Mel max

Package leaflet: Information for the patient

MEL MAX, 15 mg
orally disintegrating tablets
Meloxicam
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

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

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

MEL MAX contains the active substance meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and relieve joint and muscle pain.
The medicine has anti-inflammatory, analgesic, and antipyretic properties.

Indications for use of MEL MAX:
MEL MAX is indicated in adults when a dose of 7.5 mg meloxicam has been insufficiently effective, for short-term treatment of acute flare-ups of rheumatic diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis, as an anti-inflammatory and analgesic agent in bone, joint, and muscular pain (e.g. spinal, back, knee pain) associated with rheumatic and degenerative joint disorders.
Do not use for longer than 7 days without consulting a doctor.
WARNING: MEL MAX may only be taken by patients in whom a dose of 7.5 mg meloxicam did not provide the expected pain relief.

2. Important information before using the medicine M M

When not to use medicine M M
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• 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 is breastfeeding,
• in children and adolescents under 18 years of age,
• if the patient is allergic 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, tightness in the chest, shortness of breath (asthma),
  • nasal obstruction 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, possibly making breathing difficult (angioedema),
• if the patient previously experienced the following during treatment with NSAIDs:
  • gastrointestinal bleeding,
  • perforation of the stomach or intestines,
• if the patient has peptic ulcer disease or bleeding from the stomach and/or duodenum,
• 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 disorders,
• 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 disorders,
• if the patient has severe heart failure.

Warnings and precautions
Medicine M M is intended for patients in whom a dose of meloxicam 7.5 mg has not provided the expected pain relief.
Medicine M M is not recommended for use during acute pain attacks.
Taking medicines such as 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 use higher doses or longer treatment duration than recommended (see section 3).
If the patient has heart problems, has had a stroke, or there is suspicion of risk for these conditions, discuss the treatment approach with a doctor or pharmacist.
In case of serious allergic reactions, discontinue use of medicine M M immediately upon the first signs of skin rash, soft tissue damage (mucosal damage), or any other allergic symptoms and contact a doctor. Discontinue medicine M M immediately if bleeding (causing black, tarry stools) or gastrointestinal ulceration (causing abdominal pain) is observed.
Before starting treatment with medicine M M, discuss this with a doctor or pharmacist if the patient:

• has previously had oesophagitis, gastritis, or any other gastrointestinal inflammatory condition, 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),

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• has reduced circulating blood volume (hypovolemia), for example due to significant blood loss or burns, surgery, or low fluid intake,
• has previously diagnosed high potassium levels in the blood,
• if the patient has ever developed a persistent rash (drug eruption) [circular or oval, red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria and itching] after taking meloxicam or other oxicams (e.g. piroxicam). In such cases, the doctor will monitor treatment progress.

Children and adolescents
Do not use medicine M M in children and adolescents under 18 years of age.
Medicine M M with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
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 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 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 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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take medicine M M if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Medicine M M may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labour. Medicine M M should not be used 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, medicine M M may cause kidney function disorders in the unborn child if taken for longer 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.
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Breastfeeding
Medicine M M is contraindicated in women who are breastfeeding.
Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of 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 medicine M M. If these symptoms occur, do not drive or operate machinery.
Medicine M M contains 3.5 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.
Medicine M M 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 MAX

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

MEL MAX 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.

Taking MEL MAX for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Recommended dose: Adults when necessary
1 tablet (15 mg meloxicam) once daily. The maximum recommended dose is 1 tablet once daily.

MEL MAX may only be used in patients in whom a previous dose of 7.5 mg meloxicam did not provide the expected pain relief.

If symptoms do not improve after 3 days of treatment, or if symptoms worsen despite taking the medicine, the patient should seek medical advice immediately.

Do not use for longer than 7 days without consulting a doctor.

Elderly patients and patients at increased risk of adverse reactions:
Particular caution is advised when using MEL MAX in elderly patients and those at increased risk of adverse reactions. Medical consultation is recommended. If pharmacological treatment is initiated by a doctor, a dose of 7.5 mg may be prescribed. Depending on efficacy and tolerability, the doctor may increase the dose to 15 mg meloxicam.

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Renal function impairment: Patients undergoing dialysis with severe renal insufficiency should not take more than 7.5 mg meloxicam per day.

Hepatic function impairment: Dose reduction is not required in patients with mild to moderate hepatic impairment.

Use in children and adolescents: MEL MAX should not be used in children and adolescents under 18 years of age.

If the patient feels that the effect of MEL MAX is too strong or too weak, or if no improvement is felt after 3 days, consult a doctor or pharmacist.

Overdose of MEL MAX
In case of overdose, seek immediate medical advice from 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 MEL MAX. Gastrointestinal bleeding (bleeding from the gastrointestinal tract) may occur.

Severe poisoning may lead to serious adverse effects:

• elevated blood pressure (hypertension),
• acute renal failure,
• hepatic 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 MEL MAX
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 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, possibly severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), 5/9

damage to soft tissues (lesions on mucous membranes) or erythema multiforme;
erythema multiforme is a severe skin allergic reaction causing spots, red or
purple patches or blisters on the skin; it may also affect the lips, 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 cause difficulty in breathing, 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 gastrointestinal effects, and in particular:

• bleeding (causing black, tarry stools),
• gastrointestinal ulcers (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 patient's progress during treatment.
If treatment with M M causes disturbances in vision, do not drive or operate machinery.
General adverse reactions associated with the use of non-steroidal anti-inflammatory
drugs (NSAIDs)
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 with high doses and prolonged treatment.
Oedema, hypertension and heart failure have been reported during NSAID therapy.
The most commonly observed adverse effects involve the gastrointestinal system (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 administration:

• nausea and vomiting,
• loose stools (diarrhoea),
• flatulence,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black stools due to gastrointestinal bleeding, haematemesis,
• oral ulcerative mucositis,
• 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
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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 out of 100 patients):

• headache.

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

• dizziness (feeling of emptiness in the head),
• dizziness or vertigo (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 water retention,
• increased potassium levels (hyperkalaemia). This may lead to symptoms such as:
  • cardiac rhythm disturbances,
  • palpitations (when the patient feels the heartbeat more than usual),
  • muscle weakness,
• belching,
• gastritis,
• gastrointestinal bleeding,
• inflammation of the oral mucosa,
• immediate hypersensitivity reactions,
• pruritus,
• 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 liver enzyme activity such as aminotransferases, or increased levels of the bile pigment bilirubin); these changes may be detected by the doctor through blood tests,
• abnormalities in renal function laboratory tests (e.g. increased creatinine or urea levels).

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 an increased risk of infection and symptoms such as bruising or nosebleeds.
• tinnitus,
• palpitations,
• peptic ulcer disease of the stomach or duodenum,
• oesophagitis,

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• onset of asthma attacks (in patients hypersensitive to aspirin or other NSAIDs),
• blistering of the skin or epidermal detachment (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• urticaria,
• visual disturbances, including:
  • blurred vision,
  • conjunctivitis (inflammation of the eyeball or eyelids),
• colitis.

Very rare (in fewer 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 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, round or oval, red and swollen skin patches or blisters (urticaria),
• heart failure reported in association with NSAID therapy,
• pancreatitis,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam together with other medicines that may suppress or damage 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 administration of meloxicam:
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 Adverse Drug Reactions, 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
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 MAX

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 packaging and other information

What the medicine contains

• The active substance is meloxicam. Each tablet contains 15 mg of meloxicam.
• The other ingredients are: betadex, 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).

What the medicine 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 odour.
One pack contains 10 orally disintegrating tablets.

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