MEL 15 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. MEL MED, 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
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 (E 951) per tablet
   8. M M contains sodium
5. How to take M M
   1. Recommended doses:
   2. Osteoarthritis exacerbations:
   3. Rheumatoid arthritis:
   4. Ankylosing spondylitis:
   5. Do not exceed the dose of 15 mg per day.
   6. Use in children and adolescents
   7. Overdose of M M
   8. Symptoms of NSAID overdose are usually limited to:
   9. Severe poisoning can lead to serious side effects:
   10. Missed dose of M M
6. Possible side effects
   1. If you experience any of the following reactions, stop taking M M and consult your doctor or the nearest hospital emergency department.
   2. General side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)
   3. Side effects of meloxicam - the active substance of M M
   4. Side effects caused by nonsteroidal anti-inflammatory drugs (NSAIDs) but not yet reported with meloxicam:
   5. Reporting side effects
7. How to store M M
8. Contents of the packaging and other information
   1. What M M contains
   2. What M M looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

MEL MED, 15 mg

orally disintegrating tablets
Meloxicam

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 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. Contents of the packaging and other information

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

M M contains the active substance meloxicam, which belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory, analgesic, and antipyretic effects.
The mechanism of anti-inflammatory action of meloxicam is based on the preferential inhibition of cyclooxygenase COX-2 compared to COX-1.

Indications for use

• Short-term symptomatic treatment of osteoarthritis exacerbations.
• Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

2. Important information before taking M M

When not to take M M

• 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 15 years of age,
• if the patient is hypersensitive to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• if the patient has experienced any of the following symptoms after taking aspirin or other nonsteroidal 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),

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• 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 previously experienced:
• gastrointestinal bleeding or perforation,
• if the patient has been diagnosed with gastric or duodenal ulcer or gastrointestinal bleeding (ulcer or bleeding that has occurred at least twice),
• if the patient has severe liver dysfunction,
• in patients with severe renal impairment who are not on dialysis,
• 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

Taking medicines like M M 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).
In case of heart disorders, previous stroke, or suspected risk of these disorders, discuss the treatment with your doctor or pharmacist.
In case of severe allergic reactions, discontinue use of M M after the first symptoms of skin rash, soft tissue damage (mucosal lesions), or any other symptoms of allergy, and contact your doctor. Discontinue use of M M immediately if you notice bleeding (causing black stools) or gastrointestinal ulcers (causing abdominal pain).
Before starting treatment with M M, discuss it with your doctor or pharmacist if the patient:

• has a history of esophagitis, gastritis, or any other inflammatory condition of the gastrointestinal tract, such as ulcerative colitis, Crohn's disease,
• has high blood pressure (hypertension),
• is elderly,
• has heart, liver, or kidney disease,
• has high blood sugar (diabetes),
• has decreased blood volume (hypovolemia), for example, 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) [circular or oval, reddened, and swollen spots on the skin, usually recurring in the same place (in the same places), blisters, hives, and itching].

In these cases, the doctor will monitor the patient's progress.

Children and adolescents

Do not give M M to children and adolescents under 15 years of age.

M M and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
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If the patient is taking any of the following medicines, always tell their doctor or pharmacist:

• other nonsteroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid;
• anticoagulants, heparin;
• medicines that dissolve blood clots (thrombolytic agents);
• medicines used for heart and kidney diseases;
• corticosteroids (e.g., used for inflammatory conditions or allergic reactions);
• cyclosporine, tacrolimus - used after organ transplantation or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome;
• diuretics; 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 baby, 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 baby or cause complications during delivery. M M may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and prolong labor. During the first 6 months of pregnancy, do not take M M unless the 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, M M may cause kidney problems in the unborn baby if taken for more than a few days (which can lead to low levels of amniotic fluid surrounding the baby or narrowing of the ductus arteriosus in the baby's heart). If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Breastfeeding
M M is contraindicated in breastfeeding women.
Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and reverses after stopping treatment.
If the patient plans to become pregnant or is having trouble 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, do not drive or operate machinery.

M M contains 3.5 mg of aspartame (E 951) per 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 impaired elimination.
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M M contains sodium

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

3. How to take M M

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Take M M orally.
Place the tablet on the tongue and let it dissolve, then swallow. If necessary, the dissolved tablet can be washed down with water.

Recommended doses:

Osteoarthritis exacerbations:

7.5 mg per day. The dose may be increased to 15 mg (1 tablet) per day.

Rheumatoid arthritis:

15 mg (1 tablet) per day.

Ankylosing spondylitis:

15 mg (1 tablet) per day.

Do not exceed the dose of 15 mg per day.

The medicine is also available in a 7.5 mg dose - MEL.
Patients with renal or hepatic impairment: see section 2.

Use in children and adolescents

Do not give M M to children and adolescents under 15 years of age.

Overdose of M M

In case of overdose, seek medical attention immediately 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 stopping M M. The patient may experience gastrointestinal bleeding (gastrointestinal hemorrhage).

Severe poisoning can lead to serious side effects:

• high 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,

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• 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.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following reactions, stop taking M M and consult your 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), 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, which can also occur 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 can make breathing difficult, swelling of the feet and ankles (peripheral edema);
• shortness of breath or asthma attack;
• hepatitis, which can cause symptoms such as:
• yellowing of the skin and eyes (jaundice),
• abdominal pain,
• loss of appetite.

Any gastrointestinal side effects, particularly:

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

Gastrointestinal bleeding or perforation 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 their progress simultaneously.
If taking M M causes visual disturbances, do not drive or operate machinery.

General side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (arterial occlusion), such as myocardial infarction or stroke, especially after taking the medicine in high doses and for long-term treatment.
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Edema, high blood pressure, and heart failure have been reported in association with NSAID treatment.
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 after taking NSAIDs:

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

Side effects of meloxicam - the active substance of M M

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

• indigestion (dyspepsia),
• nausea (nausea) and vomiting,
• abdominal pain,
• constipation,
• flatulence,
• 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),
• high blood pressure (hypertension),
• flushing (transient flushing of the face and neck),
• fluid and sodium retention,
• high potassium levels (hyperkalemia). This can lead to symptoms such as:
• heart rhythm disturbances,
• palpitations (feeling of heartbeat more than usual),
• muscle weakness,
• bloating,
• gastritis,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reactions,
• itching,
• skin rash,

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• edema due to fluid retention, including swelling of the feet and ankles (peripheral edema),
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which can make breathing difficult (angioedema),
• temporary disturbances in liver function test results (e.g., increased liver enzyme activity, such as transaminases, or increased bilirubin levels); the doctor may detect these changes through a blood test,
• disturbances in kidney function test results (e.g., increased creatinine or urea levels).

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

• mood disturbances,
• 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),
• gastric or duodenal ulcer,
• esophagitis,
• asthma attacks (in patients allergic to aspirin or other NSAIDs),
• blistering skin or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• visual disturbances, including:
• blurred vision,
• conjunctivitis (inflammation of the conjunctiva or eyelids),
• colitis.

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

• blistering skin reactions and erythema multiforme,
• hepatitis. 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 or anaphylactoid),
• skin rashes caused by sun exposure (photosensitivity reactions),
• a characteristic skin allergic reaction known as fixed drug eruption, usually recurring in the same place (in the same places) after re-exposure to the medicine and may appear as itchy, round or oval, reddened, and swollen spots on the skin, blisters (hives),
• heart failure reported in association with NSAID treatment,
• pancreatitis,

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• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam with other medicines that can suppress bone marrow activity or damage it (myelotoxic drugs); this can cause:
• sudden fever,
• throat pain,
• infections.

Side effects caused by nonsteroidal 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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store M M

Store in a temperature below 25°C, in the original packaging to protect from moisture.
Keep the medicine 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.
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 packaging 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, malin 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).

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What M M looks like and contents of the pack

M M is a round, biconvex, light yellow tablet with a diameter of 12 mm and a characteristic odor.
One pack of M M contains 20 or 30 orally disintegrating tablets.

Marketing authorization holder and manufacturer

Hasco-Lek Pharmaceutical Company S.A.
51-131 Wrocław, Żmigrodzka 242E
Medicine information
phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

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