Aglan 15

Patient Information Leaflet: Patient Information

AGLAN 15; 15 mg, tablets

Meloxicam

Read the 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Aglan 15 and what is it used for
• 2. Important information before taking Aglan 15
• 3. How to take Aglan 15
• 4. Possible side effects
• 5. How to store Aglan 15
• 6. Contents of the pack and other information

1. What is Aglan 15 and what is it used for

Aglan 15 contains 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 the joints and muscles.
Aglan 15 is intended for adults and adolescents from 16 years of age.
Aglan 15 is indicated for

• short-term treatment of exacerbations of osteoarthritis
• long-term treatment of rheumatoid arthritis
• long-term treatment of ankylosing spondylitis

2. Important information before taking Aglan 15

When not to take Aglan 15

• if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• if you have ever had wheezing, shortness of breath, asthma (difficulty breathing), nasal polyps (stuffy nose caused by swelling of the nasal mucosa) with runny nose, 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), hives during the use of acetylsalicylic acid or other anti-inflammatory drugs,
• if you have had more than two episodes of gastrointestinal ulcers (stomach or duodenal ulcers) or gastrointestinal bleeding (which may be the cause of, for example, black stools),
• if you have ever had gastrointestinal bleeding or perforation of the gastrointestinal tract associated with previous treatment with NSAIDs,
• if you have had a cerebral hemorrhage (bleeding from the brain's blood vessels) or bleeding for other reasons,
• if you have severe liver disease,
• if you have severe kidney disease and are not being treated with dialysis,
• if you have severe heart failure,
• if you are in the last 3 months of pregnancy.

Do not take Aglan 15 in children and adolescents under 16 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aglan 15.

Warnings

Taking medicines like Aglan 15 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment (see section 3).
Stop taking Aglan 15 immediately if you notice bleeding (causing black stools) or gastrointestinal ulcers (causing abdominal pain).
If you have heart disease, have had a stroke, or suspect that you are at risk of these disorders, discuss your treatment with your doctor or pharmacist.
For example, if you have

• high blood pressure (hypertension),
• high blood sugar (diabetes),
• high cholesterol (hypercholesterolemia),
• you smoke.

Meloxicam has been associated with potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially appear as red spots or round patches on the torso, often with central blisters.
Additional symptoms that may be observed include ulcers in the mouth, throat, nose, genitals, and 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 of the skin.
The highest risk of severe skin reactions occurs in the first few weeks of treatment.
In patients who have developed Stevens-Johnson syndrome, toxic epidermal necrolysis while taking meloxicam, meloxicam should never be restarted.
If a rash or the above symptoms occur, stop taking meloxicam and seek medical advice immediately, informing your doctor that you are taking this medicine.
Before starting to take Aglan 15, discuss this with your doctor or pharmacist if you have ever had a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g. piroxicam), such as round or oval, red and swollen patches on the skin, usually recurring in the same place (in the same places), blisters, hives, and itching.
Aglan 15 is not suitable for the treatment of acute pain attacks.
Aglan 15 may mask the symptoms of an infection (e.g. fever). If you suspect you have an infection, contact your doctor.

Precautions for use

Due to the need to adjust the treatment, consult your doctor before starting to take Aglan 15 if you have

• a history of esophagitis, gastritis, or any other gastrointestinal disease, such as ulcerative colitis, Crohn's disease;
• high blood pressure (hypertension);
• you are elderly;
• decreased blood volume (hypovolemia), which may occur in the case of significant blood loss or severe burns, after surgical procedures, or inadequate fluid intake;
• heart, liver, or kidney disease;
• high blood sugar (diabetes);
• high potassium levels in the blood, previously diagnosed by a doctor;

In these cases, your doctor will monitor the treatment results.

Aglan 15 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including

• other anti-inflammatory medicines, including acetylsalicylic acid;
• corticosteroids (e.g. used as anti-inflammatory or to treat allergic reactions);
• medicines that prevent blood clots, such as warfarin or medicines that dissolve clots (thrombolytics);
• potassium salts - used to treat low potassium levels in the blood
• trimethoprim - used to treat urinary tract infections
• selective serotonin reuptake inhibitors (SSRIs, medicines used to treat depression and other mental disorders);
• medicines used to treat high blood pressure (e.g. beta blockers) and diuretics. Your doctor may monitor kidney function if you are taking diuretics;
• calcineurin inhibitors (e.g. cyclosporine, tacrolimus) - medicines often used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome;
• deferazirox - a medicine used to remove excess iron from the body;
• lithium - a medicine used to treat mood disorders;
• methotrexate - a medicine used mainly to treat cancer or severe skin diseases and active rheumatoid arthritis;
• pemetrexed - a medicine used to treat cancer;
• cholestyramine - mainly used to lower cholesterol levels;
• oral anti-diabetic medicines (sulfonylurea derivatives, nateglinide) - used to treat diabetes. Your doctor should ensure regular monitoring of your blood sugar levels to detect 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 or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will only prescribe this medicine in the first and second trimester of pregnancy if the benefits to you outweigh the risks. In this case, you should be given the lowest possible dose for the shortest possible time,
Do not take Aglan 15 if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery. It may cause problems with the baby's kidneys and heart. It may increase the risk of bleeding in you and your baby and cause prolongation or delay of labor. Do not take Aglan 15 during the first 6 months of pregnancy unless your doctor considers it absolutely necessary.
If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Aglan 15 may cause kidney problems in the unborn baby, which can 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 than a few days, your doctor may recommend additional monitoring.
If you have taken this medicine during pregnancy, tell your doctor/midwife immediately so that you can be closely monitored if necessary.
Breastfeeding
This medicine is not recommended during breastfeeding.
Fertility
Aglan 15 may make it more difficult for women to become pregnant.

Driving and using machines

Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo (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 15 contains lactose monohydrate and sodium

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Aglan 15

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
To take a dose of 7.5 mg, take half a tablet of Aglan 15. The Aglan 15, 15 mg tablet can be divided into equal doses.

Recommended doses for adults and adolescents over 16 years of age are as follows:

Exacerbations of osteoarthritis:
7.5 mg per day, if necessary the dose can be increased to 15 mg per day
Rheumatoid arthritis:
15 mg per day, however the dose can be reduced to 7.5 mg per day if necessary.
Ankylosing spondylitis:
15 mg per day, however the dose can be reduced to 7.5 mg per day if necessary.
Special patient groups
In elderly patients, with liver or kidney function disorders, or in patients with an increased risk of side effects (regarding all diseases listed under "Warnings and precautions") your doctor may reduce the dose to 7.5 mg once a day.
Use in children and adolescents
Aglan 15 should not be used in children and adolescents under 16 years of age.
DO NOT EXCEED THE MAXIMUM DAILY DOSE OF 15 MG.
The entire daily dose should be taken in a single dose once a day.
Take the tablet with food, swallow it with water or another liquid.
If you think that the effect of Aglan 15 is too strong or too weak, or if you do not feel any improvement after a few days, contact your doctor or pharmacist.

Overdose of Aglan 15

If you have taken more than the recommended dose of Aglan 15, contact your doctor immediately.
Symptoms of overdose are: lack of energy (lethargy), drowsiness, nausea, vomiting, abdominal pain (epigastric pain).
These symptoms usually disappear after stopping Aglan 15. You may experience gastrointestinal bleeding (gastrointestinal bleeding).
Severe poisoning can lead to increased blood pressure (hypertension), acute kidney failure, liver dysfunction, respiratory depression, loss of consciousness (coma), seizures (convulsions), and circulatory collapse (cardiovascular collapse), cardiac arrest, immediate allergic reactions (hypersensitivity), including fainting, shortness of breath, skin reactions.

Missed dose of Aglan 15

Do not worry if you miss a dose. Skip the missed dose and take the next dose of the medicine at the right time according to the dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping treatment with Aglan 15

Stopping treatment prematurely may lead to a relapse or worsening of the disease and/or its symptoms, which were the reason for starting treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical help immediately and stop taking Aglan 15if you experience

• any allergic reactions (hypersensitivity), which may manifest as
• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be life-threatening (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 patches, red or purple stripes or blisters on the skin. It can 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 attacks.
• liver inflammation. This can cause symptoms such as
• yellowing of the skin and eyes (jaundice),
• abdominal pain,
• loss of appetite.

any symptoms of gastrointestinal disorders, in particular

• bleeding (causing black stools).
• gastrointestinal ulcers (causing abdominal pain).

Gastrointestinal bleeding (gastrointestinal bleeding), ulcers, or perforation of the gastrointestinal tract can sometimes be severe and potentially 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.
Common side effects of non-steroidal anti-inflammatory drugs (NSAIDs)
Taking some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombotic events (arterial thrombotic events), such as myocardial infarction or stroke (apoplexy), especially when the medicine is used in high doses and for long-term treatment.
NSAID therapy has been associated with fluid retention (edema), high blood pressure (hypertension), and heart failure.
The most commonly observed side effects are related to the gastrointestinal tract (stomach and intestine disorders):

• stomach and duodenal ulcers (gastric and duodenal ulcers),
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting,
• diarrhea (diarrhea),
• bloating,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black stools due to gastrointestinal bleeding,
• bloody vomiting,
• mouth ulcers (ulcerative stomatitis),
• worsening of inflammatory bowel disease (e.g. exacerbation of ulcerative colitis or Crohn's disease). Rarely, gastritis has been observed.

Side effects of meloxicam - the active substance of Aglan 15:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• headache.

Uncommon: may affect up to 1 in 100 people

• dizziness (dizziness),
• vertigo (vertigo or vestibular origin),
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• high blood pressure (hypertension),
• flushing (flushing),
• fluid and sodium retention,
• high potassium levels (hyperkalemia). This can lead to symptoms such as
• heart rhythm disorders (arrhythmia),
• palpitations (feeling of heartbeat),
• muscle weakness,
• bloating,
• gastritis,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reactions (hypersensitivity),
• itching,
• skin rash,
• edema due to fluid retention, including ankle or foot swelling (peripheral edema),
• 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),
• temporary changes in liver function tests (e.g. increased activity of liver enzymes, such as transaminases, or increased bilirubin levels). Your doctor may detect these changes with a blood test,
• kidney function disorders confirmed by laboratory tests (e.g. increased creatinine or urea levels).

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

• mood disorders,
• nightmares,
• blood disorders, including
• abnormal blood test results,
• low white blood cell count (leukopenia),
• low platelet count (thrombocytopenia). These side effects can increase the risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus),
• palpitations (palpitations),
• gastric or duodenal ulcers (gastric and duodenal ulcers),
• esophagitis,
• asthma attacks (in aspirin-sensitive or other NSAID-sensitive patients),
• blistering of the skin or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• visual disturbances, including
• blurred vision,
• conjunctivitis (conjunctival inflammation or eyelid inflammation),
• colitis.

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 patches, 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 can 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

• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid reactions), sun-induced skin reactions (photosensitivity reactions),
• heart failure reported in association with NSAID treatment,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Aglan 15 with other medicines that may have a bone marrow suppressive effect (myelotoxic agents). This can cause
• sudden fever,
• sore throat,
• infections,
• pancreatitis.
• 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).

Side effects of non-steroidal anti-inflammatory drugs (NSAIDs) that have not been reported with Aglan 15:

Acute kidney failure due to changes in kidney structure:

• very rare cases of kidney inflammation (interstitial nephritis),
• death of some kidney cells (acute tubular necrosis),
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +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.
Side effects can also be reported to the marketing authorization holder.

5. How to store Aglan 15

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage precautions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Aglan 15 contains

The active substance is meloxicam in a quantity of 15 mg per tablet.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, sodium citrate dihydrate, crospovidone (type A).

What Aglan 15 looks like and contents of the pack

Aglan 15: light yellow, round, biconvex tablets with beveled edges, with the inscription "B" and "19" on both sides of the dividing line on one side, smooth on the other.
The tablet can be divided into equal doses.
Aglan 15, 15 mg, tablets are available in blisters of 10 tablets.
Pack sizes: Aglan 15: 10, 20, 30, 60, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
This medicine is authorized in the Member States of the European Economic Area under the following names:
Czech Republic: RECOXA 15
Poland: AGLAN 15
Estonia: Recoxa
Latvia: Recoxa 15 mg tablets
Lithuania: Recoxa 15 mg tablets

For further information on this medicine, please contact:

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