Mel

Package leaflet: Information for the patient

MEL, 7.5 mg
orally disintegrating tablets
Meloxicamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

1. What the medicine is and what it is 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 package and other information

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

The medicine 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 action of meloxicam is based on preferential inhibition of cyclooxygenase COX-2 over COX-1.
Indications
Anti-inflammatory and analgesic medicine used in bone, joint and muscle pain associated with rheumatic and degenerative joint diseases.
Used for short-term treatment of flare-ups of rheumatic diseases, such as rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using the medicine

When not to use 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 during breastfeeding,
• in children and adolescents under 15 years of age,

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• 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 non-steroidal anti-inflammatory drugs (NSAIDs):
• wheezing, tightness in the chest, shortness of breath (asthma),
• nasal congestion due to swelling of the nasal mucosa (nasal polyps),
• skin rash (urticaria),
• sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat, which may possibly make breathing difficult (angioedema),
• if the patient has previously experienced:
• gastrointestinal bleeding or perforation during treatment with NSAIDs,
• if the patient has a diagnosed peptic ulcer or gastrointestinal bleeding,
• if the patient has a history of peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding (ulcer disease or bleeding occurring at least twice),
• if the patient has severe liver function impairment,
• in non-dialysed patients with severe renal insufficiency,
• if the patient has recently experienced bleeding within the brain (cerebral haemorrhage),
• if the patient has any other bleeding conditions,
• if the patient has severe heart failure.

Warnings and precautions
Taking medicines such as this may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with prolonged use of high doses. Do not use higher doses or for longer than recommended (see section 3 “How to use the medicine”).

If the patient has heart problems, has had a stroke, or there is suspicion of an increased risk of such conditions, the treatment should be discussed with a doctor or pharmacist.

In case of serious allergic reactions, discontinue the medicine immediately upon the first signs of skin rash, soft tissue damage (mucosal damage), or any other allergic symptoms, and contact a doctor. Discontinue the medicine immediately if bleeding (resulting in black, tarry stools) or gastrointestinal ulceration (causing abdominal pain) occurs.

Before starting treatment with this medicine, consult a 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 circulating blood volume (hypovolemia), for example due to significant blood loss or burns, surgical procedures, or low fluid intake,
• has previously diagnosed high potassium levels in the blood,
• has ever developed a persistent drug-induced erythema (rash) after taking meloxicam or other oxicams (e.g. piroxicam) [circular or oval red, swollen skin lesions, usually recurring in the same location(s), blisters, urticaria, and itching].

In the above cases, the doctor will monitor the patient’s progress during treatment.
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Children and adolescents
This medicine should not be used in children and adolescents under 15 years of age.

Medicine and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

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 (thrombolytic agents);
• medicines used in 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;
• diuretics; if the patient is taking such medicines, the doctor may monitor kidney function;
• medicines used to treat hypertension (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 cancers, severe uncontrolled skin disease, or 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 or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take this medicine 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 increase the risk of bleeding in both mother and child and may delay or prolong labour. During the first 6 months of pregnancy, do not use this medicine 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 week 20 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 a 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
This medicine is contraindicated in breastfeeding women.

Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after stopping treatment. If the patient is planning to become pregnant or has difficulty conceiving, she should inform her doctor about using this medicine.
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Driving and operating machinery
Disturbances in vision, drowsiness, dizziness, or other central nervous system disturbances may occur after taking this medicine. If these symptoms occur, do not drive or operate machinery.

The medicine contains 1.75 mg of aspartame 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 improper excretion.

The medicine 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 take this medicine

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Place the tablet on the tongue and allow it to dissolve, then swallow. If necessary, the dissolved tablet may be followed with water.
The recommended dose is: 1 tablet per day.
This medicine may be used as a continuation of treatment following a prior visit to the doctor.
Do not use for longer than 7 days without consulting a doctor.
Patients with renal or hepatic impairment: see section 2 "Important information before use".

Use in children and adolescents
This medicine should not be used in children and adolescents under 15 years of age.

Taking more than the recommended dose
If more than the recommended dose is taken, consult a doctor 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 the medicine. Gastrointestinal bleeding (bleeding from the gastrointestinal 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),

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

Missed dose
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 doctor 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 taking the medicine immediately 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, possibly 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 patches or blisters on the skin; it may also affect the lips, eyes and other moist parts of the body;
• swelling of the skin or mucous membranes, for example swelling around the eyes, face and lips, mouth or throat, possibly causing breathing difficulties, swelling of the ankles and legs (peripheral oedema);
• shortness of breath or asthma attack;
• liver inflammation, which may cause symptoms such as:
• yellowing of the skin and whites of the eyes (jaundice),
• abdominal pain,
• loss of appetite.

Any gastrointestinal adverse effects, particularly:

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

Gastrointestinal bleeding, ulceration or perforation may occasionally 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 the progress of treatment.
If taking the medicine causes visual disturbances, do not drive or operate machinery.
General adverse reactions associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs)
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The use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g. heart attack or stroke), particularly when used at high doses and for prolonged periods.
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,
• intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients). The following adverse reactions have been reported after NSAID administration:
• nausea and vomiting,
• loose stools (diarrhoea),
• flatulence,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black, tarry stools due to gastrointestinal bleeding, haematemesis (vomiting blood),
• oral ulceration,
• exacerbation of colitis,
• exacerbation of gastrointestinal inflammation (exacerbation of Crohn's disease). Gastritis was observed less frequently.

Adverse reactions of meloxicam — the active substance of the medicine
Very common (in more than 1 out of 10 patients):

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

Common (in 1 to 10 out of 100 patients):

• headache.

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

• dizziness (feeling of emptiness in the head),
• vertigo or sensation of spinning (of labyrinthine 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 water retention,
• increased potassium levels (hyperkalaemia). This may lead to symptoms such as:
• cardiac arrhythmias,
• palpitations (when the patient feels heartbeat more than usual),
• muscle weakness,
• belching,
• gastritis,
• gastrointestinal bleeding,
• inflammation of the oral mucosa,
• immediate hypersensitivity reactions,

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• pruritus (itching),
• skin rash,
• fluid retention-related oedema, including swelling of the ankles or legs (peripheral oedema),
• sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat, possibly causing breathing difficulties (angioedema),
• transient abnormalities in liver function tests (e.g. increased activity of liver enzymes 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 levels of creatinine or urea). Rare (in 1 to 10 out of 10,000 patients):
• mood disturbances,
• nightmares,
• blood morphology disorders, including:
• abnormal blood smear,
• decreased white blood cell count (leukopenia),
• decreased 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 (sensation of rapid or irregular 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 out of 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 reactions),
• 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 appearing as itchy, circular or oval, red and swollen skin patches or blisters (urticaria),
• heart failure reported in association with NSAID therapy,

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• pancreatitis,
• complete loss of certain types of white blood cells (agranulocytosis), particularly 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 meloxicam administration:
acute renal failure due to structural changes in the kidneys:

• very rare cases of kidney inflammation (interstitial nephritis),
• death of certain kidney cells (acute necrosis of glomeruli or renal papillae),
• presence of protein in the 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 of 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 the medicine

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 container. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is meloxicam. Each tablet contains 7.5 mg of meloxicam.
• The other ingredients (excipients) are: beta-cyclodextrin, raspberry flavour SD0621M (containing propylene glycol), strawberry flavour SD1634, vanilla flavour SD1333 (containing 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
These are round, biconvex, light yellow tablets, 9 mm in diameter, with a characteristic odour.
One pack contains 10, 20 or 30 orally disintegrating tablets.

Marketing Authorisation 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]
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