MEL 15 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. MEL MAX, 15 mg
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is M M and what is it used for
   1. Indications for use of M M:
   2. WARNING: M M should only be taken by patients who have not achieved the desired result in pain relief with a dose of 7.5 mg of meloxicam.
4. Important information before taking M M
   1. When not to take M M
   2. Warnings and precautions
   3. Children and adolescents
   4. M M and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. M M contains 3.5 mg of aspartame in each tablet.
   8. M M contains sodium
5. How to take M M
   1. Recommended dose: Adults if necessary
   2. Elderly patients and patients with increased risk of side effects
   3. Overdose of M M
   4. Symptoms of NSAID overdose are usually limited to:
   5. Severe poisoning can lead to serious side effects:
   6. Missed dose of M M
6. Possible side effects
   1. If any of the following reactions occur, the patient should stop taking M M and consult their doctor or the nearest hospital emergency department.
   2. General side effects of non-steroidal anti-inflammatory drugs (NSAIDs)
   3. Side effects of meloxicam - the active substance of M M
   4. Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet reported with meloxicam:
   5. Reporting side effects
7. How to store M M
8. Package contents and other information
   1. What M M contains
   2. What M M looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

MEL MAX, 15 mg

orally disintegrating tablets
Meloxicam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is M M and what is it used for
• 2. Important information before taking M M
• 3. How to take M M
• 4. Possible side effects
• 5. How to store M M
• 6. Package contents and other information

1. What is M M and what is it used for

M M 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.
The medicine has anti-inflammatory, analgesic, and antipyretic effects.

Indications for use of M M:

The medicine is used in adults when a dose of 7.5 mg of meloxicam was not sufficiently effective, for short-term treatment of exacerbations of symptoms of rheumatoid diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis, as an anti-inflammatory and analgesic in musculoskeletal and muscular pain (e.g., back pain, neck pain, knee pain) in rheumatoid and degenerative joint diseases.
Do not use for more than 7 days without consulting a doctor.

WARNING: M M should only be taken by patients who have not achieved the desired result in pain relief with a dose of 7.5 mg of meloxicam.

2. Important information before taking M M

When not to take M M

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• if the patient is hypersensitive to meloxicam or any of the other ingredients of this medicine (listed in section 6),
• if the patient is in the last three months of pregnancy or breastfeeding,
• in children and adolescents under 18 years of age,
• if the patient is hypersensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has experienced any of the following symptoms after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs):
• wheezing, feeling of chest tightness, 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, e.g., swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema),
• if the patient has experienced:
• gastrointestinal bleeding,
• perforation of the stomach or intestines,
• if the patient has been diagnosed with peptic ulcer disease or gastrointestinal bleeding (ulcer disease 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.

Warnings and precautions

M M is intended for patients who have not achieved the desired result in pain relief with a dose of 7.5 mg of meloxicam.
M M is not recommended for use during acute pain attacks.
Taking such medicines as M M may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not use higher doses or longer treatment than recommended (see section 3).
In case of heart disorders, stroke, or suspected risk of these disorders, the treatment method should be discussed with a doctor or pharmacist.
In case of severe allergic reactions, the use of M M should be discontinued after the first symptoms of skin rash, soft tissue damage (mucosal damage), or any other symptoms of allergy, and a doctor should be consulted. The use of M M should be discontinued immediately if bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain) occurs.
Before starting treatment with M M, it is necessary to discuss it with a doctor or pharmacist if the patient:

• has had esophagitis, gastritis, or any other inflammatory condition of the digestive system, e.g., ulcerative colitis, Crohn's disease,
• has high blood pressure (hypertension),
• is elderly,
• has heart, liver, or kidney disease,
• has high blood sugar levels (diabetes),

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• has decreased blood volume (hypovolemia), e.g., due to significant blood loss or burns, surgery, or low fluid intake,
• has high potassium levels in the blood, previously diagnosed by a doctor,
• has ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam). In these cases, the doctor will monitor the patient's progress.

Children and adolescents

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

M M and other medicines

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.
If the patient is taking any of the following medicines, they should always tell their doctor or pharmacist:

• other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid;
• anticoagulant medicines, heparin;
• medicines that dissolve blood clots (thrombolytic medicines);
• medicines used to treat heart and kidney diseases;
• corticosteroids (e.g., used in inflammatory conditions or to treat allergic reactions);
• cyclosporine - used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome;
• diuretic medicines; if the patient is taking these medicines, the doctor may monitor their kidney function;
• medicines used to treat high blood pressure (e.g., beta-blockers);
• lithium - used to treat mood disorders;
• selective serotonin reuptake inhibitors (SSRIs) - used to treat depression;
• methotrexate - used to treat cancer or severe uncontrolled skin disease and active rheumatoid arthritis;
• cholestyramine - used to reduce cholesterol levels;
• if the patient is using an intrauterine contraceptive, commonly known as an IUD.

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 their doctor or pharmacist before taking this medicine.
Pregnancy
Do not take M M if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. M M may cause kidney and heart problems in the unborn child.
It may increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, M M should not be used 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, M M may cause kidney problems in the unborn child if taken for more than a few days. This can lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
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Breastfeeding
M M is contraindicated in breastfeeding women.
Fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is temporary and reverses after the end of treatment.
If the patient plans to conceive or has problems conceiving, they should inform their doctor.

Driving and using machines

Visual disturbances, drowsiness, dizziness, or other central nervous system disorders may occur after taking M M. If these symptoms occur, the patient should not drive or operate machines.

M M contains 3.5 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

M M 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 M M

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
M M is taken orally.
The tablet should be placed on the tongue and allowed to dissolve, then swallowed. If necessary, the dissolved tablet can be rinsed with water.
Taking M M for the shortest period necessary to relieve symptoms reduces the risk of side effects.

Recommended dose: Adults if necessary

1 tablet (15 mg of meloxicam) once a day. The maximum recommended dose of M M is 1 tablet once a day.
M M should only be taken by patients who have not achieved the desired result in pain relief with a dose of 7.5 mg of meloxicam.
If symptoms do not improve after 3 days of taking M M or if they worsen despite taking the medicine, the patient should consult their doctor immediately.
Do not use for more than 7 days without consulting a doctor.

Elderly patients and patients with increased risk of side effects

Caution should be exercised when taking M M in elderly patients and those with an increased risk of side effects.Consultation with a doctor is recommended. If pharmacological treatment is decided by a doctor, they may recommend a dose of 7.5 mg. Depending on the effectiveness and tolerance of the medicine, the doctor may increase the dose to 15 mg of meloxicam.
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Kidney problems:patients with severe kidney impairment should not take a dose higher than 7.5 mg of meloxicam per day.
Liver problems:dose reduction is not necessary in patients with mild or moderate liver dysfunction.
Use in children and adolescents:M M should not be used in children and adolescents under 18 years of age.
If the patient thinks the effect of M M is too strong or too weak, or if they do not feel any improvement after 3 days, they should consult their doctor or pharmacist.

Overdose of M M

In case of 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 (lethargy),
• drowsiness,
• nausea and vomiting,
• stomach pain. These symptoms usually resolve after discontinuation of M M. The patient may experience gastrointestinal bleeding (gastrointestinal hemorrhage).

Severe poisoning can lead to serious side effects:

• 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),
• cardiac arrest,
• immediate allergic reaction (hypersensitivity), including:
• fainting,
• shortness of breath,
• skin reactions.

Missed dose of M M

Do not take a double dose to make up for a missed dose.
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, M M can cause side effects, although not everybody gets them.

If any of the following reactions occur, the patient should stop taking M M and consult their doctor or the nearest hospital emergency department.

Any allergic reactions (hypersensitivity), which may manifest as:

• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), 5/9

soft tissue damage (mucosal lesions) or erythema multiforme;
erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, and may also occur on the lips, eyes, and other moist body parts;

• swelling of the skin or mucous membranes, e.g., 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, which may cause symptoms such as:
• yellowing of the skin and eyes (jaundice),
• abdominal pain,
• loss of appetite.

Any gastrointestinal side effects, in particular:

• bleeding (causing black stools),
• ulceration of the gastrointestinal tract (causing abdominal pain).

Gastrointestinal bleeding, ulceration, or perforation of the gastrointestinal tract can sometimes be severe and potentially 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 patient's progress simultaneously.
If taking M M causes visual disturbances, the patient should not drive or operate machines.

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 slight increase in the risk of arterial thrombosis (arterial occlusion), e.g., myocardial infarction or stroke, especially when the medicine is taken in high doses and for a long time.
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):

• peptic ulcer disease,
• 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),
• flatulence with gas passage,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black stools due to gastrointestinal bleeding, vomiting blood,
• mouth ulcers,
• worsening of ulcerative colitis,
• worsening of Crohn's disease (worsening of inflammatory bowel disease).

Side effects of meloxicam - the active substance of M M

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Very common(affects more than 1 in 10 people):

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

Common(affects 1 to 10 people in 100):

• headache.

Uncommon(affects 1 to 10 people in 1,000):

• dizziness (feeling of emptiness in the head),
• vertigo or feeling of spinning (of labyrinthine origin),
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• increased blood pressure (hypertension),
• flushing (temporary flushing of the face and neck),
• fluid and sodium retention,
• increased potassium levels (hyperkalemia). This can lead to symptoms such as:
• arrhythmias,
• palpitations (feeling of heartbeat more than usual),
• muscle weakness,
• bloating,
• gastritis,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reactions,
• itching,
• skin rash,
• edema due to fluid retention, including ankle or foot edema (peripheral edema),
• sudden swelling of the skin or mucous membranes, e.g., swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema),
• temporary changes in liver function test results (e.g., increased liver enzyme activity, such as transaminases, or increased bilirubin levels); the doctor may detect these changes with a blood test,
• changes in kidney function test results (e.g., increased creatinine or urea levels).

Rare(affects 1 to 10 people in 10,000):

• mood disorders,
• nightmares,
• blood disorders, including:
• abnormal blood smear,
• reduced white blood cell count (leukopenia),
• reduced platelet count (thrombocytopenia). These side effects can increase the risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus),
• feeling of heartbeat (palpitations),
• peptic ulcer disease,
• esophagitis,

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• onset of 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),
• colitis.

Very rare(affects less than 1 in 10,000 people):

• blistering skin reactions and erythema multiforme,
• 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 available data):

• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic or anaphylactoid),
• skin rashes caused by exposure to sunlight (photosensitivity reactions),
• 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 spots on the skin, blisters (hives),
• heart failure reported in association with NSAID treatment,
• pancreatitis,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam with other medicines that may suppress bone marrow function or damage it (myelotoxic medicines); this can cause:
• sudden fever,
• throat pain,
• infections.

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

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 or renal papillary necrosis),
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
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Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store M M

Store in a temperature below 25°C, in the original packaging to protect from moisture.
The 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.
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. Package contents and other information

What M M contains

• The active substance of M M is meloxicam. One tablet contains 15 mg of meloxicam.
• Other ingredients are: betadex, strawberry flavor SD0621M (contains propylene glycol), strawberry flavor SD1634, vanilla flavor SD1333 (contains propylene glycol and cinnamaldehyde), anhydrous sodium citrate, aspartame (E 951), Pearlitol Flash (D-mannitol, cornstarch, purified water) Ludiflash (polyvinyl acetate, povidone K30, crospovidone (type B), D-mannitol, purified water), crospovidone (type B), sodium stearyl fumarate, acesulfame potassium (E 950).

What M M looks like and what the package contains

M M is a round, biconvex, light yellow tablet with a diameter of 12 mm and a characteristic smell.
One package of M M contains 10 orally disintegrating tablets.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

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