Meloksam

Leaflet accompanying the packaging: patient information

MELOKSAM, 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.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Meloksam and what is it used for

Meloksam 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 joints and muscles.
Meloksam tablets are intended for adults and children over 16 years of age.
Meloksam is used:

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

2. Important information before taking Meloksam

When not to take Meloksam:

• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• In pregnant women in the last three months of pregnancy;
• In children and adolescents under 16 years of age;
• If the patient has experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (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 (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);
• If the patient has experienced:
• gastrointestinal bleeding or perforation after previous NSAID therapy;
• If the patient currently has peptic ulcer or gastrointestinal bleeding;
• If the patient has a history of peptic ulcer or gastrointestinal bleeding (ulcer or bleeding that has occurred at least twice);
• If the patient has severe liver dysfunction;
• In non-dialyzed patients with severe renal impairment;
• If the patient has recently experienced cerebral bleeding (cerebral hemorrhage);
• If the patient has experienced any other bleeding;
• If the patient has severe heart failure;
• If the patient has intolerance to some sugars, as the product contains lactose (see also "Meloksam contains lactose").

If the patient is unsure whether any of the above points apply to them, they should consult a doctor.

Warnings and precautions

Before starting treatment with Meloksam, the patient should discuss it with their doctor or pharmacist.

Warnings

Taking medicines like Meloksam 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 take higher doses or longer treatment than recommended (see section 3).
With the use of Meloksam, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as red spots or circular patches on the torso, often with central blisters. Additional symptoms that may be observed include mouth ulcers, 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 skin peeling. 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 Meloksam, meloxicam treatment should not be resumed.
In case of rash or the above-mentioned symptoms, the patient should stop taking Meloksam and seek medical attention immediately, informing their doctor that they are taking this medicine.
Meloksam is not recommended for the treatment of acute pain attacks.
Meloksam may mask signs of infection (e.g., fever). If the patient suspects they have an infection, they should consult a doctor.

Precautions for use

Due to the need to modify treatment, the patient should consult a doctor before starting treatment with Meloksam in the following cases:

• if the patient has a history of esophagitis, gastritis, or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis;
• high blood pressure (hypertension);
• use in the elderly;
• heart, liver, or kidney disease;
• high blood sugar levels (diabetes);
• reduced blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery, or low fluid intake;
• intolerance to certain sugars diagnosed by a doctor, as the medicine contains lactose;
• high potassium levels in the blood, previously diagnosed by a doctor.

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

Meloksam and other medicines

Meloksam may affect the action of other medicines taken, and other medicines may affect the action of Meloksam.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking any of the following medicines:

• other non-steroidal anti-inflammatory drugs (NSAIDs);
• potassium salts - used to treat low potassium levels in the blood
• tacrolimus - used after organ transplants
• trimethoprim - used to treat urinary tract infections
• anticoagulants;
• medicines that dissolve blood clots (thrombolytic medicines);
• medicines used to treat heart and kidney diseases;
• corticosteroids (e.g., used as anti-inflammatory or to treat allergic reactions);
• cyclosporine - used after organ transplantation or in case of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome;
• deferazirox - used to treat iron overload after frequent blood transfusions
• diuretics; the doctor may monitor kidney function when taking diuretics;
• medicines used to treat high blood pressure (e.g., beta-blockers);
• lithium - used to treat mental disorders;
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression;
• methotrexate - used to treat cancer or severe uncontrolled skin diseases and active rheumatoid arthritis;
• pemetrexed - used to treat cancer;
• cholestyramine - used to reduce cholesterol levels;
• oral anti-diabetic medicines (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure regular monitoring of blood sugar levels to prevent hypoglycemia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

If the patient becomes pregnant while taking Meloksam, they should inform their doctor.
Meloksam should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Meloksam should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, the medicine may cause kidney problems in the unborn child if taken for more than a few days. This 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 than a few days, the doctor may recommend additional monitoring.

Breastfeeding

This medicine is not recommended for use in breastfeeding women.

Fertility

This medicine may make it harder to get pregnant. The patient should inform their doctor if they plan to get pregnant or have problems getting pregnant.

Driving and using machines

Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system disorders may occur after taking Meloksam. If these symptoms occur, the patient should not drive or operate machinery.

Meloksam contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

Meloksam contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Meloksam

This medicine should always be taken exactly as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended doses are:

Exacerbations of osteoarthritis:

7.5 mg once a day. The dose may be increased to 15 mg once a day.

Rheumatoid arthritis:

15 mg once a day. The dose may be reduced to 7.5 mg (once a day).

Ankylosing spondylitis:

15 mg once a day. The dose may be reduced to 7.5 mg (once a day).

Do not exceed the recommended maximum dose of 15 mg per day.

If any of the conditions listed in the "Warnings and precautions" section apply to the patient, the doctor may reduce the dose to 7.5 mg per day.
Elderly patients
The recommended dose for elderly patients in long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg per day.
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.
Kidney problems
In dialyzed patients with severe renal impairment, the dose should not exceed 7.5 mg per day. Dose reduction is not necessary in patients with mild or moderate renal impairment.
Liver problems
Dose reduction is not necessary in patients with mild or moderate liver impairment.
Use in children and adolescents

Meloksam should not be used in children and adolescents under 16 years of age.

If the patient thinks that the effect of Meloksam is too strong or too weak, or if they do not feel any improvement after a few days, they should consult their doctor or pharmacist.
Method of administration
Oral use.
Tablets should be swallowed with water, during meals.
The tablet can be divided into equal doses. The tablet should be divided manually, not with sharp objects (e.g., a knife).

Taking a higher dose of Meloksam than recommended

In case of taking a higher dose of Meloksam than recommended or suspected overdose, the patient should immediately consult a doctor or go to the nearest hospital emergency department.

Symptoms of NSAID overdose are usually limited to:

• weakness (feeling of lack of energy);
• drowsiness;
• nausea and vomiting;
• abdominal pain (in the upper abdomen). These symptoms usually disappear after stopping Meloksam. The patient may experience gastrointestinal bleeding.

Severe poisoning can lead to serious side effects of the medicine (see section 4):

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

Missing a dose of Meloksam

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the scheduled time.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Meloksam can cause side effects, although not everybody gets them.

The patient should stop taking Meloksam and consult their doctor or the nearest hospital immediately if they 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), 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.
• 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.

Any symptoms of gastrointestinal disorders, in particular:

• bleeding (causing black stools);
• gastrointestinal ulceration (causing abdominal pain).

Gastrointestinal bleeding or perforation may have a severe course and can be life-threatening, especially in elderly patients.
If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult their doctor, especially if they are elderly. The doctor may monitor the treatment progress.
If Meloksam causes visual disturbances, the patient should not drive or operate machinery.

General side effects of non-steroidal anti-inflammatory drugs (NSAIDs)

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increase in the risk of arterial thrombosis (arterial occlusion), such as myocardial infarction or stroke, especially with long-term use of high doses of the medicine.
NSAID treatment has been associated with reports of edema, hypertension, and heart failure.
The most commonly observed side effects are related to the gastrointestinal tract (stomach and intestine disorders):

• gastric or duodenal ulcer;
• 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,
• flatulence with gas release,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black stools due to gastrointestinal bleeding,
• vomiting blood,
• mouth ulcers,
• inflammatory bowel disease (e.g., exacerbation of ulcerative colitis or Crohn's disease).

Gastritis has been observed less frequently.

Side effects of meloxicam - the active substance of Meloksam

Very common: may occur in more than 1 in 10 people

Gastrointestinal disorders such as:

• indigestion (dyspepsia),
• nausea (nausea) and vomiting,
• abdominal pain,
• constipation,
• flatulence,
• diarrhea.

Common: may occur in less than 1 in 10 people

• headaches.

Uncommon: may occur in less than 1 in 100 people

• dizziness (feeling of emptiness in the head),
• dizziness or feeling of spinning (vertigo),
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• increased blood pressure (hypertension),
• flushing (temporary flushing of the face and neck),
• retention of sodium and water,
• increased potassium levels (hyperkalemia). This may lead to symptoms such as:
• heart rhythm disorders
• palpitations (when the patient feels their heartbeat more than usual)
• muscle weakness,
• reflux (regurgitation of food from the stomach into the esophagus),
• gastritis,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reactions (hypersensitivity),
• itching,
• skin rash,
• edema due to fluid retention, including ankle and foot edema (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 disturbances in liver function tests (e.g., increased liver enzyme activity, such as transaminases, or increased bilirubin levels). The doctor may detect these changes with a blood test.
• disturbances in kidney function tests (e.g., increased creatinine or urea levels).

Rare: may occur in less than 1 in 1,000 people

• mood disorders,
• nightmares,
• blood disorders, including:
• abnormal blood smear,
• 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.
• ringing in the ears (tinnitus),
• feeling of heartbeat (palpitations),
• gastric or duodenal ulcer,
• esophagitis,
• asthma attacks (in patients allergic to aspirin or other NSAIDs),
• blistering or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• visual disturbances, including:
• blurred vision,
• conjunctivitis (inflammation of the eye or eyelids),
• inflammatory bowel disease (colitis).

Very rare: may occur in less than 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

• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid) caused by exposure to sunlight (photosensitivity reactions),
• heart failure reported in association with NSAID treatment,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Meloksam with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic medicines). This may cause:
• sudden fever,
• throat pain,
• infections,
• pancreatitis,
• infertility in women, delayed ovulation.

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet reported with Meloksam:

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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Meloksam

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Meloksam contains

• The active substance of Meloksam is meloxicam (Meloxicamum). Each tablet contains 15 mg of meloxicam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium citrate, crospovidone.

What Meloksam looks like and contents of the pack

The tablet is light yellow, round, slightly convex on both sides, with "B 19" engraved on one side and a dividing line allowing it to be divided into halves.
The outer packaging (carton) contains 10 or 20 tablets and an information leaflet.

Marketing authorization holder:

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

Manufacturer:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
To obtain more detailed information, the patient should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet:

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