Aglan

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Aglan (Recoxa)
15 mg/1.5 ml, solution for injection
Meloxicamum
Aglan and Recoxa are different trade names of 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 pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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 relieve joint and muscle pain.
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 hives;
• sudden swelling of the skin or mucous membranes, such as swelling 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 of the gastrointestinal tract associated with previous treatment with NSAIDs;
• In patients who currently have or have previously had stomach ulcers 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 this 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:
• taking 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 suspicion of risk of these disorders (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 the use of meloxicam. These initially appear as red spots or circular patches on the trunk, often with central blisters. Additional symptoms may include mouth ulcers, throat, nose, genital organs, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to generalized blisters or skin detachment. The highest risk of severe skin reactions occurs during the first weeks of treatment.
• In patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Aglan, treatment with Aglan must never be restarted.
• In case of skin rash or the above-mentioned skin symptoms, discontinue use of Aglan and seek immediate medical advice, informing the doctor about taking this medicine.
• If the patient has ever developed a persistent erythema (rash) after taking meloxicam or other oxicams (e.g. piroxicam) [circular or oval, red and swollen patches on the skin, usually recurring in the same location(s), blisters, urticaria and itching].
• In case of impaired liver or kidney function.
• Reduction in circulating blood volume (hypovolemia), which may occur in case of significant blood loss or burns, after surgery or due to 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 medicines known to increase potassium levels in the blood. Your doctor will monitor your progress 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 their doctor.
Adverse effects can be minimized by using the lowest effective dose
for the shortest period necessary to relieve symptoms.
If gastrointestinal bleeding or ulceration occurs in patients taking Aglan, treatment should be discontinued.
Aglan and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used
by the patient, as well as any medicines the patient plans to use.
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 medicines, such as acetylsalicylic acid;
• medicines dissolving blood clots (thrombolytics);
• corticosteroids (e.g. used for anti-inflammatory purposes or treating allergic reactions);
• 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. Your doctor may monitor kidney function if you are taking diuretics;
• medicines lowering blood pressure (e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers);
• lithium - a medicine used to treat mood disorders;
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression or other psychiatric disorders;
• deferasirox (used to remove excess iron from the body);
• methotrexate - a medicine used to treat cancers or severe skin diseases and active rheumatoid arthritis;
• pemetrexed (a medicine used to treat cancers);
• cholestyramine (a medicine used to lower cholesterol levels);
• oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) - used to treat diabetes. Your doctor should ensure regular monitoring of the patient's blood sugar levels for the occurrence of hypoglycaemia.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a
child, she should consult her doctor before using this medicine.
Pregnancy
Do not use Aglan if the patient is in the last 3 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 cause delayed or prolonged labour. Do not use Aglan during the first 6 months of pregnancy unless your doctor considers its use absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest dose and for the shortest possible duration. From week 20 of pregnancy, Aglan may cause kidney function disorders in the unborn child if taken for longer 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 longer 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
Use of Aglan during breastfeeding is not recommended.
Fertility
Aglan may make it more difficult to get pregnant. You should inform your doctor if you are planning
to become pregnant or if you are having difficulty getting 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, i.e. this medicine is considered "sodium-free".

3. How to use Aglan

The injection must be administered only by qualified medical personnel.
The medicine will be slowly injected into the buttock. If the patient is to receive more than one injection,
the doctor will administer the injections alternately on the right and left side.
In case of hip joint replacement, the doctor should administer the injection on the opposite side.
If severe pain occurs during injection, the doctor should discontinue administration of the medicine.
Administration is limited to one injection per day to initiate treatment. This may be extended 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 ampoule of Aglan).

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 ampoule of Aglan).

Patients with renal impairment
In dialysed 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.

Hepatic impairment
Dose reduction is not necessary in patients with mild or moderate hepatic 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: loss of energy, 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 dysfunction,
• shallow breathing or respiratory arrest (respiratory depression),
• loss of consciousness (coma),
• seizures (convulsions),
• circulatory collapse (cardiovascular collapse),
• circulatory collapse, cardiac arrest,
• drop in blood pressure, cardiac arrest,
• immediate allergic (hypersensitivity) reactions, including:
• fainting,
• shortness of breath,
• skin reactions.

If you have any further questions about 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.
Seek immediate medical attention and discontinue use of Aglan if any of the following occur:

Any allergic (hypersensitivity) reactions, which may manifest 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 (mucosal lesions), 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, mouth or throat, which may make breathing difficult, swelling of the ankles and legs (peripheral edema);
• 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, particularly:

• Bleeding (resulting in black, tarry stools);
• Gastrointestinal ulceration (causing abdominal pain). Gastrointestinal bleeding (gastrointestinal hemorrhage), ulcer formation, or gastrointestinal perforation may sometimes be severe and potentially fatal, especially in elderly patients.

If the 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 physician may monitor treatment progress.
Do not drive or operate machinery if experiencing visual disturbances.

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 (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 concentration of the red blood pigment – hemoglobin),
• Acute 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 levels of the bile pigment bilirubin). These changes may be detected by the physician through blood tests,
• Itching (pruritus), skin rash,
• Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, potentially impairing breathing (angioedema),
• Renal 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 disturbances (arrhythmia),
• Palpitations (when the patient feels heartbeat more than usual),
• Muscle weakness,
• Swelling due to fluid retention, including swelling of the ankles and/or legs (peripheral edema).

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

• Blood morphology disorders, including:
• Abnormal blood smear results,
• Decreased white blood cell count (leukopenia),
• Decreased platelet count (thrombocytopenia). These adverse effects may increase the 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 individuals hypersensitive to acetylsalicylic acid or other NSAIDs),
• Colitis,
• Peptic ulcer disease of the stomach or upper part of the small intestine (gastric and/or duodenal ulcer),
• Esophagitis,
• 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):

• Bullous 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 occur 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 kidney failure (renal failure), particularly in patients with risk factors such as heart disease, diabetes, or kidney disease,
• Perforation of the intestinal wall.

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

• Shortness of breath and skin reactions (anaphylactic and/or anaphylactoid reactions),
• Confusion, disorientation,
• Sunlight-induced skin rashes (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-exposure to the drug, which may appear as itchy, round or oval, red and swollen skin lesions, blisters (urticaria).

Reporting of adverse effects
If any adverse effects occur, including those 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 sewage systems or household waste. Ask a pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Aglan contains
The active substance is meloxicam, 15 mg in each 1.5 ml ampoule. 1 ml of solution contains 10 mg of meloxicam.
The other components 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 without visible particles, with a pH between 8.4 and 9.2, packed in colourless glass ampoules.
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 marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Latvia, 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

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Latvia, country of export: 09-0195
Parallel import authorisation number: 201/25

This medicinal product is authorised for sale in the European Economic Area (EEA) under the following names:
Estonia: Recoxa 10 mg/ml süstelahus
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