antiplatelet agents such as acetylsalicylic acid;
• Medicines that dissolve blood clots (thrombolytics);
• Corticosteroids (e.g. used for anti-inflammatory or allergic reaction treatment);
• Cyclosporine, tacrolimus – used after organ transplantation or in severe skin diseases, rheumatoid arthritis or nephrotic syndrome;
• Trimethoprim (antibiotic) – used to treat urinary tract infections;
• Diuretics. The doctor may monitor kidney function if the patient is taking diuretics;
• Medicines lowering blood pressure (e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers);
• Lithium – used in the treatment of mood disorders;
• Selective serotonin reuptake inhibitors (SSRI) used to treat depression or other psychiatric disorders;
• Deferasirox (used to remove excess iron from the body);
• Methotrexate – used in the treatment of cancers, severe skin diseases or active rheumatoid arthritis;
• Pemetrexed (used in cancer treatment);
• Cholestyramine (used to lower cholesterol levels);
• Oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) – used in diabetes treatment. The doctor should ensure regular monitoring of the patient's blood glucose levels for possible hypoglycemia.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Aglan must not be used if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleed in both the mother and the child and may delay or prolong labour. Aglan should not be used during the first 6 months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose and the shortest possible duration should be used. From the 20th week of pregnancy, Aglan may cause kidney dysfunction in the unborn child; if taken for longer than a few days, it may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
If you have taken this medicine during pregnancy, you must speak immediately with your doctor and/or midwife so that appropriate monitoring can be considered.

Breastfeeding
The use of Aglan during breastfeeding is not recommended.

Fertility
Aglan may make it more difficult to become pregnant. Inform your doctor if you are planning to become pregnant or if you are experiencing difficulty becoming pregnant.

Driving and operating machinery
Visual disturbances, drowsiness, dizziness (of labyrinthine origin) or other central nervous system disorders may occur after using this medicine. If these symptoms occur, do not drive or operate machinery.

Aglan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ampoule, meaning the medicine is considered "sodium-free".

3. How to use Aglan

The injection must be administered only by qualified medical personnel.
The medicine will be injected slowly into the buttock. If the patient receives more than one injection,
the doctor will administer the injections alternately on the right and left side.
In case of hip joint replacement, the injection should be given on the opposite side.
If severe pain occurs during the injection, the doctor should discontinue administering the medicine.
Administration is limited to one injection per day to initiate treatment. This may be increased in exceptional
cases (when oral or rectal administration is not possible) for 2 to 3 days.
In patients at increased risk of adverse reactions, treatment should be initiated at a dose of 7.5 mg per day.
The daily dose of meloxicam should not exceed 15 mg.

Elderly patients
In elderly patients, the recommended daily dose is 7.5 mg (half an Aglan vial).

Patients at increased risk of adverse reactions
In patients at increased risk of adverse reactions, treatment should be initiated at a dose of 7.5 mg per day (half an Aglan vial).

Renal function impairment
In dialyzed patients with severe renal function impairment, the daily dose should not exceed 7.5 mg (half an Aglan vial). Dose reduction is not necessary in patients with mild or moderate renal impairment.

Hepatic function impairment
Dose reduction is not necessary in patients with mild or moderate hepatic function impairment.

Use in children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.

Use of a higher than recommended dose of Aglan
If a higher than recommended dose of Aglan is used, contact a doctor immediately.
Symptoms of overdose include: fatigue, drowsiness, nausea and vomiting, abdominal pain.
Severe poisoning may lead to serious adverse effects (see section 4):

• increased blood pressure (hypertension),
• acute renal failure,
• hepatic function disorders,
• shallow breathing or respiratory arrest (respiratory depression),
• loss of consciousness (coma),
• epileptic seizures (convulsions),
• circulatory collapse (cardiovascular collapse),
• circulatory collapse, cardiac arrest,
• low blood pressure, cardiac arrest,
• immediate allergic reactions (hypersensitivity), including:
• fainting,
• shortness of breath,
• skin reactions.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should seek immediate medical help and stop using Aglan if any of the following occur:

Any allergic (hypersensitivity) reactions, which may present as:

• skin reactions such as itching, blistering and peeling of the skin, which may potentially be life-threatening;
• skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue damage (lesions of mucous membranes), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple patches or blisters on the skin. It may also appear on the lips, eyes and other moist areas of the body;
• swelling of the skin or mucous membranes, such as swelling around the eyes, face and lips, inside the mouth or throat, possibly causing breathing difficulties, swelling of the ankles and legs (peripheral oedema);
• shortness of breath or asthma attack;
• hepatitis. This may cause symptoms such as:
• yellowing of the skin and whites of the eyes (jaundice);
• abdominal pain;
• loss of appetite.

Any gastrointestinal adverse effects, and in particular:

• bleeding (resulting in black, tarry stools);
• gastrointestinal ulceration (causing abdominal pain). Gastrointestinal bleeding (gastrointestinal haemorrhage), ulceration or perforation of the gastrointestinal tract may sometimes be severe and potentially fatal, especially in elderly patients.

If a patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, medical advice should be sought immediately, especially if the patient is elderly. The doctor may monitor the progress of treatment.
Do not drive or operate machinery if visual disturbances occur.
The following adverse effects may occur:

Very common (may affect more than 1 in 10 people):

• gastrointestinal disorders such as: indigestion (dyspepsia), nausea, vomiting, abdominal pain, constipation, bloating, loose stools (diarrhoea).

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

• headache,
• pain and swelling at the injection site.

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

• anaemia (reduced concentration of the red blood pigment - haemoglobin),
• sudden allergic (hypersensitivity) reactions,
• dizziness, vertigo (vestibular origin), drowsiness (somnolence),
• increased blood pressure (hypertension),
• flushing of the face and neck (transient flushing of the face and neck),
• gastrointestinal bleeding,
• inflammation of the oral mucosa,
• gastritis,
• belching,
• transient abnormalities in liver function tests (e.g. increased activity of liver enzymes such as aminotransferases or increased concentration of the bile pigment bilirubin). These changes may be detected by the doctor through blood tests,
• itching (pruritus), skin rash,
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, possibly causing breathing difficulties (angioedema),
• renal function impairment confirmed by laboratory tests (e.g. increased creatinine or urea concentration),
• fluid and sodium retention,
• increased potassium levels (hyperkalaemia). This may lead to symptoms such as:
• heart rhythm disturbances (arrhythmia),
• palpitations (when the patient feels the heartbeat more than usual),
• muscle weakness,
• oedema due to fluid retention, including swelling of the ankles and (or) legs (peripheral oedema).

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

• blood morphology disorders, including:
• abnormal blood smear results,
• reduced white blood cell count (leukopenia),
• reduced platelet count (thrombocytopenia). These adverse effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds,
• mood changes, nightmares,
• visual disturbances, including:
• blurred vision,
• conjunctivitis (inflammation of the eyeball or eyelids),
• ringing in the ears (tinnitus),
• palpitations,
• asthma attacks (in patients hypersensitive to acetylsalicylic acid or other NSAIDs),
• colitis,
• peptic ulcer disease of the stomach or upper part of the small intestine (ulceration of the stomach and (or) duodenum),
• oesophagitis,
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, see section 2),
• urticaria.

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

• blistering skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple patches or blisters on the skin. It may also appear on the lips, eyes and other moist areas of the body,
• hepatitis. This may cause symptoms such as:
• yellowing of the skin and whites of the eyes (jaundice),
• abdominal pain,
• loss of appetite,
• acute renal failure (kidney failure), particularly in patients with risk factors such as heart disease, diabetes or kidney disease,
• intestinal wall perforation.

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

• shallow breathing and skin reactions (anaphylactic and/or anaphylactoid reactions),
• confusion, disorientation,
• skin rashes caused by exposure to sunlight (photosensitivity reactions),
• pancreatitis,
• use of medicines such as Aglan may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke,
• infertility in women, delayed ovulation,
• a characteristic allergic skin reaction known as fixed drug eruption, usually recurring in the same location(s) upon re-administration of the drug,
  and may appear as itchy, round or oval, red and swollen patches on the skin, blisters (urticaria).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 .
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aglan

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep ampoules in the original outer packaging to protect from light.
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 Aglan contains
The active substance is meloxicam, 15 mg in one 1.5 ml ampoule. 1 ml of solution contains 10 mg of meloxicam.
The other ingredients are: meglumine, poloxamer 188, glycine, sodium hydroxide, sodium chloride, glycofurol, water for injections.

What Aglan looks like and contents of the pack
Aglan is a clear yellow to yellowish-green solution free from visible particles, with a pH between 8.4 and 9.2, packed in ampoules made of transparent neutral glass.
Type I ampoules with a capacity of 2 ml, containing 1.5 ml of injection solution.
Pack sizes:
5 x 1.5 ml
10 x 1.5 ml

For more detailed information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in Lithuania, country of export:
Zentiva, k.s.
U kabelovny 130
Dolní Mĕcholupy
102 37 Prague 10
Czech Republic

Manufacturer:
Zentiva, k.s.
U kabelovny 130
Dolní Mĕcholupy
102 37 Prague 10
Czech Republic

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Relabelled and/or repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Lithuania, country of export: LT/1/05/0268/011
LT/1/05/0268/012

Parallel Import Authorisation Number: 142/25

This medicinal product is authorised for sale in the European Economic Area (EEA) under the following names:
Estonia: Recoxa 10 mg/ml solution for injection
Hungary: Meloxicam-Zentiva 15 mg/ 1.5 ml oldatos injekció
Latvia: Recoxa 10 mg/ ml šķīdums injekcijām
Lithuania: Recoxa 10 mg/ ml injekcinis tirpalas
Poland: Aglan, 15 mg/1.5 ml, solution for injection