AGLAN 15 mg Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Aglan
3. 15 mg/1.5 ml, Solution for Injection
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Aglan and what is it used for
5. Important information before using Aglan
   1. When not to use Aglan
   2. Warnings and precautions
   3. Aglan and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Pregnancy
   6. Breastfeeding
   7. Fertility
   8. Driving and using machines
   9. Aglan contains sodium
6. How to use Aglan
   1. Elderly patients
   2. Patients at increased risk of side effects
   3. Patients with renal impairment
   4. Liver function disorders
   5. Use in children and adolescents
   6. Overdose of Aglan
7. Possible side effects
   1. Very common (may affect more than 1 in 10 people):
   2. Common (may affect up to 1 in 10 people):
   3. Uncommon (may affect up to 1 in 100 people):
   4. Rare (may affect up to 1 in 1,000 people):
   5. Very rare (may affect up to 1 in 10,000 people):
   6. Frequency not known (frequency cannot be estimated from the available data):
   7. Reporting side effects
8. How to store Aglan
9. Contents of the pack and other information
   1. What Aglan contains
   2. What Aglan looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. For more information about this medicine, please contact:

Package Leaflet: Information for the User

Aglan

15 mg/1.5 ml, Solution for Injection

Meloxicam

Read the package leaflet carefully before using 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 medicines called nonsteroidal 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 you are 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 NSAIDs; if any of the following symptoms have occurred after taking acetylsalicylic acid or other NSAIDs:
• wheezing, feeling of 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 make breathing difficult (angioedema);
• In patients with bleeding disorders or being treated with anticoagulant medications;
• If you have ever had bleeding from the gastrointestinal tract or perforation of the gastrointestinal tract associated 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 you have recently had bleeding in the brain or bleeding for any other reason;
• If you have 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, discuss with your doctor:

• if you have a history of 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 increased risk of heart attack (myocardial infarction) or stroke. 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 disorders (e.g., the patient has high blood pressure, diabetes, high cholesterol, or smokes), discuss treatment with your doctor or pharmacist.
• If skin diseases occur:
• With meloxicam, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as reddish spots or round patches on the torso, often with central blisters. Additional symptoms that may be observed include ulcers in the mouth, throat, nose, and genitals, 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 skin 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 resumed.
• If a rash or the above-mentioned skin symptoms occur, discontinue Aglan and seek medical attention immediately, informing your doctor that you are taking this medicine.
• If the patient has ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam) [round or oval, reddened and swollen spots 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 signs 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, before using Aglan, inform your doctor about all medicines you are currently taking or have recently taken:

• other nonsteroidal 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 the patient is taking diuretics;
• medicines that lower blood pressure (e.g., beta blockers, 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 signs of hypoglycemia.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice 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 baby or cause problems during delivery. It may cause kidney or heart problems in the unborn baby. It may increase the risk of bleeding in the mother and child and prolong 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 lowest dose and shortest possible duration should be used. From the 20th week of pregnancy, Aglan may cause kidney problems in the unborn baby if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
If you have taken this medicine during pregnancy, you must immediately discuss this with 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 are planning 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 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, which means it is essentially 'sodium-free'.

3. How to use Aglan

Injection should only be performed 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 the 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 function disorders

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

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, contact your doctor immediately.
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),
• circulatory collapse (cardiovascular collapse),
• circulatory failure, cardiac arrest
• drop in blood pressure, cardiac arrest
• immediate allergic reactions (hypersensitivity), including:
• fainting
• shortness of breath
• skin reactions.

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

4. Possible side effects

Like all medicines, Aglan can cause side effects, although not everybody gets them.
Seek medical attention immediately and discontinue 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), 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 may also occur on the lips, eyes, and other moist body parts;
• 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 hemorrhage), ulceration, or perforation of the gastrointestinal tract may sometimes have a severe course and can be life-threatening, especially in the elderly.

If you have previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, seek medical attention immediately, especially if you are elderly. Your doctor may monitor your progress.

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 (transient flushing of the face and neck)
• gastrointestinal bleeding,
• mouth ulcers,
• gastritis,
• regurgitation,
• temporary 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 the patient feels their 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),
• feeling of heartbeat (palpitations),
• asthma attacks (in people with hypersensitivity to acetylsalicylic acid or other NSAIDs),
• ulcerative colitis,
• gastric or duodenal ulcer disease (gastric or duodenal ulcer),
• 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 may 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, reddened and swollen spots on the skin, blisters (hives).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. 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.: 22 49 21 301, fax: 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.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Aglan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (after "EXP").
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C. Ampoules should be stored in the original outer packaging to protect from light.
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 Aglan contains

The active substance of Aglan is meloxicam, 15 mg in one 1.5 ml ampoule.
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 solution without visible particles, with a pH between 8.4 and 9.2, packaged in transparent neutral glass ampoules.
Ampoules of type I with a capacity of 2 ml, containing 1.5 ml of solution for injection.
Pack sizes:
5 x 1.5 ml
10 x 1.5 ml
Not all pack sizes may be marketed.

Marketing authorization holder:

Zentiva k.s., U kabelovny 130, Dolni M ě cholupy, 102 37 Prague, Czech Republic

Manufacturer:

Zentiva k.s., U kabelovny 130, Dolni M ě cholupy, 102 37 Prague, Czech Republic

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 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

For more information about this medicine, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:October 2023