Mel med

Package leaflet: information for the patient

MEL MED, 15 mg
orally disintegrating tablets
Meloxicamum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What MEL MED is and what it is used for

MEL MED contains the active substance meloxicam, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory, analgesic and antipyretic properties.
The anti-inflammatory mechanism of meloxicam is based on preferential inhibition of cyclooxygenase COX-2 over COX-1.
Indications

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

2. Important information before using MEL MED

When not to use MEL MED

• 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 during breastfeeding,
• in children and adolescents under 15 years of age,
• if the patient is allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has experienced any of the following symptoms after taking aspirin or other NSAIDs:
  • wheezing, tightness in the chest, shortness of breath (asthma),
  • nasal congestion due to swelling of the nasal mucosa (nasal polyps),
  • skin rash (urticaria),

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• sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioedema),
  • if the patient has previously experienced the following while being treated with NSAIDs:
• gastrointestinal bleeding,
• stomach or intestinal perforation,
  • if the patient has peptic ulcer disease or gastrointestinal bleeding (stomach or duodenum),
  • if the patient has a history of peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding (peptic ulcer or bleeding occurring at least twice),
  • if the patient has severe liver function impairment,
  • in non-dialysed patients with severe renal failure,
  • if the patient has recently experienced bleeding in the brain (cerebral haemorrhage),
  • if the patient has any other bleeding disorders,
  • if the patient has severe heart failure.

Warnings and precautions
Taking medicines such as MEL MED 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 use higher doses or longer treatment duration than recommended (see section 3).
If you have heart problems, a history of stroke, or suspect you may be at risk of such conditions, discuss the treatment approach with your doctor or pharmacist.
In case of serious allergic reactions, stop using MEL MED at the first signs of skin rash, soft tissue damage (mucosal damage), or any other allergic symptoms, and contact your doctor. Immediately discontinue use of MEL MED if you notice bleeding (causing black, tarry stools) or gastrointestinal ulceration (causing abdominal pain).
Before starting treatment with MEL MED, consult your doctor or pharmacist if the patient:

• has previously had oesophagitis, gastritis, or any other inflammatory condition of the gastrointestinal tract, e.g. ulcerative colitis, Crohn's disease,
• has high blood pressure (hypertension),
• is elderly,
• suffers from heart, liver or kidney disease,
• has high blood sugar levels (diabetes),
• has reduced blood volume (hypovolemia), for example due to significant blood loss, burns, surgery, or low fluid intake,
• has previously diagnosed high potassium levels in the blood,
• has ever experienced fixed drug eruption (persistent rash) after taking meloxicam or other oxicams (e.g. piroxicam) [circular or oval red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria, and itching].

In the above cases, the doctor will monitor the progress of treatment.
Children and adolescents
Do not use MEL MED in children and adolescents under 15 years of age.
MEL MED with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
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If the patient is taking any of the following medicines, always inform the doctor or pharmacist:

• other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid;
• anticoagulants, heparin;
• medicines that dissolve blood clots (thrombolytics);
• medicines used in heart and kidney diseases;
• corticosteroids (e.g. used for inflammatory conditions or allergic reactions);
• cyclosporine, tacrolimus – used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome;
• diuretics; if the patient is taking such medicines, the doctor may monitor 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 in the treatment of cancer or severe uncontrolled skin disease and active rheumatoid arthritis;
• cholestyramine – used to reduce cholesterol levels;
• if the patient uses an intrauterine contraceptive device, commonly known as an IUD.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take MEL MED if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. MEL MED may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour. Do not use MEL MED during the first six months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required 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, MEL MED may cause kidney problems in the unborn child if used 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 longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
MEL MED is contraindicated in breastfeeding women.
Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may temporarily impair fertility in women. This effect is reversible and resolves after stopping treatment.
If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Visual disturbances, drowsiness, dizziness or other central nervous system disorders may occur after taking MEL MED. If these symptoms occur, do not drive or operate machinery.
MEL MED 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 impaired excretion.
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MEL MED contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use MEL MED

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
MEL MED is taken orally.
Place the tablet on the tongue and allow it to dissolve, then swallow. If necessary, the dissolved tablet may be washed down with water.
Recommended doses:
Osteoarthritis flare-ups:
7.5 mg once daily. The dose may be increased to 15 mg (1 tablet) per day.
Rheumatoid arthritis:
15 mg (1 tablet) once daily.
Ankylosing spondylitis:
15 mg (1 tablet) once daily.
The daily dose should not exceed 15 mg.
This medicine is also available in a 7.5 mg strength – MEL.
Patients with renal or hepatic impairment: see section 2.
Use in children and adolescents
MEL MED should not be used in children and adolescents under 15 years of age.
Taking more MEL MED than recommended
If more MEL MED has been taken than recommended, consult a physician 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 discontinuation of MEL MED. Gastrointestinal bleeding (bleeding from the digestive tract) may occur in the patient.

Severe poisoning may lead to serious adverse effects:

• elevated blood pressure (hypertension),
• acute renal failure,
• liver function disorders,
• 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 reactions (hypersensitivity), including:
  • fainting,
  • shortness of breath,
  • skin reactions.

If you miss a dose of MEL MED
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the reactions described below occur, stop using M M
and consult a doctor or the nearest hospital emergency department.
Any allergic reactions (hypersensitivity) which may manifest as follows:

• skin reactions such as itching (pruritus), blistering and peeling of the skin, which may be severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue damage (lesions of mucous membranes) or erythema multiforme; erythema multiforme is a serious allergic skin reaction causing spots, red or purple patches or blisters on the skin; it may also occur in the mouth, eyes and other moist areas of the body;
• swelling of the skin or mucous membranes, for example swelling around the eyes, face and lips, mouth or throat, which may make breathing difficult, swelling of the ankles and legs (peripheral oedema);
• shortness of breath or asthma attack;
• hepatitis, which may cause symptoms such as:
  • yellowing of the skin and whites of the eyes (jaundice),
  • abdominal pain,
  • loss of appetite.

Any adverse effects affecting the gastrointestinal tract, and in particular:

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

Gastrointestinal bleeding, ulceration or perforation may sometimes be severe and potentially fatal, especially in elderly patients.
If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, the patient should seek immediate medical advice, especially if elderly. The doctor may monitor treatment progress simultaneously.
If use of M M causes visual disturbances, do not drive or operate machinery.
General adverse reactions associated with use of non-steroidal anti-inflammatory drugs (NSAIDs)
Use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g. myocardial infarction or stroke), particularly following high-dose and long-term treatment.
Oedema, hypertension and heart failure have been reported during NSAID therapy.
The most commonly observed adverse effects involve the gastrointestinal tract (stomach and intestinal disturbances):

• peptic ulcer disease of the stomach and duodenum,
• intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse reactions have been reported with NSAID use:

• nausea and vomiting,
• loose stools (diarrhoea),
• flatulence,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black, tarry stools due to gastrointestinal bleeding, haematemesis,
• ulcerative stomatitis,
• exacerbation of colitis,
• exacerbation of gastrointestinal inflammation (exacerbation of Crohn's disease). Gastritis has been observed less frequently.

Adverse reactions of meloxicam – the active substance in M M
Very common (in more than 1 in 10 patients):

• indigestion (dyspepsia),
• nausea and vomiting,
• abdominal pain,
• constipation,
• flatulence,
• loose stools (diarrhoea).

Common (in 1 to 10 in 100 patients):

• headache.

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

• dizziness (feeling of emptiness in the head),
• vertigo or spinning sensation (vestibular origin),
• somnolence (drowsiness),
• anaemia (reduced concentration of the red blood pigment haemoglobin),
• increased blood pressure (hypertension),
• facial flushing (transient redness of the face and neck),
• sodium and fluid retention,
• increased potassium levels (hyperkalaemia). This may lead to symptoms such as:
  • cardiac rhythm disturbances,
  • palpitations (when the patient feels heartbeat more than usual),
  • muscle weakness,
• belching,
• gastritis,
• gastrointestinal bleeding,
• inflammation of the oral mucosa,
• immediate allergic reactions,
• itching,
• skin rash,

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• fluid retention-related oedema, including swelling of ankles or legs (peripheral oedema),
• sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema),
• transient abnormalities in liver function tests (e.g. increased liver enzyme activity such as aminotransferases, or increased levels of the bile pigment bilirubin); the doctor may detect these changes through blood tests,
• abnormalities in laboratory tests of kidney function (e.g. increased creatinine or urea levels).

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

• mood disturbances,
• nightmares,
• blood morphology disorders, including:
  • abnormal blood smear,
  • reduced white blood cell count (leucopenia),
  • reduced platelet count (thrombocytopenia). These adverse reactions may lead to increased risk of infection and symptoms such as bruising or nosebleeds.
• tinnitus (ringing in the ears),
• palpitations (awareness of heartbeat),
• peptic ulcer disease of the stomach or duodenum,
• oesophagitis,
• onset of asthma attacks (in patients hypersensitive to aspirin or other NSAIDs),
• blistering of the skin or skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• urticaria,
• visual disturbances, including:
  • blurred vision,
  • conjunctivitis (inflammation of the eyeball or eyelids),
• colitis.

Very rare (occurring in less than 1 in 10,000 patients):

• blistering skin reactions and erythema multiforme,
• hepatitis. This may cause symptoms such as:
  • yellowing of the skin and whites of the eyes (jaundice),
  • abdominal pain,
  • loss of appetite,
• acute renal failure, particularly in patients with risk factors such as heart disease, diabetes or kidney disease,
• intestinal wall perforation.

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 allergic skin reaction known as fixed drug eruption, usually recurring in the same location(s) upon re-administration of the drug and may appear as itchy, round or oval, red and swollen skin patches, blisters (urticaria),
• heart failure reported in association with NSAID therapy,
• pancreatitis,

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• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam together with other medicines that may suppress or destroy bone marrow function (myelotoxic drugs); this may cause:
  • sudden fever,
  • sore throat,
  • infections.

Adverse reactions caused by non-steroidal anti-inflammatory drugs (NSAIDs), but
not yet reported after use of meloxicam:

• acute renal failure due to changes in kidney structure:
  • very rare cases of kidney inflammation (interstitial nephritis),
  • death of certain kidney cells (acute necrosis of glomeruli or renal papillae),
  • presence of protein in urine (nephrotic syndrome with proteinuria).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store MEL MED

Store below 25°C, in the original packaging to protect from moisture.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What M M contains

• The active substance is meloxicam. Each tablet contains 15 mg of meloxicam.
• Other ingredients are: betadex, raspberry flavour SD0621M (contains propylene glycol), strawberry flavour SD1634, vanilla flavour 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).

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What M M looks like and contents of the pack
M M are round, biconvex, light yellow tablets, 12 mm in diameter, with a characteristic odour.
One pack contains 20 or 30 orally disintegrating tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]
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