Aglan

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging 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 drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Aglan and what is it 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 packaging and other information

1. What is Aglan and what is it used for

Aglan is a medicine that contains the active substance meloxicam. Meloxicam belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles.
Aglan is intended for short-term treatment of exacerbations 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 an allergy (hypersensitivity) to acetylsalicylic acid or other anti-inflammatory drugs (NSAIDs); if any of the following symptoms have occurred after taking acetylsalicylic acid or other NSAIDs:
• wheezing, feeling of pressure in the chest, shortness of breath (asthma);
• nasal congestion due to swelling of the nasal mucosa (nasal polyps);
• skin rash and/or hives;
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema);
• In patients with bleeding disorders or being treated with anticoagulant medications;
• If gastrointestinal bleeding or perforation has occurred with previous NSAID treatment;
• In patients who have or have had stomach or duodenal ulcers or bleeding (ulceration or bleeding has occurred at least twice);
• If the patient has recently had a brain hemorrhage or bleeding for any other reason;
• If the patient has severe liver dysfunction;
• In non-dialyzed patients with severe renal impairment;
• In patients with severe heart failure;
• In pregnant women in the last three months of pregnancy;
• In children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Aglan, you should discuss it with your doctor:

• if you have had esophagitis, gastritis, or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis.
• in case of heart disease:
• taking medicines like 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, a history of stroke, or suspected risk of these disorders (e.g., the patient has high blood pressure, diabetes, high cholesterol, or smokes), you should discuss treatment with your doctor or pharmacist.
• If skin diseases occur:
• Meloxicam has been associated with potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), initially appearing as red spots or round patches on the torso, often with central blisters. Additional symptoms that may be observed include oral, throat, nasal, and genital ulcers, as well as conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may develop into generalized blisters or peeling. The highest risk of severe skin reactions occurs in the first few weeks of treatment.
• In patients who have had Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Aglan, treatment with Aglan should never be restarted.
• If a rash or the above-mentioned skin symptoms occur, you should stop taking Aglan and seek medical attention immediately, informing your doctor that you are taking this medicine.
• If the patient has ever had a persistent drug rash (fixed drug eruption) after taking meloxicam or other oxicams (e.g., piroxicam), which is a round or oval, red, and swollen patch on the skin, usually recurring in the same place (in the same places), blisters, hives, and itching.
• In case of liver or kidney dysfunction.
• Decreased blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery, or low fluid intake.
• In case of previously diagnosed high potassium levels in the blood.
• In case of high blood pressure (hypertension).
• If the patient is elderly.
• If the patient has diabetes or is taking medications known to increase potassium levels in the blood. The doctor will monitor progress during treatment.

Weak and frail patients may exhibit poorer tolerance to potential side effects and should be under close medical supervision.
Aglan is not suitable for the treatment of acute pain.
Aglan may mask symptoms of infection (e.g., fever). If the patient suspects an infection, they should contact their doctor.
Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
In case of gastrointestinal bleeding or ulceration in patients taking Aglan, treatment should be discontinued.

Aglan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, before taking Aglan, you should inform your doctor about all medicines you are currently taking or have recently taken:

• other non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines that prevent blood clots, such as warfarin, heparin injections, antiplatelet agents, such as acetylsalicylic acid;
• medicines that dissolve blood clots (thrombolytics);
• corticosteroids (e.g., used as anti-inflammatory or to treat allergic reactions);
• cyclosporine, tacrolimus - used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome;
• trimethoprim (an antibiotic) - used to treat urinary tract infections
• diuretics. The doctor may monitor kidney function if you are taking diuretics;
• medicines that lower blood pressure (e.g., beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin II receptor inhibitors);
• lithium - a medicine used to treat mood disorders;
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression or other mental disorders;
• deferazirox (used to remove excess iron from the body);
• methotrexate - a medicine used to treat cancer or severe skin diseases and active rheumatoid arthritis;
• pemetrexed (a medicine used to treat cancer);
• cholestyramine (a medicine used to lower cholesterol levels);
• oral anti-diabetic medicines (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood sugar levels for hypoglycemia.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

Pregnancy

Aglan should not be used if you are pregnant 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 risk of bleeding in you and your child and cause delayed or prolonged labor. Aglan should not be used during the first six months of pregnancy, unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose and shortest possible duration should be used. From the 20th week of pregnancy, Aglan may cause kidney problems in the unborn child if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period than a few days, your doctor may recommend additional monitoring.
If you have taken this medicine during pregnancy, you must immediately talk to your doctor and/or midwife so that appropriate monitoring can be considered.

Breastfeeding

Using Aglan during breastfeeding is not recommended.

Fertility

Aglan may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

Visual disturbances, drowsiness, dizziness (of vestibular origin), or other central nervous system disorders may occur after taking 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, which means the medicine is considered "sodium-free".

3. How to use Aglan

The injection should only be administered 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 sides.
In case of hip replacement, the doctor should administer the injection on the opposite side. If severe pain occurs during injection, the doctor should stop 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 side effects, treatment should be started with 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 per day (half an ampoule of Aglan).

Patients at increased risk of side effects

In patients at increased risk of side effects, treatment should be started with a dose of 7.5 mg per day (half an ampoule of Aglan).

Patients with renal impairment

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

Liver dysfunction

Dose reduction is not necessary in patients with mild or moderate liver dysfunction.

Use in children and adolescents

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

Overdose of Aglan

In case of overdose of Aglan, you should immediately contact your doctor.
Symptoms of overdose are: loss of energy, drowsiness, nausea, and vomiting, abdominal pain. Severe poisoning can lead to severe side effects (see section 4):

• increased blood pressure (hypertension),
• acute kidney failure,
• liver dysfunction,
• shallow breathing or respiratory arrest (respiratory depression),
• loss of consciousness (coma),
• seizures (convulsions),
• cardiovascular collapse (cardiovascular collapse)
• circulatory collapse, cardiac arrest
• decreased blood pressure, cardiac arrest
• immediate allergic reactions (hypersensitivity), including:
• fainting
• shortness of breath
• skin reactions.

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aglan can cause side effects, although not everybody gets them.
You should seek medical attention immediately and stop using Aglan if you experience:

• anyallergic reactions (hypersensitivity), which may manifest as:
• skin reactions, such as itching, blistering, and peeling, which can be life-threatening;
• skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue damage (mucosal lesions), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin. It can also occur on the lips, eyes, and other moist body parts;

red or purple spots or patches on the skin, often with central blisters. Additional symptoms that may be observed include oral, throat, nasal, and genital ulcers, as well as conjunctivitis (red and swollen eyes);

• swelling of the skin or mucous membranes, such as swelling around the eyes, face, and lips, mouth, or throat, which may make breathing difficult, swelling of the ankles and feet (peripheral edema);
• shortness of breath or asthma attack;
• liver inflammation. This may cause symptoms such as:
• yellowing of the skin and eyes (jaundice);
• abdominal pain;
• loss of appetite.

anysymptoms of gastrointestinal disorders, in particular:

• bleeding (causing black stools);
• ulceration of the gastrointestinal tract (causing abdominal pain). Gastrointestinal bleeding (gastrointestinal bleeding), ulceration, or perforation may sometimes have a severe course and can be life-threatening, especially in elderly patients.

If you have previously had gastrointestinal disorders due to long-term use of NSAIDs, you should immediately consult your doctor, especially if you are elderly. Your doctor may monitor your progress during treatment.
In case of visual disturbances, do not drive or operate machinery.
The following side effects may occur:

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

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

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):

• anemia (reduced hemoglobin levels),
• acute allergic reactions (hypersensitivity),
• dizziness, feeling of spinning (of vestibular origin), drowsiness (somnolence),
• increased blood pressure (hypertension),
• flushing of the face and neck (transient flushing of the face and neck)
• gastrointestinal bleeding,
• oral mucosal inflammation,
• gastritis,
• belching,
• liver function test abnormalities (e.g., increased liver enzyme activity, such as transaminases, or increased bilirubin levels). Your doctor may detect these changes with a blood test,
• itching (pruritus), skin rash,
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema),
• kidney function disorders confirmed by laboratory tests (e.g., increased creatinine or urea levels),
• fluid and sodium retention,
• increased potassium levels (hyperkalemia). This may lead to symptoms such as:
• heart rhythm disorders (arrhythmia),
• palpitations (when you feel your heartbeat more than usual),
• muscle weakness,
• edema caused by fluid retention, including ankle and/or foot edema (peripheral edema).

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

• blood disorders, including:
• abnormal blood test results,
• reduced white blood cell count (leukopenia),
• reduced platelet count (thrombocytopenia). These side effects may increase the risk of infection and symptoms such as bruising or nosebleeds,
• mood changes, nightmares,
• visual disturbances, including:
• blurred vision,
• conjunctivitis (conjunctival inflammation or eyelid inflammation),
• ringing in the ears (tinnitus),
• palpitations (heart palpitations),
• asthma attacks (in people with hypersensitivity to acetylsalicylic acid or other NSAIDs),
• colitis,
• gastric or duodenal ulcer disease (gastric and/or duodenal ulceration),
• esophagitis,
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, see section 2),
• hives.

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

• skin reactions with blisters and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin. It can also occur on the lips, eyes, and other moist body parts,
• liver inflammation. This may cause symptoms such as:
• yellowing of the skin and eyes (jaundice),
• abdominal pain,
• loss of appetite,
• acute kidney failure, especially in patients with risk factors such as heart disease, diabetes, or kidney disease,
• perforation of the intestinal wall.

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

• shallow breathing and skin reactions (anaphylactic and/or anaphylactoid reactions),
• confusion, disorientation,
• skin rashes caused by sun exposure (phototoxic reactions),
• pancreatitis,
• taking medicines like Aglan may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
• infertility in women, delayed ovulation
• a characteristic skin allergic reaction known as fixed drug eruption, usually recurring in the same place (in the same places) after re-administration of the medicine and

may appear as itchy, round or oval, red, and swollen patches on the skin, blisters (hives).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aglan

This medicine should be stored out of sight and reach 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 month stated.
Store in a temperature below 25°C. Store the ampoules in the original outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aglan contains

The active substance of Aglan is meloxicam, which is present in a quantity of 15 mg in one 1.5 ml ampoule. 1 ml of the 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 greenish-yellow solution without visible particles, with a pH between 8.4 and 9.2, packaged in transparent neutral glass ampoules.
Type I ampoules with a capacity of 2 ml, containing 1.5 ml of the solution for injection.
Pack sizes:
5 x 1.5 ml
10 x 1.5 ml
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, the country of export, marketing authorization number:LT/1/05/0268/011
LT/1/05/0268/012

Parallel import authorization number: 142/25

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

Estonia:
Recoxa 10 mg/ml solution for injection
Hungary:
Meloxicam-Zentiva 15 mg/1.5 ml solution for injection
Latvia:
Recoxa 10 mg/ml solution for injection
Lithuania:
Recoxa 10 mg/ml injectable solution
Poland:
Aglan, 15 mg/1.5 ml, solution for injection

Date of approval of the leaflet: 14.04.2025

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