Moilec

Leaflet accompanying the packaging: patient information

Moilec, 7.5 mg, tablets

Meloxicam

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Moilec and what is it used for
• 2. Important information before using Moilec
• 3. How to use Moilec
• 4. Possible side effects
• 5. How to store Moilec
• 6. Contents of the packaging and other information

1. What is Moilec and what is it used for

Moilec 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 action of meloxicam is based on the preferential inhibition of cyclooxygenase-2 (COX-2) compared to cyclooxygenase-1 (COX-1).

Indications for use of Moilec

As an anti-inflammatory and analgesic, it is used for musculoskeletal and joint pain in rheumatoid and degenerative joint diseases. It is used for short-term treatment of exacerbations of rheumatoid diseases, such as rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis. Moilec tablets are intended for adults and adolescents aged 16 and older.

2. Important information before using Moilec

When not to use Moilec:

• if the patient is hypersensitive to meloxicam or any of the other ingredients of this medicine (listed in section 6),
• in pregnant women in the last three months of pregnancy,
• in children and adolescents under 16 years of age,
• 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, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema),
• if the patient has had the following after previous NSAID treatment:
• gastrointestinal bleeding or perforation,
• if the patient currently has peptic ulcer or gastrointestinal bleeding,
• if the patient has had peptic ulcer or gastrointestinal bleeding (peptic ulcer or bleeding that has occurred at least twice),
• if the patient has severe liver dysfunction,
• in patients with severe renal impairment who are not on dialysis,
• if the patient has recently had cerebral bleeding (cerebral hemorrhage),
• if the patient has had any other bleeding,
• if the patient has severe heart failure,
• if the patient has intolerance to some sugars - the product contains lactose (see also "Moilec contains lactose monohydrate"). If the patient is unsure whether any of the above points apply to them, they should consult their doctor.

Warnings and precautions

Before starting Moilec, the patient should discuss the following with their doctor or pharmacist:

• if the patient has ever had a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam),
• if the patient has an infection - see "Infections" below.

Warnings

Taking medicines like Moilec 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. The patient should not take higher doses or use the medicine for longer than recommended (see section 3 "How to use Moilec"). In case of heart disease, previous stroke, or suspected risk of these disorders, the patient should discuss their treatment with their doctor or pharmacist. For example, if the patient:

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

The patient should stop using Moilec immediately if they notice bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain). There have been reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) associated with Moilec, which initially appear as red spots or round patches on the torso, often with central blisters. Additional symptoms that may be observed include oral ulcers, throat, nose, genital, and conjunctival inflammation (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may develop into generalized blisters or skin peeling. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Moilec, meloxicam should not be restarted. If a rash or the above symptoms occur, the patient should stop using Moilec and seek medical advice immediately. Moilec is not recommended for the treatment of acute pain attacks. Infections Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain. This may delay appropriate treatment of infections, which can lead to increased risk of complications. If the patient is taking this medicine during an ongoing infection and their symptoms persist or worsen, they should consult their doctor or pharmacist immediately.

Precautions for use

Due to the need to modify treatment, the patient should consult their doctor or pharmacist before starting Moilec in the following cases:

• if the patient has had esophagitis, gastritis, or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis,
• high blood pressure (hypertension),
• use in the elderly,
• heart, liver, or kidney disease,
• high blood sugar (diabetes),
• decreased blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgery, or insufficient fluid intake,
• intolerance to certain sugars diagnosed by a doctor, as the medicine contains lactose,
• high potassium levels in the blood, previously diagnosed by a doctor.

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

Moilec and other medicines

Moilec may affect the action of other medicines, and other medicines may affect the action of Moilec. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. 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);
• potassium salts - used to treat low potassium levels in the blood;
• tacrolimus - used after organ transplants;
• trimethoprim - used to treat urinary tract infections;
• anticoagulants;

methotrexate - used to treat cancer or severe uncontrolled skin diseases and active rheumatoid arthritis; pemetrexed - used to treat cancer; cholestyramine - used to reduce cholesterol levels; oral antidiabetic drugs (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood sugar levels for the occurrence of hypoglycemia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

Moilec should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Moilec may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong or delay labor. During the first 6 months of pregnancy, Moilec should not be used 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. Moilec used for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child - this may lead to low amniotic fluid levels or narrowing of the arterial duct in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

This medicine is not recommended for use in breastfeeding women.

Fertility

Moilec may make it harder to get pregnant. The patient should inform their doctor if they plan to get pregnant or are having trouble getting pregnant.

Driving and using machines

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

Moilec contains lactose monohydrate

If the patient has been previously diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Moilec contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to use Moilec

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended dose is: 1 tablet per day.Elderly patients: 1 tablet (7.5 mg) per day Patients with renal impairment: do not exceed the dose of 7.5 mg per day Patients with liver dysfunction: do not exceed the dose of 7.5 mg per day. Moilec may be used as a continuation of treatment after a previous doctor's visit. Do not use for more than 7 days without consulting a doctor. The patient should use the smallest effective dose for the shortest necessary period to relieve symptoms. If the patient has an infection, they should consult their doctor or pharmacist immediately if their symptoms (such as fever and pain) persist or worsen (see section 2). Elderly patientsThe recommended dose for elderly patients is 7.5 mg per day. Patients with renal or liver impairment: see section 2 "Important information before using Moilec". Renal impairmentDose reduction is not necessary in patients with mild or moderate renal impairment. Liver dysfunctionDose reduction is not necessary in patients with mild or moderate liver dysfunction. Use in children and adolescentsMoilec should not be used in children and adolescents under 16 years of age. If the patient thinks the effect of Moilec 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. Administration The medicine should be taken orally. The total daily dose should be taken once, with water or another liquid, during a meal.

Using a higher than recommended dose of Moilec

In case of using a higher dose of Moilec than recommended or suspected overdose, the patient should immediately consult their doctor or go to the nearest hospital emergency department.

Symptoms of NSAID overdose are usually limited to:

• weakness (feeling of lack of energy),
• drowsiness,
• nausea and vomiting,
• abdominal pain (in the upper abdomen). These symptoms usually resolve after stopping Moilec. The patient may experience gastrointestinal bleeding (gastrointestinal hemorrhage).

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

• increased blood pressure (hypertension),
• acute kidney failure,
• liver dysfunction,
• shallow breathing or respiratory arrest (respiratory depression),
• loss of consciousness (coma),
• seizures (convulsions),
• circulatory collapse (cardiovascular collapse),
• cardiac arrest,
• immediate allergic reactions (hypersensitivity), including:
• fainting,
• shortness of breath,
• skin reactions.

Missing a dose of Moilec

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the scheduled time. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following reactions occur, the patient should stop using Moilec and consult their doctor or the nearest hospital.

Any allergic reactions (hypersensitivity), which may manifest as:

• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), tissue damage (mucosal lesions), or erythema multiforme (see section 2); Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, which may also occur on the lips, eyes, and other moist body areas;
• swelling of the skin or mucous membranes, such as 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;
• liver inflammation, which may 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 or perforation may sometimes be severe and potentially life-threatening, especially in elderly patients. If the patient has previously had gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult their doctor, especially if they are elderly. The doctor may monitor their treatment progress at the same time. If Moilec causes visual disturbances, the patient should not drive or operate machinery.

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

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g., myocardial infarction or stroke), especially when used in high doses and for long-term treatment. 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):

• gastric or duodenal ulcer,
• perforation of the gastrointestinal tract or bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting,
• diarrhea (diarrhea),
• flatulence with gas release,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black stools due to gastrointestinal bleeding,
• bloody vomiting,
• mouth ulcers,
• worsening of inflammatory bowel disease (e.g., exacerbation of ulcerative colitis or Crohn's disease).

Liver inflammation is rarely observed.

Side effects of meloxicam - the active substance of Moilec

Very common: occurring in more than 1 in 10 people:

Gastrointestinal disorders, such as:

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

Common: occurring in less than 1 in 10 people but more than 1 in 100 people:

• headache.

Uncommon: occurring in less than 1 in 100 people but more than 1 in 1,000 people:

• dizziness (feeling of emptiness in the head),
• vertigo or feeling of spinning (of vestibular origin),
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• increased blood pressure (hypertension),
• flushing (temporary redness of the face and neck),
• fluid and sodium retention,
• increased potassium levels (hyperkalemia). This may lead to symptoms such as:
• heart rhythm disorders,
• palpitations (feeling of heartbeat),
• muscle weakness,
• reflux (regurgitation of stomach contents into the esophagus),
• gastritis,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reactions (hypersensitivity),
• itching,
• skin rash,
• edema due to fluid retention, including peripheral edema (swelling of the feet and ankles),
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema),
• temporary changes in liver function tests (e.g., increased liver enzyme activity or bilirubin levels); the doctor may detect these changes with a blood test,
• abnormal kidney function tests (e.g., increased creatinine or urea levels).

Rare: occurring in less than 1 in 1,000 people but more than 1 in 10,000 people:

• mood disorders,
• nightmares,
• blood disorders, including:
• abnormal blood smear,
• reduced white blood cell count (leukopenia),
• reduced platelet count (thrombocytopenia). These side effects may increase the risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus),
• palpitations (feeling of heartbeat),
• gastric or duodenal ulcer,
• esophagitis,
• asthma attacks (in patients allergic to aspirin or other NSAIDs),
• blistering skin reactions or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• visual disturbances, including:
• blurred vision,
• conjunctivitis (inflammation of the conjunctiva),
• colitis (inflammation of the colon).

Very rare: occurring in less than 1 in 10,000 people:

• blistering skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, which may also occur on the lips, eyes, and other moist body areas.
• liver inflammation. This may 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 available data

• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid), sun-induced skin rash (photosensitivity reactions),
• heart failure reported with NSAID treatment,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic agents). This may cause:
• sudden fever,
• throat pain,
• infections,
• pancreatitis,
• infertility in women, delayed ovulation,
• 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 spots on the skin, blisters (hives).

Side effects of nonsteroidal anti-inflammatory drugs (NSAIDs) not yet reported with meloxicam:

Acute kidney failure due to changes in kidney structure:

• very rare cases of kidney inflammation (interstitial nephritis),
• necrosis 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 any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Moilec

The medicine should be stored out of sight and reach of children. There are no special storage instructions for the medicine. The patient should not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date refers to the last day of the specified month. 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 packaging and other information

What Moilec contains

• The active substance of Moilec is meloxicam. Each tablet contains 7.5 mg of meloxicam.
• The excipients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium citrate, crospovidone.

What Moilec looks like and contents of the pack

The tablet is light yellow, round, slightly convex on both sides, with the inscription "B 18" on one side. The outer packaging (carton) contains 10, 20, or 30 tablets and a patient information leaflet. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, tel.: (22) 755 50 81

For more information about this medicine, please contact:

GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22) 755 96 48, [email protected]

Date of last revision of the leaflet:

(logo of the marketing authorization holder)