MELOBAX 15 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Melobax 15; 15 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Melobax and what is it used for
4. Important information before taking Melobax
   1. When not to take Melobax
   2. Warnings and precautions
   3. Precautions for use
   4. Melobax and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Melobax contains lactose
5. How to take Melobax
   1. Use in children and adolescents
   2. Overdose of Melobax
   3. Missed dose of Melobax
6. Possible side effects
   1. Severe side effects
   2. Other side effects
   3. Reporting side effects
7. How to store Melobax
8. Contents of the pack and other information
   1. What Melobax contains
   2. What Melobax looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Lithuania - Melobax

Package Leaflet: Information for the Patient

Melobax 15; 15 mg, tablets

Meloxicam

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Melobax and what is it used for

Melobax contains the active substance meloxicam. Meloxicam belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles. Melobax is intended for use in adolescents over 16 years of age and adults.

Melobax is used for:

• short-term treatment of exacerbations of osteoarthritis;
• long-term treatment of: rheumatoid arthritis, ankylosing spondylitis (also known as Bechterew's disease).

2. Important information before taking Melobax

When not to take Melobax

• If the patient is in the last three months of pregnancy.
• In children and adolescents under 16 years of age.
• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If the patient has experienced any of the following symptoms after taking acetylsalicylic acid or other NSAIDs: asthma, chest tightness, shortness of breath, nasal congestion due to swelling of the nasal mucosa (nasal polyps), hives, sudden swelling of the skin or mucous membranes, swelling around the eyes, face, lips, mouth or throat, which may cause difficulty breathing (angioedema).
• If the patient has experienced:

gastrointestinal bleeding or perforation after previous NSAID therapy.

• If the patient has a history of gastrointestinal ulcers or gastrointestinal bleeding.
• If the patient has had a stomach or intestinal ulcer or bleeding in the past (ulcer or bleeding that has occurred at least twice).
• If the patient has severe liver dysfunction.
• If the patient has severe renal impairment and is not on dialysis.
• If the patient has recently experienced bleeding in the brain (cerebral hemorrhage).
• If the patient has experienced any other bleeding.
• If the patient has severe heart failure.
• If the patient has been diagnosed with intolerance to some sugars, as the medicine contains lactose (see also "Melobax contains lactose").

If the patient is unsure whether any of the above applies to them, they should consult their doctor.

Warnings and precautions

Taking medicines like Melobax may be associated with a small increased risk of heart attack or stroke. This risk increases with higher doses and longer treatment duration. Do not exceed the recommended dose or treatment duration (see section 3 "How to take Melobax").

If the patient has heart problems, has had a stroke, or thinks they may be at risk of these problems, they should consult their doctor or pharmacist. For example, if the patient:

• has high blood pressure (hypertension),
• has high blood sugar levels (diabetes),
• has high cholesterol levels (hypercholesterolemia),
• smokes.

There have been reports of potentially life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which initially appear on the torso as red spots or circular patches, often with blisters. Additional symptoms include: ulcers of the mucous membranes of the mouth, throat, nose, genitals, conjunctivitis (redness and swelling of the eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may develop into widespread blisters or peeling of the skin. The greatest risk of serious skin reactions occurs in the first few weeks of treatment. If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam, they should never take this medicine again.

If a severe allergic reaction occurs, the patient should stop taking Melobax as soon as a rash, soft tissue damage (changes in mucous membranes), or any symptoms of allergy appear, and consult their doctor.

If the patient notices bleeding (causing black stools) or symptoms of gastrointestinal ulcers (abdominal pain), they should stop taking Melobax immediately.

Melobax is not suitable for treating acute pain.

Melobax may mask the symptoms of an infection (e.g., fever). If the patient suspects they have an infection, they should consult their doctor.

Precautions for use

Due to the need to adjust treatment, it is essential for the patient to consult their doctor before taking Melobax in the following cases:

• esophageal inflammation, stomach inflammation, or other gastrointestinal diseases that have occurred in the past, such as Crohn's disease, ulcerative colitis,
• high blood pressure (hypertension),
• advanced age,
• heart, liver, or kidney disease,
• high blood sugar levels (diabetes),
• reduced blood volume, which may occur due to significant blood loss, burns, surgery, or inadequate fluid intake,
• intolerance to certain sugars, diagnosed by a doctor, as the medicine contains lactose,
• high potassium levels in the blood, diagnosed by a doctor.

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

Melobax and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• other nonsteroidal anti-inflammatory drugs (NSAIDs);
• medicines that prevent blood clots;
• medicines used to dissolve blood clots (thrombolytic agents);
• anticoagulant medicines (heparin, warfarin);
• medicines used for heart and kidney diseases;
• corticosteroids (e.g., used to treat inflammation or allergic reactions);
• cyclosporine, tacrolimus - used after organ transplantation or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome;
• diuretics. The doctor may monitor kidney function when taking diuretics;
• medicines used to treat high blood pressure (e.g., beta blockers, ACE inhibitors, angiotensin II receptor antagonists);
• lithium - used to treat mental illnesses;
• selective serotonin reuptake inhibitors (SSRIs) - used to treat depression;
• methotrexate - used to treat cancer or severe, uncontrolled skin diseases and active rheumatoid arthritis;
• cholestyramine - used to reduce cholesterol levels;
• and if the patient is using an intrauterine contraceptive device, also known as an IUD;
• deferiprone - used to treat high levels of iron in the blood;
• pemetrexed - used to treat cancer;
• trimethoprim - used to treat bacterial infections;
• potassium salts - used to treat hypokalemia.

In case of doubt, the patient should consult their doctor or pharmacist.

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.

Fertility

Melobax may make it more difficult to become pregnant. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Pregnancy

If the patient becomes pregnant while taking meloxicam, they should inform their doctor. During the first six months of pregnancy, the doctor may prescribe this medicine if necessary.

The medicine should not be taken during the last three months of pregnancy, as even a single dose of meloxicam may have a serious effect on the baby, especially on the heart, lungs, and kidneys.

Breastfeeding

Melobax should not be taken by breastfeeding women.

Driving and using machines

Melobax may cause vision disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system disorders. If these occur, the patient should not drive or operate machinery.

Melobax contains lactose

The medicine contains a small amount of the sugar lactose. If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Melobax

This medicine should always be taken exactly as directed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.

Recommended dose:

Osteoarthritis exacerbations:

The recommended dose for the treatment of osteoarthritis is 7.5 mg/day (half a tablet). If the effect is not sufficient, the doctor may increase the dose to 15 mg/day.

Long-term treatment of rheumatoid arthritis and ankylosing spondylitis:

The recommended dose for the treatment of rheumatoid arthritis and ankylosing spondylitis is 15 mg/day. Depending on the response to treatment, the doctor may reduce the dose to 7.5 mg/day (half a tablet).

The maximum recommended dose is 15 mg per day.

Method of administration

Oral administration.

Tablets should be taken during meals, with water or another liquid.

If any of the situations listed in "Warnings and precautions" apply to the patient, the doctor may reduce the dose to 7.5 mg (half a tablet) once a day.

Use in children and adolescents

Melobax should not be taken by children and adolescents under 16 years of age.

If the patient feels that the effect of Melobax is too strong or too weak, or if they do not feel any improvement after a few days, they should consult their doctor or pharmacist.

Overdose of Melobax

If the patient has taken more than the recommended dose of Melobax or suspects an overdose, they should consult their doctor or go to the nearest hospital immediately.

Symptoms of NSAID overdose usually include:

• weakness (lethargy),
• drowsiness,
• nausea (nausea) and vomiting,
• abdominal pain (abdominal pain). These symptoms usually resolve after stopping Melobax. The patient may experience gastrointestinal bleeding (gastrointestinal bleeding).

Severe poisoning can lead to serious side effects (see section 4):

• increased blood pressure (hypertension),
• severe kidney failure,
• liver dysfunction,
• shallow breathing or respiratory arrest (respiratory depression),
• loss of consciousness (coma),
• seizures,
• cardiac arrest (cardiac arrest),
• heart attack (myocardial infarction),
• immediate allergic reactions (hypersensitivity), including: anaphylaxis, angioedema.

Missed dose of Melobax

If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should not be taken, and the patient should take the next dose at the usual time. A double dose should not be taken to make up for a missed dose.

If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

Severe side effects

If the patient experiences any of the following side effects, they should stop taking Melobax and consult their doctor or go to the nearest emergency department immediately:

• skin reactions, such as itching (pruritus), blistering, or peeling of the skin, which can be severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue damage (changes in mucous membranes), or erythema multiforme. Erythema multiforme is a severe allergic reaction of the skin that causes spots, red stripes, or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body;
• swelling of the skin or mucous membranes, swelling around the eyes, face, and lips, mouth or throat, which may cause difficulty breathing, swelling of the ankles and feet (peripheral edema);
• shortness of breath or asthma attack;
• liver inflammation. This can cause symptoms such as:

yellowing of the skin and eyes (jaundice), abdominal pain, loss of appetite.

Serious gastrointestinal side effects, in particular:

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

Gastrointestinal bleeding, ulcers, or perforation can be severe and potentially life-threatening, especially in elderly patients.

If the patient has previously experienced gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult their doctor, especially if they are elderly. The doctor may monitor the patient's treatment progress.

If taking Melobax causes vision disturbances, the patient should not drive or operate machinery.

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

Taking some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g., heart attack or stroke), especially when taken in high doses and for long periods.

Fluid retention (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID therapy.

The most common side effects observed are gastrointestinal disorders (stomach and intestine disorders):

• gastric and duodenal ulcers (peptic ulcers),
• perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea and vomiting,
• diarrhea,
• bloating,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black stools due to gastrointestinal bleeding,
• bloody vomiting,
• mouth ulcers (stomatitis),
• worsening of gastrointestinal disease (e.g., worsening of ulcerative colitis or Crohn's disease).

Less commonly, stomach inflammation has been observed.

Meloxicam side effects - the active substance of Melobax

Other side effects

The patient should inform their doctor if they experience any of the following side effects:

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

• headache.

Uncommon (may affect up to 1 in 100 people):

• dizziness,
• vertigo,
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• high blood pressure (hypertension),
• flushing (transient flushing of the face and neck),
• fluid retention (edema),
• high potassium levels (hyperkalemia). This can lead to symptoms such as: heart rhythm disorders (arrhythmia), palpitations (when the patient feels their heartbeat more than usual), muscle weakness,
• bloating,
• stomach inflammation,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reaction (hypersensitivity),
• itching (pruritus),
• rash,
• edema caused by fluid retention, including ankle and foot swelling (peripheral edema),
• sudden swelling of the skin or mucous membranes, such as: swelling around the eyes, face, lips, mouth, or throat, which may cause difficulty breathing (angioedema),
• temporary liver function test abnormalities (e.g., increased liver enzyme activity, such as transaminases, or increased bilirubin levels). The doctor may detect these abnormalities in the patient's blood tests.
• abnormal kidney function test results (e.g., increased creatinine or urea levels).

Rare (may affect up to 1 in 1,000 people):

• mood disorders,
• nightmares,
• blood disorders, including: abnormal blood smear, reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia),

These disorders can increase the risk of infection and cause bruising and bleeding.

• ringing in the ears (tinnitus),
• palpitations (feeling of heartbeat),
• stomach or intestinal ulcers (peptic ulcers),
• esophageal inflammation,
• asthma attacks (in people allergic to acetylsalicylic acid or other NSAIDs),
• blistering of the skin or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• vision disturbances, including: blurred vision, conjunctivitis (inflammation of the eye or eyelid),
• inflammation of the colon (colitis).

Very rare (may affect up to 1 in 10,000 people):

• blistering of the skin (cutaneous bullous reactions) and erythema multiforme. Erythema multiforme is a severe allergic reaction of the skin that causes spots, red stripes, or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body,
• liver inflammation. 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):

• pancreatitis,
• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions),
• skin reactions caused by exposure to sunlight (photosensitivity reactions),
• heart failure reported in association with NSAID use,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Melobax with other medicines that can potentially suppress or destroy bone marrow (myelotoxic medicines). This can cause: sudden fever, sore throat, infections.

Side effects caused by nonsteroidal anti-inflammatory drugs (NSAIDs) but not yet reported with Melobax:

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),
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. 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, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Melobax

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.

No special storage precautions are required.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Melobax contains

The active substance of Melobax is meloxicam.

Each tablet contains 15 mg of meloxicam.

The other ingredients are: microcrystalline cellulose, cornstarch, lactose monohydrate, cornstarch, sodium citrate, colloidal anhydrous silica, and magnesium stearate.

What Melobax looks like and contents of the pack

Melobax tablets are light yellow, round, with a dividing line on one side, allowing for division into equal doses.

The blister pack consists of PVC/PVDC film and hard aluminum foil. The cartons contain 10, 20, or 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o.o.

Kubickiego 11

02-954 Warsaw

Manufacturer:

Chanelle Medical Limited

IDA Industrial Estate, Loughrea, Co. Galway

Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Lithuania - Melobax

Date of last revision of the leaflet:20.10.2017