Mel

Leaflet attached to the packaging: patient information

MEL, 7.5 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 or pharmacist.

• 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 possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

1. What is the medicine and what is it used for

The medicine 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

An anti-inflammatory and analgesic medicine used for musculoskeletal and joint pain in rheumatoid and degenerative joint diseases.
Used for short-term treatment of exacerbations of rheumatoid disease symptoms, such as rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis.
If after 7 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking the medicine

When not to take the medicine

• if the patient is allergic 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,

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• if the patient is allergic 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),
• 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,
• if the patient has had peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding (ulcer disease or bleeding that has occurred at least twice),
• if the patient has severe liver dysfunction,
• in nondialyzed 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

Taking such medicines 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 use the medicine for longer than recommended (see section 3 "How to take the medicine").
In case of heart disorders, previous stroke, or suspected risk of these disorders, the patient should discuss the treatment with a doctor or pharmacist.
In case of severe allergic reactions, the patient should stop taking the medicine after the first symptoms of skin rash, soft tissue damage (mucosal lesions), or any other symptoms of allergy, and consult a doctor. The patient should stop taking the medicine immediately after noticing bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain).
Before starting to take the medicine, the patient should discuss it with a doctor or pharmacist if they:

• have had esophagitis, gastritis, or any other inflammatory condition of the gastrointestinal tract, e.g., ulcerative colitis, Crohn's disease,
• have high blood pressure (hypertension),
• are elderly,
• have heart, liver, or kidney disease,
• have high blood sugar levels (diabetes),
• have decreased blood volume (hypovolemia), e.g., due to significant blood loss or burns, surgery, or low fluid intake,
• have high potassium levels in the blood, previously diagnosed by a doctor,
• have ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam), characterized by round or oval, red, and swollen patches 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.
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Children and adolescents

The medicine should not be taken by children and adolescents under 15 years of age.

Medicine interactions

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
If the patient is taking any of the following medicines, they should 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 - used after organ transplantation or in 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 taking an intrauterine contraceptive, commonly known as an IUD.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The medicine should not be taken if the patient is in the last three 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 the child and cause prolongation or delay of labor. During the first six months of pregnancy, the medicine 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 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.
Breastfeeding
The medicine is contraindicated in breastfeeding women.
Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after stopping the treatment.
If the patient plans to become pregnant or is having trouble conceiving, they should tell their doctor about taking this medicine.
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Driving and using machines

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

The medicine contains 1.75 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.

The medicine 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 the medicine

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.
The medicine is taken orally.
The tablet should be placed on the tongue and allowed to dissolve, then swallowed. If necessary, the dissolved tablet can be washed down with water.
The recommended dose is: 1 tablet per day.
The medicine can be used as a continuation of treatment after a previous doctor's visit.
Without consulting a doctor, the medicine should not be taken for more than 7 days.
Patients with renal or hepatic impairment: see section 2 "Important information before taking the medicine".

Use in children and adolescents

The medicine should not be taken by children and adolescents under 15 years of age.

Overdose

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 stopping the medicine. The patient may experience gastrointestinal bleeding.

Severe poisoning can lead to serious side effects:

• increased blood pressure (hypertension),
• acute renal failure,
• liver dysfunction,
• shallow breathing or respiratory arrest (respiratory depression),
• loss of consciousness (coma),
• seizures (convulsions),
• circulatory collapse (cardiovascular collapse),

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• cardiac arrest,
• immediate allergic reactions, including:
• fainting,
• shortness of breath,
• skin reactions.

Missed dose

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

If any of the following reactions occur, the patient should stop taking the medicine and consult a 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 patches, red or purple stripes, or blisters on the skin, which can 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 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, in particular:

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

Gastrointestinal bleeding, ulcers, 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 a doctor, especially if they are elderly. The doctor may monitor the patient's progress simultaneously.
If taking the medicine causes visual disturbances, the patient should not drive or operate machinery.

Common side effects of NSAIDs

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (arterial occlusion), e.g., heart attack or stroke, especially after taking the medicine in high doses and for prolonged periods.
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 stomach or 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, bloody vomiting,
• stomatitis (mouth inflammation),
• worsening of ulcerative colitis,
• worsening of Crohn's disease.

Side effects of meloxicam - the active substance of the medicine

Very common(in more than 1 in 10 patients):

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

Common(in 1 to 10 patients in 100):

• headache.

Uncommon(in 1 to 10 patients 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),
• retention of sodium and water,
• increased potassium levels (hyperkalemia). This can lead to symptoms such as:
• arrhythmias,
• palpitations (when the patient feels their heartbeat more than usual),
• muscle weakness,
• bloating,
• gastritis,
• gastrointestinal bleeding,
• mucosal lesions,
• allergic reactions,

Rare(in 1 to 10 patients in 10,000):

• skin blistering reactions and erythema multiforme,
• hepatitis. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice),
• abdominal pain,
• loss of appetite,
• acute renal failure, particularly 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 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 patches on the skin, blisters (hives),
• heart failure reported in association with NSAID treatment,

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• pancreatitis,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam with other medicines that can suppress bone marrow function 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 renal failure due to changes in kidney structure:

• very rare cases of interstitial nephritis,
• necrosis 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their 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
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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, more information can be collected on the safety of the medicine.

5. How to store the medicine

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 take 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. Contents of the pack and other information

What the medicine contains

• The active substance of the medicine is meloxicam. 1 tablet contains 7.5 mg of meloxicam.
• The other ingredients (excipients) 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, corn starch, purified water), Ludiflash (polyvinyl acetate, povidone K30, crospovidone (type B), D-mannitol, purified water), crospovidone (type B), sodium stearyl fumarate, acesulfame potassium (E 950). 8/9

What the medicine looks like and contents of the pack

They are round, biconvex, light yellow tablets with a diameter of 9 mm and a characteristic odor.
One pack of the medicine contains 10, 20, or 30 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:10/2023
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