MOILEC

Package leaflet: Information for the patient

Moilec, 7.5 mg, tablets
Meloxicamum
Please read the following instructions carefully before using the medicine, as they contain
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 7 days, contact your doctor.

Table of contents

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

1. What Moilec is and what it is used for

Moilec contains the active substance meloxicam, which belongs to a 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 for Moilec
As an anti-inflammatory and analgesic agent used in bone, joint and muscular pain associated with rheumatic and degenerative joint diseases.
Used for short-term treatment of flare-ups of symptoms in rheumatic diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis.
Moilec tablets are intended for adults and adolescents aged 16 years and older.

2. Important information before using Moilec

When not to use Moilec:

• if the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6),
• in pregnant women during 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 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, which may possibly make breathing difficult (angioedema),
• if the patient has previously experienced, while being treated with NSAIDs:
• gastrointestinal bleeding,
• perforation of the stomach or intestines,
• if the patient currently has a peptic ulcer or gastrointestinal bleeding,
• if the patient has a history of peptic ulcer disease 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 within the brain (cerebral haemorrhage),
• if the patient has any other bleeding conditions,
• if the patient has severe heart failure,
• if the patient has intolerance to certain sugars – the product contains lactose (see also “Moilec contains lactose monohydrate”). If the patient is unsure whether any of the above points apply, they should consult a doctor.

Warnings and precautions
Before starting to use Moilec, discuss this with a doctor or pharmacist:

• if the patient has ever experienced, after taking meloxicam or other oxicams (e.g. piroxicam), a persistent drug-induced rash [circular or oval red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria and itching],
• if the patient develops an infection – see subsection “Infections” below.

Warnings
Taking medicines such as 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. Do not use higher doses or longer treatment duration than recommended (see section 3 “How to use Moilec”).
If the patient has heart disease, a history of stroke, or suspected risk of these conditions, discuss the treatment approach with a doctor or pharmacist.
For example, when the patient:

• has high blood pressure (hypertension),
• has elevated blood glucose (diabetes),
• has increased blood cholesterol (hypercholesterolemia),
• smokes tobacco.

Moilec should be discontinued immediately if bleeding (causing tarry stools) or gastrointestinal ulceration (causing abdominal pain) is observed.
Serious, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Moilec. These initially appear as red spots or round patches on the trunk, often with central blisters. Additional symptoms may include mouth, throat, nose, or genital ulcers, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to generalized blisters or detachment of the epidermis. The highest risk of severe skin reactions occurs during the first weeks of treatment. Moilec must not be restarted in patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking this medicine.
If a skin rash or any of the above symptoms occur, discontinue Moilec immediately and seek medical advice, informing the doctor that this medicine is being taken.
Moilec is not recommended for the treatment of acute pain attacks.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection such as fever and pain. This may delay appropriate treatment of infections, potentially increasing the risk of complications. If the patient is taking this medicine during an ongoing infection and symptoms persist or worsen, they should consult a doctor or pharmacist immediately.

Precautions for use
Due to the need for treatment adjustments, consult a doctor or pharmacist before starting Moilec if:

• the patient has previously had oesophagitis, gastritis, or any other gastrointestinal disorder, e.g. Crohn’s disease or ulcerative colitis,
• high blood pressure (hypertension),
• use in elderly patients,
• heart, liver, or kidney disease,
• high blood glucose (diabetes),
• reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgery, or low fluid intake,
• diagnosed intolerance to certain sugars, due to the presence of lactose in the medicine,
• previously diagnosed high blood potassium levels (hyperkalemia).

In the above cases, the doctor will monitor treatment outcomes.

Moilec with other medicines
Moilec may affect the action of other medicines the patient is currently taking or has recently taken, and other medicines may affect the action of Moilec.
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• other non-steroidal anti-inflammatory drugs (NSAIDs);
• potassium salts – used to treat low blood potassium;
• tacrolimus – used after organ transplantation;
• trimethoprim – used to treat urinary tract infections;
• anticoagulants;

depression;

• methotrexate – used in the treatment of cancers or severe uncontrolled skin diseases and active rheumatoid arthritis;
• pemetrexed – used in the treatment of cancer;
• cholestyramine – used to reduce cholesterol levels;
• oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) – used in the treatment of diabetes. The physician should ensure regular monitoring of the patient's blood glucose levels for the occurrence of hypoglycemia.

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 her doctor or pharmacist before using this medicine.

Pregnancy
Do not take Moilec if you are in the last three 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 both the mother and the child and may delay or prolong labour. Moilec should not be used during the first six months of pregnancy unless the physician considers it absolutely necessary. If treatment during this period or when trying to become pregnant is required, the lowest possible dose for the shortest possible duration should be used. Moilec used for longer than a few days beyond the 20th week of pregnancy may cause kidney problems in the unborn child – this may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment for longer than a few days is required, the physician may recommend additional monitoring.

Breastfeeding
This medicine is not recommended for use in breastfeeding women.

Fertility
Moilec may impair fertility. Please inform your doctor if you are planning to become pregnant or are experiencing difficulties in becoming pregnant.

Driving and using machines
Disturbances in vision, including blurred vision, drowsiness, dizziness or other central nervous system disorders may occur after taking Moilec. If these symptoms occur, do not drive or operate machinery.

Moilec contains lactose monohydrate
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Moilec contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered to be "sodium-free".

3. How to use Moilec

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your 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 a dose of 7.5 mg per day
Patients with hepatic dysfunction: do not exceed a dose of 7.5 mg per day.
Moilec may be used as continuation of treatment following a prior visit to a doctor.
Do not use for longer than 7 days without consulting a doctor.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient
has an infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain)
persist or worsen (see section 2).
Elderly patients
The recommended dose for elderly patients is 7.5 mg per day.
Patients with renal or hepatic impairment: see section 2 “Important information before taking
Moilec”.
Renal dysfunction
Dose reduction is not necessary in patients with mild to moderate renal impairment.
Hepatic dysfunction
Dose reduction is not necessary in patients with mild to moderate hepatic impairment.
Use in children and adolescents
Do not use Moilec in children and adolescents under 16 years of age.
If the patient feels that the effect of Moilec is too strong or too weak, or if there is no improvement
after a few days, the patient should consult a doctor or pharmacist.
Method of administration
This medicine is for oral use.
The total daily dose should be taken at once, with water or another liquid, during a meal.
Taking more than the recommended dose of Moilec
If more than the recommended dose of Moilec has been taken or if overdose is suspected, seek
immediate medical advice from a 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,
• stomach pain (epigastric pain). These symptoms usually resolve after discontinuation of Moilec. Gastrointestinal bleeding (bleeding from the gastrointestinal tract) may occur.

Severe poisoning may lead to serious adverse effects of the medicine (see section 4):

• increased 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 reactions (hypersensitivity), including:
• fainting,
• shortness of breath,
• skin reactions.

Missed dose of Moilec
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• skin reactions such as itching (pruritus), blistering and peeling of the skin, which may potentially be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue damage (lesions of mucous membranes), or erythema multiforme (see section 2); Erythema multiforme is a severe allergic skin reaction causing spots, red or purple rashes, 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, such as around the eyes, face and lips, inside the mouth or throat, which may cause difficulty breathing, 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 adverse gastrointestinal symptoms, and particularly:

• bleeding (resulting in black, tarry stools),
• gastrointestinal ulceration (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, particularly if elderly. The doctor may monitor treatment progress.
If taking Moilec causes disturbances in vision, do not drive or operate machinery.
General adverse effects 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 (arterial blood clots), such as myocardial infarction or stroke, particularly after high-dose or 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):

• gastric and duodenal ulcer disease,
• intestinal perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse effects 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,
• vomiting blood,
• ulcerative stomatitis,
• exacerbation of gastrointestinal inflammation (e.g. flare-up of colitis or Crohn's disease).

Gastritis has been observed less frequently.
Adverse effects of meloxicam — the active substance in Moilec
Very common: occurring in more than 1 in 10 people:
Gastrointestinal disturbances such as:

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

Common: may occur in less than 1 in 10 people:

• headache.

Uncommon: may occur in less than 1 in 100 people

• dizziness (feeling of emptiness in the head),
• vertigo or sensation of spinning (vestibular origin),
• somnolence (drowsiness),
• anaemia (reduced concentration of the red blood pigment - haemoglobin),
• increased blood pressure (hypertension),
• facial flushing (temporary 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,
• regurgitation (reflux of stomach contents into the oesophagus),
• gastritis,
• gastrointestinal bleeding,
• inflammation of the oral mucosa,
• immediate hypersensitivity reactions,
• itching,
• skin rash,
• fluid retention-related oedema, including swelling of the ankles (peripheral oedema),
• sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat, which may cause difficulty breathing (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 blood tests,
• abnormalities in laboratory kidney function tests (e.g. increased creatinine or urea levels).

Rare: may occur in less than 1 in 1,000 people

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

Very rare: may occur 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 rashes or blisters on the skin. It may also occur on the lips, eyes and other moist areas of the body.
• 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 and/or anaphylactoid), skin rashes due to exposure to sunlight (photosensitivity reactions),
• heart failure reported during NSAID therapy,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam concurrently with other medicines that potentially have bone marrow suppressive or destructive effects (myelotoxic drugs). This may cause:
• sudden fever,
• sore throat,
• infections,
• pancreatitis,
• infertility in women, delayed ovulation,
• a characteristic allergic skin reaction known as fixed drug eruption, usually recurring in the same location(s) upon re-exposure to the drug and may appear as itchy, round or oval, red and swollen skin lesions or blisters (urticaria).

Adverse effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but
not yet reported with meloxicam:
Acute renal failure due to structural kidney changes:

• 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Moilec

Keep this medicine out of sight and reach of children.
There are no special storage conditions for this medicine.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Moilec contains

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

What Moilec looks like and contents of the pack
A light yellow, round, slightly convex tablet on both sides, with an imprint
"B 18" on one side.
The outer package (cardboard box) contains 10, 20 or 30 tablets and the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation 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 further information about this medicinal product, 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]
(logo of the marketing authorisation holder)
((pharmacode))